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Introduction: Even if there is a standard procedure of CI surgery, especially in pediatric surgery surgical steps often differ individually due to anatomical variations, malformations or unforseen events. This is why every surgical report should be created individually, which takes time and relies on the correct memory of the surgeon. A standardized recording of intraoperative data and subsequent storage as well as text processing would therefore be desirable and provides the basis for subsequent data processing, e.g. in the context of research or quality assurance.
Method: In cooperation with Reutlingen University, we conducted a workflow analysis of the prototype of a semi-automatic checklist tool. Based on automatically generated checklists generated from BPMN models a prototype user interface was developed for an android tablet. Functions such as uploading photos and files, manual user entries, the interception of foreseeable deviations from the normal course of operations and the automatic creation of OP documentation could be implemented. The system was tested in a remote usability test on a petrous bone model.
Result: The user interface allows a simple intuitive handling, which can be well implemented in the intraoperative setting. Clinical data as well as surgical steps could be individually recorded and saved via DICOM. An automatic surgery report could be created and saved.
Summary: The use of a dynamic checklist tool facilitates the capture, storage and processing of surgical data. Further applications in clinical practice are pending.
In breath analysis, ambient air contaminations are ubiquitous and difficult to eliminate. This study was designed to investigate the reduction of ambient air background by a lung wash-out with synthetic air. The reduction of the initial ambient air volatile organic compound (VOC) intensity was investigated in the breath of 20 volunteers inhaling synthetic air via a sealed full face mask in comparison to inhaling ambient air. Over a period of 30 minutes, breath analysis was conducted using ion mobility spectrometry coupled to a multi-capillary column. A total of 68 VOCs were identified for inhaling ambient air or inhaling synthetic air. By treatment with synthetic air, 39 VOCs decreased in intensity, whereas 29 increased in comparison to inhaling ambient air. In total, seven VOCs were significantly reduced (P-value < 0.05). A complete wash-out of VOCs in this setting was not observed, whereby a statistically significant reduction up to 65% as for terpinolene was achieved. Our setting successfully demonstrated a reduction of ambient air contaminations from the airways by a lung wash-out with synthetic air.
Purpose: Human breath analysis is proposed with increasing frequency as a useful tool in clinical application. We performed this study to find the characteristic volatile organic compounds (VOCs) in the exhaled breath of patients with idiopathic pulmonary fibrosis (IPF) for discrimination from healthy subjects. Methods: VOCs in the exhaled breath of 40 IPF patients and 55 healthy controls were measured using a multi-capillary column and ion mobility spectrometer. The patients were examined by pulmonary function tests, blood gas analysis, and serum biomarkers of interstitial pneumonia. Results: We detected 85 VOC peaks in the exhaled breath of IPF patients and controls. IPF patients showed 5 significant VOC peaks; p-cymene, acetoin, isoprene, ethylbenzene, and an unknown compound. The VOC peak of p-cymene was significantly lower (p < 0.001), while the VOC peaks of acetoin, isoprene, ethylbenzene, and the unknown compound were significantly higher (p < 0.001 for all) compared with the peaks of controls. Comparing VOC peaks with clinical parameters, negative correlations with VC (r =−0.393, p = 0.013), %VC (r =−0.569, p < 0.001), FVC (r = −0.440, p = 0.004), %FVC (r =−0.539, p < 0.001), DLco (r =−0.394, p = 0.018), and %DLco (r =−0.413, p = 0.008) and a positive correlation with KL-6 (r = 0.432, p = 0.005) were found for p-cymene. Conclusion: We found characteristic 5 VOCs in the exhaled breath of IPF patients. Among them, the VOC peaks of p-cymene were related to the clinical parameters of IPF. These VOCs may be useful biomarkers of IPF.
Background: Multicapillary column ion-mobility spectrometry (MCC-IMS) may identify volatile components in exhaled gas. The authors therefore used MCC-IMS to evaluate exhaled gas in a rat model of sepsis, inflammation, and hemorrhagic shock.
Methods: Male Sprague-Dawley rats were anesthetized and ventilated via tracheostomy for 10 h or until death. Sepsis was induced by cecal ligation and incision in 10 rats; a sham operation was performed in 10 others. In 10 other rats, endotoxemia was induced by intravenous administration of 10 mg/kg lipopolysaccharide. In a final 10 rats, hemorrhagic shock was induced to a mean arterial pressure of 35 +/- 5 mmHg. Exhaled gas was analyzed with MCC-IMS, and volatile compounds were identified using the BS-MCC/IMS-analytes database (Version 1209; B&S Analytik, Dortmund, Germany).
Results: All sham animals survived the observation period, whereas mean survival time was 7.9 h in the septic animals, 9.1 h in endotoxemic animals, and 2.5 h in hemorrhagic shock. Volatile compounds showed statistically significant differences in septic and endotoxemic rats compared with sham rats for 3-pentanone and acetone. Endotoxic rats differed significantly from sham for 1-propanol, butanal, acetophenone, 1,2-butandiol, and 2-hexanone. Statistically significant differences were observed between septic and endotoxemic rats for butanal, 3-pentanone, and 2-hexanone. 2-Hexanone differed from all other groups in the rats with shock.
Conclusions: Breath analysis of expired organic compounds differed significantly in septic, inflammation, and sham rats. MCC-IMS of exhaled breath deserves additional study as a noninvasive approach for distinguishing sepsis from inflammation.
In order to evaluate the performance of different stapes prosthesis types, a coupled finite element (FE) model of human ear was developed. First, the middle-ear FE model was developed and validated using the middle-ear transfer function measurements available in literature including pathological cases. Then, the inner-ear FE model was developed and validated using tonotopy, impedance, and level of cochlea amplification curves from literature. Both models are based on pre-existing research with some improvements and were combined into one coupled FE model. The stapes in the coupled FE ear model was replaced with a model of a stapes prosthesis to create a reconstructed ear model that can be used to estimate how different types of protheses perform relative to each other as well as to the natural ear. This will help in designing of new innovative types of stapes prostheses or any other type of middle-ear prostheses as well as to improve the ones that are already available on the market.
Durch das stetige Wachstum an neuen Technologien und Möglichkeiten steht der Verschmelzung von Technologien mit dem Menschen kaum noch etwas im Wege. Die Untersuchung der Implantate und die damit verbundenen Risiken sind ein Teil dieser Arbeit. Von Bedeutung sind hier die Funktionsweise und die IT-Sicherheitsaspekte. Alle in dieser Arbeit dargestellten Implantate benötigen eine Kommunikation nach außen. Diese Kommunikationsmöglichkeit birgt Risiken, die nicht nur auf die Daten der Träger beschränkt sind, sondern auch gesundheitliche Risiken beinhalten.
Online measurement of drug concentrations in patient's breath is a promising approach for individualized dosage. A direct transfer from breath- to blood-concentrations is not possible. Measured exhaled concentrations are following the blood-concentration with a delay in non-steady-state situations. Therefore, it is necessary to integrate the breath-concentration into a pharmacological model. Two different approaches for pharmacokinetic modelling are presented. Usually a 3-compartment model is used for pharmacokinetic calculations of blood concentrations. This 3-compartment model is extended with a 2-compartment model based on the first compartment of the 3-compartment model and a new lung compartment. The second approach is to calculate a time delay of changes in the concentration of the first compartment to describe the lung-concentration. Exemplarily both approaches are used for modelling of exhaled propofol. Based on time series of exhaled propofol measurements using an ion-mobility-spectrometer every minute for 346 min a correlation of calculated plasma and the breath concentration was used for modelling to deliver R2 = 0.99 interdependencies. Including the time delay modelling approach the new compartment coefficient ke0lung was calculated to ke0lung = 0.27 min−1 with R2 = 0.96. The described models are not limited to propofol. They could be used for any kind of drugs, which are measurable in patient's breath.
Tumorzellen on the move : mikrosystem-basierter Assay zur Untersuchung der Tumorzellen-Migration
(2016)
Die Invasion von Tumorzellen in umliegendes Gewebe und die Bildung von Metastasen transformieren einen lokal wachsenden Tumor in eine systemische und lebensbedrohliche Krankheit mit schlechter Prognose. Dabei spielt die aktive Migration der Tumorzellen eine entscheidende Rolle. Tumorzellen gelangen durch die aktive Zellbewegung in das Lymph- oder Blutsystem und breiten sich im Körper aus. Bei der Invasion in ein neues Organ migrieren die Zellen ebenfalls wieder in komplexer Weise durch das Gewebe und können schließlich dort Metastasen bilden. Auf Grund der enormen medizinischen Relevanz der Tumorzell-Invasion, wird die Bewegung von Tumorzellen seit Jahrzehnten unter Laborbedingungen umfassend untersucht und ist ein wichtiger Marker für die Aggressivität der Tumorzellen. Zur Bewegungsanalyse gibt es mehrere experimentelle und auch kommerziell erhältliche in-vitro Untersuchungsmethoden. Ziel des interdisziplinären Projektes „MigChip“ ist die Entwicklung, Herstellung und experimentelle Validierung eines Mikrofludik-Chips zur verbesserten, detailgenauen in-vitro Untersuchung der Tumorzellen-Migration.
In the era of precision medicine, digital technologies and artificial intelligence, drug discovery and development face unprecedented opportunities for product and business model innovation, fundamentally changing the traditional approach of how drugs are discovered, developed and marketed. Critical to this transformation is the adoption of new technologies in the drug development process, catalyzing the transition from serendipity-driven to data-driven medicine. This paradigm shift comes with a need for both translation and precision, leading to a modern Translational Precision Medicine approach to drug discovery and development. Key components of Translational Precision Medicine are multi-omics profiling, digital biomarkers, model-based data integration, artificial intelligence, biomarker-guided trial designs and patient-centric companion diagnostics. In this review, we summarize and critically discuss the potential and challenges of Translational Precision Medicine from a cross-industry perspective.
Intraoperative brain deformation, so called brain shift, affects the applicability of preoperative magnetic resonance imaging (MRI) data to assist the procedures of intraoperative ultrasound (iUS) guidance during neurosurgery. This paper proposes a deep learning-based approach for fast and accurate deformable registration of preoperative MRI to iUS images to correct brain shift. Based on the architecture of 3D convolutional neural networks, the proposed deep MRI-iUS registration method has been successfully tested and evaluated on the retrospective evaluation of cerebral tumors (RESECT) dataset. This study showed that our proposed method outperforms other registration methods in previous studies with an average mean squared error (MSE) of 85. Moreover, this method can register three 3D MRI-US pair in less than a second, improving the expected outcomes of brain surgery.
Purpose
For the modeling, execution, and control of complex, non-standardized intraoperative processes, a modeling language is needed that reflects the variability of interventions. As the established Business Process Model and Notation (BPMN) reaches its limits in terms of flexibility, the Case Management Model and Notation (CMMN) was considered as it addresses weakly structured processes.
Methods
To analyze the suitability of the modeling languages, BPMN and CMMN models of a Robot-Assisted Minimally Invasive Esophagectomy and Cochlea Implantation were derived and integrated into a situation recognition workflow. Test cases were used to contrast the differences and compare the advantages and disadvantages of the models concerning modeling, execution, and control. Furthermore, the impact on transferability was investigated.
Results
Compared to BPMN, CMMN allows flexibility for modeling intraoperative processes while remaining understandable. Although more effort and process knowledge are needed for execution and control within a situation recognition system, CMMN enables better transferability of the models and therefore the system. Concluding, CMMN should be chosen as a supplement to BPMN for flexible process parts that can only be covered insufficiently by BPMN, or otherwise as a replacement for the entire process.
Conclusion
CMMN offers the flexibility for variable, weakly structured process parts, and is thus suitable for surgical interventions. A combination of both notations could allow optimal use of their advantages and support the transferability of the situation recognition system.
There are several intra-operative use cases which require the surgeon to interact with medical devices. We used the Leap Motion Controller as input device and implemented two use-cases: 2D-Interaction (e.g. advancing EPR data) and selection of a value (e.g. room illumination brightness). The gesture detection was successful and we mapped its output to several devices and systems.
Due to the rising need for palliative care in Russia, it is crucial to provide timely and high-quality solutions for patients, relatives, and caregivers. A methodology for remote monitoring of patients in need of palliative care and the requirements will be developed for a hardware-software complex for remote monitoring of patients' health at home.
We investigated the state of artificial intelligence (AI) in pharmaceutical research and development (R&D) and outline here a risk and reward perspective regarding digital R&D. Given the novelty of the research area, a combined qualitative and quantitative research method was chosen, including the analysis of annual company reports, investor relations information, patent applications, and scientific publications of 21 pharmaceutical companies for the years 2014 to 2019. As a result, we can confirm that the industry is in an ‘early mature’ phase of using AI in R&D. Furthermore, we can demonstrate that, despite the efforts that need to be managed, recent developments in the industry indicate that it is worthwhile to invest to become a ‘digital pharma player’.
The digital twin concept has been widely known for asset monitoring in the industry for a long time. A clear example is the automotive industry. Recently, there has also been significant interest in the application of digital twins in healthcare, especially in genomics in what is known as precision medicine. This work focuses on another medical speciality where digital twins can be applied, sleep medicine. However, there is still great controversy about the fundamentals that constitute digital twins, such as what this concept is based on and how it can be included in healthcare effectively and sustainably. This article reviews digital twins and their role so far in what is known as personalized medicine. In addition, a series of steps will be exposed for a possible implementation of a digital twin for a patient suffering from sleep disorders. For this, artificial intelligence techniques, clinical data management, and possible solutions for explaining the results derived from artificial intelligence models will be addressed.
Artificial intelligence (AI) technologies, such as machine learning or deep learning, have been predicted to highly impact future organizations and radically change the way how projects are managed. The Project Management Institute (PMI), the network of around 1.1 million certified project managers, ranked AI as one of the top three disruptors of their profession. In an own study on the effect of AI, 37% of the project management processes can be executed by machine learning and other AI technologies. In addition, Gartner recently postulated that 80% of the work of today's project managers may be eliminated by AI in 2030.
This editorial aims to outline today's project and portfolio management in context of pharmaceutical research and development (R&D), followed by an AI-vision and a more tangible mission, and illustrate what the consequences of an AI-enabled project and portfolio management could be for pharmaceutical R&D.
Purpose
Injury or inflammation of the middle ear often results in the persistent tympanic membrane (TM) perforations, leading to conductive hearing loss (HL). However, in some cases the magnitude of HL exceeds that attributable by the TM perforation alone. The aim of the study is to better understand the effects of location and size of TM perforations on the sound transmission properties of the middle ear.
Methods
The middle ear transfer functions (METF) of six human temporal bones (TB) were compared before and after perforating the TM at different locations (anterior or posterior lower quadrant) and to different degrees (1 mm, ¼ of the TM, ½ of the TM, and full ablation). The sound-induced velocity of the stapes footplate was measured using single-point laser-Doppler-vibrometry (LDV). The METF were correlated with a Finite Element (FE) model of the middle ear, in which similar alterations were simulated.
Results
The measured and calculated METF showed frequency and perforation size dependent losses at all perforation locations. Starting at low frequencies, the loss expanded to higher frequencies with increased perforation size. In direct comparison, posterior TM perforations affected the transmission properties to a larger degree than anterior perforations. The asymmetry of the TM causes the malleus-incus complex to rotate and results in larger deflections in the posterior TM quadrants than in the anterior TM quadrants. Simulations in the FE model with a sealed cavity show that small perforations lead to a decrease in TM rigidity and thus to an increase in oscillation amplitude of the TM mainly above 1 kHz.
Conclusion
Size and location of TM perforations have a characteristic influence on the METF. The correlation of the experimental LDV measurements with an FE model contributes to a better understanding of the pathologic mechanisms of middle-ear diseases. If small perforations with significant HL are observed in daily clinical practice, additional middle ear pathologies should be considered. Further investigations on the loss of TM pretension due to perforations may be informative.
Due to the wide variety of benign and malignant salivary gland tumors, classification and malignant behavior determination based on histomorphological criteria can be difficult and sometimes impossible. Spectroscopical procedures can acquire molecular biological information without destroying the tissue within the measurement processes. Since several tissue preparation procedures exist, our study investigated the impact of these preparations on the chemical composition of healthy and tumorous salivary gland tissue by Fourier-transform infrared (FTIR) microspectroscopy. Sequential tissue cross-sections were prepared from native, formalin-fixed and formalin-fixed paraffin-embedded (FFPE) tissue and analyzed. The FFPE cross-sections were dewaxed and remeasured. By using principal component analysis (PCA) combined with a discriminant analysis (DA), robust models for the distinction of sample preparations were built individually for each parotid tissue type. As a result, the PCA-DA model evaluation showed a high similarity between native and formalin-fixed tissues based on their chemical composition. Thus, formalin-fixed tissues are highly representative of the native samples and facilitate a transfer from scientific laboratory analysis into the clinical routine due to their robust nature. Furthermore, the dewaxing of the cross-sections entails the loss of molecular information. Our study successfully demonstrated how FTIR microspectroscopy can be used as a powerful tool within existing clinical workflows.
Perivascular stromal cells, including mesenchymal stem/stromal cells (MSCs), secrete paracrine factor in response to exercise training that can facilitate improvements in muscle remodeling. This study was designed to test the capacity for muscle-resident MSCs (mMSCs) isolated from young mice to release regenerative proteins in response to mechanical strain in vitro, and subsequently determine the extent to which strain-stimulated mMSCs can enhance skeletal muscle and cognitive performance in a mouse model of uncomplicated aging. Protein arrays confirmed a robust increase in protein release at 24 h following an acute bout of mechanical strain in vitro (10%, 1 Hz, 5 h) compared to non-strain controls. Aged (24 month old), C57BL/6 mice were provided bilateral intramuscular injection of saline, non strain control mMSCs, or mMSCs subjected to a single bout of mechanical strain in vitro (4 ×104). No significant changes were observed in muscle weight, myofiber size, maximal force, or satellite cell quantity at 1 or 4 wks between groups. Peripheral perfusion was significantly increased in muscle at 4 wks post-mMSC injection (p < 0.05), yet no difference was noted between control and preconditioned mMSCs. Intramuscular injection of preconditioned mMSCs increased the number of new neurons and astrocytes in the dentate gyrus of the hippocampus compared to both control groups (p < 0.05), with a trend toward an increase in water maze performance noted (p=0.07). Results from this study demonstrate that acute injection of exogenously stimulated muscle-resident stromal cells do not robustly impact aged muscle structure and function, yet increase the survival of new neurons in the hippocampus.
Pharmaceutical companies are among the top investors into research and development (R&D) globally, as product innovation is still the main growth driver for the industry and because the related complexities necessitate enormous R&D investments. The market demand for new medicines to be more efficacious or to provide better safety than existing drugs and the regulatory need to prove superiority in clinical trials are reasons why drug R&D is increasingly expensive and pharmaceutical companies need to manage extraordinarily high costs per approved new compound.
Today, virtualizing pharma R&D is increasingly related with data analytics and artificial intelligence (AI), technologies that have been developed by software companies outside the healthcare sector. The process of virtualizing pharma R&D is closely related to the technological advancements that result in the generation of large data sets ranging from genomics, proteomics, metabolomics, medical imaging, IoT wearables and large clinical trials, making it necessary for pharma companies to find new ways to store and ultimately analyze information. As a consequence, pharma companies are experimenting with AI in R&D ranging from in-silico drug design to clinical trail participants identification or dosage error reduction.
The physiology of vascular cells depends on stimulating mechanical forces caused by pulsatile flow. Thus, mechano-transduction processes and responses of primary human endothelial cells (ECs) and smooth muscle cells (SMCs) have been studied to reveal cell-type specific differences which may contribute to vascular tissue integrity. Here, we investigate the dynamic reorientation response of ECs and SMCs cultured on elastic membranes over a range of stretch frequencies from 0.01 to 1 Hz. ECs and SMCs show different cell shape adaptation responses (reorientation) dependent on the frequency. ECs reveal a specific threshold frequency (0.01 Hz) below which no responses is detectable while the threshold frequency for SMCs could not be determined and is speculated to be above 1 Hz. Interestingly, the reorganization of the actin cytoskeleton and focal adhesions system, as well as changes in the focal adhesion area, can be observed for both cell types and is dependent on the frequency. RhoA and Rac1 activities are increased for ECs but not for SMCs upon application of a uniaxial cyclic tensile strain. Analysis of membrane protrusions revealed that the spatial protrusion activity of ECs and SMCs is independent of the application of a uniaxial cyclic tensile strain of 1 Hz while the total number of protrusions is increased for ECs only. Our study indicates differences in the reorientation response and the reaction times of the two cell types in dependence of the stretching frequency, with matching data for actin cytoskeleton, focal adhesion realignment, RhoA/Rac1 activities, and membrane protrusion activity. These are promising results which may allow cell-type specific activation of vascular cells by frequency selective mechanical stretching. This specific activation of different vascular cell types might be helpful in improving strategies in regenerative medicine.
Autism spectrum disorders (ASD) affect a large number of children both in the Russian Federation and in Germany. Early diagnosis is key for these children, because the sooner parents notice such disorders in a child and the rehabilitation and treatment program starts, the higher the likelihood of his social adaptation. The difficulties in raising such a child lie in the complexity of his learning outside of children's groups and the complexity of his medical care. In this regard, the development of digital applications that facilitate medical care and education of such children at home is important and relevant. The purpose of the project is to improve the availability and quality of healthcare and social adaptation at home of children with ASD through the use of digital technologies.
Background
Although teledermatology has been proven internationally to be an effective and safe addition to the care of patients in primary care, there are few pilot projects implementing teledermatology in routine outpatient care in Germany. The aim of this cluster randomized controlled trial was to evaluate whether referrals to dermatologists are reduced by implementing a store-and-forward teleconsultation system in general practitioner practices.
Methods
Eight counties were cluster randomized to the intervention and control conditions. During the 1-year intervention period between July 2018 and June 2019, 46 general practitioner practices in the 4 intervention counties implemented a store-and-forward teledermatology system with Patient Data Management System interoperability. It allowed practice teams to initiate teleconsultations for patients with dermatologic complaints. In the four control counties, treatment as usual was performed. As primary outcome, number of referrals was calculated from routine health care data. Poisson regression was used to compare referral rates between the intervention practices and 342 control practices.
Results
The primary analysis revealed no significant difference in referral rates (relative risk = 1.02; 95% confidence interval = 0.911–1.141; p = .74). Secondary analyses accounting for sociodemographic and practice characteristics but omitting county pairing resulted in significant differences of referral rates between intervention practices and control practices. Matched county pair, general practitioner age, patient age, and patient sex distribution in the practices were significantly related to referral rates.
Conclusions
While a store-and-forward teleconsultation system was successfully implemented in the German primary health care setting, the intervention's effect was superimposed by regional factors. Such regional factors should be considered in future teledermatology research.
During two researches the influence of technologies on sleep were analyzed. The first one is about the effect of light on the circadian rhythm and as consequence on sleep quality of persons in a vegetative state. The second one, which is still running, surveys the influence of several technical tools on the sleep of elderly people living in a nursing home.
It has been widely shown that biomaterial surface topography can modulate host immune response, but a fundamental understanding of how different topographies contribute to pro-inflammatory or anti-inflammatory responses is still lacking. To investigate the impact of surface topography on immune response, we undertook a systematic approach by analyzing immune response to eight grades of medical grade polyurethane of increasing surface roughness in three in vitro models of the human immune system. Polyurethane specimens were produced with defined roughness values by injection molding according to the VDI 3400 industrial standard. Specimens ranged from 0.1 μm to 18 μm in average roughness (Ra), which was confirmed by confocal scanning microscopy. Immunological responses were assessed with THP-1-derived macrophages, human peripheral blood mononuclear cells (PBMCs), and whole blood following culture on polyurethane specimens. As shown by the release of pro-inflammatory and anti-inflammatory cytokines in all three models, a mild immune response to polyurethane was observed, however, this was not associated with the degree of surface roughness. Likewise, the cell morphology (cell spreading, circularity, and elongation) in THP-1-derived macrophages and the expression of CD molecules in the PBMC model on T cells (HLA-DR and CD16), NK cells (HLA-DR), and monocytes (HLA-DR, CD16, CD86, and CD163) showed no influence of surface roughness. In summary, this study shows that modifying surface roughness in the micrometer range on polyurethane has no impact on the pro-inflammatory immune response. Therefore, we propose that such modifications do not affect the immunocompatibility of polyurethane, thereby supporting the notion of polyurethane as a biocompatible material.
Background
Personalized medicine requires the integration and analysis of vast amounts of patient data to realize individualized care. With Surgomics, we aim to facilitate personalized therapy recommendations in surgery by integration of intraoperative surgical data and their analysis with machine learning methods to leverage the potential of this data in analogy to Radiomics and Genomics.
Methods
We defined Surgomics as the entirety of surgomic features that are process characteristics of a surgical procedure automatically derived from multimodal intraoperative data to quantify processes in the operating room. In a multidisciplinary team we discussed potential data sources like endoscopic videos, vital sign monitoring, medical devices and instruments and respective surgomic features. Subsequently, an online questionnaire was sent to experts from surgery and (computer) science at multiple centers for rating the features’ clinical relevance and technical feasibility.
Results
In total, 52 surgomic features were identified and assigned to eight feature categories. Based on the expert survey (n = 66 participants) the feature category with the highest clinical relevance as rated by surgeons was “surgical skill and quality of performance” for morbidity and mortality (9.0 ± 1.3 on a numerical rating scale from 1 to 10) as well as for long-term (oncological) outcome (8.2 ± 1.8). The feature category with the highest feasibility to be automatically extracted as rated by (computer) scientists was “Instrument” (8.5 ± 1.7). Among the surgomic features ranked as most relevant in their respective category were “intraoperative adverse events”, “action performed with instruments”, “vital sign monitoring”, and “difficulty of surgery”.
Conclusion
Surgomics is a promising concept for the analysis of intraoperative data. Surgomics may be used together with preoperative features from clinical data and Radiomics to predict postoperative morbidity, mortality and long-term outcome, as well as to provide tailored feedback for surgeons.
Stent graft visualization and planning tool for endovascular surgery using finite element analysis
(2014)
Purpose: A new approach to optimize stent graft selection for endovascular aortic repair is the use of finite element analysis. Once the finite element model is created and solved, a software module is needed to view the simulation results in the clinical work environment. A new tool for Interpretation of simulation results, named Medical Postprocessor, that enables comparison of different stent graft configurations and products was designed, implemented and tested. Methods Aortic endovascular stent graft ring forces and sealing states in the vessel landing zone of three different configurations were provided in a surgical planning software using the Medical Imaging Interaction Tool Kit (MITK) Software system. For data interpretation, software modules for 2D and 3D presentations were implemented. Ten surgeons evaluated the software features of the Medical Postprocessor. These surgeons performed usability tests and answered questionnaires based on their experience with the system.
Results: The Medical Postprocessor visualization system enabled vascular surgeons to determine the configuration with the highest overall fixation force in 16 ± 6 s, best proximal sealing in 56±24 s and highest proximal fixation force in 38 ± 12 s. The majority considered the multiformat data provided helpful and found the Medical Postprocessor to be an efficient decision support system for stent graft selection. The evaluation of the user interface results in an ISONORMconform user interface (113.5 points).
Conclusion: The Medical Postprocessor visualization Software tool for analyzing stent graft properties was evaluated by vascular surgeons. The results show that the software can assist the interpretation of simulation results to optimize stent graft configuration and sizing.
One of the key challenges for automatic assistance is the support of actors in the operating room depending on the status of the procedure. Therefore, context information collected in the operating room is used to gain knowledge about the current situation. In literature, solutions already exist for specific use cases, but it is doubtful to what extent these approaches can be transferred to other conditions. We conducted a comprehensive literature research on existing situation recognition systems for the intraoperative area, covering 274 articles and 95 cross-references published between 2010 and 2019. We contrasted and compared 58 identified approaches based on defined aspects such as used sensor data or application area. In addition, we discussed applicability and transferability. Most of the papers focus on video data for recognizing situations within laparoscopic and cataract surgeries. Not all of the approaches can be used online for real-time recognition. Using different methods, good results with recognition accuracies above 90% could be achieved. Overall, transferability is less addressed. The applicability of approaches to other circumstances seems to be possible to a limited extent. Future research should place a stronger focus on adaptability. The literature review shows differences within existing approaches for situation recognition and outlines research trends. Applicability and transferability to other conditions are less addressed in current work.
Personalized remote healthcare monitoring is in continuous development due to the technology improvements of sensors and wearable electronic systems. A state of the art of research works on wearable sensors for healthcare applications is presented in this work. Furthermore, a state of the art of wearable devices, chest and wrist band and smartwatches available on the market for health and sport monitoring is presented in this paper. Many activity trackers are commercially available. The prices are continuously reducing and the performances are improving, but commercial devices do not provide raw data and are therefore not useful for research purposes.
The implementation of a web based portal QA solution will lead to a high acceptance of the staff as the usage of commonly known standard software (e.g. web browser) allows intuitive handling. In the daily use a significant simplification of the workflow and Performance enhancement can be achieved by easy access to the check documents. As the data is now saved in a database it can easily be processed and long-term trends can be displayed. Therefore possible errors can be detected much easier and earlier. By the usage of time stamps and user authentication procedures and user responsibilities are comprehensibly documented. As the software is browser based, integration into an existing software Environment is not critical. As only technical QA data is processed, no further data security measures are necessary. A certification as a medical product is not required.
A sleep study is a test used to diagnose sleep disorders and is usually done in sleep laboratories. The golden standard for evaluation of sleep is overnight polysomnography (PSG). Unfortunately, in-lab sleep studies are expensive and complex procedures. Furthermore, with a minimum of 22 wire attachments to the patient for sleep recording, this medical procedure is invasive and unfamiliar for the subjects. To solve this problem, low-cost home diagnostic systems, based on noninvasive recording methods requires further researches.
For this intention it is important to find suitable bio vital parameters for classifying sleep phases WAKE, REM, light sleep and deep sleep without any physical impairment at the same time. We decided to analyse body movement (BM), respiration rate (RR) and heart rate variability (HRV) from existing sleep recordings to develop an algorithm which is able to classify the sleep phases automatically. The preliminary results of this project show that BM, RR and HRV are suitable to identify WAKE, REM and NREM stage.
Children undergoing systemic chemotherapy often suffer from severe immunosuppression usually associated to severe neutropenia (neutrophils < 0.5 x 109/l). Clinical courses during those periods range from asymptomatic to septic general conditions. Development of septic symptoms can be very fast and life-threatening. Swift detection of risk factors in those patients is therefore needed. So far no early, rapid and reliable marker or tool exists. Ion-Mobility-Spectrometry coupled with a Multi-Capillary-Column (IMS-MCC) can analyze more than 600 volatile components from exhaled air within a few minutes and hence is a potential, rapid detection-tool. As a proof of concept we measured the exhaled breath of 11 patients with neutropenia and 10 healthy controls ranging from 3 to 18 years of age at the time of measurement. Ten milliliters breath samples were taken at the outpatient clinic and analyzed with an onsite IMS-MCC (BreathDiscovery, B&S Analytik, Dortmund, Germany). Dead-space-volume was adapted to two groups (small 250 ml, large 500 ml). Interestingly 59 differing peaks were measured. Eleven were significantly different (p ≤ 0.05), three of which highly significant (p ≤ 0.01) in Mann-Whitney-Rank-Sum-testing. The corresponding analytes used in the decision tree are 2-Propanol, D-Limonene and Acetone. The analytes with the lowest rank sum identified are 2-Hexanone, Iso-Propylamine and 1-Butanol. Eventually we were able to show a three-step-decision-tree, which discerns the 21 samples except one from each group. Sensitivity was 90 % and specificity was 91 %. Naturally these findings need further confirmation within a bigger population. Our pilot-study proves that Ion-Mobility-Spectrometry coupled with a Multi-Capillary-Column is a feasible rapid diagnostic tool in the setting of a pediatric oncology out-patient clinic for patients 3 years and older. Our first results furthermore encourage additional analysis as to whether patients at risk for septic events during immunosuppression can be diagnosed in advance by rapidly assessing risk factors such as Neutropenia in exhaled breath.
Several diseases occur due to asbestos exposure. Until today, asbestos predicted mortality and morbidity will increase because of the long latency period. Actually, the methods to investigate asbestos related disease are mostly invasive. Therefore, the aim of the present paper was to investigate, whether signals in human breath could be correlated to Asbestos related lung diseases using a multi-capillary column (MCC) connected to an ion mobility spectrometer (IMS) as non-invasive method. Here, the breath samples of 10 mL of 25 patients suffering from asbestos related diseases. This group includes patients with asbestos related pleural thickening with and without pulmonary fibrosis. Twelve healthy persons constitute the control group and the breath samples are compared with those of the BK4103 patients. In total 83 peaks are found in the IMS-Chromatogram. A discrimination was possible with p-values <0.001 for two peaks (99.9 %), <0.01 (99 %) for 5 peaks and <0.05 (95 %) for 17 peaks. The most discrimination peaks alpha pinene and 4-ethyltoluol were identified among some others with lower p-values. The corresponding Box-and-Whisker-Plots comparing both groups are presented. In addition, a decision tree including all peaks was created that shows a differentiation with alpha pinene between BK4103 (pleural plaques group) and the control group. In addition, the sensitivity was calculated to 96 %, specificity was 50 %, positive and negative predictive values were 80 % and 86 %. Ion mobility spectrometry was introduced as non-invasive method to separate both groups Asbestos related and healthy. Naturally, the findings need further confirmation on larger population groups, but encourage further investigations, too.
Diese Arbeit liefert einen Konzeptentwurf, der die Integration verschiedener Systeme mit prozessrelevanten klinischen Diensten gewährleistet. Chirurgische Abläufe werden in Form von Prozessen modelliert. Die Wahl der Notation und die Art der Modellierung dieser Prozesse spielt in der heutigen Forschung in diesem Gebiet eine zentrale Rolle. Sind diese Prozesse modelliert, besteht die Möglichkeit, diese in einer Workflow-Engine automatisiert auszuführen. Im Rahmen der Entwicklung eines Workflow-Managment-Systems stellt sich die Frage, wie die Anbindung dieser Workflow-Engine mit anderen Systemen erfolgen soll. In der Arbeit werden Schnittstellen abstrakt in der Web Services Description Language (WSDL) definiert. Darum werden automatisiert Artefakte erzeugt. Auf der Grundlage dieser Artefakte erfolgt die Integration der Systeme. Die Workflow-Engine kommunizieren über SOAP-Nachrichten (Simple Object Access Protocol) mit den entsprechenden Systemen. Dieser Ansatz wurde mithilfe eines Prototyps validiert und umgesetzt.
Purpose
Context awareness in the operating room (OR) is important to realize targeted assistance to support actors during surgery. A situation recognition system (SRS) is used to interpret intraoperative events and derive an intraoperative situation from these. To achieve a modular system architecture, it is desirable to de-couple the SRS from other system components. This leads to the need of an interface between such an SRS and context-aware systems (CAS). This work aims to provide an open standardized interface to enable loose coupling of the SRS with varying CAS to allow vendor-independent device orchestrations.
Methods
A requirements analysis investigated limiting factors that currently prevent the integration of CAS in today's ORs. These elicited requirements enabled the selection of a suitable base architecture. We examined how to specify this architecture with the constraints of an interoperability standard. The resulting middleware was integrated into a prototypic SRS and our system for intraoperative support, the OR-Pad, as exemplary CAS for evaluating whether our solution can enable context-aware assistance during simulated orthopedical interventions.
Results
The emerging Service-oriented Device Connectivity (SDC) standard series was selected to specify and implement a middleware for providing the interpreted contextual information while the SRS and CAS are loosely coupled. The results were verified within a proof of concept study using the OR-Pad demonstration scenario. The fulfillment of the CAS’ requirements to act context-aware, conformity to the SDC standard series, and the effort for integrating the middleware in individual systems were evaluated. The semantically unambiguous encoding of contextual information depends on the further standardization process of the SDC nomenclature. The discussion of the validity of these results proved the applicability and transferability of the middleware.
Conclusion
The specified and implemented SDC-based middleware shows the feasibility of loose coupling an SRS with unknown CAS to realize context-aware assistance in the OR.
Segmentierung von Polypen in Koloskopie-Bilddaten : eine Potentialanalyse von Deep-Learning-Methoden
(2018)
Kolorektale Karzinome haben eine hohe Sterblichkeitsrate, wenn sie spät entdeckt werden. Eine frühzeitige Entfernung von bösartigen Polypen im Magen-Darm-Trakt, die deren Vorstufen bilden, bietet jedoch hohe Überlebenschancen. Bei Darmspiegelungen werden gerade kleine Polypen aber recht häufig übersehen. Zuverlässige bildverarbeitende Systeme, die Polypen in einem Koloskopie-Frame nicht nur detektieren, sondern pixelgenau segmentieren, könnten Ärzten bei Darmkrebs-Screenings helfen. Diese Arbeit analysiert den aktuellen Stand der Segmentierung von Polypen im Gastrointestinaltrakt. Weiterführend wird untersucht, inwiefern die in letzter Zeit sehr erfolgreichen Methoden des Deep Learning hier Vorteile bieten.
Die Segmentierung und das Tracking von minimal-invasiven robotergeführten Instrumenten ist ein wesentlicher Bestandteil für verschiedene computer assistierte Eingriffe. Allerdings treten in der minimal-invasiven Chirurgie, die das Anwendungsfeld für den hier beschriebenen Ansatz darstellt, häufig Schwierigkeiten durch Reflexionen, Schatten oder visuelle Verdeckungen durch Rauch und Organe auf und erschweren die Segmentierung und das Tracking der Instrumente.
Dieser Beitrag stellt einen Deep Learning Ansatz für ein markerloses Tracking von minimal-invasiven Instrumenten vor und wird sowohl auf simulierten als auch realen Daten getestet. Es wird ein simulierter als auch realer Datensatz mit Ground Truth Kennzeichnung für die binäre Segmentierung von Instrument und Hintergrund erstellt. Für den simulierten Datensatz werden Bilder aus einem simulierten Instrument und realem Hintergrund zusammengesetzt. Im Falle des realen Datensatzes spricht man von der Zusammensetzung der Bilder aus einem realen Instrument und Hintergrund. Insgesamt wird auf den simulierten Daten eine Pixelgenauigkeit von 94.70 Prozent und auf den realen Daten eine Pixelgenauigkeit von 87.30 Prozent erreicht.
Motivation: Aim of this project is the automatic classification of total hip endoprosthesis (THEP) components in 2D Xray images. Revision surgeries of total hip arthroplasty (THA) are common procedures in orthopedics and trauma surgery. Currently, around 400.000 procedures per year are performed in the United States (US) alone. To achieve the best possible result, preoperative planning is crucial. Especially if parts of the current THEP system are to be retained.
Methods: First, a ground truth based on 76 X-ray images was created: We used an image processing pipeline consisting of a segmentation step performed by a convolutional neural network and a classification step performed by a support vector machine (SVM). In total, 11 classes (5 pans and 6 shafts) shall be classified.
Results: The ground truth generated was of good quality even though the initial segmentation was performed by technicians. The best segmentation results were achieved using a U-net architecture. For classification, SVM architectures performed much better than additional neural networks.
Conclusions: The overall image processing pipeline performed well, but the ground truth needs to be extended to include a broader variability of implant types and more examples per training class.
Methods based exclusively on heart rate hardly allow to differentiate between physical activity, stress, relaxation, and rest, that is why an additional sensor like activity/movement sensor added for detection and classification. The response of the heart to physical activity, stress, relaxation, and no activity can be very similar. In this study, we can observe the influence of induced stress and analyze which metrics could be considered for its detection. The changes in the Root Mean Square of the Successive Differences provide us with information about physiological changes. A set of measurements collecting the RR intervals was taken. The intervals are used as a parameter to distinguish four different stages. Parameters like skin conductivity or skin temperature were not used because the main aim is to maintain a minimum number of sensors and devices and thereby to increase the wearability in the future.
Die Erfindung betrifft einen Rollstuhl mit einem Gestell mit Rädern, einem Sitz sowie zwei gegenüber dem Sitz verlagerbaren Fußplatten und ein Trainingsgerät zur Bewegungstherapie der unteren Extremitäten einer in dem Rollstuhl sitzenden Person. Um das Trainingsgerät vereinfacht auszubilden, enthält das Trainingsgerät unabhängig von einer Fahrbewegung des Rollstuhls betreibbar eine an dem Gestell befestigbare, von einer Steuereinheit gesteuerte Elektromaschine, welche zur wechselweise erzwungenen Verlagerung der beiden Fußplatten mit den Fußplatten mechanisch gekoppelt ist.
Perforations of the tympanic membrane (TM) can occur as a result of injury or inflammation of the middle ear. These perforations can lead to conductive hearing loss (HL), where in some cases the magnitude of HL exceeds that attributable to the observed TM perforation alone. We aim with this study to better understand the effects of location and size of TM perforations on the sound transmitting properties of the middle ear.
The middle ear transfer function (METF) of six human temporal bones (TB; freshly frozen specimen of body donors) were compared before and after perforation of the TM at different locations (anterior or posterior lower quadrant) and of different sizes (1mm, ¼ of the TM, ½ of the TM, and full ablation). The
METF were correlated with a Finite Element (FE) model of the middle ear, in which similar alterations were simulated.
The measured and simulated FE model METFs exhibited frequency and perforation size dependent amplitude losses at all locations and severities. In direct comparison, posterior TM perforations affected the transmission properties to a larger degree than perforations of the anterior quadrant. This could possibly be caused by an asymmetry of the TM, where the malleus-incus complex rotates and results in larger deflections in the posterior TM half than in the anterior TM half. The FE model of the TM with a sealed cavity suggest that small perforations result in a decrease of TM rigidity and thus to an increase in oscillation amplitude of the TM, mostly above 1 kHz.
The location and size of TM perforations influence the METF in a reproducible way. Correlating our data with the FE model could help to better understand the pathologic mechanisms of middle-ear diseases. If small TM perforations with uncharacteristically significant HL are observed in daily clinical practice, additional middle ear pathologies should be considered. Further investigations on the loss of TM pretension due to perforations may be informative.
The recovery of our body and brain from fatigue directly depends on the quality of sleep, which can be determined from the results of a sleep study. The classification of sleep stages is the first step of this study and includes the measurement of vital data and their further processing. The non-invasive sleep analysis system is based on a hardware sensor network of 24 pressure sensors providing sleep phase detection. The pressure sensors are connected to an energy-efficient microcontroller via a system-wide bus. A significant difference between this system and other approaches is the innovative way in which the sensors are placed under the mattress. This feature facilitates the continuous use of the system without any noticeable influence on the sleeping person. The system was tested by conducting experiments that recorded the sleep of various healthy young people. Results indicate the potential to capture respiratory rate and body movement.
Die minimal-invasive Chirurgie (MIC) entwickelt sich durch den Einsatz von medizinischen Robotern wie dem da Vinci System von Intuitive Surgical stetig weiter. Hierdurch kann eine bessere oder gleichwertige Operation bei deutlich geringerer körperlicher Belastung des Operateurs erreicht werden. Dabei entstehen jedoch neue Problemstellungen wie beispielsweise Kollision zwischen Roboterarmen und die benötigte Zeit zum Einrichten einer geeigneten Roboterkonfiguration. Daher ist eine effiziente Vorbereitung und Planung der Interventionen erforderlich. Diese Arbeit präsentiert einen Ansatz für eine verbesserte Planung mit Augmented Reality (AR) und einer Robotik Simulationssoftware (RS). Die Robotik Simulation dient zur Berechnung einer Roboterkonfiguration unter Vorgabe der Port-Positionen. Augmented Reality wird verwendet, um die berechneten Pose in der realen Umgebung zu visualisieren und somit leichter in den Operationssaal zu übertragen.
Proceedings of the International Workshop on Mobile Networks for Biometric Data Analysis (mBiDA)
(2014)
Prevention and treatment of common and widesprea (chronic) diseases is a challenge in any modern Society and vitally important for health maintenance in aging societies. Capturing biometric data is a cornerstone for any analysis and Treatment strategy. Latest advances in sensor technology allow accurate data measurement in a non-intrusive way. In many cases, it is necessary to provide online monitoring and real-time data capturing to support patients´ prevention plans or to allow medical professionals to access the current status. Different communication standards are required to push sensor data and to store and analyze them on different (mobile) platforms. The objective of the workshop is to show new and innovative approaches dedicated to biometric data capture and analysis in a non-intrusive way maintaining mobility. Examples can be found in human centered ambient intelligence attributed with sensors or even in methodologies applied in automotive real-time conform mobile system design. The workshop´s main challenge is to focus on approaches promoting non-intrusiveness, reliable prediction algorithms and high user-acceptance. The workshop will provide overview presentations, Young researcher poster tracks, doctoral tracks and classical peer-review full paper tracks. Especially, would like to encourage students and young researchers to participate and to contribute to the workshop. Scientific contributions to the event are peer-reviewed by a suited program committee.
This review gives a short overview of the physical processes involved in the formation of the polyelectrolyte multilayers (PEMs) and their destruction. These two processes are vital for the formation of PEMs with desired physical and chemical structures, and for loading them with active substances and their spatial controlled release. It includes a survey of the physical and chemical properties that are key points for controlling film nanostructure in relation to biological processes and different possibilities for controlling cell behavior by means of film composition, bioactivity, mechanical properties, and three-dimensional organization.
The imaging and force-distance curve modes of atomic force microscopy (AFM) are explored to compare the morphological and mechanical signatures of platelets from patients diagnosed with classical neurodegenerative diseases (NDDs) and healthy individuals. Our data demonstrate the potential of AFM to distinguish between the three NDDs-Parkinson’s disease (PD), amyotrophic lateral sclerosis (ALS) and Alzheimer’s disease (AD), and normal healthy platelets. The common features of platelets in the three pathologies are reduced membrane surface roughness, area and height, and enhanced nanomechanics in comparison with healthy cells. These changes might be related to general phenomena associated with reorganization in the platelet membrane morphology and cytoskeleton, a key factor for all platelets’ functions. Importantly, the platelets’ signatures are modified to a different extent in the three pathologies, most significant in ALS, less pronounced in PD and the least in AD platelets, which shows the specificity associated with each pathology. Moreover, different degree of activation, distinct pseudopodia and nanocluster formation characterize ALS, PD and AD platelets. The strongest alterations in the biophysical properties correlate with the highest activation of ALS platelets, which reflect the most significant changes in their nanoarchitecture. The specific platelet signatures that mark each of the studied pathologies can be added as novel biomarkers to the currently used diagnostic tools.
Assistive environments are entering our homes faster than ever. However, there are still various barriers to be broken. One of the crucial points is a personalization of offered services and integration of assistive technologies in common objects and therefore in a regular daily routine. Recognition of sleep patterns for the preliminary sleep study is one of the Health services that could be performed in an undisturbing way. This article proposes the hardware system for the measurement of bio-vital signals necessary for initial sleep study in a nonobtrusive way. The first results confirm the potential of measurement of breathing and movement signals with the proposed system.
Perceptual integration of kinematic components in the recognition of emotional facial expressions
(2018)
According to a long-standing hypothesis in motor control, complex body motion is organized in terms of movement primitives, reducing massively the dimensionality of the underlying control problems. For body movements, this low dimensional organization has been convincingly demonstrated by the learning of low-dimensional representations from kinematic and EMG data. In contrast, the effective dimensionality of dynamic facial expressions is unknown, and dominant analysis approaches have been based on heuristically defined facial ‘‘action units,’’ which reflect contributions of individual face muscles. We determined the effective dimensionality of dynamic facial expressions by learning of a low dimensional model from 11 facial expressions. We found an amazingly low dimensionality with only two movement primitives being sufficient to simulate these dynamic expressions with high accuracy. This low dimensionality is confirmed statistically, by Bayesian model comparison of models with different numbers of primitives, and by a psychophysical experiment that demonstrates that expressions, simulated with only two primitives, are indistinguishable from natural ones.
In addition, we find statistically optimal integration of the emotion information specified by these primitives in visual perception. Taken together, our results indicate that facial expressions might be controlled by a very small number of independent control units, permitting very low dimensional parametrization of the associated facial expression.