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The aim of this work was to investigate the mean fill weight control of a continuous capsule-filling process, whether it is possible to derive controller settings from an appendant process model. To that end, a system composed out of fully automated capsule filler and an online gravimetric scale was used to control the filled weight. This setup allows to examine challenges associated with continuous manufacturing processes, such as variations in the amount of active pharmaceutical ingredient (API) in the mixture due to fluctuations of the feeders or due to altered excipient batch qualities. Two types of controllers were investigated: a feedback control and a combination of feedback and feedforward control. Although both of those are common in the industry, determining the optimal parameter settings remains an issue. In this study, we developed a method to derive the control parameters based on process models in order to obtain optimal control for each filled product. Determined via rapid automated process development (RAPD), this method is an effective and fast way of determining control parameters. The method allowed us to optimize the weight control for three pharmaceutical excipients. By conducting experiments, we verified the feasibility of the proposed method and studied the dynamics of the controlled system. Our work provides important basic data on how capsule filler can be implemented into continuous manufacturing systems.
In networked operating room environments, there is an emerging trend towards standardized non-proprietary communication protocols which allow to build new integration solutions and flexible human-machine interaction concepts. The most prominent endeavor is the IEEE 11073 SDC protocol. For some uses cases, it would be helpful if not just medical devices could be controlled based on SDC, but also building automation systems like light, shutters, air condition, etc. For those systems, the KNX protocol is widely used. We build an SDC-to-KNX gateway which allows to use the SDC protocol for sending commands to connected KNX devices. The first prototype system was successfully implemented at the demonstration operating room at Reutlingen University. This is a first step toward the integration of a broader variety of KNX devices.
Documentation of clinical processes, especially in the perioperative are, is a base requirement for quality of service. Nonetheless, the documentation is a burden for the medical staff since it distracts from the clinical core process. An intuitive and user-friendly documentation system could increase documentation quality and reduce documentation workload. The optimal system solution would know what happened and the person documenting the step would need a single “confirm” button. In many cases, such a linear flow of activities is given as long as only one profession (e.g. anaestesiology, scrub nurse) is considered, but even in such cases, there might be derivations from the linear process flow and further interaction is required.
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.
Checklists are a valuable tool to ensure process quality and quality of care. To ensure proper integration in clinical processes, it would be desirable to generate checklists directly from formal process descriptions. Those checklists could also be used for user interaction in context-aware surgical assist systems. We built a tool to automatically convert Business Process Model and Notation (BPMN) process models to checklists displayed as HTML websites. Gateways representing decisions are mapped to checklist items that trigger dynamic content loading based on the placed checkmark. The usability of the resulting system was positively evaluated regarding comprehensibility and end-user friendliness.
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.
Purpose: Gliomas are the most common and aggressive type of brain tumors due to their infiltrative nature and rapid progression. The process of distinguishing tumor boundaries from healthy cells is still a challenging task in the clinical routine. Fluid attenuated inversion recovery (FLAIR) MRI modality can provide the physician with information about tumor infiltration. Therefore, this paper proposes a new generic deep learning architecture, namely DeepSeg, for fully automated detection and segmentation of the brain lesion using FLAIR MRI data.
Methods: The developed DeepSeg is a modular decoupling framework. It consists of two connected core parts based on an encoding and decoding relationship. The encoder part is a convolutional neural network (CNN) responsible for spatial information extraction. The resulting semantic map is inserted into the decoder part to get the full-resolution probability map. Based on modified U-Net architecture, different CNN models such as residual neural network (ResNet), dense convolutional network (DenseNet), and NASNet have been utilized in this study.
Results: The proposed deep learning architectures have been successfully tested and evaluated on-line based on MRI datasets of brain tumor segmentation (BraTS 2019) challenge, including s336 cases as training data and 125 cases for validation data. The dice and Hausdorff distance scores of obtained segmentation results are about 0.81 to 0.84 and 9.8 to 19.7 correspondingly.
Conclusion: This study showed successful feasibility and comparative performance of applying different deep learning models in a new DeepSeg framework for automated brain tumor segmentation in FLAIR MR images. The proposed DeepSeg is open source and freely available at https://github.com/razeineldin/DeepSeg/.
In Zusammenarbeit mit dem Medizinproduktehersteller ulrich medical wird eine User Experience und Usability Studie an der Software der im Moment eingesetzten Kontrastmittelinjektoren durchgeführt. Das Unternehmen möchte eine neue Variante eines Kontrastmittelinjektors entwickeln, der als Basis eine verbesserte Version dieser Softwares enthält. Benutzerstudien können mit den unterschiedlichsten Methoden durchgeführt werden. Das geeignete Vorgehen muss definiert und die Testpersonen in Bezug zur eingesetzten Methode ermittelt werden. Bei Medizinprodukten muss zusätzlich auf strikte Auflagen in Normen und Gesetzen geachtet werden. Die Grundlage zur Methodenauswahl bildet eine Recherche zu Usability und User Experience Vorgaben für Medizinprodukte. Die Studie wird anhand quantitativer Daten eines Usability Tests im Labor, Fragebögen zur User Experience und qualitativen Post Test- Interviews evaluiert. In erster Linie dient diese Studie der Ermittlung von möglichen Verbesserungen, welche in der darauf folgenden Masterthesis vertieft und umgesetzt werden.
The field of breath analysis has developed to be of growing interest in medical diagnosis and patient monitoring. The main advantages are that it’s noninvasive, painless and repeatable in flexible cycles. Even though breath analysis is being researched for a couple of decades there are still many unanswered questions. Human breath contains volatile organic compounds which are emitted from inside the body. Some of these compounds can be assigned to specific sources, such as inflammation or cancer, but also to non health related origins. This paper gives an overview of breath analysis for the purpose of disease diagnosis and health monitoring. Therefore, literature regarding breath analysis in the medical field has been analyzed, from its early stages to the present. As a result, this paper gives an outline of the topic of breath analysis.
Haptisches Feedback ist nach zahlreichen Studien ein wichtiger Bestandteil in der medizinischen Robotik. Die meisten Systeme befinden sich jedoch noch im Forschungsstatus und verfolgen unterschiedliche Ansätze. In der Teleoperation wird mit sensorlosen und Sensor-Systemen geforscht. Sensoren bieten, im Gegensatz zu den Encodern in sensorlosen Systemen, genaue Messungen, sind allerdings teuer in der Anschaffung, schwer zu desinfizieren und müssen in OP-Besteck integriert werden. In Hands-On Systemen fühlt der Operateur im Gegensatz zu Teleoperationssystemen direkt die auftretenden Kräfte bei der Benutzung. Der Roboter bietet in diesen Systemen nur die benötigte Stabilität und Genauigkeit, gesteuert werden sie direkt durch den Menschen. Dagegen werden in Teleoperationssystemen gezielte Controller eingesetzt. Hier hat sich der für den OP entwickelte sigma.7 durchgesetzt. Gegenüber der für die Allgemeinheit entwickelten Konkurrenz bietet er haptisches Feedback in allen nötigen Freiheitsgraden und eine entsprechende Kraftrückkoppelung.