Michael Scholtes, Karolina Sojka, Keywan Sohrabi, Volker Gross
{"title":"Reflection of the Medical Device Regulation","authors":"Michael Scholtes, Karolina Sojka, Keywan Sohrabi, Volker Gross","doi":"10.1515/cdbme-2023-1051","DOIUrl":"https://doi.org/10.1515/cdbme-2023-1051","url":null,"abstract":"Abstract The MDR states the objectives of the law in the preface. There you will find, among other things, a consideration of small and medium-sized enterprises as well as high health protection and an innovative effect. Therefore, the question arises to what extent these goals have been achieved so far or can be achieved in the foreseeable future. To this end, a systematic literature review was conducted to present the perspectives of various stakeholders in the healthcare sector. Critical situations certainly arise for certain manufacturers, Notified Bodies and certain patient groups. The adopted extension of the transitional periods could be helpful but will not solve all problems.","PeriodicalId":10739,"journal":{"name":"Current Directions in Biomedical Engineering","volume":"9 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135394426","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Gökhan Güney, Talisa S. Jansen, Anne K. Braczynski, Maurice Rohr, Sebastian Dill, Christoph Hoog Antink
{"title":"Analyzing the Effect of Age and Gender on the Blink Reflex using MediaPipe","authors":"Gökhan Güney, Talisa S. Jansen, Anne K. Braczynski, Maurice Rohr, Sebastian Dill, Christoph Hoog Antink","doi":"10.1515/cdbme-2023-1106","DOIUrl":"https://doi.org/10.1515/cdbme-2023-1106","url":null,"abstract":"Abstract The glabellar tapping reflex (GTR) is a sign related to brain conditions and can be analyzed by clinicians for diagnostic purposes. To facilitate the quantitative analysis of this reflex, we developed a video-based tool using the MediaPipe framework. We tested our approach on healthy subjects to assess the effect of age and gender on reaction time and blinking duration. The reaction time results show that the young group has a mean value (±standard deviation) of 0.091 (±0.066) seconds and the old group has 0.085 (±0.052) seconds, while female and male subjects have 0.097 (±0.053) seconds and 0.080 (±0.064) seconds respectively. For blinking duration, males have a mean value of 0.216 (±0.077) seconds and, females have 0.189 (±0.115) seconds, while old and young groups have 0.132 (±0.039) seconds 0.267(±0.084) seconds respectively.","PeriodicalId":10739,"journal":{"name":"Current Directions in Biomedical Engineering","volume":"57 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135394429","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Fast 4D FEM Model for EIT Source Separation Benchmarking","authors":"Diogo Filipe Silva, Steffen Leonhardt","doi":"10.1515/cdbme-2023-1097","DOIUrl":"https://doi.org/10.1515/cdbme-2023-1097","url":null,"abstract":"Abstract The accurate separation of cardiac and ventilatory contributions to electrical impedance tomography signals is crucial for complete and non-invasive cardiorespiratory monitoring. However, no consensus on a suitable source separation algorithm was achieved despite several proposals due to lacking systematic evaluation. To address this, we propose a benchmarking 4D finite element method generative model for mixed, cardiac, and ventilatory signals. Our model implements dynamic modelling of the heart, lungs, and pulmonary arteries using realistic volume and flow curve templates, along with cardiac and respiratory frequency coupling.We also employed variable alveolar and blood conductivities. The model was able to obtain long recordings faster than comparably complex models while maintaining significant physiological effects and signal properties such as non-stationarity, spatial delays, time and frequency profiles. The realistic physiological model can be used to taxonomize and evaluate source separation algorithms, as well as aid in the development and training of new ones.","PeriodicalId":10739,"journal":{"name":"Current Directions in Biomedical Engineering","volume":"78 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135394544","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Thomas Wittenberg, Ibrahim Ibrahim, Tobias Draeger
{"title":"Identification of Surgical Instruments Using a Low Frequency Magnetic Field","authors":"Thomas Wittenberg, Ibrahim Ibrahim, Tobias Draeger","doi":"10.1515/cdbme-2023-1015","DOIUrl":"https://doi.org/10.1515/cdbme-2023-1015","url":null,"abstract":"Abstract Background: As part of a open surgical intervention, it is desirable to identify, track and count the surgical instruments used, in order to document and potentially optimize the process. In the past, various technologies have been proposed to this end, as e.g. RFIDs attached to or included in the instruments, contact-less identification by image analysis or (bar-, QR-) codes, or counting by human resources, but all of them having their individual drawbacks. Objective: We present and evaluate a new method to identify metallic-conductive surgical instruments using Low Frequency (LF) magnetic fields. Method: The investigated LF magnetic field approach is based on the IndLoc system developed by the Fraunhofer IIS - originally for metallic asset identification within the field of supply chain management - and is applied on small collection of 13 typical surgical tools (four scissors, two needle holders, four tweezers, two retractors, a bone curette) for open surgery. Results: 9 out of the 13 instruments can be correctly identified, two pairs (2 short and 2 medium tweezers) are too self-similar and could not discriminated correctly from each other. Conclusion: These initial experiments show that an LF-based identification of metallic surgical tools is feasible, but the system needs to be modified (with more and smaller coils) to increase the geometrical resolution to better distinguish between self-similar and potentially more objects.","PeriodicalId":10739,"journal":{"name":"Current Directions in Biomedical Engineering","volume":"23 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135394549","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Third-order SVD based denoising of multi-channel ECG","authors":"Thomas Schanze","doi":"10.1515/cdbme-2023-1045","DOIUrl":"https://doi.org/10.1515/cdbme-2023-1045","url":null,"abstract":"Abstract Denoising of time series is still a challenge, especially when the spectral components of wanted signal and noise overlap. However, denoising is an inverse problem and its solution is of often ambiguous. Standard methods often use predefined functions, e.g., sine waves, to decompose a time series into wanted and unwanted parts. More recent methods calculate the basis for the representation of a time series by the time series itself. Such a method is singular spectrum analysis (SSA). SSA uses Hankel matrix embedding of a time series and singular value decomposition to determine wanted and unwanted components, e.g., noise. The wanted components are then used to compute the wanted part of the time series. Here we present a method that provides an extension of SSA for analyzing and - in particular - denoising multi-channel time series, i.e., multi-channel SSA-based denoising of multi-channel time series (MSSAD). The performance of the new method, which is based on Hankel embedding and tensor decomposition, is demonstrated on a 12-lead ECG.","PeriodicalId":10739,"journal":{"name":"Current Directions in Biomedical Engineering","volume":"97 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135394551","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Michael de Wild, Simon Zimmermann, Falko Schlottig, Carol Hasler, Karina Klein, Thomas Steffen, Brigitte von Rechenberg
{"title":"Immediate stabilization of pedicle screws","authors":"Michael de Wild, Simon Zimmermann, Falko Schlottig, Carol Hasler, Karina Klein, Thomas Steffen, Brigitte von Rechenberg","doi":"10.1515/cdbme-2023-1004","DOIUrl":"https://doi.org/10.1515/cdbme-2023-1004","url":null,"abstract":"Abstract This study was designed as proof of principle and safety test of the novel technique, the Immediate Stabilization System (ISS). The technique is designed to immediately stabilize polymer-augmented pedicle screws (PAS) in deficient bone and avoid complications of loosening pedicle screws at the bone-screw interface, especially in osteoporotic patients. A polymer sleeve was designed as augmentation to improve screw anchorage after drilling the screw hole. By applying ultrasonic energy, the polymeric tube was molded into the pores of the host bone forming a strong and uniform bond with the adjacent bone. The original screw was then implanted into the denser bony environment leading to an enhanced immediate stability. The ISS-treated implants were compared to conventionally placed pedicle screws in ex-vivo cadaver bones (2 sheep spines, n = 6 implants per spine, total 12 screws) and in-vivo in a spinal sheep model (Swiss alpine sheep, n = 5, 4 implants per animal, total 20 screws). The primary stability of ISS-treated pedicle screws was increased in ex-vivo bone (+24% insertion torque (IT)) and in-vivo (+32.9% IT) in sheep spine. Removal torque (RT) was lower in the in PAS tested for 8 weeks in-vivo. The ISS technology demonstrated improved anchorage of pedicle screws in ex-vivo cadaver bones as well as in-vivo studies in sheep spine.","PeriodicalId":10739,"journal":{"name":"Current Directions in Biomedical Engineering","volume":"23 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135394559","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Stefan Sesselmann, Michael Turcanu, Alexander Schuh, Christopher Fleischmann, Irina Leher, Sebastian Buhl, Robert Schleip
{"title":"Validation of ergonomic running handgrip elements to improve arm posture of running novices","authors":"Stefan Sesselmann, Michael Turcanu, Alexander Schuh, Christopher Fleischmann, Irina Leher, Sebastian Buhl, Robert Schleip","doi":"10.1515/cdbme-2023-1086","DOIUrl":"https://doi.org/10.1515/cdbme-2023-1086","url":null,"abstract":"Abstract Running is one of the most popular sports worldwide motivating many non-athletic people to start new physical activities. But especially novice runners are at risk to develop injuries as they tend to run with prejudicial posture. Hence, there has been considerable research to identify factors improving running performance. One of these factors is the correct movement of arms as a swinging pendulum during running. Based on this knowledge ergonomically shaped handgrip elements were designed to improve the posture of the shoulder-arm complex during running. The main objective of this study was the validation of the actual effectiveness on shoulder-arm posture of these handgrips. In this sense 25 adult, healthy persons without running experience were examined by motion capture analysis during running on a treadmill with and without the use of the handgrips. The focus of movement analysis was on changes of hand supination, shoulder abduction and shoulder rotation. Flexion of elbows and shoulders were not expected to change and thus, were investigated as an internal control. Significant changes were found in sense of a reduction of forearm pronation, shoulder abduction, and internal rotation of the shoulder, resulting in improved posture during running. At the same time, no significant changes were found in elbow flexion and shoulder flexion. Future studies are needed to investigate the effects of the detected improvement of arm posture on other important running parameters, such as trunk stability, movement of lower limbs, running economy, and risk of injury. These studies should also compare effects in competitive athletes, recreational runners, and novice runners.","PeriodicalId":10739,"journal":{"name":"Current Directions in Biomedical Engineering","volume":"43 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135394986","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Martin Kasparick, Tobias Klotz, Björn Andersen, Gregor Thürk, Thomas Neumuth, Max Rockstroh, Benjamin Rother, Frank Golatowski
{"title":"Silent ICU based on IEEE 11073 SDC","authors":"Martin Kasparick, Tobias Klotz, Björn Andersen, Gregor Thürk, Thomas Neumuth, Max Rockstroh, Benjamin Rother, Frank Golatowski","doi":"10.1515/cdbme-2023-1076","DOIUrl":"https://doi.org/10.1515/cdbme-2023-1076","url":null,"abstract":"Abstract Patients and caregivers suffer from alarm-related noise in today’s hospitals. While this is a topic for all fields of care, this challenge is especially relevant for intensive care units (ICUs). The noise harms patients, hinders the recovery process, or can even lead to psychosis. For the caregivers, noise causes an enormous stress level and in combination with the high number of clinically irrelevant or false alarms it leads to alarm fatigue and desensitization. These problems result in documented deaths of patients. Therefore, we present a demonstrator of a Silent ICU. Based on a distributed alarm system, the medical devices at the bedside do not create any audio alarm signals, as long as a remote alarm notification system is connected and works properly. An ICU bed place consists of devices from different manufacturers. Thus, a standardized interconnection is necessary. Therefore, we use IEEE 11073 Service-oriented Device Connectivity (SDC) to create a cross-manufacturer distributed alarm system with components from three different companies. A fourth company provides a documentation system for this demonstrator. Patients and caregivers will greatly benefit from Silent ICUs and smart distributed alarm systems that will be build based on interoperable cross-manufacturer environments.","PeriodicalId":10739,"journal":{"name":"Current Directions in Biomedical Engineering","volume":"40 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135394991","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Ingo Hoyer, Alexander Utz, André Lüdecke, Karsten Seidl, Özgü Roßman, Lukas Straczek, Onur Akboyraz, Sebastian Hessel
{"title":"The ARTEMIS project: Mixed-Signal IC for Edge-AI-based Classification of ECG Signals","authors":"Ingo Hoyer, Alexander Utz, André Lüdecke, Karsten Seidl, Özgü Roßman, Lukas Straczek, Onur Akboyraz, Sebastian Hessel","doi":"10.1515/cdbme-2023-1082","DOIUrl":"https://doi.org/10.1515/cdbme-2023-1082","url":null,"abstract":"Abstract Atrial fibrillation (AF) is a common heart arrhythmia and is closely associated with causing strokes. Diagnosis is usually performed with Holter monitors over longer periods of time, causing discomfort to the patient. The proposed mixed-signal integrated circuit (IC) is designed for small patch electrocardiogram (ECG) devices and combines, an analog front-end (AFE) with tailored recording channel characteristics and 12-bit successive-approximation-register analog digital converter (SAR ADC) as well as an RISC-V based microcontroller (μC) for edge artificial intelligence (AI)-based AF-detection. The digital signal processing is supported with hardware accelerators. Including 160 kB of SRAM, the system on chip (SoC) requires 25.56 mm² in silicon area in a 180 nm technology. The recording channel shows promising simulation results with an input impedance of 230 MΩ, an input referred noise of below 1.6 μVrms and a CMMR of 95 dB. The digital part enables the integration of AI-based classification on the IC. Due to the flexibility of the software-based classification approach, this IC can also be used to detect other arrhythmias.","PeriodicalId":10739,"journal":{"name":"Current Directions in Biomedical Engineering","volume":"79 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135394994","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Max B. Schäfer, Jolanda H. Friedrich, Jonas Hotz, Lukas Worbs, Sophie Weiland, Peter P. Pott
{"title":"Robotic Scrub Nurse: Surgical Instrument Handling with a Granular Jamming Gripper","authors":"Max B. Schäfer, Jolanda H. Friedrich, Jonas Hotz, Lukas Worbs, Sophie Weiland, Peter P. Pott","doi":"10.1515/cdbme-2023-1044","DOIUrl":"https://doi.org/10.1515/cdbme-2023-1044","url":null,"abstract":"Abstract The global shortage of healthcare staff has led to high workloads and subsequent risks to patient well-being. One of the professions affected is that of the scrub nurse. Robotic scrub nurse systems have the potential to reduce workload and to assist in handling surgical instruments. Existing approaches mostly use two-finger grippers or electromagnetic grippers. However, it is assumed that a granular jamming gripper is more suitable for handling various surgical instruments, regardless of material and shape. A gripping unit based on a granular jamming gripper and attached to a robotic arm is presented. For evaluation, six surgical instruments were repeatedly gripped and transported. The granular jamming gripper was found to be suitable for picking up and transferring most instruments, however, handling very flat instruments turned out to be challenging.","PeriodicalId":10739,"journal":{"name":"Current Directions in Biomedical Engineering","volume":"58 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135394997","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}