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Reflection of the Medical Device Regulation 《医疗仪器规例》的反映
Q4 Engineering Pub Date : 2023-09-01 DOI: 10.1515/cdbme-2023-1051
Michael Scholtes, Karolina Sojka, Keywan Sohrabi, Volker Gross
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.
摘要MDR在前言中阐述了法律的目标。在那里,除其他外,你会发现对中小型企业的考虑,以及高度的健康保护和创新效果。因此,问题是到目前为止,这些目标在多大程度上已经实现,或者在可预见的将来能够实现。为此,进行了系统的文献综述,以提出医疗保健部门各利益相关者的观点。某些制造商、公告机构和某些患者群体肯定会出现危急情况。通过的延长过渡时期的办法可能有所帮助,但不能解决所有问题。
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引用次数: 0
Analyzing the Effect of Age and Gender on the Blink Reflex using MediaPipe 用MediaPipe分析年龄和性别对眨眼反射的影响
Q4 Engineering Pub Date : 2023-09-01 DOI: 10.1515/cdbme-2023-1106
Gökhan Güney, Talisa S. Jansen, Anne K. Braczynski, Maurice Rohr, Sebastian Dill, Christoph Hoog Antink
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.
glabellar叩击反射(GTR)是一种与脑部疾病相关的体征,临床医生可以对其进行分析以用于诊断目的。为了便于对这种反射进行定量分析,我们使用MediaPipe框架开发了一个基于视频的工具。我们在健康受试者身上测试了我们的方法,以评估年龄和性别对反应时间和眨眼时间的影响。反应时间结果显示,年轻组平均(±标准差)为0.091(±0.066)秒,老年组为0.085(±0.052)秒,女性和男性分别为0.097(±0.053)秒和0.080(±0.064)秒。眨眼时间,男性为0.216(±0.077)秒,女性为0.189(±0.115)秒,老年组为0.132(±0.039)秒,年轻组为0.267(±0.084)秒。
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引用次数: 0
Fast 4D FEM Model for EIT Source Separation Benchmarking EIT源分离标杆快速四维有限元模型
Q4 Engineering Pub Date : 2023-09-01 DOI: 10.1515/cdbme-2023-1097
Diogo Filipe Silva, Steffen Leonhardt
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.
准确分离电阻抗断层扫描信号对心脏和通气的贡献对于完整和无创的心肺监测至关重要。然而,由于缺乏系统的评估,尽管有一些建议,但对合适的源分离算法没有达成共识。为了解决这个问题,我们提出了一个基准的四维有限元方法生成模型,用于混合,心脏和呼吸信号。我们的模型使用真实的体积和流量曲线模板,以及心脏和呼吸频率耦合,实现了心脏、肺和肺动脉的动态建模。我们还采用了可变肺泡和血液电导率。该模型能够比相当复杂的模型更快地获得长时间记录,同时保持显著的生理效应和信号特性,如非平稳性、空间延迟、时间和频率分布。真实的生理模型可以用来分类和评估源分离算法,也可以帮助开发和训练新的源分离算法。
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引用次数: 1
Identification of Surgical Instruments Using a Low Frequency Magnetic Field 利用低频磁场识别手术器械
Q4 Engineering Pub Date : 2023-09-01 DOI: 10.1515/cdbme-2023-1015
Thomas Wittenberg, Ibrahim Ibrahim, Tobias Draeger
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.
背景:作为开放式手术干预的一部分,需要识别、跟踪和计数所使用的手术器械,以便记录和潜在地优化该过程。在过去,为此目的提出了各种技术,例如附加在仪器上或包含在仪器中的rfid,通过图像分析或(条形码,QR码)进行非接触式识别,或由人力资源进行计数,但所有这些技术都有各自的缺点。目的:提出并评价一种利用低频磁场识别金属导电手术器械的新方法。方法:所研究的低频磁场方法基于Fraunhofer IIS开发的IndLoc系统(最初用于供应链管理领域的金属资产识别),并应用于开放手术的13种典型手术工具(4把剪刀、2把针架、4把镊子、2把牵开器、1把骨镊)的一小部分。结果:13个镊子中有9个可以正确识别,2对(2对短镊子和2对中镊子)自相似度过高,无法正确区分。结论:这些初步实验表明,基于lf的金属手术工具识别是可行的,但系统需要修改(使用更多和更小的线圈)以提高几何分辨率,以更好地区分自相似和潜在的更多物体。
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引用次数: 0
Third-order SVD based denoising of multi-channel ECG 基于三阶奇异值分解的多通道心电信号去噪
Q4 Engineering Pub Date : 2023-09-01 DOI: 10.1515/cdbme-2023-1045
Thomas Schanze
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.
时间序列的去噪仍然是一个挑战,特别是当所需信号和噪声的频谱成分重叠时。然而,去噪是一个反向问题,其解决方案往往是模糊的。标准方法通常使用预定义的函数,例如正弦波,将时间序列分解为需要和不需要的部分。较新的方法是通过时间序列本身来计算时间序列表示的基。这种方法就是奇异谱分析(SSA)。SSA使用时间序列的汉克尔矩阵嵌入和奇异值分解来确定需要和不需要的成分,例如噪声。然后使用所需分量来计算时间序列的所需部分。本文提出了一种扩展SSA的方法来分析多通道时间序列,特别是去噪多通道时间序列,即基于多通道SSA的多通道时间序列去噪(MSSAD)。基于Hankel嵌入和张量分解的新方法在12导联心电图上的性能得到了验证。
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引用次数: 0
Immediate stabilization of pedicle screws 立即稳定椎弓根螺钉
Q4 Engineering Pub Date : 2023-09-01 DOI: 10.1515/cdbme-2023-1004
Michael de Wild, Simon Zimmermann, Falko Schlottig, Carol Hasler, Karina Klein, Thomas Steffen, Brigitte von Rechenberg
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.
摘要本研究旨在验证即时稳定系统(ISS)新技术的原理和安全性。该技术旨在立即稳定缺失骨中的聚合物增强椎弓根螺钉(PAS),避免在骨-螺钉界面处松动椎弓根螺钉的并发症,特别是在骨质疏松患者中。设计了聚合物套筒作为增强物,提高了螺杆钻孔后的锚固效果。通过施加超声波能量,聚合物管被塑造成宿主骨的孔隙,与邻近的骨形成牢固而均匀的结合。然后将原始螺钉植入更致密的骨环境中,从而增强了即刻的稳定性。将iss处理的植入物与常规放置椎弓根螺钉的离体尸骨(2根羊椎骨,每根脊椎n = 6个植入物,总共12个螺钉)和体内脊椎羊模型(瑞士高山羊,n = 5,每只动物4个植入物,总共20个螺钉)进行比较。iss处理的椎弓根螺钉在离体骨(+24%插入扭矩(IT))和在体羊脊柱(+32.9% IT)中的初步稳定性均有提高。在体内测试8周后,在PAS中移除扭矩(RT)较低。ISS技术在离体尸体骨骼和绵羊脊柱的体内研究中证明了椎弓根螺钉锚固的改进。
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引用次数: 0
Validation of ergonomic running handgrip elements to improve arm posture of running novices 符合人体工程学的跑步握把元件改善跑步新手手臂姿势的验证
Q4 Engineering Pub Date : 2023-09-01 DOI: 10.1515/cdbme-2023-1086
Stefan Sesselmann, Michael Turcanu, Alexander Schuh, Christopher Fleischmann, Irina Leher, Sebastian Buhl, Robert Schleip
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.
跑步是世界上最受欢迎的运动之一,它激励着许多非运动人士开始新的体育活动。但是,特别是新手跑步者有受伤的风险,因为他们倾向于用不正确的姿势跑步。因此,已经有相当多的研究来确定提高跑步性能的因素。其中一个因素是在跑步时手臂的正确运动,就像摆动的钟摆一样。在此基础上,我们设计了符合人体工程学的握把元素,以改善跑步时肩臂复合的姿势。本研究的主要目的是验证这些握法对肩臂姿势的实际效果。在这个意义上,25名没有跑步经验的健康成年人在使用和不使用手柄的跑步机上跑步时,通过动作捕捉分析进行了研究。运动分析的重点是手旋后、肩外展和肩旋转的变化。肘部和肩部的屈曲不期望改变,因此,被调查作为一个内部控制。在前臂内旋、肩部外展和肩部内旋的感觉减少方面发现了显著的变化,从而改善了跑步时的姿势。同时,肘关节屈曲和肩关节屈曲未见明显变化。未来的研究还需要进一步研究手臂姿势的改善对其他重要的跑步参数的影响,如躯干稳定性、下肢运动、跑步经济性和受伤风险。这些研究还应该比较竞技运动员、休闲跑步者和新手跑步者的效果。
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引用次数: 0
Silent ICU based on IEEE 11073 SDC 基于IEEE 11073 SDC的静默ICU
Q4 Engineering Pub Date : 2023-09-01 DOI: 10.1515/cdbme-2023-1076
Martin Kasparick, Tobias Klotz, Björn Andersen, Gregor Thürk, Thomas Neumuth, Max Rockstroh, Benjamin Rother, Frank Golatowski
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.
在当今的医院里,患者和护理人员遭受着与警报器相关的噪音的困扰。虽然这是一个适用于所有护理领域的主题,但这一挑战与重症监护病房(icu)尤其相关。噪音会伤害病人,阻碍康复过程,甚至会导致精神错乱。对于护理人员来说,噪音造成巨大的压力水平,并与大量临床无关或虚假警报相结合,导致警报疲劳和脱敏。这些问题导致有记录的患者死亡。因此,我们提出了一个无声ICU的演示。基于分布式报警系统,床边的医疗设备不产生任何音频报警信号,只要连接远程报警通知系统并正常工作即可。ICU病床由不同厂家的设备组成。因此,标准化的互连是必要的。因此,我们使用IEEE 11073面向服务的设备连接(SDC)来创建一个来自三家不同公司的组件的跨制造商分布式报警系统。第四家公司为该演示器提供文档系统。患者和护理人员将极大地受益于无声icu和智能分布式报警系统,这些系统将基于可互操作的跨制造商环境而构建。
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引用次数: 0
The ARTEMIS project: Mixed-Signal IC for Edge-AI-based Classification of ECG Signals ARTEMIS项目:基于边缘人工智能的心电信号分类混合信号IC
Q4 Engineering Pub Date : 2023-09-01 DOI: 10.1515/cdbme-2023-1082
Ingo Hoyer, Alexander Utz, André Lüdecke, Karsten Seidl, Özgü Roßman, Lukas Straczek, Onur Akboyraz, Sebastian Hessel
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.
心房颤动(AF)是一种常见的心律失常,与脑卒中的发生密切相关。诊断通常是通过更长时间的动态心电图来进行的,这会给病人带来不适。所提出的混合信号集成电路(IC)是为小贴片心电图(ECG)设备设计的,结合了具有定制记录通道特性的模拟前端(AFE)和12位连续逼近寄存器模拟数字转换器(SAR ADC),以及基于RISC-V的微控制器(μC),用于基于边缘人工智能(AI)的af检测。硬件加速器支持数字信号处理。包括160 kB的SRAM,系统片上(SoC)在180纳米技术中需要25.56 mm²的硅面积。该记录通道的输入阻抗为230 MΩ,输入参考噪声低于1.6 μVrms, CMMR为95 dB,仿真结果令人满意。数字部分可以将基于人工智能的分类集成到集成电路上。由于基于软件的分类方法的灵活性,该集成电路也可以用于检测其他心律失常。
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引用次数: 0
Robotic Scrub Nurse: Surgical Instrument Handling with a Granular Jamming Gripper 机器人擦洗护士:用颗粒夹持器处理手术器械
Q4 Engineering Pub Date : 2023-09-01 DOI: 10.1515/cdbme-2023-1044
Max B. Schäfer, Jolanda H. Friedrich, Jonas Hotz, Lukas Worbs, Sophie Weiland, Peter P. Pott
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.
全球卫生保健人员短缺导致高工作量和患者福祉的后续风险。受影响的职业之一是清洁护士。机器人磨砂护理系统有可能减少工作量,并协助处理手术器械。现有的方法大多使用两指夹持器或电磁夹持器。然而,我们假设颗粒状夹持器更适合处理各种手术器械,而不考虑材料和形状。提出了一种基于颗粒夹持器的机械臂夹持装置。为了评估,6个手术器械被反复抓握和搬运。颗粒卡爪被发现适合拾取和转移大多数仪器,然而,处理非常扁平的仪器被证明是具有挑战性的。
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引用次数: 0
期刊
Current Directions in Biomedical Engineering
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