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Development of quality criteria for long-term testing of intracortical electrodes 皮质内电极长期试验质量标准的制定
Q4 Engineering Pub Date : 2023-09-01 DOI: 10.1515/cdbme-2023-1105
Charlotte Sielaff, Ute Urban, Ulrich P. Froriep
Abstract The use of intracortical electrodes is a crucial method for medical diagnosis and treatment and holds the promise for overcoming various neural diseases and challenges in prosthetics. The general physical and electrical function as well as the biocompatibility is extensively tested before intracortical electrodes are implanted, however, their longterm performance, is still limited through tissue scarring and electrode deterioration, and consequently a decrease in signal quality. To overcome this challenge, aspects such as materials selection, coatings, flexibility, and surgical procedures are often addressed. To date, however, a systematic, industry - compatible process for long-term functional testing of new intracortical electrodes technologies is still lacking. Implementation of a general overall in vivo testing procedure with defined quality criteria would enable reliable in vivo longterm (> 30 days) device assessment. This could reduce the risk in developing probes for long-term performance and pave the way for clinical application in patients suffering from neural diseases.
皮质内电极的使用是医学诊断和治疗的重要方法,有望克服各种神经疾病和假肢的挑战。在植入皮质内电极之前,对其一般的物理和电功能以及生物相容性进行了广泛的测试,然而,由于组织瘢痕和电极退化,它们的长期性能仍然受到限制,从而导致信号质量下降。为了克服这一挑战,材料选择、涂层、灵活性和手术程序等方面经常得到解决。然而,到目前为止,对于新的皮质内电极技术的长期功能测试,仍然缺乏一个系统的、工业兼容的过程。实施具有明确质量标准的一般总体体内检测程序将实现可靠的体内长期(>30天)器械评估。这可以降低开发具有长期性能的探针的风险,并为神经疾病患者的临床应用铺平道路。
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引用次数: 0
Auditory Neurons on the Silk Road – spider silk for bridging the nerve-electrode-gap 丝绸之路上的听觉神经元——用来连接神经电极间隙的蜘蛛丝
Q4 Engineering Pub Date : 2023-09-01 DOI: 10.1515/cdbme-2023-1062
Jana Schwieger, Verena Scheper, Thomas Lenarz, Peter M. Vogt, Sarah Strauß
Abstract The cochlear implant (CI) restores hearing to patients with severe to profound sensorineural hearing loss by stimulating the spiral ganglion neurons (SGN). Due to the inner ear anatomy, a fluid-filled gap remains between the SGN and the electrode array. This gap impedes focused stimulation and thus optimized performance with the CI. Regenerating neurites may bridge this fluid-filled gap for a direct nerveelectrode- link but require a supportive matrix. Spider silk might be a suitable candidate for this support. Therefore, silk fibers were tested for biocompatibility with inner ear neuronal tissue, suitability as neurite outgrowth matrix and applicability to the CI-electrode array. Dragline silk from female Trichonephila spiders was woven around a frame and autoclaved. Spiral ganglia of young rats were prepared, cut and placed in a drop of medium on the parallel silk fibers for pre-cultivation to support adherence before remaining medium was added. After 5d of cultivation, cells were fixed and immunocytologically stained. For CIapplication, silk was wrapped around a silicone dummy and a one-sided spacer. Opposite the spacer, alginate-hydrogel was applied for silk-fixation and -shielding. After gelation, silk loops were cut in the middle to form protruding threads. Cells showed a high degree of migration and neurite regeneration along the silk fibers and in some cases the outgrown neurites directly contacted the silk. It was possible to fix the silk to the dummy as protruding fibers. The tested spider silk is compatible with the inner ear tissue in culture, supports cell growth and seems to be an attractive material for neurite contacting. Application to the CI as protruding fibers is possible, making it a promising candidate for structural support to bridge the nerve-electrode-gap.
人工耳蜗(CI)通过刺激螺旋神经节神经元(SGN)恢复重度至重度感音神经性听力损失患者的听力。由于内耳的解剖结构,在SGN和电极阵列之间仍然存在充满液体的间隙。这个间隙阻碍了集中增产,从而优化了CI的性能。再生的神经突可以为直接的神经电极连接桥接这个充满液体的间隙,但需要支持基质。蜘蛛丝可能是这种支持的合适人选。因此,我们测试了蚕丝纤维与内耳神经元组织的生物相容性、作为神经突生长基质的适用性以及对ci电极阵列的适用性。从雌性Trichonephila蜘蛛身上提取的拖丝被编织在一个框架上,然后被高压灭菌。制备幼龄大鼠螺旋神经节,切开后滴入培养液于平行丝纤维上预培养以支持粘附,再加入剩余培养液。培养5d后,固定细胞并进行免疫细胞染色。对于CIapplication,丝绸被包裹在硅胶假人和单侧垫片上。与隔离剂相对,海藻酸盐水凝胶用于固丝和屏蔽。胶凝后,从中间切断丝环,形成突出的线。细胞沿丝纤维高度迁移和神经突再生,在某些情况下,脱落的神经突直接接触丝。有可能将丝绸固定在假人身上,使其成为突出的纤维。测试的蜘蛛丝与培养的内耳组织兼容,支持细胞生长,似乎是神经突接触的有吸引力的材料。作为突出纤维应用于CI是可能的,使其成为一种有希望的结构支持候选者,以桥接神经电极间隙。
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引用次数: 1
Symmetry of Respiration Induced Upper Body Movements 呼吸的对称性引起上半身的运动
Q4 Engineering Pub Date : 2023-09-01 DOI: 10.1515/cdbme-2023-1120
Bernhard Laufer, Sabine Krueger-Ziolek, Nour Aldeen Jalal, Knut Moeller, Paul D. Docherty, Fabian Hoeflinger, Leonhard Reindl
Abstract Many researchers have postulated inexpensive methods to estimate respiratory volumes from respirationinduced movements of the upper body. In the development of smart garments, the number and the optimal positioning of sensors is an essential aspect. Therefore, the symmetry of upper body respiratory movements was investigated based on the measurement data from a motion capture system. In the ventral central area, coefficients of determination above 0.99 regarding movements of symmetrical markers mean that sensors can be placed without restrictions in the position mirrored on the sagittal plane. This simplifies sensor positioning in a smart shirt and expands the range of applications of smart shirts for respiratory monitoring.
许多研究人员已经提出了一些廉价的方法来估算由呼吸引起的上半身运动的呼吸量。在智能服装的开发中,传感器的数量和最佳定位是一个重要的方面。因此,基于运动捕捉系统的测量数据,研究了上半身呼吸运动的对称性。在腹侧中心区域,对称标记移动的决定系数大于0.99,意味着传感器可以不受限制地放置在矢状面镜像位置。这简化了智能衬衫中的传感器定位,扩展了呼吸监测智能衬衫的应用范围。
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引用次数: 0
Design of a Flexible mechatronic system for mechanical impedance measurement of the wrist as one step towards robotic rehabilitation 腕部机械阻抗测量的柔性机电系统设计,作为机器人康复的第一步
Q4 Engineering Pub Date : 2023-09-01 DOI: 10.1515/cdbme-2023-1164
Ornella Tortorici, Alireza Abbasimoshaei, Thorsten A. Kern, Arndt F. Schilling
Abstract Home rehabilitation is a great complement to inpatient rehabilitation, because it allows for more regular training, especially in rural areas, where the access to physiotherapists is limited. However, unsupervised training carries the risk of deviation from the prescribed protocol. An obvious solution is to introduce a technical means for rehabilitation and continuous monitoring of performance. This paper presents a robotic system for rehabilitation of three degrees of freedom of the wrist independently, implemented with only one actuator, optimizing the design and size of the system. The device provides measurements of joint torque-position dependence, allowing objective assessment of mechanical impedance and range of motion to evaluate the progress of rehabilitation. Derived from research on haptic devices, a measurement method was implemented to measure hand impedance in the high frequency range between 100 and 200 Hz using a combination of exciters and accelerometers in the handles. This allows continuous monitoring of gripping forces without the need for complex contact-based force sensors. In collaboration between the authors’ technical and medical universities, a set of two-level passive and active safety measures was implemented to ensure the safety of the system’s users. Therefore, the presented system shows the potential to evaluate the mechanical impedance of the wrist at both low and high frequencies and to monitor the progress during rehabilitation. In the next step, a baseline of wrist impedance will be measured in a target group of healthy volunteers in order to prepare for studies in motion-restricted subjects.
家庭康复是住院康复的一个很好的补充,因为它允许更多的定期培训,特别是在农村地区,在那里获得物理治疗师是有限的。然而,无监督的培训有偏离规定方案的风险。一个显而易见的解决方案是引入一种技术手段,用于康复和持续监测性能。本文提出了一种仅使用一个致动器实现腕部三自由度独立康复的机器人系统,并对系统的设计和尺寸进行了优化。该设备提供关节扭矩-位置依赖性测量,允许客观评估机械阻抗和运动范围,以评估康复进展。在触觉设备研究的基础上,提出了一种测量手部阻抗的方法,该方法在100 ~ 200 Hz的高频范围内,通过在手柄中结合激励器和加速度计来测量手部阻抗。这允许连续监测夹持力,而不需要复杂的接触式力传感器。在作者所在的技术大学和医学大学的合作下,实施了一套两级被动和主动安全措施,以确保系统用户的安全。因此,该系统显示了在低频和高频下评估手腕机械阻抗和监测康复过程的潜力。下一步,将在健康志愿者的目标组中测量手腕阻抗基线,以便为运动受限受试者的研究做准备。
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引用次数: 0
Randomized Registry Trials - efficient post market clinical follow-up for medical devices 随机注册试验:有效的医疗器械上市后临床随访
Q4 Engineering Pub Date : 2023-09-01 DOI: 10.1515/cdbme-2023-1122
Matthias Leuchter, Stefan Siewert, Michael Stiehm, Andrea Bock, Klaus-Peter Schmitz, Sebastian Kaule, Ernst Klar
Abstract In spite of advances in the treatment of cardiovascular disease, there remains a significant need for high-quality evidence for clinical practice given the rising prevalence worldwide. Next to the increase of regulatory requirements, poor screening-to-recruitment ratios, lack of patient engagement, and long timelines for contracting and institutional review board (IRB) approval are leading to an outflow of clinical trials in the EU. Patient registries are a potentially rich source of data, especially for evaluating the course of rare diseases and effects of new treatments. In the sectors of regulatory assessments of medical devices they are greatly underused. Health-related real world data provide crucial support for regulatory decision-making, particularly post-market assessments of medical products. Registries can be used not only for observational studies, but also for conducting experimental study designs. Register-based randomized controlled trials (RRCTs) are of particular importance here, as they can combine the advantages of randomized controlled trials (RCT) and registers. The government's financial support and reduction of regulatory barriers to the implementation of registry-based RCT are incentive factors for manufacturers to let their medical devices (re-)certified. Furthermore, it is essential that the necessary criteria are already taken into account when setting up the German implant registry in order to enable future RRCTs. The presented work is an additional pleading for the use and extension of registries for all medical products.
尽管心血管疾病的治疗取得了进展,但鉴于全球范围内发病率的上升,临床实践仍然需要高质量的证据。除了监管要求的增加之外,筛选与招募比率低、患者参与度低、合同签订和机构审查委员会(IRB)批准的时间过长,这些都导致了欧盟临床试验的外流。患者登记是一个潜在的丰富数据来源,特别是用于评估罕见疾病的病程和新疗法的效果。在医疗器械的监管评估部门,它们的使用严重不足。与健康相关的真实世界数据为监管决策,特别是医疗产品上市后评估提供了至关重要的支持。登记不仅可用于观察性研究,也可用于进行实验研究设计。基于注册表的随机对照试验(RRCTs)在这里特别重要,因为它们可以结合随机对照试验(RCT)和注册表的优点。政府的财政支持和减少基于注册的RCT实施的监管障碍是激励制造商让他们的医疗器械(重新)认证的因素。此外,在建立德国植入物注册时,必须考虑到必要的标准,以便实现未来的随机对照试验。提出的工作是一个额外的恳求,为所有医疗产品的使用和扩展注册。
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引用次数: 0
Manufacture and extraction of PLLA films with incorporated metal ions 含金属离子PLLA薄膜的制备与提取
Q4 Engineering Pub Date : 2023-09-01 DOI: 10.1515/cdbme-2023-1113
Thomas Eickner, Sabine Illner, Niels Grabow, Olga Hahn, Kirsten Peters, Brigitte Müller-Hilke, Anika Jonitz-Heincke, Rainer Bader, Tomas Fiedler
Abstract For the in vitro examination of the effects on cells and tissues of metal ions derived from implants by wear and corrosion, a system is needed to release metal ions in a controlled and sustained manner. As small concentrations may have an impact on biological systems, a corresponding slow release over a defined period of time is necessary. Here, a manufacturing method of polymeric Poly(L-lactic acid) (PLLA) films with incorporated cobalt ions via dip coating is reported. The establishment of two analytical methods for the detection and quantification of cobalt ions is shown. High performance liquid chromatography enables cobalt quantification over a concentration range of 0.33 μg/mL up to 33 μg/mL in sample solutions. Extraction and detection of cobalt ions from solvent cast PLLA-cobalt-films shows the feasibility of the manufacturing method. Initial biocompatibility tests with manufactured PLLA-cobaltfilms showed no effects on adipose derived primary mesenchymal stem cells (adMSCs).
为了在体外检测植入物产生的金属离子对细胞和组织的磨损和腐蚀的影响,需要一个系统以可控和持续的方式释放金属离子。由于小浓度可能对生物系统产生影响,因此在规定的时间内进行相应的缓慢释放是必要的。本文报道了一种采用浸涂法制备钴离子掺杂聚乳酸(PLLA)薄膜的方法。建立了两种检测和定量钴离子的分析方法。高效液相色谱法可在样品溶液中0.33 μg/mL至33 μg/mL的浓度范围内对钴进行定量。溶剂铸造pla -钴膜中钴离子的提取和检测表明了该制备方法的可行性。用人造pla -钴膜进行的初步生物相容性测试显示,对脂肪来源的原代间充质干细胞(adMSCs)没有影响。
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引用次数: 0
Optimization and evaluation of a mobile IMU-based ballistocardiography system 基于移动imu的ballocardiography系统的优化与评价
Q4 Engineering Pub Date : 2023-09-01 DOI: 10.1515/cdbme-2023-1170
Lucas Klauth, Andreas Mühlen, Andreas Kitzig, Edwin Naroska, Gudrun Stockmanns
Abstract In recent decades ballistocardiography (BCG) has regained popularity as a way to measure the mechanical activ- ity of the heart. In this paper we present and evaluate a new iteration of our mobile BCG measurement system. The pro- posed system uses an inertial measurement unit (IMU) placed on the carotid artery to derive the BCG. We conducted a mea- surement series to evaluate the system and to do an initial in- vestigation into whether more complex heart parameters can be derived from BCG data. The evaluation shows that heart rate (HR) and heart rate variability (HRV) calculated using BCG data, agrees well with the reference measurement and amplitudes calculated are mostly comparable in range to other papers. In conclusion, the system can reliably derive features from BCG data that can be used in further research.
近几十年来,作为一种测量心脏机械活动的方法,ballicstocardiography (BCG)重新受到人们的欢迎。在本文中,我们提出并评估了我们的移动BCG测量系统的一个新的迭代。该系统使用放置在颈动脉上的惯性测量单元(IMU)来获得BCG。我们进行了一系列的测量来评估该系统,并对是否可以从BCG数据中得出更复杂的心脏参数进行了初步的调查。评价结果表明,用BCG数据计算的心率(HR)和心率变异性(HRV)与参考测量值吻合较好,计算出的幅度与其他文献的范围基本相当。综上所述,该系统可以可靠地从BCG数据中提取出可用于进一步研究的特征。
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引用次数: 0
Outer ear reconstruction using 3D technology 利用3D技术进行外耳重建
Q4 Engineering Pub Date : 2023-09-01 DOI: 10.1515/cdbme-2023-1001
György Wersényi, Balázs Gasz
Abstract Manufacturing replicas for replacing missing or defective body parts also incorporates 3D technology, including scanning, image processing and printing. In the case of the ears, both aesthetics and functionality play a significant role. Based on these techniques, outer ear replicas were produced using 3D scans of human skulls in a rapid prototyping procedure for actual patients. Hand-held scanners delivered accurate images for post-processing of the mesh and for printing in a cost- and time efficient way. Use cases of patients demonstrate applicability, allowing the technology to be available also for the general population in the future.
用于替换缺失或有缺陷的身体部位的制造复制品也采用3D技术,包括扫描、图像处理和打印。就耳朵而言,美学和功能都起着重要作用。基于这些技术,外耳复制品是通过对人类头骨的3D扫描在实际患者的快速原型程序中生产出来的。手持式扫描仪提供准确的图像,用于网格的后处理和以成本和时间效率的方式进行打印。患者用例证明了该技术的适用性,从而使该技术在未来也可用于普通人群。
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引用次数: 1
Proof-of-Concept: Conceptual design and realisation of an educational augmented reality (AR) application for anaesthesia induction 概念验证:用于麻醉诱导的教育增强现实(AR)应用的概念设计和实现
Q4 Engineering Pub Date : 2023-09-01 DOI: 10.1515/cdbme-2023-1063
Leonie Maleszka, Andreas Breuer-Kaiser, Marcel Schäfer, Karsten Lehn, Thomas Felderhoff
Abstract Increasing patient safety during operations is an inevitable topic in anaesthesiology. The cockpit strategy presented by Vogelsang et al. addresses this issue with elements such as closed loop communication and the use of checklists. In this paper, the use of checklists is taken up further. An AR application is presented that augments checklists for anaesthesia induction into the user’s field of view. The application is to be implemented in teaching and help prospective physicians to internalise the workflows in anaesthesiology more quickly and sustainably. A working prototype has been created and loaded onto the HoloLens 2. The prototype is being assessed and evaluated by an anaesthetist. The feedback will be included into the following development steps. The application will be further adapted to the needs and requirements of the users. In order to evaluate the usability and the user experience, students and medical professionals should test and evaluate the application repeatedly.
提高手术患者的安全是麻醉学研究中不可回避的课题。Vogelsang等人提出的座舱策略通过闭环通信和使用清单等元素解决了这个问题。本文进一步探讨了核对表的使用。提出了一种增强现实应用程序,将麻醉诱导的检查清单增强到用户的视野中。该应用程序将在教学中实施,并帮助未来的医生更快、更可持续地内化麻醉学的工作流程。一个工作原型已经创建并加载到HoloLens 2上。麻醉师正在对模型进行评估和评估。反馈将包含在以下开发步骤中。应用程序将进一步适应用户的需要和要求。为了评估可用性和用户体验,学生和医疗专业人员应该反复测试和评估应用程序。
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引用次数: 0
Deep.Neural.Signal.Pre-Processor - Towards Development of AI-enhanced End-to-End BCIs Deep.Neural.Signal。Pre-Processor -迈向ai增强型端到端BCIs
Q4 Engineering Pub Date : 2023-09-01 DOI: 10.1515/cdbme-2023-1118
Leo Buron, Andreas Erbslöh, Karsten Seidl, Gregor Schiele, Karsten Seidl, Zia Ur-Rehman, Christian Klaes
Abstract This paper presents a software-based Python framework for developing future AI-enhanced end-to-end Brain-Computer-Interfaces (BCI). This framework contains modules from the emulated analogue front-end and from neural signal pre-processing for invasive neural applications. These modules can be assembled into several pipeline versions for evaluation and benchmarking. The aim of this framework is to accelerate the development of BCIs due to system-wide optimizations in order to set the requirements for hardware development without prior knowledge on the basis of accuracy (recall and precision) and latency. In the next step, the pipeline can be optimised for on-chip and embedded execution.
本文提出了一个基于软件的Python框架,用于开发未来ai增强的端到端脑机接口(BCI)。该框架包含来自仿真模拟前端和用于侵入性神经应用的神经信号预处理的模块。这些模块可以组装成几个管道版本,以进行评估和基准测试。该框架的目的是通过系统范围的优化来加速bci的开发,以便在没有基于准确性(召回率和精度)和延迟的先验知识的情况下设置硬件开发的需求。在下一步,流水线可以优化芯片上和嵌入式执行。
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引用次数: 0
期刊
Current Directions in Biomedical Engineering
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