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Simulating Baroreflex Activation Therapy for the Treatment of Heart Failure with Preserved Ejection Fraction 模拟压反射激活治疗保留射血分数的心力衰竭
Pub Date : 2022-04-11 DOI: 10.1115/dmd2022-1043
J. Clemmer, W. Pruett, R. Hester
Clinical trials demonstrate baroreflex activation therapy (BAT) reduces LV mass and blood pressure (BP) in hypertensive patients and in patients with hypertensive heart failure with preserved ejection fraction (HFpEF). It is thought that high sympathetic nerve activity (SNA) in the heart plays a role in the disease progression seen in these patients. However, the impact of BAT on hemodynamics, cardiac SNA, and disease progression during HFpEF is unknown. In the present study, we used HumMod, a large physiology model to predict the time-dependent changes of BAT during HFpEF. Our results demonstrate a progressive cardiac hypertrophy and fibrosis during HFpEF. After 6 months of BAT however, left ventricular mass was reduced (-11%), associated with decreased blood pressure, decreased cardiac SNA, and restoration of β1-adrenergic activity. Interestingly, when cardiac SNA suppression was blocked during BAT, the improvement in cardiac mass was attenuated. These simulations indicate that the suppression of cardiac SNA could be the primary determinant of the cardioprotective effects from BAT in this HF population.
临床试验表明,压反射激活疗法(BAT)可以降低高血压患者和保留射血分数(HFpEF)的高血压心力衰竭患者的左室质量和血压(BP)。据认为,高交感神经活动(SNA)在心脏发挥作用,在这些患者的疾病进展中看到。然而,在HFpEF期间,BAT对血流动力学、心脏SNA和疾病进展的影响尚不清楚。在本研究中,我们使用大型生理模型HumMod来预测HFpEF期间BAT的时间依赖性变化。我们的研究结果表明,HFpEF期间出现了进行性心肌肥大和纤维化。然而,在BAT治疗6个月后,左心室重量减少(-11%),与血压降低、心脏SNA降低和β1-肾上腺素能活性恢复有关。有趣的是,当在BAT期间阻断心脏SNA抑制时,心脏质量的改善减弱。这些模拟表明,心脏SNA的抑制可能是BAT对HF人群心脏保护作用的主要决定因素。
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引用次数: 0
Proof of Concept: Hand Extension Device to Aid Impaired Hand Functionn 概念验证:手部延伸装置,以帮助受损的手部功能
Pub Date : 2022-04-11 DOI: 10.1115/dmd2022-1032
Robin Johannes, Abigail R. Clarke-Sather
Human hands are made to do everything: grasp objects, communicate, perform daily tasks, and learn. Certain people with difficulties using their hands are affected greatly by spasticity, uncontrolled tightness in hand muscles, and impaired motor function in their hands. Hand spasticity specifically can be caused by several medical conditions including cerebral palsy, stroke, arthritis, and carpal tunnel. Often an individual's hand remains in a clenched fist position causing pain and limited mobility within the fingers. Many products exist on the market that specifically help meet the clinical needs of opening and extending a hand for long periods of time. Individuals can purchase products, but they are usually only used during occupational therapy sessions due to their high cost. The Hand Extender is a wearable designed for participants who struggle with functional use of their hands, and over time the Hand Extender is designed to support and aid their hand in everyday functions. Similar products only come in a few standard sizes, resulting in potentially poorer fit, e.g., commercially available products are not currently sized for the pediatric population or participants with an abnormal hand size. The custom fit glove of the Hand Extender made possible via 3D printed parts accommodates all participant populations with a variety of different hand sizes. The tailored glove also provides more accurate extension due to the better fit. A custom fit 3D Hand Extender was able to accurately fit two adult participants with different sized hands and normal hand function.
人类的手可以做任何事情:抓握物体、交流、执行日常任务和学习。某些使用双手有困难的人受到痉挛、手部肌肉不受控制的紧绷和手部运动功能受损的严重影响。具体来说,手痉挛可能是由几种疾病引起的,包括脑瘫、中风、关节炎和腕管。通常一个人的手保持握拳的姿势,导致疼痛和手指的活动受限。市场上存在许多产品,专门帮助满足长时间打开和伸出手的临床需求。个人可以购买产品,但由于价格昂贵,通常只在职业治疗期间使用。Hand Extender是一款专为手部功能使用困难的参与者设计的可穿戴设备,随着时间的推移,Hand Extender旨在支持和帮助他们的手进行日常功能。类似的产品只有几种标准尺寸,这可能导致更不适合,例如,目前市售产品的尺寸不适合儿科人群或手尺寸异常的参与者。手扩展器的定制手套可以通过3D打印部件容纳所有参与者的各种不同的手尺寸。量身定制的手套也提供了更准确的延伸,由于更好的适合。定制的3D手扩展器能够准确地适合两个具有不同大小和正常手功能的成年参与者。
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引用次数: 0
Designing an Accurate Benchtop Characterization Device: An Acoustic Measurement Platform for Localizing and Implementing Therapeutic Ultrasound Devices and Equipment (Amplitude) 设计一个精确的台式表征设备:用于定位和实施治疗超声设备和设备的声学测量平台(振幅)
Pub Date : 2022-04-11 DOI: 10.1115/dmd2022-1046
Ruixing Liang, Max J. Kerensky, Eli Curry, Griffin Mess, Rasika Thombre, Serene Kamal, Fariba Aghabaglou, Richard Mejia, Francisco Chavez, Kyle Morrison, Nitish Thakor, N. Theodore, A. Manbachi
Focused ultrasound (FUS) is becoming widely researched for medical therapies due to its high penetration depth, spatial resolution, and affordability. Applications of FUS range from high intensity focused ultrasound (HIFU) for the ablation of cancerous tumors to low intensity focused ultrasound (LIFU) for the treatment of neurological conditions like essential tremors. A key step in developing these treatments and their corresponding FUS devices is characterizing the emitted ultrasound from the proposed transducer. However, a bottleneck exists at this verification and validation stage; current characterization techniques lack the robustness of reliably recording below a 5μm resolution. This level of accuracy is needed to adequately design devices which can target cells like astrocytes or other desired target tissues at this scale. Our Acoustic Measurement Platform for Localizing and Implementing Therapeutic Ultrasound Devices and Equipment (AMPLITUDE) is a solution which enables engineers, scientists, and clinicians to confidently characterize their equipment in a benchtop setting. It achieves this resolution by utilizing an all-in-one water conditioning unit, linear stepper motors with a theoretical step size of 1 μm and a 1% standard deviation on repetitive experiments, as well as signal processing techniques. This system can be used throughout the product timeline including prototyping, verifying efficacy, FDA testing, and routine check-ups during clinical use.
聚焦超声(FUS)因其高穿透深度、空间分辨率和可负担性而在医学治疗中得到广泛研究。FUS的应用范围从用于癌性肿瘤消融的高强度聚焦超声(HIFU)到用于治疗原发性震颤等神经系统疾病的低强度聚焦超声(LIFU)。开发这些治疗方法及其相应的FUS装置的关键步骤是表征所提出的换能器发射的超声波。然而,在这个验证和确认阶段存在瓶颈;目前的表征技术缺乏在5μm分辨率以下可靠记录的鲁棒性。这种精度水平是需要充分设计的设备,可以靶向细胞,如星形胶质细胞或其他期望的目标组织在这个规模。我们用于定位和实施治疗超声设备和设备的声学测量平台(振幅)是一种解决方案,使工程师,科学家和临床医生能够在台式设置中自信地表征他们的设备。它通过使用一体化水处理单元、理论步长为1 μm、重复实验标准偏差为1%的线性步进电机以及信号处理技术来实现这一分辨率。该系统可以在整个产品时间线中使用,包括原型设计,验证功效,FDA测试和临床使用期间的常规检查。
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引用次数: 0
Control Design and Preliminary Evaluation of a Medical Education Simulator for Ankle Tendon Reflex Assessment Training 踝腱反射评估训练医学教育模拟器的对照设计与初步评价
Pub Date : 2022-04-11 DOI: 10.1115/dmd2022-1072
Yinan Pei, Christopher M. Zallek, E. Hsiao-Wecksler
Ankle (or Achilles) tendon reflex is commonly assessed in a neurological examination. For a clinician trainee to master the correct assessment technique of Achilles tendon reflex and to be able to distinguish among various reflex activity levels indicating health or abnormality, repetitive training and practice are necessary. We propose to develop a robotic medical education training simulator that would generate a realistic reflex behavior depending on the simulated reflex activity level selected when given a tendon tap assessment. This development was based on an existing ankle-foot simulator [5]. A modified sensing system is still under development. In this paper, a reflex model was developed to estimate the ankle reflexive torque based on the input tap force. This reflex model prediction was validated in simulation and then implemented into our robotic simulator prototype. Preliminary benchtop results demonstrated that our simulator was able to accurately deliver the reflexive torque pattern required to simulate the clinical reflex movement to the trainee.
踝(或跟腱)腱反射通常在神经学检查中评估。临床实习医师要掌握正确的跟腱反射评估技术,并能够区分各种反映健康或异常的反射活动水平,需要反复的训练和练习。我们建议开发一个机器人医学教育训练模拟器,该模拟器将根据给定肌腱拍打评估时选择的模拟反射活动水平产生真实的反射行为。这项研究是基于现有的踝足模拟器[5]。一种改进的传感系统仍在开发中。本文建立了基于输入抽头力的踝关节反射力矩估算模型。该反射模型预测在仿真中得到验证,然后在机器人模拟器原型中实现。初步的实验结果表明,我们的模拟器能够准确地向受训者提供模拟临床反射运动所需的反射扭矩模式。
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引用次数: 0
Development and Evaluation of Simulation Education for University of Minnesota Master of Medical Device Innovation Students in a Post-COVID World 后疫情时代明尼苏达大学医疗器械创新硕士学生模拟教育的发展与评价
Pub Date : 2022-04-11 DOI: 10.1115/dmd2022-1066
Courtney Backstrom, Abhishek Chandra, Joseph Hale, Dan Mooradian
The COVID-19 pandemic has fundamentally altered the pedagogical approach to education at every level of training, including at the undergraduate level and graduate or professional level. These unprecedented times have tested academic resilience, agility, creativity, and adaptability in all aspects, including inventive alternative teaching methods. With an increasing reliance on virtual instruction, self-directed learning, and hybrid models of instruction, certain approaches of hands-on training, practice-based learning, and evaluation have had to evolve. The University of Minnesota’s Master of Medical Device Innovation students are typically immersed in clinical environments through physician shadowing in the operating room, evaluating unmet needs and untapped areas of potential innovation. Engineers who can immerse themselves in surgical education, shadowing, and frontline medical experience can better appreciate, recognize, and enhance current medical technologies and processes. With the OR case restrictions in the era of COVID-19, these learners were faced with limited clinical exposure and thus limited familiarity with the dynamics and processes of clinical practice. As such not only education, but the functioning of the entire industry is stunted. From an instructive perspective, this creates a challenge for students attempting to generate relevant and feasible practicum ideas, accurate prototypes, and offers fewer opportunities to develop these ideas alongside the experts and medical professionals - the target audience. Simulation education provides a means for students to engage with clinical practice in a meaningful way that bridges the gap between clinical exposure and virtual learning. A hands-on approach in which students were able to practice fundamental surgical skills of suturing, knot-tying, and the basics of laparoscopy. Learners were offered three didactic workshop sessions that introduced these skills and then were given opportunities to perform with supervision from expert educators. Low-cost, low-fidelity models of pertinent anatomy and physiology provided students an immersive experience that allowed them to develop a deeper understanding of interventional skills. Three two hour-long sessions of guided skills practice on low-cost simulators were attended by the 2022 Masters of Medical Device Innovation cohort and subjective measures of their understanding of the fundamental concepts were evaluated. High-level findings of these workshops suggest that simulation education is an effective tool in advancing the baseline understanding of surgical principles as opposed to virtual instruction and may offer some further benefit, not possible even through clinical shadowing itself.
2019冠状病毒病大流行从根本上改变了各级培训的教学方法,包括本科和研究生或专业水平。这些前所未有的时代在各个方面都考验了学术的弹性、敏捷性、创造力和适应性,包括创造性的替代教学方法。随着对虚拟教学、自主学习和混合教学模式的日益依赖,实践培训、基于实践的学习和评估的某些方法必须发展。明尼苏达大学医疗器械创新硕士的学生通常通过医生在手术室的跟踪,沉浸在临床环境中,评估未满足的需求和未开发的潜在创新领域。能够沉浸在外科教育、实习和一线医疗经验中的工程师可以更好地欣赏、识别和提高当前的医疗技术和流程。由于新冠肺炎时代的手术室病例限制,这些学习者面临的临床接触有限,因此对临床实践的动态和过程的熟悉程度有限。因此,不仅是教育,整个行业的运作都受到了阻碍。从有益的角度来看,这给试图产生相关和可行的实习想法,准确的原型的学生带来了挑战,并且提供了更少的机会与专家和医疗专业人员-目标受众一起发展这些想法。模拟教育为学生提供了一种以有意义的方式参与临床实践的手段,弥合了临床接触和虚拟学习之间的差距。通过动手操作的方法,学生能够练习缝合、打结和腹腔镜基本手术技巧。学习者被提供了三个介绍这些技能的教学研讨会,然后有机会在专家教育工作者的监督下表演。低成本、低保真度的相关解剖学和生理学模型为学生提供了身临其境的体验,使他们能够更深入地了解介入技能。对2022年医疗器械创新硕士队列进行了三次为期两小时的低成本模拟器指导技能练习,并对他们对基本概念的理解进行了主观评估。这些研讨会的高水平研究结果表明,与虚拟教学相比,模拟教育是一种有效的工具,可以促进对外科原理的基本理解,并可能提供一些甚至通过临床实习本身也无法实现的进一步好处。
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引用次数: 0
Evaluation of Endoscope Control Assessment System 内窥镜控制评估系统的评价
Pub Date : 2022-04-11 DOI: 10.1115/dmd2022-1035
Saira Hussain, Yuqi Zhou, Ruiji Liu, E. Pauli, R. Haluck, B. Fell, J. Moore
Colonoscopy procedures are commonly performed to screen the colon for cancer-causing polyps. These procedures require highly trained practitioners and extensive training is necessary to perform proficiently. The Endoscopic Control Assessment System (ECAS) was developed to train and assess practitioners using a magnetic tracker and camera imaging. The magnetic tracker is used to track the tip motion of an endoscope during the insertion and retraction procedure of colonoscopy. In addition, camera imaging is used to track the angle of the control knobs during the procedure. The colon deflection of a manikin during a colonoscopy was successfully tracked to be averaged as 31, 54, and 10 mm for the three trials. Visual processing showed the control knob motion could be successfully tracked during a manikin colonoscopy procedure. The ECAS system was shown to be able to successfully measure user inputs during a manikin procedure.
结肠镜检查通常用于筛查结肠癌息肉。这些程序需要训练有素的从业人员,并且需要广泛的培训才能熟练地执行。内窥镜控制评估系统(ECAS)的开发是为了培训和评估从业人员使用磁跟踪器和相机成像。磁性跟踪器用于在结肠镜插入和收回过程中跟踪内窥镜的尖端运动。此外,相机成像用于跟踪过程中控制旋钮的角度。在结肠镜检查期间,人体模型的结肠偏转成功地跟踪到三个试验的平均为31,54和10mm。视觉处理显示,在人体结肠镜检查过程中,控制旋钮的运动可以成功地跟踪。ECAS系统被证明能够在人体模型过程中成功地测量用户输入。
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引用次数: 1
Fueling Innovation For Medical Devices: An Interactive Market Visualization Studio For Rapid Assessment Of Healthcare Opportunities 推动医疗设备创新:用于快速评估医疗保健机会的交互式市场可视化工作室
Pub Date : 2022-04-11 DOI: 10.1115/dmd2022-1005
Mugdha Tasgaonkar, Maneesh Shrivastav, Michael Brandt
An essential component of innovation for medical devices is a comprehensive market sizing assessment. This evaluation is useful for creating a solid business case and understanding market potential. This project involves the development of an online medical information dashboard for rapid market sizing assessments using business intelligence tools. A Spotfire front end was paired with a robust SQL database with market information. A visually appealing, simple, and clickable user interface was developed. This tool is designed with the technologist in mind and has value in the early prototyping stages of innovative new medical therapies.
医疗器械创新的一个重要组成部分是全面的市场规模评估。这种评估对于创建可靠的业务案例和理解市场潜力非常有用。该项目涉及使用商业智能工具开发用于快速评估市场规模的在线医疗信息仪表板。Spotfire前端与具有市场信息的强大SQL数据库配对。开发了一个视觉上吸引人的、简单的、可点击的用户界面。该工具在设计时考虑了技术专家,在创新的新医学疗法的早期原型阶段具有价值。
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引用次数: 0
On the Impacts of Flow on the Migration and Growth of Cancer Cells 流动对癌细胞迁移和生长的影响
Pub Date : 2022-04-11 DOI: 10.1115/dmd2022-1050
Lahcen Akerkouch, T. Le, Haneesh Jasuja, K. Katti, D. Katti
Our study aims to identify the role of fluid flow in the growth of human bone cancer cells during metastasis. In our experiments, the cancer cells are seeded on the surface of cylindrical scaffolds in a bioreactor. The flow is laminar flow, which mimics the physiological conditions of the human body. A full-scale 3D high-resolution computational mesh of scaffold was created based on the physical scaffold's Micro-CT scans using open-source imaging software Slicer3D and Meshmixer. To investigate the influences of the flow on the seeded cells, we performed Computational Fluid Dynamics (CFD) simulations with the immersed boundary method (Gilmanov, Le, Sotiropoulos, JCP 300, 1, 2015). The computational domain was generated using the commercial software Gridgen. Our results show that the fluid flow velocity is highly dependent on the shape and pore sizes. In addition, the magnitude of the velocity on the surface where the cells are seeded is in between [0-0.05] μm/sallowing the cells to grow without being detached from the surface of the scaffold. Our future work will focus on (i) investigating the role of the shear stress on the distribution and orientation of the cancer cells. (ii) Simulating multiple scaffolds within the bioreactor to further quantify the impact of the gap on the flow velocity and shear.
我们的研究旨在确定液体流动在人骨癌细胞转移过程中生长的作用。在我们的实验中,癌细胞被植入生物反应器的圆柱形支架表面。这种流动是层流,它模仿人体的生理状况。基于实体支架的Micro-CT扫描,利用开源成像软件Slicer3D和Meshmixer创建全尺寸三维高分辨率支架计算网格。为了研究流动对种子细胞的影响,我们使用浸入边界法进行了计算流体动力学(CFD)模拟(Gilmanov, Le, Sotiropoulos, JCP 300, 1, 2015)。利用商业软件Gridgen生成计算域。我们的研究结果表明,流体的流动速度高度依赖于形状和孔径。此外,细胞播种表面的速度大小在[0-0.05]μm/之间,允许细胞在不脱离支架表面的情况下生长。我们未来的工作将集中在(1)研究剪切应力对癌细胞分布和取向的作用。(ii)模拟生物反应器内的多个支架,进一步量化间隙对流速和剪切的影响。
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引用次数: 0
Designing a Murine Model of Human Glioblastoma Brain Tumor: Development of a Platform for Validation Using Ultrasound Elastography 人类胶质母细胞瘤脑肿瘤小鼠模型的设计:超声弹性成像验证平台的开发
Pub Date : 2022-04-11 DOI: 10.1115/dmd2022-1025
Griffin Mess, Rasika Thombre, Max J. Kerensky, Eli Curry, Fariba Abhabaglou, S. Alomari, H. Brem, N. Theodore, B. Tyler, A. Manbachi
Glioblastoma Multiforme (GBM) is a malignant brain cancer with low overall survival. Therefore, researchers are looking to augment its current therapeutic regimen, which includes surgical tumor resection, chemotherapy and radiation. A promising treatment modality, focused ultrasound, has been used as a non-invasive treatment for GBM through multiple approaches such as thermal ablation, immunomodulation, and blood brain barrier disruption. In order to develop these treatments for clinical trials, testing in animal models needs to be performed to investigate the efficacy of the treatment in complex biological environments, as well as to evaluate any side-effects. The more biologically relevant the animal model is to human anatomy, the more applicable the results will be for translation to clinical trials. Here, we report a human GBM rat model, which utilizes an IDH-wildtype, EGFRvIII mutant patient-derived xenograft in athymic rats. The in vivo tumor growth rate was assessed over a period of 20 days to evaluate reproducibility and to develop the model for future testing of FUS in the treatment of GBM.
多形性胶质母细胞瘤(GBM)是一种总体生存率较低的恶性脑癌。因此,研究人员正在寻求增加其目前的治疗方案,包括手术肿瘤切除,化疗和放疗。聚焦超声是一种很有前景的治疗方式,它通过热消融、免疫调节和血脑屏障破坏等多种方法作为GBM的非侵入性治疗方法。为了开发用于临床试验的这些治疗方法,需要在动物模型中进行测试,以调查在复杂的生物环境中治疗的功效,并评估任何副作用。动物模型与人体解剖学的生物学相关性越强,其结果就越适用于临床试验。在这里,我们报道了一个人类GBM大鼠模型,该模型在胸腺大鼠中使用idh野生型,EGFRvIII突变患者来源的异种移植物。在20天的时间内评估体内肿瘤生长速度,以评估可重复性,并为未来测试FUS治疗GBM建立模型。
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引用次数: 0
Development of a New Generation of Neurovascular Devices for the Treatment of Cerebral Bifurcation Aneurysms with the Fusiform Opathology: A Computational Approach 发展新一代神经血管装置治疗脑分叉动脉瘤与梭状病理:计算方法
Pub Date : 2022-04-11 DOI: 10.1115/dmd2022-1075
Mehdi Jahandardoost, D. Grecov, Donald Ricci, A. Milani, Y. Hsiang
Cerebral aneurysm (CA) is an abnormal dilation of the cerebral arterial wall, which accounts for more than half a million deaths each year worldwide. Flow diverters (FDs) represent one method recently developed in treating CAs. Typically, they do not need coiling (releasing micro-coils within the aneurysm) and act purely to prevent substantial blood inflow into the aneurysm. In collaboration with Evasc Neurovascular Enterprises (Vancouver, Canada), whose area of expertise is developing novel CA therapies, we have developed a novel FD for the treatment of bifurcation CAs with fusiform-like properties involving the confluence of the main and daughter branches. To the best of authors’ knowledge, currently there is no device for an effective treatment of such complex aneurysms. Through a stepwise design modification process and utilizing CFD modeling, we have developed a new design for the Evasc FD (eCLIPs) with improved hemodynamics, which is characterized by more than 30% reduction in the aneurysm inflow and wall shear stress (WSS) for the new implant design over eCLIPs for this subset of aneurysms. The new device design, modified-design eCLIPs (MD-eCLIPs), can represent the only device available for the treatment of such CAs with fusiform pathology.
脑动脉瘤(CA)是一种脑动脉壁的异常扩张,每年在世界范围内造成50多万人死亡。分流器(FDs)是最近发展起来的一种治疗CAs的方法。通常,它们不需要缠绕(在动脉瘤内释放微线圈),而仅仅是为了防止大量血液流入动脉瘤。我们与Evasc Neurovascular Enterprises (Vancouver, Canada)合作开发了一种新型FD,用于治疗分叉型CA,这些CA具有梭状样特征,涉及主分支和子分支的交汇处。据作者所知,目前还没有一种设备可以有效治疗这种复杂的动脉瘤。通过逐步设计修改过程并利用CFD建模,我们开发了一种新的Evasc FD (eCLIPs)设计,改善了血流动力学,其特点是在eCLIPs上减少了30%以上的动脉瘤流入和壁面剪切应力(WSS)。新的设备设计,修改设计的eCLIPs (MD-eCLIPs),可以代表唯一可用于治疗梭状病变的ca的设备。
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引用次数: 0
期刊
2022 Design of Medical Devices Conference
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