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AR-CPR 2.0: Validation of the Accuracy and Precision of a Wearable Coaching System for Improving Chest Compression Performance. AR-CPR 2.0:提高胸部按压性能的可穿戴教练系统的准确性和精确性验证
IF 0.7 4区 医学 Q4 ENGINEERING, BIOMEDICAL Pub Date : 2025-02-01 Epub Date: 2025-11-27 DOI: 10.1115/1.4070016
Keith Kleinman, James L Dean, Erika Yu, Blake A Schreurs, Justin M Jeffers

Pediatric cardiopulmonary resuscitation (CPR) quality remains inconsistent, with low adherence to guideline-recommended compression rate and depth. Augmented reality cardiopulmonary resuscitation (AR-CPR) is an augmented reality feedback system designed to improve CPR performance using real-time, in-view coaching via smart glasses. To validate the accuracy and precision of the AR-CPR system in measuring chest compression rate and depth across clinically relevant ranges, we tested AR-CPR using a programable oscillation platform at five rates (100-140 compressions per minute (CPM)) and four depths (4.0-5.5 cm), and with the Stryker LUCAS3 device at 102 CPM and 5.3 cm. A total of 473 compressions (slide test) and 559 compressions (LUCAS3 test) were analyzed. Statistical methods included intraclass correlation coefficients (ICC[2,1]), paired t-tests, Bland-Altman analysis, root-mean-square error (RMSE), kernel density estimation for error distribution, and group error modeling to estimate clinical thresholds (±2.5 CPM, ±0.5 cm). Linearity was assessed via linear regression. The AR-CPR system demonstrated high accuracy and reliability in 473 simulated and 559 mechanical compressions. Mean biases were minimal for rate (-0.48, -0.44 CPM) and depth (+0.39, +0.59 cm), with excellent ICCs (0.997 rate, 0.944 depth). Errors were normally distributed, with <7% exceeding clinically relevant thresholds. R2 values (0.994 rate, 0.903 depth) confirmed strong linear agreement with reference values. AR-CPR reliably measured compression rate and depth with high accuracy and precision across variable and fixed testing conditions. Its portability, real-time feedback, and robust signal processing support its potential for improving pediatric resuscitation training and clinical performance.

小儿心肺复苏(CPR)质量仍然不一致,对指南推荐的按压率和按压深度的依从性较低。增强现实心肺复苏(AR-CPR)是一种增强现实反馈系统,旨在通过智能眼镜进行实时、可视指导,提高心肺复苏的效果。为了验证AR-CPR系统在临床相关范围内测量胸部按压率和深度的准确性和精确性,我们使用可编程振荡平台在五种速率(100-140次按压每分钟(CPM))和四种深度(4.0-5.5 cm)下测试AR-CPR,并使用Stryker LUCAS3装置在102 CPM和5.3 cm下测试AR-CPR。共分析473例(滑动试验)和559例(LUCAS3试验)。统计方法包括类内相关系数(ICC[2,1])、配对t检验、Bland-Altman分析、均方根误差(RMSE)、误差分布核密度估计和组误差建模来估计临床阈值(±2.5 CPM,±0.5 cm)。通过线性回归评估线性。AR-CPR系统在473次模拟和559次机械按压中表现出较高的准确性和可靠性。平均偏差最小的速率(-0.48,-0.44 CPM)和深度(+0.39,+0.59 cm),良好的icc(0.997率,0.944深度)。误差呈正态分布,2个值(0.994率,0.903深度)与参考值线性吻合。AR-CPR在可变和固定的测试条件下,以高精度可靠地测量压缩率和深度。它的便携性、实时反馈和强大的信号处理支持其改善儿科复苏训练和临床表现的潜力。
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引用次数: 0
Controlled Ice Nucleation With a Sand-PDMS Film Device Enhances Cryopreservation of Mouse Preantral Ovarian Follicles. 利用 Sand-PDMS 薄膜装置控制冰核形成可提高小鼠前卵巢卵泡的冷冻保存效果。
IF 0.7 4区 医学 Q4 ENGINEERING, BIOMEDICAL Pub Date : 2024-12-01 Epub Date: 2024-09-30 DOI: 10.1115/1.4066445
Samantha Stewart, Alisa White, Wenquan Ou, Wei Liu, Jennifer Nagashima, Nucharin Songsasen, Xiaoming He

Ovarian follicle cryopreservation is a promising strategy for fertility preservation; however, cryopreservation protocols have room for improvement to maximize post-thaw follicle viability and quality. Current slow-freezing protocols use either manual ice-seeding in combination with expensive programmable-rate freezers or other clinically incompatible ice initiators to control the ice-seeding temperature in the extracellular solution, a critical parameter that impacts post-cryopreservation cell/tissue quality. Previously, sand has been shown to be an excellent, biocompatible ice initiator, and its use in cryopreservation of human induced pluripotent stem cells enables high cell viability and quality after cryopreservation. This study applies sand as an ice initiator to cryopreserve multicellular microtissue, preantral ovarian follicles, using a simple slow-freezing protocol in the mouse model. Ovarian follicles cryopreserved using the sand partially embedded in polydimethylsiloxane (PDMS) film to seed ice in the extracellular solution exhibit healthy morphology, high viability, and the ability to grow similarly to fresh follicles in culture post-thaw. This sand-based cryopreservation strategy can facilitate convenient ovarian follicle cryopreservation using simple equipment, and this study further demonstrates the translatability of this strategy to not only single cells but also multicellular tissues.

卵泡冷冻保存是一种很有前景的生育力保存策略;然而,冷冻保存方案仍有改进的余地,以最大限度地提高卵泡解冻后的存活率和质量。目前的缓慢冷冻方案要么使用人工植冰,要么使用昂贵的可编程速率冷冻机或其他临床上不兼容的冰启动器来控制细胞外溶液中的植冰温度,而这是影响冷冻保存后细胞/组织质量的关键参数。以前的研究表明,沙子是一种生物相容性极佳的冰引发剂,将其用于人类诱导多能干细胞的冷冻保存可使细胞在冷冻保存后具有较高的存活率和质量。本研究在小鼠模型中采用简单的缓慢冷冻方案,将沙子作为冰引发剂冷冻保存多细胞微组织--前卵巢卵泡。使用部分包埋在聚二甲基硅氧烷(PDMS)薄膜中的沙子在细胞外溶液中播撒冰种子进行冷冻保存的卵泡形态健康、存活率高,并能在解冻后与新鲜卵泡在培养液中相似地生长。这种基于沙子的冷冻保存策略可以方便地使用简单的设备进行卵泡冷冻保存,这项研究进一步证明了这种策略不仅适用于单细胞,也适用于多细胞组织。
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引用次数: 0
A Novel Design Method for the Knee Joint of the Exoskeleton Based On the Modular Wearable Sensor 基于模块化可穿戴传感器的外骨骼膝关节设计新方法
4区 医学 Q4 ENGINEERING, BIOMEDICAL Pub Date : 2023-10-07 DOI: 10.1115/1.4063672
Jian Cao, Chang Wang, Jianhua Zhang, Kexiang Li, Jianjun Zhang
Abstract This paper innovatively proposes an artificial knee joint customization design scheme based on modular wearable sensors. It aims to solve the compatibility and security problem of wearable devices for different individual knee joints. The method consists of two main parts: measurement and customization. A wearable sensor with three joints is proposed and analyzed. The sensor can measure the kinematic characteristics of human knee joints to obtain the customized design parameters of artificial joints. Designed a bionic four-link knee joint, and the parameters of the connecting rod were optimized by a genetic algorithm based on the measured data. In particular, the measuring device and knee joint are designed in a modular way, and they can be used on the same platform. The modular design method can be used to customize joints for different individuals, which simplifies the difficulty of customization and effectively reduces the cost. After the modular knee joint's optimized design, this paper mainly conducted a number of comparative tests. The comparative test results of three joints show that the dynamic tracking accuracy of customized joints is 54.9% higher than that of ordinary joints and 70.5% higher than that of hinge joints. The results show that personalized customization for individuals can improve human-machine coupling performance.
创新性地提出了一种基于模块化可穿戴传感器的人工膝关节定制设计方案。旨在解决不同个体膝关节可穿戴设备的兼容性和安全性问题。该方法包括两个主要部分:测量和定制。提出并分析了一种具有三关节的可穿戴传感器。该传感器可以测量人体膝关节的运动特性,从而获得定制的人工关节设计参数。设计了仿生四连杆膝关节,并基于实测数据采用遗传算法对连杆参数进行了优化。其中,测量装置和膝关节采用模块化设计,可在同一平台上使用。采用模块化设计方法可针对不同个体定制关节,简化了定制难度,有效降低了成本。在模块化膝关节优化设计后,本文主要进行了多项对比试验。三种关节的对比试验结果表明,定制关节的动态跟踪精度比普通关节高54.9%,比铰链关节高70.5%。结果表明,针对个体的个性化定制可以提高人机耦合性能。
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引用次数: 0
Experimental Investigation of the Calcified Plaque Material Removal Rate in Coronary Rotational Atherectomy 冠脉旋转动脉粥样硬化切除术中钙化斑块材料去除率的实验研究
4区 医学 Q4 ENGINEERING, BIOMEDICAL Pub Date : 2023-10-07 DOI: 10.1115/1.4063671
Xinxiao Li, Jiaqi Yang, Patrick Chernjavsky, Katerina Angjeli, Yang Liu, Yihao Zheng
Abstract Rotational atherectomy (RA) is a minimally invasive procedure to remove the calcified atherosclerotic plaque from arteries to restore blood flow. It uses a high-speed, metal-bonded diamond abrasive grinding wheel to pulverize the calcified plaque into absorbable debris via a catheter through the artery. Although RA has been clinically used for over two decades, procedural complications persist and there remains a lack of consensus on the optimal device parameters. This study aims to investigate RA material removal rate (MRR) with respect to grinding wheel sizes and rotational speeds based on a tissue-mimicking phantom. Three grinding wheel sizes, 1.25, 1.5, and 1.75 mm in diameter, and three rotational speeds, 120,000, 150,000, and 180,000 rpm, were investigated. The RA MRR was presented as the luminal area gain and measured by microscopy and image processing. The results show the increase of the grinding wheel size or rotational speed leads to a higher MRR and luminal gain in RA. With a 1.75 mm diameter grinding wheel rotating at 180,000 rpm in a 2 mm initial diameter lumen, the max MRR and the luminal gain are 2.49 mm2/(three passes) and 5.09 mm2, respectively. The MRR decreases as the number of grinding passes increases during RA with the same grinding wheel rotating at a constant speed. This study provides a thorough understanding of the wheel size and speed effects on RA MRR for improvements in RA devices and clinical operational guidelines.
旋转动脉粥样硬化切除术(RA)是一种微创手术,从动脉中去除钙化的动脉粥样硬化斑块,以恢复血液流动。它使用高速金属结合金刚石磨料砂轮,通过导管穿过动脉,将钙化斑块磨成可吸收的碎片。尽管RA在临床上已经使用了二十多年,但手术并发症仍然存在,并且对最佳装置参数缺乏共识。本研究旨在研究基于组织模拟模型的RA材料去除率(MRR)与砂轮尺寸和转速的关系。研究了直径为1.25、1.5和1.75 mm的三种砂轮尺寸,以及120,000、150,000和180,000 rpm的三种转速。RA MRR以管腔面积增益表示,并通过显微镜和图像处理进行测量。结果表明,砂轮尺寸和转速的增加会导致RA的MRR和光增益的增加。当直径为1.75 mm的砂轮在初始直径为2 mm的流明内以180,000 rpm转速旋转时,最大MRR和流明增益分别为2.49 mm2/(三道)和5.09 mm2。同一砂轮匀速旋转时,MRR随磨削道次的增加而减小。本研究对车轮尺寸和速度对RA MRR的影响提供了深入的了解,为RA设备的改进和临床操作指南提供了依据。
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引用次数: 0
Assessment of a Novel Application of the Capture-Trap-Terminate Approach for Treating Aerosol Products During Dental Procedures 评估捕获-捕获-终止方法在牙科过程中处理气溶胶产品的新应用
4区 医学 Q4 ENGINEERING, BIOMEDICAL Pub Date : 2023-09-16 DOI: 10.1115/1.4063457
Muh Anshar, Erni Marlina, Yossy Yoanita, Muhammad Ruslin, Dewiani Djamaluddin, Muhammad Arsyad Thaha, Muhammad Rusman, Andi Sitti Hajrah Yusuf
Abstract The present study aimed to report a novel developed technology for disinfecting pathogens in aerosols produced by dental health applications. The proposed method was integrated into a disinfection room installed inside an extraoral dental aerosol suction system. The experimental phase was designed to measure the application of the system during dental care management. These experiments assessed the effectiveness of the proposed mechanism in disinfecting captured microorganisms. The results showed that the system reduced the quantity and coverage area of harmful splatters and aerosols by ~50%. Future studies should verify the effectiveness of the approach for measuring the temperature inside the disinfection room and the number of pathogens, including coronavirus, that remains after the disinfection process.
摘要:本研究旨在报道一种新的开发技术,用于消毒口腔卫生应用中生产的气溶胶中的病原体。所提出的方法被整合到安装在口腔外口腔气溶胶吸入系统内的消毒室中。实验阶段旨在衡量该系统在牙科护理管理中的应用。这些实验评估了所提出的机制对捕获的微生物进行消毒的有效性。结果表明,该系统可减少有害飞溅物和气溶胶的数量和覆盖面积约50%。未来的研究应验证测量消毒室内温度和消毒过程后剩余病原体(包括冠状病毒)数量的方法的有效性。
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引用次数: 0
Development And Mechanical Testing Of Implant For Cranial Reconstruction After Burr Hole Trepanation 钻孔后颅骨重建种植体的研制及力学性能测试
IF 0.9 4区 医学 Q4 ENGINEERING, BIOMEDICAL Pub Date : 2023-09-04 DOI: 10.1115/1.4063344
Julia Bodnarova, Adam Kratochvil, Matej Daniel
Burr hole trepanation is a surgical procedure in which one or more small holes, or trephines, are made in the skull to allow for the drainage of fluids or to relieve pressure within the skull. Burr hole trepanation is generally considered a safe and effective treatment for conditions such as brain abscesses and subdural hematomas. However, the bone defects must be closed after the surgery with a suitable implant. Current designs are mostly based on bone plates with limited lifetime, revision access, and low aesthetic. Within this study, a new type of cranial implant is proposed made using additive manufacturing (AM) techniques. The implant is anchored in the burr hole and does not penetrate the skull space or prominate the skull. Four different types of implants have been proposed on the basis of an analytical model and verified using finite element analysis (FEA). New push-in mechanical tests are introduced using artificial bone to determine the strength of the locking mechanisms and ensure the safety of implants. The burr-hole implant with an overlap on the bone surface after implantation was proven to be the safest solution. The design of the new cranial implant can significantly improve the aesthetic outcome after surgery and minimize invasiveness in reoperations.
钻孔穿刺术是一种外科手术,在颅骨上打一个或多个小孔或钻孔,以便排出液体或缓解颅骨内的压力。钻孔钻孔术通常被认为是一种安全有效的治疗脑脓肿和硬膜下血肿的方法。然而,骨缺损必须在手术后用合适的种植体封闭。目前的设计大多基于骨板,其使用寿命有限,可进行翻修,美观度低。在本研究中,提出了一种使用增材制造(AM)技术制造的新型颅骨植入物。植入物固定在毛刺孔内,不穿透颅骨间隙或突出颅骨。在分析模型的基础上提出了四种不同类型的植入物,并使用有限元分析(FEA)进行了验证。介绍了采用人工骨的新型推入式力学试验,以确定锁定机构的强度,确保植入物的安全性。在骨表面重叠的钻孔种植体被证明是最安全的解决方案。新颅种植体的设计可以显著改善术后的美观效果,并减少再手术的侵入性。
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引用次数: 0
Preliminary Assessment of a Laparoscopic Training System Using Magneto-Rheological Clutches and Virtual Reality 基于磁流变离合器和虚拟现实的腹腔镜训练系统的初步评估
4区 医学 Q4 ENGINEERING, BIOMEDICAL Pub Date : 2023-09-01 DOI: 10.1115/1.4063389
Bruno-Pier Busque, Louis-Philippe Lebel, Yves Collin, Jean-Sébastien Plante
Abstract Although laparoscopy has revolutionized modern medicine, its training remains long and complex due to reduced haptic feedback and loss of depth perception. Training also poses an ethical challenge when performed on living patients, and access to cadavers is becoming rare and difficult. In the early 2000s, medical simulators began to appear to help mitigate these problems: virtual reality simulators (VRS) and physical reality simulators (PRS). Current VRS can provide guidance and performance evaluation with fewer instructors but are expensive and bulky. PRS, on the other hand, are less expensive, compact and offer haptic feedback through real physical interactions with mockup objects. However, they require guidance from an instructor, and cannot provide objective assessment or complex and realistic surgical scenarios. This paper assesses the potential of a VRS based on magneto-rheological (MR) actuators that could offer the haptic capabilities of current VRS with the size envelopes of PRS. Technical specifications for a laparoscopic VRS are extracted from the literature, a prototype is built and evaluated experimentally. In addition, three simulation scenarios are built and presented to surgeons to confirm simulation capabilities. In its current form, the MR-powered prototype is shown to meet targeted functional specifications but future work is needed to reduce friction, reduce size, and optimize packaging.
虽然腹腔镜手术已经彻底改变了现代医学,但由于触觉反馈减少和深度知觉丧失,其训练仍然漫长而复杂。当对活着的病人进行训练时,也会带来道德上的挑战,而且接触尸体变得越来越罕见和困难。在21世纪初,医疗模拟器开始出现,以帮助缓解这些问题:虚拟现实模拟器(VRS)和物理现实模拟器(PRS)。目前的VRS可以用较少的指导员提供指导和性能评估,但价格昂贵且体积庞大。另一方面,PRS更便宜,更紧凑,并通过与模型物体的真实物理交互提供触觉反馈。然而,他们需要教练的指导,不能提供客观的评估或复杂而现实的手术场景。本文评估了基于磁流变(MR)致动器的VRS的潜力,该致动器可以提供当前VRS的触觉能力和PRS的尺寸信封。从文献中提取了腹腔镜VRS的技术指标,建立了样机并进行了实验评估。此外,建立了三个模拟场景,并向外科医生展示,以验证模拟能力。在目前的形式下,mr驱动的原型被证明满足目标功能规格,但需要未来的工作来减少摩擦,减小尺寸和优化包装。
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引用次数: 0
A Novel Quasilinear Viscoelastic Model of the Bending of a Steerable Catheter 一种新型的可操纵导管弯曲拟线性粘弹性模型
IF 0.9 4区 医学 Q4 ENGINEERING, BIOMEDICAL Pub Date : 2023-08-23 DOI: 10.1115/1.4063215
Jajun Ryu, Jung-Hwa Ahn, Hwa-Young Kim
The present study proposes a novel model that establishes the relationship between the bending moment and the curvature of a steerable catheter. The catheters exhibit a nonlinear viscoelastic tendency, so the moment-curvature relationship is modeled as a bending of a quasilinear viscoelastic (QLV) cantilever beam. Stress relaxation tests with multiple magnitudes are performed on a catheter, and the parameter tuning is carried out with the test results to find out the coefficients of the model. The form of the instantaneous moment response, which is an important term within the QLV equation, is selected as a logarithmic form by analyzing the test results. This differentiates the accuracy of the model from using the commonly used exponential form. The performance of the logarithmic QLV model is compared to the conventional models by checking the curvature range each model can cover with a certain accuracy. The covering range for elastic, linear viscoelastic, and exponential QLV models are 22.1%, 64.4%, and 55.5%, respectively, whereas the covering range of the logarithmic QLV model is 100%.
本研究提出了一种新的模型,建立了可操纵导管弯矩与曲率之间的关系。导管表现出非线性粘弹性倾向,因此弯矩-曲率关系被建模为准线性粘弹性悬臂梁的弯曲。对导管进行了多量级的应力松弛试验,并根据试验结果进行了参数整定,得到了模型的系数。通过对试验结果的分析,选择QLV方程中重要的一项瞬时矩响应形式为对数形式。这区别于使用常用的指数形式的模型的准确性。通过检查每个模型在一定精度下所能覆盖的曲率范围,将对数QLV模型的性能与传统模型进行比较。弹性、线性粘弹性和指数QLV模型的覆盖范围分别为22.1%、64.4%和55.5%,而对数QLV模型的覆盖范围为100%。
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引用次数: 0
Trajectory Planning Software for Deep Brain Stimulation Driven by Patient Specific Data 由患者特定数据驱动的脑深部刺激轨迹规划软件
IF 0.9 4区 医学 Q4 ENGINEERING, BIOMEDICAL Pub Date : 2023-08-11 DOI: 10.1115/1.4063142
Kathryn R Marusich, N. Harel, Matthew D. Johnson, Paul Rothweiler, A. Erdman
Deep brain stimulation (DBS) is a treatment for several neurological disorders including Parkinson's Disease, Essential tremor, and Epilepsy. The neurosurgical procedure involves implanting a lead of electrodes to a deep brain target and thereafter electrically stimulating that target to suppress symptoms. To reduce the probability of intracranial bleeding during implantation, neurosurgeons carefully plan out a patient-specific lead trajectory that avoids passing the lead through regions with major blood vessels. This process can be tedious, and there is a need to provide neurosurgeons with a more efficient and quantitative means to identify major blood vessels on a patient specific basis. Here, we developed a modular graphical user interface (GUI) containing anatomically segmented digital reconstructions of patient vasculature, cortex, and deep brain target anatomy from preoperative high-field (3T and 7T) MRI. The system prompts users to identify the deep brain target, and then algorithmically calculates a log-scale blood vessel density along the length of potential lead trajectories that pivot around the deep brain target. Heatmaps highlighting regions with low blood vessel density were calculated for cortical and subcortical vasculature models. The modeling framework enabled users to further interact with the models by panning, rotating, zooming, showing, or hiding the various anatomical reconstructions and heatmaps. Providing surgeons with quantitative, patient specific vasculature data has potential to further reduce the likelihood of hemorrhage events during microelectrode mapping and DBS lead implantation.
脑深部刺激(DBS)是一种治疗多种神经系统疾病的方法,包括帕金森病、原发性震颤和癫痫。神经外科手术过程包括将一串电极植入大脑深部目标,然后对目标进行电刺激以抑制症状。为了减少植入过程中颅内出血的可能性,神经外科医生仔细规划了一个针对患者的导联轨迹,以避免导联穿过有大血管的区域。这个过程可能很繁琐,需要为神经外科医生提供一种更有效、更定量的方法,根据患者的具体情况识别主要血管。在这里,我们开发了一个模块化的图形用户界面(GUI),其中包含了术前高场(3T和7T) MRI对患者脉管系统、皮层和深部脑靶解剖的解剖分割数字重建。该系统提示用户识别深部脑目标,然后通过算法计算出围绕深部脑目标的潜在导程长度的对数尺度血管密度。计算皮层和皮层下血管模型中血管密度低区域的热图。建模框架使用户能够通过平移、旋转、缩放、显示或隐藏各种解剖重建和热图来进一步与模型交互。为外科医生提供定量的、患者特异性的血管数据有可能进一步减少微电极定位和DBS导联植入期间出血事件的可能性。
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引用次数: 0
Surgical Microgrippers: A Survey And Analysis 外科显微夹持器:调查与分析
IF 0.9 4区 医学 Q4 ENGINEERING, BIOMEDICAL Pub Date : 2023-07-11 DOI: 10.1115/1.4062950
L. Pasaguayo, Z. Al Masry, Sergio Lescano, N. Zerhouni
This review article provides an overview of some challenges that arise when developing new medical robotic microgrippers. The main challenges are due to miniaturization and are present in the manufacturing and assembly processes, the types of mechanisms, the biomaterials used, the actuation principles, and the compliance with some standards and regulations. The main medical fields where these microgrippers are used are in MIS and biomedical applications. Therefore, taking these two large groups into account, this review presents a microgrippers classification according to the type of mechanism used (traditional rigid-body mechanisms and complaint mechanisms). Moreover, parameters such as applications, functionalities, DOF, sizes, range of motion, biomaterial used, and proposed methods are highlighted. In total, the analysis of 21 microgrippers among commercial and developed by research institutes is presented.
这篇综述文章概述了在开发新型医疗机器人微撕裂器时出现的一些挑战。主要挑战是小型化,存在于制造和组装过程、机构类型、使用的生物材料、驱动原理以及对一些标准和法规的遵守方面。使用这些微撕裂器的主要医疗领域是MIS和生物医学应用。因此,考虑到这两大类,本综述根据所使用的机构类型(传统的刚体机构和投诉机构)对微撕裂机进行了分类。此外,还重点介绍了应用、功能、自由度、尺寸、运动范围、使用的生物材料和提出的方法等参数。对商业和研究机构开发的21种微型抛石机进行了分析。
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引用次数: 1
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Journal of Medical Devices-Transactions of the Asme
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