Equipment Failure Analysis

设备故障分析
  • 文章类型: Journal Article
    In modern ophthalmic surgery, an intraocular lens (IOL) is commonly implanted into the patient\'s eye with an IOL injector. Many injectors are available, showing various technological differences, from the early manually loaded injector systems to the modern preloaded injectors. This review aims to give a concise overview of the defining characteristics of injector models and draws attention to complications that may occur during IOL implantation. One can differentiate injectors according to their preoperative preparation (manually loaded or preloaded), their implantation mechanism (push-type or screw-type or combined or automated), the size of the nozzle tip, the presence of an insertion depth control feature, and the injector\'s reusability. Potential complications are IOL misconfigurations such as a haptic-optic adhesion, adherence of the IOL to the injector plunger, an overriding plunger, uncontrolled IOL rotation, a trapped trailing haptic, or damage to the IOL. Additionally, during IOL implantation, the nozzle can become damaged with scratches, extensions, cracks, or bursts to the tip. While these complications rarely produce long-term consequences, manufacturers should try to prevent them by further improving their devices. Similarly, surgeons should evaluate new injectors carefully to ensure the highest possible surgical safety.
    In der modernen Augenchirurgie wird eine Intraokularlinse (IOL) i. d. R. mithilfe eines IOL-Injektors in das Auge implantiert. Es gibt eine Vielzahl von Injektoren, die sich technologisch unterscheiden, von den frühen manuell zu ladenden Injektorsystemen bis hin zu den moderneren vorgeladenen IOL-Injektoren. Dieser Übersichtsartikel soll einen prägnanten Überblick über die charakteristischen Merkmale der unterschiedlichen Injektormodelle geben und auf Komplikationen aufmerksam machen, die während der IOL-Implantation auftreten können. Die Injektoren lassen sich nach ihrer präoperativen Vorbereitung (manuell geladen oder vorgeladen), ihrem Implantationsmechanismus (Druck- oder Schraubmechanismus, eine Kombination von beidem oder ein Automatismus), der Größe der Injektorspitze, dem Vorhandensein einer Funktion zur Kontrolle der Einführtiefe und der Wiederverwendbarkeit des Injektors unterscheiden. Zu den potenziellen Komplikationen gehören Fehlkonfigurationen der IOL, wie z. B. eine Haptik-Optik-Adhäsion, ein Anhaften der IOL am Kolben des Injektors, ein vorbeischiebender Injektorkolben, eine unkontrollierte IOL-Rotation, eine eingeklemmte Haptik oder eine Beschädigung der IOL. Darüber hinaus kann die Injektorspitze während der IOL-Implantation durch Kratzer, Ausdehnungen, Risse oder Aufplatzen der Spitze beschädigt werden. Obwohl diese Komplikationen selten langfristige Folgen haben, sollten die Hersteller versuchen, das Auftreten von Komplikationen durch weitere Verbesserungen der Injektoren zu verhindern. In der Zwischenzeit sollten Chirurgen vor der IOL-Implantation die IOL-Injektor-Systeme genaustens begutachten, um eine größtmögliche chirurgische Sicherheit zu gewährleisten.
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  • 文章类型: Journal Article
    目的:皮下植入式心律转复除颤器(S-ICD)已在预防心源性猝死中确立,与经静脉除颤器系统相比有一些优势,包括较低的引线故障发生率。尽管技术进步,S-ICD携带者可能患有严重的并发症,例如电池过早耗尽(PBD),这导致了近4万名患者的咨询。这项多中心研究评估了大量S-ICD患者中PBD的发生率。
    结果:回顾了2012年10月至2023年7月在欧洲和美国的9个中心植入S-ICD模型A209和A219的患者的数据。PBD的发生率和影响,定义为临床观察到的电池寿命突然下降,进行了分析,并与60个月内电池耗尽的定义的PBD进行了比较。前瞻性收集的临床数据从病历中获得,设备遥测,和制造商报告。该注册表列在ClinicalTrials.gov(NCT05713708)上。在分析的1112台S-ICD装置中,547(49.2%)配备了与PBD事件相关的潜在受影响的电容器,目前在食品和药物管理局的咨询。所有患者的中位随访时间为46[四分位距(IQR)24-63]个月。在159例(29.1%)中观察到临床怀疑的PBD,去除或更换发电机的中位时间为65个月(IQR55-72),表明与预期电池寿命有显著偏差。在91.7%的返回用于分析的设备中,制造商确认了PBD。未在未咨询的装置中观察到PBD病例。
    结论:这项独立于制造商的分析强调了在咨询下配备S-ICD模型的患者中PBD的显著发生率,本研究中PBD的比率与制造商目前估计的比率相对应。据我们所知,本研究提供了当代最大的同行评审研究队列,调查了S-ICD患者中PBD的实际发病率.这些发现强调了上市后注册在临床医生和制造商之间合作以优化S-ICD治疗的安全性和有效性的重要性。
    OBJECTIVE: Subcutaneous implantable cardioverter-defibrillators (S-ICDs) have become established in preventing sudden cardiac death, with some advantages over transvenous defibrillator systems, including a lower incidence of lead failures. Despite technological advancements, S-ICD carriers may suffer from significant complications, such as premature battery depletion (PBD), that led to an advisory for nearly 40 000 patients. This multicentre study evaluated the incidence of PBD in a large set of S-ICD patients.
    RESULTS: Data from patients implanted with S-ICD models A209 and A219 between October 2012 and July 2023 across nine centres in Europe and the USA were reviewed. Incidence and implications of PBD, defined as clinically observed sudden drop in battery longevity, were analysed and compared to PBD with the definition of battery depletion within 60 months. Prospectively collected clinical data were obtained retrospectively from medical records, device telemetry, and manufacturer reports. This registry is listed on ClinicalTrials.gov (NCT05713708). Of the 1112 S-ICD devices analysed, 547 (49.2%) were equipped with a potentially affected capacitor linked to PBD occurrence, currently under Food and Drug Administration advisory. The median follow-up time for all patients was 46 [inter-quartile range (IQR) 24-63] months. Clinically suspected PBD was observed in 159 (29.1%) of cases, with a median time to generator removal or replacement of 65 (IQR 55-72) months, indicative of significant deviations from expected battery lifespan. Manufacturer confirmation of PBD was made in 91.7% of devices returned for analysis. No cases of PBD were observed in devices that were not under advisory.
    CONCLUSIONS: This manufacturer-independent analysis highlights a notable incidence of PBD in patients equipped with S-ICD models under advisory, and the rate of PBD in this study corresponds to the rate currently estimated by the manufacturer. To the best of our knowledge, this provides the largest contemporary peer-reviewed study cohort investigating the actual incidence of PBD in S-ICD patients. These findings emphasize the importance of post-market registries in collaboration between clinicians and the manufacturer to optimize safety and efficacy in S-ICD treatment.
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  • 文章类型: Journal Article
    目的:对描述基于规则的临床决策支持(CDS)故障的研究进行范围审查。
    方法:2022年4月,我们检索了三个书目数据库(MEDLINE,CINAHL,和Embase)引用CDS故障的文献。我们根据现有的CDS故障分类对识别出的故障进行了编码,并为尚未捕获的因素添加了新的类别。我们还提取和总结了与CDS系统相关的信息,比如建筑,数据源,和数据格式。
    结果:28篇文章符合纳入标准,捕获130个故障。使用的架构包括独立系统(例如,基于网络的计算器),集成系统(例如,最佳实践警报),和面向服务的体系结构(例如,分布式系统,如SMART或CDSHooks)。没有发现基于标准的CDS故障。原始分类法的“原因”类别包括三种新类型(组织策略、硬件错误,和数据源)和两个现有的原因被扩展到包括额外的层。只有29个故障(22%)描述了故障对患者护理的潜在影响。
    结论:虽然存在大量关于CDS的研究,我们的审查表明,对CDS故障的关注有限,对与SMART和CDSHooks等现代交付架构相关的故障的关注甚至更少。
    结论:CDS故障可以并且确实发生在几种不同的护理交付架构中。考虑到卫生信息技术的进步,CDS故障的现有分类必须不断更新。这对于面向服务的体系结构尤其重要,连接几个不同的系统,并且正在增加使用。
    OBJECTIVE: Conduct a scoping review of research studies that describe rule-based clinical decision support (CDS) malfunctions.
    METHODS: In April 2022, we searched three bibliographic databases (MEDLINE, CINAHL, and Embase) for literature referencing CDS malfunctions. We coded the identified malfunctions according to an existing CDS malfunction taxonomy and added new categories for factors not already captured. We also extracted and summarized information related to the CDS system, such as architecture, data source, and data format.
    RESULTS: Twenty-eight articles met inclusion criteria, capturing 130 malfunctions. Architectures used included stand-alone systems (eg, web-based calculator), integrated systems (eg, best practices alerts), and service-oriented architectures (eg, distributed systems like SMART or CDS Hooks). No standards-based CDS malfunctions were identified. The \"Cause\" category of the original taxonomy includes three new types (organizational policy, hardware error, and data source) and two existing causes were expanded to include additional layers. Only 29 malfunctions (22%) described the potential impact of the malfunction on patient care.
    CONCLUSIONS: While a substantial amount of research on CDS exists, our review indicates there is a limited focus on CDS malfunctions, with even less attention on malfunctions associated with modern delivery architectures such as SMART and CDS Hooks.
    CONCLUSIONS: CDS malfunctions can and do occur across several different care delivery architectures. To account for advances in health information technology, existing taxonomies of CDS malfunctions must be continually updated. This will be especially important for service-oriented architectures, which connect several disparate systems, and are increasing in use.
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  • 文章类型: Journal Article
    在二十一世纪初,随着显微镜技术的进步,壁虎爬垂直墙壁的能力已经进行了广泛的研究。前所未有的研究和发展集中在粘附机理上,结构设计,制备方法,和生物启发干粘合剂的应用。值得注意的是,已发现并提出了坚持接触分裂和应力均匀分布原则的强粘附力。柔性电子皮肤的日益普及,柔软的爬行机器人,和智能组装系统已经使可切换的粘合性能对于智能粘合剂至关重要。这些粘合剂被设计为可编程的和可切换的,以响应外部刺激,如磁场,热变化,电信号,曝光以及机械过程。本文全面回顾了生物启发干粘合剂从实现强粘合到实现可转换粘合的发展历史。 .
    In the early twenty-first century, extensive research has been conducted on geckos\' ability to climb vertical walls with the advancement of microscopy technology. Unprecedented studies and developments have focused on the adhesion mechanism, structural design, preparation methods, and applications of bioinspired dry adhesives. Notably, strong adhesion that adheres to both the principles of contact splitting and stress uniform distribution has been discovered and proposed. The increasing popularity of flexible electronic skins, soft crawling robots, and smart assembly systems has made switchable adhesion properties essential for smart adhesives. These adhesives are designed to be programmable and switchable in response to external stimuli such as magnetic fields, thermal changes, electrical signals, light exposure as well as mechanical processes. This paper provides a comprehensive review of the development history of bioinspired dry adhesives from achieving strong adhesion to realizing switchable adhesion.
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  • 文章类型: Journal Article
    这项工作研究了人工鞭毛微型游泳者(AFMS)的声学驱动运动,并将这些微型游泳者的运动性与基于校正阻力理论(CRFT)和我们先前工作中提出的杠关节模型的预测进行了比较。该理论的关键要素是引入校正因子Kin阻力系数以校正常规阻力理论,从而可以准确地对具有矩形横截面的声学致动AFMS的动力学进行建模。实验上,这样的AFMS可以基于UV可固化树脂的数字光处理(DLP)容易地制造。我们首先通过动态力学分析(DMA)确定了UV固化树脂的粘弹性。特别是,基于时间-温度叠加(TTS)的假设,获得了高频储能模量和损耗因子,然后应用于理论计算中。尽管基于TTS的外推法暗示了高频材料响应的不确定性,并且确定磁头振荡幅度的准确性有限,AFMS的测量终端速度与预测终端速度之间的差异小于50%,which,对我们来说,是可以接受的。这些结果表明,声学AFMS的运动可以预测,因此,设计,这为他们期待已久的靶向治疗应用铺平了道路。
    This work examines the acoustically actuated motions of artificial flagellated micro-swimmers (AFMSs) and compares the motility of these micro-swimmers with the predictions based on the corrected resistive force theory (RFT) and the bar-joint model proposed in our previous work. The key ingredient in the theory is the introduction of a correction factorKin drag coefficients to correct the conventional RFT so that the dynamics of an acoustically actuated AFMS with rectangular cross-sections can be accurately modeled. Experimentally, such AFMSs can be easily manufactured based on digital light processing of ultra-violet (UV)-curable resins. We first determined the viscoelastic properties of a UV-cured resin through dynamic mechanical analysis. In particular, the high-frequency storage moduli and loss factors were obtained based on the assumption of time-temperature superposition (TTS), which were then applied in theoretical calculations. Though the extrapolation based on the TTS implied the uncertainty of high-frequency material response and there is limited accuracy in determining head oscillation amplitude, the differences between the measured terminal velocities of the AFMSs and the predicted ones are less than 50%, which, to us, is well acceptable. These results indicate that the motions of acoustic AFMS can be predicted, and thus, designed, which pave the way for their long-awaited applications in targeted therapy.
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  • 文章类型: Journal Article
    目的:微皮质图(μECoG)阵列能够记录皮质表面的神经活动,不需要穿透大脑实质.部分由于小的电极尺寸,先前的研究表明,可以从皮质表面检测到单个单位的尖峰,可能来自新皮层的第一层神经元。在这里,我们测试了使用μECoG阵列解码的能力,在老鼠身上,在野外导航期间的身体位置,通过孤立的单一单位活动。

方法:将μECoG阵列长期植入Wistar大鼠的初级运动皮层(M1),神经记录是在清醒时进行的,在露天围栏中表现出老鼠的行为。在300至3000Hz之间对信号进行带通滤波。根据定义的标准,包括波形形态和不应期,确定了阈值交叉尖峰,并将其分为不同的单位。身体位置来自视频记录。我们使用梯度增强机来根据之前100毫秒的尖峰数据预测身体位置,和相关分析,以阐明位置和尖峰模式之间的关系。

主要结果:在长期记录过程中可以从μECoG中提取单单位尖峰,和空间位置可以从这些尖峰中解码,在x和y维度(归一化范围从0到1)中预测的平均绝对误差为0.135和0.090,皮尔逊的r分别为0.607和0.571。

意义:μECoG可以检测可能来自皮质浅层神经元的单单位活动,是皮质内阵列的有希望的替代方案,具有可扩展性的额外好处,以最小的增量风险覆盖大皮质表面。应该在人类中进行更多与其用作脑机接口有关的研究。
    Objective.Micro-electrocorticographic (μECoG) arrays are able to record neural activities from the cortical surface, without the need to penetrate the brain parenchyma. Owing in part to small electrode sizes, previous studies have demonstrated that single-unit spikes could be detected from the cortical surface, and likely from Layer I neurons of the neocortex. Here we tested the ability to useμECoG arrays to decode, in rats, body position during open field navigation, through isolated single-unit activities.Approach. μECoG arrays were chronically implanted onto primary motor cortex (M1) of Wistar rats, and neural recording was performed in awake, behaving rats in an open-field enclosure. The signals were band-pass filtered between 300-3000 Hz. Threshold-crossing spikes were identified and sorted into distinct units based on defined criteria including waveform morphology and refractory period. Body positions were derived from video recordings. We used gradient-boosting machine to predict body position based on previous 100 ms of spike data, and correlation analyses to elucidate the relationship between position and spike patterns.Main results.Single-unit spikes could be extracted during chronic recording fromμECoG, and spatial position could be decoded from these spikes with a mean absolute error of prediction of 0.135 and 0.090 in the x- and y- dimensions (of a normalized range from 0 to 1), and Pearson\'s r of 0.607 and 0.571, respectively.Significance. μECoG can detect single-unit activities that likely arise from superficial neurons in the cortex and is a promising alternative to intracortical arrays, with the added benefit of scalability to cover large cortical surface with minimal incremental risks. More studies should be performed in human related to its use as brain-machine interface.
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  • 文章类型: Journal Article
    反应堆冷却剂泵是核电站的关键设备。如果泄漏超过某一阈值,它可能导致反应堆过热和停机。反应堆冷却剂泵泄漏故障通常存在两个问题:腐蚀和结垢。尽早准确有效地诊断泄漏故障模式并预测其剩余使用寿命(RUL)对于及时采取维护措施非常重要。在本文中,提出了一种综合方法。首先,提取第一密封件的横截面面积作为故障指示器。动机是腐蚀可能会扩大横截面积,和缩放可以减小横截面积。基于流体力学理论,在横截面积之间建立了具有多个不确定参数的集成模型,温度,以及在第一密封件的入口和出口处的泄漏。在诊断过程中,提出了一种改进的变化检测方法来检测退化的起点。然后,估计先前关系中的未知参数,并且在退化开始点之前的退化数据用于诊断泄漏故障模式。第二,建立了自回归综合移动平均(ARIMA)时间序列模型,根据退化起点后的退化数据预测剩余使用寿命。最后,利用某核电厂六个反应堆冷却剂泵的泄漏退化数据进行泄漏故障模式诊断和寿命预测,退化点检测误差率不超过4%,故障模式诊断修正率100%和实用的RUL预测结果,证明了所提出的集成方法的准确性和高效性。所提出的集成方法结合了物理模型诊断和数据驱动模型诊断的优点,创新性地利用主泵输出侧的流量作为监测指标,横截面积作为特征指标一起诊断密封发生的泄漏故障模式并预测其RUL。能满足实际运行和维护的需要,确保泵的健康稳定运行,防止核电站意外停机和严重事故的发生。
    The reactor coolant pump is a key equipment in a nuclear power plant. If the leakage exceeds a certain threshold, it may cause reactor overheating and shutdown. The reactor coolant pump leakage fault usually has two problems: corrosion and scaling. Accurately and efficiently diagnosing the leakage fault mode as early as possible and predicting its remaining useful life (RUL) are important for taking timely maintenance measures. In this paper, an integrated method is proposed. First, the cross-sectional area of the first seal is extracted as a fault indicator. The motivation is that corrosion may enlarge the cross-sectional area, and scaling may reduce the cross-sectional area. Based on the fluid mechanics theory, an integrated model with several uncertain parameters is established among the cross-sectional area, temperature, and leakage at the inlet and outlet of the first seal. In the diagnosing process, a modified change-detection method is proposed to detect the starting point of degradation. Then, the unknown parameters in the previous relation are estimated, and the degrading data before the starting point of degradation are used to diagnose the leakage fault mode. Second, a time-series model of the autoregressive integrated moving average (ARIMA) is established to predict the remaining useful life based on the degrading data after the starting point of degradation. Finally, the leakage degrading data from six reactor coolant pumps of a nuclear power plant is used to perform the leakage fault mode diagnosis and life prediction with degradation point detection error rates not exceeding 4%, fault mode diagnosis correction rates 100% and practical RUL predicting results, which proves that the proposed integrated method is accurate and efficient. The proposed integrated method combines the advantages of both the physical model diagnosis and the data-driven model diagnosis and innovatively make use of the quantity of flow from the output side of the primary pump as the monitoring indicator and the cross-sectional area as the characteristic index together to diagnose the leakage fault mode happened to the seal and predict its RUL, which can meet the needs of actual operation and maintenance to ensure a healthy and stable operation of the pump and prevent unexpected shutdowns of nuclear power plants and serious accidents.
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  • 文章类型: Journal Article
    目的:皮下植入型心律转复除颤器(S-ICD)已在预防心源性猝死中确立,与经静脉除颤器系统相比有一些优势,包括较低的引线故障发生率。尽管技术进步,S-ICD携带者可能患有严重的并发症,例如电池过早耗尽(PBD),导致近40,000名患者的咨询。这项多中心研究评估了大量S-ICD患者中PBD的发生率。
    方法:回顾了2012年10月至2023年7月在欧洲和美国的9个中心植入S-ICD模型A209和A219的患者的数据。PBD的发生率和影响,分析了临床观察到的电池寿命突然下降的定义,并将其与PBD与60个月内电池耗尽的定义进行了比较.前瞻性收集的临床数据从医疗记录中获得,设备遥测,和制造商报告。该注册表列在clinicaltrials.gov(NCT05713708)上。
    结果:在分析的1,112台S-ICD设备中,547(49.2%)配备了与PBD事件相关的潜在受影响的电容器,目前在FDA咨询。所有患者的中位随访时间为46(IQR24~63)个月。在159例(29.1%)中观察到临床怀疑的PBD,去除或更换发电机的中位时间为65个月(IQR55-72),表明与预期电池寿命有显著偏差。在91.7%的返回用于分析的设备中,制造商确认了PBD。未在未咨询的装置中观察到PBD病例。
    结论:此独立于制造商的分析强调了在咨询下配备S-ICD模型的患者中PBD的显着发生率,并且该研究中的PBD比率与制造商目前估计的比率相对应。据我们所知,这提供了当代最大的同行评审研究队列,调查了S-ICD患者中PBD的实际发生率。这些发现强调了上市后注册在临床医生和制造商之间合作以优化S-ICD治疗的安全性和有效性的重要性。
    OBJECTIVE: Subcutaneous implantable cardioverter-defibrillators (S-ICDs) have become established in preventing sudden cardiac death, with some advantages over transvenous defibrillator systems, including a lower incidence of lead failures. Despite technological advancements, S-ICD carriers may suffer from significant complications, such as premature battery depletion (PBD), that led to an advisory for nearly 40 000 patients. This multicentre study evaluated the incidence of PBD in a large set of S-ICD patients.
    RESULTS: Data from patients implanted with S-ICD models A209 and A219 between October 2012 and July 2023 across nine centres in Europe and the USA were reviewed. Incidence and implications of PBD, defined as clinically observed sudden drop in battery longevity, were analysed and compared to PBD with the definition of battery depletion within 60 months. Prospectively collected clinical data were obtained retrospectively from medical records, device telemetry, and manufacturer reports. This registry is listed on ClinicalTrials.gov (NCT05713708). Of the 1112 S-ICD devices analysed, 547 (49.2%) were equipped with a potentially affected capacitor linked to PBD occurrence, currently under Food and Drug Administration advisory. The median follow-up time for all patients was 46 [inter-quartile range (IQR) 24-63] months. Clinically suspected PBD was observed in 159 (29.1%) of cases, with a median time to generator removal or replacement of 65 (IQR 55-72) months, indicative of significant deviations from expected battery lifespan. Manufacturer confirmation of PBD was made in 91.7% of devices returned for analysis. No cases of PBD were observed in devices that were not under advisory.
    CONCLUSIONS: This manufacturer-independent analysis highlights a notable incidence of PBD in patients equipped with S-ICD models under advisory, and the rate of PBD in this study corresponds to the rate currently estimated by the manufacturer. To the best of our knowledge, this provides the largest contemporary peer-reviewed study cohort investigating the actual incidence of PBD in S-ICD patients. These findings emphasize the importance of post-market registries in collaboration between clinicians and the manufacturer to optimize safety and efficacy in S-ICD treatment.
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  • 文章类型: Journal Article
    目的:在血管检查中,有时需要从线性阵列换能器的边缘引导超声束,以达到具有所需多普勒角度的样本体积。这项体模研究旨在评估位于阵列边缘的孔径对峰值速度(PV)测量的影响。
    方法:使用带有水平管的流动体模对3个主要超声供应商的装有8个换能器的3个超声扫描仪系统进行了测试。使用所有可用的扫描器-换能器组合,同时将所有扫描参数和样品体积保持在相同的管位置中,获得了具有定位在阵列的一个边缘处的孔径和具有在阵列的中心处的孔径的5个频谱多普勒测量。在4个恒定流速下比较中心孔和边缘孔之间的PV差异。
    结果:所有体模流速的平均PV距阵列中心的范围为24.4cm/s至138.2cm/s。对于每个流速,来自中心孔的平均PV显著大于来自边缘孔的相应测量值(所有p<0.001)。所有传感器和流速的相对PV差异范围为6.7%至19.4%。
    结论:在所有测试系统中,阵列边缘与中心的多普勒波束孔径一致显示出明显较低的PV。这可能是由于孔径宽度较窄,移动的中心轴,阵列边缘的固有光谱展宽误差较小。控制多普勒孔径位置的变化在依赖于一致的速度测量的临床应用中是重要的。
    OBJECTIVE: Ultrasound beams sometimes need to be steered from the edge of linear array transducers to reach the sample volume with a desired Doppler angle in vascular exams. This phantom study aims to evaluate the impact of apertures located at the array edge on peak velocity (PV) measurements.
    METHODS: Three ultrasound scanner systems equipped with eight transducers from 3 major ultrasound vendors were tested using a flow phantom with a horizontal tube. Five spectral Doppler measurements with the aperture positioned at one edge of the array and 5 with the aperture at the center of the array were obtained using all available scanner-transducer combinations while maintaining all scan parameters and the sample volume in the same tube location. Differences in PVs between center and edge apertures were compared across 4 constant flow rates.
    RESULTS: The averaged PVs for all phantom flow rates ranged from 24.4 cm/s to 138.2 cm/s from the array center. The averaged PVs from the center aperture were significantly greater than the corresponding measurements from the edge aperture for each flow rate (all p < 0.001). The relative PV differences ranged from 6.7% to 19.4% across all transducers and flow rates.
    CONCLUSIONS: Significantly lower PVs were consistently shown with the Doppler beam aperture at the array edge compared to center among all tested systems. This may be due to a narrower aperture width, shifted central axis, and less intrinsic spectral broadening error at the array edge. Controlling variations in Doppler aperture location is important in clinical applications which depend on consistent velocity measurements.
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  • 文章类型: Journal Article
    目的:本研究比较了新型骨螺钉紧固件(BSF)与传统支撑螺钉(TBS)在合成骨质疏松和尸体骨模型中螺纹剥离前的最大压缩力。
    方法:使用校准的测压元件在自攻3.5mmBSF和3.5mmTBS之间测量螺钉拧紧过程中丢失螺钉之前板-骨界面的最大压缩力。使用了三个合成生物力学模型:合成骨质疏松骨干(模型1),3层生物力学聚氨酯泡沫,每立方英尺分层50-10-50磅(型号2),和具有50-15-50磅/立方英尺分层的3层聚氨酯泡沫(模型3)。对于尸体干phy端模型,使用了3套尸体胫骨平台和3套尸体胫骨平台。在骨和板界面之间带有传感器的板用于测量合成骨模型中螺钉拧紧过程中的压缩力。而在尸体模型中使用环形测力传感器测量螺钉在导轨中滑动时的压缩。
    结果:在所有合成骨质疏松骨模型中,与TBS[型号1,155.51N(SD=7.77N)对138.78N(SD=12.74N)相比,BSF在剥离前显示出更大的最大压缩力,P=0.036;模型2,218.14N(SD=14.15N)与110.23N(SD=8.00N),P<0.001;模型3,382.72N(SD=20.15)与341.09N(SD=15.57N),P=0.003]。BSF在整个尸体试验中具有更大的最大压缩力,胫骨平台试验,和胫骨平台试验[总体而言,111.27Nvs.97.54N(SD32.32N),P=0.002;扁桃体,149.6N对132.92N(SD31.32N),P=0.006;高原,81.33N对69.89N(SD33.38N),P=0.03]。
    结论:在合成的骨质疏松和尸体干phy端骨模型中,新型骨-螺钉-紧固件产生的最大压缩力比TBS大11%-65%。更大的压缩力可以增加结构稳定性,有利于早期负重,并减少结构故障。
    OBJECTIVE: This study compared the maximal compression force before thread stripping of the novel bone-screw-fastener (BSF) with the traditional buttress screw (TBS) in synthetic osteoporotic and cadaveric bone models.
    METHODS: The maximum compression force of the plate-bone interface before loss of screw purchase during screw tightening was measured between self-tapping 3.5-mm BSF and 3.5-mm TBS using calibrated load cells. Three synthetic biomechanical models were used: a synthetic osteoporotic diaphysis (model 1), a 3-layer biomechanical polyurethane foam with 50-10-50 pounds-per-cubic-foot layering (model 2), and a 3-layer polyurethane foam with 50-15-50 pounds-per-cubic-foot layering (model 3). For the cadaveric metaphyseal model, 3 sets of cadaveric tibial plafonds and 3 sets of cadaveric tibial plateaus were used. A plate with sensors between the bone and plate interface was used to measure compression force during screw tightening in the synthetic bone models, while an annular load cell that measured screw compression as it slid through a guide was used to measure compression in the cadaver models.
    RESULTS: Across all synthetic osteoporotic bone models, the BSF demonstrated greater maximal compression force before stripping compared with the TBS [model 1, 155.51 N (SD = 7.77 N) versus 138.78 N (SD = 12.74 N), P = 0.036; model 2, 218.14 N (SD = 14.15 N) versus 110.23 N (SD = 8.00 N), P < 0.001; model 3, 382.72 N (SD = 20.15) versus 341.09 N (SD = 15.57 N), P = 0.003]. The BSF had greater maximal compression force for the overall cadaver trials, the tibial plafond trials, and the tibial plateau trials [overall, 111.27 N vs. 97.54 N (SD 32.32 N), P = 0.002; plafond, 149.6 N versus 132.92 N (SD 31.32 N), P = 0.006; plateau, 81.33 N versus 69.89 N (SD 33.38 N), P = 0.03].
    CONCLUSIONS: The novel bone-screw-fastener generated 11%-65% greater maximal compression force than the TBS in synthetic osteoporotic and cadaveric metaphyseal bone models. A greater compression force may increase construct stability, facilitate early weight-bearing, and reduce construct failure.
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