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Engineered surfaces for biomedical implants: advances in coatings, materials, and techniques. 生物医学植入物的工程表面:涂层、材料和技术的进展。
IF 7.7 Q1 ENGINEERING, BIOMEDICAL Pub Date : 2026-03-26 DOI: 10.1088/2516-1091/ae4d91
Muhammad Usama Zaheer, Muhammad Hassan Razzaq, Emerson Coy, Mehmet Fatih Aycan, Yogendra Kumar Mishra

The longevity and performance of biomedical implants depend strongly on surface properties, motivating coatings that enhance biocompatibility, mechanical resilience, and resistance to wear and infection. This review analyzes state-of-the-art coatings for orthopedic and dental implants, linking material choice, deposition method, and demonstratedin vitroperformance. Bioinert systems (e.g. TiN, diamond-like carbon), bioactive coatings such as hydroxyapatite and bioactive glass, and antibacterial approaches using silver-, zinc-oxide-, and graphene-based layers are compared for their effects on osseointegration, bacterial control, and durability. Deposition routes from plasma spraying to advanced methods including pulsed laser deposition, atomic layer deposition (ALD), and plasma-enhanced chemical vapor deposition are evaluated for adhesion, microstructure control, and clinical practicality. Across recent studies, nanostructured and multifunctional coatings consistently accelerate early osteogenic responses, ion- or carbon-modified hydroxyapatite improves interfacial bonding while adding antibacterial activity, conformal ultrathin films from ALD enhance corrosion resistance on complex geometries without impairing cell viability, and multilayer or hybrid architectures reduce tribocorrosion under cyclic loading. Remaining challenges include maintaining long-term stability and uniform coverage on intricate implant designs and scaling fabrication economically. Emerging directions focus on stimuli-responsive surfaces and biodegradable, drug-eluting coatings aimed at reducing infection risk and speeding integration, with the overall trajectory pointing toward coatings that couple mechanical reliability with targeted biological function.

生物医学植入物的使用寿命和性能在很大程度上取决于其表面特性、激发涂层的生物相容性、机械弹性以及对磨损和感染的抵抗力。这篇综述分析了骨科和牙科种植体的最新涂层,连接材料的选择,沉积方法和体外性能。生物惰性系统(如TiN、DLC)、生物活性涂层(如羟基磷灰石和生物活性玻璃)以及使用银、氧化锌和石墨烯基层的抗菌方法对骨整合、细菌控制和耐久性的影响进行了比较。从等离子喷涂到先进的方法,包括脉冲激光沉积、原子层沉积和等离子增强化学气相沉积,对粘附性、微观结构控制和临床实用性进行了评估。在最近的研究中,纳米结构和多功能涂层持续加速早期成骨反应,离子或碳修饰的羟基磷灰石在增加抗菌活性的同时改善界面键合,原子层沉积的保形超薄膜在不损害细胞活力的情况下增强了复杂几何形状的耐腐蚀性,多层或混合结构减少了循环载荷下的摩擦腐蚀。剩下的挑战包括在复杂的植入物设计中保持长期稳定性和均匀覆盖,以及经济地扩展制造。新兴方向集中在刺激响应表面和可生物降解的药物洗脱涂层,旨在降低感染风险和加速整合,总体轨迹指向将机械可靠性与目标生物功能结合起来的涂层。
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引用次数: 0
Navigation Paradigms for Non-invasive BCI-controlled Wheelchairs: A Systematic Review. 非侵入式脑机接口控制轮椅的导航范式:系统综述。
IF 7.7 Q1 ENGINEERING, BIOMEDICAL Pub Date : 2026-03-20 DOI: 10.1088/2516-1091/ae5563
Uchechi F Faithful Ukaegbu, Sara Houshmand, Leah Hammond, Kim Adams, John Andersen, Hossein Rouhani

Brain-controlled powered wheelchairs represent a promising advancement for individuals with neurological conditions that significantly impair motor function. Despite substantial progress, brain-controlled wheelchairs have not been adapted for real-world settings. This article systematically reviews recent trends in brain-computer interface (BCI) technology for wheelchair navigation and control, highlighting the contributions and limitations of various navigation paradigms. This review was conducted in accordance with the PRISMA guidelines, sourcing studies from four databases (PubMed, Scopus, IEEE Xplore, Google Scholar) published between 2000 and April 2025. This review focused on non-invasive BCI paradigms and real-world navigation experiments. The results were narratively synthesized and classified into two primary categories: BCI-based navigation paradigms and wheelchair-based navigation paradigms, along with intersecting concepts such as single-variant BCI, hybrid BCI, control switches, and proportional control. Of the 149 full-text articles reviewed, 47 were included and categorized by navigation paradigm, comprising 20 BCI-based and 27 wheelchair-based studies, with 6 involving participants with motor disabilities. Quality assessment scores ranged from 40% to 95%, with approximately 40% of the studies demonstrating a low risk of bias. The findings indicate that low-level navigation control was predominant in BCI wheelchair studies, with 31 studies employing minimal or no obstacle avoidance. Most studies (57%) integrated sensors for obstacle avoidance, localization, mapping, and autonomous navigation. Twenty-two studies utilized control switches, and five incorporated proportional control for wheelchair navigation. Additionally, motor imagery and steady-state visually evoked potential (SSVEP) paradigms have emerged as the most common approaches for generating control commands, highlighting their potential for effective navigation. Given the potential societal impact on a large number of individuals, future research should prioritize enhancing the reliability and adaptability of BCI wheelchair systems in real-world environments. .

脑控动力轮椅代表了一个有前途的进步,个人神经疾病,严重损害运动功能。尽管取得了重大进展,但大脑控制的轮椅还没有适应现实世界的环境。本文系统地回顾了脑机接口(BCI)技术在轮椅导航和控制方面的最新发展趋势,重点介绍了各种导航范式的贡献和局限性。本综述按照PRISMA指南进行,从2000年至2025年4月期间发表的四个数据库(PubMed, Scopus, IEEE Xplore,谷歌Scholar)中检索研究。本文主要综述了无创脑机接口范式和现实世界的导航实验。将研究结果综合归纳为两大类:基于脑机接口的导航范式和基于轮椅的导航范式,以及单变量脑机接口、混合脑机接口、控制开关和比例控制等交叉概念。在审查的149篇全文文章中,47篇被纳入并按导航范式分类,其中包括20篇基于脑机接口的研究和27篇基于轮椅的研究,其中6篇涉及运动障碍的参与者。质量评估得分从40%到95%不等,大约40%的研究显示低偏倚风险。研究结果表明,在BCI轮椅研究中,低水平的导航控制占主导地位,有31项研究采用了最小程度的或没有避障。大多数研究(57%)集成了用于避障、定位、绘图和自主导航的传感器。22项研究使用了控制开关,5项研究采用了轮椅导航的比例控制。此外,运动意象和稳态视觉诱发电位(SSVEP)范式已经成为生成控制命令的最常见方法,突出了它们在有效导航方面的潜力。考虑到对大量个体的潜在社会影响,未来的研究应优先考虑提高BCI轮椅系统在现实环境中的可靠性和适应性。
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引用次数: 0
Enhancing the functionality of soft continuum robots for minimally invasive and endoluminal interventions: a review. 增强软连续体机器人在微创和腔内干预中的功能:综述。
IF 7.7 Q1 ENGINEERING, BIOMEDICAL Pub Date : 2026-03-17 DOI: 10.1088/2516-1091/ae4d92
Alistair Bacchetti, Benjamin Calmé, Mikolaj Kowal, James Avery, Shamsa Al Harthy, Peter R Lloyd, Sophie J Stewart, Ryan K Mathew, Christos Bergeles, Russell A Harris, Pietro Valdastri, James H Chandler

The introduction and development of soft continuum robots (SCRs) for minimally invasive surgery and endoluminal intervention offers a promising option for navigating delicate, convoluted human anatomy across various procedures. However, successful translation of SCRs from research prototypes through to clinically viable tools relies on overcoming the challenge of functionalization for targeted diagnostic and therapeutic intervention. Functionalization demands specialized design and fabrication strategies to ensure practical integration of operational components, such as stimuli-responsive materials and tip-mounted transducers, with soft bioinspired geometry and actuation mechanisms. This review aims to highlight the state of the art in the development of functionalized SCRs for minimally invasive and endoluminal applications. Drawing on advances over the past twenty-five years, we provide a comprehensive discussion of the innovations to date and of the pivotal clinical and developmental challenges to be overcome for the functionalization, therapeutic benefit and therefore, clinical translation of SCRs. Through developing coherence between the fields of bio-inspired soft robotic design, digitally driven fabrication, materials engineering and intra-operative control, further clinically significant advances may be realized in the domain of functionalized SCRs.

用于微创手术和腔内介入的软连续体机器人的引入和发展为在各种程序中导航微妙、复杂的人体解剖提供了一个有希望的选择。然而,软连续体机器人从研究原型到临床可行工具的成功转化依赖于克服功能化的挑战,以进行针对性的诊断和治疗干预。功能化需要专门的设计和制造策略,以确保操作组件的实际集成,例如刺激响应材料和尖端安装的换能器,以及柔软的仿生几何和驱动机制。这篇综述的目的是强调在开发用于微创和腔内应用的功能化软连续体机器人的最新进展。借鉴过去25年的进展,我们提供了迄今为止的创新和关键的临床和发展挑战的全面讨论,以克服功能化,治疗效益,因此,软连续体机器人的临床翻译。通过发展仿生软机器人设计、数字驱动制造、材料工程和术中控制领域之间的一致性,功能化软连续体机器人领域可能会取得进一步的临床重大进展。
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引用次数: 0
Trustworthy AI in Digital Health: A Comprehensive Review of Robustness and Explainability. 数字健康中值得信赖的人工智能:稳健性和可解释性的全面回顾。
IF 7.7 Q1 ENGINEERING, BIOMEDICAL Pub Date : 2026-03-06 DOI: 10.1088/2516-1091/ae4e74
Abdullah Mamun, Shovito Barua Soumma, Hassan Ghasemzadeh

Ensuring trust in AI systems is essential for the safe and ethical integration of machine learning (ML) systems into high-stakes domains such as digital health. Key dimensions, including robustness, explainability, fairness, accountability, and privacy, need to be addressed throughout the AI lifecycle, from problem formulation and data collection to model deployment and human interaction. While various contributions address different aspects of trustworthy AI, a focused synthesis on robustness and explainability, especially tailored to the healthcare context, remains limited. This review addresses that need by organizing recent advancements into an accessible framework, highlighting both technical and practical considerations. We present a structured overview of methods, challenges, and solutions, aiming to support researchers and practitioners in developing reliable and explainable AI solutions for digital health. This review article is organized into three main parts. First, we introduce core pillars of trustworthy AI and discuss the technical and ethical challenges they pose, particularly in the context of digital health. Second, we explore application-specific trust considerations across domains such as intensive care, mental health, metabolic disease, and public health surveillance, highlighting how explainability, clinical validation, and human oversight support trust. Lastly, we present recent advancements in techniques aimed at improving robustness under data scarcity and distributional shifts, as well as explainable AI methods ranging from feature attribution to gradient-based interpretations and counterfactual explanations. This paper is further enriched with detailed discussions of the contributions toward robustness and explainability in digital health, the development of trustworthy AI systems in the era of LLMs, and various evaluation metrics for measuring trust and related parameters such as validity, fidelity, and diversity, offering a roadmap for building safer and more reliable AI systems.

确保人们对人工智能系统的信任,对于将机器学习(ML)系统安全和合乎道德地整合到数字健康等高风险领域至关重要。关键维度,包括健壮性、可解释性、公平性、问责制和隐私,需要在整个人工智能生命周期中得到解决,从问题制定和数据收集到模型部署和人类交互。虽然各种贡献涉及可信赖人工智能的不同方面,但对鲁棒性和可解释性的集中综合,特别是针对医疗保健背景的综合,仍然有限。本综述通过将最近的进展组织成一个可访问的框架来解决这一需求,突出了技术和实际考虑。我们对方法、挑战和解决方案进行了结构化概述,旨在支持研究人员和从业者为数字健康开发可靠且可解释的人工智能解决方案。这篇综述文章分为三个主要部分。首先,我们介绍了值得信赖的人工智能的核心支柱,并讨论了它们带来的技术和伦理挑战,特别是在数字健康的背景下。其次,我们探索了重症监护、精神健康、代谢疾病和公共卫生监测等领域特定应用的信任考虑因素,强调了可解释性、临床验证和人类监督如何支持信任。最后,我们介绍了旨在提高数据稀缺性和分布变化下的鲁棒性的技术的最新进展,以及可解释的人工智能方法,从特征归因到基于梯度的解释和反事实解释。本文进一步详细讨论了对数字健康的鲁棒性和可解释性的贡献,法学硕士时代值得信赖的人工智能系统的发展,以及用于测量信任和相关参数(如有效性,保真度和多样性)的各种评估指标,为构建更安全,更可靠的人工智能系统提供了路线图。
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引用次数: 0
Meta-analysis of technologies for diabetes treatment: glycemic control, prediction, meal and physical activity detection. 糖尿病治疗技术的荟萃分析:血糖控制、预测、膳食和身体活动检测。
IF 7.7 Q1 ENGINEERING, BIOMEDICAL Pub Date : 2026-02-20 DOI: 10.1088/2516-1091/ae39b9
Tomáš Koutný, Martin Kukrál, Jana Romová, Jan Vašátko

Diabetes mellitusis a widespread chronic disease with steadily growing prevalence and associated comorbidities. Current treatment of diabetes can be quite cumbersome for the patients, leading to global efforts to develop a fully-automated artificial pancreas. Such a device will need to employ some form of blood glucose prediction, as well as algorithms to detect meal intake and various physical activities. Many methods were already developed for these tasks, enabling the meta-analysis of the current state of the art. First, an overview of glycemic control strategies and sensors is provided. Then, the relevant studies are introduced and described prior to the meta-analysis. The resulting meta-analysis quantifies the accuracy of prediction models for the various prediction horizons (15, 30, 45, 60, and 120 min) and the performance of meal and physical activity detection models using sensitivity and metrics related to false-positivity. Following the observed patterns across the prediction horizons, a novel approach to evaluating the physiological plausibility of prediction methods is proposed. The baseline state-of-the-art model performance for said tasks is estimated. Finally, a discussion about the current issues in the research of diabetic technologies and their potential solutions is conducted.

糖尿病是一种广泛存在的慢性疾病,其患病率和相关合并症呈稳步增长趋势。目前的糖尿病治疗对患者来说相当麻烦,这导致全球都在努力开发全自动人工胰腺。这样的设备将需要采用某种形式的血糖预测,以及检测膳食摄入量和各种身体活动的算法。针对这些任务已经开发了许多方法,使当前最先进的荟萃分析成为可能。首先,概述了血糖控制策略和传感器。然后,在进行meta分析之前,对相关研究进行了介绍和描述。由此产生的荟萃分析量化了各种预测期(15、30、45、60和120分钟)的预测模型的准确性,以及使用与假阳性相关的敏感性和指标的膳食和身体活动检测模型的性能。根据整个预测层的观察模式,提出了一种评估预测方法生理合理性的新方法。对所述任务的基线最先进模型性能进行估计。最后,对目前糖尿病技术研究中存在的问题及其解决方案进行了讨论。
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引用次数: 0
Bioengineeredin vitrobone scaffolds to investigate bone metastases: a systematic review of mechanical and biological model validation. 生物工程体外骨支架研究骨转移:机械和生物模型验证的系统综述。
IF 7.7 Q1 ENGINEERING, BIOMEDICAL Pub Date : 2026-02-20 DOI: 10.1088/2516-1091/ae3f6a
Alissa Reinke, Gregory Ward, Jessica Feldman, Eliza J Whiteside, Burey Polly Paulomi, Louisa C E Windus

One of the most common sites of cancer metastasis is the bone, with a large proportion of both breast cancer and prostate cancer patients who develop metastases having involvement of the skeleton. The prognosis for patients with bone metastases is poor as there are limited effective treatment options. The lack of reliable models to recapitulate the native bone micro-environment during the drug discovery process, has resulted in a poor understanding of the biological processes that enable and drive metastases, and difficulty evaluating potential treatments. Animal models that have been successful in the genesis of cutting-edge treatments for primary cancer have not been able to be used for treatments for metastases, in part due to their inability to accurately recapitulate the native human microenvironment. Consequently, the development and availability of drugs to treat and/or prevent bone metastases are lacking. The last decade has seen an increase in the development and use of three dimensional (3D) scaffolds in cell culture to investigate cancer, as these models have demonstrated similar cancer cellular growth and gene/protein expression to the native human microenvironment. The majority of 3D cell culture systems for studying cancer processes comprise a soft matrix, which fails to accurately replicate the rigidity and structural complexity of bone tissue, which further alters the behaviour of cells. This systematic literature review focuses on the research to date on the development and characterisation of solid scaffolds that have been used for the purpose ofin vitroinvestigation of bone metastases. It highlights the importance of materials testing to characterise the models, ensuring they have a composition, structure and strength similar to bone, to give appropriate mechanical cues to cells, while also highlighting the biological validation completed to ensure the models are an accurate representation of the metastatic niche.

最常见的癌症转移部位之一是骨骼,大部分乳腺癌和前列腺癌患者的转移都涉及骨骼。骨转移患者的预后很差,因为有效的治疗选择有限。在药物发现过程中,缺乏可靠的模型来概括天然骨微环境,导致对能够和驱动转移的生物学过程的理解不足,并且难以评估潜在的治疗方法。动物模型在原发性癌症的尖端治疗中取得了成功,但却无法用于转移性癌症的治疗,部分原因是它们无法准确地概括人体的微环境。因此,治疗和/或预防骨转移的药物的开发和可用性是缺乏的。在过去的十年中,在细胞培养中使用三维支架研究癌症的发展和使用有所增加,因为这些模型已经显示出与天然人类微环境相似的癌细胞生长和基因/蛋白质表达。大多数用于研究癌症过程的3D细胞培养系统都包含一个软基质,它不能准确地复制骨组织的刚性和结构复杂性,这进一步改变了细胞的行为。本系统的文献综述侧重于迄今为止用于骨转移体外研究的固体支架的发展和特性的研究。它强调了材料测试的重要性,以表征模型,确保它们具有类似于骨骼的成分,结构和强度,为细胞提供适当的机械线索,同时也强调了完成的生物学验证,以确保模型是转移性生态位的准确代表。
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引用次数: 0
Advancing physical activity monitoring through bioimpedance measurement: a review. 通过生物阻抗测量推进身体活动监测:综述。
IF 7.7 Q1 ENGINEERING, BIOMEDICAL Pub Date : 2026-02-18 DOI: 10.1088/2516-1091/ae3671
Ifeanyi Jacobs, Andrew Lowe, Lorenzo Garcia, Huiyang Zhang

Bioimpedance measurements have gained significant attention due to their ability to assess body composition, muscle health, and internal physiological states without the need for intrusive procedures. This review paper explores the advancements and applications of bioimpedance technology, a non-invasive and cost-effective method for real-time monitoring of physiological parameters and physical activities. It discusses key measurement modalities such as bioelectrical impedance analysis, electrical impedance myography, and electrical impedance tomography, highlighting their unique advantages and applications. It also examines the role of biopotential electrodes, both polarizable and non-polarizable, in ensuring accurate physiological measurements. Despite challenges such as low spatial resolution, motion artifacts and sensitivity to electrode placement, the review highlights promising solutions. These include the integration of hybrid sensor systems, machine learning algorithms for signal interpretation, and the development of wearable and flexible electronics. The paper concludes by emphasizing the growing potential of bioimpedance technology in fields such as sports science, rehabilitation, personalised healthcare, fitness monitoring, and human-machine interaction, suggesting a future where continuous physiological monitoring becomes seamlessly embedded in daily life.

生物阻抗测量由于能够评估身体成分、肌肉健康和内部生理状态而无需侵入性手术而获得了极大的关注。生物阻抗技术是一种无创、低成本的生理参数和身体活动实时监测方法,本文综述了生物阻抗技术的进展及其应用。讨论了生物电阻抗分析(BIA)、电阻抗肌图(EIM)和电阻抗断层扫描(EIT)等主要测量方法,并强调了它们的独特优势和应用。它还检查了生物电位电极的作用,极化和非极化,在确保准确的生理测量。尽管存在诸如低空间分辨率、运动伪影和电极放置敏感性等挑战,但该综述强调了有前途的解决方案。其中包括混合传感器系统的集成,用于信号解释的机器学习算法,以及可穿戴和柔性电子产品的开发。论文最后强调了生物阻抗技术在运动科学、康复、个性化医疗保健、健身监测和人机交互等领域日益增长的潜力,表明未来连续的生理监测将无缝嵌入日常生活中。
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引用次数: 0
Motion Perception with Visual Prostheses. 运动感知与视觉假体。
IF 7.7 Q1 ENGINEERING, BIOMEDICAL Pub Date : 2026-02-17 DOI: 10.1088/2516-1091/ae46fd
Kai T Renshaw, John S Pezaris

Visual prostheses represent a groundbreaking avenue for restoring vision in individuals with visual impairments. These devices utilize electrode arrays positioned in early visual processing areas, like the retina, thalamus, or primary visual cortex. Connected to a camera, they transform a stream of video to electrical stimulation to present the visual environment through patterned activation of phosphenes. Visual prostheses offer the potential to enhance visual function and thereby quality of life for users, however, understanding and replicating motion perception in a manner akin to natural vision remains a critical challenge for device designers. This review presents studies of motion perception in different visual prosthesis modalities and discusses their advantages and limitations. Retinal and cortical visual prostheses show significant potential in enhancing motion perception, but many implementations have shortcomings. Some challenges which remain for better motion perception in visual prosthesis are gaze contingency, the effective integration of machine vision, and understanding the involvement of higher-order visual areas. Despite these challenges, the current research should be viewed with substantial optimism for the future of restoring functional vision to visually impaired individuals.

视觉假体是恢复视力障碍患者视力的开创性途径。这些装置利用放置在早期视觉处理区域的电极阵列,如视网膜、丘脑或初级视觉皮层。它们与摄像机相连,将视频流转换为电刺激,通过磷光幻灯的模式激活来呈现视觉环境。视觉假体提供了增强视觉功能的潜力,从而提高了用户的生活质量,然而,以类似于自然视觉的方式理解和复制运动感知仍然是设备设计师面临的一个关键挑战。本文综述了不同视觉假体模式下运动感知的研究,并讨论了它们的优点和局限性。视网膜和皮质视觉假体在增强运动感知方面显示出巨大的潜力,但许多实现都存在不足。视觉假体运动感知的改善还面临着凝视偶然性、机器视觉的有效整合以及对高阶视觉区域参与的理解等方面的挑战。尽管存在这些挑战,但目前的研究应该对视力受损个体恢复功能视力的未来持相当乐观的态度。
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引用次数: 0
Modeling spasticity: a systematic review. 痉挛模型:系统综述。
IF 7.7 Q1 ENGINEERING, BIOMEDICAL Pub Date : 2026-02-16 DOI: 10.1088/2516-1091/ae3aed
G González, J Marsden, A Besinis, P Borja, H Gunn

Spasticity, a type of hypertonia characterized by a velocity-dependent increase in muscle tone, is associated with damage to the brain and/or spinal cord in different neurological conditions. However, secondary non-neurological factors, such as soft tissue changes, can complicate the assessment and differentiation of the underlying causes. Accurate assessment is crucial for effective treatment planning, with clinicians relying on passive movement to grade the 'feel' of the spastic limb. This review aims to identify and evaluate the feasibility of spasticity models or simulations for clinical teaching. Models based on human spastic limbs were examined, with no restrictions on specific conditions or populations. A comprehensive search of four databases and gray literature was conducted to identify relevant studies. Criteria for inclusion focused on model development, data, and evaluation processes. Study selection and data extraction were carried out by independent reviewers, and data synthesis was performed by systematically mapping model properties, methods, and utility. The quality of the studies was assessed using an adapted framework for health technology assessments. The findings highlight opportunities for the development of simulation models to support training. However, significant limitations to the existing evidence base limit the feasibility of developing spasticity models based on existing literature.

痉挛是一种以肌肉张力的速度依赖性增加为特征的高张力症,在不同的神经系统疾病中与脑和/或脊髓的损伤有关。然而,继发性非神经学因素,如软组织改变,可能使潜在原因的评估和区分复杂化。准确的评估对于有效的治疗计划至关重要,临床医生依靠被动运动来评定痉挛肢体的“感觉”。本综述旨在确定和评估痉挛模型或模拟在临床教学中的可行性。研究人员检查了基于人类四肢痉挛的模型,没有特定条件或人群的限制。我们对四个数据库和灰色文献进行了全面的检索,以确定相关的研究。纳入标准侧重于模型开发、数据和评估过程。 ;研究选择和数据提取由独立审稿人进行,通过系统地映射模型属性、方法和效用来进行数据合成。 ;使用适用于卫生技术评估的框架来评估研究的质量。研究结果强调了开发模拟模型以支持培训的机会。然而,现有证据基础的显著局限性限制了基于现有文献建立痉挛模型的可行性。 。
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引用次数: 0
Computational modeling and simulation for medical devices: a summary of the 2024 FDA/MDIC Symposium. 医疗器械的计算建模和仿真:2024年FDA/MDIC研讨会综述
IF 7.7 Q1 ENGINEERING, BIOMEDICAL Pub Date : 2026-02-02 DOI: 10.1088/2516-1091/ae1c05
Brent A Craven, Christopher A Basciano, Payman Afshari, Kenneth I Aycock, Jeffrey J Ballyns, Andrew P Baumann, Jeffrey E Bischoff, Jeff Bodner, Paul Briant, Mark Driscoll, Alejandro F Frangi, Conrad J Grant, Ismail Guler, David M Hoganson, Carl W Imhauser, Linda Knudsen, Xiangyi Cheryl Liu, Brandon A Lurie, Vinay M Pai, Mark Palmer, Pras Pathmanathan, Fernando J Quevedo Gonzalez, Devashish Shrivastava, Emmanuelle Voisin

Computational modeling and simulation (CM&S) is a powerful tool that can be used to support the development, evaluation, and regulatory authorization of medical devices. CM&S can provide valuable insights into device performance, safety, and effectiveness, as well as reduce the need for animal or human testing. Computational models are, however, idealized digital representations that often have many assumptions and need to be credible before they are used in decision making that could incur patient harm. While the medical device community has made great strides to advance the use of CM&S, a number of challenges remain. To begin addressing these challenges, the US Food and Drug Administration (FDA) and the Medical Device Innovation Consortium (MDIC) co-sponsored theFDA/MDIC Symposium on Computational Modeling and Simulationon April 16-17, 2024 in College Park, Maryland, USA, where attendees from around the world convened to hear from leaders in the field through a unique blend of invited presentations and interactive panel discussions. The symposium agenda covered several major themes, including credibility considerations for CM&S used across the medical device total product life cycle, practical examples of performing model credibility assessment, and the use of CM&S for clinical decision making and the emerging areas ofin silicoclinical trials and digital twins. The objective of this article is to summarize the major takeaways of the symposium. We first provide an overview of the invited presentations followed by summaries of the topics covered during the interactive panel discussions. In doing so, we highlight the main takeaways and identify areas in which panelists had shared perspectives or differences of opinion. Next, we present the results of a survey conducted at the symposium that sought attendees' perspectives on different aspects of medical device CM&S. Finally, we conclude by summarizing the major outcomes of the symposium, including areas where more work and investment are needed to advance the field.

计算建模和仿真(CM&S)是一种强大的工具,可用于支持医疗设备的开发、评估和监管授权。CM&S可以提供有关设备性能、安全性和有效性的宝贵见解,并减少对动物或人体测试的需求。然而,计算模型是理想化的数字表示,通常具有许多假设,并且在用于可能导致患者伤害的决策之前需要具有可信度。虽然医疗设备界在推进CM&S的使用方面取得了长足的进步,但仍然存在许多挑战。为了应对这些挑战,美国食品药品监督管理局(FDA)和医疗器械创新联盟(MDIC)于2024年4月16日至17日在美国马里兰州大学公园共同主办了FDA/MDIC计算建模和仿真研讨会,来自世界各地的与会者通过独特的邀请演讲和互动小组讨论的方式听取了该领域领导者的意见。研讨会议程涵盖了几个主要主题,包括在医疗设备整个产品生命周期中使用CM&S的可信度考虑因素、执行模型可信度评估的实际示例、CM&S在临床决策中的使用以及计算机临床试验和数字孪生等新兴领域。本文的目的是总结研讨会的主要结论。我们首先提供受邀演讲的概述,然后是互动小组讨论期间所涵盖主题的摘要。在此过程中,我们强调了主要的要点,并确定了小组成员分享观点或意见分歧的领域。接下来,我们将介绍在研讨会上进行的一项调查的结果,该调查旨在寻求与会者对医疗器械CM&S不同方面的看法。最后,我们总结了研讨会的主要成果,包括需要更多工作和投资来推进该领域的领域。
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Progress in biomedical engineering (Bristol, England)
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