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Editorial: New technologies improve maternal and newborn safety. 社论:新技术提高了孕产妇和新生儿的安全性。
Q3 ENGINEERING, BIOMEDICAL Pub Date : 2024-05-30 eCollection Date: 2024-01-01 DOI: 10.3389/fmedt.2024.1372358
Jieyun Bai, Yaosheng Lu, Huishu Liu, Fang He, Xiaohui Guo
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引用次数: 0
Evolutionary trends and innovations in cardiovascular intervention. 心血管干预的演变趋势和创新。
Q3 ENGINEERING, BIOMEDICAL Pub Date : 2024-05-02 eCollection Date: 2024-01-01 DOI: 10.3389/fmedt.2024.1384008
Vincenzo Vento, Salomé Kuntz, Anne Lejay, Nabil Chakfe

Cardiovascular diseases remain a global health challenge, prompting continuous innovation in medical technology, particularly in Cardiovascular MedTech. This article provides a comprehensive exploration of the transformative landscape of Cardiovascular MedTech in the 21st century, focusing on interventions. The escalating prevalence of cardiovascular diseases and the demand for personalized care drive the evolving landscape, with technologies like wearables and AI reshaping patient-centric healthcare. Wearable devices offer real-time monitoring, enhancing procedural precision and patient outcomes. AI facilitates risk assessment and personalized treatment strategies, revolutionizing intervention precision. Minimally invasive procedures, aided by robotics and novel materials, minimize patient impact and improve outcomes. 3D printing enables patient-specific implants, while regenerative medicine promises cardiac regeneration. Augmented reality headsets empower surgeons during procedures, enhancing precision and awareness. Novel materials and radiation reduction techniques further optimize interventions, prioritizing patient safety. Data security measures ensure patient privacy in the era of connected healthcare. Modern technologies enhance traditional surgeries, refining outcomes. The integration of these innovations promises to shape a healthier future for cardiovascular procedures, emphasizing collaboration and research to maximize their transformative potential.

心血管疾病仍然是一项全球性的健康挑战,促使医疗技术不断创新,尤其是心血管医疗技术。本文全面探讨了 21 世纪心血管医疗技术的变革格局,重点关注干预措施。心血管疾病发病率的不断攀升和对个性化医疗服务的需求推动了医疗技术的不断发展,可穿戴设备和人工智能等技术重塑了以患者为中心的医疗服务。可穿戴设备提供实时监测,提高了程序的精确性和患者的治疗效果。人工智能促进了风险评估和个性化治疗策略,彻底改变了干预的精确性。在机器人技术和新型材料的辅助下,微创手术最大程度地减少了对患者的影响,提高了治疗效果。三维打印技术实现了针对患者的植入物,而再生医学则有望实现心脏再生。增强现实耳机使外科医生能够在手术过程中提高精准度和认知度。新型材料和减少辐射技术进一步优化了干预措施,并将患者安全放在首位。数据安全措施确保了互联医疗时代的患者隐私。现代技术强化了传统手术,改善了手术效果。这些创新技术的融合有望为心血管手术塑造一个更健康的未来,同时强调合作与研究,以最大限度地发挥其变革潜力。
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引用次数: 0
Hemodynamics of the VenusP Valve System™-an in vitro study. VenusP Valve System™ 的血液动力学--体外研究。
Q3 ENGINEERING, BIOMEDICAL Pub Date : 2024-05-02 eCollection Date: 2024-01-01 DOI: 10.3389/fmedt.2024.1376649
Huang Chen, Milad Samaee, Michael Tree, Lakshmi Dasi, Ajit Yoganathan

This study aims to evaluate the fluid dynamic characteristics of the VenusP Valve System™ under varying cardiac outputs in vitro. A thorough hemodynamic study of the valve under physiological cardiac conditions was conducted and served as an independent assessment of the performance of the valve. Flow fields downstream of the valve near the pulmonary bifurcation were quantitatively studied by two-dimensional Particle Image Velocimetry (PIV). The obtained flow field was analyzed for potential regions of flow stasis and recirculation, and elevated shear stress and turbulence. High-speed en face imaging capturing the leaflet motion provided data for leaflet kinematic modeling. The experimental conditions for PIV studies were in accordance with ISO 5840-1:2021 standard, and two valves with different lengths and different orientations were studied. Results show good hemodynamics performance for the tested valves according to ISO 5840 standard without significant regions of flow stasis. Observed shear stress values are all well below established hemolysis limits.

本研究旨在评估 VenusP Valve System™ 在体外不同心输出量下的流体动力学特性。在生理心脏条件下对瓣膜进行了全面的血液动力学研究,作为对瓣膜性能的独立评估。通过二维粒子图像测速仪(PIV)对瓣膜下游靠近肺动脉分叉处的流场进行了定量研究。对所获得的流场进行了分析,以确定是否存在潜在的流动停滞和再循环区域,以及剪应力和湍流的升高。捕捉小叶运动的高速面成像为小叶运动学建模提供了数据。PIV 研究的实验条件符合 ISO 5840-1:2021 标准,研究了两个不同长度和不同方向的瓣膜。结果表明,根据 ISO 5840 标准测试的瓣膜具有良好的血液动力学性能,没有明显的血流停滞区域。观察到的剪切应力值均远低于既定的溶血极限。
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引用次数: 0
Editorial: Understanding the impact of lung ventilation heterogeneity. 社论:了解肺通气异质性的影响。
Q3 ENGINEERING, BIOMEDICAL Pub Date : 2024-03-04 eCollection Date: 2024-01-01 DOI: 10.3389/fmedt.2024.1332958
Brooks Kuhn, Igor Barjaktarevic
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引用次数: 0
Animal models in medical translation: the grand challenge of developing new treatments for human diseases. 医学转化中的动物模型:开发人类疾病新疗法的巨大挑战。
Q3 ENGINEERING, BIOMEDICAL Pub Date : 2024-02-16 eCollection Date: 2024-01-01 DOI: 10.3389/fmedt.2024.1367521
Philip V Peplow
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引用次数: 0
Sex-specific outcomes in cancer therapy: the central role of hormones. 癌症治疗的性别特异性结果:激素的核心作用。
Q3 ENGINEERING, BIOMEDICAL Pub Date : 2024-02-01 eCollection Date: 2024-01-01 DOI: 10.3389/fmedt.2024.1320690
Parisa Bakhshi, Jim Q Ho, Steven Zanganeh

Sex hormones play a pivotal role in modulating various physiological processes, with emerging evidence underscoring their influence on cancer progression and treatment outcomes. This review delves into the intricate relationship between sex hormones and cancer, elucidating the underlying biological mechanisms and their clinical implications. We explore the multifaceted roles of estrogen, androgens, and progesterone, highlighting their respective influence on specific cancers such as breast, ovarian, endometrial, and prostate. Special attention is given to estrogen receptor-positive (ER+) and estrogen receptor-negative (ER-) tumors, androgen receptor signaling, and the dual role of progesterone in both promoting and inhibiting cancer progression. Clinical observations reveal varied treatment responses contingent upon hormonal levels, with certain therapies like tamoxifen, aromatase inhibitors, and anti-androgens demonstrating notable success. However, disparities in treatment outcomes between males and females in hormone-sensitive cancers necessitate further exploration. Therapeutically, the utilization of hormone replacement therapy (HRT) during cancer treatments presents both potential risks and benefits. The promise of personalized therapies, tailored to an individual's hormonal profile, offers a novel approach to optimizing therapeutic outcomes. Concurrently, the burgeoning exploration of new drugs and interventions targeting hormonal pathways heralds a future of more effective and precise treatments for hormone-sensitive cancers. This review underscores the pressing need for a deeper understanding of sex hormones in cancer therapy and the ensuing implications for future therapeutic innovations.

性激素在调节各种生理过程中起着举足轻重的作用,新出现的证据强调了性激素对癌症进展和治疗效果的影响。本综述深入探讨了性激素与癌症之间错综复杂的关系,阐明了其潜在的生物学机制及其临床意义。我们探讨了雌激素、雄激素和孕激素的多方面作用,强调了它们各自对乳腺癌、卵巢癌、子宫内膜癌和前列腺癌等特定癌症的影响。特别关注雌激素受体阳性(ER+)和雌激素受体阴性(ER-)肿瘤、雄激素受体信号转导以及孕酮在促进和抑制癌症进展中的双重作用。临床观察显示,激素水平不同,治疗反应也不同,某些疗法,如他莫昔芬、芳香化酶抑制剂和抗雄激素,取得了显著的疗效。然而,男性和女性对激素敏感的癌症在治疗效果上存在差异,这需要进一步探讨。从治疗角度看,在癌症治疗期间使用激素替代疗法(HRT)既有潜在的风险,也有潜在的益处。根据个人荷尔蒙特征量身定制的个性化疗法为优化治疗效果提供了一种新方法。与此同时,针对荷尔蒙通路的新药和干预措施的探索也在蓬勃发展,这预示着未来将有更有效、更精确的方法来治疗对荷尔蒙敏感的癌症。这篇综述强调了深入了解性激素在癌症治疗中的作用及其对未来治疗创新的影响的迫切需要。
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引用次数: 0
Framework for creating a qualified medical device development tool of autoinjectors. 创建自动注射器合格医疗器械开发工具的框架。
Q3 ENGINEERING, BIOMEDICAL Pub Date : 2023-11-24 eCollection Date: 2023-01-01 DOI: 10.3389/fmedt.2023.1281403
Marlon Luca Machal

Objectives: Autoinjectors are pivotal for precise self-administration of medications across a wide range of medical conditions. Nevertheless, the absence of a dedicated Medical Device Development Tool (MDDT) for autoinjectors represents a gap that may result in variations in the quality and regulatory compliance of autoinjectors as components of combination products. This research aim is to utilize the recently introduced Primary Functions outlined in ISO 11608-1:2022 with the title "Needle-based injection systems for medical use. Requirements and test methods. Part 1: Needle-based injection systems" to create a comprehensive MDDT framework tailored specifically for autoinjectors.

Methods: To support the creation of the framework, the analysis of the FDA MDDTs that were already approved, FDA's design controls regulations, FDA's guidance related to autoinjectors, and the Primary functions outlined in ISO 11608-1:2022 were utilized.

Results: The research identifies the Primary Functions in autoinjector to be Holding Force, Cap Removal Force, Activation Force, Extended Needle Length, Injection Time, Dose Accuracy and Needle Guard Lockout. Leveraging these Primary Functions and the FDA's MDDT approach, the research aims to bridge the gap by proposing a structured framework for the development of a specific MDDT tailored to autoinjectors.

Conclusion: This study presents a MDDT framework tailored to the development of autoinjectors for drug delivery. This framework provides a structured methodology to support predictability and effectiveness of the autoinjector development and support regulatory review process, thereby expediting FDA approval for autoinjectors as part of combination product.

目标:自动注射器对于在各种医疗条件下精确地自行给药至关重要。然而,自动注射器专用医疗器械开发工具(MDDT)的缺乏是一个空白,可能会导致作为组合产品组成部分的自动注射器在质量和合规性方面出现差异。本研究旨在利用 ISO 11608-1:2022(标题为 "医用针式注射系统")中最近推出的主要功能。要求和测试方法。方法:为了支持该框架的创建,我们分析了已获批准的 FDA MDDT、FDA 的设计控制法规、FDA 与自动注射器相关的指南以及 ISO 11608-1:2022 中概述的主要功能:研究发现,自动注射器的主要功能包括保持力、瓶盖移除力、激活力、延长针头长度、注射时间、剂量准确性和针头保护锁定。本研究利用这些主要功能和 FDA 的 MDDT 方法,提出了一个结构化框架,用于开发专门针对自动注射器的 MDDT,从而弥补了这一差距:本研究提出了一个 MDDT 框架,专门用于开发用于给药的自动注射器。该框架提供了一种结构化方法,可支持自动注射器开发的可预测性和有效性,并支持监管审查流程,从而加快美国食品及药物管理局对作为组合产品一部分的自动注射器的审批。
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引用次数: 0
Designing for flexibility in hybrid care services: lessons learned from a pilot in an internal medicine unit. 混合护理服务的灵活性设计:从内科试点中汲取的经验教训。
Q3 ENGINEERING, BIOMEDICAL Pub Date : 2023-11-20 eCollection Date: 2023-01-01 DOI: 10.3389/fmedt.2023.1223002
Nirit Putievsky Pilosof, Michael Barrett, Eivor Oborn, Galia Barkai, Eyal Zimlichman, Gad Segal

Digital transformation in healthcare during the COVID-19 pandemic led to the development of new hybrid models integrating physical and virtual care. The ability to provide remote care by telemedicine technologies and the need to better manage and control hospitals' occupancy accelerated growth in hospital-at-home programs. The Sheba Medical Center restructured to create Sheba Beyond as the first virtual hospital in Israel. These transformations enabled them to deliver hybrid services in their internal medicine unit by managing inpatient hospital-care with remote home-care based on the patients' medical condition. The hybrid services evolved to integrate care pathways multiplied by the mode of delivery-physical (in person) or virtual (technology enabled)-and the location of care-at the hospital or the patient home. The study examines this home hospitalization program pilot for internal medicine at Sheba Medical Center (MC). The research is based on qualitative semi-structured interviews with Sheba Beyond management, medical staff from the hospital and the Health Maintenance Organization (HMO), Architects, Information Technology (IT), Telemedicine and Medtech organizations. We investigated the implications of the development of hybrid services for the future design of the physical built-environment and the virtual technological platform. Our findings highlight the importance of designing for flexibility in the development of hybrid care services, while leveraging synergies across the built environment and digital platforms to support future models of care. In addition to exploring the potential for scalability in accelerating the flexibility of the healthcare system, we also highlight current barriers in professional, management, logistic and economic healthcare models.

在 COVID-19 大流行期间,医疗保健领域的数字化转型促进了新的混合模式的发展,将实体医疗和虚拟医疗融为一体。通过远程医疗技术提供远程护理的能力,以及更好地管理和控制医院占用空间的需求,加速了医院上门服务项目的发展。示巴医疗中心进行了重组,创建了以色列首家虚拟医院 Sheba Beyond。这些转型使他们能够根据病人的病情,在内科病房提供混合服务,通过远程家庭护理管理住院病人的护理。混合服务的发展整合了护理路径,并根据提供方式--实体(亲自)或虚拟(技术)--以及护理地点--医院或患者家中--进行了倍增。本研究探讨了沙巴医疗中心(MC)内科的家庭住院计划试点。研究以半结构化定性访谈为基础,访谈对象包括舍巴 Beyond 管理层、医院和健康维护组织 (HMO) 的医务人员、建筑师、信息技术 (IT)、远程医疗和医疗技术组织。我们调查了混合服务的发展对未来实体建筑环境和虚拟技术平台设计的影响。我们的研究结果强调了在开发混合医疗服务时进行灵活设计的重要性,同时利用建筑环境和数字平台的协同作用来支持未来的医疗模式。除了探索加速医疗保健系统灵活性的可扩展性潜力,我们还强调了目前在专业、管理、物流和经济医疗保健模式方面存在的障碍。
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引用次数: 0
Eye tracking technology in medical practice: a perspective on its diverse applications. 眼动追踪技术在医疗实践中的应用
Q3 ENGINEERING, BIOMEDICAL Pub Date : 2023-11-17 eCollection Date: 2023-01-01 DOI: 10.3389/fmedt.2023.1253001
Mohammed Tahri Sqalli, Begali Aslonov, Mukhammadjon Gafurov, Nurmukhammad Mukhammadiev, Yahya Sqalli Houssaini

Eye tracking technology has emerged as a valuable tool in the field of medicine, offering a wide range of applications across various disciplines. This perspective article aims to provide a comprehensive overview of the diverse applications of eye tracking technology in medical practice. By summarizing the latest research findings, this article explores the potential of eye tracking technology in enhancing diagnostic accuracy, assessing and improving medical performance, as well as improving rehabilitation outcomes. Additionally, it highlights the role of eye tracking in neurology, cardiology, pathology, surgery, as well as rehabilitation, offering objective measures for various medical conditions. Furthermore, the article discusses the utility of eye tracking in autism spectrum disorders, attention-deficit/hyperactivity disorder (ADHD), and human-computer interaction in medical simulations and training. Ultimately, this perspective article underscores the transformative impact of eye tracking technology on medical practice and suggests future directions for its continued development and integration.

眼动追踪技术已经成为医学领域的一种有价值的工具,在各个学科中提供了广泛的应用。这篇观点文章旨在全面概述眼动追踪技术在医疗实践中的各种应用。通过总结最新的研究成果,本文探讨了眼动追踪技术在提高诊断准确性、评估和改善医疗绩效以及改善康复效果方面的潜力。此外,它还强调了眼动追踪在神经病学、心脏病学、病理学、外科以及康复中的作用,为各种医疗条件提供了客观的衡量标准。此外,本文还讨论了眼动追踪在自闭症谱系障碍、注意缺陷/多动障碍(ADHD)以及医学模拟和训练中的人机交互中的应用。最后,这篇观点文章强调了眼动追踪技术对医疗实践的变革性影响,并提出了其持续发展和整合的未来方向。
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引用次数: 0
Feasibility of Parylene C for encapsulating piezoelectric actuators in active medical implants. 聚对二甲苯在主动医疗植入物中封装压电驱动器的可行性。
Q3 ENGINEERING, BIOMEDICAL Pub Date : 2023-11-17 eCollection Date: 2023-01-01 DOI: 10.3389/fmedt.2023.1211423
Alina Kohler, Felix Blendinger, Sonja Müller, Ulrich Mescheder, Volker Bucher

Parylene C is well-known as an encapsulation material for medical implants. Within the approach of miniaturization and automatization of a bone distractor, piezoelectric actuators were encapsulated with Parylene C. The stretchability of the polymer was investigated with respect to the encapsulation functionality of piezoelectric chips. We determined a linear yield strain of 1% of approximately 12-µm-thick Parylene C foil. Parylene C encapsulation withstands the mechanical stress of a minimum of 5×105 duty cycles by continuous actuation. The experiments demonstrate that elongation of the encapsulation on piezoelectric actuators and thus the elongation of Parylene C up to 0.8 mm are feasible.

聚对二甲苯是一种众所周知的医用植入物的封装材料。为了实现骨牵张器的小型化和自动化,将压电驱动器封装在聚对二甲苯c中,研究了聚合物的可拉伸性,并对压电芯片的封装功能进行了研究。我们确定了约12微米厚的聚对二甲苯C箔的线性屈服应变为1%。通过连续驱动,聚对二甲苯封装承受最小5×105占空比的机械应力。实验表明,在压电致动器上延长包封率,从而使聚对二甲苯的延伸率达到0.8 mm是可行的。
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引用次数: 0
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Frontiers in medical technology
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