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Ethical, legal, and social issues related to ingestible, implantable electronic devices and mRNA delivery devices. 与可摄取、可植入的电子设备和mRNA传递设备相关的伦理、法律和社会问题。
IF 8 Pub Date : 2025-11-21 DOI: 10.1016/j.device.2025.100841
Lisa Bero, Natalie Banacos, Christine M Baugh, Peter R Chai, Tiffany R Glynn, Matthew DeCamp, Ben Harnke, Hannah Scotch, Jelena Durdic, Matthew Wynia, Eric G Campbell

Oral delivery systems are being developed to treat disease, including ingestible devices that implant in the gut and deliver electrical stimulation or mRNA therapeutics. The implementation of these devices raises questions about the associated ethical, legal, and social implications (ELSIs). Our scoping review examined 83 scholarly publications published between 1946 and 2024 that investigate ELSI topics around the development and use of these technologies. We highlight the characteristics of the publications, the ethics topics mentioned, and a content analysis to describe ELSI themes. Themes particularly relevant to ingestible, implantable electronics and mRNA delivery devices were data use, invasiveness, and possible impacts on patient-clinician trust. This review suggests solutions to better protect patients from ethical and clinical risks resulting from data misuse and future empirical research engaging clinicians, patients, and researchers in this field.

正在开发用于治疗疾病的口服给药系统,包括植入肠道并提供电刺激或mRNA治疗的可食用装置。这些设备的实施引发了有关相关伦理、法律和社会影响(elsi)的问题。我们的范围审查审查了1946年至2024年间发表的83篇学术出版物,这些出版物调查了围绕这些技术的开发和使用的ELSI主题。我们强调了出版物的特点,提到的伦理主题,以及描述ELSI主题的内容分析。与可食用、可植入电子设备和mRNA传递设备特别相关的主题是数据使用、侵入性以及对患者-临床信任的可能影响。这篇综述提出了解决方案,以更好地保护患者免受因数据滥用而导致的伦理和临床风险,以及未来临床医生、患者和研究人员在该领域的实证研究。
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引用次数: 0
Magnetic Soft Robotic Valve for Minimally Invasive Therapy of Gastroesophageal Reflux Disease. 磁性软机器人瓣膜用于胃食管反流病的微创治疗。
IF 8 Pub Date : 2025-11-21 DOI: 10.1016/j.device.2025.100932
Yi Zhu, Boyang Xiao, Ane Kirk-Jadric, Hanwen Fan, Rishi Naik, Yuxiao Zhou, Xiaoguang Dong

Sphincter dysfunction contributes to various diseases, notably in gastroesophageal reflux disease (GERD). Current GERD treatments are limited by side effects, invasive surgical implants, risk of nerve injury, and complications such as dysphagia. To overcome this challenge, we report a magnetic soft robotic valve for minimally invasive treatment of sphincter dysfunction. The valve employs soft magnetic ring-shaped lattice structures that attract each other to form a robust seal, preventing leakage under external pressures exceeding 7.5 kPa, well above typical gastric reflux pressures (3.2 kPa). On-demand valve opening is enabled via a wearable magnetic actuation system, ensuring controlled passage of food. The device withstands radial forces exceeding 3.5 N during simulated peristalsis and is validated through delivery, sealing, and solid-passage tests in esophageal phantom and ex vivo sheep models, visualized using X-ray imaging. The proposed method thus is promising for enabling early, minimally invasive intervention for gastrointestinal and other organ disorders.

括约肌功能障碍有助于多种疾病,特别是胃食管反流病(GERD)。目前的反流胃食管反流治疗受到副作用、侵入性手术植入物、神经损伤风险和吞咽困难等并发症的限制。为了克服这一挑战,我们报道了一种用于微创治疗括约肌功能障碍的磁性软机器人瓣膜。该阀门采用软磁环形晶格结构,相互吸引形成坚固的密封,在超过7.5千帕的外部压力下防止泄漏,远高于典型的胃反流压力(3.2千帕)。通过可穿戴式磁力驱动系统,按需开启阀门,确保食物的受控通道。该装置在模拟蠕动过程中承受超过3.5 N的径向力,并通过食管幻肢和离体羊模型的输送、密封和固体通道测试进行验证,并使用x射线成像进行可视化。因此,提出的方法有望实现胃肠道和其他器官疾病的早期微创干预。
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引用次数: 0
Wearable organic-electrochemical-transistor-based lithium sensor for precision mental health. 用于精密心理健康的可穿戴有机电化学晶体管锂传感器。
IF 8 Pub Date : 2025-11-21 DOI: 10.1016/j.device.2025.100862
Mohammad Shafiqul Islam, Brince Paul Kunnel, Munia Ferdoushi, Md Farhad Hassan, Sangwon Cha, Wenxin Cai, Adam Frank, Yasser Khan

Mental health disorders, including bipolar disorder, pose significant challenges worldwide, necessitating precise monitoring of lithium, a gold-standard medication for this condition. We introduce a fully-printed, wearable Organic-Electrochemical-Transistor (OECT)-based sensor for non-invasive and continuous monitoring of lithium levels in sweat. This sensor integrates inkjet and 3D printing to fabricate multilayer OECTs with an ion-selective membrane, alongside iontophoretic sweat induction and microfluidic guidance for real-time sensing. Our sensor demonstrates sensitivity of ΔI ds /I 0 = 0.5/decade, a 0.1 mM detection limit in artificial sweat and selectivity for lithium over common interfering ions. A complete wearable system with wireless readout enables real-time data transmission to a smartphone interface. Validation in both healthy individuals and bipolar patients confirms the device's ability to detect therapeutically significant lithium levels. This report provides a promising path for precision mental health management, presenting a first-of-its-kind wearable real-time monitoring solution for lithium-a vital medication in treating bipolar disorder.

精神健康障碍,包括双相情感障碍,在世界范围内构成重大挑战,需要对锂进行精确监测,锂是治疗这种疾病的黄金标准药物。我们推出了一种全印刷、可穿戴的基于有机电化学晶体管(OECT)的传感器,用于非侵入性和连续监测汗液中的锂含量。该传感器集成了喷墨和3D打印,以制造具有离子选择膜的多层oect,以及用于实时传感的离子渗透汗液感应和微流体引导。我们的传感器灵敏度为ΔI ds /I 0 = 0.5/decade,对人工汗液的检测限为0.1 mM,对锂的选择性优于常见干扰离子。一个完整的可穿戴系统,具有无线读出功能,可以将数据实时传输到智能手机界面。在健康个体和双相患者中的验证证实了该设备检测治疗意义重大的锂水平的能力。这份报告为精确的精神健康管理提供了一条有希望的道路,提出了首个可穿戴的锂实时监测解决方案,锂是治疗双相情感障碍的重要药物。
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引用次数: 0
Scalable Bioelectronic Production of Extracellular Vesicles for Cardiac Tissue Regeneration. 用于心脏组织再生的细胞外小泡的可扩展生物电子生产。
IF 8 Pub Date : 2025-10-23 DOI: 10.1016/j.device.2025.100968
Lingyuan Meng, Jing Zhang, Pengju Li, Wen Li, Jiuyun Shi, Zhe Cheng, Eleanor Ostroff, Chuanwang Yang, Jiping Yue, Aleksander Prominski, Saehyun Kim, Jiwang Chen, Bozhi Tian

EV-based therapies are hindered by low production efficiency and poor scalability. Conventional methods to enhance EV yield-such as hypoxia or chemical stimulation-often compromise vesicle quality and cell health. This study introduces a bioelectronic platform featuring a planar interdigitated electrode array that enables simultaneous low-voltage (±1 V), low-frequency (2 Hz) biphasic stimulation and real-time super-resolution imaging of EV biogenesis via TIRF microscopy. This bioelectrical stimulation on primary cardiac cells significantly increases EV secretion without affecting cell viability. The resulting electrically-induced EVs (e-EVs) exhibit enhanced microRNA cargo-loading capacity, preserved tissue tropism, and functional therapeutic potential. In a murine model of acute myocardial infarction, miRNA-loaded e-EVs improved cardiac function and reduced fibrosis. These results highlight the potential of bioelectronic modulation as a scalable, non- destructive strategy for improving EV yield and functional performance in translational regenerative medicine.

基于ev的治疗受到生产效率低和可扩展性差的阻碍。提高EV产率的传统方法(如缺氧或化学刺激)往往会损害囊泡质量和细胞健康。本研究介绍了一种生物电子平台,该平台具有平面交错电极阵列,可以通过TIRF显微镜同时进行低压(±1 V),低频(2 Hz)双相刺激和EV生物发生的实时超分辨率成像。这种对原代心肌细胞的生物电刺激可显著增加EV分泌,但不影响细胞活力。由此产生的电诱导ev (e- ev)表现出增强的microRNA载货能力、保留的组织亲和性和功能治疗潜力。在小鼠急性心肌梗死模型中,携带mirna的e- ev改善了心功能并减少了纤维化。这些结果突出了生物电子调制作为一种可扩展的、非破坏性的策略在转化再生医学中提高EV产量和功能性能的潜力。
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引用次数: 0
Acoustic emissions dose and spatial control of blood-brain barrier opening with focused ultrasound. 聚焦超声对血脑屏障开口的声发射剂量及空间控制。
IF 8 Pub Date : 2025-10-17 DOI: 10.1016/j.device.2025.100894
Graeme F Woodworth, Pavlos Anastasiadis, Ahmad Ozair, Chixiang Chen, Dheeraj Gandhi, Ying Meng, Agessandro Abrahao, Jeffrey S Carpenter, Christopher P Cifarelli, Howard Eisenberg, Mary Jane Lim-Fat, Kullervo Hynynen, Ali R Rezai, Arjun Sahgal, Jason P Sheehan, Erickson Torio, Zhiyuan Xu, Nir Lipsman, Costas Arvantis, Nathan J McDannold, Alexandra J Golby

Focused ultrasound (FUS), when combined with circulating microbubbles (MB), enables transient blood-brain barrier opening (BBBO). Numerous trials using different devices, treatment parameters, and monitoring technologies have created a need for approaches enabling comparative evaluation and standardization of MB-enhanced FUS treatments (MB-FUS). Analyzing 972 MB-FUS sonications performed with closed-feedback loop (CFL) power control in patients with high-grade gliomas, we investigated patient-specific, operator-adjusted, and device-related variables contributing to BBBO with a transcranial multi-element device with integrated acoustic emissions (AE) detectors and image-guidance. Real-time monitoring of AE signals and CFL-controller-automated adaptive adjustment allowed for spatiotemporal power control, along with enabling a dosing paradigm for gauging MB-FUS BBBO treatments. We find that 'AE dose' is an independent, continuous, and robust predictor of BBBO. We identify a dynamic dose range where BBBO increase per unit was maximized. This work provides comprehensive technical descriptions of AE-based CFL control and dosing of transcranial, targeted MB-FUS.

聚焦超声(FUS)与循环微泡(MB)结合,可实现瞬时血脑屏障打开(BBBO)。使用不同设备、治疗参数和监测技术的大量试验产生了对mb增强FUS治疗(MB-FUS)的比较评估和标准化方法的需求。我们分析了972例高级别胶质瘤患者在闭环反馈(CFL)功率控制下进行的MB-FUS超声,研究了患者特异性、操作员调整和设备相关的变量,这些变量与带集成声发射(AE)探测器和图像引导的经颅多元件装置对BBBO的影响。实时监测声发射信号和cfl控制器自动自适应调节,实现了时空功率控制,同时实现了测量MB-FUS BBBO处理的剂量范例。我们发现“AE剂量”是BBBO的一个独立、连续和稳健的预测因子。我们确定了一个动态剂量范围,其中BBBO每单位增加是最大的。这项工作提供了基于ae的CFL控制和经颅靶向MB-FUS给药的全面技术描述。
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引用次数: 0
Analysis and management of thermal loads generated in vivo by miniaturized optoelectronic implantable devices. 微型光电植入装置体内热负荷的分析与管理。
IF 8 Pub Date : 2025-08-21 DOI: 10.1016/j.device.2025.100898
Mingzheng Wu, Kaiqing Zhang, Priscilla J Y Fok, Haohui Zhang, Andrew I Efimov, Yue Wang, Jingyuan Feng, Shupeng Li, Jianyu Gu, Xinyue Lu, Dane Hintermueller, Liangsong Zeng, Jinglan Zhang, Emily A Waters, Tianyu Yang, Jiaqi Liu, Glingna Wang, Zengyao Lv, Yuanting Wei, Yiyuan Yang, Chad R Haney, Yevgenia Kozorovitskiy, Raudel Avila, Abraham Vázquez-Guardado, Yonggang Huang, John A Rogers

Miniaturized implantable optoelectronic technologies for in vivo biomedical applications are gaining interest, but require strict thermal management for safe operation. Here, we introduce a comprehensive framework combining analytical solutions and numerical modeling to estimate and manage thermal effects of optoelectronic devices. We propose Green's functions to analytically solve temperature distributions in tissue from a point source with coupled thermal-optical power, capturing the influence of critical tissue properties and spatiotemporal parameters. Integrating the Green's function derives temperature distributions for sources with definable geometry. Numerical modeling defines scaling factors to account for variations in radiation patterns and material designs, enabling direct performance comparisons across systems. Guided by this framework, iterative optimization of a filamentary optogenetic probe for deep brain stimulation significantly reduces thermal loads while preserving typical behaviors in freely moving mice. Experimental validation through in vitro and in vivo characterization demonstrates scalable strategies to overcome thermal challenges in advanced bio-optoelectronic systems.

用于体内生物医学应用的微型化植入式光电技术正在引起人们的兴趣,但为了安全操作,需要严格的热管理。在这里,我们介绍了一个综合的框架,结合解析解和数值模拟来估计和管理光电器件的热效应。我们提出了Green函数来解析求解具有耦合热光功率的点源组织中的温度分布,捕获关键组织特性和时空参数的影响。对格林函数进行积分,可以得到具有可定义几何形状的源的温度分布。数值模拟定义比例因子,以考虑辐射模式和材料设计的变化,从而实现跨系统的直接性能比较。在此框架的指导下,用于深部脑刺激的丝状光遗传探针的迭代优化显着降低了热负荷,同时保留了自由运动小鼠的典型行为。通过体外和体内表征的实验验证展示了克服先进生物光电系统中热挑战的可扩展策略。
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引用次数: 0
Safer breastfeeding with a wearable sensor for monitoring maternal acetaminophen transfer through breast milk. 使用可穿戴传感器监测母体对乙酰氨基酚通过母乳转移的安全母乳喂养。
IF 8 Pub Date : 2025-08-15 DOI: 10.1016/j.device.2025.100774
Mona A Mohamed, Sina Khazaee Nejad, Haozheng Ma, Abdulrahman Al-Shami, Melissa Banks, Ali Soleimani, Victor Ong, Daniel Vargas Ramos, Maral P S Mousavi

Acetaminophen is the most prescribed medication for the management of postpartum pain as well as infant fever. Medications taken by breastfeeding mothers are released into the breast milk at different levels, creating concern for indirect infant exposure to acetaminophen through milk. This work develops a new tool for rapid, direct, and quantitative measurement of acetaminophen in breast milk. We have developed an innovative wearable device for milk sampling and analysis by integrating microfluidic channels and flexible laser-induced graphene sensors into a lactation pad. The fabrication process for the flexible sensors has been optimized using a rotatable central composite design. The wearable sensor achieves high sensitivity to acetaminophen in a large dynamic range of 10-600 μM, providing a promising tool for preventing acetaminophen toxicity in nursing mothers and breastfed infants. This device fills a healthcare gap, advancing breast milk analysis.

对乙酰氨基酚是治疗产后疼痛和婴儿发烧最常用的处方药。母乳喂养的母亲服用的药物会以不同程度释放到母乳中,这引起了婴儿通过母乳间接接触对乙酰氨基酚的担忧。本研究开发了一种快速、直接、定量测定母乳中对乙酰氨基酚的新工具。我们开发了一种创新的可穿戴设备,通过将微流体通道和柔性激光诱导石墨烯传感器集成到泌乳垫中,用于牛奶采样和分析。采用可旋转中心复合材料设计,优化了柔性传感器的制造工艺。该可穿戴传感器在10-600 μM的大动态范围内对乙酰氨基酚具有高灵敏度,为预防哺乳期母亲和母乳喂养的婴儿对乙酰氨基酚的毒性提供了一种很有前景的工具。该设备填补了医疗保健空白,推进了母乳分析。
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引用次数: 0
Autonomous cryoprotectant loading of the oocyte using microfluidic transistors. 利用微流控晶体管的卵母细胞自主冷冻保护剂加载。
IF 8 Pub Date : 2025-06-20 Epub Date: 2025-02-27 DOI: 10.1016/j.device.2025.100715
Li Zhan, Hunter Hinnen, Kaustav A Gopinathan, Mehmet Toner

Oocyte cryopreservation is a critical step of in vitro fertilization (IVF). The handling and loading of cryoprotectant currently rely on manual pipetting methods, which leads to outcome variations, high cost and limited accessibility. Here we developed a low-cost and user-friendly microfluidic device to automate the complex multistep process of oocyte CPA loading, delivering cryopreservation-ready oocytes. We utilized microfluidic transistors to create fluidic timers and logic gates, which generated time-dependent pressure signals to control the embedded valves, thereby regulating the flow conditions over the oocyte. Using constant pressure supplies, we demonstrated autonomous mouse oocyte trapping, linear loading of equilibrium solution, dehydration with vitrification solution and oocyte extraction from the device. Our work represents an important step towards autonomous IVF-on-a-chip to enhance the accessibility and affordability of IVF.

卵母细胞冷冻保存是体外受精的关键步骤。冷冻保护剂的处理和装载目前依赖于人工移液方法,这导致结果变化,成本高,可及性有限。在这里,我们开发了一种低成本和用户友好的微流体装置,以自动化复杂的多步骤卵母细胞CPA加载过程,提供冷冻保存的卵母细胞。我们利用微流体晶体管制造流体计时器和逻辑门,它们产生随时间变化的压力信号来控制嵌入的阀门,从而调节卵母细胞的流动条件。使用恒压供应,我们演示了自主小鼠卵母细胞捕获,平衡溶液线性加载,玻璃化溶液脱水和从设备中提取卵母细胞。我们的工作代表了自主试管婴儿芯片的重要一步,以提高试管婴儿的可及性和可负担性。
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引用次数: 0
Public Perceptions of Neurotechnologies Used to Target Mood, Memory, and Motor Symptoms. 公众对用于治疗情绪、记忆和运动症状的神经技术的看法。
IF 8 Pub Date : 2025-05-22 DOI: 10.1016/j.device.2025.100804
Rémy A Furrer, Amanda R Merner, Ian Stevens, Peter Zuk, Theresa Williamson, Francis X Shen, Gabriel Lázaro-Muñoz

Public attitudes toward four neurotechnologies for treating three types of brain disorders (mood, motor, and memory) vary on a range of metrics such as perceived risk, invasiveness, and likelihood of use. In a survey of 1,052 U.S. participants, deep brain stimulation (DBS) was seen as the most invasive and risky among the surveyed methods, involving the greatest perceived change to the person and the least likely to be used personally. Non-surgical options like transcranial magnetic stimulation (TMS) and pills were viewed as more acceptable. Devices targeting motor symptoms were rated as more beneficial and acceptable than those for mood or memory. These findings highlight barriers to adoption and the need to address public perceptions, ensure patients are informed, and promote ethical implementation of these technologies.

公众对治疗三种脑部疾病(情绪、运动和记忆)的四种神经技术的态度在一系列指标上有所不同,如感知风险、侵入性和使用可能性。在一项对1052名美国参与者的调查中,深部脑刺激(DBS)被认为是被调查方法中最具侵入性和风险的,涉及对人的最大感知变化,个人使用的可能性最小。非手术治疗如经颅磁刺激(TMS)和药物治疗被认为更容易接受。针对运动症状的设备被认为比针对情绪或记忆的设备更有益,更可接受。这些发现突出了采用这些技术的障碍和解决公众看法的必要性,确保患者知情,并促进这些技术的道德实施。
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引用次数: 0
Pressure effects on lithium anode/nickel-manganese-cobalt oxide cathode pouch cells through fixture design. 通过夹具设计研究锂阳极/镍锰钴氧化物阴极袋状电池的压力效应。
IF 8 Pub Date : 2025-04-18 Epub Date: 2025-01-17 DOI: 10.1016/j.device.2024.100660
Corey M Efaw, Zihan Wang, Hongxing Zhang, Pete L Barnes, Leidong Xu, Yulong Wang, Daniel Olds, Sangwook Kim, Bumjun Park, Aashray Narla, Hui Xiong, Eric J Dufek, Peter G Khalifah, Hongyi Xu, Bin Li

Applying external pressure to a pouch cell results in improved performance, implicating systems-level design of batteries. Here, different formats and amounts of external pressure to Li-LixNi0.8Mn0.1Co0.1O2 (Li-NMC811) pouch cells were studied under lean electrolyte conditions. Due to the more uniform lithium plating/stripping, a constant gap fixture that retains the distance of the frame during cycling performed greater than a constant pressure fixture that retains applied pressure to the cell. In addition, the use of flexible foam in a constant gap fixture revealed enhanced cycle life at 10 psi; however, at 30 psi, the use of a rigid plate extended cycle life to over 250 cycles, while the foam severely shortened cycle life. This discrepancy with pressure was proven to be driven by stress distribution on cell components. The failure mechanisms and the effects of pressure fixture design on cell components were unveiled, shedding light on improving high-energy battery performance through at-scale fixture design.

在袋状电池上施加外部压力可以提高性能,这意味着电池的系统级设计。本研究在贫电解质条件下,对Li-LixNi0.8Mn0.1Co0.1O2 (Li-NMC811)袋状电池进行了不同形式和外压量的研究。由于更均匀的锂电镀/剥离,在循环过程中保持框架距离的恒定间隙夹具比保持对电池施加压力的恒定压力夹具性能更好。此外,在固定间隙固定装置中使用柔性泡沫材料可以在10psi下提高循环寿命;然而,在30psi的压力下,使用刚性板将循环寿命延长至250次以上,而泡沫则严重缩短了循环寿命。这种与压力的差异被证明是由细胞组件上的应力分布驱动的。揭示了压力夹具设计对电池组件的失效机制和影响,为通过大规模夹具设计提高高能电池性能提供了线索。
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引用次数: 0
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