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Correction: Pneumatic driven pulsatile ECMO in vitro evaluation with oxygen tanks. 校正:气动脉冲ECMO体外氧气罐评估。
IF 2.8 4区 医学 Q2 ENGINEERING, BIOMEDICAL Pub Date : 2025-11-25 eCollection Date: 2026-01-01 DOI: 10.1007/s13534-025-00532-1
Changyoung Yoo, Seongmin Kang, Seong-Wook Choi

[This corrects the article DOI: 10.1007/s13534-023-00295-7.].

[这更正了文章DOI: 10.1007/s13534-023-00295-7]。
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引用次数: 0
Physiological swelling imaging in human calf under stocking compression by sparse Bayesian learning implemented into electrical impedance tomography (SBL-EIT). 将稀疏贝叶斯学习应用于电阻抗断层扫描(SBL-EIT)对人小腿在袜子压迫下的生理肿胀成像。
IF 2.8 4区 医学 Q2 ENGINEERING, BIOMEDICAL Pub Date : 2025-11-22 eCollection Date: 2026-01-01 DOI: 10.1007/s13534-025-00524-1
Kota Asano, Ryoma Ogawa, Prima Asmara Sejati, Shinsuke Akita, Masahiro Takei

Physiological swelling in human calf has been imaged under stocking compression by the sparse Bayesian learning implemented into electrical impedance tomography (SBL-EIT) to evaluate the in situ treatment effect of various compression pressures. SBL-EIT reconstructs conductivity distribution [Formula: see text] to image excessive extracellular fluid in subcutaneous adipose tissue (SAT), indicating the susceptibilities to physiological swelling due to various compression pressures. The SBL-EIT was applied to the imaging of eight-subject calves during prolonged standing under three types of net compression pressures P net measured by pressure sensor - strong pressure: P net, Strong = 11.9 [Formula: see text] 2.0 mmHg, weak pressure: P net, Weak = 4.47 [Formula: see text] 3.1 mmHg, and control pressure: P net, Control = 0.00 [Formula: see text] 0.0 mmHg, respectively. From the experimental results, the spatial-mean conductivity ⟨σα2 with two pre-processing steps to eliminate undesirable effects, i.e., the difference in skin condition and effect of wearing stockings itself, is the highest in the case of stocking with control pressure, followed by weak and strong pressures across all subjects. Moreover, the ⟨σα2 has a strong positive correlation with the conventional inversed impedance 1/z BIA by bioelectrical impedance analysis (BIA) (a correlation coefficient 0.528 < R < 0.990; n = 19 and p < 0.05), which is mainly increased during the prolonged standing. Moreover, various susceptibilities to physiological swelling are investigated based on the increase in [Formula: see text] for each subject, which is associated with subject external factors such as postural changes and circumference and internal factors like SAT.

通过将稀疏贝叶斯学习应用于电阻抗断层扫描(SBL-EIT),对人小腿在袜子压迫下的生理肿胀进行成像,以评估各种压迫压力的原位治疗效果。SBL-EIT重建电导率分布[公式:见文],对皮下脂肪组织(SAT)中过量的细胞外液进行成像,表明由于各种压缩压力对生理性肿胀的敏感性。将SBL-EIT应用于8名受试者小腿在压力传感器测量的三种净压缩压力下的长时间站立成像:强压力:P net, strong = 11.9[公式:见文]2.0 mmHg,弱压力:P net, weak = 4.47[公式:见文]3.1 mmHg,控制压力:P net, control = 0.00[公式:见文]0.0 mmHg。从实验结果来看,空间平均电导率⟨σ⟩α2具有两个预处理步骤以消除不良影响,即皮肤状况和穿长袜本身的效果的差异,在具有控制压力的长袜的情况下最高,其次是所有受试者的弱压力和强压力。此外,通过生物电阻抗分析(BIA),⟨σ⟩α2与传统的逆阻抗1/z BIA具有很强的正相关(相关系数0.528 R n = 19和p
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引用次数: 0
Advancing neurological disease treatment: a computational approach for fibroblast growth factor detection. 推进神经系统疾病治疗:成纤维细胞生长因子检测的计算方法。
IF 2.8 4区 医学 Q2 ENGINEERING, BIOMEDICAL Pub Date : 2025-11-17 eCollection Date: 2026-01-01 DOI: 10.1007/s13534-025-00520-5
Farman Ali, Amal Babour, Othman Asiry, Wajdi Alghamdi, Atef Masmoudi, Naif Waheb Rajkhan

Fibroblast Growth Factor plays a crucial role in neurological health, contributing to neuron protection, injury recovery, and angiogenesis. It is also significantly involved in the onset and progression of neurodegenerative disorders such as Huntington's, Alzheimer's, Parkinson's disease, and stroke, making FGF a vital target for therapeutic interventions. Despite its importance, no computational tool has been developed to predict FGF proteins. In this study, we present the first novel deep learning-based computational approach designed for the prediction of FGF proteins. We constructed two novel, high-quality datasets curated from the UniProt database for training and evaluation. Sequences were transformed into numerical representations using three complementary feature encoding methods including Dipeptide Composition, Dipeptide Deviation from Expected Mean, and Grouped Amino Acid Composition. These features capture both local and global sequence information. Multiple deep learning models were explored, including Convolutional Neural Network, Bidirectional Long Short-Term Memory, Generative Adversarial Network, and Gated Recurrent Unit. Among these, our proposed Convolutional Neural Network-based model outperformed all others, achieving an accuracy of 83.50%, sensitivity of 84.30%, specificity of 82.67%, F1 score of 83.42%, and a Matthews Correlation Coefficient of 0.671. The proposed approach has the potential to advance therapeutic discovery by enabling accurate identification of Fibroblast Growth Factor and improving our understanding of their role in neurological health and disease.

成纤维细胞生长因子在神经系统健康中起着至关重要的作用,有助于神经元保护、损伤恢复和血管生成。FGF还与神经退行性疾病(如亨廷顿氏病、阿尔茨海默病、帕金森病和中风)的发病和进展密切相关,这使得FGF成为治疗干预的重要靶点。尽管它很重要,但目前还没有开发出预测FGF蛋白的计算工具。在这项研究中,我们提出了第一个新的基于深度学习的计算方法,旨在预测FGF蛋白。我们从UniProt数据库中构建了两个新的、高质量的数据集,用于培训和评估。利用二肽组成、二肽偏离预期均值和分组氨基酸组成三种互补特征编码方法将序列转换为数值表示。这些特征捕获本地和全局序列信息。探讨了多种深度学习模型,包括卷积神经网络、双向长短期记忆、生成对抗网络和门控循环单元。其中,我们提出的基于卷积神经网络的模型优于所有其他模型,准确率为83.50%,灵敏度为84.30%,特异性为82.67%,F1评分为83.42%,马修斯相关系数为0.671。提出的方法有可能通过准确识别成纤维细胞生长因子和提高我们对其在神经健康和疾病中的作用的理解来推进治疗发现。
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引用次数: 0
The method for quantified analysis and pattern visualization for eye blinking using high-frame-rate video. 基于高帧率视频的眨眼定量分析与模式可视化方法。
IF 2.8 4区 医学 Q2 ENGINEERING, BIOMEDICAL Pub Date : 2025-11-11 eCollection Date: 2025-11-01 DOI: 10.1007/s13534-025-00522-3
Woon-Hee Lee, Jongmo Seo, Jeong-Min Hwang

This study proposes a visualization and analysis method for eye blinking pattern using high-frame-rate videos. The high-frame-rate video clips for visualization are taken using a camera without additional equipment. The partial video clips of eye blinking except for eyelid flutters and microsleeps are extracted from the entire video clip. The changes in shapes and positions of the upper eyelid during the eye blinking sequences are evaluated, and each eye blinking is visualized as a single image. The various parameters regarding eye blinking are calculated to analyze blinking patterns. The single eye blinking sequence is divided into phases to analyze and classify eye blinking patterns in more detail. In this experiment conducted on 80 volunteers, the proposed method was able to quantitatively analyze eyelid movements, and various parameters related to eye blinking were calculated. Additionally, different types of eye blinking patterns were visualized as graph images, and incomplete eye blinking and consecutive eye blinking were defined and detected. The proposed method can overcome the spatial and situational limitations of conventional bio-signal analysis methods, as it allows non-contact measurement in ordinary environments. In addition, since quantitative eye blink data obtained from high-frame-rate video contain more information than data obtained from bio-signals, it is expected that analysis methods using videos can be easily applied to a wider range of fields.

本研究提出了一种基于高帧率视频的人眼眨眼模式可视化分析方法。用于可视化的高帧率视频剪辑使用摄像机拍摄,无需额外设备。从整个视频片段中提取除眼皮抖动和微睡眠外的部分眨眼视频片段。评估眨眼过程中上眼睑形状和位置的变化,并将每次眨眼可视化为单个图像。计算眨眼的各种参数,分析眨眼模式。将单个人眼的眨眼序列划分为几个阶段,对眨眼模式进行更详细的分析和分类。在对80名志愿者进行的实验中,提出的方法能够定量分析眼睑运动,并计算出与眨眼相关的各种参数。此外,将不同类型的眨眼模式可视化为图形图像,并对不完全眨眼和连续眨眼进行定义和检测。该方法可以克服传统生物信号分析方法的空间和情境限制,因为它允许在普通环境中进行非接触测量。此外,由于从高帧率视频中获得的定量眨眼数据比从生物信号中获得的数据包含更多的信息,因此使用视频的分析方法可以很容易地应用于更广泛的领域。
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引用次数: 0
An experimental study on estimating sleep period time using accelerometer and electrodermal activity in ring-shaped wearable devices. 环形可穿戴设备中基于加速计和皮肤电活动估算睡眠时间的实验研究。
IF 2.8 4区 医学 Q2 ENGINEERING, BIOMEDICAL Pub Date : 2025-11-06 eCollection Date: 2026-01-01 DOI: 10.1007/s13534-025-00521-4
Eunju Lee, Jaewook Shin, Kwang Ik Yang, Jaegeol Cho

There has been growing interest in sleep tracking technologies utilizing ring-shaped wearable devices. This study aimed to develop a method for accurately estimating sleep duration, onset, and offset using such a device. Conventional wrist-worn accelerometer-based devices often show limited accuracy, particularly during periods of low movement. Likewise, algorithms relying solely on electrodermal activity (EDA) signals struggle to detect frequent wake episodes due to their low temporal resolution. To address these limitations, we developed a ring-shaped wearable device and a set of algorithms that integrate both accelerometer and EDA signals. The performance of the proposed algorithms was evaluated through a clinical study involving 25 participants, the majority of whom had sleep disorders. Results showed that combining these complementary signals enabled accurate detection of sleep onset and offset within 10 min and maintained high accuracy even in conditions such as minimal movement or frequent wake episodes. These findings suggest that multimodal sensing may offer a promising direction for enhancing the reliability of sleep monitoring in real-world settings.

人们对利用环形可穿戴设备的睡眠跟踪技术越来越感兴趣。本研究旨在开发一种使用这种设备准确估计睡眠持续时间、开始和偏移的方法。传统的手腕上佩戴的基于加速度计的设备通常显示有限的准确性,特别是在低运动期间。同样,仅依靠皮肤电活动(EDA)信号的算法由于其低时间分辨率而难以检测频繁的觉醒事件。为了解决这些限制,我们开发了一种环形可穿戴设备和一套集成加速度计和EDA信号的算法。通过一项涉及25名参与者的临床研究评估了所提出算法的性能,其中大多数参与者患有睡眠障碍。结果表明,结合这些互补信号可以在10分钟内准确检测睡眠开始和偏移,即使在最小运动或频繁醒来的情况下也能保持高精度。这些发现表明,多模态传感可能为提高现实环境中睡眠监测的可靠性提供了一个有希望的方向。
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引用次数: 0
Effects of non-invasive trigeminal nerve stimulation frequency and duration on cardiovascular responses. 无创三叉神经刺激频率和持续时间对心血管反应的影响。
IF 2.8 4区 医学 Q2 ENGINEERING, BIOMEDICAL Pub Date : 2025-11-03 eCollection Date: 2026-01-01 DOI: 10.1007/s13534-025-00518-z
Chaeyeon Kim, Seokbeen Lim, Hun-Gyeom Kim, Dohyoung Kim, Youngmin Park, Joowan Seo, Dong Pyo Jang

This study investigated the effects of trigeminal nerve (TN) stimulation on cardiovascular responses in healthy individuals. Sixty-one participants received electrical stimulation to the ophthalmic and maxillary branches of the trigeminal nerve at different frequencies (2 Hz, 20 Hz, and 200 Hz) while heart rate (HR), pulse arrival time (PAT), and heart rate variability (HRV) were monitored. Results demonstrated frequency-dependent cardiovascular responses, with higher frequencies (particularly 200 Hz) producing more pronounced effects on both HR and PAT. HR showed significant decreases during stimulation, with recovery times proportional to stimulation frequency. PAT changes, which inversely reflect blood pressure alterations, occurred more rapidly than HR changes, suggesting baroreflex-mediated regulation. Notably, habituation effects were observed with repeated stimulation at 2-min intervals, but these effects were minimized when using shorter (30-s) stimulation periods. HRV analysis revealed a significant negative correlation between resting LF/HF ratio and stimulation-induced changes, indicating that TN stimulation particularly influences autonomic balance in individuals with sympathetic hyperactivity. These findings provide insights into the mechanisms of TN stimulation on cardiovascular function and suggest potential therapeutic applications for conditions characterized by autonomic dysregulation.

本研究探讨了三叉神经(TN)刺激对健康人心血管反应的影响。61名参与者接受了不同频率(2 Hz、20 Hz和200 Hz)的三叉神经眼支和上颌支电刺激,同时监测心率(HR)、脉搏到达时间(PAT)和心率变异性(HRV)。结果显示频率依赖性心血管反应,较高的频率(特别是200赫兹)对HR和PAT产生更明显的影响。在刺激过程中,心率显著降低,恢复次数与刺激频率成正比。与血压变化相反的PAT变化比HR变化发生得更快,提示血压反射介导的调节。值得注意的是,在间隔2分钟的重复刺激中观察到习惯化效应,但当使用更短(30秒)的刺激周期时,这些效应最小化。HRV分析显示静息LF/HF比值与刺激引起的变化呈显著负相关,表明TN刺激特别影响交感神经过度活跃个体的自主神经平衡。这些发现为TN刺激心血管功能的机制提供了见解,并为以自主神经失调为特征的疾病提供了潜在的治疗应用。
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引用次数: 0
Intravenous pole-integrated automated urinary status-monitoring technique using image-based artificial intelligence: a simulation study. 使用基于图像的人工智能的静脉注射杆集成自动尿状态监测技术:模拟研究。
IF 2.8 4区 医学 Q2 ENGINEERING, BIOMEDICAL Pub Date : 2025-11-03 eCollection Date: 2026-01-01 DOI: 10.1007/s13534-025-00525-0
Min Jae Kim, Gun Ho Kim, Subrata Bhattacharjee, Hongje Lee, Kyoung Won Nam

To improve the long-term monitoring of patients receiving catheterized urination support, it is necessary to develop an automated tool that can monitor variations in urine color and void patterns during hospitalization. In this study, a novel intravenous (IV) pole-integrated urination-status monitoring technique was developed to detect the color and volume of in-bag liquids using a deep learning technique and to detect urinary disease symptoms, and performed a proof-of-concept simulation study using various simulated urine samples. In experiments, the error rates of in-bag liquid volume prediction were 5.14 ± 3.72%, 2.93 ± 5.70%, 2.48 ± 5.57%, and 2.00 ± 4.93%, at normal, hematuria, bilirubinuria, and purple urinary bag syndrome, respectively. The range of the average error rate between the threshold of the bag-flush request alarm and the model prediction was 0.71-1.08%. During the long-term testing over 24 h, the prototype IV pole classified the types of urinary disease symptoms with 100% accuracy and estimated the total volume of void with an error rate of 14.47 ± 6.29%, 8.75 ± 4.61%, 15.43 ± 8.23%, 14.22 ± 8.13%, and 11.86 ± 4.73% at normal, polyuria, oliguria, anuria, and nocturnal polyuria, respectively. Based on these results, we conclude that the proposed IV pole-integrated urinary monitoring technique has the potential to be used as a tool for real-time, simplified urination-status monitoring of patients with catheterized urination support, and for improving the safety of patients with renal and urological diseases. Nevertheless, further clinical evaluations using actual urine samples are required in future studies.

Supplementary information: The online version contains supplementary material available at 10.1007/s13534-025-00525-0.

为了改善对接受导尿支持的患者的长期监测,有必要开发一种能够监测住院期间尿液颜色和空洞模式变化的自动化工具。在本研究中,开发了一种新的静脉(IV)极点集成尿状态监测技术,使用深度学习技术检测袋内液体的颜色和体积,并检测泌尿系统疾病症状,并使用各种模拟尿液样本进行了概念验证模拟研究。在正常、血尿、胆红素尿和紫尿袋综合征时,袋内液量预测的错误率分别为5.14±3.72%、2.93±5.70%、2.48±5.57%和2.00±4.93%。冲袋请求报警阈值与模型预测之间的平均错误率范围为0.71-1.08%。在超过24小时的长期测试中,原型IV极对泌尿系统疾病症状类型的分类准确率为100%,对尿路总量的估计在正常、多尿、少尿、无尿和夜间多尿的误差率分别为14.47±6.29%、8.75±4.61%、15.43±8.23%、14.22±8.13%和11.86±4.73%。基于这些结果,我们得出结论,所提出的IV极集成尿监测技术有潜力作为一种工具,用于实时、简化尿管支持患者的尿状态监测,并提高肾脏和泌尿系统疾病患者的安全性。然而,在未来的研究中,需要使用实际尿液样本进行进一步的临床评估。补充信息:在线版本包含补充资料,提供地址为10.1007/s13534-025-00525-0。
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引用次数: 0
Institutionalizing convergence education for medical artificial intelligence. 将医疗人工智能融合教育制度化。
IF 2.8 4区 医学 Q2 ENGINEERING, BIOMEDICAL Pub Date : 2025-11-01 DOI: 10.1007/s13534-025-00523-2
Tae In Park, Jongmo Seo, Hyung-Jin Yoon, Kyu Eun Lee

As artificial intelligence (AI) becomes increasingly central to modern healthcare, medical education must move beyond passive knowledge transfer and adopt a system-wide approach to convergence training. This narrative review shares a 5-year case study from Seoul National University College of Medicine (SNU Medicine), which developed a comprehensive, multi-level model for integrating AI into medical education. Instead of relying on pilot programs or piecemeal curriculum updates, SNU Medicine established a governance-driven, modular framework that includes institutional infrastructure, interdisciplinary teaching strategies, cross-campus credit integration, and alignment with national digital health policies. Based on this long-term case, we propose four key design principles-modularity, transdisciplinary alignment, infrastructure-curriculum coupling, and policy embeddedness-as a framework for creating scalable and sustainable convergence education in medical AI. While rooted in Korea's unique policy environment, this model provides transferable insights for medical institutions worldwide, particularly those operating within public or policy-constrained environments.

随着人工智能(AI)在现代医疗保健中变得越来越重要,医学教育必须超越被动的知识转移,采用全系统的融合培训方法。这篇叙述性评论分享了首尔国立大学医学院(SNU Medicine) 5年的案例研究,该学院开发了将人工智能融入医学教育的全面、多层次模型。首尔大学医学院没有依赖试点项目或零碎的课程更新,而是建立了一个治理驱动的模块化框架,其中包括机构基础设施、跨学科教学策略、跨校园学分整合,并与国家数字卫生政策保持一致。基于这一长期案例,我们提出了四个关键设计原则——模块化、跨学科一致性、基础设施-课程耦合和政策嵌入——作为在医疗人工智能中创建可扩展和可持续的融合教育的框架。虽然植根于韩国独特的政策环境,但该模式为世界各地的医疗机构,特别是那些在公共或政策约束环境中运营的医疗机构提供了可转移的见解。
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引用次数: 0
Challenges in functional hydrogel application for chronic tympanic membrane perforation: practical limitations and lessons learned. 功能性水凝胶用于慢性鼓膜穿孔的挑战:实际限制和经验教训。
IF 2.8 4区 医学 Q2 ENGINEERING, BIOMEDICAL Pub Date : 2025-10-29 eCollection Date: 2026-01-01 DOI: 10.1007/s13534-025-00519-y
Gan-Erdene Narantsolmon, Yu-Jung Hwang, Min Ji Kim, Jin Young Hong, Soo Bin Yoon, Bayarmaa Enkhbat, Chang Hee Min, Myoung Ju Kim, Myung-Whan Suh, Young Bin Choy

Chronic tympanic membrane (TM) perforations often persist due to oxidative stress and hypoxia in the middle ear. A minimally invasive, biocompatible hydrogel addressing these challenges could serve as an effective therapeutic dressing. A thiolated chitosan (CS-SH) and manganese porphyrin (MnP)-conjugated polyethylene glycol maleimide (MnP-PEG-MAL) hydrogel (Ch_MnP) was developed through in situ gelation via Michael addition reaction. Its mechanical properties and antioxidant activities (SOD- and CAT-like), were evaluated in vitro. For in vivo testing, Ch_MnP hydrogel was transtympanically injected into a chronic TM perforation rat model. Efficacy and safety were assessed using endoscopy, 3D computed tomography (CT), auditory brainstem response (ABR) testing, and histological analysis. The hydrogel exhibited optimal porosity and a swelling ratio of ~ 155%, making it well-suited as a wound healing scaffold. MnP incorporation enhanced reactive oxygen species (ROS) scavenging and O₂ generation under oxidative conditions. However, in vivo application showed no apparent improvement in TM regeneration, ABR thresholds, or histological outcomes. CT revealed a substantial hydrogel volume loss over 3 weeks, indicating significant water loss. This dehydration compromised the hydrogel's structural integrity and functionality, diminishing its role as a scaffold and therapeutic agent. The Ch_MnP hydrogel exhibited excellent biocompatibility and antioxidant properties, with potential to alleviate chronic inflammation in TM perforation. However, healing of the perforation was not observed during the study period, primarily due to dehydration in the dry middle ear. These findings underscore the importance of maintaining a hydrated environment to enhance the therapeutic efficacy of hydrogel-based TM perforation treatments.

Supplementary information: The online version contains supplementary material available at 10.1007/s13534-025-00519-y.

慢性鼓膜穿孔通常由于中耳氧化应激和缺氧而持续存在。一种微创的、生物相容性的水凝胶解决了这些挑战,可以作为一种有效的治疗敷料。采用Michael加成反应原位凝胶法制备了巯基壳聚糖(CS-SH)和卟啉锰(MnP)偶联聚乙二醇马来酰亚胺(MnP- peg - mal)水凝胶(Ch_MnP)。对其机械性能和抗氧化活性(SOD-和CAT-like)进行了体外评价。在体内实验中,将Ch_MnP水凝胶经腹腔注射到慢性TM穿孔大鼠模型中。通过内窥镜、3D计算机断层扫描(CT)、听觉脑干反应(ABR)测试和组织学分析来评估疗效和安全性。水凝胶具有最佳的孔隙率和~ 155%的溶胀率,非常适合作为伤口愈合支架。MnP掺入增强了氧化条件下活性氧(ROS)的清除和O₂的生成。然而,体内应用显示,在TM再生、ABR阈值或组织学结果方面没有明显改善。CT显示在3周内大量水凝胶体积损失,表明严重的水分损失。这种脱水损害了水凝胶的结构完整性和功能,降低了其作为支架和治疗剂的作用。Ch_MnP水凝胶具有良好的生物相容性和抗氧化性能,具有减轻TM穿孔慢性炎症的潜力。然而,在研究期间没有观察到穿孔愈合,主要是由于干燥的中耳脱水。这些发现强调了维持水合环境对提高水凝胶基TM穿孔治疗效果的重要性。补充信息:在线版本包含补充资料,提供地址为10.1007/s13534-025-00519-y。
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引用次数: 0
Biocompatibility assessment of encapsulation materials for micro LED biomedical applications: in vivo and in vitro studies. 微型LED生物医学应用封装材料的生物相容性评估:体内和体外研究。
IF 2.8 4区 医学 Q2 ENGINEERING, BIOMEDICAL Pub Date : 2025-10-28 eCollection Date: 2026-01-01 DOI: 10.1007/s13534-025-00516-1
Hyeryun Jeong, Jaewoo Baek, Seonghyun Kim, Duk-Jo Kong, Jae Gwan Kim

The integration of Micro Light-Emitting Diodes (µLEDs) into biomedical systems holds significant promise for applications such as optogenetics, neural stimulation, and implantable biosensing. A critical challenge in realizing the clinical translation of such devices lies in ensuring the long-term biocompatibility of their encapsulation materials. In this study, we systematically evaluated the short-term (4-week) biocompatibility of three candidate encapsulation materials-Polydimethylsiloxane (PDMS), Ecoflex, and Kapton-and their respective µLEDs composites through a combination of in vitro and in vivo assays. In vitro cytotoxicity was assessed using direct contact morphology analysis, MTS mitochondrial activity assay, and Annexin-V/Propidium Iodide(PI)-based flow cytometry on L-929 fibroblasts. All materials demonstrated minimal cytotoxicity and apoptosis, with cell viability exceeding 90% and apoptotic indices remaining below 2.1%, meeting ISO 10993-5 criteria. Additionally, arsenic elution testing via inductively coupled plasma-mass spectrometry (ICP-MS) revealed concentrations far below toxicological thresholds, with Ecoflex and Kapton exhibiting undetectable levels. For in vivo evaluation, the materials were subcutaneously implanted into Sprague-Dawley rats. Histological analysis (Hematoxylin and eosin staining) conducted after 4 weeks revealed no signs of necrosis or severe inflammatory response. Semiquantitative scoring indicated low fibrosis, inflammatory cell infiltration, and angiogenesis, with all materials falling within acceptable biocompatibility ranges. Collectively, these findings confirm that PDMS, Ecoflex, and Kapton, both as standalone films and in LED-integrated forms, exhibit excellent biocompatibility in short-term implantation models. This work provides a comparative foundation for selecting safe encapsulation materials in the development of implantable µLEDs bioelectronic systems and underscores the importance of multi-dimensional evaluation frameworks in preclinical safety assessment.

将微型发光二极管(µled)集成到生物医学系统中,对于光遗传学、神经刺激和植入式生物传感等应用具有重大前景。实现此类装置临床翻译的关键挑战在于确保其封装材料的长期生物相容性。在这项研究中,我们系统地评估了三种候选封装材料-聚二甲基硅氧烷(PDMS), Ecoflex和kapton -及其各自的µLEDs复合材料的短期(4周)生物相容性,通过体外和体内试验相结合。采用直接接触形态学分析、MTS线粒体活性测定和基于膜联蛋白v /碘化丙啶(PI)的流式细胞术对L-929成纤维细胞进行体外细胞毒性评估。所有材料均表现出最小的细胞毒性和凋亡,细胞存活率超过90%,凋亡指数低于2.1%,符合ISO 10993-5标准。此外,通过电感耦合等离子体质谱(ICP-MS)进行的砷洗脱测试显示,砷浓度远低于毒理学阈值,Ecoflex和Kapton的砷含量无法检测到。为了进行体内评价,将材料皮下植入Sprague-Dawley大鼠。4周后进行的组织学分析(苏木精和伊红染色)显示没有坏死迹象或严重的炎症反应。半定量评分显示低纤维化、炎症细胞浸润和血管生成,所有材料都在可接受的生物相容性范围内。总的来说,这些发现证实了PDMS、Ecoflex和Kapton,无论是作为独立薄膜还是led集成形式,在短期植入模型中都表现出良好的生物相容性。这项工作为植入式微led生物电子系统开发中选择安全封装材料提供了比较基础,并强调了多维评估框架在临床前安全性评估中的重要性。
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Biomedical Engineering Letters
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