Frontiers in medical technology最新文献

Magnetoencephalography (MEG) is a neuroimaging technique that measures neuronal activity at a millisecond scale. A few years ago, a new generation of MEG sensors emerged: optically pumped magnetometers (OPMs). The most common OPMs use alkali atoms as the sensing element. These alkali OPM sensors must be heated to approximately 150°C, in contrast to classical MEG sensors [superconducting quantum interference device MEG], which need to be cooled down to -269°C. This article focuses on a new kind of OPM that uses Helium-4 gas as the sensing element, which solves some disadvantages of alkali OPMs. ⁴He-OPM sensors operate at room temperature, with negligible heat dissipation (10 mW) and thus do not need thermal insulation. They also offer a large dynamic range (±200 nT) and frequency bandwidth (2,000 Hz). The main goal of this study is to characterize the performance of a whole-head MEG system based on ⁴He OPM sensors (⁴He OPM MEG). We first simulated different sensor configurations with three different numbers of channels and three different head sizes, from child to adult, in order to assess the signal-to-noise ratio and the source reconstruction accuracy. Experimental testing was also performed using a phantom to simulate brain magnetic activity. The simulation and experiments show equivalent detection capability and localization accuracy on both MEG systems. These results illustrate the benefit of ⁴He OPM sensors that operate at room temperature and are positioned closer to the scalp.

Background: Preventing needlestick injuries caused by hypodermic needles is crucial for healthcare personnel. In this context, port access needles play an important role. However, systematic comparisons of different safety-engineered port access needles have not been conducted. Therefore, we evaluated differences in product characteristics and user preferences of safety-engineered protection mechanisms of port access needles.

Methods: Port puncture was performed using port access needles with four different safety mechanisms: (a) EZ Huber™ PFM Medical, (b) Gripstick® Safety OMT, (c) Gripper Micro® Smiths Medical and (d) pps ct® Vygon. Each needle type was used in three consecutive tries: an uninstructed first handling, after which instructions were given according to operating manual. Subsequently, a first and second trial were conducted. Study endpoints included successful activation, activation time, way of activation (one hand or two hands), correct activation, possible risk of needlestick injury, possibility of deactivation and preferred safety mechanism.

Results: Overall, successful activation rate during the second trial was equal for all four devices (100%). Median activation time was (a) 6 s, (b) 3 s, (c) 11 s and (d) 6 s. Single-handed activation during the second trial was (a) 0%, (b) 75%, (c) 1% and (d) 1%. Single-handed activation after further preparation with two hands during the second trial was (a) 0%, (b) 0%, (c) 0% and (d) 50%. Correct activation during the second trial was (a) 97%, (b) 66%, (c) 19% and (d) 44%. Possible risk of needlestick injury during the second trial was highest with (b). Possibility of deactivation was (a) 75%, (b) 94%, (c) 97% and (d) 22%. Individual preferences for each system were (a) n = 5, (b) n = 2, (c) n = 1 and (d) n = 24. The main written reasons given for preference were the safety protection mechanism and handling of the port needle.

Conclusion: We have shown significant differences regarding product characteristics of safety mechanisms of port access needles. Our evaluation approach provides specific data for both, technical (e.g., single-handed activation) and personal device selection criteria (e.g., preference of the safety mechanism).

Introduction: Cervical cancer remains a significant health challenge around the globe, with particularly high prevalence in low- and middle-income countries. This disease is preventable and curable if detected in early stages, making regular screening critically important. Cervical cytology, the most widely used screening method, has proven highly effective in reducing cervical cancer incidence and mortality in high income countries. However, its effectiveness in low-resource settings has been limited, among other factors, by insufficient diagnostic infrastructure and a shortage of trained healthcare personnel.

Methods: This paper introduces the development of a low-cost microscopy platform designed to address these limitations by enabling automatic reading of cervical cytology slides. The system features a robotized microscope capable of slide scanning, autofocus, and digital image capture, while supporting the integration of artificial intelligence (AI) algorithms. All at a production cost below 500 USD. A dataset of nearly 2,000 images, captured with the custom-built microscope and covering seven distinct cervical cellular types relevant in cytologic analysis, was created. This dataset was then used to fine-tune and test several pre-trained models for classifying between images containing normal and abnormal cell subtypes.

Results: Most of the tested models showed good performance for properly classifying images containing abnormal and normal cervical cells, with sensitivities above 90%. Among these models, MobileNet demonstrated the highest accuracy in detecting abnormal cell types, achieving sensitivities of 98.26% and 97.95%, specificities of 88.91% and 88.72%, and F-scores of 96.42% and 96.23% on the validation and test sets, respectively.

Conclusions: The results indicate that MobileNet might be a suitable model for real-world deployment on the low-cost platform, offering high precision and efficiency in classifying cervical cytology images. This system presents a first step towards a promising solution for improving cervical cancer screening in low-resource settings.

Objectives: To evaluate the effectiveness of the Atlasprofilax intervention in the treatment of chronic cervicobrachialgia in a cohort of 162 patients. The assessment focused on measuring pain reduction, overall patient satisfaction, and improvements in the range of motion of the neck and the affected upper-limb.

Methods: A retrospective, open-label, qualitative-quantitative longitudinal cut study was conducted in an orthopedic medical center in Brazil from June 2016 to July 2017. A total of 162 Brazilian patients with diagnosed chronic cervicobrachialgia were treated with a single session of non-invasive device-mediated treatment (Atlasprofilax method) that utilizes mechanotransductive vibropercussion on the suboccipital myofascia for approximately eight minutes. Patient conditions were established at baseline, and three follow-up assessments were conducted at 1, 6, and 9 months after treatment to evaluate the endpoints. Primary endpoints included changes in the cervical VAS pain and brachial VAS pain, while secondary endpoints included changes in the range of motion of the neck and affected upper limb, as well as patient satisfaction. A single blinded examiner conducted the evaluations at baseline and follow-up assessments, and the intervention was performed by an orthopedic doctor specializing in shoulder surgery.

Results: The primary endpoints showed a significant reduction in pain. The mean cervical VAS pain score at baseline was 7.15 ± 2.15 [median VAS 8 (6;8)], which reduced to 1.47 ± 1.04 [median 0.5 (0/2)] at month 9 [mean reduction -5.67 ± 2.30 and median -6 (-7/-4), p < 0.0001]. Fifty percent of the patients reported no pain on the VAS at the 9-month follow-up. The mean brachial VAS pain score at baseline was 6.16 ± 2.31 [median 6 (3;8)], which reduced to 0.33 ± 1.79 [median 0 (0;2)] at month 9 [mean reduction -5.83 ± 2.35; median reduction -6 (-8/-4), p < 0.0001]. At the 9-month follow-up, 88.89% of patients reported no brachial pain on the VAS. Secondary endpoints indicated a marked improvement in the average range of motion of the neck and upper limb in all subtypes of measurements. Additionally, 87.04% of patients reported satisfaction with the therapy and an improvement in their daily activities. No side-effects were observed.

Conclusions: AtlasProfilax is nowadays a good option as an intervention when it comes to pain control and activities of daily living.

Gold nanoparticles (AuNPs) have emerged as a versatile platform in biomedical applications, particularly in drug delivery, cancer therapy, and diagnostics, due to their unique physicochemical properties. This review focuses on the integration of computational methods and artificial intelligence (AI) with nanotechnology to optimize AuNP-based therapies. Computational modeling is essential for understanding the interactions between AuNPs and biological molecules, guiding nanoparticle design for improved targeting, stability, and therapeutic efficacy. Recent advancements, including AI-driven models in precision cancer therapy and the combination of AuNPs with antimicrobial peptides (AMPs) to combat drug-resistant pathogens, are highlighted. The review also discusses challenges such as toxicity, targeting efficiency, and the need for scalable synthesis, alongside the limitations of computational modeling in capturing complex biological environments. Emphasizing the importance of ongoing research and interdisciplinary collaboration, this review underscores the potential of integrating computational insights with AuNP technology to enhance the precision, safety, and effectiveness of therapeutic and diagnostic approaches.

Introduction: CPAP therapy treats various respiratory disorders. The overall performance of therapy delivery can be affected by the adopted circuit configuration. Recently, parallel to the canonical open configuration (OC), closed configurations (CC) have been proposed with potential advantages in terms of oxygen consumption, noise, airway dryness and contamination. However, the mechanical performance of CPAP devices in CC has been marginally investigated. The aim of this study is to clarify whether CPAP therapy delivered in CC configuration retains mechanical performances equivalent to that achieved in the canonical OC stipulated by the manufacturers.

Methods: OCs and CCs implemented on seven different ventilation devices, classified as flowmeter, obstructive sleep apnoea device, and mechanical ventilator, were tested at different set CPAP levels. Mask and helmet interfaces were tested, and healthy, post-surgery and ARDS respiratory conditions were simulated. The mechanical performance was compared in terms of mean static pressure (P_mean), pressure oscillations, areas between pressure curve and P_mean during inspiration (A_i) and expiration (A_e), and the time in which the pressure curve remains above the P_mean along the expiration phase (T%).

Results: The mechanical performances of CCs with helmet interface were comparable to canonical OCs used with mask interface. Globally, a CC supplied a reduced Pmean (on average, -1.3 cmH₂O for the mask and -0.3 cmH₂O for the helmet) and an increased ΔP, A_e and A_i (on average +0.5, +2.5, +2 times, respectively).

Conclusion: The closed configuration proved its capability to effectively deliver CPAP therapy, thus making its intrinsic advantages available for future clinical use.

Background: Ticagrelor, a potential antithrombotic drug indicated for cardiovascular events with acute coronary syndrome, has been restricted from its oral use due to poor aqueous solubility. The present investigation aimed to develop validated bioanalytical method for the analysis of plasma samples for improving the oral bioavailability of Ticagrelor. Additionally, evaluation of the improved antiplatelet activity of the Ticagrelor formulation compared to the marketed formulation.

Methods: A bioanalytical method was developed in rat plasma samples using the isocratic separation mode. Plasma samples were processed by liquid-liquid extraction and analyzed by using reverse phase HPLC. A validated method was used for evaluating the pharmacokinetic profile of the developed formulation and marketed formulation in Sprague Dawley rats. Additionally, the ex-vivo antiplatelet aggregation activity was evaluated.

Results: The developed method was accurate and linear (100 ng-800 ng) to quantify the drug in plasma. An in-vivo pharmacokinetic study was conducted for formulation at 10 mg/kg and different pharmacokinetic parameters were evaluated. From the results, we observed∼64% enhancements in the oral bioavailability of the Ticagrelor relative to the marketed formulation. The developed formulation (SD1) showed more significant inhibition of ADP-induced platelet aggregation compared to the marketed ticagrelor (RLD) formulation.

Conclusion: In conclusion, we have successfully developed a validated analytical method for estimating Ticagrelor plasma concentration. Additionally, our study successfully enhanced Ticagrelor's oral bioavailability, and the developed formulation has more significant inhibition of ADP-induced platelet aggregation relative to the marketed formulation, indicating its substantial therapeutic potential.

Objective: This study aims to develop and validate a nomogram that combines traditional ultrasound radiomics features with clinical parameters to assess early intracranial hypertension (IH) following primary decompressive craniectomy (DC) in patients with severe traumatic brain injury (TBI). The study incorporates the Shapley Additive Explanations (SHAP) method to interpret the radiomics model.

Methods: This study included 199 patients with severe TBI (training cohort: n = 159; testing cohort: n = 40). Postoperative ultrasound images of the optic nerve sheath (ONS) were obtained at 6 and 18 h after DC. Based on invasive intracranial pressure (ICPi) measurements, patients were grouped according to threshold values of 15 mmHg and 20 mmHg. Radiomics features were extracted from ONS images, and feature selection methods were applied to construct predictive models using logistic regression (LR), support vector machine (SVM), random forest (RF), and K-Nearest Neighbors (KNN). Clinical-ultrasound variables were incorporated into the model through univariate and multivariate logistic regression. A combined nomogram was developed by integrating radiomics features with clinical-ultrasound variables, and its diagnostic performance was evaluated using Receiver Operating Characteristic (ROC) curve analysis and decision curve analysis (DCA). The SHAP method was adopted to explain the prediction models.

Results: Among the machine learning models, the LR model demonstrated superior predictive efficiency and robustness at threshold values of 15 mmHg and 20 mmHg. At a threshold of 20 mmHg, the AUC values for the training and testing cohorts were 0.803 and 0.735 for the clinical model, 0.908 and 0.891 for the radiomics model, and 0.918 and 0.902 for the nomogram model, respectively. Similarly, at a threshold of 15 mmHg, the AUC values were consistent across models: 0.803 and 0.735 for the clinical model, 0.908 and 0.891 for the radiomics model, and 0.918 and 0.902 for the nomogram model. Notably, the nomogram model outperformed the clinical model. Decision curve analysis (DCA) further confirmed a higher net benefit for predicting intracranial hypertension across all models.

Conclusion: The nomogram model, which integrates both clinical-semantic and radiomics features, demonstrated strong performance in predicting intracranial hypertension across different threshold values. It shows promise for enhancing non-invasive ICP monitoring and supporting individualized therapeutic strategies.

The aim was to identify the experiences of Notified Bodies (NBs) in Europe in applying restrictions or limitations to certificates for high-risk medical devices. A survey examining NB practices regarding restrictions or limitations applied to Class III and IIb implantable medical devices was conducted as part of the CORE-MD Horizon 2020 project. Thirteen NBs responded; three had issued certificates of conformity with restrictions or limitations. NBs reported challenges in collecting and providing data on conditional certification, which would likely increase their workload. Enhancing clarity of regulatory standards, improving data transparency, fostering stakeholders' collaboration, and providing targeted training are essential to ensure uniform and homogeneous application of conditional certifications across the EU.

This protocol paper describes how to extract small extracellular vesicles (sEVs) from dried blood spots (DBS). The methodology is described in detail and offers further evidence that the extracted particles are sEVs using western blotting (anti-CD9, CD63 and CD81) and fluorescence nanoparticle tracking analysis (fNTA). In addition, we present evidence that approximately 40% of the sEVs were recovered from DBS compared with EVs analyzed from plasma directly. The protocol proves to be robust, reliable and displays very interesting performances even after several weeks (up to 3 weeks) of storage of the DBS when analyzing the sEVs using protein microarray for the presence of the markers CD9, CD63, CD81, EpCAM, Flotilin-1, CD62E/P, CD142 and CD235a. These findings have important implications for using sEVs as future potential diagnostic tools by supporting the validity of less-invasive methods that can be implemented within vulnerable populations or in the field.