Frontiers in medical technology最新文献

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.

The first publication on the use of teletechnology in heart and large blood vessels dates back to 1961. Since then, the study of teletechnology in heart and large blood vessels has become popular, and the number of publications has drastically increased. Hence, it is imperative to establish a comprehensive research framework that enables researchers and other stakeholders to understand the use of remote technologies in heart and large blood vessels. To bridge this gap, bibliometrics was used, a novel approach to determine the most prolific countries, institutions, journals, authors, source topics, funding agencies, and the most popular category of remote technologies and solutions for disease rehabilitation. The corpus was extracted from the WOS core database and analyzed using CiteSpace 6.2R7 and VOS Viewer 1.6.18 versions. The number of publications has grown since the start of the 21st century, with the United States, the United Kingdom, and Italy being the most productive nations. The most commonly used remote technology was a 24 h dynamic electrocardiogram (ECG) and ambulatory blood pressure monitoring. The most researched objective indicators were heart rate, blood pressure, and cardiac output. The primary research focused on daily life, physical activity, exercise endurance, and quality of life. Moreover, heart failure and coronary artery disease were the most extensively researched diseases.

While optically-pumped magnetometer (OPM) technology offers a number of compelling advantages over its SQUID predecessor for magnetoencephalography (MEG), many studies and viewpoints focus on issues of (i) scalp placement, with commensurate increases in sensitivity to weak magnetic fields and (ii) room temperature operation (without the need for baths of liquid helium to maintain superconducting properties of SQUIDs). This article addresses another unique and tantalizing opportunity-the ability for the OPM array to be "wearable", and thus to move with the participant. This is critical in adoption of naturalistic paradigms that move beyond "laboratory neuroscience" toward "real world neuroscience". It is also critically important in application to pediatric populations who cannot or will not remain still during conventional MEG scan procedures. Application to the developing infant brain will be considered as well as application to pediatric neuropsychiatric and developmental disorders, such as autism spectrum disorder. Rather than present solutions, this article will highlight the challenges faced by conventional SQUID-based cryo-MEG and explore the potential avenues for OPM-MEG to make a positive impact to the field of pediatric neuroscience.

Background: The aging population is increasingly affected by periodontal disease, a condition often overlooked due to its asymptomatic nature. Despite its silent onset, periodontitis is linked to various systemic conditions, contributing to severe complications and a reduced quality of life. With over a billion people globally affected, periodontal diseases present a significant public health challenge. Current diagnostic methods, including clinical exams and radiographs, have limitations, emphasizing the need for more accurate detection methods. This study aims to develop AI-driven models to enhance diagnostic precision and consistency in detecting periodontal disease.

Methods: We analyzed 2,000 panoramic radiographs using image processing techniques. The YOLOv8 model segmented teeth, identified the cemento-enamel junction (CEJ), and quantified alveolar bone loss to assess stages of periodontitis.

Results: The teeth segmentation model achieved an accuracy of 97%, while the CEJ and alveolar bone segmentation models reached 98%. The AI system demonstrated outstanding performance, with 94.4% accuracy and perfect sensitivity (100%), surpassing periodontists who achieved 91.1% accuracy and 90.6% sensitivity. General practitioners (GPs) benefitted from AI assistance, reaching 86.7% accuracy and 85.9% sensitivity, further improving diagnostic outcomes.

Conclusions: This study highlights that AI models can effectively detect periodontal bone loss from panoramic radiographs, outperforming current diagnostic methods. The integration of AI into periodontal care offers faster, more accurate, and comprehensive treatment, ultimately improving patient outcomes and alleviating healthcare burdens.

[This corrects the article DOI: 10.3389/fmedt.2023.1130201.].

This article provides a high-level overview of US regulatory review and approval processes for the growing field of medical combination products (CPs; those merging drugs with devices and/or biological products). US law defines drugs, medical devices, and CPs in specific ways, and the components of a CP are still subject to their respective regulations while combined. The Food and Drug Administration's Office of Combination Products (OCP) oversees the review and classification of CPs, which is based on their primary mode of action. When a manufacturer submits a Request for Designation for a new CP, the OCP conducts a technical and clinical evaluation to identify risks and verify modes of action and therapeutic benefits. Evaluating the safety and efficacy of CPs and their constituent parts can be challenging due to the many potential interactions. However, as innovation continues in the health care landscape and the variety of CPs on the market increases, manufacturers must stay proactive in complying with regulatory standards and keeping their products safe.