Frontiers in Medical Technology最新文献

Increasing research corroborates that the qualities of the setting in which a patient receives healthcare positively influence health outcomes. Therefore, it has become progressively important to review the concept of therapeutic environments, as places where patients are treated with the most advanced medicine and technology, but also support their users in psychological, emotional and social terms. This quest for the optimal healing environment brings to the forefront the need to include other parameters in our design briefs, where the application of biophilic design proves to be paramount, as exposure to nature is associated with multiple health benefits. However, current biophilic design frameworks fail to provide efficient guidance, as their design recommendations don't differentiate the level of value of each design parameter for each building programme and context. Our position is that a biophilic design framework can only be efficient if it is adapted to specific building functions and is geographically and culturally contextualized. This study assessed the application of biophilic design in therapeutic environments for cancer patients in the UK, and provided a revised conceptual framework that can more efficiently guide designers and policies in future interventions. This framework was informed by synthesised analyses from healthcare environments on the user's experiences, and primary data obtained from semi-structured interviews with architects and managers, which was then benchmarked against scientific data about the impact of biophilic design on humans. This comprehensive approach helped to identify and rank those biophilic design parameters that appear the most critical for promoting and supporting health and wellbeing in cancer healthcare settings and provided an up-to-date compilation of crucial design actions to enact the necessary change in future research and design practice.

The healthcare sector has to face changes happening fast and often in an unpredictable way, such as epidemiological trends, the advancements of medical technology and processes or evolving social and economic needs. This results in a frequent need for infrastructures' retrofitting, with an increasing focus on the environmental impact of buildings, which have one of the highest embodied carbon footprints per square meter in the construction sector. As result, interest in healthcare buildings' adaptability is growing among researchers and practitioners. After an introduction on the research topic, a focus on the definition of adaptability and the existing assessment models is provided to address the following research question: to what extent are adaptability models effective to evaluate and orient the design of healthcare buildings? A quite varied use of the term adaptability has been found in the literature, as well as a new research trend aiming to establish a link with circularity. Moreover, most of the assessment models do not have a focus and have never been tested on the healthcare sector. An approach to circular and adaptable design is presented through the case study of the Joseph Bracops Hospital (Belgium), which has been submitted for evaluation by the Reversible Building Design protocol developed by Dr. Durmisevic. The evaluation highlights some of the current barriers in the design of adaptable healthcare facilities. Insights for future research are provided to encourage data-collection about the service life of healthcare buildings, so to understand if the adaptability of these infrastructures should be mainly monofuntional or transfunctional.

Any Regenerative Medicine (RM) business requires reliably predictable cell and tissue products. Regulatory agencies expect control and documentation. However, laboratory tissue production is currently not predictable or well-controlled. Before conditions can be controlled to meet the needs of cells and tissues in culture for RM, we have to know what those needs are and be able to quantify them. Therefore, identification and measurement of critical cell quality attributes at a cellular or pericellular level is essential to generating reproducible cell and tissue products. Here, we identify some of the critical cell and process parameters for cell and tissue products as well as technologies available for sensing them. We also discuss available and needed technologies for monitoring both 2D and 3D cultures to manufacture reliable cell and tissue products for clinical and non-clinical use. As any industry matures, it improves and standardizes the quality of its products. Cytocentric measurement of cell and tissue quality attributes are needed for RM.

Researchers conducting computational fluid dynamics (CFD) modeling can spend weeks obtaining imaging data, determining boundary conditions, running simulations and post-processing files. However, results are typically viewed on a 2D display and often at one point in time thus reducing the dynamic and inherently three-dimensional data to a static image. Results from different pathologic states or cases are rarely compared in real-time, and supplementary data are seldom included. Therefore, only a fraction of CFD results are typically studied in detail, and associations between mechanical stimuli and biological response may be overlooked. Virtual and augmented reality facilitate stereoscopic viewing that may foster extraction of more information from CFD results by taking advantage of improved depth cues, as well as custom content development and interactivity, all within an immersive approach. Our objective was to develop a straightforward, semi-automated workflow for enhanced viewing of CFD results and associated data in an immersive virtual environment (IVE). The workflow supports common CFD software and has been successfully completed by novice users in about an hour, demonstrating its ease of use. Moreover, its utility is demonstrated across clinical research areas and IVE platforms spanning a range of cost and development considerations. We are optimistic that this advancement, which decreases and simplifies the steps to facilitate more widespread use of immersive CFD viewing, will foster more efficient collaboration between engineers and clinicians. Initial clinical feedback is presented, and instructional videos, manuals, templates and sample data are provided online to facilitate adoption by the community.

Background: Magnetic resonance cholangiopancreatography (MRCP) is a non-invasive imaging modality that has high diagnostic accuracy for a wide range of bile duct and pancreatic duct pathologies. Endoscopic retrograde cholangiopancreatography (ERCP) is still the gold standard for the exploration of the biliopancreatic region.

Aim: The aim of the study was to compare the diagnostic accuracy of MRCP with that of ERCP in the diagnosis of bile duct and pancreatic duct pathologies.

Material and methods: A total of 60 patients with common bile duct (CBD) and pancreatic duct pathologies detected on MRCP were subsequently evaluated by ERCP in this observational study. A comparison of MRCP findings with ERCP was made.

Results: MRCP had a sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy of 88.1%, 94.4%, 97.3%, 72.7%, and 90%, respectively, in diagnosing choledocholithiasis in comparison to ERCP. For CBD dilation, the sensitivity was 90.91%, specificity was 93.75% and the PPV, NPV, and accuracy were 97.56%, 78.95%, and 91.67%, respectively, for MRCP. In CBD stricture, MRCP showed a sensitivity, specificity, PPV, NPV, and accuracy of 83.33%, 97.92%, 90.91%, 95.92%, and 95%, respectively. In pancreatic duct dilatation, the sensitivity, specificity, PPV, NPV, and accuracy were all 100%. Pancreatic duct stricture showed a sensitivity, specificity, PPV, NPV, and accuracy of 80%, 98%, 88.89%, 96.08%, and 95%, respectively. For the diagnosis of periampullary carcinoma, the sensitivity, specificity, PPV, NPV, and accuracy rate of MRCP were 80%, 98%, 88.89%, 96.08%, and 95%, respectively.

Conclusion: No significant difference was found between MRCP and ERCP in diagnosing those six pathologies.

Objectives: Digital therapeutics (DTx) are innovative solutions that use meaningful data to provide evidence-based decisions for the prevention, treatment, and management of diseases. Particular attention is paid to software-based in vitro diagnostics (IVDs). With this point of view, a strong connection between DTx and IVDs is observed.

Methods: We investigated the current regulatory scenarios and reimbursement approaches adopted for DTx and IVDs. The initial assumption was that countries apply different regulations for the access to the market and adopt different reimbursement systems for both DTx and IVDs. The analysis was limited to the US, European countries (Germany, France, and UK), and Australia due to maturity in digital health product adoption and regulatory processes, and recent regulations related to IVDs. The final aim was to provide a general comparative overview and identify those aspects that should be better addressed to support the adoption and commercialization of DTx and IVDs.

Results: Many countries regulate DTx as medical devices or software integrated with a medical device, and some have a more specific pathway than others. Australia has more specific regulations classifying software used in IVD. Some EU countries are adopting similar processes to the Digital Health Applications (DiGA) under Germany's Digitale-Versorgung Gesetz (DVG) law, which deems DTx eligible for reimbursement during the fast access pathway. France is working on a fast-track system to make DTx available to patients and reimbursable by the public system. The US retains some coverage through private insurance, federal and state programs like Medicaid and Veterans Affairs, and out-of-pocket spending. The updated Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) in the EU includes a classification system specifying how software integrated with medical devices, and IVDs specifically must be regulated.

Conclusion: The outlook for DTx and IVDs is changing as they are becoming more technologically advanced, and some countries are adapting their device classifications depending on specific features. Our analysis showed the complexity of the issue demonstrating how fragmented are regulatory systems for DTx and IVDs. Differences emerged in terms of definitions, terminology, requested evidence, payment approaches and the overall reimbursement landscape. The complexity is expected to have a direct impact on the commercialization of and access to DTx and IVDs. In this scenario, willingness to pay of different stakeholders is a key theme.

Asymmetrical distribution of acute lung injury in mechanically ventilated patients can result in a heterogeneity of gas distribution between different regions, potentially worsening ventilation-perfusion matching. Furthermore, overdistension of healthier, more compliant lung regions can lead to barotrauma and limit the effect of increased PEEP on lung recruitment. We propose a System for Asymmetric Flow Regulation (SAFR) which, combined with a novel double lumen endobronchial tube (DLT) may offer individualized lung ventilation to the left and right lungs, better matching each lung's mechanics and pathophysiology. In this preclinical experimental model, the performance of SAFR on gas distribution in a two-lung simulation system was tested. Our results indicate that SAFR may be a technically feasible and potentially clinically useful although further research is warranted.

Background: Single pulmonary nodules are a common issue in everyday clinical practice. Currently, there are navigation systems with radial-endobronchial ultrasound and electromagnetic navigation for obtaining biopsies. Moreover, rapid on-site evaluation can be used for a quick assessment. These small lesions, even when they do not have any clinically significant information with positron emission tomography, are important to investigate.

Case description: Radiofrequency and microwave ablation have been evaluated as local treatment techniques. These techniques can be used as therapy for a patient population that cannot be operated on. Currently, one verified operating system is used for endoscopic radiofrequency ablation through the working channel of a bronchoscope.

Conclusion: In our case, a new system was used to perform radiofrequency ablation with long-term follow-up.