Medical Devices-Evidence and Research最新文献

{"title":"Patient-Reported Outcomes and Wound-Related Quality of Life in Adults with Diabetic Foot Ulcers Treated with Silicone Superabsorbent Polymer Dressings: Exploratory Results from a Prospective Multicenter Nonrandomized Cohort Study.","authors":"David G Armstrong, Jacek Mikosinski, Konrad Panczak, Adam Wegrzynowski, Dorota Piechota, Marek Kotala, Przemyslaw Lipinski, Katarzyna Rybolowicz, Agnieszka Lipinska, Vladica Velickovic, Jacek Bil, Teresa Szenk, Patrycja Buczak, Anitha Pitchika, Sebastian Probst","doi":"10.2147/MDER.S619815","DOIUrl":"10.2147/MDER.S619815","url":null,"abstract":"<p><strong>Background: </strong>Diabetic foot ulcers (DFUs) are associated with substantial clinical and economic burden and impaired health-related quality of life (HRQoL). Although wound healing remains a core endpoint, recent consensus work identifies HRQoL as an essential outcome in DFU studies. This study describes wound healing, patient-reported outcomes, function, and safety in adults with DFU treated with silicone superabsorbent polymer (SAP) dressings.</p><p><strong>Methods: </strong>This exploratory prospective, multicenter, nonrandomized cohort study reports the DFU subgroup from a broader single-arm investigation conducted at eight specialist centers in Poland. Adults with superficial, noninfected DFUs received silicone SAP dressings for up to 6 weeks with standard offloading. Prespecified patient-reported outcome measures were the Patient Benefit Index for wounds (PBI-W) and the Wound Quality of Life questionnaire (Wound-QoL-17). Additional endpoints included wound area reduction (centralized digital planimetry), complete epithelialization, accelerometry-based activity, offloading adherence, and safety.</p><p><strong>Results: </strong>Twenty-eight participants were included (75.0% male; mean age, 63.4 years), with a median wound duration of 166 days. By the final visit, 21 (77.8%) achieved at least 20% wound area reduction before cleansing/debridement and 24 (85.7%) after cleansing/debridement; 6 (22.2%) achieved complete epithelialization. Mean global Wound-QoL improved from 2.4 ± 0.6 to 1.5 ± 1.0 (mean change, -1.0 ± 0.8; P < 0.001), with greatest improvements in psyche and everyday-life domains. Mean PBI-W increased from 2.44 ± 0.94 to 2.94 ± 0.87 (mean change, 0.45 ± 1.10; P = 0.043). Activity intensity remained stable, offloading adherence exceeded 95%, and no device-related adverse events were reported.</p><p><strong>Conclusion: </strong>In this prospective DFU cohort, use of silicone SAP dressings within a structured care setting was associated with improvements in wound area reduction and wound-related quality of life over 6 weeks. These results highlight the feasibility of integrating patient-reported outcomes in DFU studies and provide a clinically relevant platform for future comparative and health-economic evaluations.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"19 ","pages":"619815"},"PeriodicalIF":1.5,"publicationDate":"2026-06-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13281877/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148296913","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Patient-Centric Design of the Lonapegsomatropin Auto-Injector for Growth Hormone Deficiency: Usability Validation of Safe and Effective Use.","authors":"Michael Lau, Paul Erik Fabricius, Nils Berg Madsen, Henrik Egesborg, Josephine Jensen","doi":"10.2147/MDER.S572536","DOIUrl":"10.2147/MDER.S572536","url":null,"abstract":"<p><strong>Purpose: </strong>Treatment of pediatric growth hormone deficiency (pGHD) with daily somatropin (human growth hormone [hGH]) injections is associated with challenges including needle anxiety, which may lead to poor adherence and ultimately result in suboptimal growth outcomes. The lonapegsomatropin (TransCon hGH, SKYTROFA^®) Auto-Injector, designed to deliver once-weekly lonapegsomatropin for the treatment of pGHD while minimizing injection challenges, was validated in usability studies in pGHD.</p><p><strong>Patients and methods: </strong>The Auto-Injector was evaluated in a usability validation study conducted under simulated-use conditions in accordance with FDA guidance, involving simulated injections performed by injection-naive or injection-experienced patients with pGHD or proxy medical conditions, caregivers, and health care providers (HCPs) responsible for injections or training patients/caregivers. Half of the patient and caregiver participants received training by a Nurse Trainer.</p><p><strong>Results: </strong>All participants (60 children, 60 caregivers, and 15 HCPs) were able to complete an injection successfully. All participants reported that they could follow the instructions as written, and 98% felt they could use the device as intended on their own or, for pediatric patients, with supervision. Use deviations observed for injection tasks for all participant groups were low: patients (3.2% of tasks), caregivers (2.4%), and HCPs (2.8%).</p><p><strong>Conclusion: </strong>The user-centric design of the lonapegsomatropin Auto-Injector enables successful and confident use to deliver an injection as intended, with the potential to overcome known barriers associated with GH injections and facilitate adherence, which may improve treatment outcomes.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"19 ","pages":"572536"},"PeriodicalIF":1.5,"publicationDate":"2026-06-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13242251/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148200650","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Real-World Performance of the Veriset Hemostatic Patch: A Multicenter Study of Adjunctive Hemostasis.","authors":"Aaron Quyn, Alex Navarro, Tulio Caldonazo, John M Findlay, Torsten Doenst, Melissa Anderson, Xue Gong, Joost M J Botman","doi":"10.2147/MDER.S595863","DOIUrl":"10.2147/MDER.S595863","url":null,"abstract":"<p><strong>Purpose: </strong>Uncontrolled bleeding remains a major surgical challenge, increasing morbidity, operative time, and costs, highlighting the need for effective adjunctive hemostats. Veriset is a synthetic, absorbable patch that promotes clotting and provides mechanical hemostasis. While early studies show efficacy, real-world evidence across diverse settings is needed. This post-market, multicenter study evaluated the safety and effectiveness of Veriset in various surgical procedures.</p><p><strong>Methods: </strong>This observational, single-arm, prospective study was nested within Medtronic's product surveillance registry. Sites were selected for procedural diversity (cardiovascular, soft-tissue, solid-organ), high Veriset use, and clinical study experience. Patients treated with Veriset as part of usual care were followed for 30 days post-procedure to monitor adverse events (AEs). The primary safety and effectiveness endpoints were device-related AEs within 30 days and hemostasis within 5 minutes, respectively. Secondary outcomes included time to hemostasis, length of hospital stay, and bleeding-site severity. Results were summarized using descriptive statistics and exact (Clopper-Pearson) confidence intervals.</p><p><strong>Results: </strong>Veriset was used on-label in 100 patients in cardiovascular (56), soft-tissue (18), solid-organ (18), and other (8) procedures. Most were performed via open surgery (90.0%), with 34% involving anastomoses. Median blood loss was 600 mL (interquartile range 200-1500), with transfusions in 24 patients. Of the 120 bleeding sites treated, pre-Veriset methods included sutures (55.8%, 67/120) and pressure (29.2%, 35/120). Bleeding was mostly mild/moderate (82.5%, 99/120). Device-related AEs occurred in 1 patient, with no deaths. Hemostasis within 5 minutes was achieved at 91.7% (110/120) of sites and in 96.0% (96/100) of patients. Median time to hemostasis was 2.0 minutes; median hospital stay was 7 days.</p><p><strong>Conclusion: </strong>This study provides real-world evidence that Veriset is safe and suggests that it may be an efficacious and rapid adjunct for surgical hemostasis, including in high-risk cardiovascular and solid-organ procedures, supporting and extending prior trial data for routine clinical use.</p><p><strong>Clinicaltrialsgov identifier: </strong>NCT01524276, Dec 24, 2025.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"19 ","pages":"595863"},"PeriodicalIF":1.5,"publicationDate":"2026-05-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13228841/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148158535","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Efficacy, Safety and Oncological Outcomes of Minimally Invasive Approaches (EMR, ESD and TAMIS) for Early Rectal Tumors: A Systematic Review and Meta-Analysis.","authors":"Mariam Hussain, Fatima Kayali, Abdelaziz O Surkhi, Roy Shartouni, Thurkga Moothathamby, Ahmed Hamza Akmal, Rohan Vyas, Leen Ammari, Ibrahim Sharaf, Mona Jaffar-Karballai, Mohamed Refaie, Yousif F Jubouri, Matti Jubouri, Mohamad Bashir, Ali Murtada","doi":"10.2147/MDER.S599781","DOIUrl":"10.2147/MDER.S599781","url":null,"abstract":"<p><strong>Background: </strong>Device-based minimally invasive techniques have transformed the management of early rectal tumors by enabling organ-preserving treatment while reducing morbidity compared with radical surgery. Endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD) are flexible endoscopic techniques, whereas transanal minimally invasive surgery (TAMIS) is a transanal access platform that allows excision using laparoscopic or robotic instrumentation. These approaches differ in access route, instrumentation, and depth of tissue excision. However, comparative evaluation from a device-centered and oncological perspective remains limited.</p><p><strong>Methods: </strong>A systematic review and proportional meta-analysis were conducted in accordance with PRISMA guidelines. PubMed, MEDLINE, Embase, Ovid, Scopus, and Web of Science were searched for studies reporting outcomes of EMR, ESD, or TAMIS in adult patients with early rectal tumors. Primary outcomes included R0 resection rate, en bloc resection rate, and local and distant recurrence. Secondary outcomes included procedure time, bleeding, and reintervention rates. Random-effects models were applied, and heterogeneity was assessed using the I² statistic.</p><p><strong>Results: </strong>A total of 108 studies encompassing 8705 patients were included. EMR demonstrated the shortest procedure time, ESD showed the lowest local and distant recurrence rates, and TAMIS achieved the highest en bloc resection rates. Despite differences in technical performance, R0 resection rates were broadly comparable across platforms. Substantial heterogeneity was observed, reflecting variation in tumor characteristics, access platforms, instrumentation, and operator expertise.</p><p><strong>Conclusion: </strong>EMR, ESD, and TAMIS are safe and effective device-based minimally invasive platforms for the treatment of early rectal tumors. Despite differences in access route and technological configuration, oncological outcomes appear more strongly influenced by tumor biology, depth, and pathological assessment than by the choice of platform alone. These findings support device-informed decision-making by guiding platform selection according to lesion characteristics and oncological outcomes while highlighting the need for randomized trials to optimize device selection in early rectal cancer management.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"19 ","pages":"599781"},"PeriodicalIF":1.5,"publicationDate":"2026-05-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13179808/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147965092","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Preclinical Feasibility of the ELANA End-to-End Anastomotic Technique in a Porcine Pilot Study.","authors":"Marieke Hoogewerf, Bart P Van Putte, David Stecher, Wilhelmina Bergmann, Patrick Klein, Pieter A Doevendans","doi":"10.2147/MDER.S520029","DOIUrl":"10.2147/MDER.S520029","url":null,"abstract":"<p><strong>Purpose: </strong>To advance minimally invasive surgical techniques, we developed the sutureless ELANA^® End-to-End anastomotic technique. This preclinical study aimed to evaluate the technical feasibility, hemostatic performance, and short-term patency of the new approach in a porcine model.</p><p><strong>Methods: </strong>Six pigs underwent implantation of the ELANA End-to-End device in a divided in situ right internal mammary artery (RIMA) via partial sternotomy. The pigs were followed-up for either 35 days (N=3) or 90 (N=3) days. Feasibility was evaluated based on technical success, achievement of hemostasis, and anastomotic construction time. Patency was assessed at the end of follow-up through angiography and histological analysis.</p><p><strong>Results: </strong>The anastomosis was successfully constructed in four of six animals. Among these, hemostasis was achieved in three cases without additional intervention; one required a single hemostatic stitch. The median anastomotic construction time was 18 (15-45) minutes. Technical failure in two animals was due to difficulty maintaining vessel alignment during deployment. All four successfully constructed anastomoses were patent at the end of follow-up (N=2, 35 days; N=2, 90 days), with no evidence of stenosis on angiography or histology.</p><p><strong>Conclusion: </strong>The ELANA End-to-End technique demonstrated promising patency outcomes. However, the current procedure is technically demanding. Design improvements aimed at stabilizing vessel positioning are warranted to enhance feasibility and reduce construction time.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"19 ","pages":"520029"},"PeriodicalIF":1.5,"publicationDate":"2026-05-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13159944/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147934663","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"AI Characterisation of Discordance Profiles Between Stress Electrocardiogram and Myocardial Tomoscintigraphy Using Random Forest XGBoost and SHAP.","authors":"Youness El Maadaoui, Abdelaziz Belaguid, Mohamed Aziz Bsiss, Aboubaker Matrane","doi":"10.2147/MDER.S595176","DOIUrl":"10.2147/MDER.S595176","url":null,"abstract":"<p><strong>Purpose: </strong>The evaluation of Coronary Artery Disease (CAD) using stress ECG and Myocardial Perfusion SPECT (MPS) frequently reveals discrepancies, particularly in patients with a positive ECG and a negative MPS (MPS-/ECG+). This paradoxical group poses a diagnostic challenge, often unexplained by classic statistical analyses. Our study aims to characterize this profile using interpretable Artificial Intelligence (AI).</p><p><strong>Patients and methods: </strong>A cohort of 86 patients with negative MPS was stratified into a \"discordant\" group (MPS-/ECG+, n=19) and a \"concordant\" group (MPS-/ECG-, n=67). A two-pronged analytical approach was used: (1) bivariate statistical analysis and (2) machine learning modelling. Two algorithms, Random Forest and XGBoost, were trained on a dataset rebalanced using SMOTE. Performance was assessed by AUC, and interpretability was ensured by SHAP analysis.</p><p><strong>Results: </strong>Conventional univariate statistical analysis did not identify any variable significantly associated with discordance (all p>0.05). In contrast, the XGBoost model, exploiting multivariate interactions, surpassed Random Forest, achieving a moderate but informative performance (AUC = 0.78), with a Sensitivity (Recall) of 67%, a Precision (Positive Predictive Value) of 50% for the discordant class (Class 1), and an overall Accuracy of 76%. SHAP analysis revealed that the most important predictors of discordance were female gender, advanced age, and the presence of diabetes, indicating that the prediction was influenced by the combination of these factors rather than a single one.</p><p><strong>Conclusion: </strong>This exploratory study demonstrates the potential value of explainable AI for deciphering complex clinical problems such as MPS/ECG discordance. Our multivariate models identified a potential patient profile associated with of MPS-/ECG+ discordance, characterized by the synergy of clinical factors. These preliminary results suggest that ECG abnormalities in the absence of a perfusion deficit might reflect an underlying pathology (e.g. microvascular disease) rather than a simple false positive, warranting further prospective validation.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"19 ","pages":"595176"},"PeriodicalIF":1.5,"publicationDate":"2026-05-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13156977/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147869995","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Malfunctions and Management of Home Medical Equipment in Visiting Nursing Stations and Collaboration with Clinical Engineers.","authors":"Shuichi Hamasaka, Kaoru Kyota, Satoko Mizohata, Keiko Tsukasaki","doi":"10.2147/MDER.S598103","DOIUrl":"10.2147/MDER.S598103","url":null,"abstract":"<p><strong>Background: </strong>Home medical equipment is extensively utilized in Japan; however, its management is typically overseen by visiting nurses or medical equipment manufacturers rather than by clinical engineers (CEs), who are specialized professionals. Visiting nurses often lack expertise in medical equipment, and manufacturers face legal limitations regarding equipment management. Improper operation or maintenance threatens patient safety. This study aims to elucidate the relationship between equipment malfunctions and management practices at visiting nursing stations (stations), as well as to assess the perceived need for CEs.</p><p><strong>Methods: </strong>A nationwide cross-sectional questionnaire survey was conducted, in which a stratified random sample of 500 stations was selected nationwide by region, with 76 stations providing valid responses. A questionnaire survey was conducted to assess the incidence and management of malfunctions across six types of medical equipment: infusion pumps, syringe pumps, electric suction units, oxygen concentrators, non-invasive positive pressure ventilation devices, and tracheostomy positive pressure ventilation devices. The survey also evaluated the perceived necessity for CEs. Associations between equipment malfunctions and management practices were analyzed using the chi-square or Fisher's exact tests.</p><p><strong>Results: </strong>Among the 76 stations, device abnormalities were the most frequently reported cause of malfunctions across all six equipment types, accounting for over half of the cases. In more than half of the incidents, responses were managed by visiting nurses and manufacturers. Significant associations were identified between infusion pump malfunctions and hospital affiliation, as well as between syringe pump malfunctions and the presence of operation manuals and safety information collection. Notably, 81.6% of stations recognized the need for CEs in home medical care.</p><p><strong>Conclusion: </strong>This study elucidated the relationship between equipment malfunctions, management practices at stations, and the perceived need for CEs. Our findings highlight the importance of establishing a collaborative framework between stations and CEs.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"19 ","pages":"598103"},"PeriodicalIF":1.5,"publicationDate":"2026-05-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13148265/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147844380","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Dynamic Changes in Exhaled Breath Glucose by Condensate Collection During Oral Glucose Tolerance Testing in Healthy Adults.","authors":"Wen Xu, Qingping Zhang, Yilian Hong, Zhenjun Mao","doi":"10.2147/MDER.S568279","DOIUrl":"10.2147/MDER.S568279","url":null,"abstract":"<p><strong>Purpose: </strong>Invasive blood glucose monitoring is associated with pain and suboptimal patient adherence, creating a need for non-invasive alternatives. In this study, we investigated the dynamic relationship between glucose levels in exhaled breath and blood during an oral glucose tolerance test (OGTT) in healthy adults, to assess the feasibility of using exhaled breath glucose as a non-invasive marker for glycemic monitoring.</p><p><strong>Methods: </strong>Twenty healthy volunteers (12 males, 8 females; mean age 23.1 ± 2.4 years) underwent a standardized OGTT test. Exhaled breath condensate (EBC) and blood samples were collected simultaneously at fasting (0h) and at 0.5h, 1h, 2h, and 3h post-glucose load. EBC glucose concentration was measured using ion chromatography. The temporal profiles of both parameters were analyzed, and the correlation between the rate of change in exhaled breath glucose and blood glucose at each time point was assessed using Pearson or Spearman correlation test.</p><p><strong>Results: </strong>Both blood glucose and exhaled breath glucose exhibited similar temporal patterns, peaking within 0.5-1 h after glucose administration and returning to baseline by 3h. Exhaled breath glucose increased from a fasting level of 0.49 ± 0.11 ng/L to a peak of 4.07 ± 1.44 ng/L at 1h. A statistically significant positive correlation between the rate of change in exhaled breath glucose and blood glucose was observed at 1h (<i>r</i> = 0.84, <i>p</i> < 0.000), whereas the correlation at 0.5h was not significant after correction for multiple comparisons (<i>ρ</i> = 0.45, adjusted <i>p</i> = 0.196). No significant correlations were detected at 2h or 3h. The changes in exhaled breath glucose were not associated with baseline pulmonary function-as measured by forced vital capacity (<i>p</i> > 0.05).</p><p><strong>Conclusion: </strong>Exhaled breath glucose levels dynamically track blood glucose changes during the early postprandial phase in healthy adults, demonstrating strong concordance during periods of rapid glycemic excursion. These findings support the feasibility of EBC as a non-invasive tool for monitoring glycemic trends. Further validation in larger cohorts and diabetic patients is required to establish its clinical utility.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"19 ","pages":"568279"},"PeriodicalIF":1.5,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13142279/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147844384","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Female Supine Urination Tech: Patent Landscape & Indicators.","authors":"Ana Mesa La Guardia, Maria Teresa Prats Valls, Mónica Micó Cabedo, Nuria Domenech Climent, Pablo Juan Verdoy, Jaume Gual Ortí","doi":"10.2147/MDER.S584153","DOIUrl":"10.2147/MDER.S584153","url":null,"abstract":"<p><strong>Purpose: </strong>Female urination in the supine position is a frequent bedside need, yet common workarounds (bedpans, diapers, improvised receptacles) can be uncomfortable, increase caregiver workload, and contribute to potentially avoidable urinary catheterization. We mapped the patent landscape of non-invasive female urine-collection technologies intended for supine use and derived actionable innovation and access priorities.</p><p><strong>Methods: </strong>We searched Espacenet (EPO), WIPO PATENTSCOPE, the USPTO database, Google Patents, and INVENES for January 2000-September 2025. Records were screened for functional relevance to female supine voiding and de-duplicated at the DOCDB family level. For each patent family we extracted priority/publication timing, jurisdictions, assignees, IPC/CPC codes, and forward citations; coded solution archetypes; and coded adoption-relevant attributes (workflow feasibility, infrastructure dependence, and single-use vs reusable design intent). A structured multi-domain appraisal (0-2 per domain; total 0-12) was applied to representative families to support consistent comparison.</p><p><strong>Results: </strong>Twenty-six patent families met inclusion criteria. Innovation activity was sustained but low-intensity and uneven over time, with most filings clustered in 2010-2020; interpretation of late years was limited by publication lag. Most inventions followed single-use/disposable pathways (≈69%). The set covered 16 IPC subclasses, although >60% of families were concentrated in A61F 5/455. Passive external collectors showed the strongest maturity signals. Adhesive patch-type and intravaginal concepts were sporadic and heterogeneous. Suction/capillary approaches introduced stronger containment mechanisms but increased dependence on external infrastructure and proprietary consumables, limiting feasibility in home care and low-resource settings.</p><p><strong>Conclusion: </strong>The most consistent gap lies at the intersection of ergonomics, autonomy, and reusability-female-specific supine interfaces that contain leakage without adhesives or invasive elements, operate passively or with minimal infrastructure, and enable sterilizable/reusable pathways. Priorities for R&D include usability- and risk-informed evaluation, sustainability-by-design, and access-oriented IP strategies to support diffusion beyond high-resource settings.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"19 ","pages":"584153"},"PeriodicalIF":1.5,"publicationDate":"2026-04-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13110041/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147785477","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Optimizing Respiratory Care with NEXThaler: Bridging Technology and Treatment.","authors":"Omar Usmani, Fulvio Braido, Daiana Stolz, Anh Tuan Dinh-Xuan, Borja G Cosio, Laura Franzini, Alessio Piraino, Ulrica Scaffidi Argentina","doi":"10.2147/MDER.S577725","DOIUrl":"10.2147/MDER.S577725","url":null,"abstract":"<p><p>Inhaled therapy is central in the management of asthma and chronic obstructive pulmonary disease, with inhaler device selection significantly influencing treatment efficacy and patient adherence. NEXThaler is a breath-actuated dry powder inhaler (DPI) designed to deliver extrafine formulations of inhaled corticosteroids (ICS) and bronchodilators, ensuring consistent drug deposition across both central and peripheral airways. This review provides a clinically oriented overview of inhaler technologies, focusing on the design features and clinical performance of this breath-actuated DPI. Notably, this narrative review is based on a comprehensive analysis of peer-reviewed clinical and preclinical studies on the NEXThaler DPI. Most evidence presented is derived from non-comparative studies, modeling approaches, or sponsor-supported trials. Key features of the NEXThaler DPI include a breath-actuated mechanism, flow-independent dosing, a dose counter and a triple feedback system that enhances correct usage, and a simplified open-inhale-close mechanism. The delivery of extrafine particles (<2 µm) facilitates deeper lung penetration, improving small airway targeting and potentially allowing for lower ICS doses with maintained efficacy. Lung deposition studies demonstrate superior peripheral distribution and consistent dosing across varying inspiratory flow rates. Clinical trials and real-world studies confirm the efficacy and safety of bronchodilators and ICS combinations delivered via the NEXThaler DPI in both asthma and chronic obstructive pulmonary disease populations, showing noninferiority to pressurized metered-dose inhalers and improved outcomes in lung function, symptom control, and adherence. The device's usability and patient satisfaction further support its role in respiratory care. Additionally, its propellant-free design contributes to reducing the environmental impact of inhaler therapy. Overall, thanks to its technological innovations, the NEXThaler DPI represents a clinically validated and patient-friendly option for the delivery of inhaled therapies in chronic respiratory diseases.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"19 ","pages":"577725"},"PeriodicalIF":1.5,"publicationDate":"2026-04-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13070343/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147677729","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}