Background:The coordination gap between the Central Sterile Supply Department (CSSD) and the Operating Room (OR) in surgical consumables management has become a bottleneck constraining surgical turnover and patient safety, yet existing digital implementations remain largely fragmented. Objective:This study aims to propose a conceptual framework for CSSD-OR consumable collaborative management based on information ecology theory, and to synthesize the integration pathways of key digital technologies. Methods:Using information ecology theory as the analytical framework (encompassing information, technology, human actors, and environment), this paper synthesizes the current literature on UDI, RFID, SPD models, data middleware, machine learning, and blockchain technologies in the CSSD-OR context. An integrated analytical framework is constructed by incorporating supply chain integration theory and socio-technical systems theory. Results:Information chain ruptures were identified at three critical nodes: distribution-receiving, usage-billing, and recycling-reprocessing. A three-tier analytical framework is proposed, comprising a foundation layer (information chain integration), an intermediate layer (technology-process adaptation), and a guarantee layer (institutional-performance synergy). The "collection-transmission-processing-feedback" closed-loop mechanism is conceptualized as the core operational logic linking material flows, risk warning, and responsibility traceability. Conclusion:The digital transformation of CSSD-OR consumable management requires systematic restoration of information ecosystem imbalances rather than isolated technology deployment. The proposed framework offers a theoretical reference for hospitals seeking to move beyond technology stacking toward ecological collaboration, particularly within the Chinese healthcare context where UDI mandates and DRG/DIP reforms are ongoing.
Purpose:Experimental studies have shown that the olfactory sensory receptor neurons not only identify odors and assess odor concentrations, but also act as respiratory mechanical sensors that respond to nasal airflow during breathing. Both odor detection and mechanical sensing appear mediated by a shared cellular mechanism. This prospective, single-arm, uncontrolled, pilot study was conducted to ascertain whether olfactory nerve mechanical stimulation provided by a nasal breathing oscillation device (Goodair Nosebuds) could influence olfaction when olfaction was assessed objectively. The study was performed on participants, who felt that their olfaction could be improved. Methods:Participants wore a nasal breathing oscillation device (Goodair Nosebuds) ten minutes twice a day for four weeks. At the beginning of the study and after four weeks, the participants' olfaction was assessed. Olfactory testing was performed using Sniffin' Sticks (phenyl ethyl alcohol threshold, odor discrimination and odor identification). Results:After four weeks, participants using the nasal breathing oscillation device (Goodair Nosebuds), had an increase in olfactory function in phenyl ethyl alcohol threshold, and odor identification when compared to baseline. The global olfactory score (the sum of the three scores) increased. Conclusion:This prospective, single-arm, uncontrolled, pilot study indicates that olfactory nerve mechanical stimulation was associated with an improvement in olfactory scores. Trial Registration:The study was registered with the Australian New Zealand Clinical Trials Registry (ANZCTR; ACTRN12625001131448).
Background and Rationale:Various guidance techniques can be performed under ultrasound (US), computed tomography (CT), fluoroscopy, and magnetic resonance imaging (MRI) guidance; They pave the way for simple, intermediate, and complex minimally invasive procedures by improving visualization of the target, the access route, and device progression. Objective:This study aimed to evaluate the availability and utilization of radiological guidance tools in interventional radiology units in Kinshasa, Democratic Republic of the Congo. Materials and Methods:This descriptive study was conducted in selected medical facilities in Kinshasa. Data were collected from January 2018 to June 2024 using a structured questionnaire and medical record review. Eligible cases included patients who underwent semi-invasive diagnostic or therapeutic interventional radiology procedures performed under direct imaging guidance, with acceptable hemostatic parameters and documented informed consent. The evaluated outcomes included the type of radiological guidance used, anatomical or disease target, procedure complexity, and procedure-related incidents. Data were analyzed using descriptive statistics. Categorical variables were summarized as frequencies and percentages, and continuous variables were summarized as means and standard deviations when applicable. Results:A total of 471 image-guided interventional radiology procedures were analyzed. The evaluated cases involved a range of anatomical and disease-related targets, including liver, breast, thyroid, prostate, spinal, cervical soft-tissue, splenic, pancreatic, renal, lymph-node, and other abdominal or soft-tissue lesions. Female patients represented 55.3% of the study population. Among the 471 interventional radiology procedures analyzed, age was available for 469 cases. The mean age was 48.2 ± 17.2 years, with a range of 1 to 84 years. Ultrasound was the most frequently used guidance modality, accounting for 384 procedures (81.5%), followed by CT guidance in 63 procedures (13.4%) and fluoroscopic guidance in 24 procedures (5.1%). Cone-beam CT guidance was not used. Simple interventional radiology procedures were the most common, accounting for 327 procedures (69.4%), followed by intermediate procedures in 126 cases (26.8%) and complex procedures in 18 cases (3.8%). Conclusion:This study shows that ultrasound guidance remains the most commonly used radiological guidance method in interventional radiology settings in Kinshasa. However, MRI, fluoroscopy-CT, electromagnetic, and cone-beam CT guidance were not used in this series. These findings provide baseline local evidence on current technical capacity and unmet equipment needs, and may help guide future planning and development of interventional radiology services in the Democratic Republic of the Congo.
Objective:Objective was to compare spring-driven mechanical and electronic infusion systems used for subcutaneous immunoglobulin (SCIg) therapy in patients with primary or secondary immunodeficiency (PID, SID) and chronic inflammatory demyelinating polyneuropathy (CIDP), with a focus on local infusion-site reactions and reliable dose delivery. Methods:A structured literature review was conducted (PubMed, Cochrane Library, Google Scholar; January 26, 2026). Eligible studies reported safety outcomes. As direct measures of dose delivery were not consistently reported, infusion system performance was evaluated using pharmacodynamic response, with immunoglobulin G (IgG) levels at the end of the study period considered an indicator of successful dose delivery. Data were extracted and descriptively aggregated across studies. Risk of bias was appraised using validated tools appropriate to study design. Results:Fourteen studies met the inclusion criteria (4 mechanical, 10 electronic). Mechanical infusion systems were associated with lower reported proportions of local infusion-site reactions, including swelling (23.1% vs 61.4%), redness (28.6% vs 44.0%), and soreness (22.9% vs 50.0%) compared with electronic infusion systems. Variability across studies was substantial, likely reflecting differences in patient populations, immunoglobulin formulations, infusion protocols, publication era, and outcome reporting methods. Across studies, both mechanical and electronic infusion systems achieved IgG levels consistent with therapeutic targets, supporting effective SCIg delivery. Conclusion:Mechanical infusion systems were associated with consistently lower reported rates of local infusion-site reactions compared with electronic infusion systems in this descriptive synthesis, while both system types effectively achieved IgG levels consistent with adequate dose delivery. Although variability across studies warrants cautious interpretation, the overall pattern suggests a favorable tolerability profile for mechanical systems. Device selection should remain individualized, and further comparative research is warranted.
Background:Medical oxygen delivery systems require adaptable connection interfaces capable of supporting different clinical configurations during oxygen therapy. Integrating multifunctional connection mechanisms within a single component offers an opportunity to improve system versatility and connection management in respiratory care settings. Objective:To design and experimentally validate a novel dual-connection fitting for medical oxygen delivery, designated as the O2 Mixed Fitting, that enables simultaneous attachment of both a bubble humidifier and conventional oxygen tubing while remaining installed on the flowmeter. Methods:A comprehensive state-of-the-art review informed the conceptual development of the device. Iterative design refinement was performed using computer-aided design. The final device was manufactured by injection molding using medical-grade Acrylonitrile Butadiene Styrene. Validation included gas flow analysis, leak and pressure-holding tests, microbiological and physical stability evaluation under controlled climatic conditions, and sustainability assessment using a structured eco-design framework. Results:The integrated dual-connection mechanism enabled transition between humidified and non-humidified oxygen delivery without detachment from the flowmeter. Gas flow measurements remained within predefined accuracy tolerances, including ±0.5 L/min at low flows and ±10% at higher flows. No leakage was detected during pressure testing up to 10 psi. During the 12-month natural stability study, physical and microbiological parameters remained within predefined acceptance criteria under climatic zone IVb conditions. The eco-design assessment demonstrated favorable environmental performance. Conclusion:The O2 Mixed Fitting represents an innovative dual-connection solution for medical oxygen delivery applications. Laboratory validation confirmed structural integrity, flow stability, pressure resistance, and physical and microbiological stability under the evaluated conditions. The integrated design enhances functional versatility while maintaining full compatibility with existing clinical infrastructure. Further clinical and operational studies are warranted to evaluate its potential impact on patient care and clinical workflow.
Introduction:Silicone elastomers are widely used in maxillofacial prostheses owing to their elasticity, esthetic properties, and biocompatibility. Clean-grade silicone serves as an affordable alternative to medical-grade silicone. The addition of Cellulose Nanocrystals (CNC) and intrinsic pigments is expected to enhance the performance of clean-grade silicone. Purpose:This study aims to evaluate the effects of CNC and intrinsic pigments on the tensile strength, elongation percentage, and tear strength of clean-grade silicone as an alternative material for maxillofacial prostheses. Materials and Methods:Six groups of clean-grade silicone were evaluated: control, A (with pigment), B (with 0.5% CNC), C (with 0.5% CNC and pigment), D (with 1% CNC), and E (with 1% CNC and pigment). Scanning Electron Microscopy (SEM) and Fourier Transform Infrared Spectroscopy (FTIR) were conducted to evaluate the morphological and functional group characteristics; tensile strength, elongation percentage, and tear strength were measured to assess changes in mechanical properties and were analyzed statistically. Results:SEM analysis showed microstructure formation characterized by dispersed particles with the addition of 1% CNC and intrinsic pigments. As the filler and pigment were added, the FTIR revealed increased absorption intensities of Si-O-Si functional groups, detected at 1022-1026 cm-1. The tensile trength (3.87-4.84 MPa) was successfully increased compared to the control group (3.63 MPa), a statistically significant difference (p<0.05). Group D had the highest tensile strength, aligning closely with medical-grade silicone (approximately 2.53-8.36 MPa). Meanwhile, the lowest elongation percentage and the highest tear strength (3.84 kN/m) resulted in Group E, both of which are close to the range of maxillofacial prosthesis requirements. Conclusion:The addition of 1% CNC and intrinsic pigments successfully increased tensile and tear strength while reducing the elongation percentage of clean-grade silicone that potential as an alternative material; however, future optimization on the tear strength still required before maxillofacial prosthesis application.
Purpose:To compare post-occlusion surge pressure at various intraocular pressures using the Active Sentry handpiece. Methods:This experimental (in vitro chamber) study used the Alcon Centurion platform and Active Sentry handpiece with balanced tips. Quad preset was used with settings: vacuum 500 mmHg, aspiration flow 50 mmHg, and IOPs of 30, 50, and 70 mmHg. A rubber disk was fixed within a sealed chamber fitted with an electric pressure sensor to monitor pressure changes. The phacoemulsification tip was inserted into the water-tight port of the pressure chamber, and the foot pedal was set to position two. The tip was put in contact with the disk to replicate tip occlusion and pulled from the disk to simulate occlusion break. Ten trials were performed at each IOP; pressure changes were recorded continuously. Results:At 70 mmHg IOP, average post-occlusion surge magnitude was 5.76 mmHg ± 0.54; average surge duration was 0.45 s ± 0.10. At 50 mmHg IOP, surge magnitude was 5.76 mmHg ± 1.15; surge duration surge was 0.52 s ± 0.23. At 30 mmHg IOP, surge magnitude was 10.46 mmHg ± 2.86; surge duration was 1.27 s ± 0.51. There was a statistically significant difference between surge magnitude and duration at 30 vs. 50 mmHg IOP (P < 0.05) and at 30 vs. 70 mmHg IOP (P < 0.05). Conclusion:When utilizing the Active Sentry handpiece, an increased surge risk was not observed when operative IOP was decreased from 70 mmHg to 50 mmHg. However, our data suggest that surge risk increases when operative IOP is decreased to 30 mmHg. The Active Sentry handpiece at 50 mmHg IOP would not introduce greater surge risk than at 70 mmHg IOP.
Background: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. Methods: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. Results: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. Conclusion: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.
Purpose: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. Patients and Methods: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. Results: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%). Conclusion: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.
Purpose: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. Methods: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. Results: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. Conclusion: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. Clinicaltrialsgov Identifier:NCT01524276, Dec 24, 2025.
Purpose: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. Methods: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. Results: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. Conclusion: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.
Purpose: 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). Patients and Methods: 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. Results: 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. Conclusion: 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.
Background: 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. Methods: 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. Results: 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. Conclusion: 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.
Purpose: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. Methods: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. Results: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 (r = 0.84, p < 0.000), whereas the correlation at 0.5h was not significant after correction for multiple comparisons (ρ = 0.45, adjusted p = 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 (p > 0.05). Conclusion: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.
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.
Purpose:The growing number of patients with hand dysfunction caused by conditions such as stroke has led to increasing demand for soft finger rehabilitation actuators. However, existing devices of this type often face issues such as irregular deformation, insufficient driving force, the inability to achieve segmented control, and poor rigidity retention. Methods:A multi-segment exoskeleton design is proposed, which achieves a functional separation between actuation and load-bearing. Utilizing the principle of virtual work and the Yeoh constitutive model, derive the pressure-to-angle transfer function to facilitate the establishment of the overall equation of motion. Results:The finite element analysis and experimental tests conducted in this study prove that the design prevents irregular deformation, enables segmented control, and maintains high rigidity. Through physical testing, a maximum bending angle of 338.7° and a maximum driving force of 11.50 N were achieved, which is 25.27% higher than the 9.18 N force found in existing studies. Conclusion:The multi-segment reconfigurable soft finger exoskeleton actuator proposed in this study demonstrates significant advantages over conventional devices, with its enhanced bending range and force output facilitating patients' performance of daily grasping tasks. The segmented control capability enables personalized rehabilitation training targeting specific finger joints. This innovation holds substantial promise for improving hand function recovery in stroke patients.
Purpose:Improving image quality without increasing patient discomfort remains a challenge in mammography. This study evaluated the ability of the Envision™ platform in a prospective, multicenter observational case-collection study (NCT05199701), focusing on patient comfort and radiologist-assessed image quality. Patients and Methods:Across nine US breast-imaging sites, 929 women aged ≥35 years undergoing a clinically indicated screening or diagnostic mammogram, or a mammogram in the context of a recommended biopsy, were enrolled. All subjects received a standard four-view bilateral exam (RCC, RMLO, LCC, LMLO) on the Envision platform. Radiologists rated image quality (positioning, contrast, sharpness, tissue visibility, noise, artifacts, and overall clinical image quality) using a three-category scale (requires reimaging, acceptable, excellent). Patient comfort and device preference were assessed via questionnaire. Analyses were descriptive. Results:Most subjects (79%) preferred the investigational mammogram over prior mammograms, and 70% reported greater compression comfort. Discomfort scores were low: 34% reported no discomfort (0/10) and 52.5% reported minimal discomfort (1-2/10). Radiologists rated the majority of images acceptable or excellent, with excellent ratings of 41.9-48.5% for contrast, 41.8-42.0% for sharpness, 50.2-50.5% for tissue visibility, and 33.4-34.5% for artifacts. Repeat-imaging recommendations were infrequent (0-6.6% across views), and overall clinical image quality was acceptable or excellent in 94.1-100% of images. Conclusion:The Envision platform produced consistently high levels of clinically acceptable image quality while maintaining or improving patient comfort compared to prior mammography experiences. These findings support its feasibility for routine clinical use.
Objective:Growing interest in quantitative Doppler assessment has underscored the need for reliable, operator-independent tools to evaluate peripheral arterial circulation. This study aimed to evaluate the reliability of a novel ultrasound Doppler device (earlybird) for measuring blood-flow velocity in lower-extremity arteries and to validate its consistency across raters. We further explored multiple hemodynamic parameters derived from the Doppler spectrogram to examine their reproducibility and potential clinical applicability. Methods:Thirty-five participants, including 25 with varying degrees of peripheral arterial disease (PAD) and 10 healthy individuals, were recruited. Four raters performed independent measurements of the peripheral blood-flow velocity in each participant (280 measurements). Six blood-flow parameters were extracted from the Doppler spectrograms: peak systolic velocity (PSV), time-averaged velocity (TAV), end-diastolic velocity (EDV), pulsatility index (PI), resistive index (RI), and acceleration time (AT). The intraclass correlation coefficient (ICC) was used to assess reliability, which was visualized in scatter plots and Bland-Altman plots with 95% limits of agreement. Results:Good correlation and agreement among the different raters were observed, with inter-rater reliability ranging from an ICC of 0.755-0.835 (p < 0.001). Intra-rater reliability showed poor to excellent correlation, with ICCs ranging from 0.450 to 0.961, (p < 0.001). Bland-Altman plots revealed wide 95% limits of agreement for PSV, TAV, EDV, and PI, but narrower limits for RI (-9.8% to 9.8%) and AT (-17.3% to 17.1%). Conclusion:Earlybird was shown to be a reliable tool for assessing peripheral arteries across raters, with good inter- and intra-rater reliability. The angle-independent variables, RI and AT, showed narrow 95% limits of agreement, which justifies further exploration.
