Medical Devices-Evidence and Research最新文献

{"title":"Computed Tomographic Characterization for Basivertebral Nerve Ablation Utilizing a Radiofrequency Multitined Expandable Electrode.","authors":"Dawood Sayed, Douglas P Beall, Amitabh Gulati, Eric Hyman, Jon E Block","doi":"10.2147/MDER.S487201","DOIUrl":"https://doi.org/10.2147/MDER.S487201","url":null,"abstract":"<p><strong>Background: </strong>A growing body of clinical evidence has demonstrated that intraosseous minimally invasive basivertebral nerve (BVN) ablation results in significant and durable improvements in vertebrogenic back pain. Thus, it is important to develop, refine and validate new and additional devices to accomplish this procedure.</p><p><strong>Methods: </strong>Using reconstructions of 31 patient computed tomography (CT) scans of the lumbosacral spine (L1-S1), the primary objective was to simulate the intravertebral placement of a novel multitined expandable electrode in bipolar configuration at the targeted ablation site and determine if the proper trajectories could be achieved in order for the device tips to be in the correct position for lesion formation at the BVN plexus. Successful device deployment required that the distance between tips was between 10 mm and 20 mm.</p><p><strong>Results: </strong>The mean distances between device tips ranged from 11.35 mm (L5) to 11.87 mm (L3), and there were no statistically significance differences across the six vertebral levels (F = 0.72, p = 0.61). The percentage of successful intraosseous device placements within the tip distance acceptable range (≥ 10 mm to ≤ 20 mm) was 90% (162 of 180), with no tip-to-tip distances > 20 mm. There was a notable association between decreasing vertebral level and mean degree of angulation between contralateral devices ranging from 50.90° at L1 to 91.51° at S1, and the difference between across the six vertebral levels was significant (F = 89.5, p < 0.01).</p><p><strong>Conclusion: </strong>Feasibility evidence is provided from real world CT imaging data that validates using the multitined electrode for proper intraosseous placement within the vertebral body to effectively ablate the BVN plexus.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"17 ","pages":"323-337"},"PeriodicalIF":1.3,"publicationDate":"2024-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11412689/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142298537","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":"Emerging Trends and Hot Topics of Non-Invasive Electroencephalography Research in the Elderly: A Bibliometric Analysis from 2014 to 2023.","authors":"Chunyong Tang, Yanhua Peng, Jing Sui, Wencai Jiang, Rui Zhou","doi":"10.2147/MDER.S480900","DOIUrl":"10.2147/MDER.S480900","url":null,"abstract":"<p><strong>Background: </strong>Electroencephalography (EEG) has been rapidly developed and is widely used in both clinical and scientific fields. Original studies on non-invasive EEG in the elderly have been of great importance owing to the global aging trend. The present study aimed to provide a bibliometric overview on current status and trends in this research field.</p><p><strong>Methods: </strong>We searched the Web of Science Core Collection for articles published during 2014 and 2023. Synonyms for EEG and the elderly were combined as a retrieval strategy. Invasive EEG and secondary studies were excluded. Online filters and manual reviews were applied to select eligible articles. Basic bibliometric parameters were analyzed and visualized using VOSviewer and Excel software.</p><p><strong>Results: </strong>A total of 1656 publications were filtered, and 655 of which were finally included. In general, publication counts have steadily increased over the last 10 years. A sharp rise in publications occurred in 2021, and then remained at a high level. Authors and institutions from high-income countries/regions such as the United States of America (USA), China, and Germany were more productive and made significant contributions. Journals specialized in neuroscience, such as Frontiers in Aging Neuroscience, Neurobiology of Aging, and Clinical Neurophysiology, were popular among authors. Articles on aging, Alzheimer's disease (AD), mild cognitive impairment (MCI), dementia, memory, event-related potentials, attention, and the brain were more likely to use EEG. The newer topics included anesthesia, postoperative delirium (POD), confusion assessment method, connectivity, validation, and power.</p><p><strong>Conclusion: </strong>This bibliometric study provides fundamental knowledge on the current status and hot spots of the original studies on EEG in elderly, which is beneficial to researchers in paving future investigations of neuroscience and neural diseases.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"17 ","pages":"311-322"},"PeriodicalIF":1.3,"publicationDate":"2024-08-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11365532/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142113364","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":"Evaluation of Radiant Power of the Light Curing Units Used in Clinics at Governmental and Privates Dental Faculties.","authors":"Sami Abdulsalam Ali Hasan, Ibrahim Zaid Al-Shami, Mohsen Ali Al-Hamzi, Ghadeer Saleh Alwadai, Nada Ahmad Alamoudi, Saleh Ali Alqahtani, Arwa Daghrery, Wafa H Alaajam, Mansoor Shariff, Hussain Mohammed Kinani, Mohammed M Al Moaleem","doi":"10.2147/MDER.S478042","DOIUrl":"10.2147/MDER.S478042","url":null,"abstract":"<p><strong>Background: </strong> To evaluate the radiant power of the light cure units (LCUs) in relation to their type, radiant exitance, number of years in clinical use, and condition of LCUs tips in governmental and public clinics in Dental Faculties in Sana'a City.</p><p><strong>Materials and methods: </strong>LCUs were collected from different colleges at Sanaa City, Yemen, then LCU data as type, clinical age (<1 year, between 1-5 and ˃ 5-years), tip condition was visually inspected for damage and adhering debris, and the radiant exitance values of the tested LCUs. Radiant exitance values were subcategorized into three groups: <400, 400-850, and >850 mW/cm², labeled as inadequate, marginal, and adequate radiant exitances, respectively. A Woodpecker radiometer was used with a mode lasting of 20 seconds was used with each LCU. Descriptive statistics of the different parameters were evaluated with SPSS version 25. One-way ANOVA and Mann-Whitney tests were performed to determine the mean difference between the groups with a significance value of ˂ 0.05 was considered.</p><p><strong>Results: </strong>Two hundred twenty-three LCUs were surveyed, and the majority were Light-emitting diode (LED). Forty-nine (21.9%), 117 (52.4%), 57 (25.6%) recorded lesser than, 400-850, and more than 850 mW/cm², respectively. Radiant exitances of < year-old units were found to be higher than those of units used for ˃ 5 years with significant differences (p=0.001). The ANOVA test showed significant differences between the radiant exitance with clinical age and LCU tip conditions and a strong correlation p ˃ 0.050.</p><p><strong>Conclusion: </strong>LED curing lights were the most used in the tested Dental Faculties. More than half of the used LCU offered sufficient radiant exitance. Clinical age, the presence or absence of composite buildups, and damage to curing tips showed significantly affect radiant exitance values.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"17 ","pages":"301-310"},"PeriodicalIF":1.3,"publicationDate":"2024-08-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11363918/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142113365","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":"Improving Radial EBUS Signal with Creation of False Airway to Target Lesion During Electromagnetic Navigational Bronchoscopy: A Case Series.","authors":"Jennifer Wong, Monika Kakol, H Erhan Dincer","doi":"10.2147/MDER.S478541","DOIUrl":"10.2147/MDER.S478541","url":null,"abstract":"<p><p>Navigational bronchoscopy is increasingly used to target peripheral pulmonary nodules using electromagnetic navigational platforms (ENB), fluoroscopic navigation, or robotic-assisted bronchoscopy. The selection of equipment largely depends on the availability of technology, expertise, and the characteristics of the nodule and patient. Radial EBUS (r-EBUS) is often combined with these techniques for real-time confirmation of the nodule location. A bronchus sign is considered to have a higher diagnostic yield when biopsy tools can directly reach the nodule. We describe a case series of creating a false airway into the nodule when an eccentric r-EBUS signal is seen to subsequently obtain a concentric signal.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"17 ","pages":"295-300"},"PeriodicalIF":1.3,"publicationDate":"2024-08-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11335003/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142009692","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":"Innovative Hematology Analysis Using Menstrual Blood.","authors":"Endah Wulandari, Rr Ayu Fitri Hapsari","doi":"10.2147/MDER.S468500","DOIUrl":"10.2147/MDER.S468500","url":null,"abstract":"<p><strong>Purpose: </strong>The main aim of this study was to compare and analyze hematological profiles using menstrual blood, as an alternative to peripheral blood.</p><p><strong>Patients and methods: </strong>This study used menstrual and peripheral blood samples from women who were menstruating. The design of this research is analytical observational.</p><p><strong>Results: </strong>Menstrual blood can show an overall hematological profile similar to peripheral blood. Data shows the detection of blood component parameters, white blood cells and reticulocytes in MB with a range within and outside normal blood. Data on MB that show higher values (WBC, MCH, MCHC, PLT, RDW-CV, PDW, MPV, P-LCR, PCT, neutrophils, lymphocytes, monocytes, basophils, reticulocytes, LFR, Ret-He) and lower values lower (RBC, HGB, HCT, MVC, RDW-SD, Eosinophils, IRF, MFR, HFR) when compared with peripheral blood controls. The hematological profiles of Menstrual and peripheral blood showed significant differences (p < 0.01) for several parameters, while several other parameters did not show significant differences (p > 0.05) according to the Wilcoxon test.</p><p><strong>Conclusion: </strong>All hematological profile parameters were detected in menstrual blood. The new concept that menstrual blood can be used as a supporting medium for hematological examinations opens up opportunities for developing independent hematological detection tools in productive women.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"17 ","pages":"285-293"},"PeriodicalIF":1.3,"publicationDate":"2024-08-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11313484/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141917731","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":"Quantifying Patient Capabilities and Setting the Stage for Future Development: Insights from a Sensor-Augmented Simulated Use Study with Pen Injectors.","authors":"Jakob Lange, Andreas E Schneider, Christoph Jordi","doi":"10.2147/MDER.S478141","DOIUrl":"10.2147/MDER.S478141","url":null,"abstract":"<p><strong>Background: </strong>While formative and summative usability testing is essential to confirm safe and effective product use, it may not be sufficient to comprehensively understand user capabilities and limitations in device interactions. Therefore, this research aims to quantify user handling forces for different device handling steps of pen injectors through sensor-augmented simulated use studies.</p><p><strong>Research design and methods: </strong>The study involved 46 participants who were divided into two groups: a healthy control group and a group of users with dexterity impairments. All participants were instructed to perform simulated handling steps using non-functional dummy devices equipped with force and torque sensors. Each handling step was performed twice: first at what participants considered a comfortable force level and then at their maximum force. The study then analyzed force data to investigate the impact of user characteristics and device geometry on force exertion during the different handling steps.</p><p><strong>Results: </strong>The study demonstrates differences in the perceived comfortable and maximum force levels between the control and patient groups. These force levels decrease slightly with the user's age and level of dexterity impairment. Furthermore, the forces applied by the users are dependent on the geometry of the device and the holding pattern.</p><p><strong>Conclusion: </strong>The results highlight the significance of sensor-augmented simulated use studies as a tool for providing quantitative insights into users' ability to exert force while handling self-injection devices. These data offer comprehensive insights that inform the definition of performance requirements and specifications for injection device design, thereby supporting the advancement of future self-injection devices.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"17 ","pages":"271-283"},"PeriodicalIF":1.3,"publicationDate":"2024-07-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11298175/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141890405","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":"Design and Driving Performance Study of Soft Actuators for Hand Rehabilitation Training.","authors":"Zhilin Zhang, Aldrin D Calderon, Xingyu Huang, Guixian Wu, Chuanjian Liang","doi":"10.2147/MDER.S476464","DOIUrl":"10.2147/MDER.S476464","url":null,"abstract":"<p><strong>Purpose: </strong>To address the application requirements of soft actuators in rehabilitation training gloves, and in combination with ergonomic requirements, we designed a segmented soft actuator with bending and elongation modules. This actuator can achieve independent or coupled movements of the finger joints.</p><p><strong>Methods: </strong>A finite element model of the joint actuator was established to compare the driving performance of actuators with different structural forms. Numerical calculations were used to analyze the effects of structural size parameters on the bending characteristics and end output force of the actuator. The design was then refined based on these analyses.</p><p><strong>Results: </strong>The joint actuator designed in this study demonstrated a 71% increase in bending angle compared to the standard fast pneumatic network structure. Key factors affecting the driving performance include the thickness of the constraint layer, the inner wall thickness of the chamber, chamber height, chamber width, chamber spacing, chamber length, and the number of chambers. After improvements, the bending angle of the joint actuator increased by 60.6%, and the output force increased by 145.9%, indicating significant improvement.</p><p><strong>Conclusion: </strong>This study designed and improved a soft actuator for hand rehabilitation training, achieving independent and coupled joint movements. The bending angle, bending shape, and joint driving force of the soft actuator meet the requirements for finger rehabilitation training.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"17 ","pages":"237-260"},"PeriodicalIF":1.3,"publicationDate":"2024-06-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11216218/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141477667","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":"Human Factors Validation of a Wearable, On-Body Infusor for Subcutaneous Administration of Furosemide.","authors":"Anthony D Andre, John F Mohr, Barbara W Cornelius, Matthew M Goodwin, Carson P Whitaker, Bhavini H Patel, Jessica A Huckleberry, Michael D Hassman","doi":"10.2147/MDER.S462573","DOIUrl":"10.2147/MDER.S462573","url":null,"abstract":"<p><strong>Purpose: </strong>Furoscix^® (subcutaneous furosemide) is administered using a wearable On-Body Infusor (OBI) and is approved for the treatment of congestion associated with heart failure (HF). The purpose of this study was to assess the safe and effective use of the OBI and Instructions for Use (IFU) by patients with HF, caregivers, and healthcare practitioners (HCPs).</p><p><strong>Methods: </strong>Sixty participants (patients, n=30; caregivers, n=15; HCPs, n=15) were evaluated on completion of OBI use tasks and IFU knowledge tasks in a simulated use environment. Fifteen of the patients received OBI/IFU training before evaluation.</p><p><strong>Results: </strong>Overall, 893/900 (99.2%) use tasks and 2211/2220 (99.6%) knowledge tasks were completed successfully, without differences due to training. The most common (n=6) use error was failure to wipe skin or cartridge tip with an alcohol wipe. Errors were due to forgetfulness/misinterpretation rather than IFU clarity.</p><p><strong>Conclusion: </strong>The subcutaneous furosemide OBI can be safely and effectively used by patients, caregivers, and HCPs, regardless of training.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"17 ","pages":"229-235"},"PeriodicalIF":1.3,"publicationDate":"2024-06-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11212806/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141471523","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":"Mechanical Improvement of Gas Monitoring System in Monoplace Hyperbaric Chamber to Advance the Safety and Efficacy.","authors":"Hee Young Lee, Yoonsuk Lee, Hyun Kim, Jin Hui Paik","doi":"10.2147/MDER.S465022","DOIUrl":"10.2147/MDER.S465022","url":null,"abstract":"<p><strong>Introduction: </strong>A Monoplace hyperbaric chamber delivers oxygen to the patient's tissues through breathing. Gas monitoring inside the chamber is important because oxygen (O₂) is consumed, and carbon dioxide (CO₂) is increased because treatment is performed in a closed volume. This study aimed to advance the safety and efficacy of the monoplace hyperbaric chamber (MHC) through mechanical improvement in a gas monitoring system (GMS).</p><p><strong>Methods: </strong>First, as the oxygen supply method was changed to the direction of the patient's face, it was compared the values of O₂, CO₂, humidity, and temperature were measured in the MHC and the GMS when operating at 2.0 atmosphere absolute (ATA) and 3.0 ATA. Second, to evaluate the effects of variables across measuring time, it was analyzed in a 3-way repeated measure ANOVA (10 min.×20 min.×30 min.). Lastly, the values before and after the optimization of the MHC were compared by applying a cooler to prevent temperature rise inside the MHC.</p><p><strong>Results: </strong>In 2.0 ATA, the average humidity was higher in the MHC than in the GMS (p<0.001). Also, the average temperature was lower in the MHC than in the GMS (p<0.001). In 3.0 ATA, the average CO₂ and humidity were higher in the MHC than in the GMS, respectively (p<0.001, p=0.004). The 3-way repeated measures ANOVA revealed a significant difference in most main and interacted factors (p<0.05). O₂ and temperature, comparing before and after MHC optimization, revealed a significant difference (p<0.05).</p><p><strong>Conclusion: </strong>Few studies have verified safety and effectiveness by evaluating the pressure, oxygen concentration, etc. of a monoplace hyperbaric chamber. Further research is expected to verify the effectiveness of providing comfort to patients receiving hyperbaric oxygen treatment and increase the treatment effect.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"17 ","pages":"217-227"},"PeriodicalIF":1.3,"publicationDate":"2024-06-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11195672/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141447311","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":"The Hearing Test App for Android Devices: Distinctive Features of Pure-Tone Audiometry Performed on Mobile Devices [Response to Letter].","authors":"Marcin Masalski","doi":"10.2147/MDER.S480072","DOIUrl":"10.2147/MDER.S480072","url":null,"abstract":"","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"17 ","pages":"215-216"},"PeriodicalIF":1.3,"publicationDate":"2024-06-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11179668/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141332157","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}