Medical Devices-Evidence and Research最新文献

Purpose: To concurrently assess and compare the fixation efficacy, invasiveness, and fusion potential of a posterior integrated transfixation cage system to the posterolateral threaded implant and lateral triangular rod systems, in a cadaveric model.

Methods and materials: Twelve (12) cadaveric sacroiliac joint specimens were utilized and tested within the single-leg stance multidirectional pure moment bending model. Each specimen was tested in the intact, destabilized, treated (using posterior, posterolateral, and lateral systems), and post-fatigue conditions by applying 0 to ± 7.5 Nm of moment in flexion-extension, axial rotation, and lateral bending while measuring the angular range of motion between the sacrum and ilium. Computational models were reconstructed from Computed Tomography (CT) scans and manufacturer surgical technique guides. The models were utilized to quantify the volume of bone removed during implantation and the surface area available for fusion.

Results: The posterior integrated transfixation cage system and the lateral triangular rods produced equivalent motion reduction in all motion planes (P > 0.583). The posterolateral cylindrical threaded implant produced less motion reductions than the posterior and lateral implants in flexion-extension (6% ± 3% vs 37% ± 10% and 33% ± 11%, respectively, P <0.05). The posterior system removed 22%-60% less bone volume from the sacrum and ilium (P<0.10), introduced 200%-270% more implant surface to the joint space (P<0.01) and decorticated 75%-375% more joint surface area (P<0.01).

Conclusion: The posterior integrated transfixation single-implant cage system is superior to the posterolateral cylindrical threaded single-implant system. Its performance in osteopenic bone is equivalent to the lateral triangular rod system in healthy bone; however, the posterior integrated transfixation cage system requires a single implant, while the lateral triangular rod system requires three. The posterior implant removes the least bone volume and has the most surface area for fusion, providing a significantly better opportunity for robust sacroiliac joint arthrodesis.

Purpose: This study aims to investigate the differences between the heat energy produced during cataract surgery and Cumulative dissipated energy (CDE). CDE is often used as a medium for understanding the energy delivered to the eye during cataract surgery. However, the actual energy produced at the tip level of the tip is not well understood. We propose that a discrepancy may exist between the CDE reported by the surgical machine and the actual energy delivered to the eye.

Methods: About 50 mL of distilled water were degassed and placed in an isobaric calorimeter. Using the Alcon Centurion and Ozil handpiece fitted with the balanced tip, an investigator immersed the phaco tip into the water and pressed the foot pedal to position 3. The device was set to 100% continuous power, vacuum to 0 mmHg, with aspiration 12 mL/min aspiration. To prevent system changes in the system within the calorimeter, the aspiration tubing was occluded. Temperature change recorded by another investigator was observed from 0 to 60 seconds. After 60 seconds the first researcher immediately released the pedal and removed the phaco tip from the water. Trials were performed 10 times using solely torsional or longitudinal settings and averaged. CDE also was recorded and averaged.

Results: No significant difference was seen in the temperature change or energy calculated in Joules between ultrasound modalities, with torsional producing a magnitude of 163 J and longitudinal producing 172 J (P = 0.2). However, the CDE generated in the 60 seconds period was significantly different, with a magnitude of 61 for longitudinal compared to 24 for torsional (P < 0.001).

Conclusion: Significantly more energy was generated using torsional ultrasound than longitudinal at the tip level of the tip. CDE did not appear to accurately reflect these differences. This suggests that other factors should be considered when evaluating CDE and surgical outcomes.

Background: 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.

Methods: 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.

Results: 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).

Conclusion: 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.

Background: 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.

Methods: 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.

Results: 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.

Conclusion: 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.

Background:  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.

Materials and methods: 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.

Results: 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.

Conclusion: 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.

Purpose: The main aim of this study was to compare and analyze hematological profiles using menstrual blood, as an alternative to peripheral blood.

Patients and methods: This study used menstrual and peripheral blood samples from women who were menstruating. The design of this research is analytical observational.

Results: 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.

Conclusion: 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.

Purpose: 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.

Methods: 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.

Results: 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.

Conclusion: 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.

Purpose: 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).

Methods: 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.

Results: 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.

Conclusion: The subcutaneous furosemide OBI can be safely and effectively used by patients, caregivers, and HCPs, regardless of training.

Introduction: 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).

Methods: 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.

Results: 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).

Conclusion: 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.