Medical Devices-Evidence and Research最新文献

Purpose: To explore the effect of fine management combined with man-machine fixation mode in reducing the attrition rate of laparoscopic instruments.

Methods: This is a non-randomized, concurrent controlled study, from December 1, 2023, to May 1, 2024, the use of 4 laparoscopic instruments in the operating room which belongs to shanghai first maternity and infant hospital was analyzed. The instruments were divided into two groups, and the control group was managed by conventional methods. The observation group implemented with fine management combined with man-machine fixed mode. We used instrument attrition rate and physician satisfaction as outcome indicators.

Results: In this study, four laparoscopic instruments were investigated, and a total of 858 cases were used, including 429 cases in the control group (machine 1, machine 2) and 429 cases in the observation group (machine 3, machine 4). After the implementation of refined management combined with man-machine fixed mode, the observation group had significantly lower attrition rate and failure rate of laparoscopic instruments than the control group, including insufficient instrument preparation (p = 0.000), unstable light source (p = 0.012), air leakage (p = 0.000), screen color distortion (p = 0.040), and blurred visual field (p = 0.000). The satisfaction of doctors in the observation group was significantly higher than that in the control group, including preoperative preparation, process cooperation, operation proficiency, trouble solving ability, instrument debugging ability, communication and service attitude (p < 0.01).

Conclusion: The use of fine management combined with man-machine fixed mode in the management of laparoscopic instruments in the operating room can effectively reduce the incidence of instrument attrition rate, improve the efficiency of surgery, and the economic benefit of the hospital, which is worthy of popularization and application.

Purpose: Adherence to growth hormone treatment is known to affect growth outcomes. Both device preference and ease of use have been shown to affect treatment adherence. In this study, we assessed device preference and ease of use with two long-acting growth hormones, somapacitan (Sogroya^®, Novo Nordisk A/S) and somatrogon (Ngenla^®, Pfizer).

Patients and methods: In a randomized, crossover study conducted between September 20 and November 2, 2023, we recruited 33 adolescents with a growth-related disorder, and 37 caregivers, at six locations in the United States. Each participant was trained in the use of both devices and asked to perform a simulated injection. Device training time, preparation and injection time, and injection completeness were recorded. Participants also completed the Device Handling and Preference Questionnaire (DHPAQ) to indicate their device preference and ease of use opinions. Following conclusion of the "standard" visit, 10 adolescents and 10 caregivers were randomly selected to participate in a sub-study to validate the relevance, comprehensiveness, and comprehension of the DHPAQ.

Results: The majority of participants (84.3%; 95% confidence interval [CI]: 74;92) preferred the somapacitan device to the somatrogon device (p < 0.0001). Almost all (98.6%; 95% CI: 92;100) participants answered that the somapacitan device was easy or very easy to use, while three-quarters (74.3%; 95% CI: 62;84) answered the same for the somatrogon device. Average training and injection times were lower for the somapacitan device than for the somatrogon device. Also, more patients successfully completed the injection with the somapacitan device than with the somatrogon device (97.1% vs 92.9%). Cognitive debriefing interviews indicated the DHPAQ was relevant, comprehensive, and fully comprehended.

Conclusion: The somapacitan device was preferred to the somatrogon device by a majority of participants. More participants considered the somapacitan device to be easy or very easy to use than the somatrogon device.

Background: The cerebral fluid-dynamic system plays a critical role in maintaining brain health and function. Recent studies identify the glymphatic system as primarily responsible for removing waste products and toxins from brain tissue. In recent years, we have achieved beneficial improvements in MS patients' symptoms and lifestyle using a specific Fluid Dynamic Intensive MAM (FD-MAM) protocol.

Methods: We treated 40 outpatients with progressive MS, aged 45-55 years and with EDSS scores from 6 to 9. We applied FD-MAM in 10 daily sessions over two weeks. Before and after glymphatic drainage by FD-MAM, we assessed each patient's clinical status and quality of life using six validated questionnaires.

Results: Data from the six validated questionnaires administered to the 40 MS patients show an improvement in 83% of the scores. At the same time, we observed a shift from pathological to physiological values in 50% of the pathological scores after 10 sessions of FD-MAM protocol.

Conclusion: This study confirms the positive improvements on life quality in outpatients with progressive multiple sclerosis after one cycle of Fluid Dynamic Intensive MAM (FD-MAM) protocol. Initial follow-up on few patients treated with the FD-MAM protocol suggests that the results persist for six to ten months post-treatment. Future detailed studies, on MS outpatients' larger cohort, are essential to assess the duration of results and its effect on glymphatic system.

Introduction: The aim of the article is to determine the appropriate concentration of desflurane to effectively counteract the increase in blood pressure resulting from surgical stress. In medical practice, this increase is often limited by using additional doses of opioid drugs. Additional medications or higher doses of those already used may adversely affect your health. During anesthesia, physician must note the use of drugs and remember them, especially those that he has recently administered, which affect his concentration. For this purpose, the authors decided to propose support for the selection of desflurane concentration so that frequent use of opioid drugs is not necessary. The authors used a system based on AI issues to accomplish this task. The learned system supports the anesthesiologist's work by imitating him.

Patients and methods: The proposed method for selecting the desflurane concentration is based on a fuzzy controller. This system includes a learning mechanism that allows for minimizing the operating error. The main advantage of this system is the ability to build a function allowing the selection of anesthesia parameters without knowledge of the mathematical description of the process. To accomplish this task, you need an expert who will provide information in the construction of logical if-then sentences (points in space). The fuzzy controller connects the points in the consideration space appropriately, generating a hypersurface. The algorithm test was performed only by computer without the participation of patients.

Results: The operation of the proposed algorithm was verified by computer simulation. The authors of the article analyzed the compliance of the obtained results with the table provided by the expert. The desflurane concentration values obtained by computer simulation are similar to those given in the table Minimal driver error does not affect the patient's clinical response. This error results from the functions used in the fuzzy system and its settings. The results of the performance test of the proposed algorithm are presented in a time course, and it has the shape of a step function. The work proposes a function that allows you to enter the time needed for the body's reaction to reach the desired E_tdes level.

Conclusion: In this study, a controller was created to support the selection of the concentration of desflurane allowing for a reduction in blood pressure (resulting from surgical stress). The results obtained by computer simulation provide valuable insights for optimizing anesthesia. This system can also be used as an important simulation program for teaching purposes.

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: Therapeutic proteins are often delivered by subcutaneous (SC) autoinjector to enable self-administration. Autoinjectors typically deliver up to 1 mL injected volumes per dose. Delivery of larger volumes may be limited by injection site discomfort, including pain, swelling, and redness. Delivery at a slower rate may mitigate this discomfort. This single-center, randomized, crossover study evaluated the acceptability and tolerability of varying volumes and delivery rates of SC saline in healthy volunteers.

Patients and methods: Eligible participants were adults (18-65 years) with a body mass index of 18.5-32.0 kg/m². Participants (N = 24) were randomized to multiple sequences of infusions over five visits, with infusions ranging from 1 to 5 mL at rates of 1.50-6.00 mL/minute (min) and including a 1 mL SC infusion in 10 seconds (s) at a rate of 6.00 mL/min. The primary objective was to identify acceptable volume and delivery rates of SC saline, as assessed by visual analogue scale (VAS) pain scores, a tolerability and acceptability questionnaire, and infusion leakage.

Results: Infusions that met the acceptability criteria were 1 mL in 10s, 4 mL in 58s, and 3 mL in 2 mins. Higher delivery volumes and rates were associated with higher VAS pain scores but remained within the VAS acceptability criteria.

Conclusion: These findings may support the development of larger-volume injectors for self-administration of future medicines.

Objective: The purpose of the current review is to identify the main problems of endotracheal intubation, which will serve as a basis for the design requirements for a novel endotracheal tube.

Methodology: A PICO systematic search was conducted in PubMed up to December 2021 to identify issues related both to the endotracheal intubation procedure and device-specific factors.

Results: Two primary categories of problems were identified during endotracheal intubation: a) Issues related to laryngotracheal symptoms such as cough, hoarseness, aphonia, dysphonia, dysphagia, swallowing difficulties and the risk of stenosis with long-term intubation. The underlying pressure, abrasion and/or decubitus phenomena should be considered in a new design approach. b) Issues related to the cuff sealing and microaspirations, where the risk of ventilator-associated pneumonia (VAP) highlights the need to improve the design.

Discussion & conclusion: This review has yielded valuable input for rethinking the design of endotracheal tubes to ensure an efficient and safe airway. This new design should focus on the protection of anatomical structures, avoid or reduce the phenomena of laryngotracheal symptoms, and even reduce the risk of ventilator-associated-pneumonia (VAP) and/or prevent the need for certain tracheostomies.

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.