Medical Devices-Evidence and Research最新文献

Background: Multiple needle punctures during central venous line insertion can lead to serious complications. Needle deterioration owing to repeated punctures may be a major cause. We hypothesized that there is an optimal bevel angle for a back-cut point needle that is resistant to deterioration. In this study, we examined the effect of bevel angle differences in a back-cut point needle on needle tip deterioration caused by multiple punctures.

Methods: The resin target was punctured perpendicularly using back-cut point needles with three bevel angles (15°, 17°, and 19°; n=8 for each angle) at a speed of 200 mm/min. The same needle was used for ten consecutive punctures at different locations on the target. The force applied to the needle was recorded as puncture force. The puncture force waveform is bimodal. The second peak values, which formed the maximum values of puncture force, were the focus of the main analysis. We considered a 5% elevation from the first to the 10th puncture force as needle deterioration, and the average slope value of the regression line between the puncture number and puncture force was used. When the upper limit of the 95% confidence interval (CI) of the slope value was less than 0.008889, the needle was considered to be resistant to deterioration.

Results: The slopes of the second peak values during 10 consecutive punctures for each bevel angle (15°, 17°, 19°) were 0.003011 ± 0.01085 [-0.006056, 0.012077], 0.006116±0.007431 [-0.000096, 0.012328], and 0.001515 ± 0.005783 [-0.003320, 0.006349], respectively (mean ± standard deviation [95% CI]). Only the 19° angle needle had a smaller upper limit of the 95% CI for a slope value of 0.008889.

Conclusion: The 19° bevel angle back-cut point needle was more resistant to deterioration than the 15° and 17° angle needles were.

Subarachnoid haemorrhage (SAH) can trigger a range of poorly understood cerebrovascular responses that may play a role in delayed cerebral ischemia. The brain pulse monitor is a novel non-invasive device that detects a brain photoplethysmography signal that provides information on intracranial pressure (ICP), compliance, blood flow and tissue oxygen saturation. We monitored the cerebrovascular responses in a patient with Lundberg B waves following a SAH. The patient presented with a Fischer grade 4 SAH that required urgent left posterior communicating artery aneurysm coiling and ventricular drain insertion. On hospital day 4 oscillations or spikes on the invasive ICP were noted, consistent with Lundberg B waves. Brain pulse monitoring demonstrated concurrent pulse waveform features consistent with reduced brain compliance and raised ICP over both brain hemispheres. Oxygen levels also demonstrated slow oscillations correlated with the ICP spikes. Brief infrequent episodes of reduced and absent brain pulses were also noted over the right hemisphere. Our findings suggest that the brain pulse monitor holds promise for early detection of delayed cerebral ischemia and could offer insights into the vascular mechanisms at play.

Purpose: RebiSmart^® is an electromechanical multidose autoinjector developed for administering subcutaneous interferon beta-1a in patients with multiple sclerosis (pwMS). This online survey aimed to understand MS nurses' and pwMS preferences and perceptions regarding the features of an upgraded version of the RebiSmart device (RebiSmart 3.0) compared to other assistive devices used for multiple sclerosis (MS) therapy.

Patients and methods: Eligible MS nurses and pwMS from Germany, Italy, and the United Kingdom completed a double-blind, 30-minute online self-administered questionnaire, including a 10-minute video describing the features of RebiSmart 3.0 and its use in administering interferon beta-1a.

Results: In total, 102 participants (MS nurses, n=52; patients, n=50) completed the survey. Overall, 70% respondents found the RebiSmart 3.0 device "very"/"extremely" appealing, 53% were "very"/"extremely" interested in learning more, and 71% stated they would be "very"/"extremely" comfortable using (pwMS) or educating (MS nurses) on it. Among current or recent RebiSmart 2.0 users (vs RebiSmart 2.0 nonusers), 67% (vs 52%) rated RebiSmart 3.0 "very" or "extremely" appealing, 52% (vs 43%) were "very" or "extremely" interested in learning more about the device, and 67% (vs 48%) stated they would be "very" or "extremely" comfortable using the RebiSmart 3.0 device. Respondents ranked customizable injection process (including injection speed, hold time, depth and rotation guide), self-injection process, and hidden needle as the most important self-assistive device features. RebiSmart 3.0 was rated higher than other self-injecting devices on all tested features. Overall, with respect to the top three features, 89% of the MS nurses and 73% of PwMS rated RebiSmart 3.0 "very good" or "excellent". After reviewing the video, 52% respondents had no questions, 67% nurses recommended providing more information on the customizable injection process feature of RebiSmart 3.0 to patients, and 88% nurses considered patient demonstration materials to be the most helpful type of information for them when initiating and educating pwMS on self-assistive devices.

Conclusion: The overall reactions of MS nurses and pwMS to the RebiSmart 3.0 device features were positive. The incremental advances over previous versions of the device as well as in comparison with other currently available assistive devices were welcomed. The MS nurses identified key needs for patient education on the use of the device and the suitable approaches (training videos and educational leaflets) to support MS nurses and pwMS.

Purpose: Medical Device Regulation (EU) 2017/745 requires the principal mode of action (MoA) to be demonstrated by experimental data. The MoA of Ialuril^® Prefill (combined as HA+CS+CaCl₂: sodium hyaluronate 1.6%, sodium chondroitin sulphate 2% w/v and calcium chloride 0.87%) Class III medical device, indicated for intravesical instillation to reduce urinary tract infections, has been evaluated on a 3D reconstructed human bladder epithelium (HBE).

Methods: Three experimental designs; i) E. coli strain selection (DSM 103538, DSM 1103) to investigate the HA+CS+CaCl₂ properties in modifying bacterial growth in liquid broth (CFU 4h and 24h) at 80%, 50% and 25% concentrations; ii) evaluation of film forming properties on HBE after 15 min exposure by quantifying caffeine permeation across the epithelium; iii) capacity to counteract E. coli adhesion and biofilm formation on colonized HBE by viable counts and ultrastructural analysis by scanning electron microscopy (SEM) using ciprofloxacin as the reference antimicrobial molecule.

Results: No significant differences were observed in bacterial viability for both the E. coli strains. HA+CS+CaCl₂ reduced caffeine permeation of 51.7% and 38.1% at 1h and 2h, respectively and determined a significant decrease in caffeine permeation rate at both timepoints supporting HA+CS+CaCl₂ capacity to firmly adhere to the bladder epithelium creating a physical barrier on the surface. The viable counts in HBE treated tissues then infected with E. coli resulted not different from the negative control suggesting that the device did not inhibit E. coli growth. SEM images showed homogenous product distribution over the HBE surface and confirmed the capacity of HA+CS+CaCl₂ to adhere to the bladder epithelium, counteracting biofilm formation.

Conclusion: The results support the capacity of HA+CS+CaCl₂ to counteract bacterial invasion by using a physico-mechanical mode of action: this medical device represents a valid alternative to antibiotics in the treatment of recurrent UTIs.

Purpose: Mechanical ventilation is a life-supporting intervention but is associated with known risks and complications. To improve the efficacy and safety profile of mechanical ventilation, manufacturers have developed advanced ventilator settings, modes, and alarm strategies to optimize ventilation for patient needs while avoiding complications. However, there is little real-world data published on the deployment of ventilator technology. The main objective of this study was to assess the clinical safety and performance of the Puritan Bennett™ 980 Ventilator System (PB980) using real-world clinical data collected from a diverse, global patient population.

Methods: This was a multi-center, post-market registry study that included nine sites: four in the United States of America, one in Europe, and four in China. Patients were enrolled into the registry if they were intended to be treated with a PB980. Data collection began at the start of ventilation and continued until extubation off the ventilator or up to seven days of ventilation, whichever occurred first. Subjects were divided by age into three categories: infants (0-365 days), pediatric (1-17 years), and adult (18 years and older). The primary outcome was device-related complication rate.

Results: Two-hundred-and-eleven subjects were enrolled (41 infants, 48 pediatric, and 122 adults). Sixteen deaths, unrelated to device deficiency, occurred during the data collection timeframe (relative frequency: 7.58, 95% CI: 4.40, 12.0). Only one device-related adverse event was reported (relative frequency: 0.47% 95% CI: 0.01%, 2.61%).

Conclusion: Ventilation by the PB980 was delivered safely in this multi-center observational study, which included a diverse sample of patients with broad ventilatory needs.

Introduction: Common in vitro cell culture systems for testing implant material immune compatibility either rely on immortal human leukocyte cell lines or isolated primary cells. Compared to in vivo conditions, this generates an environment of substantially reduced complexity, often lacking important immune cell types, such as neutrophil granulocytes and others. The aim of this study was to establish a reliable test system for in vitro testing of implant materials under in vivo-like conditions.

Methods: Test materials were incubated in closed, CO₂-independent, tube-based culture vessels containing a proprietary cell culture medium and human whole blood in either a static or occasionally rotating system. Multiplex cytokine analysis was used to analyze immune cell reactions.

Results: To demonstrate the applicability of the test system to implant materials, three commercially available barrier membranes (polytetrafluoroethylene (PTFE), polycaprolactone (PCL) and collagen) used for dental, trauma and maxillofacial surgery, were investigated for their potential interactions with immune cells. The results showed characteristic differences between the static and rotated incubation methods and in the overall activity profiles with very low immune cell responses to PTFE, intermediate ones to collagen and strong reactions to PCL.

Conclusion: This in vitro human whole blood model, using a complex organotypic matrix, is an excellent, easily standardized tool for categorizing immune cell responses to implant materials. Compared to in vitro cell culture systems used for materials research, this new assay system provides a far more detailed picture of response patterns the immune system can develop when interacting with different types of materials and surfaces.

About 80% of stroke patients have hand motor dysfunction, and wearing finger rehabilitation machinery can enable patients to carry out efficient passive rehabilitation training independently. At present, many typical finger rehabilitation machines have been developed, and clinical experiments have confirmed the effectiveness of mechanically assisted finger rehabilitation. In this paper, the finger rehabilitation machinery will be classified in the actuation mode, and the terminal traction drive/motor drive/spring drive/rope drive/memory alloy drive/electroactive material drive/hydraulic drive/pneumatic drive technology and its typical applications are analyzed. Study the structure, control methods, overlap between mechanical bending nodes and finger joints, training modes, response speed, and driving force of various types of finger rehabilitation machinery. The advantages and disadvantages of various actuation methods of finger rehabilitation machinery are summarized. Finally, the difficulties and opportunities faced by the future development of finger rehabilitation machinery are prospected. In general, with the continuous improvement of quality of life, stroke patients need flexible, segmented control, accurate bending, multi-training mode, fast response, and good driving force finger rehabilitation machinery. This will also be a future hot research direction.

Purpose: In Germany, there are several microcurrent medical devices that are certified for the treatment of patients suffering from one of the indications chronic back pain, skeletal system pain, fibromyalgia, migraine or depression. While certification is based on controlled, randomized clinical trials, evidence of efficacy and safety under real-world conditions is limited to very few observational studies. To fill this gap, this study was conducted.

Patients and methods: Fifty patients per indication already using the investigational device before study entry were included and followed for a total 6 months. Each participant used the Healy in an individualized schedule to optimize the treatment of his/her special indication. This means that each participant performed on average 1-2 microcurrent applications per day for 20 to 30 minutes each. In all indications, the improvement of health-related quality of life was assessed by the SF-36 questionnaire and other validated indication specific surveys.

Results: In all indications, the improvement of health-related quality of life as assessed by the SF-36 questionnaire was statistically highly significant and clinically relevant. These findings were supported by more specific outcome measures applied in each indication. Only four adverse events related to the application of microcurrent occurred during the trial.

Conclusion: Microcurrent therapy has been demonstrated to be efficient and safe under real-world conditions for the treatment of each of the conditions for which the device is certified.

The measurement of urinary flow is a vital medical indicator for critically ill patients in intensive care units. However, there is a clinical need to automate the real-time measurement of diuresis using Internet of Medical Things devices, allowing continuous monitoring of urine flow. A systematic review of scientific literature, patents, and available commercial products was conducted, leading to the conclusion that there is no suitable device to fulfill this need. We identified six characteristics that such a device should possess: minimizing contact with urine, detecting changes in flow patterns, the ability to record minute-by-minute data, capable of sending early alerts, not relying on exclusive disposable components, and being user-friendly for clinical professionals. Additionally, cost-effectiveness is crucial, encompassing the device, infrastructure, maintenance, and usage.

Background: Design of surgical staplers continues to advance with more consistent staple formation that can lead to higher leak pressures and lower rates of leak along the staple line. This study was performed to compare the Ethicon Echelon™+ Stapler with Thunderbird reloads to two other currently available commercial staplers, Reach Anzhi and Fulbright Lunar with corresponding reloads.

Methods: The rate of malformed staples for three staplers was determined in porcine stomach (3.0-3.3 mm thickness) via CT scanning. Staple line air leak pressures in bronchial tissue (3.0-3.3 mm) and fluid leak pressures in colon (1.3-1.7 mm) were measured and compared to a standard success criterion for both tissues.

Results: The rate of malformed staples in gastric tissue for Echelon+ was more than 90% lower than for the two other commercial staplers (p < 0.001). In bronchus, Echelon+ had 56% higher air leak pressures than Reach Anzhi (p < 0.001) and was not significantly different from Fulbright Lunar. In colon, Echelon+ had over twice the fluid leak pressures of the comparators (p < 0.001).

Conclusion: The Echelon+ Stapler with Thunderbird reloads exhibited a low rate of malformed staples, and its staple lines withstood high leak pressures in both thick and thin tissues. Clinical studies are needed to confirm that these observed benefits carry over into actual practice.