中国医疗器械杂志最新文献

This study aims to develop an independent control system for radiofrequency electrode arrays, intended for the conformal ablation of unwanted tissues. Unlike traditional single radiofrequency voltage applications, this study employs high-frequency transformer isolation and radiofrequency load matching technologies to divide the radiofrequency signal source into eight independent groups. Each group operates at the same phase and frequency but with different voltage values. Experimental results indicate that the designed system can independently output various combinations of radiofrequency signals. The actual output voltage has a relative error controlled within 6%, the frequency error is less than 0.5%, and the phase difference among the groups is less than 1°. In the biomimetic tissue heating experiments, it is found that by controlling the voltage of each electrode within the electrode array, ablation of different shapes can be achieved, and the ablation depth is positively correlated with the applied radiofrequency voltage.

Bowel sounds can reflect the movement and health status of the gastrointestinal tract. However, the traditional manual auscultation method has subjective deviation and is time-consuming and labor-intensive. In order to better assist doctors in diagnosing bowel sounds and improve the reliability and efficiency of bowel sound detection, this study proposed a deep neural network model that combines a residual neural network (ResNet), a bidirectional long short-term memory network (BiLSTM), and an attention mechanism. Firstly, a large number of labeled clinical data was collected using the self-developed multi-channel bowel sound acquisition system, and the multi-scale wavelet decomposition and reconstruction method was used to preprocess the bowel sounds. Then, log Mel spectrogram features were extracted and sent to the network for training. Finally, the performance and effectiveness of the model were evaluated and verified by 10-fold cross-validation and an ablation experiment. The experimental results showed that the precision, recall, and F ₁ score of the model reached 83%, 76%, and 79%, respectively, and it could effectively detect bowel sound segments and locate their start and end times, performing better than previous algorithms. This algorithm can not only provide auxiliary information for doctors in clinical practice but also offer technical support for further analysis and research of bowel sounds.

Intracranial aneurysm is a common cerebrovascular disease with high morbidity and mortality. Endovascular interventional therapy has advantages of high efficiency and minimally invasive. In this paper, the technical development of intracranial aneurysm interventional therapy Instruments was introduced, by interpreting the design mechanism of various types of coil, comparing the clinical benefits of braided and cut stents for assisting coil deployment, as well as analyzing the design principle and the optimization direction of currently the most eye-catching flow diverter, and thus the development and application of various interventional devices were discussed.

ASTM (American Society for Testing and Materials) F2052-21 (Chinese corresponding standard titled as YY/T 0987.2) introduces a test method to measure the magnetically induced displacement force on medical devices in the magnetic resonance environment. This method has been widely accepted and utilized globally, which is intended for implantable medical devices that can be suspended from a string. The angular deflection of the string from the vertical is measured and thereby measuring out the magnitude of the magnetically induced deflection force relative to gravity. When applying this method on ultralight implants, it is practically almost impossible to use a suspension string that weighs less than 1% of the mass of the implant. That study proposes a method for measuring the magnetically induced displacement force on ultralight implants based on counterweight correction by using a string and clamp that exceed 1% of the weight of the implant. And then to measure the deflection angle according to the standard requirement, following that to correct the deflection angle by using the proportion of the mass of the implant under test to the total mass of the tested object, to obtain the measurement result. That study also provides theoretical calculations and experimental verification to the counterweight correction method, the results prove that the proposed method can effectively measure the magnetically induced displacement force on ultralight implants.

The tricuspid valve has been nicknamed the "forgotten valve" and is often neglected by clinicians. However, tricuspid regurgitation is a common clinical heart valve disease. With the continuous development of transcatheter interventional medical device technology, the treatment of tricuspid regurgitation has gradually attracted attention, and more and more companies are developing interventional medical devices for treating this disease. This review will provide an overview of the current research progress on transcatheter therapy for tricuspid regurgitation repair devices at home and abroad, including the design principles, operational steps, clinical outcomes, and the advantages and disadvantages of these devices.

Brain-computer interface (BCI) devices are crucial tools for neural stimulation and recording, offering broad prospects in the diagnosis and treatment of neurological disorders. Furthermore, magnetic resonance imaging (MRI) is an effective and non-invasive technique for capturing whole-brain signals, providing detailed information on brain structures and activation patterns. Integrating the neural stimulation/recording capabilities of BCI devices with the non-invasive detection function of MRI is considered highly significant for brain function analysis. However, this combination imposes specific requirements on the magnetic and electronic performance of neural interface devices. The interaction between BCI devices and MRI is initially explored. Subsequently, potential safety risks arising from their combination are summarized and organized. Starting from the source of these hazards, such as the metallic electrodes and wires of BCI devices, the issues are analyzed, and current research countermeasures are summarized. In conclusion, the regulatory oversight of BCI's magnetic resonance safety is briefly discussed, and suggestions for enhancing the magnetic resonance compatibility of related BCI devices are proposed.

When applying for registration of an active medical device, it is necessary to submit research and verification data regarding the device's service life. This study primarily proposes how to verify and evaluate the preset service life of active medical devices through reliability testing. Initially, the definition of the product's service life is introduced. Subsequently, the determination of the test sample size, the type and magnitude of the test stress, the conventional test duration, the accelerated test duration, and the evaluation of the service life of the active medical device based on the test results are elucidated. Finally, an example of evaluating the service life of a non-invasive ventilator is provided for further illustration. This study offers a comprehensive closed-loop process for verifying and evaluating the preset service life of active medical devices using the test method, providing a scientific, reasonable, practical, and exhaustive test evaluation approach for enterprises and regulatory agencies. This has broad significance for universal dissemination and aids enterprises and testing institutions in conducting pertinent research and verification tasks.

Objective: To investigate the application of equivalent uniform dose (EUD) in intensity-modulated rotational radiotherapy and to explore optimization methods for improving the quality of modulated treatment plans.

Methods: The impact of the parameter a in the EUD formula on the characteristics of the EUD curve was analyzed using Python. Thirty cases of head and neck tumors, thoracic tumors, and pelvic tumors were randomly selected for treatment planning. Dose optimization for the target area and organs at risk were performed using a physics-based optimization approach or an optimization approach that combines physical constraints with the EUD function. The dose distribution and compliance with constraints of the two groups of plans were compared, while also observing the effect of different values of a on the planning outcomes.

Results: The impact of the value of a on the changes in EUD curve characteristics was consistent with its impact on the results of EUD plan optimization. When -15≤ a≤-5, the dose distribution in the target area was more uniform; when 1≤ a≤7, the effect on the uniform dose and low-dose regions in organs at risk was more noticeable; when 10≤ a≤30, the effect of constraining the high-dose regions in organs at risk was more pronounced, with the EUD for the target area and organs at risk exhibiting different expressions under different a values. The study also found that the target dose distribution and the protection of organs at risk in the EUD optimization group were better than those in the physical optimization group only.

Conclusion: The a-value has a significant impact on the, the dose distribution in the target area and the organ at risk, providing a reference for the setting of a-value while using EUD to optimize the intensity modulation plan. The using of EUD optimization method can not only achieve excellent dose distribution in the target area, but also significantly reduce the normal tissue dose and the probability of complications, which has certain clinical application value.

The aim of this study is to evaluate the effectiveness of a smart non-invasive blood glucose monitor prototype during pregnancy through clinical validation. The monitor utilizes near-infrared spectroscopy combined with AI big data analysis of photoelectric volumetric pulse wave data to achieve non-invasive monitoring of blood glucose in women during pregnancy. The research team developed a monitor that employs a sensing chip, effectively overcoming the problems of weak signals and individual differences in non-invasive blood glucose monitoring. The user experience is enhanced by visualizing the test results on the accompanying cell phone APP (application) of the smart non-invasive pregnancy blood glucose monitor. Clinical validation revealed that the non-invasive monitoring data for pregnant women aged 20~30 years significantly differed from those obtained via traditional blood glucose measurement methods, whereas no significant difference ( P<0.05) was observed for pregnant women aged 31~42 years. The study concluded that further calibration of the monitor and an expansion of the sample size are necessary to enhance consistency with invasive glucose monitoring results.

To improve the level of modern hospital management and establish a scientific and effective medical equipment maintenance guarantee system, this paper proposes the construction of a dynamic interactive fault repair knowledge base system for magnetic resonance imaging (MRI) equipment based on knowledge graph technology. This innovative application of intelligent management for large medical equipment involves collecting and organizing actual maintenance data. The paper constructs the medical equipment maintenance knowledge base, with MRI equipment as a case study, and initially implements functions such as fault information retrieval, technical guidance, and training and learning for MRI equipment. These functions aim to provide an objective decision-making basis for the maintenance and management of large medical equipment, enhance the efficiency of fault repair and maintenance, and elevate the construction level of intelligent hospitals.