中国医疗器械杂志最新文献

Objective: This study aims to predict the demand for coronary stents based on different deep learning models, in order to optimize the supply plan of coronary stents and improve the efficiency of supply and use.

Methods: The centralized procurement data of coronary stents in a large tertiary hospital from January 2022 to August 2024 are selected, three deep learning models are used to predict the demand, the learning effect of the model is evaluated based on the MSE curve, and the prediction results of the dataset through different evaluation indicators are verified and the prediction error is evaluated.

Results: The MSE curve indicates that the Transformer model exhibits the strongest feature extraction and pattern recognition capabilities in this task, and the predicted demand evaluation index system verifies that the prediction results based on the Transformer model are close to the actual values.

Conclusion: This study has established a deep learning based coronary stent supply model, which effectively predicts the demand for coronary stents and provides reference for optimizing hospital stocking plans, thereby ensuring the use and supply of coronary stents.

With the widespread application of 3D printing technology in the field of orthopedic implants, 3D-printed interbody fusion cages have attracted increasing attention. This article systematically reviews the latest research progress from two main aspects: materials and manufacturing processes, as well as structural design. Titanium alloys and polyetheretherketone are the most widely used materials, while novel composite and bioresorbable materials have further expanded the diversity of applications. In the future, optimization of material properties and improvements in manufacturing processes will be needed to achieve better clinical outcomes. 3D printing technology has promoted the diversification of fusion cage structural design, showing a trend toward "de-solidification". However, the optimal design parameters for porous structures still require further research to balance mechanical properties and osseointegration requirements.

Objective: To address the limitations of existing auricular vagus nerve stimulators, which have a single stimulation mode and are open-loop, a new type of auricular vagus nerve stimulator system was developed.

Methods: Based on the programmable general-purpose stimulator chip ENS001 and the integrated analog front-end chip ADS1299, an auricular vagus nerve stimulator capable of multi-channel EEG signal acquisition, multiple stimulation waveforms, and multiple stimulation modes was designed and developed.

Results: The auricular vagus nerve stimulator, upon receiving parameter configuration instructions from the host computer, can generate four-channel output stimulation pulses with three types of waveforms and four modes (with an amplitude resolution of 0.1 mA, a frequency resolution of 1 Hz, and a pulse width resolution of 100 µs). The stimulator meets the requirements for the acquisition of human bioelectric signals and is capable of accurately acquiring human EEG signals.

Conclusion: The auricular vagus nerve stimulator is simple in structure, low in manufacturing cost, portable, and has a wide range of adjustable stimulation parameters, showing great potential for application.

Objective: To implement radiological diagnostic guidelines and improve the standardization level of radiological reports.

Methods: A multimodal structured reporting system was designed. An integrated strategy of "standard coding + structural items + key images" was adopted to develop report templates for different diseases or anatomical sites, covering both text-only structured reports and comprehensive text-image structured reports. Horizontal comparisons with traditional (unstructured) reports were conducted to evaluate differences across four dimensions: efficiency, acceptability, completeness of disease sign description, and accuracy of data classification.

Results: The quality of comprehensive text-image structured reports was significantly superior to that of traditional reports ( P<0.01), while there was no statistically significant difference between text-only structured reports and traditional reports ( P>0.01). The information completeness and compliance with diagnostic guidelines of text-image reports were significantly higher than those of both traditional reports and text-only structured reports. The acceptability of text-image reports among senior radiologists (4.04±0.55) and clinicians (4.19±0.58) was higher than that among junior radiologists (3.04±1.55). In terms of data classification accuracy, the retrieval accuracy of structured reports based on natural language processing (NLP) (F1-Score: 0.85-1.00) was significantly better than the keyword retrieval method used for traditional reports.

Conclusion: Image-text-integrated structured reporting reduces heterogeneity in traditional reports and aids competency development among junior radiologists in primary care.

Representative models of instruments for in vitro diagnostic (IVD) reagents simplify the performance evaluation of registration. Different from the concept of the US FDA instrument family, the domestic identification of representative models focuses on the risk analysis of instrument differences. However, there are problems such as unclear requirements for the identification of instruments, difficulties in the identification of new technology and high-risk instruments. The performance evaluation of the detection system can be partially simplified by representative models, and representative models can evaluate the performance of non-detection systems. Meanwhile, the comprehensive performance should be evaluated by representative models as conditions. Therefore, according to the analysis, performance evaluations using representative models can guarantee the safety and effectiveness of in vitro diagnostic reagents while promoting the high-quality development of the IVD industry.

Cardiovascular disease (CVD) is the leading cause of death worldwide. As the key pathological basis of CVD, arteriosclerosis holds great significance for early screening. However, existing clinical and homecare detection devices have many shortcomings; for instance, the commonly used non-invasive indicator PWV (pulse wave velocity) is easily interfered by blood pressure.This study developed a homecare arteriosclerosis monitoring system, which integrates the measurement functions of cardio-ankle vascular index (CAVI) and ankle-brachial index (ABI). The hardware design of the system includes an integrated structure of flexible silver ion electrodes and clip-type cuffs, a contact heart sound sensor, and a stepped deflation blood pressure measurement module. Meanwhile, a high-precision analog-to-digital conversion module and the STM32F405 main control chip are used to realize the synchronous acquisition of multiple signals.In terms of software, the underlying driver program was designed through MDK (Keil5), and a user interface was built on the Visual Studio platform to achieve functions such as data acquisition, display, and storage. At the algorithm level, the system adopted algorithms like the Pan-Tompkins algorithm to identify key feature points of physiological signals, and then calculate CAVI and ABI.System test results show that the ECG input noise of the system is less than 20 μV, the common-mode rejection ratio is 95 dB, and the blood pressure measurement error does not exceed 2 mmHg, which meets the design goals. Clinical data analysis indicates that CAVI is highly positively correlated with pulse wave velocity (PWV) ( r=0.85, P<0.001), but CAVI is less affected by blood pressure fluctuations. In addition, with the increase of risk factors (such as hypertension, hyperlipidemia, coronary heart disease, etc.) and age, arteriosclerosis indicators (CAVI, PWV, ABI) all show an upward trend.In conclusion, the homecare arteriosclerosis monitoring system proposed in this study not only overcomes the problems of traditional devices that rely on professional operation and are susceptible to blood pressure interference, but also provides a reliable tool for arteriosclerosis screening in home scenarios, and has important reference value for clinical diagnosis.

Objective: Evaluate the clinical application effect of low-field infant MRI.

Methods: Using literature review, expert consultation, and two rounds of Delphi to determine the evaluation index system. Then retrospectively analyze and compare the data of low-field infant MRI and high-field MRI from January 2023 to December 2024.

Results: There is a certain gap between low-field infant MRI and high-field MRI in terms of signal-to-noise ratio, image uniformity, software system reliability, scanning time, user interface friendliness and image result consistency. However, there was no difference in terms of spatial resolution and image quality. The noise, hardware system reliability, mean time between failure and the rate of examination completed without sedation are better than that of high-field MRI.

Conclusion: Low-field infant MRI meets needs of clinical diagnostic and has stable performance. It can be used as a routine screening tool for brain diseases near the bed.

One of the key components of adsorbents for blood purification is the microsphere adsorbent. Microsphere adsorbents should meet the following requirements: stable physical and chemical structures, easy for functional modification to endow the adsorbents with specific adsorption functions or characteristics, with good biocompatibility and with low non-specific adsorption, as well as with enough mechanical strength. Microsphere adsorbents prepared from polysaccharide bio-based materials fulfill the above requirements and have been widely used in the field of blood adsorption. In this article, adsorbents prepared from polysaccharide bio-based materials such as cellulose, agarose, alginate, as well as adsorbents prepared from the aforementioned materials and carbon materials and the application of the said bio-based adsorbents in blood adsorption is reviewed. The future development is also discussed, aiming to provide guidance and reference for the preparation, functional modification and application research of bio-based adsorbents for blood adsorption.

With the continuous progress of medical technology, the application of stereotactic surgical robots in the field of neurosurgical operations has become increasingly extensive and important. This paper focuses on the registration principle of ultra-wideband positioning technology in stereotactic surgical robots during neurosurgical operations. It elaborates in detail on the processes of positioning and navigation, and illustrates different registration algorithms with examples. In addition, this paper looks ahead to the future development directions of ultra-wideband positioning technology in surgical robots, aiming to provide references for further development of surgical robots.

Oral and maxillofacial tumors, due to their complex anatomical structures and vital physiological functions, pose significant risks, not only affecting patients' appearance and function but also potentially endangering their lives. Traditional tumor resection and reconstruction surgeries face challenges such as inadequate precision, long surgical durations, and unsatisfactory postoperative outcomes. In the treatment of oral and maxillofacial tumors, 3D printing technology can be used for preoperative planning, surgical guide plate production, and the design and manufacture of personalized prosthetics, providing new solutions for functional reconstruction after tumor resection. This article reviews the progress of 3D printing technology in the medical field and explores its potential value in the resection and reconstruction of oral and maxillofacial tumors, aiming to provide references for clinical practice and promote the further application and development of this technology in oral and maxillofacial surgery.