中国医疗器械杂志最新文献

Surgical robot is the national strategic diagnostic and therapeutic equipment research focus, get a number of scientific research institutes, colleges and universities and enterprises pay extensive attention to the design and development of a variety of surgical robots, and registration declaration. This article explores the critical technologies of surgical robots and key areas for optimizing their performance, including kinematic positioning errors, pose errors, feedback model errors, image recognition positioning errors, path planning, and safety aspects. The findings not only provide a scientific basis for future standardization research on surgical robots but also offer significant theoretical and practical references for the research, manufacturing, and registration processes in the medical robotics industry.

With the development of the economy and technological progress, more and more animal-derived mesh products are being utilized in the medical field for tissue and organ repair and replacement. Owing to the complexity of their structure and production process, these animal-derived meshes still face several challenges in practical applications, such as insufficient mechanical strength, rapid degradation rates, and the detection of harmful leachable substances. Among these challenges, the production process is a key factor affecting product quality. This paper reviews the key aspects of the production process and quality control for animal-derived meshes in China, offering new insights for the quality control and regulatory oversight of such products.

This paper investigates the mechanism of radio-frequency (RF) heating that occurs when two adjacent orthopedic implants are present together under magnetic resonance imaging (MRI) at 1.5 Tesla and 3.0 Tesla. When a patient has multiple implants close to each other, interactions between the implants may increase RF heating. Typical generic interlocking plate and antibiotic nail implants are adopted as examples. To analyze the effect of adjacent implants, the amplitude and direction of incident and scattering vector electric fields at the hot spot position are calculated and extracted using numerical simulation based on Huygens principle. It is shown that a strong coupling effect occurs due to the existence of both the incident field and a strong scattering field. Huygens principle can be used to obtain the first and second order scattering fields generated between implants. If the first- and second-order electric field terms are summed within a certain region, the RF-induced heating of this dual-implant system increases.

This study summarizes the clinical application, technical characteristics, and production process of intravascular shockwave catheters. It collects statistics on adverse events of related products from the MAUDE database, analyzes the causes of adverse events and failure modes of intravascular shockwave catheters, and identifies risk points. Based on the whole life cycle management method of medical devices, combined with product risks and the requirements of Good Manufacturing Practice for Medical Devices and related appendices, the critical control points of such products in the design and development, manufacturing, sales, and use stages are discussed.

Needle-free jet injectors refer to a kind of medical device that uses a specific device to form a small, high-speed jet of medication to pierce the human skin, thereby achieving the delivery of medication into the human body without the use of needles. In the past few decades, needle-free jet injectors have undergone many changes with the development of healthcare systems and advancements in related technologies. In this article, the history, research status, and clinical application of needle-free jet injectors are introduced. The principles of different driving modes for needle-free jet injectors are briefly summarized, and their respective advantages and the existing problems are summarized. Combining the current research status and market application, the technical problems faced by the development of needle-free jet injectors are analyzed. Under the background of intelligent and automatic development of medical equipment, the future development and opportunities for needle-free jet injectors are prospected.

Objective: A wearable wireless chest patch monitoring terminal is designed to realize the acquisition, processing, and wireless transmission of ECG, respiration, and body temperature signals.

Methods: The analog front-end ADS1292R, which integrates respiratory impedance and ECG front-end, is utilized to collect human ECG and respiratory signals. The body temperature is collected using a low-power, high-precision digital temperature sensor MAX30208. A filter algorithm for signal processing and wireless transmission is designed through a low-power nRF52840 Bluetooth SoC with an Arm Cortex-M4F kernel.

Results: The experimental results show that the designed monitoring terminal can monitor the ECG, respiration, and body temperature parameters of the human body in real-time and send the monitoring results via Bluetooth, with a continuous working time of more than 13 hours.

Conclusion: The wearable wireless chest patch monitoring terminal features good portability, long standby time, and high measurement accuracy, and it has promising application prospects in the fields of family health monitoring, mobile medical treatment, and smart healthcare.

ECG signals and sleep monitoring parameters complement each other and can be used for qualitative diagnosis of sleep apnea syndrome and cardio-related diseases. However, due to the limitations of the instrument volume and the detection environment, it is often challenging to integrate these two functions in practical applications. In this paper, a 12-lead dynamic electrocardiograph integrated with sleep monitoring is designed. The system's volume is reduced by combining the integrated ECG simulation front end with a miniature sensor. The system achieves the extraction, conditioning, and calculation of 12-lead ECG signals and sleep-related parameters and writes the data to a memory card in real time, which offers convenience for users and doctors in the diagnostic process.

High-voltage pulsed electric field (HV-PEF) ablation technology has demonstrated promising applications in the clinical treatment of chronic obstructive pulmonary disease (COPD). However, its use has been limited to exploratory applications in a small number of cases, and the underlying mechanisms remain largely undefined. To facilitate broader clinical implementation, comprehensive molecular mechanism studies via extensive animal experimentation are essential. Rats, due to their ease of modeling COPD and the availability of comprehensive molecular reagents, serve as an optimal model for such studies. Consequently, the development of electrodes specifically designed for HV-PEF respiratory ablation in SD rats is of significant importance. In this study, we meticulously examined the anatomical structure of rat airways and investigated various equipment parameters, including material composition, rigidity, diameter, electrode ring dimensions, spacing between positive and negative poles, insulation coating for the catheters, welding techniques between the guidewire and electrode ring, and the design of vent holes in the catheter. Based on these considerations, we fabricated PVC ablation electrode catheters with integrated ventilation functionality. Subsequently, we employed finite element simulation to estimate the field strengths that could be applied by these electrodes. The simulation results were then validated in normal rats to assess the electrical safety and efficacy of the electrodes. These findings laid the groundwork for further investigation into the mechanisms of HV-PEF treatment for COPD.

This research utilizes a deep learning-based image generation algorithm to generate pseudo-sagittal STIR sequences from sagittal T1WI and T2WI MR images. The evaluations include both subjective assessments by two physicians and objective analyses, measuring image quality through SNR and CNR in ROIs of five different tissues. Further analyses, including MAE, PSNR, SSIM, and COR, establish a strong correlation between the generated STIR sequences and the gold standard, with Bland-Altman analysis indicating pixel consistency. The findings indicate that the deep learning-generated STIR sequences not only align with but potentially surpass the gold standard in terms of image quality and clinical diagnostic capabilities. Moreover, the approach demonstrates promise for clinical implementation, offering reduced scan time and enhanced imaging efficiency.

Objective: In order to address the issues of inconvenience, high medical costs, and lack of universality associated with traditional knee rehabilitation equipment, a portable intelligent wheelchair for knee rehabilitation was designed in this study.

Methods: Based on the analysis of the knee joint's structure and rehabilitation mechanisms, an electric pushrod-driven rehabilitation institution was developed. A multi-functional module was designed with a modular approach, and the control of the wheelchair body and each functional module was implemented using an STM32 single-chip microcomputer. A three-dimensional model was established using SolidWorks software. In conjunction with Adams and Ansys simulation software, kinematic and static analyses were conducted on the knee joint rehabilitation institution and its core components. A prototype was constructed to verify the equipment's actual performance.

Results: According to the prototype testing, the actual range of motion for the knee joint swing rod is 15.1°~88.9°, the angular speed of the swing rod ranges from -7.9 to 8.1°/s, the angular acceleration of the swing rod varies from -4.2 to 1.6°/s², the thrust range of the electric pushrod is -82.6 to 153.1 N, and the maximum displacement of the load pedal is approximately 1.7 mm, with the leg support exhibiting a maximum deformation of about 1.5 mm.

Conclusion: The intelligent knee joint rehabilitation wheelchair meets the designed functions and its actual performance aligns with the design criteria, thus validating the rationality and feasibility of the structural design.