The sterile electrode acupuncture needle for single use is an innovative product that combines traditional acupuncture with modern electronic technology, and it has obtained Class Ⅱ medical device registration certificate. This acupuncture device consists of a needle body and a handle. The diameter of the needle body ranges from 0.16 mm to 0.55 mm, and the length from 7 mm to 150 mm. The spiral spray technology is adopted to modify the micron-level insulating coat on stainless steel needle body. The needle holder is connected to the electroacupuncture device (conductive), the micro-film insulated needle body (non-conductive) and the membrane-free needle tip (conductive) can provide a precise electrical stimulation for different tissue layers of acupoints (such as deep nerves and fascia). The intradermal stimulation test, cytotoxicity test and hypersensitivity reaction test have showed a favorable biocompatibility, laying a solid and reliable safety for clinical application. This acupuncture device is suitable for the in-depth invasive stimulation at the sites of human body surface in combination with electroacupuncture equipment in medical institutions.
Humans ; Needles ; Acupuncture Therapy/instrumentation* ; Electrodes ; Equipment Design ; Electroacupuncture/instrumentation* ; Acupuncture Points ; Animals

Transcranial temporal interference stimulation (tTIS) is a novel non-invasive transcranial electrical stimulation technique that achieves deep brain stimulation through multiple electrodes applying electric fields of different frequencies. Current studies on the mechanism of tTIS effects are primarily based on rodents, but experimental outcomes are often significantly influenced by electrode configurations. To enhance the performance of tTIS within the limited cranial space of rodents, we proposed various electrode configurations for tTIS and conducted finite element simulations using a realistic mouse model. Results demonstrated that ventral-dorsal, four-channel bipolar, and two-channel configurations performed best in terms of focality, diffusion of activated brain regions, and scalp impact, respectively. Compared to traditional transcranial direct current stimulation (tDCS), these configurations improved by 94.83%, 50.59%, and 3 514.58% in the respective evaluation metrics. This study provides a reference for selecting electrode configurations in future tTIS research on rodents.
Animals ; Transcranial Direct Current Stimulation/instrumentation* ; Electrodes ; Mice ; Computer Simulation ; Finite Element Analysis ; Brain/physiology*

To address the challenges of capturing micro-strains in detecting esophageal motility disorders and the limitations of existing high-resolution manometry and functional intraluminal imaging probes in directly measuring esophageal tissue electrical impedance, this study proposes a novel flexible balloon sensor structure that integrates a piezoelectric film assembly with a distributed impedance electrode array. Using the electrical analysis module in the finite element analysis (FEA) software, simulations of the forward problem for esophageal impedance detection were conducted to optimize the excitation source parameters, and a physical prototype was fabricated. Under a relative excitation mode with a voltage sensitivity of 2.059%, the voltage output characteristics of the impedance electrode array were analyzed during linear changes in the balloon filling volume. Based on the performance variation of the piezoelectric film assembly, 80% was selected as the optimal filling volume. Force-electric coupling tests were conducted on the balloon sensor using a pressure testing platform, revealing that both the piezoelectric film assembly inside the balloon and the impedance electrodes outside the balloon exhibited significant load differentiation characteristics as the force application point shifted. In summary, this balloon sensor facilitates the localization of force application while simultaneously analyzing esophageal tissue properties, offering a novel diagnostic approach and objective tool for esophageal disease detection.
Esophagus/physiology* ; Electric Impedance ; Humans ; Finite Element Analysis ; Manometry/methods* ; Electrodes ; Esophageal Motility Disorders/physiopathology* ; Equipment Design

Tumor treating fields (TTF) therapy is an innovative tumor treatment modality. Currently, the TTF devices predominantly employ insulated ceramic electrodes as the electric field transmission medium, resulting in low energy transfer efficiency of the electric field and poor portability of the devices. This study proposed an innovative TTF transmission mode and independently designed a conducted-electrode TTF cell culture dish utilizing inert titanium materials. The electric field conduction characteristics were verified through finite element simulations and experimental tests. Finally, based on the self-manufactured conducted-electrode TTF cell culture dish, experiments on the proliferation inhibition of U87 tumor cells by TTF were conducted. The results demonstrated that under an applied TTF voltage of 10 V and frequency of 200 kHz, the electric field intensities within the medium for conducted and insulated electrodes are approximately 2.5 V/cm and 0.7 V/cm, respectively. Compared to conventional insulated TTF systems, the conducted-electrode TTF configuration exhibited a lower electrode voltage drop and a higher electric field intensity in the culture medium, indicating superior electric field transmission efficiency. Following 36 hours of treatment with conducted-electrode TTF on U87 cells, the proliferation inhibition rate reached approximately 50%, demonstrating effective suppression of tumor cell growth. This approach presents a potential direction for optimizing TTF treatment modality and device design.
Humans ; Electrodes ; Neoplasms/pathology* ; Cell Line, Tumor ; Cell Proliferation/radiation effects* ; Electric Stimulation Therapy/methods* ; Electromagnetic Fields

OBJECTIVE: To investigate the efficacy of 3D-printed navigation guided pudendal lead implantation on nervous regulation of lower urinary tract symptoms（LUTS） in male patients. METHODS: Twenty-eight male patients who underwent perineal nervous regulation treatment for LUTS in Gongli Hospital of Pudong New Area from October 2021 to October 2023 were randomly divided into observation group and control group. The technology assisted with 3D-printed navigation to regulate the genital nerves was used in observation group. And the patients in control group were treated with regulation of the genital nerves by routine puncture. Operation time of puncture, number of surgical punctures, and stimulator debugging time compared between the two groups. The improvement of postoperative symptoms and surgical complications of patients in the observation group were recorded as well. RESULT: A total of 12 male LUTS patients were included in the observation group, with an average age of 36.5±6.5 years, including 7 cases of frequent micturition, 3 cases of perineal pain, and 2 cases of dysuria. Four patients showed no significant improvement in symptoms, including two patients with pain and two cases of frequent micturition who did not undergo secondary surgery. While the other eight patients showed significant improvement in symptoms. The average time for successful puncture in control group was (21.13 ± 4.53) minutes, which was longer than that of the 3D-printed navigation group (［10.32 ± 3.42］ min) significantly (P<0.05). The average number of punctures in the ordinary puncture group was 5.62 ± 1.43, which was significantly higher than that in the 3D-printed navigation group (1.5 ± 0.56). There was no statistically significant difference in the average time for stimulator debugging between the two groups of patients. The conversion rate of the 3D-printed navigation group in the second phase was 66.7%, which was higher than that (37.5%) significantly (P<0.05). CONCLUSION 3D printing navigation of pudendal nerve electrode wire implantation can improve the accuracy of electrode implantation and the conversion rate to a certain extent, which has the advantages of reducing the difficulty of surgery.
Humans ; Male ; Printing, Three-Dimensional ; Lower Urinary Tract Symptoms/surgery* ; Adult ; Pudendal Nerve ; Middle Aged ; Electrodes, Implanted

This study aims to evaluate the application of flower petal-structured electrodes in pulsed field ablation (PFA) technology, with a particular focus on their performance in myocardial tissue ablation. Through a combination of simulation techniques and in vitro experiments, the study investigates the effects of different voltage levels, electrode-to-tissue contact distances, and their impact on ablation depth, continuity, and transmurality. The research methods include the construction of a myocardial tissue simulation model, electric field distribution simulation using COMSOL Multiphysics, and in vitro ablation experiments on potato tissue. The results indicate that as voltage increases, the ablation depth significantly increases. At a voltage of 2500 V, a transmural ablation depth of 4 mm can be achieved, and the ablation area remains relatively continuous. The in vitro experiments confirm the consistency of the simulation results, and pulsed field ablation does not induce significant temperature rise, confirming its non-thermal characteristic. The conclusion suggests that PFA technology requires less electrode contact and offers higher ablation efficiency, providing a new technological pathway for the clinical treatment of atrial fibrillation and effectively reducing the risk of complications associated with traditional ablation techniques.
Electrodes ; Catheter Ablation/instrumentation* ; Computer Simulation ; Flowers ; Atrial Fibrillation/surgery* ; Myocardium

Phantom limb pain (PLP) is a form of neuropathic pain occurring after limb amputation, and its underlying mechanisms remain unclear, posing significant challenges for clinical management. Spinal cord stimulation (SCS), a neuromodulation technique, has shown potential in relieving chronic pain, though its long-term efficacy and safety in treating PLP require further validation. This report presents a case of a 42-year-old male experiencing persistent radiating, lightning-like pain [Visual Analog Scale (VAS) score 8-9], following right upper limb amputation. Preoperative imaging revealed signal loss in the right nerve roots at C₆-T₁. A percutaneous electrode was implanted surgically to achieve full coverage of the painful region. Five days postoperatively, the VAS score dropped to 2-3, and after 1 year of follow-up, the patient continued to experience significant pain relief (VAS 1-2), with complete resolution of depressive symptoms and cessation of analgesic medication. Existing studies suggest that the long-term outcomes of SCS may fluctuate, and attention should be paid to potential complications such as infection and electrode displacement.
Humans ; Phantom Limb/therapy* ; Male ; Adult ; Spinal Cord Stimulation/methods* ; Electrodes, Implanted ; Amputation, Surgical/adverse effects*

Objective:To investigate the application value of intraoperative sliding rail computed tomography （CT） in complicated and difficult cochlear implantation by analyzing the cases of complicated and difficult cochlear implantation. Methods:The clinical data of patients with complicated and difficult cochlear implantation assisted by sliding rail CT were retrospectively analyzed, the intraoperative complications and the number of electrode adjustments were summarized, and the patients were followed up. Results:A total of 51 subjects were included in this study, including 46 patients with inner ear malformation, 2 patients with cochlear ossification, there were 7 patients underwent secondary scanning to adjust the electrode and achieved satisfactory implantation position. Conclusion:Intraoperative CT scanning is a reliable adjunctive tool for determining the placement of complex cochlear implantation, and it improves the accuracy of difficult cochlear implantation surgeries.
Humans ; Cochlear Implantation/methods* ; Retrospective Studies ; Tomography, X-Ray Computed ; Cochlear Implants ; Male ; Female ; Child, Preschool ; Child ; Cochlea ; Electrodes, Implanted ; Infant

As a new energy source for atrial fibrillation ablation, electric pulse ablation has higher tissue selectivity and biosafety, so it has a great application prospect. At present, there is very limited research on multi-electrode simulated ablation of histological electrical pulse. In this study, a circular multi-electrode ablation model of pulmonary vein will be built on COMSOL5.5 platform for simulation research. The results show that when the voltage amplitude reaches about 900 V, it can make some positions achieve transmural ablation, and the depth of continuous ablation area formed can reach 3 mm when the voltage amplitude reaches 1 200 V. When the distance between catheter electrode and myocardial tissue is increased to 2 mm, a voltage of at least 2 000 V is required to make the depth of continuous ablation area reach 3 mm. Through the simulation of electric pulse ablation with ring electrode, the research results of this project can provide reference for the voltage selection in the clinical application of electric pulse ablation.
Humans ; Heart Rate ; Atrial Fibrillation/surgery* ; Electrodes ; Catheter Ablation ; Electricity

Implanted brain-computer interface (iBCI) is a system that establishes a direct communication channel between human brain and computer or an external devices by implanted neural electrode. Because of the good functional extensibility, iBCI devices as a platform technology have the potential to bring benefit to people with nervous system disease and progress rapidly from fundamental neuroscience discoveries to translational applications and market access. In this report, the industrialization process of implanted neural regulation medical devices is reviewed, and the translational pathway of iBCI in clinical application is proposed. However, the Food and Drug Administration (FDA) regulations and guidances for iBCI were expounded as a breakthrough medical device. Furthermore, several iBCI products in the process of applying for medical device registration certificate were briefly introduced and compared recently. Due to the complexity of iBCI in clinical application, the translational applications and industrialization of iBCI as a medical device need the closely cooperation between regulatory departments, companies, universities, institutes and hospitals in the future.
Humans ; Brain-Computer Interfaces ; Brain/physiology* ; Electrodes, Implanted