1.Research and development of sterile electrode acupuncture needle for single use based on medicine-engineering integration and its clinical application.
Wanying XIA ; Tianxin LI ; Lingli QIN ; Yue GAO ; Hanxi DAI ; Jie ZHANG ; Jinsheng YANG ; Lu ZHANG
Chinese Acupuncture & Moxibustion 2025;45(10):1527-1532
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
2.Quantitative analysis of transcranial temporal interference stimulation in rodents: A simulation study on electrode configurations.
Xiaoxi LIU ; Hongli YU ; Fushuai GOU ; Boai DU ; Pengyi LU ; Chunfang WANG
Journal of Biomedical Engineering 2025;42(2):280-287
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*
3.Development of a balloon sensor device for force-electrical coupling measurement of esophagus.
Peng RAN ; Ying ZHONG ; Yingbing LAI ; Lei LIU ; Yanhang ZHU ; Huantao ZHU
Journal of Biomedical Engineering 2025;42(3):610-619
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
4.Study on the electric field transmission characteristics of conducted-electrode tumor treating fields.
Kaida LIU ; Junxia ZHANG ; Jiaqi SHI ; Haohan FANG ; Xing LI
Journal of Biomedical Engineering 2025;42(5):964-969
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
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Electrodes
;
Neoplasms/pathology*
;
Cell Line, Tumor
;
Cell Proliferation/radiation effects*
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Electric Stimulation Therapy/methods*
;
Electromagnetic Fields
5.Research of tricuspid regurgitation associated with cardiac implantable electronic devices.
Danqing YU ; Yan LIN ; Qi CHEN ; Xianbao LIU ; Jian'an WANG
Journal of Zhejiang University. Medical sciences 2025;54(2):219-229
Tricuspid regurgitation associated with cardiac implantable electronic devices (CIED) constitutes a significant subset of secondary tricuspid regurgitation, characterized by a multifactorial etiology involving pacing lead-mediated mechanical interference and CIED-related systemic factors. The pathogenesis of CIED-related tricuspid regurgitation encompasses direct mechanical trauma or functional disruption of the tricuspid valve apparatus by pacing leads, pacing mode-induced hemodynamic alterations, and clinical risk factors such as permanent atrial fibrillation, apical pacing, and high right ventricular pacing burden. The natural progression and clinical outcomes of CIED-related tricuspid regurgitation parallel those of tricuspid regurgitation stemming from other etiologies. Advanced imaging modalities, including echocardiography, cardiac computed tomography, and cardiac magnetic resonance imaging, enable precise diagnosis and longitudinal assessment of CIED-related tricuspid regurgitation. Management strategies emphasize multidisciplinary collaboration as well as integration of preventive approaches-such as refined lead implantation techniques and tailored pacing modalities-with therapeutic interventions ranging from pharmacotherapy to surgical valve repair or replacement. This article reviews the current understanding of CIED-related tricuspid regurgitation to provide a reference for clinical practice and research.
Tricuspid Valve Insufficiency/diagnosis*
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Humans
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Defibrillators, Implantable/adverse effects*
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Pacemaker, Artificial/adverse effects*
6.Application of 3D-printed navigation for genital nerve regulation in male with lower urinary tract symptoms.
Zi-Qin ZHOU ; Xin SONG ; Yin-Jun GU ; Jian-Wei LÜ
National Journal of Andrology 2025;31(8):698-702
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
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Male
;
Printing, Three-Dimensional
;
Lower Urinary Tract Symptoms/surgery*
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Adult
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Pudendal Nerve
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Middle Aged
;
Electrodes, Implanted
7.Simulation Study of Myocardial Tissue Ablation Effects Using Flower Petal-Structured Electrodes in Pulsed Ablation.
Chinese Journal of Medical Instrumentation 2025;49(2):125-133
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
8.Spinal cord stimulation for the treatment of phantom limb pain: A case report and literature review.
Lanxing WU ; Rong HU ; Honglian ZHANG ; Yuncheng NI ; Jianping ZHANG ; Gangwen GUO ; Yonghui LI
Journal of Central South University(Medical Sciences) 2025;50(2):313-318
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
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Phantom Limb/therapy*
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Male
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Adult
;
Spinal Cord Stimulation/methods*
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Electrodes, Implanted
;
Amputation, Surgical/adverse effects*
9.Issues of auditory implant in children with cochlear nerve deficiency.
Journal of Clinical Otorhinolaryngology Head and Neck Surgery 2025;39(1):7-9
Cochlear nerve deficiency(CND) is a rare inner ear malformation characterized by a hypoplastic or absent cochlear nerve, resulting in variable hearing loss or total deafness, depending on the quantity of nerve fibers present. About 18% of congenital hearing loss are associated with CND. It is a disease of uncertain cause. The outcome of auditory implant in CND patients varies widely. This article will discuss the related issues of CND.
Humans
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Cochlear Nerve/abnormalities*
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Cochlear Implants
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Child
;
Cochlear Implantation/methods*
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Deafness
;
Hearing Loss
10.Perception of Mandarin aspirated/unaspirated consonants in children with cochlear implants.
Yani LI ; Qun LI ; Jian WEN ; Lin LI ; Yun ZHENG
Journal of Clinical Otorhinolaryngology Head and Neck Surgery 2025;39(4):312-318
Objective:This study aims to investigate the perception of Mandarin aspirated and unaspirated consonants by children with cochlear implants (CIs) under quiet and noisy conditions. It also examines factors that may affect their acquisition, such as auditory conditions, place of articulation, manner of articulation, chronological age, age at implantation, and non-verbal intelligence. Methods:Twenty-eight CI children aged 3 to 5 years who received implantation from 2018 to 2023 were recruited. Additionally, 88 peers with normal hearing (NH) were recruited as controls. Both groups participated in a perception test for aspirated/unaspirated consonants under quiet and noisy conditions, along with tests for speech recognition, speech production, and non-verbal intelligence. The study analyzed the effects of group (CI vs. NH), auditory condition, and consonant characteristics on children's perception of aspirated/unaspirated consonants in Mandarin, as well as the factors contributing to CI children's acquisition of these consonants. Results:①CI children's ability to perceive aspirated/unaspirated consonants was significantly poorer than that of their NH peers (χ²= 14.16, P<0.01), and their perception accuracy was influenced by the acoustic features of consonants (P<0.01); ②CI children's consonant perception abilities were adversely affected by noise (P<0.01), with accuracy in noisy conditions particularly influenced by the manner of articulation (P<0.05); ③The age at implantation significantly affected CI children's ability to perceive aspirated/unaspirated consonants (β= -0.223, P=0.012), with earlier implantation associated with better performance. Conclusion:It takes time for CI children to acquire Mandarin aspirated/unaspirated consonants, and early implantation shows many advantages, especially for the perception ability of fine speech features.
Humans
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Cochlear Implants
;
Child, Preschool
;
Speech Perception
;
Cochlear Implantation
;
Male
;
Female
;
Language

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