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

Electrode array misplacement is a rare complication of cochlear implant. This article reports an 11-year-old boy who was mistakenly implanted the cochlear electrode array into the superior semicircular canal during the initial cochlear implant. After the diagnosis was confirmed, he underwent a second cochlear implant and the electrode array were successfully implanted into the cochlea. This article conducted a systematic review of the literature on electrode array misplacement, and the causes of electrode array misplacement were analyzed from different implantation position.
Male ; Humans ; Child ; Electrodes, Implanted ; Reoperation ; Cochlea ; Cochlear Implantation ; Cochlear Implants/adverse effects* ; Semicircular Canals/surgery*

Objective: To investigate the effect of insertion technique and electrode array type on the insertion force of electrode array, and to provide a basis for further optimizing electrode design and facilitating mini-invasive electrode insertion. Methods: Three types of electrode array from Nurotron (Standard Electrode, Slim-medium Electrode, Slim-long Electrode) were studied. from July 2019 to December 2019. These electrode arrays were inserted into the phantom models of the cochlea, manually or robot-assisted(medium speed and low speed). The real-time force during electrode array insertion was recorded by ATI Nano 17 Ti sensors and was analyzed by accessory software. Origin 2020b software was used for statistical processing. Results: The insertion force of all electrode arrays progressively increased with the insertion depth. With the manual technique, the peak force of slim-medium electrode insertion was significantly smaller than that of the standard electrode insertion((71.0±16.6) mN vs (140.9±52.7) mN, Z=3.683, P<0.01), and the peak force of the slim-long electrode insertion was between the peak force of standard electrode and slim-medium electrode(P>0.05). No difference was found in the force variation of insertion among the three electrodes(P>0.05). With medium-speed and low-speed robotic assistance, the peak force characteristics of three electrodes were similar to those with the manual technique, but the force variation of standard electrode insertion ((83.9±9.7) mN/s) at medium speed was significantly larger than that of the slim-long electrode insertion ((69.2±4.0)mN/s), and the force variation of the standard electrode insertion at low speed was significantly greater than the other two electrodes. For the same electrode, robot-assisted insertion presented significantly lower peak force and force variation than manual insertion for each type of electrode array. But there was no difference in the peak force and force variation between two-speed levels of robot assistance (P>0.05). Conclusions: The insertion force of the electrode array will be lower when a slim electrode array or robot technique is applied. Long electrode array might make manual insertion difficult or less precise. Robot assistance has advantage on force control during electrode array insertion.
Cochlea/surgery* ; Cochlear Implantation ; Cochlear Implants ; Electrodes, Implanted ; Humans ; Robotics

In order to accurately implant the brain electrodes of carp robot for positioning and navigation, the three-dimensional model of brain structure and brain electrodes is to be proposed in the study. In this study, the tungsten electrodes were implanted into the cerebellum of a carp with the aid of brain stereotaxic instrument. The brain motor areas were found and their three-dimensional coordinate values were obtained by the aquatic electricity stimulation experiments and the underwater control experiments. The carp brain and the brain electrodes were imaged by 3.0 T magnetic resonance imaging instrument, and the three-dimensional reconstruction of carp brain and brain electrodes was carried out by the 3D-DOCTOR software and the Mimics software. The results showed that the brain motor areas and their coordinate values were accurate. The relative spatial position relationships between brain electrodes and brain tissue, brain tissue and skull surface could be observed by the three-dimensional reconstruction map of brain tissue and brain electrodes which reconstructed the three-dimensional structure of brain. The anatomical position of the three-dimensional reconstructed brain tissue in magnetic resonance image and the relationship between brain tissue and skull surface could be observed through the three-dimensional reconstruction comprehensive display map of brain tissue. The three-dimensional reconstruction model in this study can provide a navigation tool for brain electrodes implantation.
Animals ; Brain/diagnostic imaging* ; Carps ; Electrodes ; Electrodes, Implanted ; Imaging, Three-Dimensional ; Magnetic Resonance Imaging

Deep brain stimulation (DBS) surgery is an important treatment for patients with Parkinson's disease in the middle and late stages. The accuracy of the implantation of electrode at the location of the nuclei directly determines the therapeutic effect of the operation. At present, there is no single imaging method that can obtain images with electrodes, nuclei and their positional relationship. In addition, the subthalamic nucleus is small in size and the boundary is not obvious, so it cannot be directly segmented. In this paper, a complete end-to-end DBS effect evaluation pipeline was constructed using magnetic resonance (MR) data of T1, T2 and SWI weighted by DBS surgery. Firstly, the images of preoperative and postoperative patients are registered and normalized to the same coordinate space. Secondly, the patient map is obtained by non-rigid registration of brain map and preoperative data, as well as the preoperative nuclear cluster prediction position. Then, a three-dimensional (3D) image of the positional relationship between the electrode and the nucleus is obtained by using the electrode path in the postoperative image and the result of the nuclear segmentation. The 3D image is helpful for the evaluation of the postoperative effect of DBS and provides effective information for postoperative program control. After analysis, the algorithm can achieve a good registration between the patient's DBS surgical image and the brain map. The error between the algorithm and the expert evaluation of the physical coordinates of the center of the thalamus is (1.590 ± 1.063) mm. The problem of postoperative evaluation of the placement of DBS surgical electrodes is solved.
Brain Mapping ; methods ; Deep Brain Stimulation ; Electrodes, Implanted ; Humans ; Imaging, Three-Dimensional ; Magnetic Resonance Imaging ; Multimodal Imaging ; Parkinson Disease ; surgery ; Subthalamic Nucleus

BACKGROUND: Chronic inflammation can lower the seizure threshold and have influence on epileptogenesis. The components of red ginseng (RG) have anti-inflammatory effects. The abundance of peripherally derived immune cells in resected epileptic tissue suggests that the immune system is a potential target for anti-epileptogenic therapies. The present study used continuous electroencephalography (EEG) to evaluate the therapeutic efficacy of RG in intrahippocampal kainic acid (IHKA) animal model of temporal lobe epilepsy.METHODS: Prolonged status epilepticus (SE) was induced in 7-week-old C57BL/6J mice via stereotaxic injection of kainic acid (KA, 150 nL; 1 mg/mL) into the right CA3/dorsal hippocampus. The animals were implanted electrodes and monitored for spontaneous seizures. Following the IHKA injections, one group received treatments of RG (250 mg/kg/day) for 4 weeks (RG group, n=7) while another group received valproic acid (VPA, 30 mg/kg/day) (VPA group, n=7). Laboratory findings and pathological results were assessed at D29 and continuous (24 h/week) EEG monitoring was used to evaluate high-voltage sharp waves on D7, D14, D21, and D28.RESULTS: At D29, there were no differences between the groups in liver function test but RG group had higher blood urea nitrogen levels. Immunohistochemistry analyses revealed that RG reduced the infiltration of immune cells into the brain and EEG analyses showed that it had anticonvulsant effects.CONCLUSION: Repeated treatments with RG after IHKA-induced SE decreased immune cell infiltration into the brain and resulted in a marked decrease in electrographic seizures. RG had anticonvulsant effects that were similar to those of VPA without serious side effects.
Animals ; Blood Urea Nitrogen ; Brain ; Electrodes, Implanted ; Electroencephalography ; Epilepsy, Temporal Lobe ; Hippocampus ; Immune System ; Immunohistochemistry ; Inflammation ; Kainic Acid ; Liver Function Tests ; Mice ; Models, Animal ; Panax ; Seizures ; Status Epilepticus ; Temporal Lobe ; Valproic Acid

BACKGROUNDThe conventional venous access for cardiovascular implantable electronic device (CIED) is the subclavian vein, which is often accompanied by high complication rate. The aim of this study was to assess the efficacy and safety of optimized axillary vein technique.

METHODSA total of 247 patients undergoing CIED implantation were included and assigned to the axillary vein group or the subclavian vein group randomly. Success rate of puncture and complications in the perioperative period and follow-ups were recorded.

RESULTSThe overall success rate (95.7% vs. 96.0%) and one-time success rate (68.4% vs. 66.1%) of punctures were similar between the two groups. In the subclavian vein group, pneumothorax occurred in three patients. The subclavian gaps of three patients were too tight to allow operation of the electrode lead. In contrast, there were no puncture-associated complications in the axillary vein group. In the patient follow-ups, two patients in the subclavian vein group had subclavian crush syndrome and both of them received lead replacement. The incidence of complications during the perioperative period and follow-ups of the axillary vein group and the subclavian vein group was 1.6% (2/125) and 8.2% (10/122), respectively (χ2 = 5.813, P = 0.016).

CONCLUSIONOptimized axillary vein technique may be superior to the conventional subclavian vein technique for CIED lead placement.

TRIAL REGISTRATIONwww.clinicaltrials.gov, NCT02358551; https://clinicaltrials.gov/ct2/show/NCT02358551?term=NCT02358551& rank=1.

Aged ; Axillary Vein ; Defibrillators, Implantable ; adverse effects ; Electrodes, Implanted ; adverse effects ; Female ; Humans ; Male ; Middle Aged ; Pacemaker, Artificial ; adverse effects ; Perioperative Care ; Pneumothorax ; diagnosis ; etiology ; Postoperative Complications ; Prosthesis Implantation ; adverse effects ; Subclavian Vein

Vision is one of the most important human sensations about the surrounding world. Visual deprivation not only markedly affects the life of blind people, but also gives a heavy burden to their family and the society. A visual prosthesis is an electronic device that helps the blinds to regain visual perception by directly stimulating the visual pathway using the microelectrodes implanted into the body. In recent years, visual prostheses have been developed rapidly and some devices have already become clinically available. In this paper, we reviewed the history of visual prosthesis, introduced different visual prostheses classified according to the location of the implanted stimulating electrodes. Clinical study results as well as the functional status of the currently available visual prosthesis devices were also summarized.
Blindness ; Electrodes, Implanted ; Humans ; Microelectrodes ; Visual Perception ; Visual Prosthesis

The main shortcomings of using electrocortical stimulation (ECS) in identifying the motor functional area around the focus in neurosurgery are certainly time-consuming, possibly cerebral cortex injuring and perhaps triggering epilepsy. To solve these problems, we in our research presented an intraoperative motor cortex functional mapping based on electrocorticography (ECoG). At first, using power spectrum estimation, we analyzed the characteristic of ECoG which was related to move task, and selected Mu rhythm as the move-related feature. Then we extracted the feature from original ECoG by multi-resolution wavelet analysis. By calculating the sum value of feature in every channel and observing the distribution of these sum values, we obtained the correlation between the cortex area under the electrode and motor cortex functional area. The results showed that the distribution of the relationship between the cortex under the electrode and motor cortex functional area was almost consistent with those identified by ECS which was called as the gold-standard. It indicated that this method was basically feasible, and it just needed five minutes totally. In conclusion, ECoG-based and passive identification of motor cortical function may serve as a useful adjunct to ECS in the intraoperative mapping.
Brain Mapping ; Electric Stimulation ; Electrocorticography ; Electrodes, Implanted ; Electroencephalography ; Epilepsy ; Humans ; Motor Cortex ; physiology ; Wavelet Analysis

Cochlear implantation has gradually been accepted as an effective treatment for many patients with severe to pround sensorineural hearing loss. The traditional cochlear implantation does not exist up to expectations in some respects. With the soft surgery technique brought forward, the idea of minimally invasive cochlear implantation is deely rooted among the people. Now many institutions are carring out a series of clinical researches and practices to improve the results of cochlear implantation surgery and reduce the complications around the world. It includes minimally invasive approach, cochleostomy and electrode insertion techniques, especially the latter two affect the preservation of residual hearing. This article is a review of the advances in minimally invasive cochlear implantation from the above three aspects.
Cochlear Implantation ; methods ; Cochlear Implants ; Electrodes, Implanted ; Hearing ; Humans ; Minimally Invasive Surgical Procedures ; methods