Brain-computer interface system

Abstract

The invention relates to a brain-computer interface system which comprises a flexible electrode array, a receiving device, a flexible connecting wire and external equipment, wherein the flexible electrode array is implanted into a meninx middle artery in a minimally invasive manner through a superficial temporal artery puncture and a vascular intervention procedure; the receiving device is embedded under the skin of a head and is provided with a signal transmitter; the external equipment is provided with a signal receiver. A flexible electrode array is implanted in an anterior branch or posterior branch of a main branch of a middle meninx artery through a superficial temporal artery intravascular minimally invasive technology, the number of electrodes and the array are arranged according to needs, and a receiving device buried in the subcutaneous part of the head is electrically connected with the flexible electrode array implanted in the middle meninx artery. Craniotomy is not needed, operative complications are avoided, minimally invasive implantation reaches the surface of the cerebral cortex, operation of a doctor is easier, the operation time is shortened, and the comfort level of a patient is improved.

Description

Technical Field

[0001] This application relates to the field of medical devices, and in particular to a transdural brain-computer interface system implanted via the middle meningeal artery. Background Technology

[0002] Brain-computer interface (BCI) is a technology that establishes a direct communication pathway between the brain and external devices. Its core objective is to interpret the intentions or states generated by brain activity and translate them into commands to control external devices; or to encode external information into specific neural stimulation signals and input them into the brain, thereby modulating neural function for repair or enhancement. BCI technology can be categorized into brain-sensing technology and brain-modulation technology based on its ultimate purpose. BCI technology has a wide range of applications in the healthcare field, bringing about significant changes in the treatment and rehabilitation of neurological diseases, such as stroke, infant brain injury, Alzheimer's disease, epilepsy, and autism.

[0003] Currently, there are roughly four technical approaches to brain-computer interfaces:

[0004] The first type is non-invasive brain-computer interface technology. This involves wearing an electrode cap on the patient's scalp and extracting brain signals through the cap. A significant drawback is the low spatial resolution of the signals.

[0005] The second type is invasive brain-computer interface technology. It involves surgically implanting electrodes into the brain to obtain high-quality brainwave signals. This requires craniotomy to insert the electrodes into the cerebral cortex. The advantage is that it can accurately extract signals from each nerve cell, but the disadvantages are that changes in body position can easily cause signal drift and brainwave instability. Furthermore, craniotomy inevitably carries the risk of complications such as wound infection and bleeding. Also, with the electrodes located inside the brain, over time, an immune response can occur, causing impaired signal transmission.

[0006] The third type is interventional brain-computer interface technology. This involves a minimally invasive approach, where stent electrodes are inserted into the superior sagittal sinus via jugular vein puncture to acquire brain signals. However, this method has drawbacks such as a limited number of stent electrodes, their location in the superior sagittal sinus being relatively far from important functional areas like the frontal and parietal lobes, and signal instability.

[0007] The fourth type is minimally invasive or semi-invasive brain-computer interface technology. Electrodes are not inserted directly into the cerebral cortex, but are placed between the skull and the dura mater. However, due to the dura mater in between, receiving brain signals is unstable and requires craniotomy, resulting in significant trauma.

[0008] Therefore, there is an urgent need in this field for a novel brain-computer interface system that can overcome the shortcomings of the current four types of brain-computer interfaces. Summary of the Invention

[0009] To address the shortcomings of existing technologies, this application provides a new generation of brain-computer interface design that can be implanted minimally invasively with electrodes located on the surface of the cerebral cortex. By using minimally invasive endovascular interventional techniques, electrodes are implanted into the middle meningeal artery between the dura mater layers, reaching important functional areas of the cerebral cortex such as the frontal and parietal lobes, making it easier to receive EEG signals from the cortex. At the same time, it is minimally invasive, does not require craniotomy, avoids surgical complications, is easier for doctors to operate, shortens the operation time, and improves patient comfort.

[0010] This application utilizes minimally invasive endovascular techniques to implant minimally invasive electrodes into the anterior or posterior branches of the main branches of the middle meningeal artery. The number and array of electrodes are arranged as needed. Simultaneously, a receiving device is implanted subcutaneously in the head and connected to the electrodes implanted within the middle meningeal artery via minimally invasive endovascular techniques. The middle meningeal artery runs within the dura mater, with important branches distributed on the surface of the frontal and parietal cortex. This trans-middle meningeal artery implanted electrode is closer to the cortex, making it easier to receive EEG signals such as motor and speech signals from the cortex. Furthermore, because the dura mater is a fixed structure between the skull and brain tissue, electrode drift due to changes in body position is avoided. Additionally, minimally invasive superficial temporal artery puncture and endovascular implantation eliminate the need for craniotomy.

[0011] This application provides a brain-computer interface system, comprising: a flexible electrode array minimally invasively implanted into the middle meningeal artery via superficial temporal artery puncture and vascular interventional procedure; the flexible electrode array including a first electrode branch, the first electrode branch having at least one signal acquisition channel for capturing electroencephalogram (EEG) signals in a first branch of the middle meningeal artery, each signal acquisition channel having multiple electrodes; a receiving device implanted under the scalp, the receiving device having a signal transmitter; a flexible connecting wire, one end of the flexible connecting wire being electrically connected to the flexible electrode array, and the other end of the flexible connecting wire being electrically connected to the receiving device; and an external device having a signal receiver, the signal transmitter being used to wirelessly transmit the EEG signals acquired by the flexible electrode array to the signal receiver.

[0012] Furthermore, each signal acquisition channel of the first electrode branch includes an insulating flexible substrate, at least one power supply wire and at least one signal wire arranged in parallel on the surface of the flexible substrate, and each electrode, at least one power supply wire and at least one signal wire in each signal acquisition channel of the first electrode branch are electrically connected to each other.

[0013] Furthermore, the flexible electrode array includes a second electrode branch, which has at least one signal acquisition channel for capturing electroencephalogram (EEG) signals in the second branch of the middle meningeal artery. Each signal acquisition channel of the second electrode branch has multiple electrodes. Each signal acquisition channel of the second electrode branch includes an insulating flexible substrate, at least one power supply wire and at least one signal wire arranged parallel to the surface of the flexible substrate. Each electrode, at least one power supply wire, and at least one signal wire in each signal acquisition channel of the second electrode branch are electrically connected.

[0014] Furthermore, the flexible electrode array includes a third electrode branch, which has at least one signal acquisition channel for capturing electroencephalogram (EEG) signals in the third branch of the middle meningeal artery. Each signal acquisition channel of the third electrode branch has multiple electrodes. Each signal acquisition channel of the third electrode branch includes an insulating flexible substrate, at least one power wire and at least one signal wire arranged parallel to the surface of the flexible substrate, and each electrode in each signal acquisition channel of the third electrode branch, the at least one power wire and the at least one signal wire are electrically connected.

[0015] Furthermore, the first branch and the second branch are selected from the frontal branch of the anterior branch of the middle meningeal artery, the top branch of the anterior branch of the middle meningeal artery, the first trunk of the posterior branch of the middle meningeal artery, the second trunk of the posterior branch of the middle meningeal artery, or the accessory meningeal branch.

[0016] Furthermore, the proximal end of each signal acquisition channel of each electrode branch is connected to a common connector, one end of the flexible connecting wire is electrically connected to the connector, and the other end is electrically connected to the receiving device along a subcutaneous tunnel established from the superficial temporal artery puncture point to the subcutaneous region behind the ear.

[0017] Furthermore, the connector is located in the subcutaneous tissue layer near the puncture point of the middle meningeal artery or the superficial temporal artery.

[0018] Furthermore, the outer peripheral surface of the connector is provided with an anchoring structure. Further, the anchoring structure is selected from barbs or hook-shaped protrusions with a size of 50-100 micrometers.

[0019] Furthermore, the signal transmitter is equipped with a battery for powering the flexible electrode array, or the external device powers the flexible electrode array by wirelessly charging the signal transmitter.

[0020] This application also provides a brain-computer interface system, including a flexible electrode array. The flexible electrode array includes a first electrode branch, which is provided with at least one signal acquisition channel for capturing electroencephalogram (EEG) signals in a first branch of the middle meningeal artery. Each signal acquisition channel is provided with multiple electrodes. The flexible electrode array is minimally invasively implanted into at least one branch of the middle meningeal artery or at least one sub-branch of the at least one branch via a vascular interventional procedure through superficial temporal artery puncture.

[0021] Furthermore, the flexible electrode array enters the middle meningeal artery retrogradely via the superficial temporal artery via the following path: superficial temporal artery → maxillary artery → main trunk of middle meningeal artery → frontal branch of the anterior branch of the middle meningeal artery, top branch of the anterior branch of the middle meningeal artery, first main trunk of the posterior branch of the middle meningeal artery, second main trunk of the posterior branch of the middle meningeal artery, accessory meningeal branches, or other branches of the middle meningeal artery.

[0022] The beneficial effects of this application are as follows: (1) This application provides a new generation of implantable brain-computer interface design, which revolutionarily selects the micro-puncture path through the superficial temporal artery and uses interventional radiology technology to minimally invasively implant a flexible electrode array in the anterior and / or posterior branches of the middle meningeal artery. The entire operation is performed intravascularly, completely avoiding craniotomy; (2) Given that the middle meningeal artery runs within the dura mater and its important branches are distributed on the key cortical surfaces such as the frontal and parietal lobes, a flexible electrode array with a series of signal acquisition channels is placed within the branches of the middle meningeal artery. Multiple electrodes in each signal acquisition channel can monitor cortical electrical signals at close range (only separated by the vessel wall and the inner layer of the dura mater). The signal acquisition quality is far superior to scalp electroencephalography (EEG) and comparable to invasive brain-computer interfaces. (3) Because the dura mater is firmly attached to the inner table of the skull and hardly shifts, the flexible electrode array implanted in the lumen of the middle meningeal artery has a highly fixed spatial position relative to the cerebral cortex below. This fundamentally eliminates the relative movement (drift) between the electrode and brain tissue caused by breathing, heartbeat, head movement or cerebrospinal fluid fluctuations, ensuring long-term signal stability and reliability. This fundamentally solves the problem of signal attenuation or loss caused by micro-movement of traditional implanted electrodes. This is the core advantage of this scheme that distinguishes it from all other extracerebral / epidural implantation schemes. (4) As an intravascular implant, the flexible electrode array implanted in the lumen of the middle meningeal artery The array avoids direct contact with the brain parenchyma, greatly reducing the risk of inflammation, immune rejection, glial scar formation and brain tissue damage. Moreover, unlike the venous sinus implantation electrode, the minimally invasive implantation of the flexible electrode array in the middle meningeal artery on the surface of the important functional areas of the frontal and parietal lobes results in higher signal acquisition quality and a significantly lower risk of thrombosis compared to the venous sinus. (5) Placing the receiving device in the subcutaneous area behind the ear, which is rich in blood supply, easy to implant and aesthetically pleasing, avoids opening windows in the skull or long-term percutaneous puncture of the guide wire, greatly reducing the risk of infection and improving the comfort and aesthetics of long-term implantation, thereby improving safety and user experience. (6) The signal acquisition channel is a flexible linear type, and the number of signal acquisition channels and the electrical current on each signal acquisition channel are relatively small. The spacing and number of electrodes can be customized and arranged according to the anatomical location of the target brain region (such as the hand motor area and language area) to achieve optimal signal coverage and multi-point signal acquisition; (7) It has a high degree of system integration. The acquired EEG signals are transmitted to a miniature receiving device implanted under the scalp through a flexible connecting wire. The receiving device can perform preliminary processing and wirelessly transmit to external devices to achieve complete brain-computer interface functions; (8) The brain-computer interface system of this application not only supports high-precision signal acquisition, but also can be easily upgraded to a deep brain stimulation or closed-loop neuromodulation system by integrating microcurrent stimulation functions on multiple electrodes. It has the potential to be used to treat neurological diseases such as epilepsy, Parkinson's disease, and depression. Attached Figure Description

[0023] Figure 1This is a schematic diagram of the brain-computer interface system of this application. For ease of display, the flexible electrode array and the middle meningeal artery are placed separately. In addition, the branching structure of the middle meningeal artery is not shown.

[0024] Figure 2 This is a schematic diagram of the middle meningeal artery in the human body. This is not a complete diagram of the middle meningeal artery, but only shows its main parts. In addition, the green lines in the diagram indicate the path through which the artery enters the anterior and posterior branches of the middle meningeal artery via puncture of the superficial temporal artery.

[0025] Figure 3 This is a schematic diagram of a flexible electrode array in one embodiment of the present application, showing five signal acquisition channels distributed along the axial direction of the middle meningeal artery, and the spatial layout of the five signal acquisition channels and 20 electrodes on each signal acquisition channel within the axial vessel of the middle meningeal artery. For ease of demonstration, the middle meningeal artery is "cut open" and laid flat.

[0026] Figure 4 This is a schematic diagram showing the connection between each electrode in each signal acquisition channel and two power supply wires (P1, P2) and two signal wires (S1, S2) in one embodiment of this application.

[0027] Figure 5 This is a schematic diagram of the brain-computer interface system in the first embodiment of this application. The three front branch signal acquisition channels, two rear branch signal acquisition channels, and flexible connecting wires are not shown.

[0028] Figure 6 This is a schematic diagram of the brain-computer interface system in the first embodiment of this application, showing three anterior branch signal acquisition channels, two posterior branch signal acquisition channels, and flexible connecting wires. In order to highlight some of the signal acquisition channels and flexible connecting wires, the blood vessels of the middle meningeal artery are staggered from some of the signal acquisition channels and flexible connecting wires.

[0029] Figure 7 This is a schematic diagram of the first connection between the three front support signal acquisition channels and the two rear support signal acquisition channels, as well as the flexible connecting wires and the connector, in the first embodiment of this application.

[0030] Figure 8 This is a schematic diagram of the second connection between the three front support signal acquisition channels and the two rear support signal acquisition channels, as well as the flexible connecting wires and connectors, in the first embodiment of this application.

[0031] Figure 9 This is a schematic diagram of the three front-end signal acquisition channels, two rear-end signal acquisition channels, and the third connection of the flexible connecting wire and connector in the first embodiment of this application.

[0032] Figure 10Schematic cross-sectional view of the proximal end of the multi-lumen microcatheter in the third embodiment of the present application. The multi-lumen microcatheter is located in the vascular lumen of the middle meningeal artery and has three independent lumens in a "one main and two secondary" configuration, arranged in a "pin" shape to ensure structural stability.

[0033] Figure 11 is Figure 10 side view of the distal end of the multi-lumen microcatheter in the middle. The distal end of the multi-lumen microcatheter includes three independent outlets and multiple radiopaque marker rings for precise positioning.

[0034] Figure 12 Schematic structural view of the control handle in the third embodiment of the present application. Detailed implementation manners

[0035] To make the above objects, features, and advantages of the present application more obvious and understandable, the following will describe the detailed implementation manners of the present application in conjunction with the accompanying drawings. Many specific details are set forth in the following description to fully understand the present application. However, the present application can be implemented in many other ways different from those described herein, and those skilled in the art can make similar improvements without departing from the connotation of the present application. Therefore, the present application is not limited by the specific embodiments disclosed below.

[0036] It should be noted that when a component is referred to as being "fixed to" or "disposed on" another component, it can be directly on the other component or there may also be an intermediate component. When a component is considered to be "connected" to another component, it can be directly connected to the other component or there may be an intermediate component at the same time. The terms "vertical", "horizontal", "upper", "lower", "left", "right" and similar expressions used in the description of the present application are only for illustrative purposes and do not represent the only implementation manner.

[0037] In addition, the terms "first" and "second" are only used for descriptive purposes and cannot be construed as indicating or implying relative importance or implicitly specifying the quantity of the indicated technical features. Thus, features defined with "first" and "second" may explicitly or implicitly include at least one of such features. In the description of the present application, the meaning of "multiple" is at least two, such as two, three, etc., unless otherwise specifically and clearly defined.

[0038] In this application, unless otherwise expressly specified and limited, "above" or "below" the second feature can mean that the first feature is in direct contact with the second feature, or that the first feature and the second feature are in indirect contact through an intermediate medium. Furthermore, "above," "on top of," and "over" the second feature can mean that the first feature is directly above or diagonally above the second feature, or simply indicates that the first feature is at a higher horizontal level (or in a usage state, or from a certain viewpoint in the drawing) than the second feature. "Below," "below," and "under" the second feature can mean that the first feature is directly below or diagonally below the second feature, or simply indicates that the first feature is at a lower horizontal level (or in a usage state, or from a certain viewpoint in the drawing) than the second feature.

[0039] Unless otherwise defined, all technical and scientific terms used in this application have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used in this application is for the purpose of describing particular embodiments only and is not intended to be limiting of this application. The term "and / or" as used in this application includes any and all combinations of one or more of the associated listed items.

[0040] When used to indicate direction, the proximal end in the text generally refers to the side closest to the operator (e.g., a doctor), and the distal end is the side relatively far away. Correspondingly, each component itself has a relative distal end and a proximal end. When used to refer to a structure, the "end" in the text indicates the endpoint of the structure or a point or region in that lateral direction, or a specific structure connected to that point or region.

[0041] like Figure 1 and Figure 2 As shown, the transdural brain-computer interface system via the middle meningeal artery provided in this application includes a flexible electrode array 1, a flexible connecting wire 3, and a receiver 2 implanted subcutaneously in the head. The receiver 2 is equipped with a signal transmitter and can be implanted subcutaneously behind the ear or in other subcutaneous areas of the head.

[0042] The flexible electrode array 1 is punctured through the superficial temporal artery 39 and minimally invasively implanted into the lumen of the main trunk 40 or its main branches 41 and 42 of the middle meningeal artery 4 via a vascular interventional procedure. Its retrograde path into the middle meningeal artery via the superficial temporal artery is: superficial temporal artery → maxillary artery → main trunk of the middle meningeal artery → anterior / posterior branch of the middle meningeal artery. As a miniature device implanted under the skin of the head, the receiving device 2 receives the electroencephalogram (EEG) signals collected by the flexible electrode array 1 and transmits these signals wirelessly to an external device 5 equipped with a signal receiver. A flexible connecting wire 3 runs from a subcutaneous tunnel near the puncture point of the superficial temporal artery to the subcutaneous tissue of the head, such as behind the ear, thereby establishing an electrical connection between the flexible electrode array 1 and the receiving device 2.

[0043] The receiving device 2 can also be equipped with a signal amplifier and a signal processor to amplify and process the EEG signals received from the flexible electrode array 1, and then transmit them to the signal receiver of the external device 5 via a signal transmitter equipped with the receiving device 2. Alternatively, the receiving device 2 can be without a signal amplifier and signal processor, directly transmitting the EEG signals received from the flexible electrode array 1 to the external device 5. The external device 5 amplifies and processes the received EEG signals, and after further decoding and analysis, the EEG signals emitted from the relevant cortical areas can be determined. Furthermore, the wireless communication between the receiving device 2 and the external device 5 can be unidirectional, i.e., transmission only from the receiving device 2 to the external device 5, or bidirectional. For example, as long as the wireless communication between the signal transmitter of the receiving device 2 and the signal receiver of the external device 5 supports Bluetooth or StarFlash protocols, bidirectional communication can be achieved. This allows doctors to adjust relevant parameters in a timely manner based on the monitored changes in EEG signals.

[0044] The receiver 2 may be equipped with a miniature power source, such as a micro battery, to power the flexible electrode array 1. Alternatively, the receiver 2 may not be equipped with a miniature power source, but may be wirelessly powered by an external device 5, such as by an electric field, magnetic field, or electromagnetic wave generated by the external device 5, which in turn powers the flexible electrode array 1.

[0045] like Figure 2 As shown, the middle meningeal artery 4 in the human body has a main trunk 40. At the distal bifurcation 43 of the main trunk 40, it divides into anterior branch 41 and posterior branch 42. Furthermore, the main trunk 40 can also produce other branches, such as accessory meningeal branches 45. The anterior branch 41 can divide into frontal lobe branches 411 and parietal lobe branches 412. As can be seen from the diagram, the frontal lobe branches 411 and 412 further divide into multiple sub-branches. For example, the frontal lobe branch 411 can branch into sub-branches such as sub-branch 415, and the parietal lobe branch 412 can further divide into sub-branch 413 and sub-branch 414 (lipid sub-branches). The posterior branch 42 is usually underdeveloped and mainly divides into two sub-branches: the first main trunk 421 and the second main trunk 422.

[0046] The flexible electrode array 1 is located within the lumen of the middle meningeal artery 44. It is ultra-flexible and can conform to the tortuous course of the middle meningeal artery, avoiding damage to the vessel wall. The flexible electrode array 1 is miniaturized, with extremely fine width and thickness to avoid affecting blood flow within the vessel, typically with a width between 0.05 and 0.5 mm.

[0047] In the flexible electrode array 1, at least one independent signal acquisition channel can be designed according to monitoring requirements. In some cases, the flexible electrode array 1 can provide multiple signal acquisition channels, for example, 2 to 10 independent signal acquisition channels. In other cases, the flexible electrode array 1 has at least 4 to 8 signal acquisition channels. The specific number of signal acquisition channels can be increased or decreased as needed.

[0048] In some cases, such as Figure 3 As shown, the flexible electrode array 1 has five signal acquisition channels 11 distributed along the axial direction of the middle meningeal artery, with 20 electrodes on each channel 11. These electrodes are located within the vessel lumen 44, close to but not penetrating the vessel wall, monitoring the electroencephalogram (EEG) signals in the underlying cortex through the vessel wall. This avoids craniotomy and reduces tissue damage.

[0049] The distal end (also called the free end) of each signal acquisition channel 11 is close to the wall of the middle meningeal artery to acquire cortical signals. The proximal end (connector end) of each signal acquisition channel 11 converges to a common connector 6 (see...). Figure 5 and Figure 6 Connector 6 is connected to a flexible connecting wire 3 covered with insulating material via welding or conductive adhesive. The flexible connecting wire 3 is led out from the superficial temporal artery puncture point 39, passes through a subcutaneous tunnel to the subcutaneous tissue behind the ear, and connects to the receiving device 2 implanted under the skin behind the ear. Different signal acquisition channels 11 are arranged in parallel or bifurcated patterns within the blood vessels to cover a wider area of ​​the brain.

[0050] Each signal acquisition channel has 11, for example Figure 7 The anterior branch signal acquisition channels 11-1A, 11-1B, and 11-1C, and the posterior branch signal acquisition channels 11-2A and 11-2B, can be equipped with multiple electrodes 12, such as 16 to 256 electrodes, to cover different brain functional areas and achieve high-density, multi-channel signal acquisition. The number of electrodes in each signal acquisition channel 11 can be all the same, or all different. Alternatively, some signal acquisition channels 11 can have the same number of electrodes (denoted as X1), while other signal acquisition channels 11 can have the same number of electrodes (denoted as X2), where X1 and X2 are not equal.

[0051] These electrodes 12 are fixed to the dura mater along with the blood vessels. The dura mater is firmly attached to the inner table of the skull, fundamentally eliminating the relative movement between the electrodes and brain tissue, and ensuring the long-term stability of the acquired EEG signals. The materials of the electrodes 12 can be selected from conductive materials such as platinum-iridium alloy, iridium oxide, gold, and platinum.

[0052] In some cases, each signal acquisition channel 11 has a length of 10-50 mm, a width of 0.1-0.3 mm, and a thickness of 0.05 mm, adjusted according to the length of the target blood vessel. Within each signal acquisition channel 11, electrodes 12 are arranged at equal intervals along the length of each channel, with a spacing of 0.5-5.0 mm between adjacent electrodes 12, to achieve linear sampling of the cortex beneath the middle meningeal artery. Each electrode 12 can be circular, elliptical, or other common geometric shapes, such as a circle with a diameter of 50-100 μm.

[0053] Each signal acquisition channel 11 has a flexible substrate 10 at the bottom, which is made of an insulating material such as polyimide, Parylene-C, or liquid crystal polymer (LCP). Each signal acquisition channel 11 also has at least one (e.g., one, two, or more) power line 13 (8-15 μm in diameter) and at least one (e.g., one, two, or more) signal line 14 (5-10 μm in diameter). Each power line 13 and each signal line 14 covers the surface of the flexible substrate 10 and is arranged parallel to each other, and is covered with an insulating layer.

[0054] At least one power lead 13 and at least one signal lead 14 in each signal acquisition channel 11 are connected to each electrode 12 in each signal acquisition channel 11. In some cases, this connection can be a substantially vertical connection, and a gold wire ball bonding process can be used for the connection. During the connection, micro-holes are formed at regular intervals on the insulation layer of each power lead 13 and each signal lead 14 connected to each electrode 12 in each signal acquisition channel 11 using laser etching or photolithography, thereby forming a plurality of pairs of aligned electrode connection points on the surface of the corresponding power lead and signal lead. The number of pairs of electrode connection points in each signal acquisition channel is the same as the number of electrodes. Then, each electrode in each signal acquisition channel is connected to a pair of aligned electrode connection points at regular intervals by soldering or conductive adhesive.

[0055] In some cases, each electrode 12 may be connected to one power supply wire 13 and one signal wire 14. In some cases, such as... Figure 4As shown, each electrode 12 can be connected to two power lines 13 (P1, P2) and two signal lines 14 (S1, S2). Microholes are periodically created on the insulating layers of the power lines P1 and P2 and the signal lines S1 and S2 using laser etching or photolithography. This allows multiple electrodes 12 to be electrically connected to the exposed power lines P1 and P2 and signal lines S1 and S2 via soldering or conductive adhesive. The two power lines 13 and two signal lines 14 are provided for redundancy; if one power line 13 or one signal line 14 fails, the other power line 13 or signal line 14 remains available. Alternatively, each electrode 12 can be connected to two power lines 13 and one signal line 14, or each electrode 12 can be connected to one power line 13 and two signal lines 14.

[0056] In each signal acquisition channel 11, in addition to some power wires 13 and some signal wires 14 establishing electrical connections with multiple electrodes 12 of each signal acquisition channel 11 at their respective electrode connection points, each signal acquisition channel 11 should be insulated. That is, all power wires 13, all signal wires 14, and all electrodes 12 in each signal acquisition channel 11 should be insulated to prevent short circuits between adjacent wires. Specifically, the outer surface of each power wire 13, each signal wire 14, and each electrode 12 in each signal acquisition channel 11 is coated with a flexible insulating material (such as polyimide or Parylene-C) to form an insulating layer with a thickness of 1~2μm.

[0057] The outer surface of the insulating layer of each signal acquisition channel 11 can also be treated with anticoagulants, for example, by adding a heparin coating or a superhydrophilic polymer coating such as a phosphoric acid choline polymer (e.g., poly(2-methacryloyloxyethyl phosphoric acid choline) coating and a polyethylene glycol (PEG) coating. Alternatively, a biocompatible coating can be formed by coating the outer surface of the insulating layer of each signal acquisition channel 11 with biomolecules that promote endothelialization, such as anti-CD146 antibodies, anti-CD144 antibodies, anti-CD47 antibodies, anti-CD34 antibodies, and anti-CD133 antibodies, to promote endothelial cell coverage, reduce the risk of thrombosis, and ensure long-term stability within the blood vessel.

[0058] In addition, tiny, flexible anchoring structures, such as micro-spirals, micro-barbs, or micro-anchors (e.g., made of shape-memory nickel-titanium alloy), can be provided at both ends or in the middle of each signal acquisition channel 11 to help the electrode 12 maintain its position within the blood vessel and prevent it from moving. However, these anchoring structures must not damage the blood vessel during use. To conform to the wall of the artery, each signal acquisition channel 11 can be designed as an "eccentric flattened" shape, with one side being the signal acquisition surface and the other side being an arc surface that conforms to the blood vessel wall.

[0059] In some cases, such as Figure 7 As shown, a first electrode branch is provided for the anterior branch 41 of the middle meningeal artery. This first electrode branch is equipped with three anterior branch signal acquisition channels: a first anterior branch signal acquisition channel 11-1A, a second anterior branch signal acquisition channel 11-1B, and a third anterior branch signal acquisition channel 11-1C. Each anterior branch signal acquisition channel is used to acquire EEG signals emitted from different regions of the cerebral cortex. A second electrode branch is provided for the posterior branch 42 of the middle meningeal artery. This second electrode branch is equipped with two posterior branch signal acquisition channels: a first posterior branch signal acquisition channel 11-2A and a second posterior branch signal acquisition channel 11-2B. Each posterior branch signal acquisition channel is used to acquire EEG signals emitted from different regions of the cerebral cortex. In this configuration, the flexible electrode array 1 includes both the first and second electrode branches.

[0060] In addition, the middle meningeal artery may also give off accessory meningeal branches 45, which participate in the blood supply to the skull base, adjacent meninges, and some cranial nerves. A third electrode branch can also be provided for the accessory meningeal branch 45, equipped with at least one signal acquisition channel to detect the corresponding electroencephalogram (EEG) signals. The flexible electrode array 1 includes a first electrode branch, a second electrode branch, and a third electrode branch. Similarly, more electrode branches can be provided for other branches that may exist in the middle meningeal artery.

[0061] Example 1: A novel brain-computer interface system with multiple signal acquisition channels

[0062] like Figure 5 and Figure 6 As shown, the middle meningeal artery enters the cranial cavity through the foramen spinosum at the base of the skull and runs anterolaterally along the middle meningeal artery groove in the middle cranial fossa, dividing into anterior branch 41 and posterior branch 42. Anterior branch 41 can generate many sub-branches. Signal acquisition channels can be set for some important sub-branches or for all sub-branches. Here, a first electrode branch equipped with three anterior branch signal acquisition channels is set for sub-branch 415 of frontal lobe branch 411, sub-branch 413 and sub-branch 414 of parietal lobe branch 412. Sub-branch 415 is equipped with a first anterior branch signal acquisition channel 11-1A, sub-branch 413 is equipped with a second anterior branch signal acquisition channel 11-1B, and sub-branch 414 is equipped with a third anterior branch signal acquisition channel 11-1C, which can be used to detect EEG signals emitted from different regions of the cerebral cortex.

[0063] The first front-end signal acquisition channel 11-1A can be equipped with 32 electrodes 12, with adjacent electrodes 12 spaced 0.8 mm apart, and a coverage length of 24.8 mm. The second front-end signal acquisition channel 11-1B can be equipped with 24 electrodes 12, with adjacent electrodes 12 spaced 0.9 mm apart, and a coverage length of 20.7 mm. The third front-end signal acquisition channel 11-1C can be equipped with 20 electrodes 12, with adjacent electrodes 12 spaced 1.0 mm apart, and a coverage length of 19.0 mm.

[0064] For the first main trunk 421 and the second main trunk 422 of the posterior branch 42, a second electrode branch equipped with two posterior branch signal acquisition channels is provided: the first main trunk 421 is equipped with a first posterior branch signal acquisition channel 11-2A and the second main trunk 422 is equipped with a second posterior branch signal acquisition channel 11-2B, which can be used to detect EEG signals emitted from different regions of the cerebral cortex. The first posterior branch signal acquisition channel 11-2A can be equipped with 28 electrodes 12, with adjacent electrodes 12 spaced 0.85mm apart, and a coverage length of 22.95mm. The second posterior branch signal acquisition channel 11-2B can be equipped with 18 electrodes 12, with adjacent electrodes 1.0mm apart, and a coverage length of 17.0mm, or it can be equipped with 16 electrodes, with adjacent electrodes 1.1mm apart, and a coverage length of 16.5mm.

[0065] In both the anterior and posterior branch signal acquisition channels, each electrode 12 is electrically connected to both a power lead 13 and a signal lead 14. The connector 6, serving as the converging center of the flexible electrode array 1, can be located in the main trunk 40 of the middle meningeal artery. Five signal acquisition channel interfaces are provided at one end or periphery of the connector 6, allowing insertion of three anterior branch signal acquisition channels and two posterior branch signal acquisition channels to collect neural signals from these channels; thus, the connector 6 also serves as a signal transmission hub. A connecting wire interface is provided at the other end or periphery of the connector 6, serving as the starting point for the flexible connecting wire 3, from which the flexible connecting wire 3 extends to the receiving device 2 implanted under the skin behind the ear.

[0066] Of course, in order to reduce the space occupancy of all anterior branch signal acquisition channels in the anterior branch 41 of the middle meningeal artery 4 and the space occupancy of all posterior branch signal acquisition channels in the posterior branch 42 of the middle meningeal artery 4, such as Figure 8As shown, the proximal ends of each anterior branch signal acquisition channel are first gathered together in the anterior branch 41 of the middle meningeal artery 4 (i.e., connected to a flexible anterior branch hub wire 15 by welding or conductive adhesive), and the proximal ends of each posterior branch signal acquisition channel are first gathered together in the posterior branch 42 of the middle meningeal artery 4 (i.e., electrically connected to a flexible posterior branch hub wire 16 by welding or conductive adhesive). At this time, only two anterior branch signal acquisition channel interfaces need to be set on the connector 6, which are electrically connected to the anterior branch hub wire 15 and the posterior branch hub wire 16 respectively.

[0067] However, considering that the anterior branch 41 or posterior branch 42 of the middle meningeal artery 4 can also form new branches, and these branches may further generate new sub-branches. For example, ... Figure 9 As shown, the front branch 41 can have three branches 11-1A, 11-1B, and 11-1C, and the rear branch 42 can have two branches 11-2A and 11-2B. Branch 11-1A can generate two new sub-branches 11-1A1 and 11-1A2. If it is necessary to set up a signal acquisition channel along each of sub-branches 11-1A1 and 11-1A2, the signal acquisition channels set up in each of sub-branches 11-1A1 and 11-1A2 can be first combined in branch 11-1A, that is, electrically connected to a flexible hub wire 17. Then, the hub wire 17 and the signal acquisition channels set up in branches 11-1B and 11-1C can be connected to connector 6 respectively. Of course, it can also be done as follows. Figure 8 In this way, the hub wire 17 and one signal acquisition channel each set in branches 11-1B and 11-1C are converged to form the front hub wire 15, and then connected to the connector 6 through the front hub wire 15. Branch 11-2A can generate two sub-branches 11-2A1 and 11-2A2. If it is necessary to set one signal acquisition channel along each sub-branch 11-2A1 and sub-branch 11-2A2, the signal acquisition channels set in each sub-branch 11-2A1 and sub-branch 11-2A2 can be converged in branch 11-2A first, that is, electrically connected to a flexible hub wire 18, and then the hub wire 18 and the signal acquisition channel set in branch 11-2B are respectively connected to the connector 6. Of course, it can also be done as follows. Figure 8 In this way, the hub wire 18 and a signal acquisition channel set in branch 11-2B are brought together to form the rear branch hub wire 16, and then the rear branch hub wire 16 is connected to the connector 6.

[0068] Connector 6 has a diameter of approximately 3 mm and is made of medical-grade titanium alloy, available in cylindrical shapes. In some cases, the surface of connector 6 is roughened, with a surface roughness ranging from 100 to 500 nanometers, to increase the adhesion of vascular endothelial cells and form bioadhesion. In some cases, a hydrophilic coating, such as a phosphocholine polymer coating, is applied to the surface of connector 6 to reduce platelet aggregation, promote endothelialization, and reduce the risk of thrombosis. In some cases, anchoring structures, such as tiny barbs or hook-like protrusions measuring 50 to 100 micrometers, are incorporated into the surface of connector 6, evenly distributed on its outer periphery. To ensure the vascular endothelium is not damaged, shape memory alloys, such as nickel-titanium alloys, can be used to allow for unfolding at body temperature upon implantation. In some cases, the diameter of connector 6 is 3.3 to 5.5 mm, slightly larger than the vessel diameter of 3 to 5 mm (approximately 10 to 15% larger), to achieve an interference fit and provide continuous radial pressure. The stable fixation of connector 6 depends not only on the bifurcation 43 of the middle meningeal artery, but also on its own vascular wall adhesion ability, the anchoring effect of the signal acquisition channel, and the tensile stability of the flexible connecting wire 3.

[0069] Connector 6 has a rigid core (such as titanium alloy to provide structural strength) and a flexible outer layer (such as silicone / polyurethane to adapt to vascular pulsation). However, the implantation location of the connector in the head is not unique; for example, the connector can also be implanted in the subcutaneous tissue layer near the puncture site of the superficial temporal artery.

[0070] In practical applications, multiple signal acquisition channels can be implanted only in the anterior branch of the middle meningeal artery (e.g., three anterior branch signal acquisition channels), or multiple signal acquisition channels can be implanted only in the posterior branch of the middle meningeal artery (e.g., two posterior branch signal acquisition channels), or multiple signal acquisition channels can be implanted simultaneously in both the anterior and posterior branches of the middle meningeal artery (e.g., three anterior branch signal acquisition channels + two posterior branch signal acquisition channels).

[0071] Example 2 Vascular Implantation Procedure

[0072] This embodiment uses the brain-computer interface system in Embodiment 1 as an example for explanation. In this case, only one anterior branch electrode with one signal acquisition channel is implanted in the anterior branch 41 of the middle meningeal artery. For example, only one signal acquisition channel is provided in the sub-branch 11-1A1 or 11-1A2 of the branch 11-2A of the anterior branch 41, or only one signal acquisition channel is provided in the branch 11-2B of the anterior branch 41. For ease of explanation, this embodiment will only use the example of providing one signal acquisition channel in the sub-branch 11-1A1 of the branch 11-2A of the anterior branch 41.

[0073] At this point, when the anterior branch electrode is implanted into the sub-branch 11-1A1 of the middle meningeal artery, the microcatheter carrying the anterior branch electrode can be manually guided into the sub-branch 11-1A1 of the branch 11-2A of the anterior branch 41 using a microguidewire under the real-time path guidance of digital subtraction angiography (DSA). Then, the microcatheter can be withdrawn to release the anterior branch electrode into the sub-branch 11-1A1 for EEG signal detection.

[0074] Example 3 Vascular Implantation Procedure

[0075] Preoperatively, the diameter and patency of the superficial temporal artery, external carotid artery, and middle meningeal artery were assessed using vascular ultrasound. Three-dimensional reconstruction of the middle meningeal artery branches was performed using CT angiography. All preoperative examinations were conducted to ensure no abnormalities were found. Furthermore, allergy testing was performed to ensure the patient was not allergic to anesthetics and contrast agents. The patient began taking 100mg of aspirin daily 3-5 days prior to surgery.

[0076] The flexible electrode array includes a front electrode branch (e.g., as the first electrode branch) and a rear electrode branch (e.g., as the second electrode branch). The front electrode branch has multiple front signal acquisition channels, and the rear electrode branch has multiple rear signal acquisition channels. Taking the novel brain-computer interface system in Embodiment 1 as an example, it can be seen that the front electrode branch has 3 front signal acquisition channels, and the rear electrode branch has 2 rear signal acquisition channels.

[0077] Step 1: Superficial temporal artery puncture

[0078] After disinfecting the temporal region and administering general anesthesia, a high-frequency ultrasound probe (10-15 MHz) was used to locate the superficial temporal artery. A segment of the superficial temporal artery with a diameter ≥2 mm was selected as the puncture point. Using the Seldinger technique, a 21G-24G micro-puncture needle was inserted into the anterior wall of the superficial temporal artery at an angle of 30°-45°. After observing arterial blood return, a sheath was inserted into the puncture port in the superficial temporal artery.

[0079] Step 2: Guide the multi-lumen microcatheter to the bifurcation of the terminal branch of the middle meningeal artery.

[0080] Under the real-time roadmap guidance of digital subtraction angiography (DSA), the distal end of the multi-lumen microcatheter 7 is advanced through the sheath to the bifurcation of the terminal branch of the middle meningeal artery. At this point, the marker ring M2 (see...) Figure 11 It is precisely aligned with the bifurcation of the blood vessel. The multi-lumen microcatheter 7 is described in detail below.

[0081] like Figure 10 and Figure 11As shown, the multi-lumen microcatheter 7 is a specially designed microcatheter. Inside the catheter 7 is a main lumen 70, a first side lumen 71, and a second side lumen 72. These three lumens have independent openings at their distal ends, ensuring that the release of different components does not interfere with each other. The main lumen 70, with the largest diameter (0.66~0.92 mm outer diameter), is used to accommodate the connector 6 and its push rod. The connector 6 is in a compressed and folded state during delivery. Initially, the distal end of the push rod may not be connected to the connector 6. When the push rod is pushed distally, it contacts the connector 6, pushing the connector 6 out of the distal outlet 701 of the main lumen. Then, retracting the push rod separates the connector 6 from the push rod. Alternatively, the distal end of the push rod can be detachably connected to the connector 6. After the connector 6 is released from the distal outlet 701 of the main lumen, the distal end of the push rod disconnects from the connector 6, achieving separation. The proximal end of the push rod is fixedly connected to the push rod latch in the control handle 8.

[0082] The first lateral lumen 71 and the second lateral lumen 72 are symmetrically distributed on both sides of the main lumen 70, with slightly smaller diameters. They are pre-loaded with anterior branch electrodes and their independent anterior branch push wires, and posterior branch electrodes and their independent posterior branch push wires, respectively. The distal end of the multi-lumen microcatheter 7 has multiple radiopaque marker rings M1-M3, clearly visible under DSA fluoroscopy, for precise positioning. For example, M1 and M3 are located proximal to the distal outlet 711 of the first lateral lumen and the distal outlet 721 of the second lateral lumen, respectively, indicating the release positions of the anterior and posterior branch electrodes. M2 is located proximal to the distal outlet 701 of the main lumen, used to precisely position the distal end of the main lumen 70 on the main trunk of the middle meningeal artery under DSA fluoroscopy. In some cases, the distal end of the multi-lumen microcatheter 7 is a gradually tapering, highly flexible conical structure, facilitating safe passage through tortuous blood vessels. In addition, the multi-lumen microcatheter 7 can also be equipped with a separate guidewire lumen (not shown) for use during initial superselection to pass through the microguidewire and establish vascular access. After this lumen is established, it can be left idle or used for injection of contrast agent.

[0083] The proximal end of the multi-lumen microcatheter 7 is equipped with a control handle 8 for physician operation. For example... Figure 12 As shown, the control handle 8 is an ergonomic multi-functional handle comprising a first side chamber control valve 81, a second side chamber control valve 82, a main chamber control valve 83, a rotation control module 84, and a flushing port 85. The main chamber control valve 83 is connected to the main chamber 70 and contains a push rod latch for controlling the release of the connector 6. Rotating the central knob 831 in the main chamber control valve 83 unlocks / locks the push rod, controlling the fixing and release of the connector 6.

[0084] The first side chamber control valve 81 is connected to the first side chamber 71 and is equipped with a first push wire knob 811 for independently and precisely controlling the extension distance of the front support electrode branch. The distal end of the front support push wire is detachably connected to the front support electrode branch, and the proximal end of the front support push wire is connected to the first push wire knob 811. Each rotation of the first push wire knob 811 to the left or right advances or retracts the front support electrode branch a certain distance, such as 0.5mm, from the distal end. The extension distance can be accurately read through the scale near the first push wire knob 811. After the front support electrode branch is released from the distal outlet 711 of the first side chamber, the front support push wire is disconnected from the front support electrode branch, achieving separation.

[0085] The second side chamber control valve 82 is connected to the second side chamber 72 and is equipped with a second push wire knob 821 for independently and precisely controlling the extension distance of the rear branch electrode. The distal end of the rear branch push wire is detachably connected to the rear branch electrode, while the proximal end is connected to the second push wire knob 821. Each rotation of the second push wire knob 821 to the left or right advances or retracts the rear branch electrode a certain distance, for example, 0.5mm, from the distal end. The extension distance can be accurately read using the scale near the second push wire knob 821. After the rear branch electrode is released from the distal outlet 721 of the second side chamber, the rear branch push wire is disconnected from the rear branch electrode, achieving separation. The second side chamber control valve 82 is independent of the first side chamber control valve 81 and can be operated individually or simultaneously. The second side chamber control valve 82 and the first side chamber control valve 81 are symmetrically designed for easy two-handed operation.

[0086] The flushing port 85 connects to a syringe for heparinized saline flushing or contrast agent injection. The flushing port 85 is connected to the main lumen 70, the first side lumen 71, and the second side lumen 72 via a fluid path, allowing for continuous heparinized saline flushing during the procedure to prevent thrombosis. When injecting contrast agent, it can be used to confirm catheter position. A self-sealing valve design is employed, automatically closing after the syringe is removed.

[0087] The rotation control module 84 is connected to the proximal end of the multi-lumen microcatheter 7, used for precise control of the rotation angle of the multi-lumen microcatheter 7 within the blood vessel. It can adjust the direction of the distal end of the multi-lumen microcatheter 7 to align it with the target vascular branch. Its rotation range is ±180°, and it has a center reset function. The control handle 8 also has a catheter connection port 86 for connecting the proximal end of the multi-lumen microcatheter 7, which can employ a Luer lock design to ensure a secure and reliable seal. A "click" sound indicates that the connection is locked.

[0088] Step 3: Release the flexible electrode array

[0089] The multi-lumen microcatheter 7 is fixed in place. First, the anterior branch push wire connected to the anterior branch electrode branch is pushed out from the first lateral lumen 71. Under the influence of blood flow and pushing action, the anterior branch electrode branch enters the anterior branch 41 of the middle meningeal artery until it is fully extended. Next, the posterior branch push wire connected to the posterior branch electrode branch is pushed out from the second lateral lumen 72. Under the influence of blood flow and pushing action, the posterior branch electrode branch enters the posterior branch 42 of the middle meningeal artery until it is fully extended.

[0090] During the pushing process of both the front and rear electrode branches, a small amount of contrast agent is injected into the main cavity to confirm correct release position. However, during release, the proximal ends of each front and rear signal acquisition channel maintain physical contact or pre-connection with the unreleased connector 6. The proximal ends of each front and rear signal acquisition channel are not simple wires, but miniaturized, standardized male connector pins. Connector 6 internally integrates corresponding female sockets with self-sealing rubber diaphragms. During release, as the front and rear electrode branches are pushed out of their respective side cavities, the male pins of each front and rear signal acquisition channel are pre-aligned and partially inserted into the female socket of connector 6.

[0091] Step 4: Release and anchor the connector

[0092] The push rod, fixed in the main lumen 70, is then slowly retracted from the entire multi-lumen microcatheter 7. The connector 6 emerges from the distal outlet 701 of the main lumen and self-expands at the bifurcation of the middle meningeal artery. During this self-expansion process, a built-in miniature locking mechanism (such as a spring clip or twist lock) is activated, firmly locking the male pins of each anterior branch signal acquisition channel and each posterior branch signal acquisition channel into their corresponding female sockets, completing both mechanical fixation and electrical connection.

[0093] The rubber diaphragm in the female socket of connector 6 tightly wraps around each male pin after insertion, preventing blood from seeping into the contact point and causing corrosion or short circuits. The multi-lumen microcatheter 7 is then completely withdrawn, leaving only the implanted connector 6, the front branch electrode, and the rear branch electrode in the body.

[0094] Step 5: Insert the receiver subcutaneously behind the ear

[0095] Make a 2-3cm incision along the postauricular fold and create a small subcutaneous pouch between the subcutaneous tissue and the fascia layer. Place the receiving device 2 into the subcutaneous pouch and fix it in place, for example, by fixing the receiving device to the fascia layer with absorbable sutures.

[0096] Using a tunneling device, a subcutaneous tunnel with a diameter of 2-4 mm is created from the superficial temporal artery puncture point to the subcutaneous region behind the ear. The length of the subcutaneous tunnel is approximately 10-15 cm, which can be adjusted according to the individual's anatomical structure. After connecting the connector 6 in the middle meningeal artery at the distal end, the flexible connecting wire 3 emerges from the superficial temporal artery puncture point and travels along the subcutaneous tunnel to the receiving device 2 implanted under the skin behind the ear. To prevent the flexible connecting wire 3 from moving or bending at sharp angles in the subcutaneous tunnel, it can be fixed with absorbable sutures at intervals (e.g., 3-4 cm).

[0097] After implantation, a test command can be sent to the receiving device 2 implanted under the skin behind the ear via the flexible connecting wire 3 to measure the electrode-tissue interface impedance of each anterior and posterior signal acquisition channel. All channel impedances should be within a reasonable and consistent range (e.g., tens to thousands of ohms), which is direct evidence of successful electrical connection and proper electrode function. Furthermore, signal quality testing can be performed by recording baseline EEG signals; low-intensity electrical stimulation can be used to test the function of each electrode 12; wireless connectivity testing can be conducted on the signal transmitter and receiver; and if a micro-battery is provided, the status of the micro-battery in the receiving device 2 can be tested to ensure proper battery function.

[0098] After confirming that all components are functioning correctly, the multi-lumen microcatheter 7 and sheath are slowly withdrawn, and pressure is applied to the superficial temporal artery puncture site for hemostasis. Postoperatively, vascular ultrasound examination must be performed to confirm the absence of vascular injury or hematoma, neurological function assessment, wound care, antibiotic prophylaxis, and observation and monitoring. Targeted preventative measures should be taken for common complications, such as preoperative nitroglycerin patch application and intraoperative papaverine administration to prevent vasospasm. If vasospasm occurs during the procedure, the operation should be stopped and the patient allowed to recover.

[0099] Alternatively, an integrated molding solution can be adopted, where the connector 6, the front branch electrode, and the rear branch electrode are an inseparable whole before leaving the factory. This integrated structure is precisely folded and placed inside the microcatheter 7, and delivered into the middle meningeal artery under the guidance of the microguidewire. This eliminates the risk of mechanical failure during intravascular docking.

Claims

1. A brain-computer interface system, characterized by, include, A flexible electrode array is minimally invasively implanted into the middle meningeal artery via a vascular interventional procedure through superficial temporal artery puncture. The flexible electrode array includes a first electrode branch, which is provided with at least one signal acquisition channel for capturing electroencephalogram (EEG) signals in the first branch of the middle meningeal artery. Each signal acquisition channel is provided with multiple electrodes. A receiving device implanted under the scalp, the receiving device being equipped with a signal transmitter; A flexible connecting wire, one end of which is electrically connected to the flexible electrode array, and the other end of which is electrically connected to the receiving device; An external device equipped with a signal receiver is provided, and the signal transmitter is used to wirelessly transmit the electroencephalogram (EEG) signals collected by the flexible electrode array to the signal receiver.

2. The brain-machine interface system of claim 1, wherein, Each signal acquisition channel of the first electrode branch includes an insulating flexible substrate, at least one power supply wire and at least one signal wire arranged in parallel on the surface of the flexible substrate, and each electrode, at least one power supply wire and at least one signal wire in each signal acquisition channel of the first electrode branch are electrically connected to each other.

3. The brain-machine interface system of claim 2, wherein, The flexible electrode array includes a second electrode branch, which has at least one signal acquisition channel for capturing electroencephalogram (EEG) signals in the second branch of the middle meningeal artery. Each signal acquisition channel of the second electrode branch has multiple electrodes. Each signal acquisition channel of the second electrode branch includes an insulating flexible substrate, at least one power supply wire and at least one signal wire arranged parallel to the surface of the flexible substrate. Each electrode, at least one power supply wire, and at least one signal wire in each signal acquisition channel of the second electrode branch are electrically connected.

4. The brain-machine interface system of claim 3, wherein, The flexible electrode array includes a third electrode branch, which has at least one signal acquisition channel for capturing electroencephalogram (EEG) signals from the third branch of the middle meningeal artery. Each signal acquisition channel of the third electrode branch has multiple electrodes. Each signal acquisition channel of the third electrode branch includes an insulating flexible substrate, at least one power wire and at least one signal wire arranged parallel to the surface of the flexible substrate. Each electrode in each signal acquisition channel of the third electrode branch, the at least one power wire, and the at least one signal wire are electrically connected to each other.

5. The brain-machine interface system of claim 4, wherein, The first branch and the second branch are selected from the frontal branch of the anterior branch of the middle meningeal artery, the top branch of the anterior branch of the middle meningeal artery, the first trunk of the posterior branch of the middle meningeal artery, the second trunk of the posterior branch of the middle meningeal artery, or the accessory meningeal branch.

6. The brain-machine interface system of claim 3 or 4, wherein, Each signal acquisition channel of each electrode branch is connected to a common connector at its proximal end. One end of the flexible connecting wire is electrically connected to the connector, and the other end is electrically connected to the receiving device along a subcutaneous tunnel established from the superficial temporal artery puncture point to the subcutaneous region behind the ear.

7. The brain-machine interface system of claim 6, wherein, The connector is located in the subcutaneous tissue layer near the puncture point of the middle meningeal artery or the superficial temporal artery.

8. The brain-computer interface system according to claim 6, characterized in that, The connector has an anchoring structure on its outer peripheral surface, which is selected from barbs or hook-shaped protrusions with a size of 50 to 100 micrometers.

9. A brain-computer interface system, characterized in that, The brain-computer interface system includes a flexible electrode array, which includes a first electrode branch. The first electrode branch is provided with at least one signal acquisition channel for capturing electroencephalogram (EEG) signals in the first branch of the middle meningeal artery. Each signal acquisition channel is provided with multiple electrodes. The flexible electrode array is minimally invasively implanted into at least one branch of the middle meningeal artery or at least one sub-branch of the at least one branch via vascular interventional procedure through superficial temporal artery puncture.

10. The brain-computer interface system according to claim 9, characterized in that, The flexible electrode array enters the middle meningeal artery retrogradely via the superficial temporal artery via the following path: superficial temporal artery → maxillary artery → main trunk of middle meningeal artery → frontal branch of the anterior branch of the middle meningeal artery, top branch of the anterior branch of the middle meningeal artery, first main trunk of the posterior branch of the middle meningeal artery, second main trunk or accessory meningeal branch of the posterior branch of the middle meningeal artery.

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