Brain-computer interface apparatus and mounting method

Abstract

The present application relates to a brain-computer interface apparatus and a mounting method. An interface base is provided with a through channel, a bottom support being provided on the inner wall of the through channel, and a top support being formed on the upper edge of the interface base. A grate is mounted on the interface base and supported on the bottom support, the center of the grate being provided with grate holes distributed in an array. A microneedle assembly comprises a microneedle base and a microneedle mechanism. The microneedle base is mounted on the grate, the center of the microneedle base being provided with microneedle guide holes distributed in an array. The microneedle mechanism is mounted on the microneedle base, microneedles of the microneedle mechanism successively passing through the microneedle guide holes, the grate holes, and the through channel of the interface base. The diameter of the grate holes is greater than that of the microneedle guide holes. The present application improves the mechanical stability of the microneedles, and ensures the reliability of microneedle implantation.

Description

A brain-computer interface device and its installation method Technical Field

[0001] This application relates to the field of human-computer interaction technology, and in particular to a brain-computer interface device and its installation method. Background Technology

[0002] Brain-computer interface is a technology that enables human-computer interaction by directly reading brain signals and input signals through external devices. It can be applied to medical rehabilitation, neuroscience research, and intelligent control.

[0003] Existing brain-computer interfaces can be mainly divided into invasive brain-computer interfaces and non-invasive brain-computer interfaces.

[0004] Non-invasive brain-computer interfaces (BCIs) refer to technologies that acquire electrical signals from the brain through an electrode array placed on the surface of a biological tissue, such as the scalp, to achieve human-computer interaction without cutting into biological tissues such as the skull or implanting electrodes inside the brain. Compared to invasive BCIs, they are safer, simpler, and easier to operate. However, their signal quality is lower, and they are more susceptible to external interference, leading to more complex signal processing.

[0005] Invasive brain-computer interfaces (BCIs) are technologies that insert electrodes or probes into relevant tissues of a biological organism, such as the cerebral cortex, to obtain neural signals. Compared to non-invasive BCIs, invasive BCIs offer higher signal accuracy and stability, provide better control precision and response speed, and enable more complex motor and interactive tasks.

[0006] Existing invasive brain-computer interface technologies have some drawbacks.

[0007] For example, because probes are usually thin, they may face mechanical stability problems during implantation or long-term use in biological tissues such as brain tissue, such as probe breakage or displacement, which reduces the reliability of the probe.

[0008] For example, probes may cause some degree of mechanical damage in biological tissues such as brain tissue, leading to problems such as local tissue inflammation and glial cell proliferation, which in turn affects signal quality and reduces long-term stability.

[0009] In addition, more probes are needed to collect more signals, while traditional implantation methods require implanting single probes one by one, which is time-consuming and labor-intensive. Summary of the Invention

[0010] This application provides a brain-computer interface device and installation method to solve the problem of low probe reliability in related technologies.

[0011] In a first aspect, a brain-computer interface device is provided, comprising:

[0012] An interface base has a through channel, and the inner wall of the through channel is provided with a bottom support, and the upper edge of the interface base forms a top support;

[0013] A grate is installed on the interface base and supported on the base support. The grate has an array of grate holes in the middle.

[0014] The microneedle assembly includes a microneedle base and a microneedle mechanism. The microneedle base is mounted on the grate and has microneedle guide holes arranged in an array in its middle. The microneedle mechanism is mounted on the microneedle base and its microneedles pass through the microneedle guide holes, the grate holes and the through-channel of the interface base in sequence.

[0015] Furthermore, the diameter of the grate holes is larger than the diameter of the microneedle guide holes.

[0016] In some embodiments, an interface guide portion extending along the axial direction of the base is provided on the inner wall of the interface base;

[0017] The side wall of the grate is provided with a grate guide that is adapted to the interface guide;

[0018] The microneedle base has a microneedle guide portion on its side wall that is adapted to the comb guide portion.

[0019] In some embodiments, there are at least two interface guides;

[0020] At least one of the interface guide portions is a guide portion with a constant diameter along the axial direction of the base;

[0021] At least one of the interface guides is a guide with a variable diameter along the axial direction of the base, and the bottom diameter of the interface guide is larger than the top diameter.

[0022] In some embodiments, the interface guide portion is a groove formed by a recess in the inner wall of the interface base, or a column formed by a protrusion.

[0023] In some embodiments, the interface base is further provided with an ear socket;

[0024] And / or, the interface base is also equipped with a top cover.

[0025] In some embodiments, the brain-computer interface device further includes a communication component, which includes a communication module connected to the microneedle mechanism.

[0026] In some embodiments, a microneedle guide portion is provided on the side wall of the microneedle base;

[0027] The communication module sidewall is provided with a communication module guide that is adapted to the microneedle guide.

[0028] In some embodiments, the communication module is provided with a temporary fixing slot for temporary fixation on the implantation device.

[0029] In some embodiments, the microneedle mechanism includes:

[0030] A microneedle mounting plate, wherein a slot is formed on the inner wall of the microneedle mounting plate;

[0031] A microneedle array structure is mounted on the slot and is used for electrical connection with the communication module. The microneedle array structure has a row of microneedles spaced apart.

[0032] In some embodiments, the microneedle mounting plate is provided with a plurality of slot groups, each of the slot groups including slots located on two opposite inner walls of the microneedle mounting plate;

[0033] The two ends of the microneedle array structure are respectively secured to the two slots of the slot group.

[0034] In some embodiments, the microneedle mechanism further includes an integrated circuit chip and a microstrip line for electrical connection with a communication module;

[0035] The microneedle array structure is connected to the integrated circuit chip, and the microneedle array structure is secured to the slot via the integrated circuit chip.

[0036] The microstrip line is electrically connected to the integrated circuit chip.

[0037] In some embodiments, a microneedle guide portion is provided on the side wall of the microneedle base;

[0038] The microneedle mounting plate has a mounting plate guide portion on its side wall that is adapted to the microneedle guide portion.

[0039] In some embodiments, the microneedle guide portion is formed by the sidewall of the microneedle base being recessed toward the side where the microneedle guide hole is located;

[0040] The mounting plate guide portion is formed by the side wall of the microneedle mounting plate being recessed towards the central region of the microneedle mounting plate;

[0041] The microneedle base is provided with a first mounting auxiliary hole corresponding to the guide portion of the mounting plate.

[0042] In some embodiments, the microneedle mechanism further includes an installation auxiliary component, which includes a retainer and a guide rod with one end for insertion into the first installation auxiliary hole and the other end for engaging with the guide portion of the mounting plate, the retainer being detachably fitted onto the guide rod.

[0043] In some embodiments, the ferrule includes a sleeve and an operating portion connected to the sleeve, the sleeve having an opening along its axial direction to make the sleeve C-shaped.

[0044] In some embodiments, the microneedle mounting plate is further provided with a second mounting auxiliary hole for connecting the implantation device.

[0045] In some embodiments, the microneedle array structure includes hard needles and soft needles for connection to a communication module. The soft needles are fixed to the surface of the hard needles by a fixing structure made of a biodegradable biocompatible material.

[0046] In some embodiments, the hard needle includes a hard needle tail and at least one hard needle body electrode formed on the hard needle tail;

[0047] The soft needle includes a soft needle tail and at least one soft needle body electrode formed on the soft needle tail;

[0048] The microneedle includes a soft needle electrode and a hard needle electrode that are fixed to each other.

[0049] In some embodiments, the tip of the soft needle electrode is provided with barbs.

[0050] In some embodiments, the biodegradable biocompatible material includes one or more of silk fibroin, spider fibroin, gelatin, and PEG.

[0051] Secondly, embodiments of this application provide a method for installing the brain-computer interface device as described above, comprising:

[0052] Install the interface base, grate, and microneedle assembly in sequence.

[0053] In some embodiments, after installing the interface base and before installing the grate, the installation method further includes:

[0054] A positioning component is installed in the interface base;

[0055] Take photos to obtain images of blood vessel distribution;

[0056] Based on the blood vessel distribution image, the microneedle assembly is trimmed to remove the microneedles corresponding to the blood vessel locations;

[0057] Remove the positioning component.

[0058] In some embodiments, the positioning component includes:

[0059] The positioning filter has crisscrossing grid lines in its center. The intersection of the grid lines corresponds to the center of the comb holes and the center of the microneedle guide holes.

[0060] In some embodiments, the inner wall of the interface base is provided with an interface guide portion extending along the axial direction of the base support, and the side wall of the positioning filter is provided with a filter guide portion adapted to the interface guide portion.

[0061] And / or, the positioning component further includes a clamping clip, and the positioning filter has a first clamping hole adapted to the clamping clip;

[0062] And / or, the material of the positioning filter is polymethyl methacrylate (PMMA), polycarbonate (PC), multilayer dielectric film, calcium fluoride, or magnesium fluoride;

[0063] And / or, the material of the grid scale lines is chromium, indium tin oxide, gold, or platinum;

[0064] And / or, the etching depth of the grid scale lines is 1-3 μm;

[0065] And / or, the line width of the grid scale lines is greater than the resolution of the near-infrared imaging system used to capture the image;

[0066] And / or, the positioning component further includes a near-infrared imaging system for capturing images.

[0067] In some embodiments, after installing the grate and before installing the microneedle assembly, the installation method further includes:

[0068] Install a pre-drilled kit on the grate;

[0069] Based on the blood vessel distribution image, the pre-drilling kit is used to drill holes while avoiding blood vessels;

[0070] After drilling is complete, remove the pre-drilled kit.

[0071] In some embodiments, the pre-drilled kit includes:

[0072] The needle plate has needle holes in its center that correspond one-to-one with the center positions of the holes in the comb.

[0073] A needle assembly comprising multiple punching needles;

[0074] The pressing assembly includes a pressure plate for pressing down the punching needle, and a pressure rod connected at one end to the pressure plate.

[0075] In some embodiments, a grate guide portion is provided on the side wall of the grate, and a needle plate guide portion adapted to the grate guide portion is provided on the side wall of the needle plate;

[0076] And / or, the material of the punching needle is selected from stainless steel, titanium alloy or tungsten;

[0077] And / or, the needle plate is made of stainless steel, titanium, titanium-aluminum-vanadium alloy, nickel-titanium alloy, cobalt-chromium alloy or polyetheretherketone (PEEK).

[0078] And / or, the needle plate is provided with a second clamping hole;

[0079] And / or, the size of the pressure plate is configured to cover a portion or all of the pinholes on the needle plate.

[0080] In some embodiments, the pressing assembly further includes a housing, the pressure plate is located inside the housing, and the pressure rod is threadedly connected to the housing to adjust the position of the pressure plate inside the housing;

[0081] The outer wall of the pressure rod is also provided with scale lines.

[0082] In some embodiments, the bottom of the pressure plate is provided with an array of punch mounting holes;

[0083] The pressure rod includes connecting rods, connecting plates, and pressing parts. Multiple connecting rods are connected at one end to the periphery of the pressure plate and at the other end to the periphery of the connecting plate. The pressing parts are installed on the connecting plate.

[0084] In some embodiments, the needle assembly has multiple different specifications, and the punching needle of each needle assembly has a different length;

[0085] And / or, the connecting rod is detachably connected to the pressure plate, the pressure plate has various different specifications, and the hole depth of the punch mounting hole of each pressure plate is different;

[0086] And / or, the size of the pressure plate is configured to cover a portion of the pinholes on the needle plate; or the side wall of the grate is provided with a grate guide, the size of the pressure plate is configured to cover all the pinholes on the needle plate, and the side wall of the pressure plate is provided with a pressure plate guide that is adapted to the grate guide.

[0087] The beneficial effects of the technical solution provided in this application include:

[0088] In the brain-computer interface device provided in this application, the microneedle passes sequentially from top to bottom through the through-channel of the microneedle guide hole, the comb hole, and the interface base before entering the relevant tissue of the organism. Because the diameter of the comb hole is larger than that of the microneedle guide hole, the size of the holes in each layer decreases progressively from bottom to top. The uppermost microneedle guide hole is designed to be as close as possible to the size of the microneedle, enabling it to play a positioning and guiding role during microneedle implantation, ensuring high precision in implantation location. Since the microneedle may tilt during processing, assembly, and implantation, the design of enlarging the lower comb hole ensures that even if the microneedle tilts slightly while passing through the implantation channel from top to bottom, the larger lower hole acts as a buffer zone. This buffer zone cushions the microneedle when it tilts, making it less likely for the microneedle to deform or break due to contact with the sidewall of the comb hole, thus improving the mechanical stability of the microneedle.

[0089] It is evident that the multi-layered pore size design of this application, which gradually increases from top to bottom, ensures the reliability of microneedle implantation. Attached Figure Description

[0090] To more clearly illustrate the technical solutions in the embodiments of this application, the accompanying drawings used in the description of the embodiments will be briefly introduced below. Obviously, the accompanying drawings described below are only some embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0091] Figure 1 is an exploded view of the brain-computer interface device provided in an embodiment of this application;

[0092] Figure 2 is a schematic diagram of the interface base provided in an embodiment of this application;

[0093] Figure 3 is a schematic diagram of the comb provided in an embodiment of this application;

[0094] Figure 4 is a schematic diagram of the microneedle assembly provided in an embodiment of this application;

[0095] Figure 5 is a schematic diagram of the microneedle base provided in an embodiment of this application;

[0096] Figure 6 is a schematic diagram of the microneedle mounting plate provided in an embodiment of this application;

[0097] Figure 7 is a schematic diagram of the microneedle mechanism provided in an embodiment of this application;

[0098] Figure 8 is a schematic diagram of the assembly of the microneedle base and the microneedle mounting plate provided in the embodiment of this application;

[0099] Figure 9 is a schematic diagram of the implantation device provided in an embodiment of this application;

[0100] Figure 10 is a schematic diagram of the microneedle array structure provided in the embodiment of this application (when torn up);

[0101] Figure 11 is a schematic diagram of the microneedle array structure provided in the embodiment of this application (when bonded);

[0102] Figure 12 is a schematic diagram of the barb provided in an embodiment of this application;

[0103] Figure 13 is a schematic diagram of the installation of an integrated circuit chip according to an embodiment of this application;

[0104] Figure 14 is a schematic diagram of the fixing structure provided in an embodiment of this application;

[0105] Figure 15 is a schematic diagram of the cutting soft needle electrode provided in an embodiment of this application;

[0106] Figure 16 is a schematic diagram of the flip-soldering of an integrated circuit chip provided in an embodiment of this application;

[0107] Figure 17 is a schematic diagram of the installation and positioning components provided in an embodiment of this application;

[0108] Figure 18 is a schematic diagram of the positioning component provided in an embodiment of this application;

[0109] Figure 19 is a schematic diagram of the installation grate provided in an embodiment of this application;

[0110] Figure 20 is a schematic diagram of the pre-drilled installation kit provided in an embodiment of this application;

[0111] Figure 21 is a schematic diagram of a pre-drilled kit provided in an embodiment of this application;

[0112] Figure 22 is a schematic diagram of Figure 21 from another perspective;

[0113] Figure 23 is a schematic diagram of another pre-drilled kit provided in an embodiment of this application;

[0114] Figure 24 is a schematic diagram of the pressing component provided in an embodiment of this application.

[0115] In the diagram: 1. Interface base; 10. Base support; 11. Interface guide; 12. Ear seat; 13. Top support; 14. Top cover; 15. Elevating block; 2. Grate; 20. Grate hole; 21. Grate guide; 3. Microneedle assembly; 30. Microneedle base; 300. Microneedle guide hole; 301. Microneedle guide; 302. First mounting auxiliary hole; 31, microneedle mechanism; 310, microneedle; 311, microneedle mounting plate; 3110, slot; 3111, mounting plate guide; 3112, second mounting auxiliary hole; 312, microneedle array structure; 3120, hard needle; 31200, hard needle tail; 31201, hard needle body electrode; 3121, soft needle; 31210, soft needle tail; 31211, soft needle body electrode; 31212, barb; 3122, fixing structure; 313, integrated circuit chip; 314, microstrip line; 315, mounting auxiliary component; 3150, guide rod; 3151, ferrule; 31510, sleeve; 31511, operating part; 4, communication component; 40, communication module; 400, communication module guide; 401, temporary fixing slot; 41, battery; 5. Implantation device; 50. Implantation plate; 500. Second elastic claw; 51. Implantation rod; 510. First elastic claw; 52. Main rod; 53. Limiting sleeve; 54. Multi-joint arm; 6. Positioning assembly; 60. Positioning filter; 601. Filter guide; 602. First clamping hole; 61. Clamping clip; 7. Pre-drilled kit; 70. Needle plate; 700. Needle hole; 701. Needle plate guide; 702. Second clamping hole; 71. Punching needle; 72. Pressure plate; 720. Punching needle mounting hole; 721. Pressure plate guide; 73. Pressure rod; 730. Connecting rod; 731. Connecting plate; 732. Pressing part; 74. Housing. Detailed Implementation

[0116] To make the objectives, technical solutions, and advantages of the embodiments of this application clearer, the technical solutions of the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this application, not all embodiments. Based on the embodiments of this application, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this application.

[0117] Referring to Figures 1, 2, 3, 4 and 5, this application provides a brain-computer interface device, which includes an interface base 1, a comb 2 and a microneedle assembly 3.

[0118] The interface base 1 has a through channel to form a hollow cylindrical structure. The inner wall of the through channel is provided with a bottom support 10 to support the parts to be installed later. The upper edge of the interface base 1 has a top support 13. The outer diameter of the top support 13 is larger than the opening diameter of the biological tissue such as the skull, so that the interface base 1 can be placed at the opening of the biological tissue such as the skull.

[0119] The comb 2 is installed on the interface base 1 and supported on the base 10. The middle part of the comb 2 is provided with comb holes 20 arranged in an array to serve as channels for microneedle implantation.

[0120] The microneedle assembly 3 includes a microneedle base 30 and a microneedle mechanism 31. The microneedle base 30 is mounted on the grate 2, and the center of the microneedle base 30 is provided with microneedle guide holes 300 arranged in an array. The microneedle mechanism 31 is mounted on the microneedle base 30, and the microneedles 310 of the microneedle mechanism 31 pass through the microneedle guide holes 300, the grate holes 20 and the through channels of the interface base 1 in sequence.

[0121] The center of the microneedle guide hole 300 corresponds one-to-one with the center of the grate hole 20, and the diameter of the grate hole 20 is larger than the diameter of the microneedle guide hole 300.

[0122] In the brain-computer interface device provided in this application, the microneedle 310 passes sequentially from top to bottom through the through-channel of the microneedle guide hole 300, the comb hole 20, and the interface base 1 before entering the relevant biological tissue, such as brain tissue. Because the diameter of the comb hole 20 is larger than the diameter of the microneedle guide hole 300, the size of the holes in each layer decreases progressively from bottom to top. The uppermost microneedle guide hole 300 is designed to be as close as possible in size to the microneedle 310, enabling it to play a positioning and guiding role during microneedle implantation, ensuring high precision in the implantation location. Since the microneedle processing, assembly, and implantation process may result in a certain degree of tilting, the design scheme of enlarging the lower grate hole 20 is to ensure that even if the microneedle tilts slightly when passing through the implantation channel from top to bottom, the extra hole space in the lower layer becomes a buffer area because the lower hole is larger than the upper hole. This buffer area plays a buffering role when the microneedle tilts, making it less likely for the microneedle to deform or break due to contact with the side wall of the grate hole 20, thus improving the mechanical stability of the microneedle.

[0123] As can be seen, the multi-layered hole size gradually increases from top to bottom in this application ensures the reliability of microneedle implantation and can reduce the deviation of implantation position caused by possible errors in the microneedle assembly process or implantation angle.

[0124] It is understood that the material of the interface base 1 can be selected from medical metals or plastics such as stainless steel, titanium, titanium-aluminum-vanadium alloy, nickel-titanium alloy, cobalt-chromium alloy, and polyetheretherketone (PEEK).

[0125] It is understood that the shape of the interface base 1 can be selected according to actual needs, including but not limited to a circle, and preferably a circle. Adaptively, the grate 2 and the microneedle base 30 are also preferably circular. Adaptively, the bottom support 10 and the top support 13 can form a ring.

[0126] Understandably, in order to facilitate assembly, prevent microneedles from being difficult to penetrate due to misalignment, and prevent adverse effects caused by misalignment between parts during long-term use, as shown in Figure 2, the inner wall of the interface base 1 is provided with an interface guide portion 11 extending along the axial direction of the base support 10; as shown in Figure 3, the side wall of the grate 2 is provided with a grate guide portion 21 that matches the interface guide portion 11; as shown in Figure 5, the side wall of the microneedle base 30 is provided with a microneedle guide portion 301 that matches the grate guide portion 21.

[0127] Specifically, referring to Figure 2, the interface guide 11 can be a column protruding from the inner wall of the interface base 1 and located on the inner wall; correspondingly, for the assembly of subsequent components, referring to Figure 3, the grate guide 21 is formed by the side wall of the grate 2 recessed towards the side where the grate hole 20 is located, so that the outer wall of the grate guide 21 forms a groove, which is adapted to the interface guide 11, while the inner wall of the grate guide 21 forms a column; correspondingly, referring to Figure 5, the microneedle guide 301 is formed by the side wall of the microneedle base 30 recessed towards the side where the microneedle guide hole 300 is located, so that the outer wall of the microneedle guide 301 forms a groove, which is adapted to the column of the grate guide 21, while the inner wall of the microneedle guide 301 forms a column.

[0128] The interface guide 11 can also be a groove formed by the recess of the inner wall of the interface base 1. In this case, the grate guide 21 and the microneedle guide 301 can be adjusted adaptively.

[0129] Referring to Figure 2, there are at least two interface guide parts 11. At least one of the interface guide parts 11 is a guide part with a constant diameter along the axial direction of the base 10; at least the other interface guide part 11 is a guide part with a variable diameter along the axial direction of the base 10, and the bottom diameter of the interface guide part 11 is larger than the top diameter. The combination of the two types of interface guide parts takes into account both the requirements of high-precision guidance and stable installation, which is beneficial for alignment and fixation during subsequent component installation.

[0130] The axial direction of each interface guide 11 is consistent with the axial direction of the base 10 (or the axial direction of the interface base 1). Some of the interface guides 11 have the same outer diameter of each cross section from top to bottom along the axial direction, while the outer diameter of each cross section of other interface guides 11 is different from top to bottom, and the outer diameter becomes smaller as you go up.

[0131] A constant-diameter interface guide 11 helps provide higher guiding accuracy, while designing a variable-diameter interface guide 11 offers the following advantages: First, it helps to fix the bottom of the interface guide 11. The thicker lower portion provides a larger contact area, making the interface guide 11 more stable at the bottom and less prone to loosening or displacement. A larger diameter also means greater torsional resistance, which is especially important when the interface guide 11 is subjected to lateral or torsional forces. Second, the thicker lower portion design optimizes stress distribution, avoiding material fatigue or cracking due to excessive local stress, which helps extend the service life of the interface guide 11 during long-term use. Third, it reduces the overall weight of the interface guide 11 while maintaining structural strength. Fourth, it facilitates installation and fastening, reducing installation errors and ensuring good positioning accuracy of the interface guide 11 during use.

[0132] It is understood that the aforementioned equal-diameter interface guides 11 can be arranged in pairs symmetrically, and similarly, the aforementioned variable-diameter interface guides 11 can be arranged in pairs symmetrically.

[0133] Referring to Figure 2, the interface base 1 is also provided with an ear seat 12. The ear seats 12 can appear in pairs. The ear seats 12 are used to provide fixing points for bolts to fix the brain-computer interface device to biological tissues such as the skull.

[0134] As shown in Figure 1, the interface base 1 is also equipped with a top cover 14. After all the components are installed, the top cover 14 is finally installed on the interface base 1 to protect the internal components.

[0135] Referring to Figures 1 and 4, the brain-computer interface device further includes a communication component 4, which comprises a communication module 40 and a battery 41. The communication module 40 is connected to the battery 41 and the microneedle mechanism 31. By setting up the communication module 40, wireless transmission of acquired signals is realized. The battery 41 provides power to the communication module 40. The battery 41 can be installed in different locations, such as the head implantation site of the brain-computer interface, the chest, or behind the ear.

[0136] Referring to Figures 6 and 7, the microneedle mechanism 31 includes a microneedle mounting plate 311 and a microneedle array structure 312. The microneedle mounting plate 311 can be mounted on the microneedle base 30. The outer periphery of the microneedle mounting plate 311 can be circular to fit the microneedle base 30, or it can be other shapes such as square as shown in Figure 6. The center of the microneedle mounting plate 311 is hollowed out to form a ring. A slot 3110 is provided on the inner wall of the microneedle mounting plate 311. The microneedle array structure 312 is snapped into the slot 3110 to realize the installation and fixation of the microneedle array structure 312. The microneedle array structure 312 is electrically connected to the communication module 40. The microneedle array structure 312 has a row of microneedles 310 distributed at intervals.

[0137] In the microneedle mechanism 31 provided in this application, a row of multiple microneedles 310 is provided on the microneedle array structure 312, which can be 4, 8, 16, 32 or more. During installation, each microneedle 310 passes through the microneedle guide hole 300 of the microneedle base 30 to enter the relevant tissues of the organism, such as brain tissue. It can be seen that the microneedle array used in this application can realize multi-channel, high-throughput bidirectional neural signal acquisition and regulation.

[0138] Furthermore, during implantation, multiple grafts are implanted in an array at once, which significantly improves implantation efficiency compared to implanting grafts one by one.

[0139] To improve the fixed installation effect of the microneedle array structure 312, simplify the component structure, and reduce production costs, as shown in Figure 6, the microneedle mounting plate 311 is provided with several slot groups. Each slot group includes slots 3110 located on two opposite inner walls of the microneedle mounting plate 311. The two ends of the microneedle array structure 312 are respectively engaged in the two slots 3110 of the slot group. The two ends of the two microneedle array structures 312 are respectively engaged in the two slots 3110, which can ensure the fixed installation effect without affecting the arrangement of the microneedles 310 in the middle position.

[0140] Referring to Figures 4 and 7, multiple slot groups can be set, and one slot group corresponds to one microneedle array structure 312. Each microneedle array structure 312 has a column of multiple microneedles 310, so that the microneedle mechanism 31 can contain multiple rows and columns of microneedles 310.

[0141] Referring to Figures 4 and 7, the microneedle mechanism 31 further includes an integrated circuit chip 313 and a microstrip line 314; the microneedle array structure 312 is connected to the integrated circuit chip 313, and the microneedle array structure 312 is secured to the slot 3110 via the integrated circuit chip 313; the communication module 40 is electrically connected to the integrated circuit chip 313 via the microstrip line 314. By using the built-in digital signal processor, i.e., the integrated circuit chip 313, local digitization can be achieved, which helps reduce the transmission loss of neural signals and improve the signal-to-noise ratio.

[0142] To facilitate assembly, prevent microneedles from failing to penetrate due to misalignment, and prevent adverse effects caused by misalignment between parts during long-term use, as shown in Figures 5 and 6, a microneedle guide portion 301 is provided on the side wall of the microneedle base 30; and a mounting plate guide portion 3111 adapted to the microneedle guide portion 301 is provided on the side wall of the microneedle mounting plate 311.

[0143] Adapted to the aforementioned comb guide 21, the microneedle guide 301 can be formed by recessing the side wall of the microneedle base 30 toward the side where the microneedle guide hole 300 is located, such that the outer wall of the microneedle guide 301 forms a groove, which is adapted to the column of the comb guide 21, while the inner wall of the microneedle guide 301 forms a column. Adapted, the mounting plate guide 3111 can be formed by recessing the side wall of the microneedle mounting plate 311 toward the central region of the microneedle mounting plate 311, such that the side wall of the mounting plate guide 3111 forms a groove, which is adapted to the column of the microneedle guide 301.

[0144] Similarly, the microneedle guide 301 can also be formed by the side wall of the microneedle base 30 protruding away from the side where the microneedle guide hole 300 is located, so that the inner wall of the microneedle guide 301 forms a groove. At this time, the mounting plate guide 3111 is formed by the side wall of the microneedle mounting plate 311 protruding away from the middle, so that the side wall of the mounting plate guide 3111 forms a column, which is adapted to the groove of the microneedle guide 301.

[0145] To facilitate the installation of the microneedle mechanism 31 on the microneedle base 30, as shown in Figure 5, the microneedle guide portion 301 is formed by the side wall of the microneedle base 30 recessed toward the side where the microneedle guide hole 300 is located; the mounting plate guide portion 3111 is formed by the side wall of the microneedle mounting plate 311 recessed toward the central region of the microneedle mounting plate 311; a first mounting auxiliary hole 302 is provided on the microneedle base 30 corresponding to the mounting plate guide portion 3111. As can be seen from Figure 5, the first mounting auxiliary hole 302 can actually be provided on the microneedle guide portion 301.

[0146] The aforementioned first mounting auxiliary hole 302 is used in conjunction with the mounting auxiliary component 315.

[0147] Referring to Figures 4, 6 and 8, the microneedle mechanism 31 further includes an installation auxiliary component 315. The installation auxiliary component 315 includes a sleeve 3151 and a guide rod 3150, one end of which is inserted into the first installation auxiliary hole 302 and the other end of which is inserted into the guide portion 3111 of the mounting plate. The guide rod 3150 can be a screw or the like. The sleeve 3151 is detachably fitted onto the guide rod 3150.

[0148] The aforementioned first mounting auxiliary hole 302 can be provided in multiple locations around the perimeter, such as four in Figure 6.

[0149] During installation, the guide rod 3150 is inserted from the guide portion 3111 of the mounting plate into the first mounting auxiliary hole 302 connected to the lower microneedle base 30. The top of the retainer 3151 on the guide rod 3150 presses against the microneedle mounting plate 311, and the bottom is supported on the microneedle guide portion 301. The microneedle mounting plate 311 and the lower microneedle base 30 can be temporarily connected together by the surrounding mounting auxiliary components 315. Here, the mounting auxiliary components 315 serve to support the microneedle mounting plate 311. When the retainer 3151 is installed, the microneedle array structure 312 maintains a certain distance from the microneedle base 30, so that the tip of the microneedle 310 can only just penetrate the microneedle guide hole 300 of the microneedle base 30. When microneedle cutting and microneedle implantation are required, after removing the ferrule 3151, the microneedle mounting plate 311 can be pulled by the implantation device and pushed downward along the guide rod 3150 until the microneedle 310 completely passes through the microneedle guide hole 300. After the mounting plate guide part 3111 around the microneedle mounting plate 311 matches and is fixed with the microneedle guide part 301 of the microneedle base 30, the guide rod 3150 can be removed.

[0150] Referring to Figure 4, the ferrule 3151 includes a sleeve 31510 and an operating part 31511 connected to the sleeve 31510. The sleeve 31510 has an opening along its axial direction, so that the sleeve 31510 is C-shaped. The diameter of the guide rod 3150 is larger than the opening of the sleeve 31510. By pulling the operating part 31511 outward, the guide rod 3150 opens the opening of the sleeve 31510, thereby removing the ferrule 3151.

[0151] To facilitate microneedle implantation, as shown in Figures 1, 6 and 9, the microneedle mounting plate 311 is also provided with a second mounting auxiliary hole 3112 for connecting the implantation device 5.

[0152] The implantation device 5 includes an implantation plate 50. The bottom of the implantation plate 50 is provided with a plurality of implantation rods 51 for insertion into the second installation auxiliary hole 3112. The top of the implantation plate 50 is provided with a main rod 52. A limiting sleeve 53 is sleeved on the main rod 52. A multi-joint arm 54 is provided on the limiting sleeve 53.

[0153] In use, the implant rod 51 is inserted into the second mounting auxiliary hole 3112 on the microneedle mounting plate 311, and the multi-joint arm 54 is fixed in a position such as an operating table to ensure that the limiting sleeve 53 is fixed in place. The limiting sleeve 53 limits the main rod 52 in the horizontal direction, and then the main rod 52 is driven to move down, thereby pushing the microneedle mounting plate 311 down, so as to realize the microneedle implantation.

[0154] As shown in Figure 9, the bottom of the implantation rod 51 is provided with a plurality of first elastic claws 510. Through the cooperation of the first elastic claws 510, the implantation rod 51 and the microneedle mounting plate 311 are temporarily fixed.

[0155] Since the microneedle array structure is connected to the communication module 40, in order to prevent the communication module 40 from moving during the implantation process and affecting the implantation, as shown in Figure 4, the communication module 40 is provided with a temporary fixing groove 401 for temporarily fixing to the implantation device 5. As shown in Figure 9, the bottom of the implantation plate 50 is provided with two opposing and spaced second elastic claws 500. When the microneedle is implanted, as shown in Figure 1, the communication module 40 is arranged vertically so that the two second elastic claws 500 are respectively engaged in the two temporary fixing grooves 401 on both sides of the communication module 40, so as to achieve the purpose of temporarily fixing the communication module 40.

[0156] After the microneedle implantation is completed, in order to prevent the communication module 40 from moving during subsequent long-term use, as shown in Figure 4, the communication module 40 is provided with a communication module guide 400 that is adapted to the microneedle guide 301 on its side wall.

[0157] Because hard probes may cause mechanical damage to biological tissues such as brain tissue, leading to problems such as local tissue inflammation and glial cell proliferation, which in turn affect signal quality and reduce long-term stability.

[0158] To address this issue, as shown in Figures 10 and 14, the microneedle array structure 312 provided in this application includes hard needles 3120 and soft needles 3121. The soft needles 3121 are fixed to the surface of the hard needles 3120 by a fixing structure 3122, which is made of a biodegradable biocompatible material. The communication module 40 is connected to the soft needles 3121.

[0159] This application employs a method of inserting a soft needle with a hard needle. Utilizing the high hardness of the hard needle, the soft needle is easily implanted along with it. After the soft needle is implanted, because the fixing structure 3122 is made of a biodegradable and biocompatible material, it dissolves under the action of biological tissues such as tissue fluid. Subsequently, the hard needle is removed, leaving only the soft needle in biological tissues such as brain tissue. Due to the low hardness of the soft needle, it is friendly to biological tissues such as brain tissue. Therefore, this application achieves minimally invasive implantation and effectively avoids damage caused by the hard needle during movement in biological tissues such as brain tissue.

[0160] Referring to Figure 10, the hard needle 3120 includes a hard needle tail 31200 and at least one hard needle body electrode 31201 formed on the hard needle tail 31200; the soft needle 3121 includes a soft needle tail 31210 and at least one soft needle body electrode 31211 formed on the soft needle tail 31210; the soft needle tail 31210 is fixed to the hard needle tail 31200, mainly by temporary adhesive fixation, and the soft needle body electrode 31211 is fixed to the hard needle body electrode 31201, mainly by fixation with a biodegradable biocompatible material; the microneedle 310 includes the soft needle body electrode 31211 and the hard needle electrode 31201 fixed to each other.

[0161] The fabrication method of the microneedle array structure 312 as a whole is as follows:

[0162] Step 1: As shown in Figure 11, a soft needle 3121 is fabricated on the hard needle 3120 using conventional MEMS technology. At this point, the soft needle is attached to the hard needle.

[0163] As shown in Figure 12, a barb 31212 is provided on the tip of the soft needle electrode 31211 to facilitate the removal of the hard needle after implantation and the long-term fixation of the soft needle.

[0164] Step 2: As shown in Figure 10, tear the soft needle 3121 from one corner of the soft needle tail 31210, leaving a portion of the needle tip of the soft needle body electrode 31211. The purpose is to maintain a high adhesive force at the needle tip of the soft needle body electrode 31211 for temporarily fixing the soft needle and the hard needle. The soft needle tail 31210 weakens the adhesive force to facilitate the removal of the hard needle after implantation.

[0165] Step 3: Reattach the soft needle 3121 to the hard needle 3120. If the part that was previously torn off cannot be glued back on, you can use glue or tape to fix it.

[0166] Step 4: Referring to Figure 13, solder the integrated circuit chip 313 and the soft needle tail 31210 of the soft needle 3121 together, and then cut off the excess part of the soft needle tail 31210. At this time, the positional relationship is that the integrated circuit chip 313 is soldered on the soft needle, and the hard needle is on the bottom layer.

[0167] Step 5: Referring to Figure 14, the needle tips of the microneedle array structure 312 are immersed in a biodegradable biocompatible material to form a fixing structure 3122 for fixation. This can also be achieved using a mold coating method. The biodegradable biocompatible material includes one or more of silk fibroin, spider silk fibroin, gelatin, and PEG.

[0168] Step 6: As shown in Figure 15, cut off the part of the soft needle body electrode 31211 that has not been torn off with a laser or other methods. Only remove the soft needle part on the hard needle, without cutting the hard needle. The laser path can be set to a curved path to ensure that the cut part has rounded corners.

[0169] Step 7: As shown in Figure 16, complete the flip soldering of microstrip line 314 and integrated circuit chip 313, and cut off the excess soft pins at the top to facilitate the removal of hard pins later.

[0170] The slot 3110 holds the integrated circuit chip 313, which is soldered to the soft needle 3121. The soft needle 3121 and the hard needle 3120 are fixed by their own adhesion and biodegradable biocompatible materials such as silk protein. Therefore, the microneedle array structure 312 can be fixed by holding the integrated circuit chip 313 in the slot 3110.

[0171] This application also provides a method for installing a brain-computer interface device, which includes the following steps: sequentially installing the interface base 1, the comb 2, and the microneedle assembly 3.

[0172] Specifically, after the surgery has been completed and the target brain region has been exposed through an opening in the skull or other relevant biological tissues, the implantation can be performed following these steps:

[0173] (1) As shown in Figure 17, use bolts or bone screws to temporarily fix the interface base 1 to the relevant tissue of the organism, such as the skull.

[0174] (2) Install the positioning component 6 in the interface base 1 and take a picture to obtain the distribution image of blood vessels in biological tissues such as the dura mater; based on the blood vessel distribution image, cut the microneedle component 3 to remove the microneedles 310 corresponding to the blood vessel positions; finally remove the positioning component 6.

[0175] Because blood vessels are distributed in biological tissues such as the subdural space, if they are not avoided during microneedle implantation, they may rupture and cause head injuries. Currently, the main method is to implant microneedles one by one, which requires the doctor's experience to determine the location of blood vessels and avoid them. However, this method is not accurate in locating blood vessels and is prone to errors. In addition, it is difficult to implant large numbers of microneedles at once, which reduces the implantation efficiency.

[0176] Therefore, this application first uses positioning component 6 to obtain images of blood vessel distribution, thereby identifying the blood vessel distribution in biological tissues such as the subdural space, and then adjusts microneedle component 3 to avoid important blood vessel locations and perform multiple microneedle implantation at once.

[0177] Specifically, in this application, referring to Figures 17 and 18, the positioning component 6 includes a positioning filter 60, the positioning filter 60 having intersecting grid lines in the middle, and the intersection of the grid lines corresponding to the center of the comb hole 20 and the center of the microneedle guide hole 300.

[0178] By capturing images and using the grid lines on the positioning filter 60 to precisely locate the areas where blood vessels need to be avoided, the microneedles that need to be cut can be determined. The corresponding microneedles are then cut off, thus achieving the goal of avoiding blood vessels in biological tissues such as the subdural space when the microneedle array is implanted, minimizing damage to biological tissues such as brain tissue and blood vessels.

[0179] Near-infrared light (700–2500 nm, short-wave near-infrared 700–1100 nm, long-wave near-infrared 1100–2500 nm) typically falls within the wavelength range of 700–900 nm. Human tissues absorb this light relatively poorly, allowing near-infrared light to penetrate deep into the skin and tissues, forming clear images. This wavelength range is known as the "bio-optical window." Within this range, the spectral absorption characteristics of hemoglobin exhibit significant differences: near-infrared light around 760 nm is highly sensitive to deoxyhemoglobin, while near-infrared light around 850 nm is more sensitive to oxyhemoglobin. Utilizing these wavelength characteristics, near-infrared imaging systems can detect differences in the levels of oxygenated and deoxyhemoglobin in the blood. By using filters and multi-wavelength excitation sources to capture images at different wavelengths, and by analyzing the light absorption characteristics of these images using algorithms, high-contrast vascular images can be generated.

[0180] Understandably, for ease of assembly and precise positioning, as shown in Figures 17 and 18, the inner wall of the interface base 1 is provided with an interface guide portion 11 extending along the axial direction of the base support 10, and the side wall of the positioning filter 60 is provided with a filter guide portion 601 that is adapted to the interface guide portion 11; by utilizing the cooperation between the filter guide portion 601 and the interface guide portion 11, precise installation and positioning can be achieved.

[0181] It is understood that if the interface guide portion 11 is a groove formed by the recess of the inner wall of the interface base 1, then the filter guide portion 601 is a column formed by the protrusion of the side wall of the positioning filter 60; if the interface guide portion 11 is a column formed by the protrusion of the inner wall of the interface base 1, then the filter guide portion 601 is a groove formed by the recess of the side wall of the positioning filter 60.

[0182] Since the interface base 1 is small, in order to facilitate the insertion or removal of the positioning filter 60, as shown in Figure 18, the positioning component 6 also includes a clamping clip 61. The positioning filter 60 is provided with a first clamping hole 602 that is adapted to the clamping clip 61. Furthermore, the first clamping holes 602 are arranged in pairs and symmetrically distributed on the positioning filter 60.

[0183] The first gripping hole 602 can be either a through hole or a semi-recessed hole to prevent the legs of the gripper 61 from protruding through the first gripping hole 602 and affecting biological tissues such as brain tissue.

[0184] The positioning filter 60 can be made of various materials, such as polymethyl methacrylate (PMMA), polycarbonate (PC), multilayer dielectric film, calcium fluoride, or magnesium fluoride, which meet the optical performance requirements.

[0185] The grid markings are made of black or dark-colored materials that have high absorption rates in the near-infrared band, creating a clear contrast. The grid markings can be relatively fine. Suitable materials include chromium, indium tin oxide, gold, or platinum.

[0186] The grid scale lines on the positioning filter 60 are processed by photolithography or laser etching to obtain a high-resolution and high-contrast grid pattern.

[0187] If the grid lines are drawn using etching, the etching depth also affects the imaging effect. Specifically, the etching depth determines the optical contrast between the grid lines and the surrounding area. Deeper grid lines generally produce more significant optical contrast, making the grid lines clearer in near-infrared imaging. However, excessively deep grid lines may lead to increased optical scattering, weakened mechanical strength of the filter, and increased risk of surface damage and cracks, which may affect the quality of vascular imaging. The etching depth of the grid lines is 1-3 μm, a range that provides sufficient optical contrast without significantly affecting the overall performance of the filter.

[0188] Taking all factors into consideration, in practical applications, to ensure that the grid lines can be clearly identified without affecting the imaging of blood vessels, the line width of the grid lines should be greater than the resolution of the near-infrared imaging system used to capture the image; for example, if the resolution of the imaging system is 50μm, the selected grid line width should be about 75μm. The specific selection should also be adjusted according to different application requirements.

[0189] The positioning component 6 also includes a near-infrared imaging system for capturing images.

[0190] (3) As shown in Figure 19, install the grate 2.

[0191] (4) Due to the presence of the dura mater, the existing approach is to remove the biological tissue, such as the dura mater, at the site where the microneedle array needs to be implanted for implantation. Although this method can successfully implant the microneedles, it requires removing the biological tissue, such as the dura mater, which is complex and inconvenient to operate. Removing a whole piece of biological tissue, such as the dura mater, may affect blood vessels, etc. At the same time, since it is a piece of biological tissue, such as the dura mater, it may cause significant damage to the entire biological tissue, such as the dura mater.

[0192] To simplify the operation and reduce damage to biological tissues such as the dura mater, this application provides a pre-drilled kit 7, which allows for drilling only at the location where microneedles need to be implanted in biological tissues such as the dura mater, without having to remove the biological tissues such as the dura mater.

[0193] Specifically, as shown in Figure 20, a pre-drilling kit 7 is installed on the grate 2. Based on the blood vessel distribution image, the pre-drilling kit 7 is used to drill holes in biological tissues such as the dura mater, avoiding blood vessels. After drilling is completed, the pre-drilling kit 7 is removed.

[0194] As shown in Figures 21, 22, 23, and 24, the pre-drilled kit 7 includes a needle plate 70, a needle assembly, and a pressing assembly. The needle plate 70 has needle holes 700 in the middle that correspond one-to-one with the center positions of the grate holes 20 of the grate 2. The needle assembly includes multiple punching needles 71. The pressing assembly includes a pressure plate 72 for pressing the punching needles 71 downwards, and a pressure rod 73 with one end connected to the pressure plate 72.

[0195] According to the vascular distribution map, the perforating needles 71 are arranged, and then the pressure plate 72 is moved down by pressing the pressure rod 73, so that multiple perforating needles 71 can be inserted into the relevant tissues of the organism, such as the dura mater, through the needle hole 700. After the perforation is completed, the pre-perforated kit 7 is removed.

[0196] Since the depth to which the perforating needle 71 can be inserted may vary depending on the specific tissue of different organisms, such as the brain, this application provides a variety of solutions to accommodate different insertion depths.

[0197] For example, as shown in Figures 21 and 22, the pressing assembly also includes a housing 74, with the pressure plate 72 located inside the housing 74. The diameter of the outer circle of the pressure plate 72 is smaller than the diameter of the inner circle of the housing 74. The pressure rod 73 is threadedly connected to the housing 74 to adjust the position of the pressure plate 72 inside the housing 74. The outer wall of the pressure rod 73 is also provided with scale lines.

[0198] Insert all the punching needles 71 into the needle hole 700. By rotating the pressure rod 73, adjust the position of the pressure plate 72 inside the housing 74. Mark the position of the pressure plate 72 with the scale lines to adjust the required insertion depth. After adjustment, press down to make the pressing component move down until it holds the needle plate 70 to achieve punching.

[0199] It is understandable that the aforementioned pressing component can press down all the microneedles at once to make holes, or it can press them down in batches to make holes. For example, as shown in Figure 21, the size of the pressure plate 72 is configured to cover a portion of the pin holes 700 on the needle plate 70, which allows multiple microneedles to be pressed down and made into holes in batches, each batch arranged in an array. Alternatively, the size of the pressure plate 72 can be configured to cover all the pin holes 700 on the needle plate 70, which allows for one-time pressing and hole making. In this case, a housing guide portion (not shown in the figure) adapted to the grate guide portion 21 can be provided on the side wall of the housing 74. For example, if the grate guide 21 is recessed from the side wall of the grate 2 toward the grate hole 20, so that the outer wall of the grate guide 21 forms a groove that matches the interface guide 11, and the inner wall of the grate guide 21 forms a column, then the housing guide is recessed from the side wall of the housing 74 to form a groove that matches the column; similarly, if the grate guide 21 is protruding, the housing guide is adjusted accordingly.

[0200] For example, as shown in Figures 23 and 24, the bottom of the pressure plate 72 is provided with an array of punch mounting holes 720. When punching, the punch 71 is inserted into the punch mounting holes 720. The pressure rod 73 includes a connecting rod 730, a connecting plate 731 and a pressing part 732. One end of the multiple connecting rods 730 is connected to the periphery of the pressure plate 72, and the other end is connected to the periphery of the connecting plate 731. The pressing part 732 is installed on the connecting plate 731.

[0201] By pressing down on the pressing part 732, the pressing rod 73 is driven to carry the punching needle 71 through the needle hole 700 and into the dura mater until the pressing plate 72 holds the needle plate 70.

[0202] To accommodate different insertion depths, the needle assembly has various specifications, distinguished by the length of the punching needle 71. The length of the punching needle 71 varies in each needle assembly. The appropriate length of punching needle 71 is selected according to the required drilling depth and inserted into the punching needle mounting hole 720.

[0203] Alternatively, the connecting rod 730 can be detachably connected to the pressure plate 72, for example, by commonly used plug-in or snap-fit ​​methods. The pressure plate 72 has various specifications, which are distinguished by the depth of the punch mounting hole 720. The depth of the punch mounting hole 720 of each pressure plate 72 is different. A pressure plate 72 of appropriate length can be selected according to the required drilling depth to be plugged into the punch 71.

[0204] It is understandable that the aforementioned pressing component can press down all the microneedles at once to make holes, or it can press down in batches to make holes. For example, the size of the pressure plate 72 is configured to cover a portion of the pin holes 700 on the needle plate 70, in which case multiple microneedles distributed in an array in batches can be pressed down to make holes together. As another example, as shown in Figure 23, the size of the pressure plate 72 is configured to cover all the pin holes 700 on the needle plate 70, in which case one-time pressing can make holes. Furthermore, the side wall of the grate 2 is provided with a grate guide 21, and the side wall of the pressure plate 72 is provided with a pressure plate guide 721 that is adapted to the grate guide 21.

[0205] For ease of installation and positioning, as shown in Figure 21, the side wall of the needle plate 70 is provided with a needle plate guide 701 that is adapted to the comb guide 21.

[0206] For example, if the grate guide 21 is recessed from the side wall of the grate 2 toward the side where the grate hole 20 is located, so that the outer wall of the grate guide 21 forms a groove that matches the interface guide 11, and the inner wall of the grate guide 21 forms a column, then the pressure plate guide 721 is recessed from the side wall of the pressure plate 72 to form a groove that matches the column, and the needle plate guide 701 is recessed from the side wall of the needle plate 70 to form a groove that matches the column; similarly, if the grate guide 21 is protruding, the pressure plate guide 721 and the needle plate guide 701 are adjusted accordingly.

[0207] In this application, the punching needle 71 is made of stainless steel, titanium alloy or tungsten; the needle plate 70 is made of stainless steel, titanium, titanium-aluminum-vanadium alloy, nickel-titanium alloy, cobalt-chromium alloy or polyetheretherketone (PEEK).

[0208] Since the interface base 1 is small, a second clamping hole 702 is provided on the needle plate 70 to facilitate the insertion or removal of the needle plate 70, as shown in Figure 21. The second clamping hole 702 is adapted to the clamping clip 61 of the positioning component 6. Furthermore, the above-mentioned second clamping holes 702 are arranged in pairs and symmetrically distributed on the needle plate 70.

[0209] (5) After drilling, install the microneedle assembly 3 on the grate.

[0210] Specifically, referring to Figures 1, 4, 5, 6, 7, and 9, first install the microneedle base 30. Then, use the implantation device 5 to pull and fix the microneedle array structure 312 and the communication module 40. The other end of the implantation device 5 should be fixed to the second mounting auxiliary hole 3112 of the microneedle mounting plate 311, ensuring that the microneedle tips are aligned with the grate holes 20 of the lower grate. Next, remove the retainer 3151 and use the implantation device 5 to slowly move the entire microneedle array structure 312 downwards along the guide rod 3150. Stop after the microneedles are implanted to the predetermined depth. Release the temporary fixation of the interface base 1. At this time, use the implantation device 5 to keep the height position of the microneedle mounting plate 311 unchanged, and simultaneously lift the interface base 1, the grate 2, and the microneedle base 30 upwards until the microneedle mounting plate 311 is smoothly nested into the microneedle base 30.

[0211] Remove the guide rod 3150 and use the shim block 15 as a temporary support around the outer ring of the interface base 1, as shown in Figure 1.

[0212] After the biodegradable biocompatible material used to temporarily fix the soft and hard needles dissolves in the relevant biological tissues, such as tissue fluid, the hard needle is removed. The soft needle remains in the relevant biological tissue, such as the brain tissue under the dura mater, to fix the communication module 40 and battery 41. The shim 15 is removed, and the raised interface base 1, grate 2, microneedle base 30, and microneedle mounting plate 311 are installed downwards into place. At this point, the soft needle has a certain amount of redundancy to prevent displacement caused by movement of the relevant biological tissue, such as the brain tissue, from pulling on the soft needle and causing damage. Next, glue is applied for encapsulation to protect the circuitry. It is then fixed with bolts or bone screws. The top cover 14 is installed, and then the scalp is sutured.

[0213] In summary, this application integrates multiple microneedles for simultaneous implantation, which greatly improves implantation efficiency compared to the traditional method of implanting single electrodes sequentially.

[0214] This application achieves minimally invasive implantation while effectively avoiding damage caused by rigid microneedle electrodes to relevant tissues of the patient's body, such as brain tissue, during movement. Using flexible microneedle electrodes avoids the need for mechanical matching with brain tissue after implantation, ensuring that brain movement does not cause displacement or shearing between the brain tissue and the electrode, thus allowing for long-term tracking of the activity of the same neuron.

[0215] This application features a higher number of channels per device and multiple detection sites distributed longitudinally along the electrodes. It can simultaneously record the Spike signal of a single neuron and the local field potential (LFP), enabling the acquisition of three-dimensional high-density EEG signals. This promotes precise and smooth thought-controlled movement and achieves high-throughput bidirectional neural signal acquisition and regulation.

[0216] Built-in integrated circuit chips enable local digitization, which helps reduce the transmission loss of neural signals and improve the signal-to-noise ratio.

[0217] The high throughput, bidirectional communication, minimally invasive implantation, and low damage during use of the overall brain-computer interface device ensure long-term stability after implantation, making the brain-computer interface implantation process more efficient, safe, and controllable.

[0218] The above description is merely a specific embodiment of this application, enabling those skilled in the art to understand or implement this application. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of this application. Therefore, this application is not to be limited to the embodiments shown herein, but is to be accorded the widest scope consistent with the principles and novel features claimed herein.

Claims

1. A brain-machine interface device, characterized by, It includes: An interface base (1) has a through channel, and a bottom support (10) is provided on the inner wall of the through channel. A top support (13) is formed on the upper edge of the interface base (1). A grate (2) is installed on the interface base (1) and supported on the base (10). The grate (2) has grate holes (20) arranged in an array in the middle. The microneedle assembly (3) includes a microneedle base (30) and a microneedle mechanism (31). The microneedle base (30) is mounted on the grate (2) and has microneedle guide holes (300) arranged in an array in its middle. The microneedle mechanism (31) is mounted on the microneedle base (30) and its microneedles (310) pass through the microneedle guide holes (300), the grate holes (20) and the through channels of the interface base (1) in sequence. Furthermore, the diameter of the comb hole (20) is larger than the diameter of the microneedle guide hole (300).

2. The brain-computer interface device as described in claim 1, characterized in that: The inner wall of the interface base (1) is provided with an interface guide (11) that extends along the axial direction of the base (10); The side wall of the grate (2) is provided with a grate guide (21) that is adapted to the interface guide (11); The microneedle base (30) has a microneedle guide (301) on its side wall that is adapted to the comb guide (21).

3. The brain-computer interface device as described in claim 2, characterized in that: There are at least two interface guides (11); At least one of the interface guides (11) is a guide with a diameter equal to that of the base (10) along the axial direction; At least one of the interface guides (11) is a guide with a variable diameter along the axial direction of the base (10), and the bottom diameter of the interface guide (11) is greater than the top diameter.

4. The brain-computer interface device as described in claim 2, characterized in that: The interface guide (11) is a groove formed by the recess of the inner wall of the interface base (1), or a column formed by the protrusion.

5. The brain-computer interface device as described in claim 1, characterized in that: The interface base (1) is also provided with an ear seat (12); And / or, the interface base (1) is also provided with a top cover (14).

6. The brain-computer interface device as described in claim 1, characterized in that: The brain-computer interface device further includes a communication component (4), which includes a communication module (40) connected to the microneedle mechanism (31).

7. The brain-computer interface device as described in claim 6, characterized in that: The microneedle base (30) is provided with a microneedle guide (301) on its side wall; The communication module (40) has a communication module guide (400) on its side wall that is adapted to the microneedle guide (301).

8. The brain-computer interface device as described in claim 6, characterized in that: The communication module (40) is provided with a temporary fixing groove (401) for temporary fixation on the implantation device (5).

9. The brain-machine interface apparatus of claim 1, wherein, The microneedle mechanism (31) includes: Microneedle mounting plate (311), wherein a slot (3110) is provided on the inner wall of the microneedle mounting plate (311); A microneedle array structure (312) is mounted on the slot (3110) and is used to electrically connect with the communication module (40). The microneedle array structure (312) has a row of microneedles (310) spaced apart.

10. The brain-computer interface device as described in claim 9, characterized in that: The microneedle mounting plate (311) is provided with a plurality of slot groups, each of the slot groups including slots (3110) located on two opposite inner walls of the microneedle mounting plate (311); The two ends of the microneedle array structure (312) are respectively secured to the two slots (3110) of the slot group.

11. The brain-computer interface device as described in claim 9, characterized in that: The microneedle mechanism (31) also includes an integrated circuit chip (313) and a microstrip line (314) for electrical connection with the communication module (40); The microneedle array structure (312) is connected to the integrated circuit chip (313), and the microneedle array structure (312) is secured to the slot (3110) through the integrated circuit chip (313); The microstrip line (314) is electrically connected to the integrated circuit chip (313).

12. The brain-computer interface device as described in claim 9, characterized in that: The microneedle base (30) is provided with a microneedle guide (301) on its side wall; The microneedle mounting plate (311) has a mounting plate guide (3111) on its side wall that is adapted to the microneedle guide (301).

13. The brain-computer interface device as described in claim 12, characterized in that: The microneedle guide portion (301) is formed by recessing the side wall of the microneedle base (30) toward the side where the microneedle guide hole (300) is located; The mounting plate guide portion (3111) is formed by the side wall of the microneedle mounting plate (311) being recessed toward the central region of the microneedle mounting plate (311); The microneedle base (30) is provided with a first mounting auxiliary hole (302) corresponding to the mounting plate guide (3111).

14. The brain-computer interface device as described in claim 13, characterized in that: The microneedle mechanism (31) further includes an installation auxiliary component (315), which includes a sleeve (3151) and a guide rod (3150) with one end for insertion into the first installation auxiliary hole (302) and the other end for insertion into the guide portion (3111) of the mounting plate. The sleeve (3151) is detachably fitted onto the guide rod (3150).

15. The brain-computer interface device as described in claim 14, characterized in that: The sleeve (3151) includes a sleeve (31510) and an operating part (31511) connected to the sleeve (31510). The sleeve (31510) has an opening along its axial direction so that the sleeve (31510) is C-shaped.

16. The brain-computer interface device as described in claim 13, characterized in that: The microneedle mounting plate (311) is also provided with a second mounting auxiliary hole (3112) for connecting the implantation device (5).

17. The brain-computer interface device as described in claim 9, characterized in that: The microneedle array structure (312) includes hard needles (3120) and soft needles (3121) for connecting to the communication module (40). The soft needles (3121) are fixed to the surface of the hard needles (3120) by a fixing structure (3122). The fixing structure (3122) is made of a biodegradable biocompatible material.

18. The brain-computer interface device as described in claim 17, characterized in that: The hard needle (3120) includes a hard needle tail (31200) and at least one hard needle body electrode (31201) formed on the hard needle tail (31200); The soft needle (3121) includes a soft needle tail (31210) and at least one soft needle body electrode (31211) formed on the soft needle tail (31210); The microneedle (310) includes the soft needle electrode (31211) and the hard needle electrode (31201) fixed to each other.

19. The brain-computer interface device as described in claim 18, characterized in that: The tip of the soft needle electrode (31211) is provided with a barb (31212).

20. The brain-computer interface device as described in claim 17, characterized in that: The biodegradable biocompatible material includes one or more of silk fibroin, spider fibroin, gelatin, and PEG.

21. A method of installing a brain-machine interface device as claimed in claim 1, characterized by, It includes: Install the interface base (1), the comb (2), and the microneedle assembly (3) in sequence.

22. The method of installing a brain-machine interface apparatus of claim 21, wherein, After installing the interface base (1) and before installing the grate (2), the installation method further includes: A positioning component (6) is installed in the interface base (1); Take pictures to obtain images of blood vessel distribution; Based on the blood vessel distribution image, the microneedle assembly (3) is cut to remove the microneedles (310) corresponding to the blood vessel locations; Remove the positioning component (6).

23. The method of installing a brain-machine interface apparatus of claim 22, wherein, The positioning component (6) includes: Positioning filter (60) with crisscrossing grid lines in its middle, the intersection of the grid lines corresponding to the center of the comb hole (20) and the center of the micro needle guide hole (300).

24. The method for installing the brain-computer interface device as described in claim 23, characterized in that: The inner wall of the interface base (1) is provided with an interface guide (11) extending along the axial direction of the base (10), and the side wall of the positioning filter (60) is provided with a filter guide (601) that is adapted to the interface guide (11). And / or, the positioning component (6) further includes a clamping clip (61), and the positioning filter (60) has a first clamping hole (602) adapted to the clamping clip (61); And / or, the material of the positioning filter (60) is polymethyl methacrylate (PMMA), polycarbonate (PC), multilayer dielectric film, calcium fluoride, or magnesium fluoride; And / or, the material of the grid scale lines is chromium, indium tin oxide, gold, or platinum; And / or, the etching depth of the grid scale lines is 1-3 μm; And / or, the line width of the grid scale lines is greater than the resolution of the near-infrared imaging system used to capture the image; And / or, the positioning component (6) further includes a near-infrared imaging system for capturing images.

25. The method of installing a brain-computer interface device of claim 22, wherein, After installing the comb (2) and before installing the microneedle assembly (3), the installation method further includes: Install a pre-drilled kit (7) on the grate (2); Based on the blood vessel distribution image, the pre-drilled kit (7) is used to drill holes while avoiding blood vessels; After drilling is completed, remove the pre-drilled kit (7).

26. The method of installing a brain-computer interface apparatus of claim 25, wherein, The pre-drilled kit (7) includes: Needle plate (70), wherein the center of the needle plate (70) is provided with needle holes (700) that correspond one-to-one with the center positions of the grate holes (20) of the grate (2); The needle assembly includes multiple punching needles (71); The pressing assembly includes a pressure plate (72) for pressing down the punch (71) and a pressure rod (73) with one end connected to the pressure plate (72).

27. The method for installing the brain-computer interface device as described in claim 26, characterized in that: The side wall of the comb (2) is provided with a comb guide (21), and the side wall of the needle plate (70) is provided with a needle plate guide (701) that is adapted to the comb guide (21). And / or, the material of the punch (71) is selected from stainless steel, titanium alloy or tungsten; And / or, the material of the needle plate (70) may be stainless steel, titanium, titanium-aluminum-vanadium alloy, nickel-titanium alloy, cobalt-chromium alloy or polyetheretherketone (PEEK); And / or, the needle plate (70) is provided with a second clamping hole (702); And / or, the size of the pressure plate (72) is configured to cover a portion or all of the pinholes (700) on the needle plate (70).

28. The method for installing the brain-computer interface device as described in claim 26, characterized in that: The pressing assembly also includes a housing (74), the pressure plate (72) is located inside the housing (74), and the pressure rod (73) is threadedly connected to the housing (74) to adjust the position of the pressure plate (72) inside the housing (74); The outer wall of the pressure rod (73) is also provided with scale lines.

29. The method for installing the brain-computer interface device as described in claim 26, characterized in that: The bottom of the pressure plate (72) is provided with an array of punch mounting holes (720); The pressure rod (73) includes a connecting rod (730), a connecting plate (731), and a pressing part (732). One end of the multiple connecting rods (730) is connected to the periphery of the pressure plate (72), and the other end is connected to the periphery of the connecting plate (731). The pressing part (732) is installed on the connecting plate (731).

30. The method for installing the brain-computer interface device as described in claim 29, characterized in that: The needle assembly has various specifications, and the length of the punching needle (71) of each needle assembly is different; And / or, the connecting rod (730) is detachably connected to the pressure plate (72), the pressure plate (72) has a variety of different specifications, and the hole depth of the punch mounting hole (720) of each pressure plate (72) is different; And / or, the size of the pressure plate (72) is configured to cover a portion of the pin holes (700) on the needle plate (70); or a grate guide (21) is provided on the side wall of the grate (2), the size of the pressure plate (72) is configured to cover all the pin holes (700) on the needle plate (70), and a pressure plate guide (721) adapted to the grate guide (21) is provided on the side wall of the pressure plate (72).

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