Brain-computer interface device and installation method

Abstract

The invention relates to a brain-computer interface device and an installation method, an interface base is provided with a through channel, the inner wall of the through channel is provided with a bottom support, and the upper edge of the interface base is provided with a top support; the perforated strainer is mounted on the interface base and supported on the bottom support, and perforated strainer holes distributed in an array mode are formed in the middle of the perforated strainer; the micro-needle assembly comprises a micro-needle base and a micro-needle mechanism, the micro-needle base is installed on the grate, micro-needle guide holes distributed in an array mode are formed in the middle of the micro-needle base, the micro-needle mechanism is installed on the micro-needle base, and micro-needles of the micro-needle mechanism sequentially penetrate through the micro-needle guide holes, holes of the grate and a penetrating channel of the connector base; and the aperture of the grate hole is larger than that of the microneedle guide hole. The mechanical stability of the microneedle is improved, and the implanting reliability of the microneedle is guaranteed.

Description

Technical Field

[0001] The present application relates to the field of human-computer interaction technology, and in particular to a brain-computer interface device and an installation method. Background Art

[0002] Brain-computer interface is a technology that directly reads brain signals and inputs signals through external devices for human-computer interaction. 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 interface refers to a technology that achieves human-computer interaction by obtaining electrical signals from the brain through an electrode array placed on the surface of biological tissues such as the scalp without cutting biological tissues such as the skull or implanting electrodes in biological tissues such as the brain. Compared with invasive brain-computer interface, it has the advantages of being safer, simpler, and easier to operate. However, its signal quality is low and it is easily affected by external interference, which makes signal processing complicated.

[0005] Invasive brain-computer interface is a technology that inserts electrodes or probes into relevant tissues of the organism, such as the cerebral cortex, to obtain neural signals. Compared with non-invasive brain-computer interface, invasive brain-computer interface has higher signal accuracy and stability, can provide better control accuracy and response speed, and can achieve more complex movement and interaction tasks.

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

[0007] For example, since the probe is usually thin, it may face mechanical stability problems during the implantation process 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, the probe may cause a certain degree of mechanical damage in biological tissues such as brain tissue, leading to 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, and traditional implantation methods require implanting single probes one by one, which is time-consuming and labor-intensive. Summary of the invention

[0010] The embodiments of the present application provide a brain-computer interface device and an installation method to solve the problem of low reliability of probes in related technologies.

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

[0012] An interface base, which is provided with 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 is formed with a top support;

[0013] A grate, which is installed on the interface base and supported on the bottom bracket, and the middle part of the grate is provided with grate holes distributed in an array;

[0014] A microneedle assembly, comprising a microneedle base and a microneedle mechanism, wherein the microneedle base is mounted on the grate and has microneedle guide holes distributed in an array in the middle thereof, and the microneedle mechanism is mounted on the microneedle base, and its microneedles sequentially pass through the microneedle guide holes, the grate holes and the through-channel of the interface base;

[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 axially along the bottom bracket is provided on the inner wall of the interface base;

[0017] A grate guide portion adapted to the interface guide portion is provided on the side wall of the grate;

[0018] A microneedle guide portion matched with the grate guide portion is arranged on the side wall of the microneedle base.

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

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

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

[0022] In some embodiments, the interface guide portion is a groove formed by a depression 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 seat;

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

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

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

[0027] A communication module guide portion adapted to the microneedle guide portion is arranged on the side wall of the communication module.

[0028] In some embodiments, the communication module is provided with a temporary fixing groove for temporarily fixing it on the implant device.

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

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

[0031] A microneedle array structure is clamped on the clamping slot and is used to be electrically connected to the communication module. The microneedle array structure has a row of microneedles distributed at intervals.

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

[0033] The two ends of the microneedle array structure are respectively clamped on the two clamping slots of the clamping slot group.

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

[0035] The microneedle array structure is connected to the integrated circuit chip, and the microneedle array structure is clamped on the card slot through 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] A mounting plate guide portion adapted to the microneedle guide portion is arranged on the side wall of the microneedle mounting plate.

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

[0040] The installation plate guide portion is formed by the side wall of the microneedle installation plate being recessed toward the middle area of ​​the microneedle installation plate;

[0041] A first auxiliary mounting hole is arranged on the microneedle base corresponding to the guide portion of the mounting plate.

[0042] In some embodiments, the microneedle mechanism also includes an installation auxiliary component, which includes a ferrule and a guide rod having one end for being inserted into the first installation auxiliary hole and the other end for being inserted into the guide portion of the installation plate, and the ferrule is detachably mounted on the guide rod.

[0043] In some embodiments, the ferrule includes a sleeve and an operating portion connected to the sleeve, and an opening is provided on the sleeve along its axial direction so that the sleeve is C-shaped.

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

[0045] In some embodiments, the microneedle array structure includes hard needles and soft needles for connecting to the communication module, and the soft needles are fixed to the surface of the hard needles through a fixing structure, and the material of the fixing structure is a degradable 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 comprises a soft needle tail and at least one soft needle body electrode formed on the soft needle tail;

[0048] The microneedle comprises the soft needle body electrode and the hard needle body electrode fixed to each other.

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

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

[0051] In a second aspect, an embodiment of the present application provides 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] Installing a positioning assembly in the interface base;

[0055] Take pictures to obtain images of vascular distribution;

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

[0057] Remove the positioning assembly.

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

[0059] The filter is positioned, and a crisscross grid scale lines are arranged in the middle, and the intersection position of the grid formed by the grid scale lines corresponds to the center of the grate hole and the center of the microneedle guide hole.

[0060] 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, and a filter guide portion matching the interface guide portion is provided on the side wall of the positioning filter;

[0061] And / or, the positioning assembly further comprises a clamping clip, and the positioning filter is provided with a first clamping hole adapted to the clamping clip;

[0062] And / or, the positioning filter is made of polymethyl methacrylate PMMA, polycarbonate PC, a 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 also 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 comprises:

[0068] installing a pre-punched hole kit on the grate;

[0069] Based on the blood vessel distribution image, using the pre-punching kit to avoid blood vessels and perform punching;

[0070] After the punching is completed, the pre-punch kit is removed.

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

[0072] A needle plate, wherein a needle hole corresponding to the center position of the grate hole of the grate is arranged in the middle of the needle plate;

[0073] a needle assembly comprising a plurality of punching needles;

[0074] The pressing assembly comprises a pressing plate for pressing the punching needle downwards, and a pressing rod with one end connected to the pressing 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 punch 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, a second clamping hole is provided on the needle plate;

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

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

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

[0082] In some embodiments, the bottom of the pressing plate is provided with array-distributed punch needle mounting holes;

[0083] The pressure rod comprises a connecting rod, a connecting plate and a pressing portion. One end of a plurality of connecting rods is connected to the periphery of the pressure plate, and the other end is connected to the periphery of the connecting plate. The pressing portion is installed on the connecting plate.

[0084] In some embodiments, the needle assembly has a plurality of different specifications, and the punching needles of each needle assembly have different lengths;

[0085] And / or, the connecting rod is detachably connected to the pressing plate, the pressing plate has a plurality of different specifications, and the perforating needle mounting holes of each pressing plate have different depths;

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

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

[0088] In the brain-computer interface device provided by the present application, the microneedle will pass through the microneedle guide hole, the grate hole and the through channel of the interface base from top to bottom and then enter the relevant tissue of the organism. Since the aperture of the grate hole is larger than the aperture of the microneedle guide hole, the hole size of each layer from bottom to top is continuously reduced. The microneedle guide hole of the top layer is designed to be as close to the size of the microneedle as possible, so that the microneedle guide hole plays a role in positioning and guiding the microneedle during implantation, ensuring the high accuracy of the implantation position. Since the microneedle processing, assembly and implantation process may produce a certain tilt, the design scheme of enlarging the grate hole of the lower layer is to ensure that when the microneedle passes through the implantation channel from top to bottom, even if the microneedle has a small tilt, since the hole of the lower layer is larger than the hole of the upper layer, the extra hole space of the lower layer becomes a buffer area, and the buffer area plays a buffering role when the microneedle is tilted, making it difficult for the microneedle to deform or break due to touching the side wall of the grate hole, thereby improving the mechanical stability of the microneedle.

[0089] It can be seen that the design of the present application in which the multi-layer hole size gradually increases from top to bottom ensures the reliability of microneedle implantation. BRIEF DESCRIPTION OF THE DRAWINGS

[0090] In order to more clearly illustrate the technical solutions in the embodiments of the present application, the drawings required for use in the description of the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present application. For ordinary technicians in this field, other drawings can be obtained based on these drawings without creative work.

[0091] Figure 1 An exploded diagram of a brain-computer interface device provided in an embodiment of the present application;

[0092] Figure 2 A schematic diagram of an interface base provided in an embodiment of the present application;

[0093] Figure 3 A schematic diagram of a grate provided in an embodiment of the present application;

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

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

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

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

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

[0099] Fig. 9 A schematic diagram of an implant device provided in an embodiment of the present application;

[0100] Fig.10 A schematic diagram of the microneedle array structure provided in an embodiment of the present application (when torn off);

[0101] Fig.11 A schematic diagram of the microneedle array structure provided in an embodiment of the present application (when fitted);

[0102] Fig.12 A schematic diagram of a barb provided in an embodiment of the present application;

[0103] Fig.13 A schematic diagram of installing an integrated circuit chip provided in an embodiment of the present application;

[0104] Fig.14 A schematic diagram of a fixed structural member provided in an embodiment of the present application;

[0105] Fig.15 A schematic diagram of a cutting soft needle electrode provided in an embodiment of the present application;

[0106] Fig.16 A schematic diagram of reverse soldering of an integrated circuit chip provided in an embodiment of the present application;

[0107] Fig.17 A schematic diagram of an installation and positioning assembly provided in an embodiment of the present application;

[0108] Fig.18 A schematic diagram of a positioning component provided in an embodiment of the present application;

[0109] Fig.19 A schematic diagram of installing a grate provided in an embodiment of the present application;

[0110] Fig. 20 A schematic diagram of a pre-punched installation kit provided in an embodiment of the present application;

[0111] Fig.21 A schematic diagram of a pre-punched kit provided in an embodiment of the present application;

[0112] Fig. 22 for Fig.21 Another perspective diagram;

[0113] Fig.23 A schematic diagram of another pre-punched kit provided in an embodiment of the present application;

[0114] Fig.24 A schematic diagram of a pressing assembly provided in an embodiment of the present application.

[0115] In the figure:

[0116] 1. Interface base; 10. Bottom bracket; 11. Interface guide; 12. Ear seat; 13. Top bracket; 14. Top cover; 15. Heightening block;

[0117] 2. grate; 20. grate hole; 21. grate guide;

[0118] 3. Microneedle assembly; 30. Microneedle base; 300. Microneedle guide hole; 301. Microneedle guide part; 302. First installation auxiliary hole; 31. Microneedle mechanism; 310. Microneedle; 311. Microneedle mounting plate; 3110. Card slot; 3111. Mounting plate guide part; 3112. Second installation 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. Fixed structure; 313. Integrated circuit chip; 314. Microstrip line; 315. Installation auxiliary assembly; 3150. Guide rod; 3151. Card sleeve; 31510. Sleeve; 31511. Operating part;

[0119] 4. Communication component; 40. Communication module; 400. Communication module guide; 401. Temporary fixing groove; 41. Battery;

[0120] 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;

[0121] 6. Positioning assembly; 60. Positioning filter; 601. Filter guide; 602. First clamping hole; 61. Clamping clip;

[0122] 7. Pre-punching kit; 70. Needle plate; 700. Needle hole; 701. Needle plate guide; 702. Second clamping hole; 71. Punching needle; 72. Pressing plate; 720. Punching needle mounting hole; 721. Pressing plate guide; 73. Pressing rod; 730. Connecting rod; 731. Connecting plate; 732. Pressing part; 74. Shell. DETAILED DESCRIPTION

[0123] In order to make the purpose, technical solution and advantages of the embodiments of the present application clearer, the technical solution in the embodiments of the present application will be clearly and completely described below in conjunction with the drawings in the embodiments of the present application. Obviously, the described embodiments are part of the embodiments of the present application, not all of the embodiments. Based on the embodiments in the present application, all other embodiments obtained by ordinary technicians in this field without making creative work are within the scope of protection of this application.

[0124] See also Figure 1 , Figure 2 , Figure 3 , Figure 4 and Figure 5 As shown, an embodiment of the present application provides a brain-computer interface device, which includes an interface base 1, a comb 2 and a microneedle assembly 3.

[0125] The interface base 1 is provided with a through channel to form a cylindrical structure with a hollow center. The inner wall of the through channel is provided with a bottom support 10 for supporting the parts to be installed subsequently. The upper edge of the interface base 1 is formed with a top support 13. The outer diameter of the top support 13 is larger than the aperture of biological-related tissues such as skull openings, so that the interface base 1 can be placed in biological-related tissues such as skull openings.

[0126] The grate 2 is installed on the interface base 1 and supported on the base 10. The middle of the grate 2 is provided with grate holes 20 distributed in an array, which serve as channels for microneedle implantation.

[0127] The microneedle assembly 3 includes a microneedle base 30 and a microneedle mechanism 31. The microneedle base 30 is installed on the grate 2, and a microneedle guide hole 300 distributed in an array is provided in the middle of the microneedle base 30. The microneedle mechanism 31 is installed on the microneedle base 30, and the microneedle 310 of the microneedle mechanism 31 passes through the microneedle guide hole 300, the grate hole 20 and the through channel of the interface base 1 in sequence.

[0128] The center of the microneedle guide hole 300 corresponds to the center of the grate hole 20 one by one, and the aperture of the grate hole 20 is larger than the aperture of the microneedle guide hole 300 .

[0129] In the brain-computer interface device provided by the present application, the microneedle 310 will pass through the microneedle guide hole 300, the grate hole 20 and the through-channel of the interface base 1 from top to bottom and then enter the relevant tissue of the organism, such as the brain tissue. Since the aperture of the grate hole 20 is larger than the aperture of the microneedle guide hole 300, the hole size of each layer from bottom to top is continuously reduced. The microneedle guide hole 300 of the top layer is designed to be as close as possible to the size of the microneedle 310, so that the microneedle guide hole 300 plays a role in positioning and guiding the microneedle during implantation, ensuring high accuracy of the implantation position. Since the microneedle processing, assembly and implantation process may produce a certain degree of tilting, the design scheme of enlarging the lower layer of the comb hole 20 is to ensure that when the microneedle passes through the implantation channel from top to bottom, even if the microneedle produces a slight tilt, since the holes in the lower layer are larger than the holes in the upper layer, the extra hole space in the lower layer becomes a buffer area. When the microneedle tilts, the buffer area plays a buffering role, making it difficult for the microneedle to deform or break due to touching the side wall of the comb hole 20, thereby improving the mechanical stability of the microneedle.

[0130] It can be seen that the design of the present application in which the multi-layer hole size gradually increases from top to bottom ensures the reliability of microneedle implantation and can reduce the implantation position deviation caused by possible errors in the microneedle assembly process or implantation angle.

[0131] It is understandable 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, polyetheretherketone PEEK, etc.

[0132] It is understandable that the shape of the interface base 1 can be selected according to actual needs, including but not limited to a circular shape, and preferably a circular shape. 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.

[0133] It is understandable that in order to facilitate assembly, to prevent the microneedle from being difficult to penetrate due to misalignment, and to prevent adverse effects caused by misalignment between parts during subsequent long-term use, see Figure 2 As shown, the inner wall of the interface base 1 is provided with an interface guide portion 11 extending axially along the base 10; see Figure 3 As shown, a grate guide portion 21 adapted to the interface guide portion 11 is provided on the side wall of the grate 2; see Figure 5 As shown, a microneedle guide portion 301 adapted to the grate guide portion 21 is disposed on the side wall of the microneedle base 30 .

[0134] Specifically, see Figure 2 As shown, the interface guide portion 11 can be a column formed by protruding from the inner wall of the interface base 1 and located on the inner wall; accordingly, for the assembly of subsequent components, see Figure 3 As shown, the grate guide portion 21 is formed by the side wall of the grate 2 being recessed toward the side where the grate hole 20 is located, so that the outer wall of the grate guide portion 21 forms a groove body, which is adapted to the interface guide portion 11, and the inner wall of the grate guide portion 21 forms a column; accordingly, see Figure 5 As shown, the microneedle guide portion 301 is formed by the side wall of the microneedle base 30 being recessed toward the side where the microneedle guide hole 300 is located, so that the outer wall of the microneedle guide portion 301 forms a groove body, which is adapted to the column of the grate guide portion 21, and the inner wall of the microneedle guide portion 301 forms a column.

[0135] The interface guide portion 11 may also be a groove formed by a depression in the inner wall of the interface base 1 , and in this case, the grate guide portion 21 and the microneedle guide portion 301 may be adaptively adjusted.

[0136] See also Figure 2As shown, there are at least two interface guides 11, at least one of which is a guide with a constant diameter along the axial direction of the base 10; at least another interface guide 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. The combined use of the two interface guides takes into account the requirements of high-precision guidance and stable installation, which is conducive to the alignment and fixation of subsequent components during installation.

[0137] The axial direction of each interface guide part 11 is consistent with the axial direction of the base 10 (or the axial direction of the interface base 1). Some of the interface guide parts 11 have consistent outer diameters of each cross section from top to bottom along the axial direction, while other interface guide parts 11 have different outer diameters of each cross section from top to bottom, and the outer diameter decreases toward the top.

[0138] The interface guide portion 11 of equal diameter helps to provide higher guiding accuracy, while the design of the interface guide portion 11 of variable diameter has the following advantages: First, it helps to fix the bottom of the interface guide portion 11, and the thicker part at the bottom can provide a larger contact area, making the fixation of the interface guide portion 11 at the bottom more stable and less likely to loosen or move. A larger diameter also means greater torsion resistance, which is particularly important when the interface guide portion 11 is subjected to lateral or torsional forces. Second, the thicker design at the bottom can optimize stress distribution and avoid material fatigue or cracking due to excessive local stress, which helps to extend the service life of the interface guide portion 11 during long-term use. Third, the overall weight of the interface guide portion 11 can be reduced while maintaining structural strength. Fourth, it is easy to install and tighten, reducing errors during installation and ensuring that the interface guide portion 11 maintains good positioning accuracy during use.

[0139] It can be understood that the above-mentioned interface guide parts 11 of equal diameter can be arranged in groups of two and symmetrically. Similarly, the above-mentioned interface guide parts 11 of variable diameter can be arranged in groups of two and symmetrically.

[0140] See also Figure 2 As shown, the interface base 1 is also provided with ear seats 12, which may appear in pairs. The ear seats 12 are used to provide fixing points for bolts so as to fix the brain-computer interface device on relevant tissues of the biological body, such as the skull.

[0141] See also Figure 1 As shown, the interface base 1 is also provided with a top cover 14. After all components are installed, the top cover 14 is finally installed on the interface base 1 to protect the internal components.

[0142] See also Figure 1 and Figure 4As shown, the brain-computer interface device also includes a communication component 4, which includes 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 the communication module 40, wireless transmission of the collected signal is realized, and the battery 41 provides power to the communication module 40. The installation position of the battery 41 can be selected from different positions such as the head implanted brain-computer interface original position, the chest or the back of the ear.

[0143] See also Figure 6 and Figure 7 As shown, 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 periphery of the microneedle mounting plate 311 can be circular and compatible with the microneedle base 30, or can be in other shapes such as Figure 6 The microneedle mounting plate 311 is hollowed out in the middle to form a ring shape, and a card slot 3110 is opened on the inner wall of the microneedle mounting plate 311; the microneedle array structure 312 is clamped on the card slot 3110 to achieve the installation and fixation of the microneedle array structure 312, the microneedle array structure 312 is electrically connected to the communication module 40, and the microneedle array structure 312 has a row of microneedles 310 distributed at intervals.

[0144] In the microneedle mechanism 31 provided in the present application, a row of multiple microneedles 310 is arranged on the microneedle array structure 312, which may be 4, 8, 16, 32 or more. When installed, each microneedle 310 passes through the microneedle guide hole 300 of the microneedle base 30 to enter the relevant tissue of the organism such as brain tissue. It can be seen that the present application uses a microneedle array to achieve multi-channel high-throughput bidirectional neural signal acquisition and regulation.

[0145] In addition, when implanting the present invention, multiple roots are implanted at once in an array, and compared with implanting one root at a time, the implantation efficiency of the present invention is significantly improved.

[0146] In order to improve the fixing and installation effect of the microneedle array structure 312, simplify the parts structure and reduce the production cost, see Figure 6 As shown, the microneedle mounting plate 311 is provided with a plurality of slot groups, each of which includes slots 3110 respectively located on two opposite inner walls of the microneedle mounting plate 311; the two ends of the microneedle array structure 312 are respectively clamped on the two slots 3110 of the slot group. The two ends of the two microneedle array structures 312 are respectively clamped on the two slots 3110, which can ensure the fixed installation effect and not affect the arrangement of the microneedles 310 in the middle position.

[0147] See also Figure 4 and Figure 7As shown, a plurality of slot groups can be provided, and one slot group is correspondingly installed with one microneedle array structure 312 . Each microneedle array structure 312 has a column of multiple microneedles 310 , so that the microneedle mechanism 31 can include multiple rows and columns of microneedles 310 .

[0148] See also Figure 4 and Figure 7 As shown, 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 clamped on the clamping slot 3110 through the integrated circuit chip 313; the communication module 40 is electrically connected to the integrated circuit chip 313 through 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 is beneficial to reducing the transmission loss of neural signals and improving the signal-to-noise ratio.

[0149] In order to facilitate assembly, to prevent the microneedle from being difficult to penetrate due to misalignment, and to prevent adverse effects caused by misalignment between parts during subsequent long-term use, see Figure 5 and Figure 6 As shown, a microneedle guide portion 301 is disposed on the side wall of the microneedle base 30 ; and a mounting plate guide portion 3111 matched with the microneedle guide portion 301 is disposed on the side wall of the microneedle mounting plate 311 .

[0150] In conformity with the above-mentioned grate guide part 21, the microneedle guide part 301 can be formed by the side wall of the microneedle base 30 being recessed toward the side where the microneedle guide hole 300 is located, so that the outer wall of the microneedle guide part 301 forms a groove body, which is adapted to the column of the grate guide part 21, and the inner wall of the microneedle guide part 301 forms a column. In conformity, the mounting plate guide part 3111 can be formed by the side wall of the microneedle mounting plate 311 being recessed toward the middle area of ​​the microneedle mounting plate 311, so that the side wall of the mounting plate guide part 3111 forms a groove body, which is adapted to the column of the microneedle guide part 301.

[0151] Similarly, the microneedle guide portion 301 may also be formed by the side wall of the microneedle base 30 protruding toward the side away from the microneedle guide hole 300, so that the inner wall of the microneedle guide portion 301 forms a groove body. At this time, the mounting plate guide portion 3111 is formed by the side wall of the microneedle mounting plate 311 protruding toward the side away from the middle, so that the side wall of the mounting plate guide portion 3111 forms a column, which is adapted to the groove body of the microneedle guide portion 301.

[0152] In order to facilitate the installation of the microneedle mechanism 31 on the microneedle base 30, see Figure 5As shown, the microneedle guide portion 301 is formed by the side wall of the microneedle base 30 being 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 being recessed toward the middle area 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, Figure 5 It can be seen that, in fact, the first mounting auxiliary hole 302 can be set on the microneedle guide part 301 .

[0153] The first auxiliary installation hole 302 is used in conjunction with the auxiliary installation component 315 .

[0154] See also Figure 4 , Figure 6 and Figure 8 As shown, the microneedle mechanism 31 also includes an installation auxiliary component 315, which includes a sleeve 3151 and a guide rod 3150, one end of which is used to be inserted into the first installation auxiliary hole 302 and the other end of which is used to be inserted into the guide part 3111 of the mounting plate. The guide rod 3150 can use a screw or the like, and the sleeve 3151 can be detachably mounted on the guide rod 3150.

[0155] The first auxiliary installation holes 302 may be provided in multiple numbers along the periphery, for example Figure 6 There are four in the set.

[0156] During installation, the guide rod 3150 is inserted from the guide part 3111 of the mounting plate into the first mounting auxiliary hole 302 connected to the lower microneedle base 30. The top of the ferrule 3151 on the guide rod 3150 supports the microneedle mounting plate 311, and the bottom is supported on the microneedle guide part 301. The microneedle mounting plate 311 and the lower microneedle base 30 can be temporarily connected together through the surrounding mounting auxiliary components 315. The mounting auxiliary components 315 here play the role of supporting the microneedle mounting plate 311. When the ferrule 3151 is installed, the microneedle array structure 312 maintains a certain distance from the microneedle base 30, so that the needle 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, the microneedle mounting plate 311 can be pulled by the implantation device after removing the sleeve 3151, and the microneedle mounting plate 311 can be pushed downward along the guide rod 3150 until the microneedle 310 completely passes through the microneedle guide hole 300. When the mounting plate guide parts 3111 around the microneedle mounting plate 311 and the microneedle guide parts 301 of the microneedle base 30 are matched and fixed to each other, the guide rod 3150 can be removed.

[0157] See also Figure 4As shown, the ferrule 3151 includes a sleeve 31510 and an operating portion 31511 connected to the sleeve 31510. The sleeve 31510 is provided with 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. The operating portion 31511 is pulled outward so that the guide rod 3150 opens the opening of the sleeve 31510, thereby pulling off the ferrule 3151.

[0158] To facilitate microneedle implantation, see Figure 1 , Figure 6 and Fig. 9 As shown, the microneedle mounting plate 311 is also provided with a second mounting auxiliary hole 3112 for connecting the implant device 5 .

[0159] Among them, the implantation device 5 includes an implantation plate 50, a plurality of implantation rods 51 for being plugged into the second mounting auxiliary hole 3112 are arranged at the bottom of the implantation plate 50, a main rod 52 is arranged at the top of the implantation plate 50, a limiting sleeve 53 is arranged on the main rod 52, and a multi-joint arm 54 is arranged on the limiting sleeve 53.

[0160] When in use, the implantation 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 to a position such as an operating table to ensure that the limiting sleeve 53 is fixed stationary. The main rod 52 is limited in the horizontal direction by the limiting sleeve 53, and then the main rod 52 is driven downward to push the microneedle mounting plate 311 downward, thereby achieving microneedle implantation.

[0161] See also Fig. 9 As shown, a plurality of first elastic claws 510 are provided at the bottom of the implant rod 51, and the implant rod 51 and the microneedle mounting plate 311 are temporarily fixed by the cooperation of the first elastic claws 510.

[0162] 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, see Figure 4 As shown, the communication module 40 is provided with a temporary fixing groove 401 for temporarily fixing on the implant device 5, see Fig. 9 As shown, two second elastic claws 500 are arranged opposite to each other and spaced apart at the bottom of the implantation plate 50. When the microneedle is implanted, Figure 1 As shown, 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 to achieve the purpose of temporarily fixing the communication module 40.

[0163] After the microneedle implantation is completed, in order to prevent the communication module 40 from moving during subsequent long-term use, see Figure 4As shown, a communication module guide portion 400 adapted to the microneedle guide portion 301 is provided on the side wall of the communication module 40 .

[0164] Because hard probes may cause a certain 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.

[0165] To address this problem, see Fig.10 and Fig.14 As shown, the microneedle array structure 312 provided in the present application includes a hard needle 3120 and a soft needle 3121, and the soft needle 3121 is fixed to the surface of the hard needle 3120 by a fixed structure 3122, and the material of the fixed structure 3122 is a degradable biocompatible material; the communication module 40 is connected to the soft needle 3121.

[0166] The present application adopts the form of introducing a hard needle into a soft needle, and utilizes the high hardness of the hard needle to conveniently implant the soft needle together. After the soft needle is implanted, since the material of the fixed structure 3122 is a degradable biocompatible material, under the action of biologically relevant tissues such as tissue fluid, the fixed structure 3122 is dissolved, and then the hard needle is removed, leaving only the soft needle in the biologically relevant tissues such as brain tissue. Since the soft needle has a low hardness and is friendly to biologically relevant tissues such as brain tissue, the present application not only realizes minimally invasive implantation, but also can effectively avoid damage caused by the hard needle when moving in biologically relevant tissues such as brain tissue.

[0167] See also Fig.10 As shown, 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 gluing, and the soft needle body electrode 31211 is fixed to the hard needle body electrode 31201, mainly by a degradable biocompatible material; the microneedle 310 includes the soft needle body electrode 31211 and the hard needle body electrode 31201 fixed to each other.

[0168] The overall preparation method of the microneedle array structure 312 is as follows:

[0169] Step 1: See Fig.11 As shown, a soft needle 3121 is prepared on a hard needle 3120 using conventional MEMS technology, and the positional relationship at this time is that the soft needle is attached to the hard needle.

[0170] See also Fig.12As shown, a barb 31212 is provided at the needle tip portion of the soft needle body electrode 31211 to facilitate the withdrawal of the hard needle after implantation and the long-term fixation of the soft needle.

[0171] Step 2: See Fig.10 As shown, the soft needle 3121 is torn off from the soft needle tail 31210 along one corner, and a portion of the needle tip of the soft needle body electrode 31211 is retained. The purpose is to allow the needle tip of the soft needle body electrode 31211 to retain a higher adhesion force for temporarily fixing the soft needle and the hard needle. The soft needle tail 31210 weakens the adhesion force to facilitate the removal of the hard needle after implantation.

[0172] Step 3: Re-stick the soft needle 3121 to the hard needle 3120. If the previously torn part cannot be stuck, you can fix it with glue or tape.

[0173] Step 4: See Fig.13 As shown, the integrated circuit chip 313 and the soft needle tail 31210 of the soft needle 3121 are reversely soldered together, and then the excess part of the soft needle tail 31210 is cut off. At this time, the positional relationship is that the integrated circuit chip 313 is reversely soldered on the soft needle, and the hard needle is at the bottom layer.

[0174] Step 5: See Fig.14 As shown, the needle tip of the microneedle array structure 312 is immersed in a biodegradable biocompatible material to form a fixing structure 3122 for fixation, which can also be achieved by a mold coating method. The biodegradable biocompatible material includes one or more of silk protein, spider silk protein, gelatin and PEG.

[0175] Step 6: See Fig.15 As shown, the untorn portion of the needle tip in the soft needle body electrode 31211 is cut off by laser or other methods, and only the soft needle portion on the hard needle is removed without cutting the hard needle. The laser path can be set as a curved path to ensure that the cut portion has rounded corners.

[0176] Step 7: See Fig.16 As shown, the reverse soldering of the microstrip line 314 and the integrated circuit chip 313 is completed, and the excess soft pins on the top are cut off to facilitate the removal of the hard pins later.

[0177] The integrated circuit chip 313 is clamped in the card slot 3110 , and the integrated circuit chip 313 and the soft needle 3121 are reversely soldered together. The soft needle 3121 and the hard needle 3120 are fixed by their own adhesion and degradable biocompatible materials such as silk protein, so the microneedle array structure 312 can be fixed by clamping the integrated circuit chip 313 in the card slot 3110 .

[0178] The embodiment of the present application also provides a method for installing a brain-computer interface device, which comprises the following steps: installing an interface base 1, a comb 2 and a microneedle assembly 3 in sequence.

[0179] Specifically, after the operation has been completed and the target brain area has been exposed at the relevant tissue of the organism, such as the skull opening, the implant installation can be performed according to the following steps:

[0180] (1) See Fig.17 As shown, the interface base 1 is temporarily fixed to the relevant tissue of the biological body such as the skull using bolts or bone screws.

[0181] (2) Installing a positioning component 6 in the interface base 1, taking pictures to obtain a vascular distribution image of biological tissues such as under the dura mater; based on the vascular distribution image, cutting the microneedle component 3 to remove the microneedles 310 corresponding to the blood vessel positions; and finally removing the positioning component 6.

[0182] Since there are blood vessels distributed in biological tissues such as under the dura mater, if the microneedles are not avoided during implantation, the blood vessels may rupture, causing head injuries, etc. Currently, the microneedles are implanted one by one, and the location of the blood vessels needs to be judged based on the doctor's experience to avoid them. However, this method is not accurate in locating the blood vessels and is prone to errors. On the other hand, it is difficult to perform large-scale one-time implantation of microneedles, which reduces the implantation efficiency.

[0183] To this end, the present application first uses the positioning component 6 to obtain a vascular distribution image to explore the vascular distribution of relevant tissues of the organism, such as under the dura mater, and then adjusts the microneedle component 3 to avoid important blood vessel locations for one-time implantation of multiple microneedles.

[0184] Specifically, in this application, see Fig.17 and Fig.18 As shown, the positioning component 6 includes a positioning filter 60 , and a criss-cross grid scale lines are arranged in the middle of the positioning filter 60 . The intersection position of the grid formed by the grid scale lines corresponds to the center of the comb hole 20 and the center of the microneedle guide hole 300 .

[0185] By taking an image and combining the grid scale lines on the positioning filter 60, the position where the blood vessels need to be avoided is accurately located, so as to determine the microneedles that need to be cut. Then, the microneedles at the corresponding positions are cut, so as to avoid the relevant tissues of the organism, such as the blood vessels under the dura mater, when the microneedle array is implanted as a whole, and to reduce the damage of the microneedles to the relevant tissues of the organism, such as the brain tissue and blood vessels, as much as possible.

[0186] Near-infrared light (700-2500nm, short-wave near-infrared 700-1100nm, long-wave near-infrared 1100-2500nm) is usually in the wavelength range of 700-900nm. The absorption of light by human tissue is relatively low, so near-infrared light can penetrate the skin and tissues deeply to form clear images. This band is called the "bio-optical window". In this wavelength range, the spectral absorption characteristics of hemoglobin show significant differences: near-infrared light around 760nm has a higher sensitivity to deoxygenated hemoglobin, while near-infrared light around 850nm is more sensitive to oxygenated hemoglobin. Using these band characteristics, the near-infrared imaging system can detect the difference in the content of oxygenated and deoxygenated hemoglobin in the blood, and use filters to capture images at different wavelengths by using a multi-wavelength excitation source, and use algorithms to analyze the light absorption characteristics of these images to generate high-contrast vascular images.

[0187] It is understandable that for ease of assembly and for precise positioning, see Fig.17 and Fig.18 As shown, an interface guide portion 11 extending axially along the base 10 is provided on the inner wall of the interface base 1, and a filter guide portion 601 matched with the interface guide portion 11 is provided on the side wall of the positioning filter 60; precise installation and positioning are achieved by the mutual cooperation between the filter guide portion 601 and the interface guide portion 11.

[0188] It can be understood that if the interface guide portion 11 is a groove formed by the depression 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 depression of the side wall of the positioning filter 60.

[0189] Since the interface base 1 is relatively small, in order to facilitate the placement or removal of the positioning filter 60, see Fig.18 As shown, the positioning assembly 6 also includes a clamping clip 61, and the positioning filter 60 is provided with a first clamping hole 602 adapted to the clamping clip 61; further, the first clamping holes 602 are formed into a pair and symmetrically distributed on the positioning filter 60.

[0190] The first clamping hole 602 can be selected as a through hole or a semi-counterfeit hole to prevent the legs of the clamping clip 61 from passing through the first clamping hole 602 and affecting the relevant tissues of the organism, such as brain tissue.

[0191] There are many choices for the material of the positioning filter 60, such as polymethyl methacrylate PMMA, polycarbonate PC, a multi-layer dielectric film, calcium fluoride or magnesium fluoride, etc., which meet the optical performance requirements.

[0192] The grid scale lines are made of black or dark materials, which have a high absorptivity in the near-infrared band and can form a clear contrast, and the grid scale lines can be relatively thin. The available materials are chromium, indium tin oxide, gold or platinum.

[0193] 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.

[0194] If etching is used to draw the grid lines, the depth of etching will also affect the imaging effect. Specifically, the depth of etching determines the optical contrast between the grid lines and the surrounding area. Deeper grid lines usually produce more obvious optical contrast, making the grid lines clearer in near-infrared imaging. However, grid lines that are too deep may cause increased optical scattering, weaken the mechanical strength of the filter, and increase the risk of surface damage and cracks, which may affect the quality of vascular imaging. The etching depth of the grid lines is 1-3μm. The etching depth within this range can provide sufficient optical contrast without significantly affecting the overall performance of the filter.

[0195] After comprehensive consideration, in practical applications, in order to ensure that the grid scale lines can be clearly identified without affecting the imaging of blood vessels, the line width of the grid scale lines is 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 scale line width should be about 75μm, and the specific selection should also be adjusted according to different application requirements.

[0196] The positioning component 6 also includes a near-infrared imaging system for capturing images.

[0197] (3) See Fig.19 As shown, the grate 2 is installed.

[0198] (4) Due to the presence of the dura mater, the existing solution is to remove the biological tissue such as the dura mater where the microneedle array is to be implanted. Although this method can successfully implant the microneedles, it is necessary to remove the biological tissue such as the dura mater, which is complicated and inconvenient to operate. Since the entire biological tissue such as the dura mater is removed, it may affect the blood vessels, etc. At the same time, after all, it is a piece of biological tissue such as the dura mater that is removed, which may cause significant damage to the entire biological tissue such as the dura mater.

[0199] In order to simplify the operation and reduce the degree of damage to biologically relevant tissues such as the dura mater, the present application provides a pre-punching kit 7, which only performs a punching operation on the biologically relevant tissues such as the dura mater where the microneedles need to be implanted, without the need to uncover the biologically relevant tissues such as the dura mater.

[0200] Specifically, see Fig. 20 As shown, a pre-punching kit 7 is installed on the grate 2. Based on the blood vessel distribution image, the pre-punching kit 7 is used to avoid blood vessels and punch related tissues of the organism such as the dura mater; after the punching is completed, the pre-punching kit 7 is removed.

[0201] Among them, see Fig.21 , Fig. 22 , Fig.23 , Fig.24 As shown, the pre-punching kit 7 includes a needle plate 70, a needle assembly and a pressing assembly. A needle hole 700 corresponding to the central position of the grate hole 20 of the grate 2 is arranged in the middle of the needle plate 70; the needle assembly includes a plurality of punching needles 71; the pressing assembly includes a pressing plate 72 for pressing the punching needles 71 downward, and a pressing rod 73 having one end connected to the pressing plate 72.

[0202] The punching needles 71 are arranged according to the blood vessel distribution map, and then the pressing rod 73 is pressed to drive the pressing plate 72 downward, so that the multiple punching needles 71 are punched into the relevant tissues of the organism such as the dura mater through the needle holes 700. After the punching is completed, the pre-punching kit 7 is taken out.

[0203] Since the penetration depth of the perforating needle 71 may be different in different biological tissues such as the brain, in order to adapt to different penetration depths, the embodiment of the present application provides a variety of solutions.

[0204] For example, see Fig.21 , Fig. 22 As shown, the pressing assembly also includes a sleeve shell 74, the pressing plate 72 is located in the sleeve shell 74, the diameter of the circumscribed circle of the pressing plate 72 is smaller than the diameter of the inscribed circle of the sleeve shell 74, and the pressing rod 73 is threadedly connected to the sleeve shell 74 to adjust the position of the pressing plate 72 in the sleeve shell 74; the outer wall of the pressing rod 73 is also provided with scale lines.

[0205] Insert all the punching needles 71 into the needle holes 700, adjust the position of the pressing plate 72 in the sleeve 74 by rotating the pressing rod 73, mark the position of the pressing plate 72 with the scale line, and adjust the required insertion depth. After adjustment, press to move the pressing assembly downward as a whole until it abuts against the needle plate 70 to achieve punching.

[0206] It is understandable that the pressing assembly can press all the microneedles down to make holes at once, or can press them down in batches to make holes. Fig.21As shown, the size of the pressing plate 72 is configured to cover a portion of the pinholes 700 on the needle plate 70, so that multiple microneedles distributed in an array in batches can be pressed down and punched together. For another example, the size of the pressing plate 72 is configured to cover all the pinholes 700 on the needle plate 70, so that one-time pressing and punching can be achieved. At this time, a casing guide portion (not shown in the figure) that matches the grate guide portion 21 can be provided on the side wall of the casing 74. For example, if the grate guide portion 21 is formed by the side wall of the grate 2 being recessed toward the side where the grate hole 20 is located, so that the outer wall of the grate guide portion 21 forms a groove body, which is adapted to the interface guide portion 11, and the inner wall of the grate guide portion 21 forms a column, then the casing guide portion is formed by the side wall of the casing 74 being recessed to form a groove body adapted to the column; similarly, if the grate guide portion 21 is convex, the casing guide portion is adaptively adjusted.

[0207] For example, see Fig.23 and Fig.24 As shown, the bottom of the pressure plate 72 is provided with an array of punch needle mounting holes 720. When punching, the punch needle 71 is inserted into the punch needle mounting hole 720; the pressure rod 73 includes a connecting rod 730, a connecting plate 731 and a pressing portion 732. One end of a plurality of connecting rods 730 is connected to the surrounding of the pressure plate 72, and the other end is connected to the surrounding of the connecting plate 731. The pressing portion 732 is installed on the connecting plate 731.

[0208] By pressing the pressing portion 732 downward, the pressing rod 73 as a whole is driven to carry the punching needle 71 through the needle hole 700 and into the dura mater until the pressing plate 72 abuts against the needle plate 70 .

[0209] In order to adapt to different insertion depths, the needle assembly has a variety of different specifications, which are distinguished by the length of the punching needle 71. The punching needle 71 of each needle assembly has a different length. According to the required punching depth, a punching needle 71 of appropriate length is selected to be inserted into the punching needle mounting hole 720.

[0210] Alternatively, the connecting rod 730 is detachably connected to the pressure plate 72, for example, by commonly used plug-in, snap-in, etc. The pressure plate 72 has a variety of different specifications, which are distinguished by the depth of the punch needle mounting hole 720. The punch needle mounting holes 720 of each pressure plate 72 have different depths. According to the required punching depth, a pressure plate 72 of appropriate length is selected to be plugged into the punch needle 71.

[0211] It is understandable that the pressing assembly can press down all the microneedles at once to punch holes, or can press down in batches to punch holes. For example, the size of the pressing plate 72 is configured to cover a portion of the pinholes 700 on the pin plate 70, so that multiple microneedles distributed in an array can be pressed down in batches to punch holes. For another example, Fig.23As shown, the size of the pressing plate 72 is configured to cover all the pinholes 700 on the needle plate 70, so that one-time pressing down punching can be achieved. Furthermore, a grate guide portion 21 is provided on the side wall of the grate 2, and a pressing plate guide portion 721 adapted to the grate guide portion 21 is provided on the side wall of the pressing plate 72.

[0212] For easy installation and positioning, see Fig.21 As shown, a needle plate guide portion 701 adapted to the grate guide portion 21 is provided on the side wall of the needle plate 70 .

[0213] For example, if the grate guide portion 21 is formed by the side wall of the grate 2 being recessed toward the side where the grate hole 20 is located, so that the outer wall of the grate guide portion 21 forms a groove body, which is adapted to the interface guide portion 11, and the inner wall of the grate guide portion 21 forms a column, then the pressure plate guide portion 721 is formed by the side wall of the pressure plate 72 being recessed to form a groove body adapted to the column, and the needle plate guide portion 701 is formed by the side wall of the needle plate 70 being recessed to form a groove body adapted to the column; similarly, if the grate guide portion 21 is convex, the pressure plate guide portion 721 and the needle plate guide portion 701 are adaptively adjusted.

[0214] In the present application, the material of the punching needle 71 is selected from stainless steel, titanium alloy or tungsten; the material of the needle plate 70 is selected from stainless steel, titanium, titanium aluminum vanadium alloy, nickel titanium alloy, cobalt chromium alloy or polyetheretherketone PEEK.

[0215] Since the interface base 1 is relatively small, in order to facilitate the insertion or removal of the needle plate 70, see Fig.21 As shown, the needle plate 70 is provided with second clamping holes 702 ; the second clamping holes 702 are matched with the clamping clips 61 of the positioning assembly 6 . Further, the second clamping holes 702 are formed into a pair and are symmetrically distributed on the needle plate 70 .

[0216] (5) After the drilling is completed, the microneedle assembly 3 is installed on the grate.

[0217] Specifically, see Figure 1 , Figure 4 , Figure 5 , Figure 6 , Figure 7 and Fig. 9As shown, first install the microneedle base 30. When using 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 on the second mounting auxiliary hole 3112 of the microneedle mounting plate 311, so that the microneedle needle tips are aligned one by one with the grate holes 20 of the grate below. Then remove the ferrule 3151, use the implantation device 5 to slowly move the microneedle array structure 312 as a whole downward along the guide rod 3150, and stop after the microneedle is implanted downward to a predetermined depth, and 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 lift the interface base 1, the grate 2 and the microneedle base 30 upward at the same time until the microneedle mounting plate 311 is smoothly nested into the microneedle base 30.

[0218] Remove the guide rod 3150 and use the spacer blocks 15 around the outer ring of the interface base 1 for temporary support, such as Figure 1 shown.

[0219] After waiting for the bio-related tissues such as tissue fluid to dissolve the degradable biocompatible material used to temporarily fix the soft needle and the hard needle, take out the hard needle. At this time, the soft needle remains in the bio-related tissues such as the brain tissue under the dura mater, fixing the communication module 40 and the battery 41. Remove the padding block 15, and install the lifted interface base 1, the grate 2, the microneedle base 30 and the microneedle mounting plate 311 downward into place. At this time, the soft needle has a certain redundant part to avoid the displacement of the bio-related tissues such as the brain tissue during the movement, which may cause certain damage to the brain tissue or the soft needle. Then fill the package with glue to protect the circuit. And fix it with bolts or bone screws. Install the top cover 14, and then suture the scalp.

[0220] In summary, the present application integrates multiple microneedles and implants them at one time, which greatly improves the implantation efficiency compared to the traditional method of implanting single electrodes one by one.

[0221] This application not only achieves minimally invasive implantation, but also effectively avoids the damage caused by hard microneedle electrodes to the patient's biological tissues such as brain tissue during movement. The use of flexible microneedle electrodes can avoid the mechanical properties of the electrodes matching the brain tissue after implantation, and brain movement will not cause displacement and mutual shearing between the brain tissue and the electrodes, so that the activity of the same neuron can be tracked for a long time.

[0222] The single device in this application has a higher number of channels, and there are also multiple detection sites distributed in the longitudinal direction of the electrode. It can simultaneously record single neuron signals Spike and local field potential LFP, and can collect three-dimensional high-density EEG signals, promote accurate and smooth mind-controlled movements, and realize high-throughput bidirectional neural signal collection and regulation.

[0223] The built-in integrated circuit chip can achieve local digitization, which is beneficial to reduce the transmission loss of neural signals and improve the signal-to-noise ratio.

[0224] The overall brain-computer interface device has the characteristics of high throughput, two-way communication, minimally invasive implantation, little damage during use, and high signal-to-noise ratio, which ensure the long-term stability of the device after implantation, making the brain-computer interface implantation process efficient, safe, and controllable and standardized.

[0225] The above description is only a specific implementation of the present application, so that those skilled in the art can understand or implement the present application. Various modifications to these embodiments will be apparent to those skilled in the art, and the general principles defined herein can be implemented in other embodiments without departing from the spirit or scope of the present application. Therefore, the present application will not be limited to the embodiments shown herein, but will conform to the widest range consistent with the principles and novel features applied for herein.

Claims

1. A brain-computer interface device, characterized in that: It includes: An interface base (1) is provided with a through channel, and a bottom support (10) is provided on the inner wall of the through channel, and a top support (13) is formed on the upper edge of the interface base (1); A grate (2) is mounted on the interface base (1) and supported on the base (10), wherein the middle portion of the grate (2) is provided with grate holes (20) distributed in an array; A microneedle assembly (3), comprising a microneedle base (30) and a microneedle mechanism (31), wherein the microneedle base (30) is mounted on the grate (2) and has microneedle guide holes (300) distributed in an array in the middle thereof, and the microneedle mechanism (31) is mounted on the microneedle base (30), and its microneedles (310) sequentially pass through the microneedle guide holes (300), the grate holes (20) and the through-channel of the interface base (1); Furthermore, the diameter of the grate holes (20) is larger than the diameter of the microneedle guide holes (300).

2. The brain-computer interface device according to claim 1, characterized in that: An interface guide portion (11) extending axially along the base (10) is provided on the inner wall of the interface base (1); A grate guide portion (21) adapted to the interface guide portion (11) is provided on the side wall of the grate (2); A microneedle guide portion (301) adapted to the grate guide portion (21) is provided on the side wall of the microneedle base (30).

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

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

5. The brain-computer interface device according to 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 according to claim 1, characterized in that: The brain-computer interface device further comprises a communication component (4), wherein the communication component (4) comprises a communication module (40), and the communication module (40) is connected to the microneedle mechanism (31).

7. The brain-computer interface device according to claim 6, characterized in that: A microneedle guide portion (301) is provided on the side wall of the microneedle base (30); A communication module guide portion (400) adapted to the microneedle guide portion (301) is provided on the side wall of the communication module (40).

8. The brain-computer interface device according to claim 6, characterized in that: The communication module (40) is provided with a temporary fixing groove (401) for temporarily fixing it on the implant device (5).

9. The brain-computer interface device according to claim 1, characterized in that: The microneedle mechanism (31) comprises: A 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 clamped on the clamping slot (3110) and is used to be electrically connected to a communication module (40). The microneedle array structure (312) has a row of microneedles (310) that are spaced apart.

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

11. The brain-computer interface device according to claim 9, characterized in that: The microneedle mechanism (31) further comprises an integrated circuit chip (313) and a microstrip line (314) for electrically connecting to the communication module (40); The microneedle array structure (312) is connected to the integrated circuit chip (313), and the microneedle array structure (312) is clamped on the clamping 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 according to claim 9, characterized in that: A microneedle guide portion (301) is provided on the side wall of the microneedle base (30); 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).

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

14. The brain-computer interface device according to claim 13, characterized in that: The microneedle mechanism (31) also includes an installation auxiliary component (315), which includes a sleeve (3151) and a guide rod (3150) one end of which is used to be inserted into the first installation auxiliary hole (302) and the other end of which is used to be inserted into the guide portion (3111) of the installation plate, and the sleeve (3151) is detachably mounted on the guide rod (3150).

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

16. The brain-computer interface device according to 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 according to claim 9, characterized in that: The microneedle array structure (312) comprises a hard needle (3120) and a soft needle (3121) for connecting to a communication module (40); the soft needle (3121) is fixed to the surface of the hard needle (3120) via a fixed structural member (3122); the material of the fixed structural member (3122) is a degradable biocompatible material.

18. The brain-computer interface device according to 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) comprises 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 body electrode (31211) and the hard needle body electrode (31201) fixed to each other.

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

20. The brain-computer interface device according to claim 17, characterized in that: The degradable biocompatible material includes one or more of silk protein, spider silk protein, gelatin and PEG.

21. A method for installing a brain-computer interface device as claimed in claim 1, characterized in that: It includes: The interface base (1), the grate (2) and the microneedle assembly (3) are installed in sequence.

22. The method for installing a brain-computer interface device according to claim 21, wherein: After installing the interface base (1) and before installing the grate (2), the installation method further comprises: Installing a positioning assembly (6) in the interface base (1); Take pictures to obtain images of vascular distribution; Based on the blood vessel distribution image, the microneedle assembly (3) is cut to remove the microneedles (310) at the positions corresponding to the blood vessels; Remove the positioning assembly (6).

23. The method for installing a brain-computer interface device according to claim 22, wherein: The positioning component (6) comprises: The positioning filter (60) has crisscross grid scale lines arranged in the middle, and the intersection position of the grid formed by the grid scale lines corresponds to the center of the grate hole (20) and the center of the microneedle guide hole (300).

24. The method for installing a brain-computer interface device according to claim 23, wherein: An interface guide portion (11) extending axially along the base (10) is provided on the inner wall of the interface base (1), and a filter guide portion (601) adapted to the interface guide portion (11) is provided on the side wall of the positioning filter (60); And / or, the positioning assembly (6) further comprises a clamping clamp (61), and the positioning filter (60) is provided with a first clamping hole (602) adapted to the clamping clamp (61); And / or, the positioning filter (60) is made of polymethyl methacrylate (PMMA), polycarbonate (PC), a multi-layer 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) also includes a near-infrared imaging system for capturing images.

25. The method for installing a brain-computer interface device according to claim 22, wherein: After installing the grate (2) and before installing the microneedle assembly (3), the installation method further comprises: Installing a pre-punching kit (7) on the grate (2); Based on the blood vessel distribution image, using the pre-punching kit (7), avoiding blood vessels and performing punching; After the punching is completed, the pre-punching kit (7) is removed.

26. The method for installing a brain-computer interface device according to claim 25, characterized in that: The pre-punching kit (7) comprises: A needle plate (70), wherein a needle hole (700) corresponding to the center position of the grate hole (20) of the grate (2) is provided in the middle of the needle plate (70); A needle assembly comprising a plurality of punching needles (71); The pressing assembly comprises a pressing plate (72) for pressing the punching needle (71) downward, and a pressing rod (73) one end of which is connected to the pressing plate (72).

27. The method for installing a brain-computer interface device according to claim 26, wherein: A grate guide portion (21) is provided on the side wall of the grate (2), and a needle plate guide portion (701) adapted to the grate guide portion (21) is provided on the side wall of the needle plate (70); And / or, the material of the punching needle (71) is selected from stainless steel, titanium alloy or tungsten; And / or, the needle plate (70) is made of stainless steel, titanium, titanium-aluminum-vanadium alloy, nickel-titanium alloy, cobalt-chromium alloy or polyetheretherketone (PEEK); And / or, a second clamping hole (702) is provided on the needle plate (70); And / or, the size of the pressing plate (72) is configured to cover a portion or all of the needle holes (700) on the needle plate (70).

28. The method for installing a brain-computer interface device according to claim 26, wherein: The pressing assembly further comprises a casing (74), the pressing plate (72) being located inside the casing (74), and the pressing rod (73) being threadedly connected to the casing (74) to adjust the position of the pressing plate (72) inside the casing (74); The outer wall of the pressure rod (73) is also provided with scale lines.

29. The method for installing a brain-computer interface device according to claim 26, wherein: The bottom of the pressing plate (72) is provided with punch needle mounting holes (720) distributed in an array; The pressure rod (73) comprises a connecting rod (730), a connecting plate (731) and a pressing portion (732); one end of a plurality of 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); and the pressing portion (732) is mounted on the connecting plate (731).

30. The method for installing a brain-computer interface device according to claim 29, wherein: The needle assembly has a plurality of different specifications, and the lengths of the punching needles (71) of each needle assembly are different; And / or, the connecting rod (730) is detachably connected to the pressing plate (72), the pressing plate (72) has a plurality of different specifications, and the hole depths of the punch needle mounting holes (720) of the pressing plates (72) are different; And / or, the size of the pressing plate (72) is configured to cover a portion of the needle holes (700) on the needle plate (70); or a grate guide portion (21) is provided on the side wall of the grate (2), the size of the pressing plate (72) is configured to cover all the needle holes (700) on the needle plate (70), and a pressing plate guide portion (721) adapted to the grate guide portion (21) is provided on the side wall of the pressing plate (72).

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