Brain-computer interface device

Abstract

The utility model relates to a brain-computer interface device which is characterized in that an interface base is provided with a through channel, and the inner wall of the through channel is provided with a bottom 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. 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 in 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) are technologies that enable human-computer interaction by acquiring electrical signals from the brain through electrode arrays placed on the surface of biological tissue, such as the scalp, without requiring incision of the skull or implantation of electrodes in biological tissue, such as the brain. Compared to invasive BCIs, these technologies offer advantages such as safety, simplicity, and ease of use. However, they suffer from lower signal quality and are susceptible to external interference, complicating signal processing.

[0005] An invasive brain-computer interface (BCI) involves inserting electrodes or probes into biological tissue, such as the cerebral cortex, to acquire neural signals. Compared to non-invasive BCIs, invasive BCIs offer higher signal accuracy and stability, better control precision and response speed, and can enable more complex movement and interaction tasks.

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

[0007] For example, since probes are usually thin, they may face mechanical stability issues 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, 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, thereby affecting signal quality and reducing 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] An embodiment of the present application provides a brain-computer interface device to solve the problem of low probe reliability in related technologies.

[0011] The present invention provides a brain-computer interface device, which includes:

[0012] An interface base is provided with a through channel, and a bottom support is provided on the inner wall of the through channel;

[0013] A grate is mounted on the interface base and supported on the bottom bracket, wherein the middle portion 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 arranged in an array in the center 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 base 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 adapted to the grate guide portion is provided 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 a constant diameter along the axial direction of the base;

[0021] At least another of the interface guide portions is a guide portion that changes diameter along the axial direction of the base, and the bottom diameter of the interface guide portion is greater than the top diameter.

[0022] In some embodiments, the interface guide portion is a groove formed by a depression of 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 further 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 provided 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 to 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 for electrically connecting with the communication module. The microneedle array structure comprises 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 the slot groups comprising 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 to a communication module;

[0035] The microneedle array structure is connected to the integrated circuit chip, and the microneedle array structure is fixed to 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] The side wall of the microneedle mounting plate is provided with a mounting plate guide portion adapted to the microneedle guide portion.

[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 mounting plate guide portion is formed by the side wall of the microneedle mounting plate being recessed toward the middle area of ​​the microneedle mounting plate;

[0041] A first auxiliary mounting hole is provided on the microneedle base 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 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 includes a soft needle tail and at least one soft needle body electrode formed on the soft needle tail;

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

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

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

[0051] The beneficial effects of the technical solution provided by this application include:

[0052] In the brain-computer interface device provided herein, microneedles sequentially pass through the microneedle guide holes, grate holes, and the through-channel of the interface base from top to bottom before entering the relevant tissue of the organism. Because the grate holes have a larger diameter than the microneedle guide holes, the hole size decreases from bottom to top. The topmost microneedle guide holes are designed to be as close to the microneedle size as possible, allowing them to serve as positioning and guidance for microneedle implantation, ensuring high precision in implant placement. Because microneedles may tilt slightly during processing, assembly, and implantation, the design scheme of enlarging the grate holes in the lower layer is intended to ensure that even if the microneedle tilts slightly as it passes through the implantation channel from top to bottom, the extra space in the lower layer, due to the larger holes in the lower layer than in the upper layer, acts as a buffer. This buffer acts as a buffer when the microneedle tilts, making it less likely that the microneedle will deform or break due to contact with the sidewalls of the grate holes, thereby improving the mechanical stability of the microneedle.

[0053] It can be seen that the design of the multi-layer hole size gradually increasing from top to bottom in the present application ensures the reliability of microneedle implantation. BRIEF DESCRIPTION OF THE DRAWINGS

[0054] In order to more clearly illustrate the technical solutions in the embodiments of the present application, the following briefly introduces the drawings required for use in the description of the embodiments. 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 any creative work.

[0055] Figure 1 An exploded diagram of a brain-computer interface device provided in an embodiment of the present application;

[0056] Figure 2 Schematic diagram of the interface base provided in an embodiment of the present application;

[0057] Figure 3 A schematic diagram of a grate provided in an embodiment of the present application;

[0058] Figure 4 A schematic diagram of a microneedle assembly provided in an embodiment of the present application;

[0059] Figure 5 Schematic diagram of the microneedle base provided in the embodiment of the present application;

[0060] Figure 6 Schematic diagram of the microneedle mounting plate provided in an embodiment of the present application;

[0061] Figure 7 Schematic diagram of the microneedle mechanism provided in the embodiment of the present application;

[0062] Figure 8 Schematic diagram of the assembly of the microneedle base and the microneedle mounting plate provided in an embodiment of the present application;

[0063] Figure 9 A schematic diagram of an implant device provided in an embodiment of the present application;

[0064] Figure 10 Schematic diagram of the microneedle array structure provided in an embodiment of the present application (when torn off);

[0065] Figure 11 Schematic diagram of the microneedle array structure provided in an embodiment of the present application (when assembled);

[0066] Figure 12 A schematic diagram of a barb provided in an embodiment of the present application;

[0067] Figure 13 A schematic diagram of installing an integrated circuit chip according to an embodiment of the present application;

[0068] Figure 14 A schematic diagram of a fixed structural member provided in an embodiment of the present application;

[0069] Figure 15 Schematic diagram of a cutting soft needle electrode provided in an embodiment of the present application;

[0070] Figure 16 A schematic diagram of a reverse solder joint of an integrated circuit chip provided in an embodiment of the present application;

[0071] Figure 17 A schematic diagram of the installation and positioning components provided in an embodiment of the present application;

[0072] Figure 18 A schematic diagram of a positioning component provided in an embodiment of the present application;

[0073] Figure 19 A schematic diagram of the installation grate provided in an embodiment of the present application;

[0074] Figure 20 Schematic diagram of the installation pre-punched kit provided in an embodiment of the present application;

[0075] Figure 21 A schematic diagram of a pre-punching kit provided in an embodiment of the present application;

[0076] Figure 22 for Figure 21 Another perspective diagram;

[0077] Figure 23 A schematic diagram of another pre-punched kit provided in an embodiment of the present application;

[0078] Figure 24 Schematic diagram of the pressing assembly provided in an embodiment of the present application.

[0079] In the picture:

[0080] 1. Interface base; 10. Bottom support; 11. Interface guide; 12. Ear seat; 13. Top support; 14. Top cover; 15. Heightening block;

[0081] 2. grate; 20. grate holes; 21. grate guide;

[0082] 3. Microneedle assembly; 30. Microneedle base; 300. Microneedle guide hole; 301. Microneedle guide portion; 302. First mounting auxiliary hole; 31. Microneedle mechanism; 310. Microneedle; 311. Microneedle mounting plate; 3110. Slot; 3111. Mounting plate guide portion; 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. Fixed structure; 313. Integrated circuit chip; 314. Microstrip line; 315. Mounting auxiliary assembly; 3150. Guide rod; 3151. Clamping sleeve; 31510. Sleeve; 31511. Operating unit;

[0083] 4. Communication assembly; 40. Communication module; 400. Communication module guide; 401. Temporary fixing groove; 41. Battery;

[0084] 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;

[0085] 6. Positioning assembly; 60. Positioning filter; 601. Filter guide; 602. First clamping hole; 61. Clamping clip;

[0086] 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. Housing. DETAILED DESCRIPTION

[0087] To make the purpose, technical solutions, and advantages of the embodiments of this application more clear, the technical solutions in the embodiments of this application will be clearly and completely described below in conjunction with the drawings in the embodiments of this application. Obviously, the described embodiments are part of the embodiments of this application, not all of the embodiments. Based on the embodiments in this application, all other embodiments obtained by ordinary technicians in this field without making creative efforts are within the scope of protection of this application.

[0088] 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 grate 2 and a microneedle assembly 3.

[0089] 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 the relevant tissue of the organism, such as the skull opening, so that the interface base 1 can be placed in the relevant tissue of the organism, such as the skull opening.

[0090] The grate 2 is mounted 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.

[0091] 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 the middle part of the microneedle base 30 is provided with microneedle guide holes 300 distributed in an array. 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 holes 300, the grate holes 20 and the through channel of the interface base 1 in sequence.

[0092] The center of the microneedle guide hole 300 corresponds one-to-one to the center of the grate hole 20 , and the aperture of the grate hole 20 is larger than the aperture of the microneedle guide hole 300 .

[0093] In the brain-computer interface device provided in this application, the microneedle 310 passes 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 enters the relevant tissue of the organism, such as brain tissue. Because the aperture of the grate hole 20 is larger than the aperture of the microneedle guide hole 300, the size of the holes in each layer decreases from bottom to top. The topmost microneedle guide hole 300 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 precision of the implantation position. Since the microneedle processing, assembly and implantation process may produce a certain degree of tilt, the design scheme of enlarging the lower layer of the grate 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 grate hole 20, thereby improving the mechanical stability of the microneedle.

[0094] It can be seen that the design of the multi-layer hole size gradually expanding from top to bottom in the present application 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.

[0095] 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.

[0096] It is understood that the shape of the interface base 1 can be selected according to actual needs, including but not limited to circular, and preferably circular. 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.

[0097] 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, the side wall of the grate 2 is provided with a grate guide portion 21 adapted to the interface guide portion 11; see Figure 5 As shown, a microneedle guide portion 301 adapted to the grate guide portion 21 is provided on the side wall of the microneedle base 30 .

[0098] 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.

[0099] The interface guide portion 11 may also be a groove formed by a depression in the inner wall of the interface base 1 , in which case the grate guide portion 21 and the microneedle guide portion 301 may be adaptively adjusted.

[0100] See also Figure 2As shown, there are at least two interface guides 11. At least one of these interface guides 11 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 this interface guide 11 is larger than the top diameter. The combination of these two interface guides achieves both high-precision guidance and stable installation, facilitating alignment and securement during subsequent component installation.

[0101] 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 becomes smaller as it goes up.

[0102] The interface guide part 11 of constant diameter helps to provide higher guiding accuracy, while the design of the interface guide part 11 with a variable diameter has the following advantages: First, it helps to fix the bottom of the interface guide part 11, and the thicker part at the bottom can provide a larger contact area, making the fixation of the interface guide part 11 at the bottom more stable and less likely to loosen or move. A larger diameter also means greater anti-torsion ability, which is especially important when the interface guide part 11 is subjected to lateral force or torsional force. 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 part 11 during long-term use. Third, the overall weight of the interface guide part 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 part 11 maintains good positioning accuracy during use.

[0103] It can be understood that the above-mentioned interface guide parts 11 with equal diameters can be arranged in groups of two and symmetrically. Similarly, the above-mentioned interface guide parts 11 with variable diameters can be arranged in groups of two and symmetrically.

[0104] See also Figure 2 As shown, the interface base 1 is further provided with an ear seat 12, which can appear in pairs. The ear seat 12 is used to provide a fixing point for a bolt to fix the brain-computer interface device on relevant tissues of the organism, such as the skull.

[0105] See also Figure 1 As shown, the interface base 1 is also configured 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.

[0106] 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 up the communication module 40, wireless transmission of the collected signal is achieved. The battery 41 provides power to the communication module 40. The battery 41 can be installed in different locations such as the head where the brain-computer interface is implanted, the chest, or behind the ear.

[0107] 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 outer periphery of the microneedle mounting plate 311 can be circular and adapted to 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.

[0108] In the microneedle mechanism 31 provided in the present application, a row of multiple microneedles 310 is provided 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 use of the microneedle array in the present application can realize multi-channel high-throughput bidirectional neural signal acquisition and regulation.

[0109] In addition, when implanting the present invention, multiple roots are implanted at once in an array. Compared with implanting one root at a time, the implantation efficiency of the present invention is significantly improved.

[0110] 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 several slot groups, each of which includes slots 3110 located on two opposing 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. The two ends of the two microneedle array structures 312 are respectively secured to the two slots 3110, ensuring a secure installation without affecting the arrangement of the microneedles 310 in the middle.

[0111] See also Figure 4 and Figure 7As shown, multiple 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 .

[0112] See also Figure 4 and Figure 7 As shown, the microneedle mechanism 31 also 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 fixed to the card 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. The built-in digital signal processor, namely the integrated circuit chip 313, can achieve local digitization, which helps reduce transmission loss of neural signals and improve the signal-to-noise ratio.

[0113] 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 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 .

[0114] To match the grate guide portion 21, the microneedle guide portion 301 can be formed by recessing the sidewall of the microneedle base 30 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 that fits with the column of the grate guide portion 21, while the inner wall of the microneedle guide portion 301 forms a column. To match, the mounting plate guide portion 3111 can be formed by recessing the sidewall of the microneedle mounting plate 311 toward the central region of the microneedle mounting plate 311, so that the sidewall of the mounting plate guide portion 3111 forms a groove that fits with the column of the microneedle guide portion 301.

[0115] Similarly, the microneedle guide portion 301 can 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.

[0116] 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 provided on the microneedle guide portion 301 .

[0117] The first auxiliary installation hole 302 is used in conjunction with the auxiliary installation component 315 .

[0118] 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 installation plate. The above-mentioned guide rod 3150 can use a screw or the like, and the sleeve 3151 can be detachably mounted on the guide rod 3150.

[0119] The first auxiliary installation holes 302 can be provided in multiple numbers along the periphery, such as Figure 6 There are four in the set.

[0120] 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 ferrule 3151 on the guide rod 3150 supports 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 through the surrounding mounting auxiliary components 315. The mounting auxiliary components 315 here serve to support 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 tips of the microneedles 310 can only just penetrate the microneedle guide holes 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 are matched and fixed with the microneedle guide parts 301 of the microneedle base 30, the guide rod 3150 can be removed.

[0121] See also Figure 4As shown, the ferrule 3151 includes a sleeve 31510 and an operating part 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. By pulling the operating part 31511 outward, the guide rod 3150 can open the opening of the sleeve 31510, thereby pulling off the ferrule 3151.

[0122] To facilitate microneedle implantation, see Figure 1 、 Figure 6 and Figure 9 As shown, the microneedle mounting plate 311 is further provided with a second mounting auxiliary hole 3112 for connecting the implant device 5 .

[0123] Among them, the implantation device 5 includes an implantation plate 50, and a plurality of implantation rods 51 for being inserted into the second mounting auxiliary hole 3112 are provided at the bottom of the implantation plate 50. A main rod 52 is provided at the top of the implantation plate 50, and a limiting sleeve 53 is provided on the main rod 52, and a multi-joint arm 54 is provided on the limiting sleeve 53.

[0124] During 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 horizontally by the limiting sleeve 53, and then the main rod 52 is driven downward to push the microneedle mounting plate 311 downward, thereby realizing microneedle implantation.

[0125] See also Figure 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 .

[0126] 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 Figure 9 As shown, the bottom of the implantation plate 50 is provided with two second elastic claws 500 that are opposite and spaced apart. When the microneedle is implanted, as shown in FIG. 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.

[0127] 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 .

[0128] 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.

[0129] To address this issue, see Figure 10 and Figure 14 As shown, the microneedle array structure 312 provided in the present application includes a hard needle 3120 and a soft needle 3121. The soft needle 3121 is fixed to the surface of the hard needle 3120 through a fixed structural member 3122. The material of the fixed structural member 3122 is a degradable biocompatible material; the communication module 40 is connected to the soft needle 3121.

[0130] This 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 organism-related 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 organism-related tissues such as brain tissue. Since the soft needle has low hardness and is friendly to organism-related tissues such as brain tissue, this application not only realizes minimally invasive implantation, but also can effectively avoid damage caused by the hard needle when it moves in organism-related tissues such as brain tissue.

[0131] See also Figure 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 fixation through gluing, and the soft needle body electrode 31211 is fixed to the hard needle body electrode 31201, mainly by fixation through degradable biocompatible material; the microneedle 310 includes the soft needle body electrode 31211 and the hard needle body electrode 31201 fixed to each other.

[0132] The overall preparation method of the microneedle array structure 312 is as follows:

[0133] Step 1: See Figure 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.

[0134] See also Figure 12As shown, a barb 31212 is provided at the needle tip of the soft needle electrode 31211 to facilitate the withdrawal of the hard needle after implantation and the long-term fixation of the soft needle.

[0135] Step 2: See Figure 10 As shown, the soft needle 3121 is torn off along one corner from the soft needle tail 31210, 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.

[0136] Step 3: Reattach the soft needle 3121 to the hard needle 3120. If the previously torn part cannot be attached, you can fix it with glue or tape.

[0137] Step 4: See Figure 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.

[0138] Step 5: See Figure 14 As shown, the needle tips of the microneedle array structure 312 are 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.

[0139] Step 6: See Figure 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.

[0140] Step 7: See Figure 16 As shown, the reverse soldering of the microstrip line 314 and the integrated circuit chip 313 is completed, and the excess soft needles on the top are cut off to facilitate the removal of the hard needles later.

[0141] The card slot 3110 clamps the integrated circuit chip 313, 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. Therefore, the microneedle array structure 312 can be fixed by clamping the integrated circuit chip 313 through the card slot 3110.

[0142] An embodiment of the present application also provides a method for installing a brain-computer interface device, which includes the following steps: installing the interface base 1, the grate 2 and the microneedle assembly 3 in sequence.

[0143] Specifically, after the surgery is completed and the target brain area is exposed at the relevant tissue of the organism, such as the skull opening, the implant installation can be performed according to the following steps:

[0144] (1) See Figure 17 As shown, the interface base 1 is temporarily fixed to the relevant tissue of the organism such as the skull using bolts or bone screws.

[0145] (2) Installing a positioning component 6 in the interface base 1 and photographing to obtain an image of the blood vessel distribution of biological tissues such as the dura mater; based on the blood vessel 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.

[0146] Since there are blood vessels distributed in biological tissues such as the dura mater, if the microneedles are not avoided during implantation, the blood vessels may rupture, causing head injuries. Currently, microneedles are implanted one by one, and the location of the blood vessels needs to be judged in combination with 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 microneedle implantation, which reduces the implantation efficiency.

[0147] 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 vascular locations for one-time implantation of multiple microneedles.

[0148] Specifically, in this application, see Figure 17 and Figure 18 As shown, the positioning component 6 includes a positioning filter 60 , and a crisscross grid scale line is set in the middle of the positioning filter 60 . The intersection position of the grid formed by the grid scale line corresponds to the center of the grate hole 20 and the center of the microneedle guide hole 300 .

[0149] By capturing the image and combining it with the grid lines on the positioning filter 60, the microneedles that need to be trimmed are accurately located at locations that need to be avoided. The microneedles at the corresponding locations are then trimmed, thereby avoiding relevant tissues such as blood vessels under the dura mater during implantation of the entire microneedle array, thereby minimizing damage to relevant tissues such as brain tissue and blood vessels.

[0150] Near-infrared light (700-2500nm, short-wave near-infrared 700-1100nm, long-wave near-infrared 1100-2500nm) typically falls within the wavelength range of 700-900nm. Human tissue has relatively low absorption of light, allowing near-infrared light to penetrate deeply into skin and tissue, producing clear images. This wavelength range is known as the "bio-optical window." Within this wavelength range, the spectral absorption properties of hemoglobin exhibit significant differences: near-infrared light around 760nm is highly sensitive to deoxygenated hemoglobin, while near-infrared light around 850nm is more sensitive to oxyhemoglobin. Leveraging these wavelength characteristics, near-infrared imaging systems can detect differences in the levels of oxygenated and deoxygenated hemoglobin in blood. By using filters and a multi-wavelength excitation source to capture images at different wavelengths, algorithms analyze the light absorption characteristics of these images to produce high-contrast vascular images.

[0151] It is understandable that for ease of assembly and for precise positioning, see Figure 17 and Figure 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 adapted to the interface guide portion 11 is provided on the side wall of the positioning filter 60; precise installation and positioning are achieved by utilizing the mutual cooperation between the filter guide portion 601 and the interface guide portion 11.

[0152] 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.

[0153] Since the interface base 1 is relatively small, in order to facilitate the placement or removal of the positioning filter 60, see Figure 18 As shown, the positioning component 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 above-mentioned first clamping holes 602 form a pair and are symmetrically distributed on the positioning filter 60.

[0154] The first clamping hole 602 can be selected as a through hole or a semi-sunk hole to prevent the legs of the clamping clip 61 from passing through the first clamping hole 602 and affecting relevant tissues of the organism, such as brain tissue.

[0155] There are many options for the material of the positioning filter 60, such as polymethyl methacrylate (PMMA), polycarbonate (PC), a multi-layer dielectric film, calcium fluoride, magnesium fluoride, or other materials that meet the optical performance requirements.

[0156] The grid scale lines are made of black or dark materials that have a high absorptivity in the near-infrared band and can form a clear contrast. The grid scale lines can be relatively thin. Available materials include chromium, indium tin oxide, gold, or platinum.

[0157] The grid lines on the positioning filter 60 are processed by photolithography or laser etching to obtain a high-resolution and high-contrast grid pattern.

[0158] 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.

[0159] After comprehensive consideration, in actual 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 larger 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 around 75μm. The specific selection should also be adjusted according to different application requirements.

[0160] The positioning component 6 also includes a near-infrared imaging system for capturing images.

[0161] (3) See Figure 19 As shown, install the grate 2.

[0162] (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. At the same time, since it is only a piece of biological tissue such as the dura mater that is removed, it may cause significant damage to the entire biological tissue such as the dura mater.

[0163] In order to simplify the operation and reduce the degree of damage to biological tissues such as the dura mater, the present application provides a pre-punching kit 7, which only performs a punching operation on the biological tissues such as the dura mater where the microneedles need to be implanted, without the need to uncover the biological tissues such as the dura mater.

[0164] Specifically, see Figure 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 relevant tissues of the organism such as the dura mater; after the punching is completed, the pre-punching kit 7 is removed.

[0165] Among them, see Figure 21 、 Figure 22 、 Figure 23 、 Figure 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 center position of the grate hole 20 of the grate 2 is provided 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 pressure rod 73 with one end connected to the pressing plate 72.

[0166] 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 tissue of the organism, such as the dura mater, through the needle holes 700. After the punching is completed, the pre-punching kit 7 is removed.

[0167] Since the penetration depth of the punching 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 multiple solutions.

[0168] For example, see Figure 21 、 Figure 22 As shown, the pressing assembly also includes a sleeve 74, the pressing plate 72 is located in the sleeve 74, the diameter of the circumscribed circle of the pressing plate 72 is smaller than the diameter of the inscribed circle of the sleeve 74, and the pressing rod 73 is threadedly connected to the sleeve 74 to adjust the position of the pressing plate 72 in the sleeve 74; the outer wall of the pressing rod 73 is also provided with scale lines.

[0169] Insert all the punching needles 71 into the needle holes 700, adjust the position of the pressure plate 72 in the housing 74 by rotating the pressure rod 73, mark the position of the pressure 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 contacts the needle plate 70 to achieve punching.

[0170] It is understood 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. Figure 21As shown, the size of the pressing plate 72 is configured to cover a portion of the pinholes 700 on the needle plate 70. In this case, multiple microneedles distributed in an array can be pressed down and punched in batches. For another example, the size of the pressing plate 72 is configured to cover all the pinholes 700 on the needle plate 70. In this case, a single press punching operation can be achieved. In this case, a housing guide portion (not shown) that is compatible with the grate guide portion 21 can be provided on the side wall of the housing 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.

[0171] For example, see Figure 23 and Figure 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 multiple 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.

[0172] By pressing the pressing portion 732 downward, the pressing rod 73 is driven as a whole 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 .

[0173] 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.

[0174] 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 punching needle mounting hole 720. The punching needle mounting hole 720 of each pressure plate 72 has a different depth; according to the required punching depth, a pressure plate 72 of appropriate length is selected to be plugged into the punching needle 71.

[0175] It is understood 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 needle plate 70. In this case, multiple microneedles distributed in an array can be pressed down in batches to punch holes. For another example, Figure 23As shown, the size of the pressing plate 72 is configured to cover all the needle holes 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.

[0176] To facilitate installation and positioning, see Figure 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 .

[0177] 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.

[0178] 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 polyether ether ketone PEEK.

[0179] Since the interface base 1 is relatively small, in order to facilitate the insertion or removal of the needle plate 70, see Figure 21 As shown, the needle plate 70 is provided with second clamping holes 702 ; the second clamping holes 702 are adapted to the clamping clips 61 of the positioning assembly 6 . Furthermore, the second clamping holes 702 are arranged in pairs and symmetrically distributed on the needle plate 70 .

[0180] (5) After the holes are punched, the microneedle assembly 3 is mounted on the grate.

[0181] Specifically, see Figure 1 、 Figure 4 、 Figure 5 、 Figure 6 、 Figure 7 and Figure 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 the predetermined depth. Release the temporary fixation of the interface base 1, and 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, grate 2 and microneedle base 30 upward at the same time until the microneedle mounting plate 311 is smoothly nested into the interior of the microneedle base 30.

[0182] Remove the guide rod 3150 and use the spacer blocks 15 around the outer ring of the interface base 1 as temporary support. Figure 1 shown.

[0183] 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, remove 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 spacer block 15, and install the lifted interface base 1, grate 2, microneedle base 30 and microneedle mounting plate 311 together. At this time, the soft needle has a certain redundant part to avoid the displacement caused by the movement of bio-related tissues such as brain tissue, which may pull on the soft needle and cause certain damage to the brain tissue or 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.

[0184] 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.

[0185] This application achieves minimally invasive implantation while effectively avoiding damage to the patient's biological tissue, such as brain tissue, caused by movement of rigid microneedle electrodes. The use of flexible microneedle electrodes can avoid displacement and shearing between brain tissue and the electrodes after intracranial implantation, as their mechanical properties match those of brain tissue. Brain movement prevents displacement and shearing between the brain tissue and the electrodes, thus enabling long-term tracking of the activity of the same neuron.

[0186] 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.

[0187] 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.

[0188] 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.

[0189] The foregoing is merely a list of specific embodiments of the present application, intended to enable those skilled in the art to understand or implement the present 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 the present application. Therefore, the present application is not limited to the embodiments shown herein, but is intended to conform to the broadest scope consistent with the principles and novel features of the present application.

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; A grate (2) is mounted on the interface base (1) and supported on the base (10), and a central 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, wherein: 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, wherein: There are at least two interface guide parts (11); At least one of the interface guide portions (11) is a guide portion having a constant diameter along the axial direction of the base (10); At least another interface guide portion (11) is a guide portion with a variable diameter along the axial direction of the base (10), and the bottom diameter of the interface guide portion (11) is larger than the top diameter.

4. The brain-computer interface device according to claim 2, wherein: The interface guide portion (11) is a groove formed by a depression of 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, wherein: The interface base (1) is further provided with an ear seat (12); And / or, the interface base (1) is further configured with a top cover (14).

6. The brain-computer interface device according to claim 1, wherein: 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, wherein: 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, wherein: The communication module (40) is provided with a temporary fixing groove (401) for temporarily fixing it to the implant device (5).

9. The brain-computer interface device according to claim 1, wherein: 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 the communication module (40). The microneedle array structure (312) has a row of microneedles (310) distributed at intervals.

10. The brain-computer interface device according to claim 9, wherein: 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, wherein: The microneedle mechanism (31) further includes 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, wherein: 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, wherein: 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, wherein: 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, wherein: The ferrule (3151) includes a sleeve (31510) and an operating portion (31511) connected to the sleeve (31510). 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, wherein: The microneedle mounting plate (311) is also provided with a second mounting auxiliary hole (3112) for connecting the implant device (5).

17. The brain-computer interface device according to claim 9, wherein: 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) via a fixing structure (3122). The material of the fixing structure (3122) is a degradable biocompatible material.

18. The brain-computer interface device according to claim 17, wherein: 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 body electrode (31211) and the hard needle body electrode (31201) fixed to each other.

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

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

Images