A microneedle assembly

Abstract

The application relates to a microneedle assembly which comprises a microneedle base and a microneedle mechanism, the middle part of the microneedle base is provided with microneedle guide holes arranged in an array; the microneedle mechanism is installed on the microneedle base, the microneedle mechanism comprises a microneedle mounting plate and a microneedle array structure, a clamping groove is formed in the inner wall of the microneedle mounting plate; the microneedle array structure is clamped on the clamping groove, the microneedle array structure is provided with a row of microneedles which are spaced apart, and the microneedles pass through the microneedle guide holes. In the microneedle assembly, a row of microneedles are arranged on the microneedle array structure, and each microneedle is arranged to pass through the microneedle guide hole of the microneedle base to enter the brain tissue. When the microneedle assembly is implanted, a plurality of microneedles are implanted in an array, and compared with one-by-one implantation, the implantation efficiency of the microneedle assembly is obviously improved. The microneedle array can realize two-way neural signal acquisition and regulation with multiple channels and high flux.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of human-computer interaction, and in particular to a microneedle assembly. BACKGROUND

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

[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 for achieving human-computer interaction by placing an electrode array on the surface of a biological tissue such as the scalp to obtain the electrical signals of the brain without cutting the biological tissue such as the skull or implanting electrodes in the biological tissue such as the brain. Compared with the invasive brain-computer interface, the non-invasive brain-computer interface has the advantages of being safer, simpler and easier to operate. However, it has lower signal quality and is easily affected by external interference, leading to complex signal processing.

[0005] Invasive brain-computer interface is a technology for obtaining neural signals by inserting electrodes or probes into a biological tissue such as the cerebral cortex. Compared with the non-invasive brain-computer interface, the invasive brain-computer interface has higher signal accuracy and stability, can provide better control accuracy and response speed, and can achieve more complex motion and interaction tasks.

[0006] The existing invasive brain-computer interface technology has some shortcomings.

[0007] For example, since the probe is usually thin, it may face mechanical stability problems such as probe breakage or displacement during implantation or long-term use in a biological tissue such as the brain tissue, reducing the reliability of the probe.

[0008] In addition, more probes are needed to collect more signals, and traditional implantation methods need to implant single probes one by one, which is time-consuming and laborious.

[0009] In addition, more probes are needed to collect more signals, and traditional implantation methods need to implant single probes one by one, which is time-consuming and laborious. SUMMARY

[0010] The embodiments of the present application provide a microneedle assembly to solve the problem that traditional implantation methods need to implant single probes one by one, which is time-consuming and laborious.

[0011] The embodiments of the present application provide a microneedle assembly, which comprises:

[0012] The microneedle base is circular, and a microneedle guide hole is arranged in the middle of the microneedle base in an array;

[0013] The microneedle mechanism is mounted on the microneedle base, and the microneedle mechanism includes a microneedle mounting plate and a microneedle array structure. The inner wall of the microneedle mounting plate is provided with a clamping groove. The microneedle array structure is clamped on the clamping groove, and the microneedle array structure has a row of microneedles arranged at intervals. The microneedles pass through the microneedle guide hole.

[0014] In some embodiments, the microneedle base is mounted on a grating of a brain-computer interface device when in use.

[0015] The side wall of the grating is provided with a grating guide part.

[0016] The side wall of the microneedle base is provided with a microneedle guide part matched with the grating guide part.

[0017] In some embodiments, the microneedle mounting plate is provided with a plurality of clamping groove groups. Each clamping groove group includes clamping grooves respectively located on the opposite inner walls of the microneedle mounting plate.

[0018] The two ends of the microneedle array structure are clamped on the two clamping grooves of the clamping groove group.

[0019] In some embodiments, the microneedle mechanism further includes an integrated circuit chip and a microstrip line for electrical connection with a communication module.

[0020] The microneedle array structure is connected to the integrated circuit chip, and the microneedle array structure is clamped on the clamping groove through the integrated circuit chip.

[0021] The microstrip line is electrically connected with the integrated circuit chip.

[0022] In some embodiments, the side wall of the microneedle base is provided with a microneedle guide part.

[0023] The side wall of the microneedle mounting plate is provided with a mounting plate guide part matched with the microneedle guide part.

[0024] In some embodiments, the microneedle guide part is recessed from the side wall of the microneedle base towards the side where the microneedle guide hole is located.

[0025] The mounting plate guide part is recessed from the side wall of the microneedle mounting plate towards the middle region of the microneedle mounting plate.

[0026] A first mounting auxiliary hole is arranged on the microneedle base corresponding to the mounting plate guide part.

[0027] In some embodiments, the microneedle mechanism further comprises a mounting auxiliary assembly, which comprises a sleeve and a guide rod, one end of which is inserted into the first mounting auxiliary hole and the other end is clamped into the guide portion of the mounting plate, and the sleeve is detachably sleeved on the guide rod.

[0028] In some embodiments, the sleeve comprises a sleeve and an operating portion connected to the sleeve, and the sleeve is provided with an opening along the axial direction thereof, so that the sleeve is C-shaped.

[0029] In some embodiments, the microneedle mounting plate is further provided with a second mounting auxiliary hole for connecting an implanted device.

[0030] In some embodiments, the microneedle array structure comprises a hard needle and a soft needle for connecting a communication module, the soft needle is fixed to the surface of the hard needle through a fixing structure, and the material of the fixing structure is a biocompatible degradable material.

[0031] In some embodiments, the hard needle comprises a hard needle tail and at least one hard needle body electrode formed on the hard needle tail.

[0032] The soft needle comprises a soft needle tail and at least one soft needle body electrode formed on the soft needle tail.

[0033] The microneedle comprises the soft needle body electrode and the hard needle body electrode fixed to each other.

[0034] In some embodiments, the needle tip portion of the soft needle body electrode is provided with a barb.

[0035] In some embodiments, the biocompatible degradable material comprises one or more of silk protein, spider silk protein, gelatin and PEG.

[0036] The technical scheme provided by the present application has the beneficial effects of:

[0037] In the microneedle assembly provided by the present application, a plurality of microneedles are arranged on the microneedle array structure, and each microneedle is inserted into the microneedle guide hole of the microneedle base during installation to enter the relevant tissue of the organism, such as brain tissue. It can be seen that the present application is implanted in an array, and a plurality of microneedles are implanted at one time, which is more efficient than implanting one microneedle at a time.

[0038] In addition, the microneedle array used in the present application can realize high-throughput bidirectional neural signal acquisition and regulation. BRIEF DESCRIPTION OF DRAWINGS

[0039] In order to more clearly illustrate the technical solutions in the embodiments of the present application, the drawings needed to be used in the embodiment description will be briefly introduced. Obviously, the drawings in the following description are only some embodiments of the present application, and other drawings can be obtained by those skilled in the art without any creative effort on the basis of these drawings.

[0040] Figure 1 The exploded view of the brain-computer interface device provided in the embodiments of the present application;

[0041] Figure 2 The schematic diagram of the interface base provided in the embodiments of the present application;

[0042] Figure 3 The schematic diagram of the sieve provided in the embodiments of the present application;

[0043] Figure 4 The schematic diagram of the microneedle assembly provided in the embodiments of the present application;

[0044] Figure 5 The schematic diagram of the microneedle base provided in the embodiments of the present application;

[0045] Figure 6 The schematic diagram of the microneedle mounting plate provided in the embodiments of the present application;

[0046] Figure 7 The schematic diagram of the microneedle mechanism provided in the embodiments of the present application;

[0047] Figure 8 The schematic diagram of the assembly of the microneedle base and the microneedle mounting plate provided in the embodiments of the present application;

[0048] Figure 9 The schematic diagram of the implant device provided in the embodiments of the present application;

[0049] Figure 10 The schematic diagram of the microneedle array structure provided in the embodiments of the present application (when being torn up);

[0050] Figure 11 The schematic diagram of the microneedle array structure provided in the embodiments of the present application (when being attached);

[0051] Figure 12 The schematic diagram of the barb provided in the embodiments of the present application;

[0052] Figure 13 The schematic diagram of the installation of the integrated circuit chip provided in the embodiments of the present application;

[0053] Figure 14 The schematic diagram of the fixing structure provided in the embodiments of the present application;

[0054] Figure 15Cutting soft needle body electrode schematic diagram provided for the embodiments of the present application;

[0055] Figure 16 Integrated circuit chip flip-chip schematic diagram provided for the embodiments of the present application;

[0056] Figure 17 Mounting and positioning assembly schematic diagram provided for the embodiments of the present application;

[0057] Figure 18 Positioning assembly schematic diagram provided for the embodiments of the present application;

[0058] Figure 19 Mounting screen schematic diagram provided for the embodiments of the present application;

[0059] Figure 20 Mounting pre-punching kit schematic diagram provided for the embodiments of the present application;

[0060] Figure 21 Pre-punching kit schematic diagram provided for the embodiments of the present application;

[0061] Figure 22 Another perspective schematic diagram provided for the embodiments of the present application; Figure 21 Another perspective schematic diagram provided for the embodiments of the present application; Another perspective schematic diagram provided for the embodiments of the present application;

[0062] Another perspective schematic diagram provided for the embodiments of the present application; Figure 23 Another perspective schematic diagram provided for the embodiments of the present application; Pressing assembly schematic diagram provided for the embodiments of the present application.

[0063] Figure 24 Pressing assembly schematic diagram provided for the embodiments of the present application.

[0064] In the figure:

[0065] 1, interface base; 10, bottom support; 11, interface guide; 12, ear seat; 13, top support; 14, top cover; 15, heightening block;

[0066] 2, screen; 20, screen hole; 21, screen guide;

[0067] 3, microneedle assembly; 30, microneedle base; 300, microneedle guide hole; 301, microneedle guide; 302, first installation auxiliary hole; 31, microneedle mechanism; 310, microneedle; 311, microneedle mounting plate; 3110, clamping groove; 3111, mounting plate guide; 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, clamping sleeve; 31510, sleeve; 31511, operation part;

[0068] 4. Communication components; 40. Communication module; 400. Communication module guide; 401. Temporary fixing slot; 41. Battery;

[0069] 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;

[0070] 6. Positioning component; 60. Positioning filter; 601. Filter guide; 602. First clamping hole; 61. Clamping clip;

[0071] 7. Pre-drilled kit; 70. Needle plate; 700. Needle hole; 701. Needle plate guide; 702. Second clamping hole; 71. Punching needle; 72. Pressure plate; 720. Punching needle mounting hole; 721. Pressure plate guide; 73. Pressure rod; 730. Connecting rod; 731. Connecting plate; 732. Pressing part; 74. Housing. Detailed Implementation

[0072] To make the objectives, technical solutions, and advantages of the embodiments of this application clearer, the technical solutions of the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this application, not all embodiments. Based on the embodiments of this application, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this application.

[0073] See Figure 1 , Figure 2 , Figure 3 , Figure 4 and Figure 5 As shown in the figure, this application provides a brain-computer interface device, which includes an interface base 1, a comb 2, and a microneedle assembly 3.

[0074] The interface base 1 has a through channel to form a hollow cylindrical structure. The inner wall of the through channel is provided with a bottom support 10 to support the parts to be installed later. The upper edge of the interface base 1 has a top support 13. The outer diameter of the top support 13 is larger than the opening diameter of the biological tissue such as the skull, so that the interface base 1 can be placed at the opening of the biological tissue such as the skull.

[0075] The comb 2 is installed on the interface base 1 and supported on the base 10. The middle part of the comb 2 is provided with comb holes 20 arranged in an array to serve as channels for microneedle implantation.

[0076] The microneedle assembly 3 comprises a microneedle base 30 and a microneedle mechanism 31, wherein the microneedle base 30 is installed on the comb 2, and the microneedle base 30 is provided with microneedle guide holes 300 arranged in an array in the middle part; and the microneedle mechanism 31 is installed on the microneedle base 30, and the microneedles 310 of the microneedle mechanism 31 sequentially pass through the microneedle guide holes 300, the comb holes 20 and the through channels of the interface base 1.

[0077] The centers of the microneedle guide holes 300 correspond to the centers of the comb holes 20, and the aperture of the comb holes 20 is larger than the aperture of the microneedle guide holes 300.

[0078] In the brain-computer interface device provided by the application, the microneedles 310 sequentially pass through the microneedle guide holes 300, the comb holes 20 and the through channels of the interface base 1 from top to bottom and then enter the biological tissue such as brain tissue, and because the aperture of the comb holes 20 is larger than the aperture of the microneedle guide holes 300, the size of the holes of each layer from bottom to top is gradually reduced. The microneedle guide hole 300 at the uppermost layer is designed to have a size as close as possible to that of the microneedle 310, so that the microneedle guide hole 300 plays a role of positioning and guiding during the implantation of the microneedle, thereby ensuring high precision of the implantation position. Because a certain inclination may be generated during the machining, assembling and implantation of the microneedle, the design of the enlarged comb holes 20 at the lower layer is to ensure that, when the microneedle passes through the implantation channel from top to bottom, the microneedle generates a small inclination, and because the hole of the lower layer is larger than that of the upper layer, the extra hole space of the lower layer becomes a buffer area, which plays a buffering role when the microneedle is inclined, so that the microneedle is difficult to be deformed or broken due to touching the side wall of the comb hole 20, thereby improving the mechanical stability of the microneedle.

[0079] It can be seen that the design of the gradually enlarged multi-layer holes from top to bottom ensures the reliability of the implantation of the microneedle, and can reduce the deviation of the implantation position caused by the errors in the assembling process or implantation angle of the microneedle.

[0080] It can be understood that the material of the interface base 1 can be selected from medical metals or plastics such as stainless steel, titanium, titanium-aluminum-vanadium alloy, nickel-titanium alloy, cobalt-chromium alloy and polyether ether ketone PEEK.

[0081] It can be understood 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, and adaptively, the comb 2 and the microneedle base 30 also preferably adopt a circular shape. Adaptively, the bottom support 10 and the top support 13 can form a ring shape.

[0082] It can be understood that, in order to facilitate assembly, prevent the microneedle from being difficult to penetrate due to misalignment, and prevent adverse effects caused by misalignment between parts during long-term use, it is preferred that the microneedle base 30 and the interface base 1 are provided with positioning holes 301 and 302. Figure 2As shown, the inner wall of the interface base 1 is provided with an interface guide 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 21 matched with the interface guide 11; see Figure 5 As shown, the side wall of the microneedle base 30 is provided with a microneedle guide 301 matched with the grate guide 21.

[0083] Specifically, see Figure 2 As shown, the interface guide 11 can be a column on the inner wall formed by the inner wall of the interface base 1 protruding; correspondingly, for the assembly of subsequent components, see Figure 3 As shown, the grate guide 21 is recessed from the side wall of the grate 2 towards the side where the grate hole 20 is located, so that the outer wall of the grate guide 21 forms a groove which is matched with the interface guide 11, and the inner wall of the grate guide 21 forms a column; correspondingly, see Figure 5 As shown, the microneedle guide 301 is recessed from the side wall of the microneedle base 30 towards the side where the microneedle guide hole 300 is located, so that the outer wall of the microneedle guide 301 forms a groove which is matched with the column of the grate guide 21, and the inner wall of the microneedle guide 301 forms a column.

[0084] The interface guide 11 can also be a groove formed by the inner wall of the interface base 1 being recessed, at which time the grate guide 21 and the microneedle guide 301 can be adjusted adaptively.

[0085] See Figure 2 As shown, the interface guide 11 is at least two, at least one of the interface guides 11 is an equal-diameter guide along the axial direction of the base 10; at least another interface guide 11 is a variable-diameter guide along the axial direction of the base 10, and the bottom diameter of the interface guide 11 is greater than the top diameter. The combination of the two types of interface guides takes into account the needs of high-precision guidance and stable installation, which is beneficial to the alignment and fixation during the installation of subsequent components.

[0086] The axial direction of each interface guide 11 is consistent with the axial direction of the base 10 (or the axial direction of the interface base 1), some of the interface guides 11 have consistent outer diameters at each cross section from top to bottom along the axial direction, and others have different outer diameters at each cross section from top to bottom along the axial direction, and the outer diameter becomes smaller as it goes up.

[0087] The constant-diameter interface guide 11 helps to provide higher guiding accuracy, while the variable-diameter interface guide 11 has the following advantages: first, it helps to fix the bottom of the interface guide 11, and the thickened part can provide a larger contact area, making the fixation of the interface guide 11 at the bottom more stable and less likely to loosen or displace. A larger diameter also means greater resistance to torsion, which is particularly important when the interface guide 11 is subjected to lateral or torsional forces. Second, the thickened design can optimize stress distribution and avoid material fatigue or rupture due to excessive local stress, which helps to extend the service life of the interface guide 11 during long-term use. Third, it can reduce the overall weight of the interface guide 11 while maintaining structural strength. Fourth, it facilitates installation and fastening, reduces installation errors, and ensures that the interface guide 11 maintains good positioning accuracy during use.

[0088] It can be understood that the constant-diameter interface guide 11 described above can be arranged in pairs and symmetrically, and similarly, the variable-diameter interface guide 11 described above can also be arranged in pairs and symmetrically.

[0089] Referring to Figure 2 , the interface base 1 is also provided with an ear seat 12, which can appear in pairs. The ear seat 12 is used to provide a fixed point for a bolt to fix the brain-computer interface device to the relevant tissue of the organism, such as the skull.

[0090] Referring to Figure 1 , the interface base 1 is also provided with a top cover 14. After all the components are installed, the top cover 14 is finally installed on the interface base 1 to protect the internal components.

[0091] Referring to Figure 1 and Figure 4 , 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 providing 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 positions such as the head implant brain-computer interface in situ, in front of the chest, or behind the ear.

[0092] Referring to Figure 6 and Figure 7 , the microneedle mechanism 31 includes a microneedle mounting plate 311 and a microneedle array structure 312. The microneedle mounting plate 311 can be installed on the microneedle base 30. The periphery of the microneedle mounting plate 311 can be circular to match the microneedle base 30, or other shapes such as Figure 6The micro needle mounting plate 311 is hollow in the middle to form a ring shape, and a clamping groove 3110 is formed on the inner wall of the micro needle mounting plate 311; the micro needle array structure 312 is clamped on the clamping groove 3110 to achieve the mounting and fixation of the micro needle array structure 312, and the micro needle array structure 312 is electrically connected with the communication module 40; the micro needle array structure 312 has a row of micro needles 310 distributed at intervals.

[0093] In the micro needle mechanism 31 provided in the application, a row of multiple micro needles 310 are arranged on the micro needle array structure 312, which can be 4, 8, 16, 32 or more, and each micro needle 310 is arranged to pass through the micro needle guide hole 300 of the micro needle base 30 to enter the biological tissue such as brain tissue during installation. It can be seen that the use of the micro needle array in the application can realize high-throughput bidirectional neural signal acquisition and regulation.

[0094] In addition, the application is implanted in an array, and multiple micro needles are implanted at one time, which is more efficient than implanting one micro needle at a time.

[0095] In order to improve the fixation and installation effect of the micro needle array structure 312, simplify the structure of the parts, and reduce the production cost, referring to Figure 6 As shown in the figure, the micro needle mounting plate 311 is provided with a plurality of clamping groove groups, each of which includes clamping grooves 3110 located on the opposite inner walls of the micro needle mounting plate 311; and the two ends of the micro needle array structure 312 are clamped on the two clamping grooves 3110 of the clamping groove group. The two ends of the two micro needle array structures 312 are clamped on the two clamping grooves 3110, which can ensure the fixation and installation effect and does not affect the arrangement of the micro needles 310 in the middle position.

[0096] As shown in the figures, Figure 4 and Figure 7 The clamping groove group can be provided with multiple clamping grooves, one clamping groove group corresponds to the installation of one micro needle array structure 312, and each micro needle array structure 312 has a row of multiple micro needles 310, so that the micro needle mechanism 31 can contain multiple rows and multiple columns of micro needles 310.

[0097] As shown in the figures, Figure 4 and Figure 7 The micro needle mechanism 31 further includes an integrated circuit chip 313 and a microstrip line 314; the micro needle array structure 312 is connected to the integrated circuit chip 313, and the micro needle array structure 312 is clamped on the clamping groove 3110 through the integrated circuit chip 313; and the communication module 40 is electrically connected with the integrated circuit chip 313 through the microstrip line 314. Through the built-in digital signal processor, i.e. the integrated circuit chip 313, local digitization can be realized, which is beneficial to reduce the transmission loss of neural signals and improve the signal-to-noise ratio.

[0098] For the convenience of assembly, to prevent the microneedle from being difficult to penetrate due to misalignment, and to prevent misalignment between parts from affecting the subsequent long-term use, see Figure 5 and Figure 6 The microneedle guide part 301 is provided on the side wall of the microneedle base 30; the mounting plate guide part 3111 is provided on the side wall of the microneedle mounting plate 311, which is matched with the microneedle guide part 301.

[0099] The microneedle guide part 301 can be recessed from the side wall of the microneedle base 30 towards the side where the microneedle guide hole 300 is located, so that the outer wall of the microneedle guide part 301 forms a groove, which is matched with the column of the comb guide part 21, and the inner wall of the microneedle guide part 301 forms a column. Adaptively, the mounting plate guide part 3111 can be recessed from the side wall of the microneedle mounting plate 311 towards the middle area of the microneedle mounting plate 311, so that the side wall of the mounting plate guide part 3111 forms a groove, which is matched with the column of the microneedle guide part 301.

[0100] Similarly, the microneedle guide part 301 can also be protruded from the side wall of the microneedle base 30 away from the side where the microneedle guide hole 300 is located, so that the inner wall of the microneedle guide part 301 forms a groove, and at this time the mounting plate guide part 3111 is protruded from the side wall of the microneedle mounting plate 311 away from the middle, so that the side wall of the mounting plate guide part 3111 forms a column, which is matched with the groove of the microneedle guide part 301.

[0101] For the convenience of installing the microneedle mechanism 31 on the microneedle base 30, see Figure 5 The microneedle guide part 301 is recessed from the side wall of the microneedle base 30 towards the side where the microneedle guide hole 300 is located; the mounting plate guide part 3111 is recessed from the side wall of the microneedle mounting plate 311 towards the middle area of the microneedle mounting plate 311; the first installation auxiliary hole 302 is provided on the microneedle base 30 corresponding to the mounting plate guide part 3111, from Figure 5 It can be seen that the first installation auxiliary hole 302 can actually be provided on the microneedle guide part 301.

[0102] The above-mentioned first installation auxiliary hole 302 is used in cooperation with the installation auxiliary assembly 315.

[0103] See Figure 4 , Figure 6 and Figure 8As shown, the microneedle mechanism 31 further comprises a mounting auxiliary assembly 315, which comprises a sleeve 3151 and a guide rod 3150, one end of which is inserted into the first mounting auxiliary hole 302 and the other end is clamped into the mounting plate guide portion 3111. The guide rod 3150 can be a screw rod or the like, and the sleeve 3151 is detachably sleeved on the guide rod 3150.

[0104] The first mounting auxiliary hole 302 can be provided with a plurality of holes around the periphery, such as Figure 6 Four are provided in the middle.

[0105] During installation, the guide rod 3150 is inserted into the first mounting auxiliary hole 302 on the lower microneedle base 30 from the mounting plate guide portion 3111, and the sleeve 3151 on the guide rod 3150 is clamped on the microneedle mounting plate 311 with the top supported on the microneedle guide portion 301. The microneedle mounting plate 311 and the lower microneedle base 30 can be temporarily connected together by the mounting auxiliary assembly 315 around the periphery. The mounting auxiliary assembly 315 supports the microneedle mounting plate 311, and when the sleeve 3151 is installed, the microneedle array structure 312 is kept at a certain distance from the microneedle base 30, so that the needle tip of the microneedle 310 can just penetrate the microneedle guide hole 300 of the microneedle base 30. When microneedle cutting and microneedle implantation are required, the sleeve 3151 can be removed, and the microneedle mounting plate 311 can be pulled by the implantation device and pushed down along the guide rod 3150 until the microneedle 310 completely penetrates the microneedle guide hole 300. When the mounting plate guide portion 3111 around the microneedle mounting plate 311 and the microneedle guide portion 301 of the microneedle base 30 are matched and fixed, the guide rod 3150 can be removed.

[0106] Referring to Figure 4 As shown, the sleeve 3151 comprises a sleeve 31510 and an operating portion 31511 connected to the sleeve 31510, and the sleeve 31510 is provided with an opening along the axial direction to form a C-shaped sleeve 31510. The diameter of the guide rod 3150 is greater than the opening of the sleeve 31510, and the sleeve 3151 is pulled out by pulling the operating portion 31511 outward to make the guide rod 3150 expand the opening of the sleeve 31510.

[0107] In order to facilitate microneedle implantation, referring to 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 implantation device 5.

[0108] The implant device 5 comprises an implant plate 50, the bottom of the implant plate 50 is provided with a plurality of implant rods 51 for inserting into the second installation auxiliary hole 3112, and the top of the implant plate 50 is provided with a main rod 52, a limiting sleeve 53 is sleeved on the main rod 52, and a multi-joint arm 54 is arranged on the limiting sleeve 53.

[0109] In use, the implant rod 51 is inserted into the second installation auxiliary hole 3112 on the microneedle installation plate 311, the multi-joint arm 54 is fixed in position on a surgical bed or the like, the limiting sleeve 53 is fixed, the main rod 52 is limited in the horizontal direction by the limiting sleeve 53, the main rod 52 is driven to move downward, and then the microneedle installation plate 311 is pushed downward, so that the microneedle implantation is realized.

[0110] Referring to Figure 9 , the bottom of the implant rod 51 is provided with a plurality of first elastic claws 510, and temporary fixation of the implant rod 51 and the microneedle installation plate 311 is realized through cooperation of the first elastic claws 510.

[0111] Since the microneedle array structure is connected with the communication module 40, in order to prevent the communication module 40 from moving during implantation and affecting implantation, referring to Figure 4 , a temporary fixing groove 401 for temporarily fixing on the implant device 5 is arranged on the communication module 40, referring to Figure 9 , the bottom of the implant plate 50 is provided with two second elastic claws 500 arranged oppositely and at intervals, and when the microneedle implantation is performed, referring to Figure 1 , the communication module 40 is arranged vertically, so that the two second elastic claws 500 are clamped in the two temporary fixing grooves 401 on the two sides of the communication module 40, and the purpose of temporarily fixing the communication module 40 is realized.

[0112] After the microneedle implantation is completed, in order to prevent the communication module 40 from moving during subsequent long-term use, referring to Figure 4 , a communication module guide portion 400 matched with the microneedle guide portion 301 is arranged on the side wall of the communication module 40.

[0113] Since the hard probe can cause a certain degree of mechanical damage in the related tissues of the organism, such as brain tissue, leading to problems such as local tissue inflammation and glial cell proliferation, and then affecting the signal quality and reducing the long-term stability.

[0114] In order to solve this problem, referring to Figure 10 and Figure 14 , the microneedle array structure 312 provided by the application comprises 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 fixing structure 3122, the fixing structure 3122 is made of a biocompatible degradable material, and the communication module 40 is connected to the soft needle 3121.

[0115] This application employs a method of inserting a soft needle with a hard needle. Utilizing the high hardness of the hard needle, the soft needle is easily implanted along with it. After the soft needle is implanted, because the fixing structure 3122 is made of a biodegradable and biocompatible material, it dissolves under the action of biological tissues such as tissue fluid. Subsequently, the hard needle is removed, leaving only the soft needle in biological tissues such as brain tissue. Due to the low hardness of the soft needle, it is friendly to biological tissues such as brain tissue. Therefore, this application achieves minimally invasive implantation and effectively avoids damage caused by the hard needle during movement in biological tissues such as brain tissue.

[0116] See 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 adhesive fixation, and the soft needle body electrode 31211 is fixed to the hard needle electrode 31201, mainly by fixation with a biodegradable biocompatible material; the microneedle 310 includes the soft needle body electrode 31211 and the hard needle electrode 31201 fixed to each other.

[0117] The fabrication method of the microneedle array structure 312 as a whole is as follows:

[0118] Step 1: See Figure 11 As shown, a soft needle 3121 is fabricated on a hard needle 3120 using conventional MEMS technology, and the positional relationship is that the soft needle is attached to the hard needle.

[0119] See Figure 12 As shown, a barb 31212 is provided at the tip of the soft needle electrode 31211 to facilitate the removal of the hard needle after implantation and the long-term fixation of the soft needle.

[0120] Step 2: See Figure 10 As shown, the soft needle 3121 is torn off from the tail 31210 of the soft needle along one corner, leaving a portion of the needle tip of the soft needle body electrode 31211 intact. The purpose is to maintain a high adhesive force at the needle tip of the soft needle body electrode 31211 for temporarily fixing the soft needle and the hard needle. The tail 31210 of the soft needle weakens the adhesive force to facilitate the removal of the hard needle after implantation.

[0121] Step 3: Reattach the soft needle 3121 to the hard needle 3120. If the part that was previously torn off cannot be glued back on, you can use glue or tape to fix it.

[0122] Step 4: See Figure 13As shown, the integrated circuit chip 313 and the soft needle tail 31210 of the soft needle 3121 are invertedly welded 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 invertedly welded on the soft needle, and the hard needle is at the lowermost layer.

[0123] Step 5: Referring to Figure 14 As shown, the needle tip part of the microneedle array structure 312 is immersed in a degradable biocompatible material to form a fixed structure 3122 for fixation, and a mold coating method can also be used. The degradable biocompatible material includes one or more of silk fibroin, spider silk protein, gelatin and PEG.

[0124] Step 6: Referring to Figure 15 As shown, the part of the soft needle body electrode 31211 that is not torn off at the needle tip is cut off by laser or other methods, only the soft needle part on the hard needle is cut off, the hard needle is not cut off, and the laser path can be set as a curved path to ensure that the cut part has a round corner.

[0125] Step 7: Referring to Figure 16 As shown, the inverted welding of the microstrip line 314 and the integrated circuit chip 313 is completed, and the excess soft needle at the top is cut off, which facilitates the later pulling out of the hard needle.

[0126] The clamping groove 3110 clamps the integrated circuit chip 313, the integrated circuit chip 313 is invertedly welded with the soft needle 3121, and the soft needle 3121 is fixed with the hard needle 3120 by the adhesion of itself and the degradable biocompatible material such as silk fibroin. Therefore, the microneedle array structure 312 can be fixed by clamping the integrated circuit chip 313 through the clamping groove 3110.

[0127] The embodiment of the present application also provides a mounting method of a brain-computer interface device, which comprises the following steps: sequentially mounting an interface base 1, a strainer 2 and a microneedle assembly 3.

[0128] Specifically, after the operation has been completed and the target brain area is exposed at the biological tissue related organization such as the skull opening, the implantation and mounting can be performed according to the following steps:

[0129] (1) Referring to Figure 17 As shown, the interface base 1 is temporarily fixed on the biological tissue related organization such as the skull by using a bolt or a bone screw.

[0130] (2) The positioning assembly 6 is mounted in the interface base 1, and a photograph is taken to obtain a vascular distribution image of the biological tissue related organization such as the subdural membrane; based on the vascular distribution image, the microneedle assembly 3 is cut to cut off the microneedle 310 corresponding to the position of the blood vessel; and finally the positioning assembly 6 is removed.

[0131] Because the blood vessels are distributed in the biological tissue such as the subdural, if the blood vessels are not avoided during the micro-needle implantation, the blood vessels will be broken, and the head will be damaged. At present, the micro-needle is implanted one by one, and the doctor's experience is combined to judge the position of the blood vessels, so as to avoid the blood vessels. However, this method is not accurate in positioning the blood vessels, and errors are prone to occur. On the other hand, it is difficult to implant a large number of micro-needles at one time, which reduces the implantation efficiency.

[0132] Therefore, the positioning assembly 6 is used first to obtain a blood vessel distribution image, so as to find out the blood vessel distribution of the biological tissue such as the subdural. Then, the micro-needle assembly 3 is adjusted, so as to avoid the important blood vessel position and implant a plurality of micro-needles at one time.

[0133] Specifically, in the present application, as shown in Figure 17 and Figure 18 , the positioning assembly 6 comprises a positioning filter 60, and the middle part of the positioning filter 60 is provided with longitudinal and transverse intersecting grid scale lines. The intersection positions of the grids formed by the grid scale lines correspond to the centers of the comb holes 20 and the centers of the micro-needle guide holes 300.

[0134] By shooting the image, the position of the blood vessels that needs to be avoided is accurately positioned in combination with the grid scale lines on the positioning filter 60, so as to judge the micro-needles that need to be cut. Then, the micro-needles at the corresponding positions are cut, so as to achieve the purpose of avoiding the blood vessels of the biological tissue such as the subdural when the micro-needle array is implanted as a whole, and to minimize the damage of the micro-needles to the biological tissue such as the brain tissue and the blood vessels.

[0135] The near-infrared light (700-2500 nm, short-wave near-infrared 700-1100 nm, and long-wave near-infrared 1100-2500 nm) is usually in the wavelength range of 700-900 nm, and the absorption of light by human tissue is relatively low. Therefore, the near-infrared light can penetrate the skin and tissue more deeply to form a clear image. This band is called the "biological optical window". In this wavelength range, the spectral absorption characteristics of hemoglobin show significant differences: the near-infrared light around 760 nm has high sensitivity to deoxyhemoglobin, and the near-infrared light around 850 nm is more sensitive to oxyhemoglobin. Using these band characteristics, the near-infrared imaging system can detect the content difference of oxyhemoglobin and deoxyhemoglobin in the blood. By using a multi-wavelength excitation source, images at different wavelengths are captured, and the light absorption characteristics of these images are analyzed by using an algorithm, so as to generate a high-contrast blood vessel image.

[0136] It can be understood that, in order to facilitate assembly and accurate positioning, as shown in Figure 17 and Figure 18As shown, the inner wall of the interface base 1 is provided with an interface guide part 11 extending axially along the bottom support 10, and the side wall of the positioning filter 60 is provided with a filter guide part 601 matching the interface guide part 11; the precise installation and positioning are realized by the cooperation of the filter guide part 601 and the interface guide part 11.

[0137] It can be understood that, if the interface guide part 11 is a groove formed by the inner wall of the interface base 1 being recessed, the filter guide part 601 is a column formed by the side wall of the positioning filter 60 being protruded; if the interface guide part 11 is a column formed by the inner wall of the interface base 1 being protruded, the filter guide part 601 is a groove formed by the side wall of the positioning filter 60 being recessed.

[0138] Due to the small size of the interface base 1, in order to facilitate the putting in or taking out of the positioning filter 60, referring to Figure 18 As shown, the positioning assembly 6 further comprises a clamping clamp 61, and the positioning filter 60 is provided with a first clamping hole 602 matching the clamping clamp 61; further, the first clamping holes 602 are arranged in pairs and symmetrically distributed on the positioning filter 60.

[0139] The first clamping hole 602 can be a through hole or a half counterbore, so as to avoid the foot of the clamping clamp 61 from penetrating out of the first clamping hole 602 and affecting the biological tissue such as brain tissue.

[0140] The material of the positioning filter 60 can be selected from a plurality of materials, such as polymethyl methacrylate PMMA, polycarbonate PC, multilayer dielectric film, calcium fluoride or magnesium fluoride, etc. which meet the optical performance requirements.

[0141] The material of the grid scale line is black or dark, which has a high absorption rate in the near-infrared wave band and can form a clear contrast, and the grid scale line can be relatively thin. The material can be selected from chromium, indium tin oxide, gold or platinum.

[0142] The grid scale line on the positioning filter 60 is processed by photoetching or laser etching, so as to obtain a high-resolution and high-contrast grid pattern.

[0143] If the grid scale lines are drawn by etching, the etching depth will also affect the imaging effect. Specifically, the etching depth determines the optical contrast between the grid scale lines and the surrounding area. Deeper grid scale lines usually produce more obvious optical contrast, making the grid scale lines clearer in near-infrared imaging. However, too deep grid scale lines can increase optical scattering, weaken the mechanical strength of the filter, and increase the risk of surface damage and cracking, which can affect the quality of vascular imaging. The etching depth of the grid scale lines is 1-3 pm, which can provide sufficient optical contrast without significantly affecting the overall performance of the filter.

[0144] In summary, 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 greater than the resolution of the near-infrared imaging system used to take images; for example, if the resolution of the imaging system is 50 pm, the selected grid scale line width should be about 75 pm, and the specific selection should also be adjusted according to different application requirements.

[0145] The positioning assembly 6 also includes a near-infrared imaging system for taking images.

[0146] (3) Referring to Figure 19 The grate 2 is installed.

[0147] (4) Due to the presence of the dura mater, the existing solution is to choose to uncover the biological tissue related to the site where the microneedle array needs to be implanted, such as the dura mater, for implantation. Although this method can successfully implant the microneedle, it is complex and inconvenient to operate because the biological tissue related to the site where the microneedle array needs to be implanted, such as the dura mater, needs to be uncovered. Since the entire biological tissue related to the site where the microneedle array needs to be implanted, such as the dura mater, is uncovered, it may affect blood vessels and the like. At the same time, after all, a piece of biological tissue related to the site where the microneedle array needs to be implanted, such as the dura mater, is uncovered, there may be a large amount of damage to the entire biological tissue related to the site where the microneedle array needs to be implanted, such as the dura mater.

[0148] In order to simplify the operation and reduce the degree of damage to the biological tissue related to the site where the microneedle array needs to be implanted, such as the dura mater, the present application provides a pre-punching kit 7 to only perform a punching operation on the biological tissue related to the site where the microneedle array needs to be implanted, such as the dura mater, without needing to perform an uncovering process on the biological tissue related to the site where the microneedle array needs to be implanted, such as the dura mater.

[0149] Specifically, referring to Figure 20 The pre-punching kit 7 is installed on the grate 2, and based on the vascular distribution image, the pre-punching kit 7 is used to punch the biological tissue related to the site where the microneedle array needs to be implanted, such as the dura mater, while avoiding blood vessels. After the punching is completed, the pre-punching kit 7 is removed.

[0150] Among them, referring to Figure 21 , Figure 22 , Figure 23 ,Figure 24 As shown, the pre-punching kit 7 comprises a needle plate 70, a needle assembly and a pressing assembly. The needle plate 70 is provided with needle holes 700 corresponding to the center positions of the sieve holes 20 of the sieve 2. The needle assembly comprises a plurality of punching needles 71. The pressing assembly comprises a pressing plate 72 for pressing the punching needles 71 downward, and a pressing rod 73 connected to the pressing plate 72.

[0151] The punching needles 71 are arranged according to the vascular distribution map, and then the pressing rod 73 is pressed to drive the pressing plate 72 to move downward, so that the plurality of 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.

[0152] Since the depth of penetration of the punching needles 71 into different relevant tissues of the organism, such as the brain, may be different, in order to adapt to different penetration depths, the present application provides a plurality of solutions.

[0153] For example, as shown in Figure 21 , Figure 22 As shown, the pressing assembly further comprises 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, the pressing rod 73 is threadedly connected to the sleeve 74 to adjust the position of the pressing plate 72 in the sleeve 74, and the outer wall of the pressing rod 73 is further provided with a scale line.

[0154] After all the punching needles 71 are inserted into the needle holes 700, the position of the pressing plate 72 in the sleeve 74 is adjusted by rotating the pressing rod 73, the position of the pressing plate 72 is identified by the scale line, and thus the required penetration depth is adjusted. After the adjustment is completed, the pressing can be performed to move the entire pressing assembly downward until it abuts against the needle plate 70 to realize the punching.

[0155] It can be understood that the above-mentioned pressing assembly can press all the microneedles at one time to punch, or can press them in batches to punch. For example, as shown in Figure 21 The size of the pressing plate 72 is configured to cover a part of the needle holes 700 on the needle plate 70, so that the microneedles in each batch distributed in an array can be pressed to punch at one time. For another example, the size of the pressing plate 72 is configured to cover all the needle holes 700 on the needle plate 70, so that the punching can be performed at one time. At this time, a sleeve guide portion (not shown in the figure) can be provided on the side wall of the sleeve 74 to be adapted to the sieve guide portion 21. For example, if the sieve guide portion 21 is recessed from the side wall of the sieve 2 to the side of the sieve hole 20, so that the outer wall of the sieve guide portion 21 forms a groove body which is adapted to the interface guide portion 11, and the inner wall of the sieve guide portion 21 forms a column body, then the sleeve guide portion is recessed from the side wall of the sleeve 74 to form a groove body which is adapted to the column body. Similarly, if the sieve guide portion 21 is protruded, the sleeve guide portion is adjusted accordingly.

[0156] For example, as shown in Figure 23 and Figure 24 , the bottom of the pressing plate 72 is provided with an array of punch needle mounting holes 720, and the punch needle 71 is inserted into the punch needle mounting hole 720 during punching. The pressing rod 73 includes connecting rods 730, a connecting plate 731, and a pressing portion 732. The connecting rods 730 are connected to the periphery of the pressing plate 72 at one end and to the periphery of the connecting plate 731 at the other end. The pressing portion 732 is mounted on the connecting plate 731.

[0157] By pressing the pressing portion 732 downward, the pressing rod 73 and the punch needle 71 are driven to penetrate the needle hole 700 into the dura mater until the pressing plate 72 abuts against the needle plate 70.

[0158] To accommodate different penetration depths, the needle assembly has multiple different specifications, which are distinguished by the length of the punch needle 71. The length of the punch needle 71 in each needle assembly is different. The punch needle 71 with the appropriate length is selected according to the desired punching depth and inserted into the punch needle mounting hole 720.

[0159] Alternatively, the connecting rods 730 are detachably connected to the pressing plate 72, such as by common plug-in, clamping, or other methods. The pressing plate 72 has multiple different specifications, which are distinguished by the depth of the punch needle mounting hole 720. The depth of the punch needle mounting hole 720 in each pressing plate 72 is different. The pressing plate 72 with the appropriate length is selected according to the desired punching depth and inserted into the punch needle 71.

[0160] It can be understood that the pressing assembly described above can press all the microneedles at once to punch, or press them in batches to punch. For example, the size of the pressing plate 72 is configured to cover a portion of the needle holes 700 on the needle plate 70. At this time, it is possible to press and punch multiple microneedles in batches, which are arranged in an array. For example, as shown in Figure 23 , the size of the pressing plate 72 is configured to cover all the needle holes 700 on the needle plate 70. At this time, it is possible to press and punch all the microneedles at once. Further, the side wall of the comb 2 is provided with a comb guide portion 21, and the side wall of the pressing plate 72 is provided with a pressing plate guide portion 721 that is adapted to the comb guide portion 21.

[0161] For easy installation and positioning, as shown in Figure 21 , the side wall of the needle plate 70 is provided with a needle plate guide portion 701 that is adapted to the comb guide portion 21.

[0162] For example, if the grate guide part 21 is recessed from the side wall of the grate 2 towards the side where the grate hole 20 is located, so that the outer wall of the grate guide part 21 forms a groove body which is adapted to the interface guide part 11, and the inner wall of the grate guide part 21 forms a column body, then the pressing plate guide part 721 is recessed from the side wall of the pressing plate 72 to form a groove body which is adapted to the column body, and the needle plate guide part 701 is recessed from the side wall of the needle plate 70 to form a groove body which is adapted to the column body; similarly, if the grate guide part 21 is protruded, the pressing plate guide part 721 and the needle plate guide part 701 are adjusted adaptively.

[0163] In this 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.

[0164] Since the interface base 1 is small, in order to facilitate the insertion or removal of the needle plate 70, as shown in Figure 21 , a second clamping hole 702 is provided on the needle plate 70; the second clamping hole 702 is adapted to the clamping clip 61 of the positioning assembly 6. Further, the above-mentioned second clamping holes 702 are two by two to form a pair, and are symmetrically distributed on the needle plate 70.

[0165] (5) After completing the punching, install the microneedle assembly 3 on the grate.

[0166] Specifically, as shown in Figure 1 , Figure 4 , Figure 5 , Figure 6 , Figure 7 and Figure 9 , first install the microneedle base 30. In use, the implantation device 5 is used 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 installation auxiliary hole 3112 of the microneedle installation plate 311, so that the microneedle tips are one by one aligned with the grate holes 20 of the grate below. Then remove the sleeve 3151, and use the implantation device 5 to slowly move the microneedle array structure 312 as a whole along the guide rod 3150 downward, and stop when the microneedles are implanted to the predetermined depth. Then 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 installation plate 311 unchanged, and simultaneously lift the interface base 1, the grate 2 and the microneedle base 30 upward until the microneedle installation plate 311 is stably nested in the interior of the microneedle base 30.

[0167] Remove the guide rod 3150, and use the cushioning block 15 to temporarily support around the outer ring of the interface base 1, as shown in Figure 1 .

[0168] After the biocompatible material used to temporarily fix the soft needle and the hard needle is dissolved, the hard needle is removed, and the soft needle is left in the brain tissue under the dura mater, fixing the communication module 40 and the battery 41. The soft needle is left with a certain redundancy to avoid damage to the brain tissue or the soft needle caused by the displacement of the brain tissue during movement. Then, the circuit is protected by encapsulation, and the device is fixed with bolts or bone screws. The top cover 14 is installed, and the scalp is sutured.

[0169] In summary, the present application integrates multiple micro-needles for one-time implantation, which greatly improves the implantation efficiency compared to the traditional method of sequentially implanting single electrodes.

[0170] The present application not only realizes minimally invasive implantation but also effectively avoids damage caused by the movement of the patient's biological tissue such as the brain tissue. The use of flexible micro-needle electrodes can avoid displacement and mutual shearing between the brain tissue and the electrodes caused by the mechanical properties of the brain tissue after intracranial implantation, thereby allowing long-term tracking of the same neuron activity.

[0171] The present application has a higher number of device channels, and multiple detection sites are distributed longitudinally along the electrodes, enabling simultaneous recording of single neuron signals Spi ke and local field potentials LFP, acquisition of three-dimensional high-density electroencephalogram signals, and promotion of precise and smooth thought-controlled movement, as well as high-throughput acquisition and regulation of bidirectional neural signals.

[0172] The built-in integrated circuit chip can realize local digitization, which is beneficial to reducing the transmission loss of neural signals and improving the signal-to-noise ratio.

[0173] The high-throughput, bidirectional communication, minimally invasive implantation, and low damage during use, as well as the high signal-to-noise ratio of the overall brain-computer interface device, ensure the long-term stability of the device after implantation, making the implantation process of the brain-computer interface efficient, safe, and controllable.

[0174] The above is only a specific embodiment of the present application, enabling those skilled in the art to 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 these embodiments shown herein, but will conform to the widest scope consistent with the principles and novel features applied herein.

Claims

1. A microneedle assembly, characterized by, The microneedle assembly (3) comprises: a microneedle base (30) in a circular shape, a middle part of the microneedle base (30) is provided with microneedle guide holes (300) in an array distribution, the microneedle base (30) is installed on a comb (2), a middle part of the comb (2) is provided with comb holes (20) in an array distribution, the centers of the microneedle guide holes (300) correspond to the centers of the comb holes (20) one by one, the aperture of the comb holes (20) is larger than the aperture of the microneedle guide holes (300); a microneedle mechanism (31) installed on the microneedle base (30), the microneedle mechanism (31) comprises a microneedle mounting plate (311) and a microneedle array structure (312), an inner wall of the microneedle mounting plate (311) is provided with a clamping groove (3110); the microneedle array structure (312) is clamped on the clamping groove (3110), the microneedle array structure (312) has a column of microneedles (310) in a spaced distribution, the microneedles (310) pass through the microneedle guide holes (300) and the comb holes (20).

2. The microneedle assembly according to claim 1, wherein: in use, the microneedle base (30) is installed on the comb (2) of a brain-computer interface device; the sidewall of the comb (2) is provided with a comb guide portion (21); the sidewall of the microneedle base (30) is provided with a microneedle guide portion (301) matched with the comb guide portion (21).

3. The microneedle assembly according to claim 1, wherein: the microneedle mounting plate (311) is provided with a plurality of clamping groove groups, each clamping groove group comprises clamping grooves (3110) respectively located on the opposite two inner walls of the microneedle mounting plate (311); the two ends of the microneedle array structure (312) are clamped on the two clamping grooves (3110) of the clamping groove group.

4. The microneedle assembly according to claim 3, wherein: the microneedle mechanism (31) further comprises an integrated circuit chip (313) and a microstrip line (314) for electrical connection with a 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 groove (3110) through the integrated circuit chip (313); the microstrip line (314) is electrically connected with the integrated circuit chip (313).

5. The microneedle assembly according to claim 1, wherein: the sidewall of the microneedle base (30) is provided with a microneedle guide portion (301); the sidewall of the microneedle mounting plate (311) is provided with a mounting plate guide portion (3111) matched with the microneedle guide portion (301).

6. The microneedle assembly according to claim 5, wherein: the microneedle guide portion (301) is recessed from the sidewall of the microneedle base (30) towards the side where the microneedle guide hole (300) is located; the mounting plate guide portion (3111) is recessed from the sidewall of the microneedle mounting plate (311) towards the middle area of the microneedle mounting plate (311). A first installation auxiliary hole (302) is arranged on the microneedle base (30) corresponding to the installation plate guide portion (3111). 7.The microneedle assembly of claim 6, wherein: The microneedle mechanism (31) further comprises an installation auxiliary assembly (315), which comprises a sleeve (3151) and a guide rod (3150) with one end inserted into the first installation auxiliary hole (302) and the other end inserted into the installation plate guide portion (3111), and the sleeve (3151) is detachably sleeved on the guide rod (3150). 8.The microneedle assembly of claim 7, wherein: The sleeve (3151) comprises a sleeve (31510) and an operation portion (31511) connected to the sleeve (31510), and the sleeve (31510) is C-shaped with an opening along the axial direction. 9.The microneedle assembly of claim 6, wherein: The microneedle installation plate (311) further comprises a second installation auxiliary hole (3112) for connecting an implant device (5). 10.The microneedle assembly of claim 1, wherein: The microneedle array structure (312) comprises a hard needle (3120) and a soft needle (3121) for connecting a communication module (40), and the soft needle (3121) is fixed to the surface of the hard needle (3120) by a fixing structure (3122), and the fixing structure (3122) is made of a biocompatible material. 11.The microneedle assembly of claim 10, wherein: The hard needle (3120) comprises 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) comprises the soft needle body electrode (31211) and the hard needle body electrode (31201) fixed to each other. 12.The microneedle assembly of claim 11, wherein: The needle tip portion of the soft needle body electrode (31211) is provided with a barb (31212). 13.The microneedle assembly of claim 10, wherein: The biocompatible material comprises one or more of silk fibroin, spider silk protein, gelatin and PEG.

Images