A method for manufacturing an implant for a brain-computer interface system and an implant

Abstract

The application discloses a preparation method of an implant for a brain-computer interface system and the implant, and belongs to the technical field of medical devices. The preparation method of the implant for the brain-computer interface system comprises the following steps: coating a coil and a communication antenna to form a flexible coating body wrapping the coil and the communication antenna, so that the coil, the communication antenna and the flexible coating body form an integrated connection coating piece, and the first end of the coil and the second end of the communication antenna both extend out of the flexible coating body; and welding the first end and the second end to a feed-through structure to form a welded assembly. The preparation method of the implant for the brain-computer interface system and the implant can prevent additional deformation and deviation of components caused by operation during the welding process, improve the welding positioning accuracy and the connection reliability, reduce the welding difficulty, and thus effectively improve the product yield and the large-scale production efficiency.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a method for preparing an implant for a brain-computer interface system and the implant itself. Background Technology

[0002] A fully implantable brain-computer interface system is an implantable product used to collect signals from the cerebral cortex. By establishing an information channel between the brain and the machine, it enables collaborative interaction between biological intelligence and machine intelligence. Users can directly express their thoughts or control external devices through their brains, completing the output of information from the brain to the device. The device can also input information to the brain through stimulation in the form of electricity, magnetism, light, sound, etc.

[0003] Brain-computer interface systems include implants, which typically integrate multiple functional components to meet various needs such as signal transmission, power supply, and neural interface. Because some implants use wire-wound structures made of small-diameter metal wires, their structure is relatively soft and has low rigidity, making them prone to deformation during assembly. This affects positioning accuracy and structural stability, further increasing assembly difficulty and leading to problems such as insufficient assembly precision and poor connection reliability, thus restricting product yield and mass production efficiency.

[0004] Therefore, there is an urgent need for a method for preparing an implant for a brain-computer interface system and an implant itself to solve the problems existing in the prior art. Summary of the Invention

[0005] The purpose of this invention is to provide a method for preparing an implant for a brain-computer interface system and the implant itself, which prevents additional deformation and displacement of components caused by operation during the welding process, improves welding positioning accuracy and connection reliability, reduces welding difficulty, and thus effectively improves product yield and mass production efficiency.

[0006] To achieve this objective, the present invention adopts the following technical solution:

[0007] A method for preparing an implant for a brain-computer interface system includes:

[0008] The coil and the communication antenna are coated with adhesive to form a flexible covering that encapsulates the coil and the communication antenna, so that the coil, the communication antenna and the flexible covering form an integrally connected coated part, and the first end of the coil and the second end of the communication antenna both extend out of the flexible covering;

[0009] Both the first end and the second end are welded to the feedthrough structure to form a welded assembly.

[0010] In some embodiments, prior to encapsulating the coil and communication antenna, the method further includes:

[0011] The first lead wire is wound to form the first lead wire body and the first end, so that the coil as a whole has a vortex ring structure;

[0012] The second lead is wound to form the second lead body and the second end, so that the communication antenna as a whole is in the shape of a helical spring.

[0013] When the coil and the communication antenna are coated with adhesive, the first lead body and the second lead body are arranged side by side, thereby dividing the flexible coating into a first part and a second part. The first part covers the first lead body, and the second part covers the second lead body.

[0014] In some embodiments, the encapsulated component includes a first insulating tube and a second insulating tube. When encapsulating the coil and the communication antenna, it further includes:

[0015] The first insulating tube is sleeved on the first end, so that the end of the first end away from the first lead body is exposed in the first insulating tube, and the rubber-coated part covers at least part of the first insulating tube; the first insulating tube extends on the feedthrough structure so that the first end is welded to a predetermined area of ​​the feedthrough structure.

[0016] The second insulating tube is sleeved on the second end, so that the end of the second end away from the second lead body is exposed in the second insulating tube, and the rubber-coated part covers at least part of the second insulating tube; the second insulating tube extends on the feedthrough structure so that the second end is welded to a predetermined area of ​​the feedthrough structure.

[0017] In some embodiments, when encapsulating the coil and the communication antenna, the process further includes:

[0018] The center lines of the first lead body and the second lead body are spaced apart and arranged at an angle. The first lead body is located on the periphery of the second lead body, and the first end and the second end both extend away from the first lead body, so that the first end and the second end both extend from the same side of the overmolded part.

[0019] When both the first end and the second end are welded to the feedthrough structure, the feedthrough structure is located on one side where the first end and the second end extend.

[0020] In some embodiments, the feedthrough structure includes an insulating substrate and a circuit board, and before both the first end and the second end are soldered to the feedthrough structure, it further includes:

[0021] The insulating substrate is processed with through-holes to form a first welding area and a second welding area. The circuit board is then surface-mounted, wherein the first welding area is used to weld to the first end and the second welding area is used to weld to the second end.

[0022] A circuit board assembly is formed by flip-chip bonding of a circuit board and an insulating substrate, wherein the first soldering area and the second soldering area are located on the side of the insulating substrate opposite to the circuit board.

[0023] In some embodiments, the feedthrough structure further includes a flange and a first cover plate; before welding both the first end and the second end to the feedthrough structure, the method further includes:

[0024] Connect the circumferential direction of the circuit board assembly to the inner side of the flange;

[0025] The first cover plate is connected to one side of the flange, the circuit board is disposed between the first cover plate and the insulating substrate, and the first welding area and the second welding area are exposed from the side of the flange away from the first cover plate.

[0026] In some embodiments, the feedthrough structure further includes a second cover plate, wherein both the first end and the second end are welded to the insulating substrate, and further includes:

[0027] The second cover plate is connected to the side of the flange opposite to the first cover plate. The first cover plate and the second cover plate are connected to both sides of the flange to form a housing. The circuit board assembly is located inside the housing, and the first end and the second end pass through the housing.

[0028] In some embodiments, the welding assembly further includes a reference electrode and a skin electrode, and before the second cover plate is connected to the side of the flange away from the first cover plate, one end of both the reference electrode and the skin electrode is electrically connected to a predetermined area of ​​the insulating substrate.

[0029] In some embodiments, after welding the first end, the second end, the reference electrode, and the skin electrode to an insulating substrate, the method further includes: injection molding at least a portion of the welded assembly to form an outer covering layer covering the welded assembly, wherein the reference electrode and the skin electrode extend out of the outer covering layer, thereby forming an implant from the welded assembly and the outer covering layer.

[0030] An implant includes a coil, a communication antenna, a flexible covering encapsulates the coil and the communication antenna, and a feedthrough structure. A first end of the coil and a second end of the communication antenna both extend out of the flexible covering and are welded to the feedthrough structure. The implant is prepared using the implant preparation method described above.

[0031] The beneficial effects of this invention are:

[0032] This invention provides a method for fabricating an implant for a brain-computer interface system and the implant itself. Since the coil and communication antenna are relatively soft, they are encased in a flexible covering to form an integrated, molded rubber-coated component, which is then welded to the feedthrough structure. The flexible covering effectively constrains the deformation freedom of the coil and communication antenna, improving structural stability, connection strength, and resistance to deformation. The coil and communication antenna, constrained within the flexible covering, effectively prevent additional deformation and misalignment caused by manipulation during welding to the feedthrough structure, improving welding positioning accuracy and connection reliability, reducing welding difficulty, and thus effectively improving product yield and mass production efficiency. Attached Figure Description

[0033] Figure 1 This is a schematic diagram of a fully implantable brain-computer interface system provided in some embodiments of the present invention;

[0034] Figure 2 This is a schematic perspective view of the overall structure of the implant in some embodiments of the present invention;

[0035] Figure 3 These are schematic diagrams of implants without an outer covering layer in some embodiments of the present invention;

[0036] Figure 4 This is a schematic diagram showing the relative positions of the coil and the communication antenna in some embodiments of the present invention;

[0037] Figure 5 This is an overall schematic diagram of the coated component in some embodiments of the present invention;

[0038] Figure 6 These are exploded views of the feedthrough structure in some embodiments of the present invention;

[0039] Figure 7 This is a schematic diagram of the connection between the rubber-coated part and the feedthrough structure without the second cover plate in some embodiments of the present invention;

[0040] Figure 8 This is an exploded view of an implant without an outer covering layer provided in some embodiments of the present invention;

[0041] Figure 9 This is a schematic diagram of the implant structure from one perspective in some embodiments of the present invention;

[0042] Figure 10 This is a schematic diagram of the implant structure from another perspective in some embodiments of the present invention;

[0043] Figure 11 This is a flowchart of a method for preparing an implant for a brain-computer interface system according to some embodiments of the present invention;

[0044] Figure 12 This is an overall schematic diagram of the overmolding mold after mold closing in some embodiments of the present invention;

[0045] Figure 13 This is a schematic diagram of the fixed mold structure in some embodiments of the present invention;

[0046] Figure 14 These are schematic diagrams of the moving mold in some embodiments of the present invention;

[0047] Figure 15 This is a flowchart of a method for coating a coated part in some embodiments of the present invention;

[0048] Figure 16 This is a schematic diagram of the overall structure of the welding fixture in some embodiments of the present invention;

[0049] Figure 17 These are schematic diagrams of welding assemblies in welding fixtures according to some embodiments of the present invention;

[0050] Figure 18 This is a schematic diagram of the structure of an injection mold from one perspective, provided by some embodiments of the present invention;

[0051] Figure 19 This is a schematic diagram of the structure of an injection mold from another perspective, provided by some embodiments of the present invention;

[0052] Figure 20 This is a schematic diagram of a post-injection implant provided in a first mold according to some embodiments of the present invention;

[0053] Figure 21 This is a structural schematic diagram of an injection mold without a second mold provided by some embodiments of the present invention;

[0054] Figure 22 This is an exploded view of an injection mold without a second mold according to some embodiments of the present invention;

[0055] Figure 23 This is a schematic diagram of the structure of the second mold provided in some embodiments of the present invention;

[0056] Figure 24 This is a flowchart of an injection molding method provided by some embodiments of the present invention;

[0057] Figure 25 This is a schematic diagram of the overall composition of the in vitro machine provided in some embodiments of the present invention;

[0058] Figure 26 This is a schematic diagram of the overall composition of the host computer provided in some embodiments of the present invention.

[0059] In the picture:

[0060] 1. Fully implantable brain-computer interface system;

[0061] 10. Implant; 11. Coil; 111. First lead body; 112. First end; 113. First insulating tube; 12. Communication antenna; 121. Second lead body; 122. Second end; 123. Second insulating tube; 13. Flexible covering; 131. First part; 1311. Through hole; 1312. First protrusion; 1313. Second protrusion; 1314. Third protrusion; 1315. Fourth protrusion; 132. Second part; 133. Third part; 134. Fourth part; 14. Feedthrough structure; 141. Circuit board assembly; 1411. Insulation Substrate; 14111, First welding area; 14112, Second welding area; 14113, Third welding area; 14114, Fourth welding area; 1412, Circuit board; 142, Housing; 1421, Flange; 1422, First cover plate; 1423, Second cover plate; 14231, Clearance hole; 151, Reference electrode; 152, Skin electrode; 16, Outer coating layer; 161, First coating area; 162, Second coating area; 163, Third coating area; 164, Fourth coating area; 165, Fifth coating area; 166, Connecting ear; 167, Marking;

[0062] 20. External unit; 21. Communication unit; 22. Power supply unit; 221. Power supply unit housing; 222. Buttons; 223. Display screen; 23. Cables;

[0063] 30. Host computer; 31. Login module; 32. User information module; 33. Data acquisition module; 34. Display module; 35. Storage module.

[0064] 50. Overmolding mold; 51. Fixed mold; 511. First groove of fixed mold; 5111. Boss of fixed mold; 5112. First forming groove of fixed mold; 5113. Limiting block; 512. Second groove of fixed mold; 513. First lead wire groove; 514. Second lead wire groove; 515. Glue overflow groove of fixed mold; 516. First positioning groove; 517. Second positioning groove; 518. Clearance space; 52. Moving mold; 521. First groove of moving mold; 5211. First forming groove of moving mold; 5212. Boost; 52121. Second forming groove of moving mold; 52122. Limiting groove; 5213. Third forming groove of moving mold; 522. Glue inlet; 53. First insert; 531. First positioning pin; 54. Second insert; 541. Second positioning pin; 55. Connector; 56. Guide; 561. Positioning post; 562. Positioning hole;

[0065] 60. Welding fixture; 61. Base body; 611. First limiting part; 6111. First mounting groove; 61111. Fixture limiting post; 61112. Fixture recess; 6112. Second mounting groove; 6113. First notch; 612. Second limiting part; 6121. Second notch;

[0066] 70. Injection mold; 71. First mold; 711. First cavity; 7111. Mold limiting post; 71111. Mold recess; 7112. Support part; 7113. Forming post; 7121. First electrode receiving groove; 7122. Second electrode receiving groove; 72. Second mold; 721. First structural block; 7211. Second cavity; 72111. Mold forming groove; 722. Second structural block; 7221. Injection port; 7222. Overflow port; 73. Base; 731. Elastic element; 74. Ejector pin assembly; 741. Pin plate; 7411. First plate; 7412. Second plate; 742. Guide post; 7431. First tube pin; 7432. Second tube pin; 75. Connecting structure; 76. Guide structure. Detailed Implementation

[0067] To make the technical problems solved by the present invention, the technical solutions adopted, and the technical effects achieved clearer, the technical solutions of the embodiments of the present invention will be further described in detail below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0068] In the description of this invention, unless otherwise explicitly specified and limited, the terms "connected," "linked," and "fixed" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components. Those skilled in the art can understand the specific meaning of the above terms in this invention based on the specific circumstances.

[0069] In this invention, unless otherwise explicitly specified and limited, "above" or "below" the second feature can include direct contact between the first and second features, or contact between the first and second features through another feature between them. Furthermore, "above," "over," and "on top" of the second feature includes the first feature directly above or diagonally above the second feature, or simply indicates that the first feature is at a higher horizontal level than the second feature. "Below," "below," and "under" the second feature includes the first feature directly below or diagonally below the second feature, or simply indicates that the first feature is at a lower horizontal level than the second feature.

[0070] In some embodiments, combined with Figure 1 As shown, this application provides a fully implantable brain-computer interface system 1. The fully implantable brain-computer interface system 1 is an implantable product for collecting signals from the cerebral cortex. The system includes an implant 10, an external unit 20, and a host computer 30. The implant 10 is surgically implanted into the brain to collect electroencephalogram (EEG) signals. The external unit 20 is connected to the implant 10, providing power and data transmission. The host computer 30 is signal-connected to the external unit 20 for data transmission interaction. The EEG signals collected by the implant 10 are transmitted to the host computer 30 via the signal link of the external unit 20 for monitoring, decoding, analysis, and control of the implant 10 to provide corresponding signal stimulation. The host computer 30 displays the collected cerebral cortex signal information, facilitating analysis of the signals by staff, and also provides feedback on the overall system operation status for monitoring.

[0071] In some embodiments, combined with Figures 2-10 As shown, this application provides an implant 10 for a brain-computer interface system, including a coil 11, a communication antenna 12, a flexible cover 13 encasing the coil 11 and the communication antenna 12, and a feedthrough structure 14. The flexible cover 13 and the coil 11 and the communication antenna 12 encased within the flexible cover 13 together form an encapsulated part. The first end 112 of the coil 11 and the second end 122 of the communication antenna 12 both extend out of the flexible cover 13 and are welded to the feedthrough structure 14 to form a welded assembly.

[0072] In some embodiments, combined with Figure 2 , Figure 7 and Figure 8 As shown, the welding assembly also includes electrodes, and the feedthrough structure 14 includes multiple feedthrough holes; the electrodes, the first end 112 and the second end 122 are electrically connected to the multiple feedthrough holes one by one.

[0073] The coil 11 is used for energy transmission and interaction with other components (such as the external unit 20), the communication antenna 12 is used for data transmission and interaction with other components (such as the external unit 20), the electrodes are responsible for transmitting and receiving neural signals, and the feedthrough structure 14 serves as the core for airtight conduction and signal transfer, realizing reliable interconnection between the internal circuit and the external functional components. This enables the implant 10 to complete the acquisition, processing and wireless transmission of neural signals, and realizes wireless power supply and command interaction between the external device and the implant 10, ensuring the stable and reliable operation of the fully implantable brain-computer interface system 1.

[0074] It is particularly important to note that the coil 11 and communication antenna 12 are relatively soft. By wrapping the coil 11 and communication antenna 12 around the flexible covering 13 to form an integrated molded part, the coil 11, communication antenna 12, and flexible covering 13 are integrated into a single design. This allows the coil 11 and communication antenna 12 to be seamlessly connected through the flexible covering 13. The flexible covering 13 effectively constrains the deformation freedom of the coil 11 and communication antenna 12, improving structural stability, connection strength, and resistance to deformation. The coil 11 and communication antenna 12, constrained within the flexible covering 13, effectively prevent additional deformation and misalignment of the coil 11 and communication antenna 12 during welding with the feedthrough structure 14, improving welding positioning accuracy and connection reliability, reducing welding difficulty, and thus effectively improving product yield and mass production efficiency.

[0075] In some embodiments, combined Figure 3 and Figure 4As shown, the coil 11 has an overall vortex ring structure. Optionally, the coil 11 includes a first lead body 111 and a first end 112. The coil 11 is formed by winding the first lead multiple times, and after winding, the first lead body 111 extends out at both ends to form two first ends 112. Further, a first insulating tube 113 is correspondingly sleeved around each first end 112, meaning the first end 112 passes through the corresponding first insulating tube 113 and is partially exposed outside the first insulating tube 113; that is, the end of the first end 112 furthest from the first lead body 111 is exposed outside the first insulating tube 113 and connected to the corresponding feedthrough hole. It can be understood that by sleeved with the first insulating tube 113, the first lead body 111 of the coil 11 can be prevented from contacting external conductive structures, thus avoiding short circuits and improving safety and reliability. Optionally, the first lead wire may be made of one or more of platinum-iridium alloy wire, silver wire, gold wire, etc., with a wire diameter ranging from 0.3mm to 0.8mm. The inner diameter of the first lead wire body 111 ranges from 10mm to 20mm, and the outer diameter ranges from 27mm to 50mm.

[0076] In some embodiments, combined Figure 3 and Figure 4 As shown, the communication antenna 12 is generally in the shape of a helical spring. Optionally, the communication antenna 12 includes a second lead body 121 and a second end 122. The communication antenna 12 is formed by helically winding the second lead, and one end of the second lead body 121 extends out to form the second end 122. Further, a second insulating tube 123 is correspondingly sleeved around the second end 122, meaning the second end 122 passes through the corresponding second insulating tube 123 and is partially exposed outside the second insulating tube 123. Specifically, the end of the second end 122 furthest from the second lead body 121 is exposed in the second insulating tube 123 and connected to the corresponding feedthrough hole. This prevents the second lead body 121 of the communication antenna 12 from contacting external conductive structures, thus avoiding short circuits and improving safety and reliability. Optionally, the communication antenna 12 is made of platinum-iridium alloy wire, with a total length ranging from 45mm to 85mm and a wire diameter ranging from 0.15mm to 0.25mm. For example, the communication antenna 12 is a Bluetooth antenna.

[0077] Optionally, in some embodiments, combined with Figures 2-4 As shown, the communication antenna 12 and the coil 11 are arranged side by side, with the center lines of the coil 11 and the communication antenna 12 spaced apart and arranged at an angle. The center line of the coil 11 is arranged along a first direction, and the coil 11 and the communication antenna 12 are arranged along a second direction. The center line of the communication antenna 12 is arranged along a third direction. The first end 112 and the second end 122 both extend along the second direction and both extend towards the side of the communication antenna 12 away from the coil 11. The first end 112 and the second end 122 are spaced apart along the third direction.

[0078] Furthermore, in some embodiments, combined with Figures 2-5 As shown, the flexible covering 13 includes an integrally connected first part 131 and second part 132. The first part 131 and the second part 132 are arranged side by side. The first part 131 corresponds to the first lead body 111 of the coil 11, and the second part 132 corresponds to the second lead body 121 and part of the first end 112 of the communication antenna 12. The first part 131 and the second part 132 are arranged side by side and are connected in a transitional manner. That is to say, the first part 131 and the second part 132 extend and transition at a certain angle to form a whole.

[0079] Optionally, in some embodiments, combined with Figures 2-5 As shown, the first part 131 completely covers the exterior of the first lead body 111. The first part 131 is circular in shape and includes a first side and a second side opposite to each other along the first direction (i.e., the vertical direction). The second part 132 covers the second lead body 121 and part of the first end 112. The second part 132 is cylindrical, and one side of the cylinder extends and transitions at a certain angle with one side of the circular shape of the first part 131. This facilitates the formation of a more portable, more easily fixed to the skull, and more physiologically compatible miniaturized device for the entire encapsulated part and even the implant 10 of the brain-computer interface system including the encapsulated part.

[0080] Furthermore, in some embodiments, combined with Figures 2-5 As shown, both the first end 112 and the second end 122 extend from the side of the second part 132 away from the first part 131.

[0081] Furthermore, combined Figures 2-5 As shown, in some embodiments, the flexible covering 13 further includes a third part 133 and a fourth part 134 connected to the side of the second part 132 opposite to the first part 131. The third part 133 at least partially covers the first insulating tube 113, and the fourth part 134 at least partially covers the second insulating tube 123, so that the first insulating tube 113 and the second insulating tube 123 are integratedly connected to the flexible covering 13.

[0082] In some embodiments, combined with Figures 6-8As shown, the feedthrough structure 14 includes an insulating substrate 1411 and a circuit board 1412 stacked together. The insulating substrate 1411 has multiple feedthrough vias. Electrodes, the first end 112, and the second end 122 are all electrically connected to the side of the insulating substrate 1411 facing away from the circuit board 1412, facilitating soldering operations and preventing the feedthrough structure 14 from flipping during soldering. The insulating substrate 1411 is used to connect and interact with external devices (such as coil 11, communication antenna 12, and electrodes) and electronic chips and other components in the circuit board 1412, enabling conduction between internal and external circuit devices. The circuit board 1412 includes a neural signal acquisition chip, a stimulation chip, and various electronic components, which will not be described in detail here.

[0083] Optionally, the insulating substrate 1411 is a thick-film ceramic plate, and the circuit board 1412 is a conventional circuit board. The insulating substrate 1411, i.e., the thick-film ceramic plate, forms a first welding area 14111, a second welding area 14112, a third welding area 14113, and a fourth welding area 14114 by completing the corresponding feedthrough hole processing. The circuit board 1412 undergoes surface mount processing. Then, the insulating substrate 1411 and the circuit board 1412 are arranged parallel to each other and welded together to form the circuit board assembly 141. The first welding area 14111 and the second welding area 14112 are both located on one side of the feedthrough structure 14 along the second direction, while the third welding area 14113 and the fourth welding area 14114 are both located on the other side of the feedthrough structure 14 along the second direction, facilitating welding operations. For example, in conjunction with... Figure 7 As shown, the first welding area 14111, the second welding area 14112, the third welding area 14113 and the fourth welding area 14114 are all disposed on the side of the insulating substrate 1411 away from the circuit board 1412.

[0084] Optionally, the feedthrough structure 14 is provided with two first welding areas 14111, and two first ends 112 are welded to the two first welding areas 14111 of the feedthrough structure 14. By sleeved with the first insulating tube 113, the first lead body 111 and the first end 112 of the coil 11 can be prevented from contacting the non-welding area of ​​the feedthrough structure 14, thus avoiding short circuit and improving safety and reliability.

[0085] Optionally, the feedthrough structure 14 is provided with a second welding area 14112, and the second end 122 is welded to a single second welding area 14112 of the feedthrough structure 14. When the second end 122 is used to weld with the feedthrough structure 14, by sleeved with a second insulating tube 123, the second lead body 121 and the second end 122 of the communication antenna 12 can be prevented from contacting the non-welded area on the feedthrough structure 14, thus avoiding short circuit and improving safety and reliability.

[0086] Optionally, the first welding area 14111 and the second welding area 14112 are arranged at intervals along the third direction on the feedthrough structure 14. Along the third direction, the arrangement order of the first welding area 14111 and the second welding area 14112 is the same as the arrangement order of the first end 112 and the second end 122, so that the first welding area 14111 is correspondingly set with the first end 112 and the second welding area 14112 is correspondingly set with the second end 122, so as to prevent the first end 112 and the second end 122 from intersecting.

[0087] Optionally, the feedthrough structure 14 and the overmolded component are arranged along the second direction. The feedthrough structure 14 is located at the end of the overmolded component near the first end 112 and the second end 122, facilitating welding of the first end 112 to the first welding area 14111 and the second end 122 to the second welding area 14112. This effectively shortens the required length of the first end 112 and the second end 122, saving materials while ensuring stable connection and stable operation between components. In some embodiments, the feedthrough structure 14 includes a housing 142, with an insulating substrate 1411 and a circuit board 1412 all disposed within the housing 142. The housing 142 has a clearance hole 14231, through which the electrode, the first end 112, and the second end 122 pass and extend into the housing 142. It is understood that by providing the housing 142, the circuit board assembly 141 is installed inside the housing 142, and the feedthrough structure 14 is set as a whole. The housing 142 has the function of protecting the internal circuit board assembly 141, improving the overall reliability of the feedthrough structure 14.

[0088] Optionally, the housing 142 includes a flange 1421 and a first cover plate 1422 and a second cover plate 1423 connected to both sides of the flange 1421. After the surface of the flange 1421 is activated, the circuit board assembly 141 is bonded to the flange 1421. Then, the first cover plate 1422 is ultrasonically welded or laser welded to the flange 1421 to form a mounting shell, and an opening is formed on the other side of the flange 1421. The first welding area 14111 and the second welding area 14112 are both located on the circuit board assembly 141 and exposed in the opening of the mounting shell. The first end 112 is welded to the first welding area 14111, and the second end 122 is welded to the second welding area 14112 using a laser welding process. By first forming a mounting shell with an opening, it is convenient for the first end 112 and the second end 122 to pass through the opening for welding operations. Subsequently, the second cover plate 1423 and the flange 1421 with an open end are ultrasonically welded or laser welded. The second cover plate 1423 is provided with a clearance hole 14231 to avoid the first end 112 and the second end 122 and prevent structural interference.

[0089] In some other embodiments, the housing 142 includes a flange 1421 and a first cover plate 1422 and a second cover plate 1423 connected to both sides of the flange 1421. After surface activation treatment of the flange 1421, the circuit board assembly 141 is bonded to the flange 1421. Then, the first cover plate 1422 and the flange 1421 are ultrasonically welded or laser welded to form a mounting shell, with an opening on the other side of the flange 1421. The second cover plate 1423 is ultrasonically welded or laser welded to the end of the flange 1421 with the opening. The second cover plate 1423 is provided with a clearance hole 14231 to avoid the first end 112 and the second end 122 and prevent structural interference. Wherein, after ultrasonic welding or laser welding of the open end of the second cover plate 1423 and the flange 1421, the first end 112 can be welded to the first welding area 14111 and the second end 122 can be welded to the second welding area 14112 by laser welding process. The clearance hole 14231 facilitates the welding operation between the first end 112 and the first welding area 14111 and the second end 122 and the second welding area 14112.

[0090] For example, the first cover plate 1422 and the second cover plate 1423 are respectively welded to both ends of the flange 1421 to form a housing 142. The feedthrough structure 14 is housed in the housing 142. The insulating substrate 1411 is a cuboid ceramic plate, including an upper surface and a lower surface. The upper surface is flip-chip welded to the circuit board 1412, and the lower surface is connected to the communication antenna 12 and the coil 11. The insulating substrate 1411 is used to connect external devices (such as the communication antenna 12 and the coil 11) to the internal electronic chip, realizing the conduction of internal and external circuit devices. The insulating substrate 1411 is generally made of biocompatible materials such as titanium, alumina ceramic, and sapphire, with alumina ceramic being preferred. The size of the insulating substrate 1411 should be as small as possible while meeting the functional and performance requirements of the product, so as to meet the clinical use requirements of the implant 10 product. In one embodiment, the length of the insulating substrate 1411 is 21mm-25mm, the width is 21mm-25mm, and the thickness is 1.2mm-1.3mm.

[0091] Optionally, the shell 142 is generally made of PEEK material or titanium alloy material with good biocompatibility. The shell 142 has a length of 23mm-27mm, a width of 23mm-27mm, and a thickness of 3.8mm-4.2mm.

[0092] Optionally, such as Figure 2 , Figure 3 and Figures 8-10 As shown, the electrode includes a reference electrode 151 and a skin electrode 152.

[0093] In some embodiments, one end of the reference electrode 151 has a cap-shaped structure for recognizing neural signals and filtering noise signals, while the other end is connected to a feedthrough via on the insulating substrate 1411. Exemplarily, the feedthrough structure 14 has two third welding areas 14113, and the two reference electrodes 151 are welded to the corresponding third welding areas 14113 of the feedthrough structure 14. Optionally, the reference electrode 151 is generally made of platinum-iridium alloy, and the cap-shaped structure at one end is stamped from a platinum-iridium alloy electrode sheet. The diameter of the cap-shaped platinum-iridium alloy sheet is 4mm-5mm, and the thickness is 0.1mm-0.2mm, to better adapt to the brain tissue structure and improve its adhesion to the brain tissue.

[0094] In some embodiments, one end of the cortical electrode 152 extends beyond the entire housing 142 of the implant 10 for contact with brain tissue; the other end is connected to a feedthrough via on the insulating substrate 1411 to enable interaction with electronic chips and components inside the circuit board 1412. Exemplarily, the feedthrough structure 14 has a fourth welding area 14114, and the cortical electrode 152 is welded to the fourth welding area 14114 of the feedthrough structure 14. Optionally, the cortical electrode 152 can also be replaced with a scalp electrode and / or a stereotactic deep electrode and / or a needle electrode and / or a microneedle electrode, preferably a flexible cortical electrode, placed on the surface of the cerebral cortex for easy attachment to brain tissue and precise recording of cortical electrical activity.

[0095] Specifically, before welding the first end 112 and the second end 122 to the feedthrough structure 14, i.e., the insulating substrate 1411, the reference electrode 151 is first welded to the third welding area 14113 on the insulating substrate 1411, and then the skin electrode 152 is welded to the fourth welding area 14114. Optionally, the skin electrode 152 is connected to the fourth welding area 14114 of the insulating substrate 1411 through a conductive paste (gold, silver, copper), and then the second cover plate 1423 is connected to the flange 1421. The second cover plate 1423 is provided with corresponding clearance holes 14231 to avoid the first end 112, the second end 122, the reference electrode 151 and the skin electrode 152, so as to facilitate the welding operation and prevent structural interference. Finally, after the reference electrode 151, the skin electrode 152 and the second cover plate 1423 are welded, the first end 112 and the second end 122 of the overmolded part are welded to the preset area of ​​the feedthrough structure 14, namely the corresponding first welding area 14111 and the second welding area 14112.

[0096] Special emphasis, combined Figure 2 , Figure 3 as well as Figures 7-10As shown, the relative positions of the first welding area 14111, the second welding area 14112, the third welding area 14113, and the fourth welding area 14114 on the feedthrough structure 14 can be flexibly adjusted according to the actual application requirements of the implant. It is only necessary to ensure that the feedthrough structure 14 is connected to the coil 11, the communication antenna 12, the reference electrode 151, and the cortical electrode 152, and that they do not interfere with each other and can work normally.

[0097] Optionally, such as Figure 2 , Figure 9 and Figure 10 As shown, the implant 10 also includes an outer covering layer 16. The welded assembly formed by the overlay and the feedthrough structure 14 is at least partially covered within the outer covering layer 16, and the electrode extends out of the outer covering layer 16. It is particularly emphasized that both the overlay and the feedthrough structure 14 are covered within the outer covering layer 16, achieving an integrated connection between the overlay and the feedthrough structure 14. By forming an integrally molded outer covering layer 16 on the overlay and the feedthrough structure 14, an integrated design is achieved, allowing the overlay and the feedthrough structure 14 to be seamlessly connected through the outer covering layer 16. The outer covering layer 16 effectively constrains the deformation freedom of the overlay and the feedthrough structure 14, improves structural stability, connection strength, and resistance to deformation, and enhances the sealing of the internal structure, effectively preventing tissue fluid from entering during use and providing reliability.

[0098] Optionally, the outer covering layer 16 is provided with connecting ears 166 to facilitate connection with the skull. Exemplarily, the connecting ears 166 have holes through which fasteners such as screws pass to connect with the skull. Further, the outer covering layer 16 is provided with at least two connecting ears 166, such as... Figure 2 As shown, for example, there are four connecting ears 166, two of which are symmetrically distributed on both sides of the feedthrough structure 14, and the remaining two are symmetrically distributed on both sides of the coil 11. Figure 9 and Figure 10 As shown, for example, there are two connecting ears 166, which are symmetrically distributed on both sides of the feedthrough structure 14.

[0099] In some embodiments, the outer surface of the flexible covering 13 is provided with a plurality of protrusions, and the outer covering layer 16 is provided with a plurality of grooves, with the protrusions correspondingly embedded in the grooves; the flexible covering 13 is provided with a plurality of through holes 1311; the outer covering layer 16 is provided with a plurality of filling portions, with the filling portions correspondingly embedded in the through holes 1311. The flexible covering 13 and the outer covering layer 16 are nested and connected to each other to enhance the bonding force.

[0100] For example, combined Figures 2-10As shown, the flexible covering 13 includes a first annular portion 131, which has opposing first and second side surfaces along the axial direction and includes an inner ring surface and an outer ring surface in the radial direction. The outer covering layer 16 includes a first covering region 161, a second covering region 162, a third covering region 163, a fourth covering region 164, and a fifth covering region 165. The first covering area 161 is a continuous, integral structure located on one side of the first part 131 along the axial direction, meaning the first covering area 161 covers the first side of the first part 131. The second covering area 162 is annular, adapted to the shape of the first part 131, and located on the other side of the first part 131 along the axial direction, meaning the second covering area 162 covers the second side of the first part 131. The third covering area 163 connects the first covering area 161 and the second covering area 162, and surrounds the outer surface of the first part 131. The fourth covering area 164 connects the first covering area 161 and the second covering area 162, and surrounds the inner surface of the first part 131, so that the outer covering layer 16 completely covers the first part 131. The fifth covering area 165 covers the remaining structure and is integrally connected to the first covering area 161, the second covering area 162, the third covering area 163, and the fourth covering area 164.

[0101] Optionally, the first portion 131 has a plurality of through holes 1311 evenly distributed, corresponding to the first and second side surfaces. The through holes 1311 extend along the axial direction of the first portion 131. A filling portion connects the first covering area 161 and the second covering area 162, filling the through holes 1311. When the overmolded part and the outer covering layer 16 are connected, they can form an interlocking structure to improve the bonding force between the overmolded part and the outer covering layer 16 for further assembly. For example, the through holes 1311 are distributed between two first protrusions 1312, and the number of both the through holes 1311 and the filling portion is 8.

[0102] Optionally, the first part 131 has protrusions on both sides and the inner ring surface along the axial direction, and the first covering area 161, the second covering area 162 and the fourth covering area 164 are respectively provided with grooves.

[0103] Optionally, a plurality of first protrusions 1312 are evenly distributed in a ring on the first side surface to fix and support the entire overmolded part, preventing accidental axial movement or displacement of the overmolded part. Simultaneously, when the overmolded part and the outer covering layer 16 are connected, the first covering area 161 is provided with a plurality of first grooves. The plurality of first grooves and the plurality of first protrusions 1312 form a one-to-one corresponding interlocking structure to improve the bonding force between the overmolded part and the outer covering layer 16 for further assembly. For example, the shape of a single first protrusion 1312 is a raised strip, and the number of first protrusions 1312 and first grooves is 16, with two raised strips forming a group. Through holes 1311 are distributed between two first protrusions 1312 in a group, with a total number of 8.

[0104] Optionally, the second side surface is provided with second protrusions 1313 evenly distributed in a ring. It is understood that the cooperation of several first protrusions 1312 and several second protrusions 1313 on opposite side surfaces can effectively support and limit accidental displacement of the overmolded component. Simultaneously, when the overmolded component is connected to the outer covering layer 16, the second covering area 162 is provided with several second grooves. These second grooves and the second protrusions 1313 form a one-to-one interlocking structure to improve the bonding force between the overmolded component and the outer covering layer 16 for further assembly. For example, each second protrusion 1313 is shaped like a boss, evenly distributed circumferentially, and the number of both second protrusions 1313 and second grooves is four.

[0105] Optionally, the inner ring of the first part 131, which has an inwardly convex protrusion, is provided with a plurality of third protrusions 1314. These third protrusions 1314 are evenly distributed. When the overmolded part and the outer covering layer 16 are connected, the fourth covering area 164 is provided with a plurality of third grooves. These third grooves and the third protrusions 1314 form a one-to-one corresponding and mutually interlocking structure to improve the bonding force between the overmolded part and the outer covering layer 16 for further assembly. Additionally, the third protrusions 1314 can prevent accidental rotation of the overmolded part, providing circumferential restraint. For example, each third protrusion 1314 is an arc-shaped protrusion, and the number of both the third protrusions 1314 and the third grooves is four.

[0106] Optionally, the first side surface is further provided with a plurality of fourth protrusions 1315, which are evenly distributed in a ring on the first side surface. The plurality of fourth protrusions 1315 and the plurality of second protrusions 1313 are arranged in a one-to-one correspondence with the first side surface and the second side surface. For example, a single fourth protrusion 1315 is a boss that is completely identical to a single second protrusion 1313, and the plurality of fourth protrusions 1315 are spaced apart, with each fourth protrusion 1315 located between two (a group of) first protrusions 1312; the number of both the fourth protrusions 1315 and the fourth grooves is 4, and they are evenly distributed circumferentially.

[0107] It is particularly important to emphasize that the several fourth protrusions 1315, several first protrusions 1312, and several second protrusions 1313 can further cooperate to fix and support the entire overmolded part, preventing accidental axial movement or displacement of the overmolded part that would lead to uneven overmolding (especially the completely consistent and corresponding second protrusions 1313 and fourth protrusions 1315, which can ensure that the distance between the first and second sides of the overmolded part and other components, such as the upper and lower mold surfaces of the whole machine injection overmolding mold, is consistent, ensuring that the overmolded part can be in the center position of the whole machine injection overmolding mold). At the same time, when the overmolded part and the outer covering layer 16 are connected, the first covering area 161 is also provided with several fourth grooves. The several fourth grooves and several fourth protrusions 1315 form a one-to-one corresponding and interlocking structure to improve the bonding force between the overmolded part and the outer covering layer 16 for further assembly and molding.

[0108] In some embodiments, the flexible coating 13 is made of one of silicone, a silicon-derived material, thermoplastic polyurethane, a liquid ionic elastomer, a thermoplastic elastomer, and polyvinylidene fluoride; and / or, the outer coating 16 is made of one of silicone, a silicon-derived material, thermoplastic polyurethane, a liquid ionic elastomer, a thermoplastic elastomer, and polyvinylidene fluoride. The flexible coating 13 and the outer coating 16 can be made of the same or different materials; when they are made of the same material, the bonding strength is better. Preferably, both the flexible coating 13 and the outer coating 16 are made of flexible fluids, such as liquid silicone.

[0109] It is particularly emphasized that the implant 10 achieves an integrated design by using a flexible covering 13 to wrap the coil 11 and the communication antenna 12, thereby improving structural stability, preventing additional deformation during welding, improving welding positioning accuracy and connection reliability, and thus improving product quality; reducing welding difficulty, thereby effectively improving product yield and large-scale production efficiency, and ultimately reducing product cost. Furthermore, by using an outer covering layer 16, both the overmolded component and the feedthrough structure 14 are covered by the outer covering layer 16, with the electrodes extending from the outer covering layer 16. This achieves an integrated connection between the overmolded component and the feedthrough structure 14. By forming an integrally molded outer covering layer 16 on the overmolded component and the feedthrough structure 14, an integrated design is achieved, allowing the overmolded component and the feedthrough structure 14 to be seamlessly connected through the outer covering layer 16. The outer covering layer 16 effectively constrains the deformation freedom of the overmolded component and the feedthrough structure 14, improves structural stability, connection strength, and resistance to deformation, and also improves the sealing of the internal structure, effectively preventing tissue fluid from entering during use, thus providing reliability.

[0110] In some embodiments, the external unit 20 includes a communication unit, a power supply unit, and a cable, with the communication unit and the power supply unit connected by the cable. The communication unit is connected to the power supply unit, the implant 10, and the host computer 30 for data transmission, and transmits the EEG signals collected by the implant 10 to the host computer 30 through the signal link of the external unit 20 (see subsequent description for details).

[0111] Understandably, the host computer 30 is used to receive physiological electrical signal data emitted by the implant 10, preprocess the signals, extract features and decode intentions, and display the signal waveform and the status of the fully implantable brain-computer interface system 1 in real time through the display unit of the host computer 30; at the same time, the host computer 30 can generate control commands according to user operations and send them to the implant 10 and the external machine 20 to realize the regulation of the working status such as the acquisition parameters and stimulation mode.

[0112] Understandably, the implant 10 is equipped with a communication antenna 12, which can be configured as a Bluetooth antenna to enable communication between the implant 10, the external unit 20, and the host computer 30. The power supply unit, including a battery, is used to power the communication unit and the implant 10. The specific structures of the external unit 20 and the host computer 30 are based on existing technologies and will not be elaborated further.

[0113] In some embodiments, combined with Figure 11 As shown, this application provides a method for preparing an implant for a brain-computer interface system, comprising:

[0114] S1. Complete the manufacturing and processing of all individual components;

[0115] S2. Coil coil 11 and communication antenna 12 are coated with adhesive to form a flexible covering body 13 that wraps coil 11 and communication antenna 12, so that coil 11, communication antenna 12 and flexible covering body 13 form an integrated coated part, and the first end 112 of coil 11 and the second end 122 of communication antenna 12 both extend out of flexible covering body 13.

[0116] S3, one end of the reference electrode 151 and the skin electrode 152 are all electrically connected to a preset area of ​​the feedthrough structure 14;

[0117] S4. Weld both the first end 112 and the second end 122 to the feedthrough structure 14 to form a welded assembly;

[0118] S5. At least a portion of the welded assembly is injection molded to form an outer covering layer 16 covering the welded assembly, with the reference electrode 151 and the skin electrode 152 extending out of the outer covering layer 16, so that the welded assembly and the outer covering layer 16 form an implant 10.

[0119] To facilitate a better understanding of the preparation method of implants for brain-computer interface systems, the following section will provide a detailed description of each step in the preparation method of implants for brain-computer interface systems.

[0120] S1. Complete the manufacturing and processing of all individual components;

[0121] Specifically, including:

[0122] S11. The first lead wire is wound to form the first lead wire body 111 and the first end 112, so that the coil 11 as a whole has a vortex ring structure, such as Figure 4 As shown;

[0123] S12. The second lead is wound to form the second lead body 121 and the second end 122, so that the communication antenna 12 as a whole is in the shape of a helical spring. Figure 4 As shown;

[0124] The fabrication and processing of S13, the first cover plate 1422, the flange 1421, and the second cover plate 1423, such as Figure 6 As shown;

[0125] S14, the surface mount processing of circuit board 1412, the fabrication of insulating substrate 1411 and its feedthrough vias, forming the first welding area 14111, the second welding area 14112, the third welding area 14113 and the fourth welding area 14114, combined Figures 6-8 As shown;

[0126] S15, fabrication and processing of reference electrode 151 and skin electrode 152;

[0127] Steps S11-S15 can be performed simultaneously or sequentially as needed, without any limitation.

[0128] S2. The coil 11 and communication antenna 12 are coated with adhesive to form a flexible covering 13 that encapsulates the coil 11 and communication antenna 12. This makes the coil 11, communication antenna 12, and flexible covering 13 an integrally connected coated component, with the first end 112 of the coil 11 and the second end 122 of the communication antenna 12 both extending out of the flexible covering 13. Figures 3-5 As shown.

[0129] Optionally, when encapsulating the coil 11 and the communication antenna 12, the following steps are also included:

[0130] S21. The first lead body 111 and the second lead body 121 are arranged side by side, so that the flexible covering body 13 is divided into a first part 131 and a second part 132. The first part 131 covers the first lead body 111, and the second part 132 covers the second lead body 121.

[0131] Understandably, by setting the coil 11 and the communication antenna 12 into a specific structure, and then setting the first lead body 111 and the second lead body 121 side by side, the first lead body 111 and the second lead body 121 can be kept in a fixed relative position, avoiding relative displacement between the two during the encapsulation process, which would cause structural interference and subsequent signal interference problems, thus ensuring the working stability of the implant 10.

[0132] Optionally, when encapsulating the coil 11 and the communication antenna 12, the process further includes:

[0133] S22. The center lines of the first lead body 111 and the second lead body 121 are spaced apart and arranged at an angle. The first lead body 111 is disposed on the periphery of the second lead body 121, so that the first end 112 and the second end 122 both extend away from the first lead body 111, thereby so that the first end 112 and the second end 122 both extend from the same side of the overmolded part.

[0134] Optionally, the encapsulated component includes a first insulating tube 113 and a second insulating tube 123. When encapsulating the coil 11 and the communication antenna 12, it also includes:

[0135] S23. The first insulating tube 113 is sleeved on the first end 112, so that the end of the first end 112 away from the first lead body 111 is exposed in the first insulating tube 113, and the rubber-coated part covers at least part of the first insulating tube 113.

[0136] S24. The second insulating tube 123 is sleeved on the second end 122, so that the end of the second end 122 away from the second lead body 121 is exposed in the second insulating tube 123, and the rubber-coated part covers at least part of the second insulating tube 123.

[0137] Steps S23 and S24 can be performed simultaneously or separately, without limitation.

[0138] Understandably, the first end 112 extends out of the first insulating tube 113 before being welded to the feedthrough structure 14. The first insulating tube 113 can prevent the second lead body 121 of the communication antenna 12 from contacting with external conductive structures, thus preventing a short circuit and improving safety and reliability. If the first insulating tube 113 is located between the first end 112 and the non-welded area of ​​the feedthrough structure 14, it can effectively prevent the first end 112 from contacting the non-welded area of ​​the feedthrough structure 14. Similarly, the second end 122 extends out of the second insulating tube 123 before being welded to the feedthrough structure 14. The second insulating tube 123 can prevent the second lead body 121 of the communication antenna from contacting with external conductive structures, thus preventing a short circuit and improving safety and reliability. If the second insulating tube 123 is located between the second end 122 and the non-welded area of ​​the feedthrough structure 14, it can effectively prevent the second end 122 from contacting the non-welded area of ​​the feedthrough structure 14. Furthermore, the first insulating tube 113 is sleeved on the first end 112, and the second insulating tube 123 is sleeved on the second end 122. During the encapsulation process, the first insulating tube 113 protects the first end 112, effectively preventing deformation, and the second insulating tube 123 protects the second end 122, effectively preventing deformation. Moreover, when the coil 11 and communication antenna 12 are subsequently encapsulated using an encapsulation mold, the first insulating tube 113 and the second insulating tube 123 isolate the first end 112 and the second end 122, preventing fluid from exerting force on the first end 112 and the second end 122, which could cause them to contact and short-circuit.

[0139] Optionally, the wound coil 11 and communication antenna 12 are placed in the corresponding positions of the overmolding mold 50, then the mold is closed, a flexible fluid is injected into the overmolding mold 50, and the flexible fluid is heated to solidify, thereby obtaining a flexible covering body 13 that forms a fixed connection between the coil 11 and the communication antenna 12, thus obtaining an integrated overmolded part.

[0140] Understandably, since the coil 11 and communication antenna 12 are relatively soft, they are wrapped in a flexible covering 13 to form an integrated, molded rubber-coated part, which is then welded to the feedthrough structure 14. The flexible covering 13 effectively constrains the deformation freedom of the coil 11 and communication antenna 12, improving structural stability, connection strength, and resistance to deformation. The coil 11 and communication antenna 12, constrained within the flexible covering 13, effectively prevent additional deformation and misalignment of the coil 11 and communication antenna 12 during welding to the feedthrough structure 14, improving welding positioning accuracy and connection reliability, reducing welding difficulty, and thus effectively improving product yield and mass production efficiency.

[0141] For example, combined Figures 12-14As shown, a rubber-coating mold 50 is provided for molding the aforementioned rubber-coated part. The rubber-coating mold 50 includes a fixed mold 51 and a movable mold 52 adapted to the fixed mold 51. The fixed mold 51 is a rectangular metal plate, serving as the base of the rubber-coating mold 50, used to fix the individual coil 11 and communication antenna 12 in a preset relative position. The movable mold 52 is a rectangular metal plate corresponding to the fixed mold 51, and the movable mold 52 can move freely between being closely against the fixed mold 51 and being completely away from the fixed mold 51. Through the cooperation of the movable mold 52 and the fixed mold 51, the individual coil 11 and communication antenna 12 can be conveniently assembled without damaging the original structure of the coil 11 and communication antenna 12, and an integrated flexible covering 13 can be conveniently formed on the assembled coil 11 and communication antenna 12, thus molding the rubber-coated part.

[0142] Optionally, combined Figure 13 As shown, the fixed mold 51 and the moving mold 52 are connected along the first direction (i.e., the vertical direction), with the fixed mold 51 located below the moving mold 52.

[0143] For example, the height of the fixed mold 51 along the first direction is 10mm-13mm, the height of the moving mold 52 along the first direction is 10mm-13mm, the total height of the overmolding mold 50 after mold closing is 20mm-26mm, the length of the fixed mold 51 and the moving mold 52 along the second direction is 60mm-80mm, and the width along the third direction is 60mm-80mm.

[0144] Optionally, the fixed mold 51 includes a fixed mold cavity, i.e., a lower mold cavity, and the moving mold 52 includes a moving mold cavity, i.e., an upper mold cavity. The lower and upper mold cavities and the corresponding mold surfaces enclose and form a molding chamber. The molding chamber is used to accommodate the aforementioned coil 11 and communication antenna 12, and a flexible covering body 13 is formed around the coil 11 and communication antenna 12.

[0145] In some embodiments, the lower cavity of the fixed mold 51 includes a first fixed mold groove 511 and a second fixed mold groove 512 that are connected to each other. The first fixed mold groove 511 is used to accommodate and limit at least a portion of the coil 11. For example, the first fixed mold groove 511 is located in the middle of the fixed mold 51 and accommodates and limits the first lead body 111 of the coil 11. The second fixed mold groove 512 is used to accommodate and limit at least a portion of the communication antenna 12. For example, the second fixed mold groove 512 is located on one side of the first fixed mold groove 511 and accommodates and limits the second lead body 121.

[0146] It is worth emphasizing that the design of the first groove 511 and the second groove 512 of the fixed mold being connected can realize the integrated connection of the coil 11 and the communication antenna 12, while also dispersing the local stress of the flexible covering body 13, improving the structural stability of the finished product, and greatly improving the flexibility of subsequent product modifications.

[0147] In some embodiments, optionally, at least three mold bosses 5111 are evenly distributed circumferentially along the groove wall of the first mold groove 511. The first lead body 111 of the coil 11 is accommodated in the gap between the mold bosses 5111 and the groove wall of the first mold groove 511. The at least three mold bosses 5111 are used to radially limit the coil 11 and correspondingly form through holes 1311 in the first part 131 that penetrate the first side and the second side. For example, as shown in the figure... Figure 7 As shown, there are 8 fixed mold bosses 5111.

[0148] It is important to emphasize that the fixed mold boss 5111 is not only used to radially limit the coil 11, but more importantly, to ensure that the aforementioned through hole 1311 is formed in the first part 131. The through hole 1311 provides space and possibility for improving the bonding force between the overmolded part and other components in subsequent assembly. For example, the obtained overmolded part is further combined with the feedthrough and other components to form the implant 10. The assembled implant 10 needs to be overmolded again to form an outer covering layer 16 covering the entire implant 10. The presence of the through hole 1311 provided in this application allows flexible fluid to flow into the through hole 1311. At the same time, the flexible covering 13 (e.g., several through holes 1311, several first protrusions 1312, several second protrusions 1313, several third protrusions 1314 and several fourth protrusions 1315) form an interlocking structure with the outer covering layer 16 to further improve the bonding force between the front and rear flexible covering 13 and the outer covering layer 16.

[0149] In some embodiments, optionally, a plurality of first molding grooves 5112 are evenly distributed circumferentially near the bottom of the first molding groove 511 of the fixed mold, so as to form a second protrusion 1313 at the first molding groove 5112 of the fixed mold; by evenly distributing and correspondingly forming a plurality of second protrusions 1313 on the second side, the second protrusions 1313 are used to fix the entire overmolded part and prevent the overmolded part from accidentally moving or shifting axially. For example, the obtained overmolded part is further combined with the feedthrough and other components to form the implant 10. The implant 10 formed by the combination needs to be injection molded again to form an outer covering layer 16 covering the entire implant 10. The several second protrusions 1313 provided in this application can fix the entire overmolded part when it is in tangential contact with one side of the injection mold 70, so as to avoid uneven or insufficient overmolding caused by the overmolded part moving upward during the injection process. At the same time, it can also further form an interlocking structure between the flexible covering 13 and the outer covering layer 16 to further improve the bonding force between the flexible covering 13 and the outer covering layer 16.

[0150] In some embodiments, the bottom of the fixed mold second groove 512 is generally arc-shaped, and a portion of the first insulating tube 113 and the first end 112 passing through the first insulating tube 113 are used to accommodate and limit the second lead body 121 of the communication antenna 12 and the coil 11.

[0151] In some embodiments, the lower cavity of the fixed mold 51 includes a first lead groove 513, which communicates with the second groove 512 of the fixed mold, for accommodating a portion of the first insulating tube 113 of the coil 11 and a first end 112 passing through the first insulating tube 113, forming a third portion 133 covering a portion of the first insulating tube 113.

[0152] In some embodiments, the lower cavity of the fixed mold 51 includes a second lead groove 514, which communicates with the second groove 512 of the fixed mold and is used to accommodate the second insulating tube 123 and the second end 122 of the communication antenna 12 passing through the second insulating tube 123, forming a fourth portion 134 covering the second insulating tube 123.

[0153] It is particularly emphasized that the first lead groove 513 and the second lead groove 514 are arranged in parallel. The first groove 511, the second groove 512, the first lead groove 513, and the second lead groove 514 are arranged in sequence. A clearance space 518 is provided on the side of the first lead groove 513 and the second lead groove 514 that is not connected to the second groove 512 of the mold. The clearance space 518 is used to accommodate the first insulating tube 113 that is not covered by the flexible covering body 13, the first end 112 passing through the first insulating tube 113, the second insulating tube 123, and the second end 122 passing through the second insulating tube 123.

[0154] In some embodiments, the fixed mold 51 is further provided with fixed mold overflow grooves 515. A plurality of fixed mold overflow grooves 515 are disposed on the periphery of the fixed mold first groove 511 and communicate with the fixed mold first groove 511. By providing fixed mold overflow grooves 515, it is possible to ensure that the molding cavity is fully filled while effectively reducing air bubbles in the flexible fluid (such as liquid silicone), thereby improving process robustness, production efficiency and product yield. Exemplarily, three fixed mold overflow grooves 515 are provided.

[0155] Understandably, by setting the lower cavity of the aforementioned structure, processing and scrap costs can be reduced, while facilitating the precise positioning of the individual coil 11 and communication antenna 12 before encapsulation, so as to form the aforementioned flexible covering body 13 with the upper cavity that is compatible with the moving mold 52, and finally obtain the encapsulated part.

[0156] In some embodiments, the upper cavity of the moving mold 52 includes a moving mold first groove 521, which corresponds to the fixed mold first groove 511 to form a first portion 131. The moving mold first groove 521 is provided with a plurality of moving mold first forming grooves 5211, so that the flexible covering 13 forms a plurality of first protrusions 1312 corresponding to the moving mold first forming grooves 5211. The plurality of first protrusions 1312 are evenly distributed on the second side surface of the flexible covering 13 to prevent accidental axial movement or displacement of the covered part, which could lead to uneven or insufficient covering. They also further increase the contact area between the flexible covering 13 and the outer covering layer 16, forming an interlocking structure and further improving the bonding force between the flexible covering 13 and the outer covering layer 16.

[0157] In some embodiments, a protrusion 5212 is provided on the bottom of the first groove 521 of the moving mold. The protrusion 5212 can abut against the bottom of the groove in the center of the first groove 511 of the fixed mold. A hollow hole is formed in the center of the corresponding part of the protrusion 5212 so that the first part 131 is generally annular. Further, a plurality of second forming grooves 52121 of the moving mold are recessed on the periphery of the protrusion 5212 so that a plurality of third protrusions 1314 are formed on the inner ring surface of the first part 131. The plurality of third protrusions 1314 are evenly distributed on the inner ring surface to prevent the overmolded part from accidentally rotating or shifting in the circumferential direction, which would cause uneven overmolding. At the same time, it can also further increase the contact area between the flexible overmolded body 13 and the outer overmolded layer 16 and form an interlocking structure, further improving the bonding force between the flexible overmolded body 13 and the outer overmolded layer 16.

[0158] Optionally, the top of the protrusion 5212 is provided with a limiting groove 52122, and the bottom of the groove of the first groove 511 of the fixed mold is provided with a limiting block 5113. The limiting block 5113 and the limiting groove 52122 cooperate to achieve circumferential limiting, so as to assist in the alignment and limiting between the moving mold 52 and the fixed mold 51.

[0159] In some embodiments, a third forming groove 5213 is provided in the first groove 521 of the moving mold, so that a plurality of fourth protrusions 1315 are formed on the third forming groove 5213 of the moving mold corresponding to the flexible covering body 13. The plurality of fourth protrusions 1315 are evenly distributed on the second side of the flexible covering body 13 to prevent accidental axial movement or displacement of the covered part, which would result in uneven or insufficient covering. At the same time, they can further increase the contact area between the flexible covering body 13 and the outer covering layer 16 and form an interlocking structure, thereby further improving the bonding force between the flexible covering body 13 and the outer covering layer 16.

[0160] In some embodiments, the moving mold 52 is provided with a glue inlet 522, which is connected to the upper and lower cavities. After the flexible fluid is injected into the upper and lower cavities through the glue inlet 522, it forms an integrally formed flexible covering 13 on the coil 11 and the communication antenna 12.

[0161] In some embodiments, the overmolding mold 50 further includes a first insert 53. One end of the fixed mold second groove 512 may extend to provide a first positioning groove 516, which communicates with the fixed mold second groove 512. The first insert 53 can be embedded in the first positioning groove 516 and passes through the second lead body 121 of the communication antenna 12 to limit the communication antenna 12, prevent the communication antenna 12 from moving radially and axially accidentally, and prevent the communication antenna 12 from deforming during the glue injection process. For example, the first insert 53 is generally in the shape of a three-step rod. The thickest part is for easy handling and extends out of the overmolding mold 50. The middle part is for easy embedding in the first positioning groove 516. The thinnest end has an insertion end, which is convenient to pass through the first positioning groove 516 into the second lead body 121 of the communication antenna 12 to limit its radial and axial movement. The specific outer diameter of the insertion end is set according to the inner diameter of the communication antenna 12.

[0162] In some embodiments, the overmolding mold 50 further includes a second insert 54. A second positioning groove 517 extends from the other end of the fixed mold second groove 512, communicating with the fixed mold second groove 512. The second insert 54 is embedded in the second positioning groove 517 and abuts against a portion of the first end 112 to maintain the overall consistency of the flexible covering 13, facilitate boundary sealing, and distribute injection pressure. Optionally, the specific structure of the second insert 54 is the same as that of the first insert 53, with the thinnest end of the second insert 54 abutting against a portion of the first end 112 accommodated in the fixed mold second groove 512.

[0163] Specifically, to create sufficient space to accommodate the communication antenna 12, the first insert 53, and the second insert 54, the moving mold 52 is provided with corresponding moving mold second grooves, moving mold first positioning grooves, and moving mold second positioning grooves on the fixed mold 51, corresponding to the fixed mold second groove 512, first positioning groove 516, and second positioning groove 517. These are not repeatedly marked in the accompanying drawings. When understanding the inventive concept of this application, unless otherwise specified, if it can be seen from the accompanying drawings that the moving mold 52 and the fixed mold 51 both have the same structure, it can be flexibly understood as an accommodating cavity formed by the moving mold 52 and the fixed mold 51.

[0164] Furthermore, the first insert 53 and the second insert 54 can be detachably connected to the moving mold 52 to achieve positioning. Specifically, the side wall of the first positioning groove 516 on the moving mold 52 is provided with a first positioning hole, and the periphery of the first insert 53 is provided with a first positioning pin 531, which is inserted into the first positioning hole to achieve positioning of the first insert 53 and the moving mold 52. The side wall of the second positioning groove 517 on the moving mold 52 is provided with a second positioning hole, and the periphery of the second insert 54 is provided with a second positioning pin 541, which is inserted into the second positioning hole to achieve positioning of the second insert 54 and the moving mold 52. Optionally, the first positioning pin 531 and the first insert 53 are an integral structure or a separate structure, and the second positioning pin 541 and the second insert 54 are an integral structure or a separate structure.

[0165] It is particularly important to emphasize that after the fixed mold 51 and the moving mold 52 are closed, the lower cavity of the fixed mold 51 (including the fixed mold first groove 511, fixed mold boss 5111, fixed mold first forming groove 5112, fixed mold second groove 512, first lead wire groove 513 and second lead wire groove 514) and the upper cavity of the moving mold 52 (including the moving mold first groove 521, moving mold second groove, moving mold first forming groove 5211, boss 5212, moving mold second forming groove 52121 and moving mold third forming groove 5213, etc.) and the corresponding mold surface are enclosed to form a forming cavity.

[0166] In some embodiments, the overmolding mold 50 further includes a connector 55. After the fixed mold 51 and the moving mold 52 are closed, the connector 55 is used to detachably connect the fixed mold 51 and the moving mold 52. For example, the connector 55 consists of a plurality of bolts and corresponding threaded holes. One of the bolts and the corresponding threaded holes is evenly distributed on the moving mold 52, and the other is correspondingly distributed on the fixed mold 51. The fixed mold 51 and the moving mold 52 are flexibly and detachably connected by bolts.

[0167] In some embodiments, the overmolding mold 50 further includes a guide member 56 for guiding and positioning. Optionally, the guide member 56 includes a plurality of positioning pins 561 and positioning holes 562. One of the moving mold 52 and the fixed mold 51 is provided with a plurality of positioning pins 561, and the other is provided with a plurality of positioning holes 562. The positioning pins 561 and the positioning holes 562 correspond one-to-one, and the positioning pins 561 can pass through the positioning holes 562.

[0168] For example, at least two positioning pins 561 are provided, symmetrically arranged on the fixed mold 51, and positioning holes 562 are provided on the moving mold 52. The position and number of positioning holes 562 correspond one-to-one with the positioning pins 561 of the fixed mold 51. The positioning holes 562 and the positioning pins 561 form a clearance fit to ensure the guiding accuracy of mold closing.

[0169] In some embodiments, combined with Figure 15As shown, this application also provides a coating method, employing a coating mold 50 as described above for coating parts, the coating method comprising:

[0170] S201. Place a single coil 11 in the first preset position to limit the movement of the coil 11.

[0171] Specifically, the first lead wire is wound multiple turns using a coil winding fixture. After winding, the first lead wire body 111 and the first end 112 extending from both ends of the first lead wire body 111 are obtained. A first insulating tube 113 is fitted over each of the first end 112. The first end 112 passes through the first insulating tube 113 and is partially exposed outside the first insulating tube 113.

[0172] For example, the first lead body 111 is placed in the first groove 511 of the fixed mold. A plurality of fixed mold bosses 5111, evenly distributed along the circumferential direction of the groove wall, abut against the inner side of the first lead body 111, and the groove wall abuts against the outer side of the coil 11 for positioning. That is, the first lead body 111 is accommodated in the gap between the fixed mold bosses 5111 and the groove wall, preventing the coil 11 from moving on the fixed mold 51. Part of the two first ends 112 are accommodated in the second groove 512 of the fixed mold, extending from the second groove 512 to the first lead groove 513. The first ends 112 accommodated in the first lead groove 513 are covered with a first insulating tube 113, which is positioned within the first lead groove 513. Further, the first ends 112 pass through the first insulating tube 113 and are partially exposed outside the first insulating tube 113, extending into the clearance space 518.

[0173] S202. Place the communication antenna 12 in the second preset position and limit the communication antenna 12.

[0174] Specifically, the second lead wire is spirally wound using a winding fixture for the communication antenna 12. After the winding is completed, a second lead wire body 121 and a second end 122 extending from one end of the first lead wire body 111 are obtained. A second insulating tube 123 is correspondingly sleeved on the outside of the second end 122. The second end 122 passes through the second insulating tube 123 and is partially exposed outside the second insulating tube 123.

[0175] For example, the second lead body 121 is accommodated at one end of the fixed mold second groove 512 away from the accommodating portion, the shape of the fixed mold second groove 512 is adapted to the second lead body 121, and the groove wall of the fixed mold second groove 512 limits the second lead body 121 to prevent it from moving within the fixed mold 51. Part of the second end 122 is accommodated in the second lead groove 514, and the second end 122 accommodated in the second lead groove 514 is covered with a second insulating tube 123, which limits the second lead groove 514. Further, the second end 122 passes through the second insulating tube 123 and is partially exposed outside the second insulating tube 123, extending into the clearance space 518.

[0176] S203, The communication antenna 12 is further restricted using the first insert 53.

[0177] Specifically, the first insert 53 is movably embedded in the first positioning groove 516 and passes through the second lead body 121, further achieving radial positioning while preventing the communication antenna 12 from deforming in subsequent processes. Furthermore, the first insert 53 can be detachably connected to the moving mold 52.

[0178] For example, the first insert 53 is in the shape of a three-step rod. The thickest part is for easy operation and gripping, the middle part is for easy embedding in the first positioning groove 516, and the thinnest end is provided with an insertion end, which is convenient to pass through the first positioning groove 516 into the second lead body 121 of the communication antenna 12 to achieve radial and axial limiting. The specific outer diameter of the insertion end is set according to the inner diameter of the communication antenna 12.

[0179] S204. Close and fix the fixed mold 51 and the moving mold 52.

[0180] Specifically, when the coil 11, communication antenna 12, and insert are all placed inside the fixed mold 51, the moving mold 52 is closed and fixed, and the coil 11 and communication antenna 12 are located in the molding cavity formed by the fixed mold 51 and the moving mold 52. The limiting groove 52122 at the top of the protrusion 5212 engages with the limiting block 5113 at the bottom of the first groove 511 of the fixed mold, thereby achieving circumferential limiting of the moving mold 52 and the fixed mold 51, and is fixed by the connecting piece 55.

[0181] Optionally, when the fixed mold 51 and the moving mold 52 are closed, the fixed mold 51 and the moving mold 52 are guided and positioned by the guide member 56 to ensure the accuracy of the installation position. For example, the guide member 56 includes a plurality of positioning pins 561 and positioning holes 562. One of the moving mold 52 and the fixed mold 51 is provided with a plurality of positioning pins 561, and the other is provided with a plurality of positioning holes 562. The positioning pins 561 and the positioning holes 562 correspond one-to-one, and the positioning pins 561 can pass through the positioning holes 562.

[0182] Optionally, the fixed mold 51 and the moving mold 52 can be detachably connected via connector 55.

[0183] S205. Inject flexible fluid into the molding chamber to integrally mold a flexible covering 13 on the coil 11 and the communication antenna 12, thereby obtaining a coated part.

[0184] Specifically, flexible fluid is injected into the molding cavity formed by the closing of the fixed mold 51 and the moving mold 52 through the injection port 522 on the moving mold 52. This allows the flexible fluid to fill the molding cavity formed by the corresponding and adapted fixed mold first groove 511, fixed mold second groove 512, first lead wire groove 513, second lead wire groove 514, moving mold first groove 521, moving mold second groove, and corresponding mold surfaces in the fixed mold 51 and the moving mold 52.

[0185] Optionally, the flexible fluid is liquid silicone. The liquid silicone is mixed in a certain proportion, centrifuged and degassed, and then enters the molding cavity through the glue inlet 522. After heating and cooling to solidify, the flexible covering 13 is integrally formed on the coil 11 and the communication antenna 12, thus obtaining the overall coated part.

[0186] By employing the aforementioned encapsulation method, the coil 11 and communication antenna 12 are positioned and physically protected, thereby integrally forming a flexible covering 13 on the coil 11 and communication antenna 12, resulting in an encapsulated component. The overall operation is simple and reliable, greatly preventing deformation of the coil 11 and communication antenna 12 during assembly and connection.

[0187] S3, one end of the reference electrode 151 and the skin electrode 152 are all electrically connected to a preset area of ​​the feedthrough structure 14.

[0188] S31, the feedthrough structure 14 includes an insulating substrate 1411 and a circuit board 1412, and the circuit board 1412 and the insulating substrate 1411 are flip-chip connected to form a circuit board assembly 141.

[0189] Optionally, the first welding area 14111, the second welding area 14112, the third welding area 14113, and the fourth welding area 14114 are all located on the side of the insulating substrate 1411 facing away from the circuit board 1412, in combination with... Figure 7 As shown.

[0190] S32. Connect the circumferential side of the circuit board assembly 141 to the inner side of the flange 1421, and combine. Figure 6 and Figure 8 As shown.

[0191] S33. The first cover plate 1422 is connected to one side of the flange 1421. The circuit board 1412 is disposed between the first cover plate 1422 and the insulating substrate 1411. The first welding area 14111, the second welding area 14112, the third welding area 14113 and the fourth welding area 14114 are all exposed from the side of the flange 1421 away from the first cover plate 1422. The circuit board 1412, insulating substrate 1411, flange 1421, and first cover plate 1422 are connected into a whole through the above steps. The first cover plate 1422 is connected to the flange 1421 to form a mounting shell with an opening. The circuit board assembly 141 is disposed inside the mounting shell. The first welding area 14111, the second welding area 14112, the third welding area 14113, and the fourth welding area 14114 are all exposed through the opening. This facilitates the fixing of the mounting shell by the welding fixture when welding the assembly using a welding jig, and also facilitates welding through the opening, thus simplifying the welding operation. Figure 7 As shown.

[0192] S34, the reference electrode 151 is welded to the third welding area 14113, and the skin electrode 152 is welded to the fourth welding area 14114, combined. Figure 3 and Figure 8 As shown.

[0193] S4. Weld both the first end 112 and the second end 122 to the feedthrough structure 14 to form a welded assembly. Figure 3 As shown.

[0194] S41, the feedthrough structure 14 also includes a second cover plate 1423. After the reference electrode 151 is welded to the third welding area 14113 and the skin electrode 152 is welded to the fourth welding area 14114, the first end 112 and the second end 122 are both welded to the feedthrough structure 14. It also includes:

[0195] The second cover plate 1423 is connected to the flange 1421 on the side opposite to the first cover plate 1422. The first cover plate 1422 and the second cover plate 1423 are connected to both sides of the flange 1421 to form a housing 142, and the circuit board assembly 141 is located inside the housing 142. Optionally, the first end 112 is welded to the first welding area 14111 of the feedthrough structure 14, and the second end 122 is welded to the second welding area 14112 of the feedthrough structure 14. The first end 112 and the second end 122 pass through the housing 142. The feedthrough structure 14 is located on the side where the first end 112 and the second end 122 extend. This facilitates the welding of the first end 112 and the second end 122 to the feedthrough structure 14, and results in a compact structure.

[0196] Optionally, the first insulating tube 113 extends onto the feedthrough structure 14 so that the first end 112 is welded to a predetermined area of ​​the feedthrough structure 14; alternatively, the second insulating tube 123 extends onto the feedthrough structure 14 so that the second end 122 is welded to a predetermined area of ​​the feedthrough structure 14.

[0197] Understandably, by setting up the housing 142, the circuit board assembly 141 is installed inside the housing 142, and the feedthrough structure 14 is set as a whole. The housing 142 has the function of protecting the internal circuit board assembly 141, improving the overall reliability of the feedthrough structure 14. In addition, during the subsequent integral injection molding process to form the outer covering layer 16, the housing 142 protects the internal circuit board assembly 141, the solder joint between the first end 112 and the first welding area 14111, the solder joint between the second end 122 and the second welding area 14112, the solder joint between the reference electrode 151 and the third welding area 14113, and the solder joint between the skin electrode 152 and the fourth welding area 14114, preventing fluid impact.

[0198] For example, combined Figure 16 and Figure 17 As shown, this application provides a welding fixture 60 for placing the aforementioned rubber-coated part and feed-through structure 14 into the corresponding positions of the welding fixture 60 for positioning and fixing, so as to realize the welding between the first end 112 and the second end 122 of the rubber-coated part and the first welding area 14111 and the second welding area 14112 of the feed-through structure 14, to obtain a welded assembly, i.e. a semi-finished product.

[0199] Optionally, the welding fixture 60 includes a base 61, on which a first limiting portion 611 and a second limiting portion 612 are provided. The overmolded part is housed in the first limiting portion 611, which is used to limit the overmolded part. The first end 112 and the second end 122 are both exposed in the groove of the first limiting portion 611. The feed-through structure 14 is housed in the second limiting portion 612, which is used to limit the feed-through structure 14. The first welding area 14111 and the second welding area 14112 are both exposed in the second limiting portion 612. When the overmolded part is limited to the first limiting portion 611 and the feed-through structure 14 is limited to the second limiting portion 612, the first end 112 can extend to the first welding area 14111 for welding, and the second end 122 can extend to the second welding area 14112 for welding.

[0200] Specifically, optionally, the feedthrough structure 14 housed within the second limiting portion 612 of the welding fixture 60 refers to the feedthrough structure 14 already connected to the reference electrode 151 and the skin electrode 152. That is, after the reference electrode 151 and the skin electrode 152 are welded to the feedthrough structure 14 respectively, the feedthrough structure 14 is placed on the welding fixture 60, and then the feedthrough structure 14 placed on the welding fixture 60 is welded to the first end 112 and the second end 122. (See attached image) Figure 18 The reference electrode 151 and the cortical electrode 152 are not shown in the diagram. When understanding the use of the welding fixture 60, please interpret it flexibly in conjunction with the aforementioned preparation method of the implant 10.

[0201] Understandably, by setting the first limiting part 611 and the second limiting part 612 on the base 61, the overmolded part and the feed passage structure 14 are constrained and limited respectively, keeping the positions of the overmolded part and the feed passage structure 14 relatively fixed. This facilitates the welding of the first end 112 to the first welding area 14111 and the second end 122 to the second welding area 14112, thereby forming a welded assembly. The overmolded part is limited by the first limiting part 611, and the feed passage structure 14 is limited by the second limiting part 612, achieving their respective limitations. Furthermore, both the overmolded part and the feed passage structure 14 are limited to the same base 61, effectively preventing relative displacement between the two, effectively ensuring welding accuracy and product qualification rate, and preventing additional deformation and displacement of the first end 112 and the second end 122 due to operation during the welding process.

[0202] Optionally, the substrate 61 is a block structure, such as stainless steel, 45 steel, hard aluminum alloy, and polyurethane.

[0203] Optionally, the flexible covering 13 includes a first part 131 and a second part 132 connected to each other. Correspondingly, the first limiting part 611 includes a first mounting groove 6111 and a second mounting groove 6112. That is, the first mounting groove 6111 and the second mounting groove 6112 are opened on the substrate 61 and are connected to each other. The opening directions of the groove openings of the first mounting groove 6111 and the second mounting groove 6112 are the same. For example, the groove opening directions are both along the same side of the first direction (along the vertical direction and facing upward). The first mounting groove 6111, the second mounting groove 6112 and the second limiting part 612 are arranged in sequence, and the arrangement direction is set at an angle with the opening direction of the groove. For example, they are arranged along the second direction, and the second direction is at an angle with the vertical direction. The angle can be an acute angle, a right angle or an obtuse angle, etc., and is not limited. The first mounting groove 6111 is used to accommodate the first part 131. The shape of the first mounting groove 6111 is adapted to the shape of the first part 131 to limit the first part 131. For example, the bottom of the first mounting groove 6111 is in contact with the bottom surface of the first part 131 to achieve axial limiting. The side wall of the second mounting groove 6112 is in contact with the circumferential surface of the first part 131 to achieve radial limiting.

[0204] Furthermore, the first part 131 is annular, and a fixture limiting post 61111 protrudes from the bottom of the first mounting groove 6111. The first part 131 is fitted onto the fixture limiting post 61111. The circumferential surface of the fixture limiting post 61111 and the inner ring surface of the first part 131 are circumferentially limited by a concave-convex fitting structure, thereby achieving circumferential limitation of the first part 131 and the first mounting groove 6111. Specifically, the fixture limiting post 61111 is provided with a plurality of fixture recesses 61112 along the circumferential direction, and the inner ring surface of the first part 131 is provided with a plurality of third protrusions 1314. The first protrusions 1312 are correspondingly provided in the fixture recesses 61112, thereby achieving circumferential limitation.

[0205] Optionally, the second mounting groove 6112 is used to accommodate the second part 132. The shape of the second mounting groove 6112 is adapted to the outer shape of the second part 132 to limit the second part 132. For example, the bottom of the second mounting groove 6112 fits against the bottom surface of the second part 132 to achieve axial limiting, and the periphery of the second mounting groove 6112 fits against the periphery of the second part 132 to achieve radial limiting. Further, the second part 132 is cylindrical, and the second mounting groove 6112 is an arc-shaped groove adapted to the second part 132.

[0206] Optionally, the second mounting groove 6112 has a first notch 6113 in its groove wall. For example, the first notch 6113 is provided on both sides along the third direction to facilitate the removal of the welding assembly from the first limiting part 611 through the first notch 6113.

[0207] In some embodiments, the feedthrough structure 14 further includes a mounting shell, and the second limiting portion 612 is groove-shaped for accommodating the mounting shell. The shape of the second limiting portion 612 is adapted to the outer shape of the mounting shell to limit the mounting shell. The first welding area 14111, the second welding area 14112, the third welding area 14113, and the fourth welding area 14114 are all exposed in the groove of the second limiting portion 612. The entire feedthrough structure 14 is limited by the mounting shell to the second limiting portion 612. The mounting shell serves to protect the internal circuit board assembly 141, and the second limiting portion 612 can be set according to the shape of the mounting shell to achieve limiting connection; for example, the bottom of the groove of the second limiting portion 612 fits with the bottom surface of the mounting shell to achieve axial limiting, and the sidewall of the second limiting portion 612 fits with the circumferential surface of the mounting shell to achieve radial limiting. Furthermore, the second limiting part 612 is a rectangular groove, and the mounting shell is a rectangular shell, thereby achieving circumferential limiting between the mounting shell, i.e., the feed-through structure 14, and the second limiting part 612.

[0208] Optionally, the groove wall of the second limiting part 612 is provided with a second notch 6121. For example, the second notch 6121 is provided on both sides along the third direction, so as to facilitate the removal of the welding assembly from the second limiting part 612 through the second notch 6121.

[0209] It is particularly emphasized that when welding using the aforementioned welding fixture 60, the coated part is first confined to the first limiting part 611, that is, the first part 131 is confined to the first mounting groove 6111. The annular first part 131 is fitted onto the fixture limiting post 61111, and the first protrusions 1312 are correspondingly provided in the fixture recesses 61112. The second part 132 is confined to the second mounting groove 6112, and the feed-through structure 14 is confined to the second limiting part 612. Since the second limiting part 612 is groove-shaped, the opening of the mounting shell is aligned with the groove opening of the second limiting part 612. With the opening and slot facing upwards, the first welding area 14111 and the second welding area 14112 are both exposed above the slot of the second limiting part 612. The two first ends 112 of the coil 11 are aligned one-to-one with the two first welding areas 14111, and the second end 122 of the communication antenna 12 is aligned with the second welding area 14112. Then the welding is completed. After welding, a welding assembly is formed. The welding assembly is taken out from the welding fixture 60 through the two first notches 6113 and the two second notches 6121.

[0210] S5. Injection molding is performed on at least a portion of the welded assembly to form an outer covering layer 16 covering the welded assembly. The reference electrode 151 and the skin electrode 152 extend from the outer covering layer 16, so that the welded assembly and the outer covering layer 16 form an implant 10, which is then combined. Figure 9 and Figure 10 As shown.

[0211] Optionally, the welded assembly is placed into the injection mold 70, then the mold is closed, fluid is injected into the injection mold 70, and after cooling, the finished product, i.e., the implant 10, is removed.

[0212] Understandably, by using the above steps to make the implant 10, the shape deformation and positioning difficulties that are likely to occur when the coil 11 and the communication antenna 12 are connected to the feedthrough structure 14 during the assembly process are prevented. By encapsulating the coil 11 and the communication antenna 12, the coil 11 and the communication antenna 12 are first made into a whole, i.e., an encapsulated part, and then the encapsulated part is fixedly connected to the feedthrough structure 14 to avoid deformation and displacement caused by operation during the connection and fixation of the coil 11 and the communication antenna 12 with the feedthrough structure 14. Finally, the implant 10 is obtained by integral injection molding.

[0213] By forming an integrally molded outer covering layer 16 on the overmolded part and the feedthrough structure 14, an integrated design is achieved, allowing the overmolded part and the feedthrough structure 14 to be seamlessly connected through the outer covering layer 16. The outer covering layer 16 can effectively constrain the deformation freedom of the overmolded part and the feedthrough structure 14, improve structural stability, connection strength and deformation resistance, and the outer covering layer 16 improves the sealing of the internal structure, effectively preventing tissue fluid from entering during use and providing reliability.

[0214] For example, combined Figures 18-23 As shown, this application provides an injection mold for injection molding the above-mentioned welded assembly to obtain an implant 10. The injection mold 70 includes a first mold 71 and a second mold 72 adapted to the first mold 71. The second mold 72 can closely abut against the first mold 71. The first mold 71 includes a first cavity 711, and the second mold 72 includes a second cavity 7211. The first cavity 711 and the second cavity 7211 surround to form a molding receiving cavity and a connecting hole. The molding receiving cavity communicates with the outside through the connecting hole. The welded assembly is housed in the molding receiving cavity, and the electrode passes through the connecting hole. A corresponding outer covering layer 16 is formed around the welded assembly, so that the electrode extends out of the outer covering layer 16.

[0215] Optionally, combined Figures 18-20 As shown, the first mold 71 and the second mold 72 are connected along a first direction (i.e., the vertical direction), with the first mold 71 located below the second mold 72. By cooperating with the first mold 71 and the second mold 72, an integrated outer covering layer 16 can be easily formed on the coil 11, communication antenna 12, feedthrough structure 14 and electrodes without damaging the original structure of the coil 11, communication antenna 12, feedthrough structure 14 and electrodes, thus forming the implant 10.

[0216] In some embodiments, the welding assembly includes an encapsulated part formed by a flexible covering 13 encapsulating the coil 11 and the communication antenna 12. The feedthrough structure 14 includes a housing 142 and an insulating substrate 1411 disposed within the housing 142. The first end 112 of the coil 11 and the second end 122 of the communication antenna 12 extend out of the flexible covering 13, pass through the housing 142, and are welded to the insulating substrate 1411, respectively. The flexible covering 13 and the housing 142 are respectively confined within a first cavity 711, so that the outer covering layer 16 covers the housing 142 and the flexible covering 13. By providing the flexible covering 13 and the housing 142, the injection molding fluid is prevented from impacting the coil 11, the communication antenna 12, the feedthrough structure 14, and the electrode structure themselves during the injection molding process of the outer covering layer 16, which could cause structural deformation or displacement and affect product quality. Furthermore, the welded connection structure between the above components is prevented from being impacted, which could lead to weld cracking and affect product quality. In addition, the flexible covering 13 and the housing 142 are respectively placed in the first cavity 711. First, compared with the coil 11 and the communication antenna 12, the flexible covering 13 has a more rigid structure, which is convenient for limiting the position. Second, it avoids limiting the coil 11, the communication antenna 12, the feedthrough structure 14 and the electrodes separately, simplifying the structure and making it easier to operate. Third, the coil 11 and the communication antenna 12 are first covered in the flexible covering 13 and then welded to the feedthrough structure 14, which avoids the deformation of the coil 11 and the communication antenna 12 during the welding process and further improves the reliability.

[0217] Optionally, such as Figures 18-22 As shown, the first mold 71 is provided with an electrode receiving groove for accommodating electrodes. The electrode receiving groove is connected to the molding cavity, and the other end of the electrode extends out of the electrode receiving groove. The electrode receiving groove provides an electrical limit stop to prevent displacement. Optionally, the electrode receiving groove includes two first electrode receiving grooves 7121 and one second electrode receiving groove 7122. The two first electrode receiving grooves 7121 are used to accommodate two reference electrodes 151 in a one-to-one correspondence, and the second electrode receiving groove 7122 is used to accommodate the skin electrode 152. Optionally, a thermoplastic polyurethane elastomer (TPU) tube can be correspondingly sleeved on the reference electrode 151 to protect the reference electrode 151, improve the flexibility and durability of the reference electrode 151, and prevent it from contacting external structures, thus avoiding short circuits and signal interference.

[0218] In some implementations, the flexible covering 13 includes a first annular portion 131, which includes a first side and a second side disposed along the axial direction, and an inner ring surface and an outer ring surface disposed along the radial direction.

[0219] Optionally, the first side is provided with a plurality of protrusions, namely, first protrusions 1312, which abut against the bottom of the cavity of the first cavity 711. The plurality of first protrusions 1312 are evenly distributed circumferentially, and the shape of the bottom of the cavity of the first cavity 711 is adapted to the plurality of first protrusions 1312, so that the bottom of the cavity of the first cavity 711 fits against the plurality of first protrusions 1312, which is used to fix and support the entire overmolded part within the first cavity 711, preventing accidental axial movement or displacement of the overmolded part, which would result in uneven or insufficient overmolding. At the same time, by increasing the contact area and forming an interlocking structure with the outer covering layer 16, the bonding force is improved.

[0220] Optionally, the second side is provided with a plurality of protrusions, namely a plurality of second protrusions 1313, which abut against the bottom of the cavity of the second cavity 7211. The plurality of second protrusions 1313 are evenly distributed circumferentially, and the shape of the bottom of the cavity of the second cavity 7211 is adapted to the plurality of second protrusions 1313, so that the bottom of the cavity of the second cavity 7211 fits against the plurality of second protrusions 1313. This is used to fix and support the entire overmolded part in the second cavity 7211, preventing the overmolded part from accidentally moving or shifting axially, resulting in uneven or insufficient overmolding. At the same time, by increasing the contact area and forming an interlocking structure with the outer covering layer 16, the bonding force is improved.

[0221] Optionally, a mold limiting post 7111 is provided in the first cavity 711, and the first part 131 is sleeved on the mold limiting post 7111. The mold limiting post 7111 and the first part 131 are circumferentially limited by a concave-convex mating structure. Specifically, the mold limiting post 7111 has a plurality of mold recesses 71111 evenly distributed along the circumference, and a plurality of third protrusions 1314 are evenly distributed on the inner ring surface. The plurality of mold recesses 71111 and the plurality of third protrusions 1314 are inserted one-to-one to prevent the overmolded part from accidentally rotating or shifting in the circumferential direction, which would cause uneven overmolding. At the same time, it can also further increase the contact area between the flexible overmolded body 13 and the outer overmolded layer 16 and form an interlocking structure, further improving the bonding force between the flexible overmolded body 13 and the outer overmolded layer 16.

[0222] Optionally, the first side is provided with a plurality of fourth protrusions 1315, which abut against the bottom of the cavity of the first cavity 711. The plurality of fourth protrusions 1315 are evenly distributed circumferentially, and the shape of the bottom of the cavity of the first cavity 711 is adapted to the plurality of fourth protrusions 1315, so that the bottom of the cavity of the first cavity 711 fits against the plurality of fourth protrusions 1315. This is used to fix and support the entire overmolded part in the first cavity 711, preventing the overmolded part from accidentally moving or shifting axially, resulting in uneven or insufficient overmolding. At the same time, by increasing the contact area and forming an interlocking structure with the outer covering layer 16, the bonding force is improved.

[0223] Optionally, a support portion 7112 is provided at the bottom of the first cavity 711, which abuts against the housing 142 to support the housing 142. This support secures and supports the entire housing 142 within the first cavity 711, preventing accidental axial movement or displacement of the housing 142 that could lead to uneven or insufficient adhesive application. Simultaneously, the support portion 7112 allows for the formation of a marking 167 on the outer covering layer 16. Figure 9 As shown.

[0224] Optionally, the connecting ear 166 protrudes from the edge of the outer covering layer 16, and the connecting ear 166 has a hole so that fasteners such as screws can pass through the connecting ear 166 to connect with the skull. Correspondingly, the first cavity 711 is provided with a corresponding molding groove and a molding post 7113 provided in the molding groove for molding the connecting ear 166.

[0225] Optionally, the injection mold 70 also includes a base 73 and an ejector assembly 74. The base 73 is located on the side of the first mold 71 away from the second mold 72 to support the first mold 71. The ejector assembly 74 is located between the base 73 and the first mold 71. The ejector assembly 74 includes a needle plate 741 and a tube pin located on the needle plate 741. The tube pin can enter and exit the first cavity 711. When the tube pin extends into the first cavity 711, it circumferentially limits the housing 142 to prevent the feedthrough structure 14 from rotating within the first cavity 711.

[0226] Optionally, the positioning pins include a plurality of first positioning pins 7431. The cross-section of the housing 142 is rectangular. The plurality of first positioning pins 7431 abut against the outer sides of the four corners of the housing 142 in a one-to-one correspondence. The inner surface shape of the first positioning pins 7431 is adapted to the outer shape of the corners of the housing 142. The first positioning pins 7431 restrict the rotation of the housing 142 to prevent the housing 142, i.e., the feedthrough structure 14, from undergoing accidental circumferential rotation or displacement, which would result in uneven coating. For example, the plurality of first positioning pins 7431 is four, and the four first positioning pins 7431 abut against the outer sides of the four corners of the housing 142 in a one-to-one correspondence.

[0227] Optionally, the positioning pin includes a plurality of second positioning pins 7432, which abut against the side wall of the housing 142. The inner surface shape of the second positioning pin 7432 is adapted to the outer shape of the side wall of the housing 142. The second positioning pins 7432 restrict the rotation of the housing 142 to prevent the housing 142, i.e., the feedthrough structure 14, from unexpected circumferential rotation or displacement, which could lead to uneven coating. Optionally, the number of the plurality of second positioning pins 7432 is four, and the four second positioning pins 7432 are correspondingly provided on the four side walls of the housing 142.

[0228] It is particularly emphasized that the overmolded part, through the perfectly matched second protrusion 1313 and fourth protrusion 1315, ensures that the distance between the first and second sides of the overmolded part and the upper and lower mold surfaces of the injection mold 70 is consistent, ensuring that the overmolded part can be centered in the injection mold 70 of the whole machine, and further enhances the bonding force with the outer covering layer 16 through several first protrusions 1312. The feed passage structure 14, through the cooperation of the needle plate 741 and the tube needle, can control the position of the housing 142 (making it suspended, so that the flexible fluid can be smoothly solidified and molded to cover the overmolded part and the feed passage structure 14), thereby flexibly adjusting the relative position between the feed passage structure 14 and the overmolded part. Optionally, part of the needle plate 741 is elastically connected to the base 73 through the elastic member 731. The elastic member 731 drives the needle plate 741 so that the tube needle can enter and exit the first cavity 711, that is, the tube needle extends into the first cavity 711 to limit the housing 142.

[0229] For example, the base 73 has a groove, and the top of the base 73 is connected to the bottom of the first mold 71. The needle plate 741 includes a first plate 7411 and a second plate 7412 accommodated in the groove of the base 73. The first plate 7411 and the second plate 7412 are connected by fasteners such as screws. The first plate 7411 is connected to the base 73 by an elastic element 731, such as a spring. One end of a plurality of first tube needles 7431 and a plurality of second tube needles 7432 are fitted into the first plate 7411 and the second plate 7412 and fixedly connected to ensure that the tube needles and the needle plate 741 remain relatively stationary. The other end can pass through the first mold 71 and enter and exit the first cavity 711, extending into the first cavity 711 to limit the housing 142. In the initial state, the first plate 7411 is tightly fitted with the base 73, the elastic element 731, such as a spring, is at its original length, and one end of the tube needle is accommodated in the first mold 71 and does not extend into the first cavity 711. In the limited-position state, starting from the initial state, a pad, such as a wedge, is inserted between the first plate 7411 and the base 73, forcing the first plate 7411 to move towards the first mold 71. This allows the tube pins to extend into the first cavity 711 along with the movement of the first plate 7411, reaching a predetermined position to limit and fix the housing 142. At this time, the first plate 7411 and the base 73 are no longer tightly fitted, and the elastic element 731, like a spring, is in a stretched state. One end of the tube pin extends into the first cavity 711, providing circumferential limitation for the housing 142. In the terminated state, the tube pins no longer provide circumferential limitation for the housing 142. The wedge is removed, and the tube pins, the second plate 7412, and the first plate 7411 all return to their initial state under the elastic force of the elastic element 731 (like a spring) attempting to restore their original length. This causes the tube pins to move out of the first cavity 711, and the first plate 7411 re-fits tightly with the base 73. This setting facilitates operation, allowing the tube needle to enter and exit the first cavity 711.

[0230] In some embodiments, the ejector pin assembly 74 further includes a guide post 742. The guide post 742 has an end cap, which is installed in the second plate 7412 and one end abuts against the first plate 7411. The guide post 742 passes through the second plate 7412 and is slidably connected to the first mold 71 to ensure that during the movement, the needle plate 741 always moves relative to the first mold 71 in a preset direction, thereby ensuring that the tube pin moves in the preset direction and preventing deviation. Since the tube pin has a thin structure, deviation is prevented from causing bending, etc.

[0231] Optionally, combined Figure 18 , Figure 19 and Figure 23 As shown, the second mold 72 has a glue injection port 7221 communicating with the second cavity 7211. Fluid is injected into the molding cavity through the glue injection port 7221 to form the outer coating layer 16. For example, the fluid is preferably a flexible fluid.

[0232] Optionally, the electrode receiving groove is provided with two first electrode grooves and one second electrode groove. The two first electrode grooves and the two first electrode receiving grooves 7121 are connected and arranged accordingly. The one second electrode groove and the one second electrode receiving groove 7122 are connected and arranged accordingly. The electrode is located in the first electrode groove and the first electrode receiving groove 7121. The skin electrode 152 is located in the second electrode groove and the second electrode receiving groove 7122.

[0233] Optionally, the bottom of the second cavity 7211 is also provided with a mold forming groove 72111, thereby forming a protrusion on the surface of the outer covering layer 16 to limit the outer covering layer 16 and the second mold 72. The protrusion can be directly used as a positioning structure for subsequent assembly on the skull without additional processing.

[0234] Optionally, the second mold 72 includes a first structural block 721 and a second structural block 722, which are connected by screws. The first structural block 721 is provided with a second cavity 7211. The second structural block 722 and the first structural block 721 communicate to form a flow channel. The injection port 7221 is provided on the second structural block 722 and communicates with the second cavity 7211 through the flow channel.

[0235] Optionally, the second structural block 722 is provided with two injection ports 7221. The second structural block 722 and the first structural block 721 form two flow channels. Both injection ports 7221 are used to inject fluid, respectively aligned with the encapsulated part and the feed structure 14 in the first cavity 711. By increasing the number of injection ports 7221, the fluid in the molding cavity is made more uniform, which is beneficial to the molding of the outer coating layer 16.

[0236] Optionally, a connecting channel is provided between the first structural block 721 and the second structural block 722 to connect the two flow channels, further making the fluid entering the molding cavity more uniform. Further optionally, the second structural block 722 also has an overflow port 7222, which is connected to the connecting channel. When there is too much fluid in the connecting channel, it overflows through the overflow port 7222, preventing the fluid from being injected into the molding cavity too quickly and affecting the molding effect.

[0237] Optionally, a connecting structure 75, such as a screw, is provided between the first mold 71 and the second mold 72. The first mold 71 has a threaded hole, and the screw passes through the second mold 72 and connects with the threaded hole, thereby achieving a fixed connection between the first mold 71 and the second mold 72.

[0238] Optionally, a guide structure 76, such as a column, is provided between the first mold 71 and the second mold 72. The first mold 71 is fixedly connected to the column, and the second mold 72 has a mating hole through which the column passes to guide the second mold 72 and ensure the positional accuracy between the first mold 71 and the second mold 72.

[0239] In some embodiments, combined with Figure 24 As shown, this application provides an injection molding method that uses an injection mold 70 as described above to injection mold a welded assembly to obtain an implant 10. The injection mold 70 includes a first mold 71, a second mold 72, a base 73, and an ejector assembly 74. The first mold 71 includes a first cavity 711, and the second mold 72 includes a second cavity 7211. The second mold 72 can tightly abut against the first mold 71 and enclose it to form a molding cavity. The ejector assembly 74 includes a needle plate 741 and a guide pin disposed on the needle plate 741. The guide pin can enter and exit the first cavity 711. The injection molding method includes:

[0240] S501. The welded assembly is placed into the first cavity 711, wherein the tube positioning pin extends into the forming cavity to limit the position of the welded assembly.

[0241] Optionally, the housing 142 of the feedthrough structure 14 is supported on the support portion 7112, and circumferentially limited by the tube positioning pin to prevent the feedthrough structure 14 from deviating or moving. Then, the first part 131 is sleeved on the mold limiting post 7111, and several mold recesses 71111 and several third protrusions 1314 are inserted one-to-one. The bottom surface of the first protrusion 1312 fits against the bottom of the cavity of the first cavity 711 to prevent the overmolded part from deviating or moving. The feedthrough structure 14, through the cooperation of the needle plate 741 and the tube positioning pin, can control the position of the housing 142 (so that it is suspended, allowing the flexible fluid to solidify and form smoothly to cover the overmolded part and the feedthrough structure 14), thereby flexibly adjusting the relative position between the feedthrough structure 14 and the overmolded part. Finally, the two reference electrodes 151 with the TPU tube sleeve are placed one-to-one in the two first electrode receiving grooves 7121, and the skin electrode 152 is placed in the second electrode receiving groove 7122.

[0242] S502. Close and fix the second mold 72 and the first mold 71 so that the welded assembly is located in the molding cavity.

[0243] The second protrusion 1313 abuts against the mold surface of the second mold 72. The completely identically arranged second protrusion 1313 and fourth protrusion 1315 ensure that the distance between the first and second sides of the overmolded part and the upper and lower mold surfaces of the injection molding overmolding mold is consistent, ensuring that the overmolded part is centered in the injection molding overmolding mold of the whole machine. Furthermore, the several first protrusions 1312 enhance the bonding force between the overmolded part and the outer coating layer 16.

[0244] Optionally, the first mold 71 is provided with a guide structure 76. When the second mold 72 approaches the first mold 71, it is guided by the guide structure 76 to ensure positional accuracy, and then connected and fixed by the connecting structure 75.

[0245] S503. Inject the flexible fluid into the molding cavity.

[0246] Optionally, a flexible fluid is injected into the molding cavity through the injection port 7221. The flexible fluid enters the second cavity 7211, i.e., the molding cavity, through the injection port 7221 and the flow channel. The flexible fluid should be injected slowly; if the flexible fluid is injected too quickly or in excessive amounts, it will overflow from the overflow port 7222. The flexible fluid is one of the following: microsilicone, silicon-derived materials, thermoplastic polyurethane, liquid ionic elastomer, thermoplastic elastomer, and polyvinylidene fluoride.

[0247] S504. After the preset time, remove the tube pin from the molding cavity.

[0248] Specifically, when the first cavity 711 contains a certain amount of flexible fluid, due to the viscosity of the flexible fluid, this amount of flexible fluid can circumferentially limit the welded assembly, especially the housing 142, within the first cavity 711. Then, the wedge block is removed, allowing the tube pin to move out of the first cavity 711. The preset time can be determined through experimentation and will not be elaborated further.

[0249] S505. Continue to inject flexible fluid into the molding cavity to form an outer coating layer 16 on the welded assembly.

[0250] Understandably, after the tube pin is removed, a gap is formed at the corresponding position. Since the flexible fluid has a certain viscosity and fluidity, it can fill the gap formed by the original tube pin, thus improving the appearance of the outer coating layer 16.

[0251] Optionally, the injection mold 70 is heated, and after the liquid flexible fluid solidifies, the second mold 72 is opened, and the finished product is taken out from the first mold 71.

[0252] By using the above method to injection mold the implant 10, the coil 11, communication antenna 12, feedthrough structure 14 and electrodes are limited, positioned and physically protected, thereby forming an outer covering layer 16 on the welded assembly. The overall operation is simple and can ensure the reliability and aesthetics of the implant 10.

[0253] In some embodiments, combined with Figure 25 As shown, this application provides an external unit 20 for a brain-computer interface system. The external unit 20 includes a communication unit 21, a power supply unit 22, and a cable 23. The cable 23 connects the communication unit 21 and the power supply unit 22. The communication unit 21 is signal-connected to the power supply unit 22, the implant 10, and the host computer 30 for data transmission. The EEG signals collected by the implant 10 are transmitted to the host computer 30 through the signal link of the external unit 20. The power supply unit 22 supplies power to the communication unit 21, and the communication unit 21 supplies power to the implant 10.

[0254] For example, the power supply unit 22 includes a power supply unit housing 221 and a power supply integrated module housed within the power supply unit housing 221. The connection ports of the power supply integrated module are used to connect to an external power adapter and a communication unit 21, respectively.

[0255] For example, the power supply integrated module includes a power supply unit circuit board and a battery, housed within the power supply unit housing 221; the power supply unit circuit board includes several chips and electronic components, which are connected to the battery to provide continuous power to the communication unit 21, enabling convenient charging, energy storage, and direct DC power supply, thereby providing power to the entire system and providing a signal transmission link to the communication unit 21.

[0256] For example, the power supply unit 22 also includes a display screen 223 and buttons 222, so that the power supply unit 22 integrates simple interactive functions such as status indication and mode switching, and displays information of each module in the communication unit 21 through the display screen 223, so that users can easily check the operating status of the device.

[0257] For example, the power supply unit housing 221 includes an upper housing and a lower housing, which are assembled by snap-fit ​​to form an internal space; the mating surfaces are designed with stop grooves to achieve an IP44 protection rating. For example, it is manufactured from 9400 photocurable resin through 3D printing or photocurable molding processes, and the overall basic dimensions of the power supply unit housing 221 are 109mm × 68mm × 16mm, forming a slim and lightweight shape.

[0258] For example, button 222 is located on the upper shell of the power supply unit. Button 222 is an on / off button and is molded from 918 silicone material. The silicone button 222 is press-fitted with the opening in the upper shell of the power supply unit to form a seal, while its flexibility ensures good tactile feedback and operating stroke. The back of the silicone button 222 is designed with conductive base posts for triggering the surface-mount switch on the circuit board of the power supply unit 22.

[0259] For example, the display screen 223 is located on the upper shell of the power supply unit. The display screen 223 can display three pages, including an implant page, a communication unit page, and a power supply unit page. The implant page displays the voltage and temperature of the implant 10. The communication unit page displays the working status, Bluetooth status, wireless power supply status, and temperature of the communication unit 21. The power supply unit page displays information such as the battery voltage, battery temperature, power supply current, and power level of the power supply unit 22. It can intuitively and comprehensively display status information, allowing users (patients or medical staff) to quickly obtain key information such as battery level, communication connection status, and whether the device is working properly. This facilitates daily management and early fault detection, and provides strong human-computer interaction and status awareness. When the communication unit 21 connects to the power supply unit 22 and communication is successful, the three pages are refreshed every approximately 5 seconds to display information for each module. If the communication unit 21 is not connected to the power supply unit 22 or communication fails, only the power supply unit 22 page is refreshed.

[0260] Specifically, the control logic of the power supply unit 22 can be implemented using existing conventional methods, and will not be elaborated further.

[0261] For example, the power supply unit 22 is provided with a male cable connector for connecting to the cable 23.

[0262] For example, the power supply unit 22 is equipped with a charging interface for connecting to an adapter. The charging interface is a Micro-USB female connector opening, and is designed with a silicone protective cover. The protective cover is connected to the shell through an integrated hinge structure. It can be opened when charging and covered when not in use, which can prevent dust and moisture. It can effectively resist the corrosion of sweat, dust and other daily environmental factors and can be worn for a long time.

[0263] In some of these examples, the power supply unit 22 is equipped with a data communication interface for connecting to the host computer 30; the data communication interface is a Type-C female connector opening.

[0264] In some embodiments, combined with Figure 26 As shown, the host computer 30 includes a user information module 32 and a display module 34.

[0265] Optionally, the user information module 32 includes a real-time date display submodule, a patient information display submodule, a port selection submodule, and a sampling rate submodule. After confirming that the implant 10, the external unit 20, and the host computer 30 are all properly connected, the host computer 30 is run to enter the user information interface. The real-time date display submodule displays the real-time date; the patient information display submodule displays patient information; the port selection submodule is configured to correspond to the ports of the implant 10 and the external unit 20; and a suitable sampling rate is set in the sampling rate submodule. The sampling rate is the number of times the EEG signal is acquired per second. A higher sampling rate results in higher signal integrity and authenticity, but also a larger data volume, leading to higher requirements for circuitry and transmission. The specific sampling rate is set according to requirements.

[0266] For example, display module 34 includes a heat map display submodule, a spectrum display submodule, and an impedance test display submodule.

[0267] The heatmap display submodule displays a visual heatmap corresponding to the processed EEG signals. The heatmap display can be changed by setting the voltage range. The heatmap display submodule includes a voltage setting button on the left and a numbered checkerboard array of heatmap views on the right, each corresponding to one of the acquisition channels of the implant 10. By setting different voltage ranges using the voltage setting button, the range of the heatmap display can be changed in real time.

[0268] The spectrum display submodule allows users to select channels for display and adjust the amplitude and frequency range of the spectrum by setting the voltage and frequency range. The spectrum display submodule includes channel selection, voltage setting, and frequency setting buttons on the left, and a real-time spectrum display interface on the right.

[0269] The impedance test display submodule includes the following parts: First, setting the impedance result color: the impedance result is displayed in colors ranging from cool to warm tones according to the selected color; second, setting the impedance range: different colors are displayed according to the impedance result range; third, saving to save module 35: the impedance result is saved as a .csv file to save module 35; fourth, starting the impedance test: the impedance test is started by clicking the start impedance test button; fifth, progress bar: the progress of the impedance test results is displayed, and 100% indicates that the impedance test is completed.

[0270] It is particularly important to note that the equipment must be in idle mode before starting the impedance test. If the equipment is in working mode, the "Start Impedance Test" button will not be clickable. The impedance test is complete when the progress bar reaches 100%, and the results will be displayed. The color of the impedance results can be changed by setting the impedance range. The "Save to" button can be clicked to save the impedance test results as a .csv file to the save module 35.

[0271] Furthermore, in some examples, the host computer 30 also includes a login module 31, a data acquisition module 33, and a data storage module 35.

[0272] Optionally, the login module 31 includes a login button. After clicking the login button and entering the account and password, the user proceeds to the user information module 32. The login module 31 is used for user authentication and registration.

[0273] Optionally, the acquisition module 33 can adjust the waveform plotting speed and amplitude according to the displayed waveform, including a start acquisition button, a stop acquisition button, a waveform display submodule, and a device information display submodule. Specifically, the acquisition module 33 includes a start acquisition button and a stop acquisition button on the top, a waveform display submodule on the left, and a device information display submodule on the right. After entering the acquisition module page, and confirming that the Bluetooth connection and chip are working properly in the device information display submodule on the right, the start acquisition button can be clicked. The waveform display submodule includes a per-screen time setting button or a waveform plotting speed setting button, used to adjust the waveform plotting speed according to the displayed waveform; a Y-axis sensitivity button, used to adjust the waveform plotting amplitude; and a channel selection button, used to determine which parts of the acquisition channel's real-time waveform are displayed by the waveform display submodule.

[0274] Optionally, the storage module 35 communicates and interacts with the login module 31, the user information module 32, the data acquisition module 33, and the display module 34 respectively. When each module needs to save data, it can save the data to the storage module 35.

[0275] Specifically, the above modules, namely login module 31, user information module 32, data collection module 33, display module 34 and storage module 35, can all be implemented using existing technologies in the field, so their specific structures and working processes will not be described in detail here.

[0276] It is particularly important to note that the external unit 20 has simple interactive functions, and the host computer 30 has a user-friendly interface, allowing users to quickly view the device status and adjust parameters. The system can flexibly adapt to the needs of different users, and the decoding algorithm can be personalized and optimized according to the user's neural signal characteristics, making it easy to operate and highly adaptable.

[0277] In the specific implementation of the above embodiments, the technical features can be combined in any non-contradictory way. For the sake of brevity, not all possible combinations of the above technical features are described. However, as long as the combination of these technical features is not contradictory, it should be considered to be within the scope of this specification.

[0278] Obviously, the above embodiments of the present invention are merely examples for clearly illustrating the present invention, and are not intended to limit the implementation of the present invention. Those skilled in the art can make other variations or modifications based on the above description. It is neither necessary nor possible to exhaustively describe all embodiments here. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of the present invention should be included within the scope of protection of the claims of the present invention.

Claims

1. A method for preparing an implant for a brain-computer interface system, characterized in that, include: The coil (11) and the communication antenna (12) are coated with adhesive to form a flexible covering (13) that wraps the coil (11) and the communication antenna (12), so that the coil (11), the communication antenna (12) and the flexible covering (13) form an integrated coated part, and the first end (112) of the coil (11) and the second end (122) of the communication antenna (12) both extend out of the flexible covering (13); Both the first end (112) and the second end (122) are welded to the feed-through structure (14) to form a welded assembly; At least a portion of the welded assembly is injection molded to form an outer covering layer (16) covering the welded assembly, so that the welded assembly and the outer covering layer (16) form an implant; wherein, the outer surface of the flexible covering body (13) is provided with a plurality of protrusions, and the outer covering layer (16) is provided with a plurality of grooves, and the protrusions are correspondingly embedded in the grooves, so that the flexible covering body (13) and the outer covering layer (16) form a mutually interlocking structure.

2. The method for preparing an implant for a brain-computer interface system according to claim 1, characterized in that, Before encapsulating the coil (11) and the communication antenna (12), the following steps are also included: The first lead wire is wound to form the first lead wire body (111) and the first end (112), so that the coil (11) as a whole has a vortex ring structure; The second lead is wound to form the second lead body (121) and the second end (122), so that the communication antenna (12) is in the shape of a helical spring. When the coil (11) and the communication antenna (12) are coated with adhesive, the first lead body (111) and the second lead body (121) are arranged side by side, so that the flexible covering body (13) is divided into a first part (131) and a second part (132). The first part (131) covers the first lead body (111), and the second part (132) covers the second lead body (121).

3. The method for preparing an implant for a brain-computer interface system according to claim 2, characterized in that, The encapsulated component includes a first insulating tube (113) and a second insulating tube (123). When encapsulating the coil (11) and the communication antenna (12), the component further includes: The first insulating tube (113) is sleeved on the first end (112), so that the end of the first end (112) away from the first lead body (111) is exposed on the first insulating tube (113), and the rubber-coated part covers at least part of the first insulating tube (113); the first insulating tube (113) extends on the feedthrough structure (14) so ​​that the first end (112) is welded to a predetermined area of ​​the feedthrough structure (14); The second insulating tube (123) is sleeved on the second end (122), so that the end of the second end (122) away from the second lead body (121) is exposed on the second insulating tube (123), and the rubber-coated part covers at least part of the second insulating tube (123); the second insulating tube (123) extends on the feed passage structure (14) so ​​that the second end (122) is welded to a predetermined area of ​​the feed passage structure (14).

4. The method for preparing an implant for a brain-computer interface system according to claim 2, characterized in that, When encapsulating the coil (11) and the communication antenna (12), the process further includes: The center lines of the first lead body (111) and the second lead body (121) are spaced apart and arranged at an angle. The first lead body (111) is located on the periphery of the second lead body (121), and the first end (112) and the second end (122) both extend away from the first lead body (111), so that the first end (112) and the second end (122) both extend from the same side of the overmolded part. When the first end (112) and the second end (122) are both welded to the feedthrough structure (14), the feedthrough structure (14) is located on one side of the extension of the first end (112) and the second end (122).

5. The method for preparing an implant for a brain-computer interface system according to claim 1, characterized in that, The feedthrough structure (14) includes an insulating substrate (1411) and a circuit board (1412). Before soldering the first end (112) and the second end (122) to the feedthrough structure (14), it also includes: The insulating substrate (1411) is processed with through-holes to form a first welding area (14111) and a second welding area (14112). The circuit board (1412) is surface mount processed, wherein the first welding area (14111) is used to weld to the first end (112), and the second welding area (14112) is used to weld to the second end (122). A circuit board assembly (141) is formed by flip-chip bonding of a circuit board (1412) and an insulating substrate (1411), wherein the first soldering area (14111) and the second soldering area (14112) are located on the side of the insulating substrate (1411) away from the circuit board (1412).

6. The method for preparing an implant for a brain-computer interface system according to claim 5, characterized in that, The feedthrough structure (14) further includes a flange (1421) and a first cover plate (1422); before welding the first end (112) and the second end (122) to the insulating substrate (1411), it further includes: The circuit board assembly (141) is circumferentially connected to the inner side of the flange (1421); The first cover plate (1422) is connected to one side of the flange (1421), the circuit board (1412) is disposed between the first cover plate (1422) and the insulating substrate (1411), and the first welding area (14111) and the second welding area (14112) are exposed from the side of the flange (1421) away from the first cover plate (1422).

7. The method for preparing an implant for a brain-computer interface system according to claim 6, characterized in that, The feedthrough structure (14) further includes a second cover plate (1423), and both the first end (112) and the second end (122) are welded to the insulating substrate (1411), and also includes: The second cover plate (1423) is connected to the flange (1421) on the side opposite to the first cover plate (1422). The first cover plate (1422) and the second cover plate (1423) are connected to both sides of the flange (1421) to form a housing (142). The circuit board assembly (141) is located inside the housing (142). The first end (112) and the second end (122) pass through the housing (142).

8. The method for preparing an implant for a brain-computer interface system according to claim 7, characterized in that, The welding assembly further includes a reference electrode (151) and a skin electrode (152), and before the second cover plate (1423) is connected to the side of the flange (1421) away from the first cover plate (1422), it further includes: one end of the reference electrode (151) and the skin electrode (152) are electrically connected to a predetermined area of ​​the insulating substrate (1411).

9. The method for preparing an implant for a brain-computer interface system according to claim 8, characterized in that, After the first end (112), the second end (122), the reference electrode (151) and the skin electrode (152) are all welded to the insulating substrate (1411), the method further includes: the reference electrode (151) and the skin electrode (152) extending out of the outer covering layer (16).

10. An implant, characterized in that, The implant includes a coil (11), a communication antenna (12), a flexible covering (13) enclosing the coil (11) and the communication antenna (12), and a feedthrough structure (14). The first end (112) of the coil (11) and the second end (122) of the communication antenna (12) both extend out of the flexible covering (13) and are welded to the feedthrough structure (14). The implant is prepared by the implant preparation method according to any one of claims 1-9.

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