A special instrument set for flexible microelectrode brain-computer interface surgery

Abstract

The application discloses a special instrument set for flexible microelectrode brain-computer interface operation, which comprises an L-shaped micro-wire flexible electrode operation tool, a bone grinding ring, an implant positioning model and a scalp thickness measuring clamp. The L-shaped micro-wire flexible electrode operation tool comprises at least one L-shaped metal wire with a diameter of 30-70 µm, which is used for combing, dragging and pulling out the electrode wire. The bone grinding ring is a cylindrical ring-shaped limiting template, which is used for limiting the operation range of the grinding drill bit. The implant positioning model is a proportional model of the implant, which is used for confirming the placement angle and embedding depth of the implant. The scalp thickness measuring clamp is provided with a scale disc with a color band for marking the charging efficiency reference interval, which is used for selecting the implant model. The application realizes the lossless operation of the flexible electrode wire in the flexible microelectrode BCI operation scene, the accurate matching of the bone window size and the multi-model implant, the one-time positioning of the implant angle and position, and the integration of the scalp thickness measurement and the implant selection decision-making.

Description

Technical Field

[0001] This invention belongs to the field of medical device technology, and in particular relates to a special instrument kit for flexible microelectrode brain-computer interface surgery. Background Technology

[0002] Invasive brain-computer interfaces (BCIs) are a core frontier in the fields of neuroscience and medical devices. By implanting microelectrode arrays in the cerebral cortex, they enable the acquisition and decoding of neural signals with high spatiotemporal resolution, providing innovative intervention methods for patients with motor dysfunction, refractory epilepsy, Parkinson's disease, and other neurological diseases.

[0003] Invasive brain incision (BCI) microelectrodes can be broadly categorized into rigid and flexible electrodes based on their morphology. Rigid electrodes (such as Utah arrays, silicon-based probes, and SEEG electrodes) have relatively mature implantation procedures, allowing direct insertion into the cortex using their inherent rigidity. However, their mechanical mismatch with brain tissue leads to chronic inflammation and glial scarring, resulting in insufficient long-term signal stability. Flexible microelectrode arrays (such as polyimide-based thin-film electrodes and SU-8-based electrodes) are closer to the mechanical properties of brain tissue, exhibiting milder chronic inflammation and enabling high-density, wide-area cortical coverage. They have become a core direction for the clinical translation of invasive BCI procedures.

[0004] Typical flexible electrodes have physical dimensions on the order of micrometers, with widths ranging from tens to hundreds of micrometers and thicknesses of 1 to 2 micrometers. These are ultrathin film structures, making them susceptible to folding, bending, or breakage under external forces. For example, Neuralink's R1 surgical robot uses 25 µm diameter tungsten-rhenium alloy needles to automate the implantation of flexible electrode wires one by one. This would be virtually impossible for surgeons to manually place these thin, flexible electrodes individually. To fill the fundamental gap in surgical instruments for flexible BCI microelectrode implantation, there is an urgent need to develop a dedicated instrumentation system for flexible microelectrode brain-computer interface surgery. This would address the limitations imposed by manual manipulation tools on the clinical translation of BCI procedures. Summary of the Invention

[0005] In view of this, the present invention aims to propose a special instrument kit for flexible microelectrode brain-computer interface surgery, as well as an L-shaped microwire flexible electrode manipulation tool and a scalp thickness measuring fixture, to systematically solve a series of technical problems in flexible microelectrode BCI surgery scenarios, such as the inability to perform non-destructive manipulation of flexible electrode wires, the difficulty in accurately matching bone window size with various implant models, the difficulty in accurately locating the orientation and position of the implant in the bone window at one time, the difficulty in quickly measuring scalp thickness and directly selecting the implant model, and the difficulty in centrally storing and sterilizing various special tools.

[0006] To achieve the aforementioned objectives, the technical solution of this application is implemented as follows: In a first aspect, the present invention provides a special instrument kit for flexible microelectrode brain-computer interface surgery, the special instrument kit comprising: an L-shaped microwire flexible electrode manipulation tool, a bone grinding ring, an implant positioning model, and a scalp thickness measuring clamp; The L-shaped microfilament flexible electrode manipulation tool consists of a hand-held section and at least one L-shaped metal wire, used for combing, dragging, and pulling out the electrode wire; The bone grinding ring is a cylindrical annular limiting template, the inner diameter of which matches the outer diameter of the implant base, and is used to limit the operating range of the grinding drill bit. The implant positioning model is a scale model of the implant with orientation indicator marks on its surface. Before placing the implant, the implant positioning model is placed in the skull window to confirm the placement angle and embedding depth of the implant after it is placed in the skull window. The scalp thickness measuring fixture includes a clamping structure consisting of a first working arm and a second working arm, which are rotatably connected by a pivot. The first working arm includes an arc-shaped upper jaw and a first hand-held end, and the second working arm includes an ultra-thin flat lower jaw and a second hand-held end. The second hand-held end is provided with a scale, and the reading represents the distance between the arc-shaped upper jaw and the ultra-thin flat lower jaw.

[0007] Furthermore, the L-shaped metal wire includes a metal wire body and a short arm working end, with an L-shaped bend between the metal wire body and the short arm working end. The diameter of the L-shaped metal wire is 30~70µm, and the material is tungsten, tungsten-rhenium alloy, platinum-iridium alloy, nickel-titanium alloy, or medical stainless steel.

[0008] Furthermore, when there are two or more L-shaped metal wires, the L-shaped metal wires of the same specification are arranged in parallel with equal spacing, and the spacing is greater than the center distance of the electrode wires or more than twice the center distance of the electrode wires.

[0009] Furthermore, a handle is fitted onto the outside of the handheld section. The surface of the handle has multiple longitudinal anti-roll surfaces and an anti-rotation latch, which is used to sense the orientation of the tip of the L-shaped metal wire.

[0010] Furthermore, the inner diameter of the bone-grinding ring can be adjusted in steps to match the outer diameter of various implant base models.

[0011] Furthermore, the bone-grinding ring is made of polyetheretherketone, and the outer wall of the bone-grinding ring is embedded with metal markers for verifying the location of the bone window through image recognition.

[0012] Furthermore, a V-shaped notch is provided on the outer edge of the bone-grinding ring to align with the orientation indicator marks on the surface of the implant positioning model, providing a rotation angle reference for the implant positioning model.

[0013] Furthermore, a small permanent magnet is placed inside the implant positioning model to confirm the position of the implant positioning model through magnetic field signals.

[0014] Furthermore, the pivot of the scalp thickness measuring fixture is connected to a spring return mechanism located at the second hand end, which ensures that the arc-shaped upper jaw and the ultra-thin flat lower jaw naturally close when no external force is applied to the first and second hand ends.

[0015] Furthermore, the scale of the scalp thickness measuring fixture is provided with a reference range for characterizing the wireless charging / data transmission efficiency corresponding to the scalp thickness.

[0016] Furthermore, the reference range corresponds directly to the implant model, and different colors are used to mark the reference range with color bands.

[0017] Furthermore, the reference range also includes a range with lower wireless charging / data transfer efficiency, used to indicate when a scalp thinning operation should be performed.

[0018] Furthermore, the scalp thickness measuring fixture is equipped with a buzzer alarm. When the scalp thickness reaches the upper limit or the dial pointer enters the reference range where wireless charging / data transmission efficiency is low, the buzzer alarm will sound a prompt to perform a scalp thinning operation.

[0019] Furthermore, the scalp thickness measuring fixture integrates a small ultrasonic thickness probe for non-invasive measurement of scalp thickness, allowing for the selection of an implant model that matches the scalp thickness before surgery.

[0020] Furthermore, the specialized instrument kit includes a skull screw and a precision screwdriver that matches the head slot of the skull screw.

[0021] Furthermore, the specialized instrument kit includes an arachnoid hook knife, which consists of a blade body and a blade head. The blade body has a cutting edge width of ≤1mm, and the blade head has bending angles of 30°, 45°, and 60°.

[0022] Furthermore, the specialized instrument kit also includes a tray with snaps or grooves for positioning the specialized instruments.

[0023] Secondly, the present invention provides an L-shaped microfilament flexible electrode manipulation tool for flexible microelectrode brain-computer interface surgery. The L-shaped microfilament flexible electrode manipulation tool consists of a handheld section and at least one L-shaped metal wire, used for combing, dragging, and pulling out the electrode wire. The L-shaped metal wire includes a metal wire body and a short arm working end, with an L-shaped bend between the metal wire body and the short arm working end. The diameter of the L-shaped metal wire is 30~70µm, and the material is tungsten, tungsten-rhenium alloy, platinum-iridium alloy, nickel-titanium alloy, or medical stainless steel.

[0024] Furthermore, when there are two or more L-shaped metal wires, the L-shaped metal wires of the same specification are arranged in parallel with equal spacing, and the spacing is greater than the center distance of the electrode wires or more than twice the center distance of the electrode wires.

[0025] Thirdly, the present invention provides a scalp thickness measuring fixture for flexible microelectrode brain-computer interface surgery. The scalp thickness measuring fixture includes a clamping structure consisting of a first working arm and a second working arm, which are rotatably connected by a pivot. The first working arm includes an arc-shaped upper jaw and a first handheld end, and the second working arm includes an ultra-thin flat lower jaw and a second handheld end. The second handheld end is provided with a scale, and the reading represents the distance between the arc-shaped upper jaw and the ultra-thin flat lower jaw. The scale of the scalp thickness measuring fixture is provided with a reference range for representing the wireless charging / data transmission efficiency corresponding to the scalp thickness. The reference range directly corresponds to the implant model, and different colors are used to mark the reference range.

[0026] This invention provides a specialized instrument kit for flexible microelectrode brain-computer interface surgery, an L-shaped microwire flexible electrode manipulation tool, and a scalp thickness measurement fixture. Compared with the prior art, this invention has at least the following advantages: (1) Since the thickness of the BCI flexible microelectrode wire is only 1~2µm and the width is only a few hundred micrometers, the tip size (millimeter level) of existing surgical forceps, nerve dissectors and other tools is much larger than the thickness of the electrode wire. The contact stress of direct contact operation can easily cause the electrode wire to fold or break. In addition, multiple electrode wires are prone to adhesion and entanglement due to the surface tension of liquid, the viscosity of blood and cerebrospinal fluid, van der Waals forces and electrostatic effects. Therefore, without special tools, it is almost impossible to manually comb, separate and directionally drag the electrode wire. To this end, the present invention has specially designed an L-shaped micro-wire flexible electrode manipulation tool with a working end diameter of 30~70µm. The diameter of the short arm of the working end is much smaller than the width of the electrode wire being manipulated and is on the same scale as the thickness of the electrode wire (1~2µm). Therefore, it can be easily inserted into the gap between the electrode wires and combed and dragged in a lateral contact manner. No clamping pressure is applied to the electrode wire throughout the process, which has good operational flexibility and adaptability. To facilitate the removal of electrode wires, this invention features a specially designed L-shaped microwire flexible electrode manipulation tool with multiple metal wires. The spacing between the L-shaped metal wires is greater than or more than twice the center-to-center distance of the electrode wires, allowing the flexible electrode wire to pass through two metal wires in an S-shape. This enables the user to easily pull the flexible electrode wire radially, thus accurately removing one or more implanted electrode wires or performing other pulling operations with minimal damage to other flexible electrode wires. This invention is the world's first dedicated manual instrument designed specifically for flexible microelectrode BCI surgery.

[0027] (2) For implants with a fixed base size, the cranial bone window needs to be precisely matched with the implant. If the area to be removed is estimated based on the doctor's experience, an excessively large or small bone window will affect the implant's embedding and sealing. In addition, for wirelessly rechargeable implants, the orientation and coverage of the charging coil within the implant must be ensured. Due to the current lack of specialized surgical tools and intraoperative spatial simulation tools, repeated adjustments to the implant position during surgery are likely to occur, prolonging the operation time and increasing the risk of anesthesia, and also easily damaging the flexible electrode wire. To address this, this invention has specially designed a matching bone grinding ring and implant positioning model. The inner diameter of the bone grinding ring is precisely matched with the outer contour of the corresponding implant model, serving as a limiting template for the cranial bone removal area, making it convenient for doctors to define the location and range of cranial bone removal. The implant positioning model is a scaled-down model without electrode wires that is completely consistent with the geometry of the corresponding model's actual implant. The surface is marked with markings representing the extension direction of the flexible electrode wires, used for intraoperative spatial simulation. After the implant placement angle and embedding depth are determined, the actual implant is placed, reducing repeated adjustments during implant placement, preventing damage to the flexible electrode wires, and shortening the effective operation time.

[0028] (3) The implant wirelessly charges or transmits data with an external coil via its internal coil. The distance between the internal and external coils affects the efficiency of wireless charging / data transmission. After the implant is placed in the skull, the distance between the internal and external coils is directly affected by the scalp thickness. Since individual scalp thickness varies, to ensure the efficiency of wireless charging / data transmission, it is necessary to select an implant model with matching wireless charging / data transmission efficiency based on the individual's scalp thickness. In some cases, it may even be necessary to thin the scalp to meet the parameter requirements of the implant's wireless charging / data transmission. Currently, there is a lack of simple quantitative measurement tools for scalp thickness, making it difficult to quickly determine the scalp thickness during surgery and select an implant model that matches the scalp thickness. Therefore, this invention specifically designs a scalp thickness measuring clamp, which can quickly and accurately determine the scalp thickness, thereby quickly selecting an implant model that matches the scalp thickness.

[0029] (4) To further improve intraoperative efficiency and shorten surgical time, this invention sets a reference range on the dial of the scalp thickness measuring fixture to characterize the wireless charging / data transmission efficiency corresponding to the scalp thickness. The reference range directly corresponds to the implant model and is marked with different colors. By observing the color of the reference range used to characterize the wireless charging / data transmission efficiency, the implant model that matches the scalp thickness can be selected directly at a glance, or a decision can be made on whether to thin the scalp. The color marking allows the scalp thickness measurement results to be directly mapped to clinical decisions, eliminating the need to select the implant model or determine whether to thin the scalp based on the measurement results and a reference table, thus achieving the integration of measurement and selection decision-making. To further improve intraoperative efficiency, this invention integrates a small ultrasonic thickness probe into the scalp thickness measuring fixture. The scalp thickness is measured in a non-invasive manner before surgery, allowing for advance medical decisions on implant model selection and whether to thin the scalp.

[0030] (5) In the prior art, the various special tools are placed and used separately, which makes it difficult to ensure the integrity of the set and the overall standardized sterilization management. To this end, the present invention designs a tray for storing various flexible microelectrode brain-computer interface surgical instruments by means of buckles or grooves, thereby realizing the overall storage and standardized sterilization of the special instrument set, and facilitating the transportation, transfer and sterilization management of the special instrument set. Attached Figure Description

[0031] To more clearly illustrate the technical solutions of the embodiments of this application, the accompanying drawings used in the description of the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments recorded in this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0032] Figure 1 This is a schematic diagram of the structure of the L-shaped microfilament flexible electrode manipulation tool of the present invention; Figure 2 This is a schematic diagram illustrating the operation method of combing and dragging electrode wires using the L-shaped microfilament flexible electrode manipulation tool of the present invention; Figure 3A This is a schematic diagram of the structure of the bone grinding ring of the present invention; Figure 3B for Figure 3A A cross-sectional view of the middle mortise bone ring along the aa direction; Figure 4A This is a schematic diagram of the implant positioning model of the present invention; Figure 4B for Figure 4A Top view of the implant positioning model; Figure 5 This is a schematic diagram of the scalp thickness measuring fixture of the present invention.

[0033] Explanation of reference numerals in the attached figures: Handheld section 1-1, L-shaped metal wire 1-2, metal wire body 1-3, short arm working end 1-4, handle 1-5, anti-roll surface 1-6, anti-rotation bayonet 1-7 Electrode wire 2-1, transverse 2-2, axial traction force 2-3 Cylindrical annular limiting template 3-1, annular step 3-2, annular step surface 3-3, bottom surface 3-4, top surface 3-5, V-shaped notch 3-6. The ear hole is fixed at 4-1, facing the indicator mark 4-2, and the internal coil faces 4-3. First working arm 5-1, second working arm 5-2, pivot 5-3, arc-shaped upper jaw 5-4, first hand-held end 5-5, ultra-thin flat lower jaw 5-6, second hand-held end 5-7, vernier scale 5-8, spring return mechanism 5-9, ribbon 5-10. Detailed Implementation

[0034] The technical solutions of the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some, not all, of the embodiments of this application. All other embodiments obtained by those skilled in the art based on the embodiments of this application without creative effort are within the scope of protection of this application.

[0035] In a first aspect, the present invention provides a special instrument kit for flexible microelectrode brain-computer interface surgery, the special instrument kit comprising: an L-shaped microwire flexible electrode manipulation tool, a bone grinding ring, an implant positioning model, a scalp thickness measuring clamp, a cranial screw, a fine threading knife, and an arachnoid hook knife.

[0036] L-shaped microfilament flexible electrode manipulation tool

[0037] The L-shaped microfilament flexible electrode manipulation tool of the present invention consists of a handheld section 1-1 and at least one L-shaped metal wire 1-2, such as... Figure 1 As shown, the L-shaped metal wire 1-2 is fixedly connected to the handheld section 1-1 and is used for combing, dragging, and pulling out the electrode wire. The L-shaped metal wire 1-2 of the present invention includes a metal wire body 1-3 and a short arm working end 1-4, with the metal wire body 1-3 and the short arm working end 1-4 forming an L-shaped bend.

[0038] Handheld segment

[0039] This invention does not have a specific limitation on the length of the handheld segment; it can be set to be comparable to the grip length of conventional microsurgical instruments, such as 120-150mm, as long as it ensures ergonomics for the surgeon operating under the microscope. The handheld segment 1-1 is fitted with a medical-grade silicone handle 1-5. Multiple longitudinal anti-roll surfaces 1-6 can be provided on the outer surface of the handle to prevent the instrument from rolling off the operating table; typically, 4-6 longitudinal anti-roll surfaces are used. An anti-rotation latch 1-7 is provided on the side of the handle near the L-shaped metal wire, ensuring that the surgeon can perceive the orientation of the short-arm working end without looking down when holding the handle with one hand. The diameter of the handle 1-5 can be designed to be approximately 8mm for easy gripping.

[0040] L-shaped metal wire

[0041] The L-shaped metal wire 1-2 of this invention has a diameter of only 30~70µm, which is smaller than the width of the flexible electrode wire being operated on (several hundred micrometers). This makes it easy to insert into the gap between adjacent electrode wires. At the same time, it is within the same order of magnitude of the 1~2µm thickness of the electrode wire that can be perceived as being in contact, thereby enabling precise control of the operating force.

[0042] The L-shaped metal wire of this invention can be made of tungsten, tungsten-rhenium alloy, platinum-iridium alloy, nickel-titanium alloy, or medical-grade stainless steel. Tungsten wire has a Vickers hardness of approximately 3430 HV and an elastic modulus of approximately 411 GPa, providing sufficient cantilever stiffness at diameters of tens of micrometers, allowing it to maintain its shape during operation without significant elastic bending. Furthermore, the diameter of the tungsten wire can be precisely controlled to the micrometer level, and its melting point of 3422℃ allows for high-temperature sterilization. Platinum-iridium alloy (Pt9Ir) offers good ductility, corrosion resistance, and excellent biocompatibility, making it suitable for applications requiring high wire bending performance. Medical-grade stainless steel (316L) is less expensive and suitable for applications with lower operating force requirements and less stringent stiffness requirements.

[0043] The L-shaped bending angle between the main metal wire 1-3 and the short arm working end 1-4 of this invention is typically 90°. It can also be serially produced with four different angle specifications: 85°, 90°, 95°, and 100°. Different colored handles can be used for differentiation to suit different surgical field entry angles and physician operating habits. The length of the short arm working end 1-4 is preferably 2-5 mm. Too short an arm results in insufficient working space, while too long an arm increases operating torque. This invention does not have a specific limitation on the length of the main metal wire 1-3, which can typically be set to 40-80 mm. The L-shaped bend of this invention is processed using a precision cold bending process, with a bending radius not exceeding twice the diameter of the metal wire. No cross-sectional shrinkage or microcracks should appear at the bend. The tip of the short arm working end 1-4 is deburred through electrochemical polishing to reduce mechanical damage to the electrode wire.

[0044] Since the flexible electrode wire is only 1-2µm thick, if it is directly clamped with conventional surgical forceps, even with the minimum controllable clamping force, the pressure acting on the cross-section of the electrode wire will far exceed the yield strength of the film material (such as polyimide), inevitably leading to film deformation or breakage. The L-shaped microfilament flexible electrode manipulation tool of this invention uses lateral line contact rather than surface clamping to manipulate the electrode wire during use.

[0045] When there is only one L-shaped metal wire, the L-shaped microwire flexible electrode operation tool of the present invention can be used for combing and dragging operations.

[0046] When using an L-shaped microfilament flexible electrode manipulation tool to comb the electrode wires, such as Figure 2 As shown in (A), the short arm working end 1-4 is inserted from the side between two adjacent electrode wires 2-1. Since the diameter of the short arm working end 1-4 is only 30~70µm, it can easily be inserted into the gap between the electrode wires 2-1. By gently moving it laterally 2-2, the multiple electrode wires 2-1 that are stuck together are separated one by one through the line contact between the side of the short arm working end 1-4 and the electrode wires 2-1. The contact form is line contact, the contact area is extremely small, and the normal force applied to the electrode wires 2-1 is extremely low, so it is insufficient to cause deformation of the electrode wires 2-1.

[0047] When using an L-shaped microfilament flexible electrode manipulation tool to drag the electrode wire, such as Figure 2 As shown in (B), the L-shaped bend of the short arm working end 1-4 is inserted into the side of the electrode wire 2-1 and rotated so that the L-shaped bend of the short arm working end 1-4 hooks the non-functional segment (proximal end of the junction area) of the electrode wire 2-1. An axial traction force 2-3 is applied along the predetermined implantation direction to guide the electrode wire 2-1 to the target position. No direct contact force is applied to the effective recording segment of the electrode wire throughout the entire process.

[0048] As an optional implementation, the L-shaped metal wires of the present invention can also be configured as two or more, with multiple L-shaped metal wires of equal specifications arranged in parallel at equal intervals. This interval is greater than or more than twice the center-to-center distance of the electrode wires, for example, twice the center-to-center distance of the electrode wires. The spacing between the L-shaped metal wires should be fixed and should not be allowed to move relative to each other. In scenarios where radial force needs to be applied to the flexible electrode wire, such as when it is necessary to pull out the electrode wire, the flexible electrode wire can be made to pass through two metal wires in an S-shape. The surgeon can then easily pull the flexible electrode wire radially, thereby pulling out the implanted electrode wire or performing other pulling operations with minimal damage to the flexible electrode wire.

[0049] As an optional implementation, the connection between the handpiece and the L-shaped wire can be designed as a detachable structure, such as a precision snap or threaded insertion. During the procedure, different specifications of L-shaped wires can be quickly replaced according to the stage of the operation (combing, dragging, pulling out) or the depth of the operation. The handpiece can be reused after disinfection, while the L-shaped wire is a disposable consumable, thereby reducing the overall cost of use.

[0050] Bone grinding ring

[0051] The bone-grinding ring of this invention is a cylindrical annular limiting template 3-1, as shown in the figure. Figure 3A As shown, its inner diameter matches the outer diameter of the implant base, which is used to limit the operating range of the grinding drill bit, and can restrict the grinding drill bit to operate within the inner area of ​​the bone grinding ring.

[0052] The inner diameter of the bone-grinding ring of this invention can be designed in a series of sizes such as Φ26mm, Φ30mm, and Φ34mm according to the implant model, with an inner wall dimensional tolerance of ≤±0.2mm. The outer diameter of the bone-grinding ring can be increased by 6~10mm in wall thickness based on the inner diameter, thereby ensuring sufficient stability of the ring when placed on the skull surface. Considering both the effectiveness of positioning and the requirements of the surgical field, the height of the bone-grinding ring is preferably 1mm or more.

[0053] As an optional implementation method, such as Figure 3B As shown, this invention features an annular step 3-2 along the lower edge of the inner wall of the bone-grinding ring. The annular step surface 3-3 is parallel to the bottom surface 3-4 of the bone-grinding ring, limiting the maximum skull grinding depth and preventing excessive drilling. The inner wall above the annular step 3-2 is perpendicular to the bottom surface of the bone-grinding ring, guiding the drill bit to remain vertical and acting as a guide. The annular step 3-2 along the lower edge of the inner wall of the bone-grinding ring is a depth-limiting step. The height difference h between the annular step surface 3-3 and the top surface 3-5 of the bone-grinding ring represents the maximum allowable skull grinding depth, which is determined based on the embedding depth requirements of each implant type. The annular step surface 3-3 prevents the drill from moving further downward, avoiding drilling into the epidural space. The bottom surface 3-4 of the bone-grinding ring is a precision-machined plane, providing a stable depth reference when placed on the outer skull plate, ensuring that the height of the limiting step is measured from the surface of the outer skull plate. A V-shaped notch 3-6 is provided at the 12 o'clock position on the outer edge of the bone grinding ring. This notch can serve as a reference mark for the orientation of the implant electrode wire. The V-shaped notch 3-6 is used in conjunction with the orientation indicator mark on the surface of the implant positioning model to provide a rotation angle reference for the implant positioning model.

[0054] The bone reshaping ring can be made of polyetheretherketone (PEEK). PEEK is completely radiolucent, meaning it does not produce artifacts under X-ray / CT fluoroscopy. PEEK can be autoclaved at 134°C, exhibiting excellent high-temperature resistance. Its tensile strength is approximately 100 MPa, meeting the mechanical performance requirements. As an optional implementation, metal markers, such as platinum wires, can be embedded in the outer wall of the PEEK bone reshaping ring, making it visible on CT scans during surgery and supporting image-guided bone window positioning verification. Of course, considering lower costs, medical-grade 316L stainless steel can also be used for the bone reshaping ring; in this case, the ring is radiolucent.

[0055] To ensure precise matching with the outer diameter of different implant base models, bone-grinding rings with corresponding inner diameters can be manufactured in a series according to implant model. Multiple bone-grinding rings can be matched with the specialized instrument kit for flexible microelectrode brain-computer interface surgery of this invention, according to model number. Alternatively, the bone-grinding ring can be designed with a segmented adjustable structure, similar to a movable inner diameter caliper. The inner diameter of the bone-grinding ring can be adjusted in steps, for example, in 2mm increments within the range of 24-36mm. This allows a single bone-grinding ring to adapt to the outer diameter of multiple implant base models, reducing the complexity of managing mushroom-shaped ring models.

[0056] Implant localization model

[0057] The implant positioning model of this invention is a scale model that perfectly matches the geometry of the actual implant, such as... Figure 4A and 4B As shown. The shape of the implant positioning model is completely consistent with the outer contour of the corresponding implant base and top cover, and it has a fixation ear hole 4-1 that is exactly the same as the implant. For the fixation ear hole of the implant, a cranial screw can be passed through the hole and tightened to the skull for fixation. The fixation ear hole 4-1 of the implant positioning model is used to simulate the drilling position of the fixation ear hole of the real implant. The dimensional error of the implant positioning model should be ≤0.1mm to ensure that the spatial relationship such as the embedding depth in the bone window and the gap with the bone edge is completely consistent with the real implant.

[0058] The implant positioning model of this invention has orientation indicator marks 4-2 and coil position contour marks on its surface. The orientation indicator marks 4-2 represent the direction of the flexible electrode wire in the actual implant and can be directional marks such as arrows. The coil position contour marks can be raised dotted circles, which can be formed by raised printing or laser etching. Before placing the implant, the implant positioning model is placed in the skull bone window, which helps the surgeon to visually confirm the accuracy of the implantation position, placement angle, and embedding depth of the actual implant after it has been placed in the skull bone window during the operation.

[0059] Implant positioning models can be manufactured using medical-grade ABS or nylon through SLS / SLA 3D printing, allowing for rapid updates as implant product forms evolve. The model surface is coated with a heat-sterilizable coating, capable of withstanding EO sterilization or gamma irradiation. Alternatively, a real implant shell with the flexible electrode wires removed can be used. To achieve a weight similar to a real implant, counterweight material can be filled inside the positioning model to provide a near-realistic intraoperative feel, helping surgeons assess the stability of the real implant within the bone window.

[0060] After the skull bone window is prepared and before the actual implant is placed, the implant positioning model is placed in the bone window. The orientation indicator mark 4-2 on the surface of the positioning model is aligned with the V-shaped notch 3-6 of the bone grinding ring to confirm that the placement angle meets the requirements. The bottom surface of the positioning model is flush with the inner table of the skull to confirm that the embedding depth meets the requirements. The orientation of the internal coil of the implant (4-3) is confirmed to be towards the outer side of the scalp to meet the requirements for wireless charging. Then, the positioning model is removed, and the actual implant is placed in a subsequent appropriate stage. By using the implant positioning model, implant positioning can be transformed from a "single, unpredictable operation" to a "verifiable, ordered operation," reducing repeated adjustments during the actual implant placement process, preventing damage to the flexible electrode wire during adjustment, and shortening the effective surgical time.

[0061] As an optional implementation, a small permanent magnet can be placed inside the implant positioning model. In conjunction with a magnetic field detector next to the operating table, the position of the positioning model can be confirmed by the magnetic field signal after the implant positioning model is removed.

[0062] Scalp thickness measuring fixture

[0063] The scalp thickness measuring fixture of the present invention includes a two-arm clamping structure consisting of a first working arm 5-1 and a second working arm 5-2, as shown below. Figure 5 As shown, the first working arm 5-1 and the second working arm 5-2 are rotatably connected by a pivot 5-3. The first working arm 5-1 includes an arc-shaped upper jaw 5-4 and a first handheld end 5-5. The second working arm 5-2 includes an ultra-thin, flat lower jaw 5-6 and a second handheld end 5-7. The second handheld end 5-7 is provided with a dial 5-8, the reading of which is used to characterize the distance between the arc-shaped upper jaw 5-4 and the ultra-thin, flat lower jaw 5-6. The pivot 5-3 of the present invention is connected to a spring return mechanism 5-9 located on the second handheld end 5-7 to ensure that the arc-shaped upper jaw 5-4 and the ultra-thin, flat lower jaw 5-6 naturally close when no external force is applied.

[0064] When using the scalp thickness measuring fixture, the curved upper jaw 5-4 is a curved soft contact claw that contacts the outer layer of the scalp; the ultra-thin flat lower jaw 5-6 is a flat hard contact claw that contacts the surface of the outer plate of the skull. Under the action of the spring return mechanism 5-9, the curved upper jaw 5-4 and the ultra-thin flat lower jaw 5-6 are naturally clamped on both sides of the scalp. The pivot 5-3 is fixedly connected to the first working arm 5-1 and rotatably connected to the second working arm 5-2. There is a trigonometric function relationship between the scalp thickness between the curved upper jaw 5-4 and the ultra-thin flat lower jaw 5-6 and the angle of rotation of the pivot 5-3 on the first working arm 5-1 relative to the second working arm 5-2. The rotation of the pivot 5-3 causes the pointer on the scale 5-8 to deflect. After performing function analysis on the scale value on the scale, the scalp thickness between the curved upper jaw 5-4 and the ultra-thin flat lower jaw 5-6 can be indicated by the pointer reading.

[0065] The preferred measuring range of the dial in this invention is 0-20mm, with a minimum graduation of 0.1mm, which can meet the measurement requirements for a typical scalp thickness range of 7-13mm. The dial preferably uses a mechanical instrument panel for reading, and the material can be PEEK or medical-grade 316L stainless steel, both of which are resistant to EO ethylene oxide sterilization or gamma-ray irradiation sterilization. As an optional implementation, the dial can also be replaced with a digital display head for more intuitive readings. The digital display head should ideally have a waterproof rating of IP67 or higher and be resistant to EO ethylene oxide sterilization or gamma-ray irradiation sterilization.

[0066] The implant wirelessly charges or transmits data with an external coil via its internal coil. The distance between the internal and external coils affects the efficiency of wireless charging / data transmission. After the implant is placed in the skull, the distance between the internal and external coils is directly affected by the thickness of the scalp. Since there are certain differences in individual scalp thickness, in order to ensure the efficiency of wireless charging / data transmission, it is necessary to select an implant model with matching wireless charging / data transmission efficiency according to the individual's scalp thickness. In some cases, it may even be necessary to thin the scalp to meet the parameter requirements of the implant's wireless charging / data transmission.

[0067] Currently, due to the lack of convenient quantitative measurement tools for scalp thickness, it is difficult to quickly determine scalp thickness during surgery and select an implant model that matches the scalp thickness. Therefore, this invention specifically designs a scalp thickness measuring clamp, which allows for rapid and accurate measurement of scalp thickness, thereby enabling quick selection of an implant model that matches the scalp thickness. In actual surgical procedures, after measuring the scalp thickness, the surgeon cannot directly select the desired implant model; instead, they need to refer to a table comparing scalp thickness with implant power to select the appropriate implant model.

[0068] In order to further improve the intraoperative efficiency, the inventor has set a reference range on the dial for characterizing the wireless charging / data transmission efficiency corresponding to the scalp thickness. The boundaries of each reference range are obtained by converting the measured power curves of the wireless charging module / data transmission module supporting the implant. The reference ranges directly correspond to the implant models, and different reference ranges are marked with color bands 5 - 10 of different colors. By directly observing the color of the color band of the reference range for characterizing the wireless charging / data transmission efficiency, the surgeon can clearly and directly select the implant model that matches the scalp thickness or make a decision on whether to thin the scalp. The color band marking directly maps the scalp thickness measurement result to a clinical decision, eliminating the need to select the implant model or determine whether to thin the scalp based on the measurement result and the look-up table, thus achieving the integration of measurement and selection decision-making. Figure 5 Only the optimal efficiency range of 6 - 15 mm (green) and the lower efficiency range greater than 15 mm (red) are schematically marked with color bands. The green range corresponds to a suitable scalp thickness, and the red range corresponds to the need to thin the scalp. For Figure 5 the dial, it can be understood that the efficiency reference range corresponding to the cursor scale can be further precisely divided according to the coil power of different implant models, and more color bands can be marked to make the reference range and the color band directly correspond to the implant model, so as to achieve the integration of measurement and selection decision-making.

[0069] In order to further improve the intraoperative efficiency, as an optional implementation mode, a small ultrasonic thickness measurement probe can be integrated into the scalp thickness measurement fixture to directly measure the depth from the outer layer of the scalp to the outer plate of the skull in a non-invasive manner before the operation, so that a medical decision on implant model selection or whether to thin the scalp can be made before the operation, effectively shortening the operation time.

[0070] As an optional implementation mode, the scalp thickness measurement fixture can also be further configured with a Bluetooth system to automatically output measurement results such as scalp thickness to the operation record system through the Bluetooth system, and the measurement results are automatically bound to the patient ID for filing.

[0071] As an optional implementation mode, the scalp thickness measurement fixture can also be further configured with a buzzer alarm. When the scalp thickness exceeds the optimal charging / data transmission spacing range, or the scalp thickness reaches the thickness upper limit, or the dial pointer enters the scalp thickness upper limit range, or the dial pointer enters the reference range with lower wireless charging / data transmission efficiency, the buzzer alarm will sound to prompt the surgeon to make a decision on whether to thin the scalp.

[0072] Arachnoid hook knife

[0073] The implantation of flexible electrodes requires meticulous incisions that minimize damage to the dura mater and arachnoid mater to create tiny channels for the electrode wires to pass through, while avoiding damage to the subarachnoid vessels. To this end, this invention also provides an arachnoid hook knife consisting of a handle and a blade. The blade's cutting edge width is preferably no more than 1 mm, significantly smaller than the 2-5 mm cutting edge width of traditional dura mater scissors, enabling precise point-to-point incisions along the flexible electrode wire entry route. The blade's bending angle can be configured in three specifications: 30°, 45°, and 60°, corresponding to the optimal wrist operating angle for different cortical regions and surgical field depths, allowing the blade to cut parallel to the cortical surface without altering the surgeon's wrist posture. The handle of the arachnoid hook knife can adopt the same handle design as the L-shaped microfilament flexible electrode operating tool, with a unified specification, facilitating single-handed identification of the cutting edge direction by the surgeon. Similar to the L-shaped microfilament flexible electrode manipulation tool, the handle of the spider web hook knife can also be designed as a replaceable blade head structure, and the same handle can be adapted to three different angle specifications of blade heads through a bayonet connector.

[0074] Skull nails and precision screwdrivers

[0075] The cranial screw is used to pass through the fixation ear hole to fix the implant base to the edge of the skull window. The head of the cranial screw can be countersunk and flush with the fixation ear hole of the implant base. The thread specification should match the fixation ear hole of the implant base. The special instrument kit of this invention includes 5 to 6 cranial screws, of which 4 are used with the 4 fixation ear holes, and 1 to 2 are spares.

[0076] The working tip of the precision screwdriver precisely matches the head groove of the skull screw, which can be Phillips, slotted, or Torx type for anti-slip grooves. The handle of the precision screwdriver features anti-slip grooves, and the handle end can optionally be equipped with a torque limiting mechanism to prevent excessive tightening from damaging the skull.

[0077] tray

[0078] To facilitate the unified storage and sterilization management of various specialized medical devices, this invention provides a tray for the specialized medical device kit. The tray uses clips or grooves to position the specialized medical devices, preventing displacement during sterilization and transportation. The tray can be designed for single use (disposable) or as a reusable consumable. The entire tray can be placed inside medical sterilization packaging (medical blister tray + dialysis paper film), thus completing the overall sterilization process in one go. It supports EO ethylene oxide sterilization or gamma ray irradiation sterilization. After placing a sterilization status indicator strip inside the sterilization packaging bag outside the tray, the sterilization packaging bag is sealed for storage.

[0079] Secondly, this invention provides an L-shaped microfilament flexible electrode manipulation tool for flexible microelectrode brain-computer interface surgery. For example... Figure 1As shown, the L-shaped microfilament flexible electrode manipulation tool of the present invention consists of a handheld section 1-1 and at least one L-shaped metal wire 1-2, used for combing, dragging, and pulling out the electrode wires. The L-shaped metal wire 1-2 includes a metal wire body 1-3 and a short arm working end 1-4, with an L-shaped bend between the metal wire body 1-3 and the short arm working end 1-4. The length of the short arm working end 1-4 is 2-5 mm. The diameter of the L-shaped metal wire 1-2 is 30-70 µm, and the material is tungsten, tungsten-rhenium alloy, platinum-iridium alloy, nickel-titanium alloy, or medical stainless steel. As an optional embodiment, when there are two or more L-shaped metal wires, the L-shaped metal wires of the same specification are arranged in parallel with equal spacing, and the spacing is greater than the center distance of the electrode wires or more than twice the center distance of the electrode wires.

[0080] Thirdly, the present invention provides a scalp thickness measuring clamp for flexible microelectrode brain-computer interface surgery. For example... Figure 5 As shown, the scalp thickness measuring fixture of the present invention includes a clamping structure composed of a first working arm 5-1 and a second working arm 5-2. The first working arm 5-1 and the second working arm 5-2 are rotatably connected by a pivot 5-3. The first working arm 5-1 includes an arc-shaped upper jaw 5-4 and a first handheld end 5-5. The second working arm 5-2 includes an ultra-thin flat lower jaw 5-6 and a second handheld end 5-7. The second handheld end 5-7 is provided with a scale 5-8, and the reading represents the distance between the arc-shaped upper jaw 5-4 and the ultra-thin flat lower jaw 5-6. The scale 5-8 of the scalp thickness measuring fixture of the present invention is provided with a reference range for representing the wireless charging / data transmission efficiency corresponding to the scalp thickness; the reference range directly corresponds to the implant model, and different colors are used to mark the reference range. The present invention will now be described in more detail with reference to exemplary embodiments. The following embodiments are intended to exemplarily illustrate the overall process of performing flexible microelectrode brain-computer interface surgery using the special instrument kit of the present invention. Those skilled in the art should understand that the present invention is not limited to these embodiments. Example 1

[0081] The procedure for performing flexible microelectrode brain-computer interface surgery using the special instrument kit of this invention includes the following steps: S1. Scalp Treatment Cut open the scalp and flip up the skin flap; S2. Measure scalp thickness The scalp thickness is measured using the scalp thickness measuring fixture of this invention. The corresponding implant model and the corresponding implant positioning model are selected by referring to the reference range of wireless charging / data transmission efficiency indicated by the dial, or the corresponding implant model and the corresponding implant positioning model are selected after the scalp is thinned. The scalp thickness measurement results and implant model are entered into the surgical record. S3. Drilling a skull bone window Place the bone-grinding ring corresponding to the implant model on the surface of the skull, so that the bottom surface of the bone-grinding ring fits against the outer plate of the skull; grind away the skull in the inner cavity of the bone-grinding ring. During the grinding process, the depth limiting step of the bone-grinding ring is used to prevent over-grinding. S4. Implant localization using an implant localization model. The implant positioning model of the present invention is placed in the bone window for spatial pre-simulation. The orientation indicator mark on the surface of the implant positioning model is aligned with the V-shaped notch of the bone grinding ring to confirm that the placement angle meets the requirements. The bottom surface of the implant positioning model is flush with the inner plate of the skull to confirm that the embedding depth meets the requirements. The coil inside the implant positioning model is oriented towards the outer side of the scalp to confirm that the coil orientation meets the requirements. After the above three conditions are met, the positions of the four fixed ear holes of the implant positioning model are marked by grinding and drilling on the surface of the outer plate of the skull. Then, the implant positioning model is removed. S5. Forming a cut for the flexible electrode wire passageway. Select an arachnoid hook knife of the appropriate angle and specifications, and precisely cut open the dura mater and arachnoid to create an incision for the flexible electrode wire to pass through; S6. Implantation of flexible electrode wire The L-shaped microfilament flexible electrode manipulation tool of the present invention is used to comb the flexible electrode wire to prevent the electrode wire from sticking and tangling, and to drag the flexible electrode wire to guide the electrode wire through the passage channel and reach the target area. S7. Insert and secure the implant. The actual implant is slowly moved into the skull window, and the four holes for fixing the ear canals of the implant are precisely aligned with the four drill marks on the outer plate of the skull. The holes for fixing the ear canals are drilled. The implant base is fixed to the edge of the skull window using four cranial screws and tightened with a fine screwdriver. S8. Suture Repair The dura mater was repaired by suturing in sequence, the skin flap was repositioned, and the scalp was sutured to complete the BCI surgery. Example 2

[0082] The procedure for performing flexible microelectrode brain-computer interface surgery using the special instrument kit of this invention includes the following steps: S0. Non-invasive measurement of scalp thickness The scalp thickness is non-invasively measured using a scalp thickness measuring clamp with an integrated small ultrasonic thickness probe. Based on the measurement results, the corresponding implant model and the corresponding implant positioning model are selected. The Bluetooth system integrated into the scalp thickness measuring clamp automatically records the scalp thickness measurement results and implant model into the surgical record. If the scalp thickness measurement result exceeds the optimal charging / data transmission interval range, the buzzer alarm integrated into the scalp thickness measurement fixture will sound an alarm to prompt the surgeon to perform the scalp thinning operation. S1. Scalp Treatment Cut open the scalp and flip up the skin flap; S2. Measure scalp thickness and verify non-invasive measurement results. The scalp thickness is measured using the scalp thickness measuring fixture of this invention. The reference range of wireless charging / data transmission efficiency indicated by the dial is used. Combined with the non-invasive scalp thickness measurement results, the corresponding implant model and the corresponding implant positioning model are selected, or the corresponding implant model and the corresponding implant positioning model are selected after thinning the scalp. If the non-invasive measurement results are incorrect, the scalp thickness measurement results and implant model are re-entered into the surgical record. The subsequent steps S3 to S8 are exactly the same as in Example 1. The BCI surgery is completed by referring to the relevant steps in Example 1.

[0083] The specialized instrument kit for flexible microelectrode brain-computer interface (BCI) surgery of this invention comprises instruments for specific stages of the surgery, with clear sequential constraints between each instrument. For example, the scalp thickness measuring clamp is used first, followed by drilling a bone window under the limiting and depth-limiting effect of a bone-grinding ring. Then, the implant positioning model is used for positioning and orientation. Next, an arachnoid hook knife is used to create an incision for the electrode wire passage. An L-shaped microwire flexible electrode manipulation tool is used to implant the flexible electrode wire. Finally, the implant is moved in and fixed, and the repair is sutured to complete the surgery. The technical necessity of this specialized instrument kit as a whole is fully demonstrated through the surgical procedure. The various specialized instruments in the kit are not randomly assembled, but rather a systematic solution for BCI surgical scenarios.

[0084] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A specialized instrument kit for flexible microelectrode brain-computer interface surgery, characterized in that, The specialized instrument kit includes: an L-shaped microwire flexible electrode manipulation tool, a bone grinding ring, an implant positioning model, and a scalp thickness measurement clamp; The L-shaped microfilament flexible electrode manipulation tool consists of a hand-held section and at least one L-shaped metal wire, used for combing, dragging, and pulling out the electrode wire; The bone grinding ring is a cylindrical annular limiting template, the inner diameter of which matches the outer diameter of the implant base, and is used to limit the operating range of the grinding drill bit. The implant positioning model is a scale model of the implant with orientation indicator marks on its surface. Before placing the implant, the implant positioning model is placed in the skull window to confirm the placement angle and embedding depth of the implant after it is placed in the skull window. The scalp thickness measuring fixture includes a clamping structure consisting of a first working arm and a second working arm, which are rotatably connected by a pivot. The first working arm includes an arc-shaped upper jaw and a first hand-held end, and the second working arm includes an ultra-thin flat lower jaw and a second hand-held end. The second hand-held end is provided with a scale, and the reading represents the distance between the arc-shaped upper jaw and the ultra-thin flat lower jaw.

2. The specialized instrument kit according to claim 1, characterized in that, The L-shaped metal wire consists of a main body and a short working arm. The main body and the short working arm are bent in an L-shape. The diameter of the L-shaped metal wire is 30~70µm, and the material is tungsten, tungsten-rhenium alloy, platinum-iridium alloy, nickel-titanium alloy, or medical stainless steel.

3. The specialized instrument kit according to claim 1, characterized in that, When there are two or more L-shaped metal wires, the L-shaped metal wires of the same specification are arranged in parallel with equal spacing, and the spacing is greater than the center distance of the electrode wires or more than twice the center distance of the electrode wires.

4. The specialized instrument kit according to claim 1, characterized in that, The handheld section is fitted with a handle, the surface of which has multiple longitudinal anti-roll surfaces and an anti-rotation latch to sense the orientation of the L-shaped metal wire tip.

5. The specialized instrument kit according to claim 1, characterized in that, The inner diameter of the bone-grinding ring can be adjusted in steps to match the outer diameter of various implant base models.

6. The specialized instrument kit according to claim 1, characterized in that, The bone-grinding ring is made of polyetheretherketone (PEEK), and the outer wall of the ring is embedded with metal markers for verifying the location of the bone window through image recognition.

7. The specialized instrument kit according to claim 1, characterized in that, The outer edge of the bone-grinding ring is provided with a V-shaped notch, which is used to align with the orientation indicator mark on the surface of the implant positioning model, providing a rotation angle reference for the implant positioning model.

8. The specialized instrument kit according to claim 1, characterized in that, The implant positioning model is equipped with a small permanent magnet, which is used to confirm the position of the implant positioning model through magnetic field signals.

9. The specialized instrument kit according to claim 1, characterized in that, The pivot of the scalp thickness measuring fixture is connected to a spring return mechanism located at the second hand end, which ensures that the arc-shaped upper jaw and the ultra-thin flat lower jaw naturally close when no external force is applied to the first and second hand ends.

10. The specialized instrument kit according to claim 1, characterized in that, The scale of the scalp thickness measuring fixture is provided with a reference range for characterizing the wireless charging / data transmission efficiency corresponding to the scalp thickness.

11. The specialized instrument kit according to claim 10, characterized in that, The reference intervals correspond directly to the implant models, and different colors are used to mark the reference intervals with color bands.

12. The specialized instrument kit according to claim 11, characterized in that, The reference range also includes a range with low wireless charging / data transmission efficiency, used to indicate the need for scalp thinning.

13. The specialized instrument kit according to claim 10, characterized in that, The scalp thickness measuring fixture is equipped with a buzzer alarm. When the scalp thickness reaches the upper limit or the dial pointer enters the reference range where the wireless charging / data transmission efficiency is low, the buzzer alarm will sound a prompt to perform a scalp thinning operation.

14. The specialized instrument kit according to claim 1, characterized in that, The scalp thickness measuring fixture integrates a small ultrasonic thickness measuring probe for non-invasive measurement of scalp thickness. The implant model that matches the scalp thickness is selected before surgery.

15. The specialized instrument kit according to claim 1, characterized in that, The specialized instrument kit includes a skull screw and a precision screwdriver that matches the head slot of the skull screw.

16. The specialized instrument kit according to claim 1, characterized in that, The specialized instrument kit includes an arachnoid hook knife, which consists of a blade body and a blade head. The blade body has a cutting edge width of ≤1mm, and the blade head has a bending angle of 30°, 45°, or 60°.

17. The specialized instrument kit according to claim 1, characterized in that, The specialized instrument kit also includes a tray with snaps or grooves for positioning the specialized instruments.

18. An L-shaped microfilament flexible electrode manipulation tool for flexible microelectrode brain-computer interface surgery, characterized in that, The L-shaped microfilament flexible electrode manipulation tool consists of a handheld section and at least one L-shaped metal wire, used for combing, dragging, and pulling out the electrode wire; the L-shaped metal wire includes a metal wire body and a short arm working end, with an L-shaped bend between the metal wire body and the short arm working end, the diameter of the L-shaped metal wire is 30~70µm, and the material is tungsten, tungsten-rhenium alloy, platinum-iridium alloy, nickel-titanium alloy or medical stainless steel.

19. The L-shaped microfilament flexible electrode manipulation tool according to claim 18, characterized in that, When there are two or more L-shaped metal wires, the L-shaped metal wires of the same specification are arranged in parallel with equal spacing, and the spacing is greater than the center distance of the electrode wires or more than twice the center distance of the electrode wires.

20. A scalp thickness measuring fixture for flexible microelectrode brain-computer interface surgery, characterized in that, The scalp thickness measuring fixture includes a clamping structure consisting of a first working arm and a second working arm, which are rotatably connected by a pivot. The first working arm includes an arc-shaped upper jaw and a first handheld end, and the second working arm includes an ultra-thin flat lower jaw and a second handheld end. The second handheld end is provided with a scale, and the reading represents the distance between the arc-shaped upper jaw and the ultra-thin flat lower jaw. The scale of the scalp thickness measuring fixture is provided with a reference range for representing the wireless charging / data transmission efficiency corresponding to the scalp thickness. The reference intervals correspond directly to the implant models, and different colors are used to mark the reference intervals with color bands.

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