Skull hole electrode fixing device

Abstract

The invention discloses a skull hole electrode fixing device, which comprises a fixing base, a first electrode, a second electrode, a third electrode and a fourth electrode, the materials of the fixing base comprise at least part of metal materials and at least part of insulating materials, and the fixing base is provided with an accommodating space penetrating along the axial direction; and the electrode lock is arranged in the accommodating space. According to the fixing base made of the metal material, under the condition that a small skull opening is guaranteed, the surgical field is improved, the implantation depth is reduced, and the surgical safety is improved.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a cranial electrode fixation device. Background Technology

[0002] An implantable neurostimulation system mainly consists of an implanted pulse generator, electrodes, and an external control device. The pulse generator is connected to the electrodes, transmitting the pulses generated by the generator to the electrodes. The pulse signals are then transmitted by the electrodes to the brain or specific nerve sites for electrical stimulation, thereby restoring the body's functions to a normal state. During the surgical implantation process, the surgeon first uses a three-dimensional positioning device to determine the target location in the patient's brain. Based on the target location, the surgeon creates a cranial foramen in the skull and inserts the electrode through the foramen into the target area. The surgeon uses a testing stimulator to test the implanted target. If the stimulation treatment effect meets expectations, a cranial electrode fixation device is used to fix the electrode to the skull.

[0003] The cranial foramen electrode fixation device, a key component of this system, is primarily used to securely fix the electrodes to the skull, preventing displacement or dislodgement. Common fixation devices typically consist of a fixation base, an electrode lock, and a cranial foramen cover. The fixation base is anchored to the skull, while the electrode lock clamps and locks the electrode position. To ensure reliable bidirectional locking, existing technologies usually incorporate a boss structure on the inner wall of the fixation base: one approach is to create an annular load-bearing boss at the lower part of the inner hole as a mechanical stop for downward movement of the electrode lock; another approach is to design a snap-fit ​​boss in the middle or upper part of the inner hole, which engages with a corresponding groove on the electrode lock to prevent the electrode lock from dislodging upwards.

[0004] However, in the existing technology, most cranial electrode fixation devices are made of polymer materials, which results in a thicker overall wall. This leads to a reduction in the effective surgical field diameter for surgical operation and observation, as well as excessively deep implantation, especially in cases where the skull is thin and the opening is small. This increases the mechanical interference of the implantation operation on the dura mater and the safety of the surgical operation. Summary of the Invention

[0005] The purpose of this invention is to provide a cranial foramen electrode fixation device for use with a fixation base made of metal material, which improves the surgical field and reduces the implantation depth while ensuring a small cranial opening and enhancing surgical safety.

[0006] The objective of this invention is achieved through the following technical solution:

[0007] A craniotomy electrode fixation device, comprising:

[0008] A fixed base, the fixed base being made of at least a portion of a metallic material and at least a portion of an insulating material, and the fixed base having an accommodating space extending axially;

[0009] An electrode lock is disposed within the accommodating space.

[0010] Preferably, the fixing base includes an inner ring and an outer ring, the outer ring covers and fixes at least a portion of the outer peripheral surface of the inner ring, the inner ring forms an accommodating space for accommodating the electrode lock, the inner ring is made of a metal material, and the outer ring is made of an insulating material.

[0011] Preferably, the inner ring of the fixed base includes an axially extending cylindrical main body and an annular support edge extending radially outward from one end of the main body, wherein the wall thickness d3 of the main body is ≤0.4mm.

[0012] Preferably, the outer ring and the inner ring are integrally formed or overlaid.

[0013] Preferably, the annular support edge has a plurality of connectors distributed circumferentially for connecting with the outer ring, and the connectors are covered inside the outer ring.

[0014] Preferably, the maximum outer diameter D1 of the outer ring of the fixed base is ≤18mm, and the outer diameter of the inner ring is 8mm≤D2≤10mm.

[0015] Preferably, when the electrode wire is inserted into the accommodating space, the minimum angle between the electrode wire and the vertical direction is 24° < α1 < 36°.

[0016] Preferably, the wall thickness of the outer ring gradually decreases from its central region to its edge region, forming an umbrella-shaped structure. The thickest part of the central region is 1.4mm ≤ h1 ≤ 2mm, and the thinnest part of the edge region is 0.5mm ≤ h2 ≤ 1mm.

[0017] Preferably, the bottom surface of the outer ring that fits against the skull is an arc-shaped profile that matches the curvature of the skull, and the radius of curvature of the arc-shaped profile is 30mm≤R≤140mm.

[0018] Preferably, the inner ring further includes at least one cantilever unit extending outward from the annular support edge, the cantilever unit being manually bent to adapt to the curvature of the skull surface.

[0019] Preferably, the cantilever unit includes a cantilever beam connected to the annular support edge and a fixing part provided at the end of the cantilever beam, wherein the fixing part is provided with mounting holes for fasteners to pass through.

[0020] Preferably, the mounting hole is a countersunk hole structure, and its cross-sectional shape is circular, racetrack-shaped, rectangular or elliptical.

[0021] Preferably, the upper and / or lower surfaces of the outer ring are provided with positioning structures adapted to the shape of the cantilever beam and the connector, for limiting the cantilever beam and the connector before or during installation;

[0022] The positioning structure includes a positioning groove and a positioning post disposed in the positioning groove, and the cantilever beam and the connecting member are provided with positioning holes that cooperate with the positioning post.

[0023] Preferably, the extension path of the cantilever beam is attached to the upper surface, lower surface, or radially inserted into the outer ring.

[0024] Preferably, the cantilever beam has an S-shaped or U-shaped curved structure.

[0025] Preferably, the bottom surface of the electrode lock is exposed relative to the fixing base.

[0026] Preferably, the main body further includes a support wall for supporting the electrode lock, wherein the thickness d2 of the support wall is ≤0.3mm.

[0027] Preferably, the support wall is disposed at the bottom of the fixed base, the support wall is used to abut against the bottom of the electrode lock and support the electrode lock, and the support wall is a metal wall made of metal material.

[0028] Preferably, the electrode lock is provided with a limiting structure, which engages with the fixed base to restrict the relative movement of the electrode lock and the fixed base.

[0029] Preferably, at least one limiting groove is provided on the side wall of the main body, the limiting groove is in communication with the accommodating space, the limiting structure is disposed on the side wall of the electrode lock, the maximum outer diameter of the limiting structure is greater than the inner diameter of the accommodating space, and the at least one limiting structure is held in the limiting groove.

[0030] Preferably, the limiting structure consists of ribs spaced circumferentially along the sidewall of the electrode lock, with a spacer between adjacent ribs, and each limiting groove accommodates at least two ribs, or each limiting groove accommodates at least one complete rib and partial structures of two ribs.

[0031] Preferably, the electrode lock and the rib are integrally formed from an elastic material, and a portion of the ribs are used to press and fit against the inner wall of the main body of the fixing base, while a portion of the ribs are held in the limiting groove.

[0032] Preferably, the center angle corresponding to the limiting groove is 30°≤α2≤60°; the center angle corresponding to the rib and the adjacent spacer is 10°≤γ≤30°.

[0033] Preferably, the central angle corresponding to the convex rib is 5°≤β≤20°, and the central angle corresponding to the interval is 2°≤∑≤4°.

[0034] Preferably, the outer wall of the electrode lock is provided with an inwardly recessed extrusion deformation groove on at least one side of the axial direction of the rib, and the extrusion deformation groove is used as the deformation space of the rib when it is extruded.

[0035] Preferably, the extrusion deformation groove is an annular groove surrounding the outer wall of the electrode lock, or a plurality of rectangular grooves, trapezoidal grooves or V-shaped grooves distributed at intervals along the axial direction.

[0036] Preferably, the rib includes a first end face and a second end face that are opposite each other. When the rib is accommodated in the limiting groove, the first end face and the second end face abut against the groove wall corresponding to the limiting groove, respectively.

[0037] Preferably, the cross-sectional shape of the rib is rectangular, trapezoidal, or arc-shaped.

[0038] Preferably, the limiting structure is a support member disposed at the upper end of the electrode lock and extending radially outward, at least a portion of the support member abutting against the fixed base and being supported by the fixed base.

[0039] Compared with the prior art, the beneficial effects of the present invention include at least the following:

[0040] By using a fixation base made of metal materials, the surgical field diameter is not only effectively increased, but the implantation depth of the fixation base is also reduced. At the same time, the mechanical interference and potential risks of the implantation operation on the dura mater are reduced, thus improving the safety of the surgery. Attached Figure Description

[0041] Figure 1 This is a schematic diagram of the existing cranial electrode fixation device and fixation base;

[0042] Figure 2 This is a schematic diagram of the cranial foramen electrode fixing device and fixing base according to an embodiment of the present invention;

[0043] Figure 3 This is a schematic diagram of the maximum outer diameter D1 of the outer ring and the distance D3 between the two fixed bases in an embodiment of the present invention.

[0044] Figure 4 This is a schematic diagram of the STN and GPI target points according to an embodiment of the present invention;

[0045] Figure 5 This is a schematic diagram illustrating the limiting angle of implantation of two wires according to an embodiment of the present invention;

[0046] Figure 6This is a table showing the test results of the radius of curvature of the fixed base fitting with the skull in an embodiment of the present invention.

[0047] Figure 7 This is a schematic diagram of the positioning structure according to an embodiment of the present invention;

[0048] Figure 8 This is a schematic diagram of the connector according to an embodiment of the present invention;

[0049] Figure 9 This is a front view of the outer ring of an embodiment of the present invention;

[0050] Figure 10 This is a schematic diagram of the outer ring reverse side of an embodiment of the present invention;

[0051] Figure 11 This is a schematic diagram of the fixed base passing through the outer ring according to an embodiment of the present invention;

[0052] Figure 12 This is a schematic diagram of the wall thickness of the outer ring in an embodiment of the present invention;

[0053] Figure 13 This is a schematic diagram of the mounting hole structure according to an embodiment of the present invention;

[0054] Figure 14 This is a schematic diagram of a cantilever beam structure according to an embodiment of the present invention;

[0055] Figure 15 This is a schematic diagram of the limiting structure, i.e., the support structure, of an embodiment of the present invention;

[0056] Figure 16 This is a cross-sectional schematic diagram of the support member according to an embodiment of the present invention;

[0057] Figure 17 This is a three-dimensional structural diagram of the support member according to an embodiment of the present invention;

[0058] Figure 18 This is a cross-sectional schematic diagram of the electrode lock according to an embodiment of the present invention;

[0059] Figure 19 This is a schematic diagram of the cooperation structure between the electrode lock with support and the inner ring according to an embodiment of the present invention;

[0060] Figure 20 This is a schematic diagram of the protruding rib and the limiting groove in an embodiment of the present invention;

[0061] Figure 21 This is a cross-sectional schematic diagram of the protruding rib and the limiting groove according to an embodiment of the present invention;

[0062] Figure 22 This is a three-dimensional schematic diagram of an electrode lock with raised ribs according to an embodiment of the present invention;

[0063] Figure 23This is a front view of an electrode lock with raised ribs according to an embodiment of the present invention;

[0064] Figure 24 This is a schematic diagram of the arrangement of the protruding ribs and the spacers in an embodiment of the present invention;

[0065] Figure 25 This is a schematic diagram of the arrangement of the limiting groove according to an embodiment of the present invention;

[0066] Figure 26 This is a schematic diagram of a positioning groove without a positioning post and a connector without a positioning hole, and a cantilever beam, according to an embodiment of the present invention.

[0067] In the diagram: 1. Skull cover; 2. Electrode lock; 201. Annular groove; 3. Fixing base; 301. Protrusion; 302. Supporting boss; 100. Cover body; 200. Fixing base; 21. Body; 211. Side wall; 212. Supporting wall; 22. Accommodating space; 23. Inner ring; 24. Outer ring; 241. Edge area; 242. Central area; 25. Annular support edge; 26. Connector; 261. Positioning hole; 27. Cantilever unit; 271. Cantilever beam; 272. Fixing part; 2721. Mounting hole; 2722. Fastener 28. Positioning structure; 281. Positioning groove; 281. Positioning post; 29. ​​Limiting groove; 210. Main body; 300. Electrode lock; 31. Support member; 311. Restriction structure; 3111. First positioning section; 3112. Second positioning section; 312. Transition structure; 3121. Horizontal transition section; 313. Support structure; 3131. Support section; 32. Flexible silicone buffer layer; 33. Rib; 331. First end face; 332. Second end face; 34. Gripping part; 35. Channel; 36. Spacing part; 37. Extrusion deformation groove. Detailed Implementation

[0068] Exemplary embodiments will now be described more fully with reference to the accompanying drawings. However, these exemplary embodiments can be implemented in many forms and should not be construed as limited to the embodiments set forth herein; rather, they are provided to make the invention more comprehensive and complete, and to fully convey the concept of the exemplary embodiments to those skilled in the art. The same reference numerals in the drawings denote the same or similar structures, and therefore repeated descriptions of them will be omitted.

[0069] The terms used to express position and direction in this invention are illustrated with the accompanying drawings, but changes can be made as needed, and all such changes are included within the scope of protection of this invention.

[0070] like Figure 1As shown, a traditional craniotomy electrode fixation device includes a fixation base 3, an electrode lock 2, and a skull cap 1. The fixation base 3 is mostly made of polymer materials, resulting in a thick wall and large volume. To prevent the electrode lock 2 from being pressed too deeply, the support protrusion 302 on the fixation base 3 must ensure sufficient structural strength to block the electrode lock 3. Since the support protrusion 302 is made of polymer material, it is often made thick to ensure strength. This also results in a deep insertion depth h of the fixation base 3 into the skull, compressing the dura mater and posing a potential risk of mechanical stimulation inducing epileptic foci. In addition, to ensure the installation stability of the electrode lock 3, an annular groove 201 is usually provided on the electrode lock 3. The annular groove 201 engages with the protrusion 301 provided on the inner wall of the fixation base 3 to improve the stability of the electrode lock 3. However, this encroaches on the internal space of the fixation base 3 and reduces the surgical field.

[0071] To solve the above problems, such as Figure 2 As shown, this invention provides a cranial foramen electrode fixation device, which achieves miniaturization of the overall structure and low invasive depth by at least partially employing high-strength metal materials. The device mainly includes a fixation base 200 and an electrode lock 300. The fixation base 200 is a hollow tubular body 21 that extends at least partially into a pre-drilled cranial foramen during implantation. To accommodate the anatomical structure of children or patients with thin skulls and to significantly reduce the risk of compression of the dura mater, this embodiment strictly controls the height H of the body 21 extending into the skull, strictly limiting it to the range of 2.5mm < H < 4.5mm. Compared to the traditional fixation base 200 made of polymer materials, which typically has an invasive depth exceeding 5mm, this embodiment can effectively reduce the implantation depth by more than 1mm, thereby significantly reducing the potential risk of mechanical stimulation of the dura mater and inducing epileptic foci.

[0072] To achieve structural reliability at the aforementioned shallow implantation depth, the body 21 is preferably made of a high-strength, highly biocompatible metallic material, such as medical-grade pure titanium, Ti6Al4V, or Ti6Al7Nb titanium alloys. The high elastic modulus of the metallic material (approximately 110 GPa) ensures that sufficient support stiffness and fatigue resistance can be maintained even with extremely thin walls.

[0073] Specifically, the body 21 includes a sidewall 211 that encloses an accommodating space 22. The sidewall 211 is a thin-walled cylindrical structure made of metal material, and its thickness d1 is significantly reduced. Preferably, d1 ≤ 0.4 mm, and more preferably 0.2 mm ≤ d1 ≤ 0.35 mm. However, the above-mentioned wall thickness setting effectively reduces the overall size of the device and expands the internal operating space of the accommodating space 22 (i.e., the surgical field). Correspondingly, the size of the opening on the skull can also be reduced to avoid excessive trauma.

[0074] At the bottom of the accommodating space 22, the main body 21 also includes a support wall 212 for supporting the electrode lock 300. This support wall 212 is also made of metal, but its thickness d2 is thinner, further reducing the space occupied at the bottom. d2 is preferably ≤0.3mm, and more preferably 0.15mm≤d2≤0.25mm. The support wall 212 can be an annular plate integrally formed with the side wall 211. The connection between the support wall 212 and the side wall 211 is rounded to avoid contact with and damage to the dura mater inside the skull. Furthermore, multiple support walls 212 can be distributed circumferentially, for example, three, as long as they can effectively support the electrode lock 300.

[0075] After the electrode is implanted and the electrode lead is locked by the electrode lock, the electrode lock 300 is installed in the receiving space 22. The electrode lock 300 is typically made of medical-grade silicone with good elasticity and biocompatibility. It has a channel 35 for clamping and fixing the electrode lead, and a gripping part 34 (i.e., a circular groove) for grasping the electrode lock 300 and inserting it into the fixation base 200 during the operation. The bottom of the electrode lock 300 abuts against the upper surface of the support wall 212, thereby providing axial support from the support wall 212 and preventing it from being excessively pressed down and contacting the dura mater during implantation.

[0076] By using high-strength metal materials and significantly reducing the wall thicknesses d1 and d2, the overall intracranial insertion depth of the device is significantly reduced while ensuring structural strength and stability. The intracranial insertion depth can be reduced by more than 0.7 mm, which effectively solves the problem of excessive intracranial insertion caused by the need to ensure the wall thickness of the traditional plastic fixation base 200. It is especially suitable for children with thinner skulls.

[0077] In some embodiments, such as Figure 2 and 16 As shown, the fixing base 200 is composed of an inner ring 23 and an outer ring 24. The inner ring 23 is made of a high-strength metal material (such as medical titanium alloy) and includes an axially extending cylindrical main body 210, which forms an accommodating space 22 for housing the electrode lock 300. The wall thickness d3 of the main body 210 is also strictly controlled, d3≤0.4mm, preferably 0.25mm≤d3≤0.35mm. The thinner wall thickness of the metal inner ring 23 provides the necessary structural strength while maximizing the inner diameter. With the same outer diameter, compared to the conventional 1.5mm thick plastic structure, the inner diameter of this device is increased by more than 2.2mm. This means that, while maintaining the same surgical field of view requirements as before, the surgeon can reduce the skull opening diameter by more than 2.2mm (e.g., from the traditional 14mm to 11.8mm or less), greatly reducing surgical trauma and the risk of infection.

[0078] like Figure 2As shown, an annular support edge 25 extends radially outward from the upper end of the main body 210 (i.e., the end furthest from the skull). A plurality of connectors 26 are distributed circumferentially along this annular support edge 25. These connectors 26 can be protrusions, recesses, through holes, or irregularly shaped structures, used to enhance the bonding force with the polymer outer ring 24 and prevent them from detaching. The annular support edge 25 is embedded within the outer ring 24.

[0079] like Figure 2 As shown, the outer ring 24 serves as a cranial interface component, covering and fixing at least a portion of the outer peripheral surface of the inner ring 23, particularly the annular support edge 25 and the connector 26 area. The outer ring 24 is made of an insulating polymer material with excellent biocompatibility and an elastic modulus matching that of human bone, such as polyetheretherketone (PEEK), polysulfone (PSU), or medical-grade polycarbonate (PC). Through overmolding injection molding or secondary injection molding processes, the polymer material flows in a molten state and encapsulates the predetermined bonding area of ​​the inner ring 23. After cooling, a strong mechanical interlock and chemical bond are formed, making the inner ring 23 and the outer ring 24 integrally integrated.

[0080] As a preferred embodiment, such as Figure 12 As shown, the wall thickness of the outer ring 24 gradually decreases from its central region 242 (corresponding to the position of the inner ring 23) towards the edge region 241, forming a smoothly transitioning "umbrella-shaped" or "disc-shaped" profile. The central region 242 is the main load-bearing and connection area, with its thickest point being 1.4mm ≤ h1 ≤ 2mm, to ensure overall rigidity and provide a reliable base for the connection structure (e.g., threads or snaps) of the skull cap 1. The thinnest point of the edge region 241 is 0.5mm ≤ h2 ≤ 1mm, preferably 0.6mm. This thin-walled edge improves the flexibility of the outer ring 24, allowing it to conform to the large curvature surface of the child's skull, achieving a highly fitted interface, reducing subcutaneous protrusions, and improving aesthetics and comfort.

[0081] In addition, such as Figure 3As shown, some surgeries require the simultaneous implantation of more than or equal to three electrode leads. For example, when implanting STN and GPI targets in PD surgery, four electrode leads need to be implanted. Currently, there is a method of using a craniotomy lock to lock two electrodes. However, because the locking range of the electrode lock 300 is limited, it restricts the implantation angle of the two electrodes, making implantation path planning difficult, taking a long time, affecting the progress of the surgery, reducing locking accuracy, and the cross-extrusion of the two leads increases the risk of insulation layer damage. If a one-lock-one-lock method is used, the existing craniotomy locks are relatively large. If the number of openings in the skull increases, for example, ≥3, it will weaken the mechanical strength of the skull, increase the risk of depressed fractures after surgery, and increase trauma to the patient. Therefore, to meet the needs of miniaturized surgery, the maximum outer diameter D1 of the outer ring 24 of the fixation base 200 is ≤18mm, preferably 14mm≤D1≤16mm, and the outer diameter of the inner ring 23 (i.e., the outer diameter of the main body 210) is designed to be 8mm≤D2≤10mm, so as to correspondingly reduce the size of the skull opening (i.e., 8-10mm). This allows the minimum center distance D3 between adjacent fixation bases to be significantly shortened when multiple electrodes are implanted, for example, ≤18mm. In comparison, the traditional 24mm outer diameter device greatly reduces the size of the skull opening, reducing damage to the patient's skull and the resulting trauma. The shortest distance from the center of the operating hole of the fixation base to the outer edge of the base is 7. <d4< 12。

[0082] Among them, such as Figure 4 and 5 As shown, when the skull opening diameter is optimized to 8-10 mm, the area of ​​a single opening is 50-80 mm². 2 This is only 33%-52% of the area of ​​a traditional 14mm cranial opening. Furthermore, when multiple openings are required in the skull, the center distance between adjacent openings in this embodiment can be shortened by up to 25%, significantly reducing spatial interference with the electrode lead path during parallel multi-hole implantation and effectively expanding the range of possible implantation angles. For example, taking the implantation of GPI and STN nuclei as an example, in the case of two cranial foramen rings being tangent, a traditional 24mm diameter fixation device restricts the implantation angle of two leads to 18 degrees, while this miniaturized cranial foramen electrode fixation device restricts the implantation angle of two leads to only 10 degrees. Therefore, during electrode lead implantation, the selectable range of the minimum angle between the electrode lead and the vertical direction is 24° < α1 < 36°, or the selectable range of the minimum angle between the electrode lead and the skull is 54° < α1 < 66°, greatly improving the feasibility and operational tolerance of dual-target surgery. Here, the horizontal plane is used as the reference plane, and the vertical direction is perpendicular to this reference plane.

[0083] When implanting multiple electrode leads, more surgical paths can be created within a similar total opening area. For example, the total area of ​​four small holes is equivalent to only two traditional holes. As mentioned above, when the opening diameter is reduced from 14 mm to 10 mm, the opening area is reduced by approximately 49%, significantly reducing disruption to the mechanical integrity of the skull and shortening healing time. In multi-target implantation, surgeons can arrange multiple implantation points within a smaller total bone window area, improving the flexibility and precision of surgical path planning.

[0084] In addition, such as Figure 6 The table shows the statistical parameters for the curvature design of the cranial fitting portion. The fitting of the lower surface of the outer ring to the surface of the skull was tested. Specifically, the bottom surface of the outer ring 24, which fits against the skull, is an arc-shaped contour adapted to the skull curvature. Based on the analysis of the curvature radii of the frontal and parietal bones in children and adults, the curvature radius of this arc-shaped contour is set within a wide range of 30mm ≤ R ≤ 140mm. Preferably, the statistical median or mean is used, and R is set to approximately 70mm. This curvature radius value ensures good fitting of the central region 242 on skulls with larger curvature radii (e.g., R 130mm), and effectively controls edge gaps when the curvature is smaller (e.g., R 45mm, or the skull is relatively flat), thereby improving the adaptability and fitting stability of the device under different skull curvatures.

[0085] In some embodiments, such as Figure 7 and 8 As shown, a deformable cantilever unit 27 for fixing the device to the skull is further added, enabling intraoperative adaptive adjustment and long-term growth adaptation. Specifically, at least one deformable cantilever unit 27 is provided, extending outward from the annular support edge 25 of the inner ring 23. Each cantilever unit 27 mainly includes a cantilever beam 271 and a fixing part 272, with one end of the cantilever beam 271 connected to the annular support edge 25 and the other end extending in a direction away from the center. In addition, the cantilever beam 271 itself has a flexible characteristic.

[0086] like Figure 8 and 21 As shown, the fixing part 272 is located at the end of the cantilever beam 271, and has a mounting hole 2721 for inserting fasteners 2722 such as bone screws to anchor the device to the skull. The number of cantilever units 27 is 2-4, evenly distributed to provide symmetrical and stable fixing force. In this embodiment, two units are preferred, symmetrically arranged on the inner ring 23 of the fixing base 200. The material used for the cantilever units 27 is the same as that used for the inner ring 23 of the fixing base 200, which is titanium alloy. This avoids cracking problems caused by long-term stress in the screw holes (i.e., mounting holes 2721), ensuring the reliability of the screw connection. The fasteners 2722 are bone screws, which can also be made of titanium alloy.

[0087] like Figure 9 and 10 As shown, the upper and / or lower surfaces of the outer ring 24 are provided with positioning structures 28 adapted to the shape of the cantilever beam 271. The positioning structure 28 may include a recessed positioning groove 281 and a positioning post 281 disposed within the positioning groove 281. Correspondingly, the cantilever beam 271 and the connecting member 26 are provided with positioning holes 261 that mate with the positioning posts 281. Before overmolding or during installation, the inner ring 23 can be precisely pre-positioned in the mold or body of the outer ring 24 through the engagement of the positioning holes 261 and the positioning posts 281, ensuring the accuracy of the composite position and facilitating intraoperative identification and operation. For example, Figure 26 As shown, the positioning structure 28 can also include only the recessed positioning groove 281 without the positioning post 281. The cantilever beam 271 and the connector 26 can be installed and adapted into the corresponding positioning groove 281. The principle and effect are the same as those with the positioning post 281, and will not be described again here.

[0088] like Figure 8 and 21 As shown, the mounting hole 2721 is a countersunk hole structure, allowing the screw head to sink into the groove after tightening, remaining flush with the outer surface of the device. This avoids the formation of a subcutaneous step, reduces mechanical irritation and potential damage to subcutaneous tissue, and improves the long-term safety and comfort of the implant. The cross-sectional shape of the mounting hole 2721 can be circular, but to provide adaptive displacement capability, a racetrack shape (e.g., oblong) is preferred; it can also be rectangular or elliptical. For example... Figure 13 As shown, when the mounting hole 2721 has a racetrack-shaped profile, the titanium alloy screw can be adaptively displaced along the racetrack direction during the development of the child's skull, avoiding squeezing out and fixation failure. At the same time, it releases the tensile stress on the skull, avoids stress concentration, and reduces the adverse effects on the normal growth of the skull.

[0089] Among them, such as Figure 7 and 8 As shown, the cantilever beam 271 adopts an integrated design. During the operation, the doctor can pre-bend and adjust the cantilever beam 271 according to the actual local curvature of the patient's skull using special tools or manually. This allows the fixation part 272 and its mounting holes 2721 to adapt to the unevenness of the skull surface, realizing the transformation from rigid instrument fixation to instrument adaptive fit, ensuring immediate stable matching between the implant and the skull, and allowing the bone screw to be in a better force angle.

[0090] Furthermore, such as Figure 14As shown, the cantilever beam 271 itself can be an elastic arm structure with a specific geometry, such as a continuous S-shaped or U-shaped bend. This structure guides the force flow and extends the deformation path through continuous curvature changes, promoting a uniform distribution of stress across the overall contour and avoiding stress concentration, thereby significantly improving fatigue resistance. More importantly, when the device is implanted into the developing skull of a child, the growth of the skull will generate a continuous, slow traction force on the external fixation point. The S-shaped or U-shaped elastic arm structure provides directional compliance through its geometry, enabling elastic deformation during skull development and expansion, passively adapting to the increase in skull volume. Simultaneously, in conjunction with the racetrack-shaped mounting hole 2721, the bone screw (i.e., fastener 2722) can undergo slight adaptive displacement along the long axis within the hole. The combined effect of these two factors effectively releases the continuous traction stress generated by skull growth, avoiding fixation loosening, screw dislodgement, or adverse effects on normal skull growth caused by stress accumulation. The shape of the cantilever beam 271 is not limited to the shape described above and is not restricted here.

[0091] In some embodiments, such as Figure 7 , 8 As shown in Figure 11, the extension path of the cantilever beam 271 can be fitted to the upper or lower surface of the outer ring 24, or a portion thereof can be radially inserted into the thickness of the outer ring 24. During the tightening of the fastener 2722, the downward force generated by the cantilever beam 271 is transmitted to the outer ring 24, thereby applying a downward pressure to it. This pressure causes the outer ring 24 to undergo elastic deformation, making it fit more tightly to the skull surface, improving interface adaptability and fixation stability. The specific design can be based on the actual overall strength, concealment and molding process requirements.

[0092] In some embodiments, such as Figure 15 As shown, the electrode lock 300 is made of silicone and metal composite material. Specifically, the silicone body of the electrode lock 300 is embedded or covered with a metal skeleton (i.e., the limiting structure below), and the upper end of the metal skeleton is provided with a horizontally outward extending flange edge (i.e., a radially outward extending support member 31).

[0093] The upper end of the fixation base 200 has a flat upper surface. After electrode implantation, the electrode lock 300 is placed into the receiving space 22 of the fixation base 200. At this time, the silicone part at the bottom of the electrode lock 300 may slightly contact the bottom of the fixation base 200 or be suspended in the air. However, the lower surface of the flange edge of its metal skeleton will contact and be supported by the upper surface of the fixation base 200. Subsequently, the skull cover 1 (i.e., cover 100) is installed. The skull cover 1 and the fixation base 200 are locked together by screwing, snap-fitting, or other means. When the skull cover 1 is locked in place, its lower surface will press against the upper surface of the flange edge of the metal skeleton. In this way, the electrode lock 300 is reliably confined axially between the upper surface of the fixation base 200 and the lower surface of the skull cover 1.

[0094] The limiting position is achieved by the flange edge engaging with the plane of the upper surface of the fixing base 200. Since the limiting point has been moved from the bottom to the top, the lower support boss (i.e., support wall 212) is completely eliminated. Therefore, the bottom of the body 21 of the fixing base 200 can be made into an open or extremely thin structure, which further reduces the overall cranial insertion depth H. For example, it can be reduced by more than 1 mm compared to the traditional lower support method. At the same time, the limiting position is achieved by the skull cap 1 pressing the flange edge to prevent the electrode lock 300 from moving upward.

[0095] In this embodiment, the limiting mechanism is positioned entirely above the cranial foramen, without occupying intracranial space, making it an effective means of achieving shallow implantation depth. Simultaneously, the metal flange provides a rigid load-bearing surface, ensuring stable and reliable operation.

[0096] In some embodiments, such as Figure 20 As shown, the present invention also provides an electrode lock fixing device to achieve a stable engagement between the electrode lock 300 and the fixing base 200, prevent the electrode lock 300 from undergoing unexpected relative movement in the axial direction (i.e., along the implantation depth direction) (upward dislodgement or excessive downward compression), and at the same time maintain the unobstructed surgical channel 35 to the maximum extent. It is particularly suitable for minimally invasive neurosurgical procedures with extremely high requirements for operating space, such as deep brain stimulation (DBS) surgery in children.

[0097] like Figure 20 , 21As shown in Figures 22, 23, 24, and 25, to achieve the axial positioning of the electrode lock 300, a limiting groove 29 is provided on the side wall 211 (i.e., the inner wall of the accommodating space 22) of the main body 210 of the inner ring 23 of the fixed base 200. This limiting groove 29 is preferably an annular groove extending circumferentially along the side wall 211. Crucially, the limiting groove 29 is formed by recessing into the side wall 211, with its groove opening plane contacting or being internally tangent to the inner wall surface of the accommodating space 22, without any structure protruding inwards from the original, smooth inner wall surface contour. In other words, the presence of the limiting groove 29 does not encroach on the effective diameter of the accommodating space 22, and the cross-sectional shape of the limiting groove 29 can be rectangular, trapezoidal, or arc-shaped. Furthermore, the central angle corresponding to the circumferential extension of the limiting groove 29 is set between 30° ≤ α2 ≤ 60°. Preferably, α2 is set to 45°. This angle range ensures sufficient space to accommodate the subsequent protruding rib 33 structure and provides the necessary fit tolerance. The number of limiting grooves 29 is set according to actual needs and is not limited here.

[0098] like Figure 21 As shown, a limiting structure is provided on the outer surface of the sidewall 211 of the electrode lock 300. This limiting structure consists of multiple ribs 33 spaced circumferentially along the sidewall 211 of the electrode lock 300. Each rib 33 is an independent, radially outward protruding unit. All ribs 33 together form an intermittent annular rib array. A gap 36 is formed between two adjacent ribs 33. The cross-sectional shape of the ribs 33 can be rectangular, trapezoidal, or arc-shaped to optimize stress distribution and assembly feel. The ribs 33 are made of elastic material and are integrally formed with the electrode lock 200. Some of the ribs 33 are pressed and fitted against the inner wall of the fixing base 200 body, and some of the ribs 33 are held in the limiting groove 29 to prevent axial movement of the electrode lock.

[0099] like Figure 24 and 25 As shown, in order to achieve a precise fit with the limiting groove 29 of the fixed base 200, the rib 33 and the spacer 36 are arranged as follows:

[0100] The central angle corresponding to a single rib 33 extending circumferentially is 5°≤β≤20°, preferably 18°. The central angle corresponding to the spacer 36 between two adjacent ribs 33 is 2°≤∑≤4°, for example, about 2°. Therefore, the total central angle corresponding to a rib 33 unit (i.e., a rib 33 plus a spacer 36 immediately following it) is 10°≤γ≤30°, preferably 20° (i.e., β +∑).

[0101] Because the central angle α2 of the limiting groove 29 (e.g., 45°) is much larger than the central angle β of a single rib 33 (e.g., 18°), but less than or equal to the total angle of several rib 33 units. More importantly, through the above-mentioned angle setting distribution, it is ensured that when the electrode lock 300 is placed into the receiving space 22 and rotated about its axis to any angle, in the circumferential direction, there are always at least two complete ribs 33 that can completely fall within the range of the limiting groove 29.

[0102] More specifically, since the ribs 33 are discontinuously distributed, at any rotation angle, the 45° arc area covered by the limiting groove 29 will necessarily contain at least two complete ribs 33, or contain at least one complete rib 33 plus the partial structure of the two ribs 33 before and after it. Both of these mating modes can form an effective mechanical interlock.

[0103] Further, the doctor presses the electrode lock 300 axially into the receiving space 22 of the fixed base 200. Since the maximum outer diameter of the protruding rib 33 (i.e., the limiting structure) is slightly larger than the inner diameter of the receiving space 22, the protruding rib 33 will be compressed and undergo elastic deformation. When the electrode lock 300 is in place (its bottom may be supported by the bottom of the base or be suspended, depending on whether a support wall 212 is designed), the doctor rotates the electrode lock 300. When rotated to a certain angle, so that at least one or two protruding ribs 33 are aligned and locked into the limiting groove 29, the protruding rib 33 springs into the groove by its elastic restoring force. At this time, the radial protrusion of the protruding rib 33 is limited.

[0104] The bottom of the groove 29 accommodates the electrode lock, while the two opposite sides of the rib 33 in the axial direction (i.e., the first end face 331 and the second end face 332) abut against the two groove walls of the limiting groove 29 in the axial direction. This effectively prevents the electrode lock 300 from moving axially relative to the fixed base 200. When the electrode lock 300 is pulled out upward, the first end face 331 of the rib 33 abuts against the groove wall; when it is pressed down, the second end face 332 of the rib 33 abuts against the groove wall (for example, if there is no other support below), or is limited by the bottom structure of the base.

[0105] Thanks to the intermittent array of multi-ribbed 33 and the wide-angle limiting groove 29, this fit does not have specific requirements for the assembly angle. Surgeons do not need to painstakingly find a specific locking point during surgery; they only need to insert the electrode lock 300 and rotate it to achieve reliable locking at any angle within a 360° range. This greatly simplifies the surgical procedure, shortens the operation time, and reduces the operational risks caused by alignment difficulties. It is particularly suitable for achieving rapid and reliable blind operation in minimally invasive surgeries with limited visibility.

[0106] Furthermore, since all limiting structures (i.e., ribs 33 and limiting grooves 29) are hidden within or beneath the contour of the sidewall 211, the inner wall of the accommodating space 22 of the fixing base 200 always remains a smooth cylindrical surface with a constant diameter in the axial direction, without any inwardly protruding bosses, locking teeth, or other obstacles. This provides an unobstructed, maximized channel 35 for the entry, exit, and operation of surgical instruments (such as electrode implantation guides, test stimulation probes, etc.), significantly expanding the surgeon's intraoperative field of vision and the freedom of instrument operation. However, compared to the annular groove machined on the electrode lock 300, the rib 33 is a protruding structure that increases the amount of material and the moment of inertia of the cross section of the outer wall of the electrode lock 300 in critical areas, thereby improving the overall structural stiffness and deformation resistance of the electrode lock 300. This allows it to better resist the effects of cerebrospinal fluid pressure fluctuations or minor external impacts after the electrode is locked, maintaining stable clamping force.

[0107] Furthermore, such as Figure 23 As shown, in order to improve the assembly feel and ensure that the rib 33 can generate sufficient elastic restoring force to achieve tight engagement, an inwardly formed extrusion deformation groove 37 is provided on the outer wall of the electrode lock 300 on at least one side of the axial direction of the rib 33 (usually on the upper and lower sides, or in the middle area of ​​the rib 33 array).

[0108] The aforementioned extrusion deformation groove 37 is a localized thin-walled area. When the protruding rib 33 is pressed through the inner wall of the accommodating space 22 (excluding the groove), this area provides additional deformation space for the root of the protruding rib 33 and the surrounding material when they are compressed, thereby significantly reducing the required assembly pressing force and making the operation easier. At the same time, it acts like a spring, ensuring that the protruding rib 33 stores sufficient elastic potential energy after being compressed. Once rotated to the position of the limiting groove 29, it can quickly and forcefully spring into the groove, generating greater contact pressure and friction, enhancing the stability and feel of the locking (or producing a clear click).

[0109] The extrusion deformation groove 37 can be a continuous annular groove surrounding the outer wall of the electrode lock 300. It can also be discontinuous, for example, an independent rectangular groove, trapezoidal groove, or V-shaped groove provided along the axial direction at the position corresponding to each rib 33 or each group of ribs 33. Among these, the V-shaped groove is beneficial for stress dispersion.

[0110] like Figure 16 As shown, this embodiment eliminates the annular load-bearing boss (i.e., support boss) located at the bottom of the fixed base 200 in the conventional method, and completely moves the axial limiting function of the electrode lock 300 to the top area of ​​the fixed base 200, thereby achieving an extremely shallow implantation depth.

[0111] Specifically, the device also includes a fixed base 200 and an electrode lock 300. The fixed base 200 has a body 21 and a receiving space 22. Its bottom can be open or have only a very thin non-load-bearing structure.

[0112] The electrode lock 300 of this embodiment adopts a composite structure, particularly a silicone and metal composite structure. Specifically, the electrode lock 300 mainly includes a main body 210 made of an elastic material (such as medical silicone) and a metal frame (i.e., a limiting structure) embedded in or covering the upper end of the main body 210. The metal frame is preferably made of medical titanium or titanium alloy.

[0113] like Figure 17 As shown, the upper end of the aforementioned metal frame is provided with a support member 31 extending radially outward. This support member 3143 serves as another limiting structure in this embodiment. The support member 31 can be a continuous annular flange or multiple independent support arms distributed circumferentially. The specific structure of the support member 31 may include a limiting structure 311, a transition structure 312, and a support structure 313 arranged sequentially from the inside out. The limiting structure 311 has a first positioning segment 3111 near the center of the electrode lock 300 and a second positioning segment 3112 inclined to the outer wall surface of the electrode lock 300, used to combine with the main body of the electrode lock 300 or provide initial positioning. The transition structure 312 is generally a roughly horizontally extending transition segment, connecting the limiting structure 311 (i.e., the first positioning segment 3111) and the support structure 313 (i.e., the second positioning segment 3112). The support structure 313 is the main load-bearing part, which is a basically horizontal, radially outward extending support segment 3131 or support surface, connected to the first positioning segment 3111. The upper end of the fixed base 200 has a flat upper surface or an upper surface with a positioning structure 28.

[0114] like Figure 18 As shown, the interior of the electrode lock 300 is a molded cavity that mates with the support member 31. The cavity is similar to an S-shaped structure rotated 90° counterclockwise. Injection-molded limiting posts are provided at the first positioning section 3111 and the second positioning section 3112 of the cavity. Each limiting structure 311 is provided with a limiting hole that mates with it, which improves the firmness between the support member 31 and the electrode lock 300.

[0115] In this embodiment, the electrode lock 300 is placed axially into the receiving space 22 of the fixed base 200. The bottom of the silicone body 210 of the electrode lock 300 may or may not make slight contact with the bottom of the base. Crucially, the support member 31 of the metal frame of the electrode lock 300 (specifically, the lower surface of its support structure 313) rests on the upper surface of the fixed base 200. This contact interface directly and effectively prevents the electrode lock 300 from moving further downwards, replacing the function of a traditional bottom support boss. Subsequently, a cover 100 (such as a skull cover 1) is installed. The cover 100 is detachably connected to the upper end of the fixed base 200 by means of threaded engagement, snap-fit, or other methods. When the cover 100 is tightened or snapped into place, its lower surface presses tightly against the upper surface of the support member 31 of the metal frame. Thus, the electrode lock 300 is firmly clamped axially between the upper surface of the fixed base 200 and the lower surface of the cover 100.

[0116] By completely eliminating the mechanical stop (i.e., support boss) at the bottom of the accommodating space 22, the body 21 of the fixation base 200 can be designed to be shorter, significantly reducing its depth H extending into the cranium. Compared to traditional under-supported structures, the overall depth into the cranium can be reduced by 1 mm or more, which is crucial for pediatric patients with limited skull thickness, significantly reducing the risk of compression and mechanical irritation of the dura mater.

[0117] Since the inner wall of the accommodating space 22 of the fixed base 200 can remain completely smooth and of uniform diameter from the entrance to the bottom without any obstructions, the surgical channel 35 is also maximized.

[0118] In this embodiment, the accommodating space 22 completely penetrates the fixation base 200 in the vertical direction, meaning the bottom of the fixation base 200 is open. Simultaneously, the bottom surface of the electrode lock 300 is exposed and visible relative to the fixation base 200; or, in other words, the bottom of the electrode lock 300 is substantially flush with or slightly recessed from the bottom of the fixation base 200. This open-bottom structure further reduces the depth of the implant within the skull and facilitates intraoperative observation and manipulation.

[0119] In some embodiments, such as Figure 19 As shown, at the bottom of the inner ring 23, a layer of medical silicone or hydrogel, namely the flexible silicone buffer layer 32, is applied by coating, pasting or secondary molding. This buffer layer protrudes slightly from the metal bottom surface in the axial direction to ensure that, in the final implantation state, it is the soft polymer rather than the hard metal that directly contacts the dura mater or arachnoid mater, providing the final physical isolation and buffer, and further eliminating any possible sources of mechanical stimulation.

[0120] In some embodiments, in a device, a combination of ribs 33 and grooves can be used simultaneously for initial, rotatably adjustable locking, supplemented by an upper support 31, which is finally pressed by the skull cap 1 to provide dual limiting.

[0121] In some embodiments, the support 31 (i.e., the metal frame) may also provide circumferential anti-rotation function by engaging with a specific slot or non-circular hole on the upper surface of the fixing base 200, ensuring the angular orientation of the electrode lock 300 and its internal electrodes.

[0122] Although embodiments of the present invention have been shown and described above, it is understood that the above embodiments are exemplary and should not be construed as limiting the present invention. Those skilled in the art can make changes, modifications, substitutions and variations to the above embodiments within the scope of the invention without departing from the principles and spirit of the invention, and all such changes should fall within the protection scope of the claims of the present invention.

Claims

1. A craniotomy electrode fixation device, characterized in that, include: A fixed base, the fixed base being made of at least a portion of metal material and at least a portion of insulating material, and the fixed base having an accommodating space extending through the axial direction; An electrode lock is disposed within the accommodating space.

2. The cranial foramen electrode fixation device according to claim 1, characterized in that, The fixing base includes an inner ring and an outer ring. The outer ring covers and fixes at least a portion of the outer circumferential surface of the inner ring. The inner ring forms an accommodating space for accommodating the electrode lock. The inner ring is made of a metal material, and the outer ring is made of an insulating material.

3. The craniotomy electrode fixation device according to claim 2, characterized in that, The inner ring of the fixed base includes an axially extending cylindrical main body and an annular support edge extending radially outward from one end of the main body, wherein the wall thickness d3 of the main body is ≤0.4mm.

4. The craniotomy electrode fixation device according to claim 3, characterized in that, The outer ring is integrally formed with the inner ring or is overlaid with it.

5. The craniotomy electrode fixation device according to claim 4, characterized in that, The annular support edge has a plurality of connectors distributed circumferentially for connecting with the outer ring, and the connectors are covered inside the outer ring.

6. The craniotomy electrode fixation device according to claim 2, characterized in that, The maximum outer diameter of the outer ring of the fixed base is D1≤18mm, and the outer diameter of the inner ring is 8mm≤D2≤10mm.

7. The craniotomy electrode fixation device according to claim 1, characterized in that, When the electrode wire is inserted into the accommodating space, the minimum angle between the electrode wire and the vertical direction is 24° < α1 < 36°.

8. The craniotomy electrode fixation device according to claim 2, characterized in that, The wall thickness of the outer ring gradually decreases from its central region to its edge region, forming an umbrella-shaped structure. The thickest part of the central region is 1.4mm ≤ h1 ≤ 2mm, and the thinnest part of the edge region is 0.5mm ≤ h2 ≤ 1mm.

9. The craniotomy electrode fixation device according to claim 2, characterized in that, The bottom surface of the outer ring that fits against the skull is an arc-shaped contour that matches the curvature of the skull, and the radius of curvature of the arc-shaped contour is 30mm≤R≤140mm.

10. The craniotomy electrode fixation device according to claim 3, characterized in that, The inner ring also includes at least one cantilever unit extending outward from the annular support edge, the cantilever unit being manually bent to adapt to the curvature of the skull surface.

11. The craniotomy electrode fixation device according to claim 10, characterized in that, The cantilever unit includes a cantilever beam connected to the annular support edge and a fixing part located at the end of the cantilever beam. The fixing part has mounting holes for fasteners to pass through.

12. The craniotomy electrode fixation device according to claim 11, characterized in that, The mounting hole is a countersunk hole structure, and its cross-sectional shape is circular, racetrack-shaped, rectangular or elliptical.

13. The craniotomy electrode fixation device according to claim 11, characterized in that, The upper and / or lower surfaces of the outer ring are provided with positioning structures adapted to the shape of the cantilever beam and connector, which are used to limit the cantilever beam and connector before or during installation. The positioning structure includes a positioning groove and a positioning post disposed in the positioning groove, and the cantilever beam and the connecting member are provided with positioning holes that cooperate with the positioning post.

14. The craniotomy electrode fixation device according to claim 13, characterized in that, The extension path of the cantilever beam is attached to the upper surface, lower surface, or radially inserted into the outer ring.

15. The craniotomy electrode fixation device according to claim 14, characterized in that, The cantilever beam has an S-shaped or U-shaped curved structure.

16. The cranial foramen electrode fixation device according to claim 1, characterized in that, The bottom surface of the electrode lock is exposed relative to the fixed base.

17. The craniotomy electrode fixation device according to claim 3, characterized in that, The main body also includes a support wall for supporting the electrode lock, wherein the thickness d2 of the support wall is ≤0.3mm.

18. The craniotomy electrode fixation device according to claim 17, characterized in that, The support wall is disposed at the bottom of the fixed base. The support wall is used to abut against the bottom of the electrode lock and support the electrode lock. The support wall is a metal wall made of metal material.

19. The craniotomy electrode fixation device according to claim 3, characterized in that, The electrode lock is provided with a limiting structure, which engages with the fixed base to restrict the relative movement of the electrode lock and the fixed base.

20. The craniotomy electrode fixation device according to claim 19, characterized in that, At least one limiting groove is provided on the side wall of the main body, the limiting groove is connected to the accommodating space, the limiting structure is provided on the side wall of the electrode lock, the maximum outer diameter of the limiting structure is greater than the inner diameter of the accommodating space, and the at least one limiting structure is held in the limiting groove.

21. The craniotomy electrode fixation device according to claim 20, characterized in that, The limiting structure consists of ribs spaced circumferentially along the side wall of the electrode lock, with a spacer between adjacent ribs. Each limiting groove accommodates at least two ribs, or each limiting groove accommodates at least one complete rib and partial structures of two ribs.

22. The craniotomy electrode fixation device according to claim 21, characterized in that, The electrode lock and the ribs are integrally formed from elastic material. Some of the ribs are used to press and fit against the inner wall of the main body of the fixing base, and some of the ribs are held in the limiting groove.

23. The craniotomy electrode fixation device according to claim 21, characterized in that, The center angle corresponding to the limiting groove is 30°≤α2≤60°; the center angle corresponding to the rib and the adjacent spacer is 10°≤γ≤30°.

24. The craniotomy electrode fixation device according to claim 23, characterized in that, The central angle corresponding to the convex rib is 5°≤β≤20°, and the central angle corresponding to the interval is 2°≤∑≤4°.

25. The craniotomy electrode fixation device according to claim 21, characterized in that, The outer wall of the electrode lock and at least one side of the axial direction of the rib are provided with an inwardly recessed extrusion deformation groove, which serves as the deformation space for the rib when it is extruded.

26. The craniotomy electrode fixation device according to claim 25, characterized in that, The extrusion deformation groove is an annular groove surrounding the outer wall of the electrode lock, or a number of rectangular grooves, trapezoidal grooves or V-shaped grooves distributed at intervals along the axial direction.

27. The craniotomy electrode fixation device according to claim 21, characterized in that, The rib includes a first end face and a second end face that are opposite each other. When the rib is accommodated in the limiting groove, the first end face and the second end face abut against the groove wall corresponding to the limiting groove, respectively.

28. The craniotomy electrode fixation device according to claim 21, characterized in that, The cross-sectional shape of the rib is rectangular, trapezoidal, or arc-shaped.

29. The craniotomy electrode fixation device according to claim 19, characterized in that, The limiting structure is a support member disposed at the upper end of the electrode lock and extending radially outward, at least a portion of the support member abutting against the fixed base and being supported by the fixed base.

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