Electrode fixation device, clamping tool and method of use thereof

Abstract

This invention discloses an electrode fixing device, its clamping tool, and its usage method, comprising a bone hole base having an axially penetrating first through hole and at least one radially penetrating first groove; a locking assembly installed in the first through hole, the locking assembly including a first locking member, a second locking member, and a third locking member, the first locking member having a first slot and a first sliding groove, the first slot having a first clamping surface; a first slider provided on the top surface of the second locking member, a second slider provided on the bottom surface of the second locking member, the side of the second locking member having an axial protrusion relative to the top surface forming a second clamping surface, and a protrusion portion formed by the axial protrusion relative to the top surface; the third locking member having a second sliding groove and a second slot, the second slot having a third clamping surface, the first clamping surface and the third clamping surface being flush to form a combined surface; the first locking member and the third locking member being snap-fitted together to axially fix the second locking member between the first locking member and the third locking member.

Description

Technical Field

[0001] This invention relates to the field of medical devices, and more particularly to an electrode fixing device, its clamping tool, and its method of use. Background Technology

[0002] Deep brain stimulation (DBS) is a type of implantable neurostimulation system, primarily consisting of an implanted pulse generator, electrodes, and an external control device. The electrodes are connected to the pulse generator, which transmits pulses to specific nerve sites to provide electrical stimulation, thereby restoring normal bodily function in those areas. During the electrode implantation surgery, the surgeon first uses a three-dimensional stereotactic device to determine the target location in the patient's brain. Based on this location, a bone hole is created in a suitable area of ​​the skull, and the electrode wire is inserted through the bone hole to the corresponding target location. A test stimulator then outputs pulses to the electrodes to verify the stimulation effect and confirm the accuracy of the electrode implantation position. In deep brain stimulation (DBS), implanted electrodes reliably stimulate target points in the brain to restore and improve the condition. The fixation and positioning device for implanted electrodes is crucial. During actual operation, doctors need to confirm the location of the stimulation target point multiple times. With existing electrode fixation devices, the intermediate locking device must be fixed in the bone hole base before additional tools are used to lock the electrode. Furthermore, unlocking the existing device after locking it once is difficult. After unlocking, the electrode locking structure, especially the lateral locking connection structure, is small and prone to failure after a few uses due to friction and wear, causing significant inconvenience to the surgeon. Moreover, with existing electrode fixation devices, the intermediate locking device must be fixed in the bone hole base before additional tools are used to lock the electrode. Summary of the Invention

[0003] The technical problem to be solved by the present invention is to provide an electrode fixation device, a clamping tool and a method of use thereof, wherein the electrode fixation device has a more reliable structure and is more convenient for doctors to operate.

[0004] To solve the above-mentioned technical problems, the present invention provides an electrode fixing device, including a bone hole base for placement within a bone hole in the skull. The bone hole base has an axially penetrating first through hole and at least one radially penetrating first groove, the first groove being used to place the electrode. A locking assembly is installed within the first through hole. The locking assembly includes a first locking member, a second locking member, and a third locking member, which are sequentially assembled axially. The first locking member has a first slot and a first sliding groove, the first slot having a first clamping surface. The top surface of the second locking member is provided with a first slider, the bottom surface of the second locking member is provided with a second slider, and the side surface of the second locking member has a second clamping surface formed by axially protruding relative to the top surface. The protrusion forms a raised portion; the third locking member has a second sliding groove and a second slot, the second slot has a third clamping surface, and the first clamping surface and the third clamping surface are flush to form a combined surface; the first locking member and the third locking member are snapped together to fix the second locking member axially between the first locking member and the third locking member, the second clamping surface is located in the space formed by the first slot and the second slot, and the second locking member controls the relative distance between the second clamping surface and the combined surface to lock or unlock the electrode by moving the first slider and the second slider in the first sliding groove and the second sliding groove, and in the locked position the second locking member is engaged with the third locking member or the first locking member; a bone hole cover is placed on the bone hole base to close the first through hole.

[0005] Preferably, the bone hole cover includes a bone hole cover body and a plurality of first buckles. One end of the first buckle is fixed to the bone hole cover body, and the other end of the first buckle is a free end with a radially outward protruding port. A plurality of first slots are matched on the bone hole base, and the free end of the first buckle is engaged in the first slot.

[0006] Preferably, the first locking member has a second groove, which is disposed on the first clamping surface, so that the attached operating tool can pry the second locking member at the second groove to unlock the electrode.

[0007] Preferably, the first locking member has a second slot for engaging with a first boss on the clamping tool, so that the clamping tool can clamp the locking assembly.

[0008] Preferably, the top surface of the first locking member is provided with a plurality of fixing blocks or a plurality of third grooves along the circumferential direction near the edge. The bone hole base includes a bone hole base body and a plurality of second buckles. One end of the second buckle is fixed to the bone hole base body, and the other end of the second buckle is a free end with a radially inward protruding port. The free end of the second buckle is engaged with the top surface between the fixing blocks or in the third groove.

[0009] Preferably, the bottom surface of the first locking member is provided with a positioning post extending axially, and the third locking member is provided with a matching positioning hole, the positioning post being inserted into the positioning hole; the bottom surface of the first locking member is provided with a third buckle, one end of the third buckle is fixed to the bottom surface of the first locking member, the other end of the third buckle is a free end and has a radially inwardly protruding port, the edge of the third locking member has a matching second clearance groove, the free end of the third buckle passes through the second clearance groove and engages with the bottom surface of the third locking member, thereby axially fixing the second locking member between the first locking member and the third locking member.

[0010] Preferably, the bottom surface of the second locking member is provided with a second protrusion, and a limiting block is provided at one end of the second clamping surface; the third locking member has a first top surface and a second top surface of different heights, and a space for the second locking member to move is formed between the second top surface at the lower position and the bottom surface of the first locking member; a third clearance groove is provided on the second top surface of the third locking member, and a third protrusion is provided on the side of the third clearance groove near the second slot; the second protrusion and the third protrusion are matched and engaged; the second protrusion can slide in the third clearance groove and slide past the third protrusion to reach the locking position; the limiting block is limited by the first clamping surface or the third clamping surface; the second protrusion is limited by the third protrusion; at this time, the electrode is clamped by the combination surface of the second clamping surface and the first clamping surface and the third clamping surface.

[0011] Preferably, the radial outer diameter of the bone hole base body is less than or equal to 25 mm.

[0012] To solve the above-mentioned technical problems, the present invention also provides a clamping tool for clamping the locking component in the electrode fixing device, comprising a gripping part and a clamping part. The bottom surface of the clamping part is provided with a first protrusion and a fourth protrusion. The first locking member has a second slot, and the third locking member is correspondingly provided with a first clearance slot. The first clearance slot allows the first protrusion to extend and move. The first protrusion is installed in conjunction with the second slot. The clamping tool can clamp the locking component and install it with the bone hole base. After the locking component is placed on the bone hole base, rotating the clamping tool causes the fourth protrusion to press against the protrusion on the second locking member, causing the second clamping surface to move and thereby lock the electrode. Alternatively, the fourth protrusion can limit the second locking member.

[0013] Preferably, the second slot is a combination of a circular slot and a long slot, the length of the first boss is less than the length of the long slot and greater than the diameter of the circular slot, the width of the first boss is less than the width of the long slot, the first clearance slot is a circular slot, and the length of the first boss is less than the diameter of the first clearance slot.

[0014] Preferably, the long axis of the gripping part is substantially parallel to the protruding extension direction of the first boss, the third locking member has a first top surface and a second top surface of different heights, the first locking member at the second slot is located on the first top surface with a higher position, and the third locking member has a corresponding first clearance groove at the first top surface, the first clearance groove allowing the first boss to extend into and move; or, the long axis of the gripping part is substantially perpendicular to the protruding extension direction of the first boss, the gripping part and the clamping part are connected by a transition section, a platform is provided near the gripping part, the third locking member has a first top surface and a second top surface of different heights, and the first locking member at the second slot is located on the second top surface with a lower position.

[0015] To solve the above-mentioned technical problems, the present invention also provides a method for using an electrode fixation device, comprising the following steps: S1: Using a placement tool, the bone hole base is placed and installed at the bone hole of the skull, so that the bone hole base is fixed in the bone hole; S2: After the electrode is implanted into the predetermined position through the bone hole, the locking component is installed on the bone hole base using the clamping tool, and the clamping tool is rotated or the protrusion in the second locking member is pushed using an operating tool, so that the second slider of the second locking member moves in the second groove and the first slider moves in the first groove, thereby moving the second locking member as a whole, so that the second clamping surface of the second locking member, together with the combination surface of the first clamping surface and the third clamping surface, jointly presses the electrode to achieve the purpose of pre-fixing the electrode, and then the electrode is pushed out from the first groove around the bone hole base; S3: After confirming that the electrode implantation position is completed, the bone hole cover is put on, and the first buckle on the bone hole cover cooperates with the first groove of the bone hole base, and the electrode is completely fixed by the compression of the bone hole cover body and the first groove on the bone hole base.

[0016] Preferably, the procedure further includes the following steps: S4: If the electrode implantation position is found to be inconsistent with the expectation and rework is required, the bone hole cover is pried open at the first groove position on the bone hole base using the attached operating tool; S5: The pre-fixed state of the electrode is released by prying open the gap between the second clamping surface and the first clamping surface on the second locking member using the attached operating tool; S6: The locking assembly is pried out at the first groove position on the bone hole base using the attached operating tool, and steps S2 and S3 are repeated.

[0017] Compared with the prior art, the present invention has the following advantages: The electrode fixation device, clamping tool, and method of use provided by the present invention consist of a locking assembly composed of three locking members axially mounted and combined. The first and third locking members are snap-fitted together to axially fix the second locking member. The first and third locking members are respectively provided with sliding grooves. Slider blocks are respectively provided on the top and bottom surfaces of the second locking member. The sliders on the second locking member move linearly along the sliding grooves to control the distance between the second clamping surface of the second locking member and the combined surface of the first and third locking members, thereby locking or unlocking the electrode. In particular, the provided clamping tool allows the doctor to quickly pre-fix the electrode directly after placing the locking assembly, eliminating the need to retrieve additional operating tools, thus optimizing the surgical procedure and making the surgery more efficient. Furthermore, the snap-fit ​​connection between the first and third locking members in the electrode fixation device provided by the present invention is an upper and lower snap-fit, which is more reliable than the existing horizontal snap-fit ​​structure and less prone to wear after repeated snap-fitting. Attached Figure Description

[0018] Figure 1 This is a schematic diagram of the overall structure of the electrode fixing device in an embodiment of the present invention;

[0019] Figure 2 This is an assembly diagram of the clamping tool clamping and locking assembly placed on the bone hole base in an embodiment of the present invention;

[0020] Figure 3 This is an assembly diagram of the bone hole base placement tool for placing the bone hole base in an embodiment of the present invention;

[0021] Figure 4 This is a schematic diagram of the assembled locking assembly in an embodiment of the present invention;

[0022] Figure 5 This is an exploded view of the locking assembly in an embodiment of the present invention;

[0023] Figure 6 This is a schematic diagram of the bone hole cover in an embodiment of the present invention;

[0024] Figure 7a and Figure 7b These are schematic diagrams of the clamping tool in two different embodiments of the present invention. Figure 7c for Figure 7b A schematic diagram showing the state of the clamping tool when it clamps the locking component;

[0025] Figure 8a , Figure 8b and Figure 8c These are schematic diagrams of the structure of the first locking member in three different embodiments of the present invention;

[0026] Figure 9a This is a schematic diagram of the structure of the second locking member in an embodiment of the present invention. Figure 9b for Figure 9a A schematic diagram of the structure after the second locking element is flipped over. Figure 9c This is a schematic diagram of the structure of the second locking member in another embodiment;

[0027] Figure 10a and Figure 10b These are schematic diagrams of the third locking member in two different embodiments of the present invention;

[0028] Figure 11a and Figure 11b These are schematic diagrams of the bone hole base at different angles in embodiments of the present invention;

[0029] Figure 12 This is a schematic diagram of the structure of the bone hole base placement tool in an embodiment of the present invention;

[0030] Figures 13a-13g This is a schematic diagram of the assembly process of the electrode fixing device and the fixing electrode in one embodiment of the present invention;

[0031] Figures 14a-14cThis is a schematic diagram of the assembly process after it was found that the electrode implantation position did not meet the expectation and rework was required in one embodiment of this utility model.

[0032] Figure 15 This is a schematic diagram of locking the electrode after installing the electrode fixing device in another embodiment of this utility model.

[0033] In the picture:

[0034] 1-Bone hole cover, 2-Locking assembly, 3-Bone hole base, 4-Clamping tool, 5-Placement tool, 6-Electrode, 7-Self-tapping screw, 8-Skull, 11-Bone hole cover body, 12-First buckle, 21-First locking element, 22-Second locking element, 23-Third locking element, 211-First slot, 212-First sliding groove, 213-First clamping surface, 214-Positioning post, 215-Second slot, 216-Third buckle, 217-Second groove, 218-Fixing block, 219-Third groove, 2131-Corrugated, 2151, 2153-Circular groove, 2152, 2154-Elongated groove, 221-First slider, 222-Second boss, 223-Second slider, 224-Second clamping surface, 225-Protrusion, 226-Limiting block, 22 7-Insertion portion, 228-Fourth relief groove, 229-Fourth recess, 231-Second sliding groove, 232-Second slot, 233-Third clamping surface, 234-First relief groove, 235-Positioning hole, 236-Second relief groove, 237-Third boss, 238-Third relief groove, 2391-First top surface, 2392-Second top surface, 31-Bone hole base body, 32-First through hole, 33-First recess, 34-First slot, 35-Second buckle, 36-Counterhole, 37-Cutting groove, 41-Grip portion, 411, 431-Wave, 42-Clamping portion, 43-Platform, 44-Transition section, 421-First boss, 422-Fourth boss, 5-Tool placement, 51-Screw hole, 52-Fifth boss, 53-Fourth buckle, 81-Bone hole. Detailed Implementation

[0035] The present invention will now be further described with reference to the accompanying drawings and embodiments.

[0036] In the description of this invention, it should be understood that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this invention through the specific circumstances. The terms "upper," "lower," "front," "rear," "left," and "right," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, and are only for the convenience of describing this invention and simplifying the description, not to indicate or imply that the device or component referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of this invention. Furthermore, the terms "first," "second," "third," "fourth," and "fifth" are used for descriptive purposes only and should not be construed as indicating or implying relative importance. The term "axial" indicates the direction of the central axis of the first through hole of the bone hole base or a direction parallel to the central axis; "radial" indicates the direction of the diameter of the first through hole of the bone hole base; and "circumferential" indicates the circumferential direction.

[0037] Please see Figure 1 The present invention provides an electrode fixing device, including a bone hole base 3, a locking component 2 and a bone hole cover 1.

[0038] Please see Figure 1 , Figure 11a , Figure 11b and Figures 13a-13g The bone hole base 3 is placed inside the bone hole 81 of the skull 8. The bone hole base 3 includes a bone hole base body 31, which has an axially penetrating first through hole 32 and at least one radially penetrating first groove 33 for placing the electrode 6. Further, the bone hole base body 31 is also provided with a first slot 34, a second buckle 35, a countersunk hole 36, and a cutting groove 37. The number of first grooves 33 is preferably four. The first grooves 33 without electrodes can be used simultaneously to pry out the bone hole cover 1 and the locking assembly 2 using an operating tool. The operating tool can be inserted into the gap between the bone hole cover 1 and the empty first groove 33 on the bone hole base 3 to pry out the bone hole cover 1; the operating tool can be inserted into the empty first groove 33 to pry out the locking assembly 2. Countersunk holes 36 are located at both ends of the bone hole base body 31, allowing the skull self-tapping screws 7 to pass through and fix the bone hole base 3 to the skull 8. Grooves 37 are axially arranged on the inner wall of the first through hole 32, making it easier for the bone hole base 3 and the skull 8 to fit together. The radial outer diameter D of the bone hole base body 31 is less than or equal to 25 mm, more preferably less than or equal to 20 mm; the smaller the radial outer diameter D, the better. The bone hole base 3 is placed into the bone hole 81 of the skull 8 using the placement tool 5. Please refer to [link to relevant documentation]. Figure 12The placement tool 5 includes a screw hole 51, a fifth boss 52, and a fourth latch 53. The screw hole 51 holds the skull self-tapping screw 7. The radially outward-protruding fifth boss 52 cooperates with the first slot 34 on the bone hole base 3 to prevent the placement tool 5 from rotating. One end of the fourth latch 53 is fixed, and the other end of the fourth latch 53 is a free end with a radially outward-protruding port. The fourth latch 53 cooperates with the second latch 35 to allow the placement tool 5 to be lifted smoothly from the bone hole base 3.

[0039] Please see Figure 1 , Figure 4 , Figure 5 , Figures 8a-10b The locking assembly 2 is installed in the first through hole 32. The locking assembly 2 includes a first locking member 21, a second locking member 22, and a third locking member 23. The first locking member 21, the second locking member 22, and the third locking member 23 are assembled sequentially along the axial direction. The first locking member 21 has a first slot 211 and a first sliding groove 212. The first slot 211 has a first clamping surface 213. The top surface of the second locking member 22 is provided with a first slider 221, and the bottom surface of the second locking member 22 is provided with a second slider 223. The side surface of the second locking member 22 has a second clamping surface 224 formed by axially protruding relative to the top surface, and a protrusion 225 is formed by axially protruding relative to the top surface. The third locking member 23 has a second sliding groove 231 and a second slot 232. The second slot 232 has a third clamping surface 233. The first clamping surface 213 and the third clamping surface 234 are also connected. 3. After being flush, a combined surface is formed; the first locking member 21 and the third locking member 23 are snapped together to fix the second locking member 22 axially between the first locking member 21 and the third locking member 23, and the second clamping surface 224 is located in the space formed by the first slot 211 and the second slot 232. The first slide groove 212 and the second slide groove 231 are both strip-shaped grooves. When the second locking member 22 is pushed, the first slider 221 moves linearly in the first slide groove 212 and the second slider 223 moves linearly in the second slide groove 231. The second locking member 22 controls the relative distance between the second clamping surface 224 and the combined surface to lock or unlock the electrode 6 by the linear movement of the first slider 221 and the second slider 223 in the first slide groove 212 and the second slide groove 231. In the locked position, the second locking member 22 is engaged with the third locking member 23 or the first locking member 21.

[0040] Please see Figure 1 and Figure 6 The bone hole cover 1 is placed on the bone hole base 3 to close the first through hole 32. Specifically, the bone hole cover 1 includes a bone hole cover body 11 and a plurality of first buckles 12. One end of the first buckle 12 is fixed to the bone hole cover body 11, and the other end of the first buckle 12 is a free end with a radially outward protruding port. A plurality of first slots 34 are matched on the bone hole base 3, and the free end of the first buckle 12 is engaged in the first slot 34.

[0041] Please see Figure 8a , Figure 8b and Figure 8c In one specific embodiment, the first locking member 21 has a second groove 217, which is disposed on the first clamping surface 213. An attached operating tool can be used to move the second locking member 22 at the second groove 217 to unlock the electrode. Furthermore, when the doctor uses the clamping tool, because the object is too small in actual surgery, the doctor often operates blindly. The second groove 217 can provide the doctor with a tactile change to determine whether the electrode is locked or unlocked. Further, please also refer to... Figure 8a and Figure 10a In one embodiment, the third locking member 23 has a first top surface 2391 and a second top surface 2392 of different heights. A space is formed between the lower second top surface 2392 and the bottom surface of the first locking member 21 for the second locking member 22 to move. The first locking member 21 has a second slot 215, with the first locking member 21 at the second slot 215 located on the higher first top surface 2391. The second slot 215 is used to engage with a first boss 421 on the clamping tool 4, allowing the clamping tool 4 to clamp the locking assembly 2. The third locking member 23 has a corresponding first clearance groove 234 on the first top surface 2391, into which the first boss 421 extends and moves. In another embodiment, please also refer to... Figure 8b and Figure 10b The third locking member 23 has a first top surface 2391 and a second top surface 2392 with different heights. The first locking member 21 at the second slot 215 is located on the lower second top surface 2392. In this embodiment, since there is a gap between the second top surface 2392 and the bottom surface of the first locking member 21, the third locking member 23 does not need to be provided with a first clearance groove 234. The setting position of the second slot 215 is determined by the clamping tool 4. Figure 7a The clamping tool 4 shown is positioned such that the second slot 215 is located as follows: Figure 8a As shown, using Figure 7b The clamping tool 4 shown is positioned such that the second slot 215 is located as follows: Figure 8b As shown. Further, in one embodiment, as... Figure 8a As shown, a plurality of fixing blocks 218 are arranged circumferentially near the edge of the top surface of the first locking member 21. Preferably, the plurality of fixing blocks 218 are evenly distributed circumferentially. Please refer to [link to previous text]. Figure 11a and Figure 11bCorrespondingly, the bone hole base 3 includes a bone hole base body 31 and a plurality of second latches 35. One end of the second latch 35 is fixed to the bone hole base body 31, and the other end of the second latch 35 is a free end with a radially inwardly protruding port. The free end of the second latch 35 engages with the top surface between the fixing blocks 218 of the first locking member 21. The fixing blocks 218 limit the second latch 35 to prevent the locking assembly 2 from rotating during operation. In another embodiment, as shown... Figure 8b As shown, the top surface of the first locking member 21 has a plurality of third grooves 219 arranged circumferentially near the edge. Preferably, the plurality of third grooves 219 are evenly spaced circumferentially. The free end of the second buckle 35 is engaged in the plurality of third grooves 219 of the first locking member 21. The structure of the third grooves 219 also limits the second buckle 35 and can also reduce the thickness of the first locking member 21. Further, the bottom surface of the first locking member 21 is provided with a positioning post 214 extending axially, and the third locking member 23 is provided with a positioning hole 235. The positioning post 214 is inserted into the positioning hole 235 for positioning. Even further, as Figure 8c As shown, the first clamping surface 213 is provided with corrugations 2131 to increase friction.

[0042] Please continue reading Figure 8a A third latch 216 is provided on the bottom surface of the first locking member 21. One end of the third latch 216 is fixed to the edge of the bottom surface of the first locking member 21, and the other end of the third latch 216 is a free end with a radially inward protruding port. Correspondingly, please refer to Figure 10a The edge of the third locking member 23 has a matching second clearance groove 236. The free end of the third buckle 216 passes through the second clearance groove 236 and is engaged with the bottom surface of the third locking member 23, thus axially limiting the second locking member 22 between the first locking member 21 and the third locking member 23.

[0043] Please continue reading Figure 9a and Figure 10aThe bottom surface of the second locking member 22 is provided with a second boss 222. One end of the second clamping surface 224 of the second locking member 22 is provided with a limiting block 226. The other end of the second clamping surface 224 of the second locking member 22 is provided with an insertion part 227. The insertion part 227 extends into the space formed between the second top surface 2392 of the third locking member 23 and the bottom surface of the first locking member 21. A third clearance groove 238 is provided on the second top surface 2392 of the third locking member 23. A third boss 237 is provided on the side of the third clearance groove 238 near the second slot 232. The second boss 222 and the second boss 226 are provided with a limiting block 226. The three protrusions 237 are matched and engaged. The second protrusion 222 can slide within the third relief groove 238 and pass over the third protrusion 237. When it reaches the locking position, it is locked with the third protrusion 237. Specifically, the second protrusion 222 at the bottom of the second locking member 22 can slide within the third relief groove 238 in the third locking member 23. When it continues to slide towards the third clamping surface 233, the second protrusion 222 collides with the third protrusion 237. The second locking member 22 can only move upward (vertically), causing the second protrusion 222 to break through the third protrusion 237 and move to the left side of the third protrusion 237 (direction reference in the text). Figure 10a The locking mechanism is engaged. At this point, the second locking member 22 cannot move further to the left due to the limit block 226, and cannot move to the right due to the restriction of the third boss 237, thus achieving the effect of clamping the electrode 6. That is, the combination surface of the second clamping surface 224 with the first clamping surface 213 and the third clamping surface 233 clamps the electrode 6. Preferably, the second boss 222 and the third boss 237 are provided with matching ramp surfaces. The ramp surface of the second boss 222 moves upward along the ramp surface of the third boss 237, causing the second locking member 22 to move upward (vertically). Please refer to [link to relevant documentation]. Figure 9c Furthermore, a fourth groove 229 is provided on the second locking member 22. When the second locking member 22 is moved using the accompanying operating tool, the fourth groove 229 can guide the operating point of the operating tool. Whether the electrode is locked by rotating the clamping tool 4 or by using the accompanying operating tool, the user will receive tactile feedback during locking, and there will be a "click" sound indicating that the second boss 222 and the third boss 237 have successfully engaged, making it easy for the operator to determine whether the electrode is locked.

[0044] Please see Figure 7a and Figure 7b The present invention also provides a clamping tool 4 for clamping the locking component 2 in the aforementioned electrode fixing device. The clamping tool 4 includes a gripping part 41 and a clamping part 42. The bottom surface of the clamping part 42 is provided with a first boss 421 and a fourth boss 422. Further, the surface of the gripping part 41 is provided with corrugations 411 to increase friction and facilitate operation. In one embodiment, as... Figure 7aAs shown, the long axis of the gripping part 41 is generally parallel to the protruding extension direction of the first boss 421. The first boss 421 is fitted with the second slot 215. The clamping tool 4 can clamp the locking component 2 and install it with the bone hole base 3. In this embodiment, after the locking component 2 is placed in the bone hole base 3, the clamping tool 4 is rotated so that the fourth boss 422 abuts against the protrusion 225 on the second locking member 22, causing the second clamping surface 224 to move and thus lock the electrode. The clamping tool 4 and the second locking component 225 provided in this embodiment are shown in the figure. Figure 8a and Figure 10a The locking component 2 of the structure shown is used in conjunction; in another embodiment, as Figure 7b As shown, the long axis of the gripping part 41 is substantially perpendicular to the protruding extension direction of the first boss 421. The gripping part 41 and the clamping part 42 are connected by a transition section 44. A platform 43 is provided near the gripping part 41. The platform 43 facilitates downward force by pressing the index finger against the platform 43 during operation. Furthermore, the platform 43 is also provided with corrugations 431. In this embodiment, the fourth boss 422 is used to restrict the position of the second locking member 22. The clamping tool 4 and the clamping part 421 provided in this embodiment are also mentioned. Figure 8b and Figure 10b The locking component 2 of the structure shown is used in conjunction with it.

[0045] Please see Figure 7a , Figure 8a and Figure 10a The first locking member 21 has a second slot 215, and the third locking member 23 is correspondingly provided with a first clearance slot 234. The first clearance slot 234 allows the first boss 421 to extend and move. The first boss 421 is installed in conjunction with the second slot 215. The clamping tool 4 can clamp the locking component 2 and install it with the bone hole base 3. After the locking component 2 is placed in the bone hole base 3, the clamping tool 4 is rotated so that the fourth boss 422 abuts against the protrusion 225 on the second locking member 22, causing the second locking member 22 to move as a whole, so that the second clamping surface 224 cooperates with the first and third clamping surfaces 213 and 233 to lock the electrode 6.

[0046] Further, please see Figure 8a and Figure 8b The second slot 215 is a combination of a circular slot 2151 and a long slot 2152. The length of the first boss 421 is less than the length of the long slot 2152 but greater than the diameter of the circular slot 2151. The width of the first boss 421 is less than the width of the long slot 2152. Figure 8a The first locking element 21 shown and Figure 10aThe third locking member 23 shown is matched. In this embodiment, the third locking member 23 is correspondingly provided with a first clearance groove 234. The first clearance groove 234 is a circular groove, and the length of the first boss 421 is less than the diameter of the first clearance groove 234. Therefore, after the first boss 421 enters along the elongated groove 2152 and rotates 90 degrees, it can be locked in the circular groove 2151, allowing the locking assembly 2 to be lifted. The elongated groove 2152 can be... Figure 8a The rectangular or elongated shape shown can also be Figure 8b As shown in the arc-shaped elongated strip, this embodiment does not impose any particular restrictions on the specific shape of the elongated groove 2152.

[0047] The specific method for using the electrode fixing device provided by this invention to fix the electrode is as follows:

[0048] For step S1, please refer to [link / reference]. Figures 13a-13c The doctor pre-drilled a hole in the skull 8, and used a placement tool 5 to place the bone hole base 3 at the bone hole 81. Then, using an operating tool, the self-tapping screw 7 pre-installed in the placement tool 5 was inserted into the skull 8. The process is as follows: Figure 13b As shown, the completed cross-section is as follows Figure 13c As shown.

[0049] For step S2, please refer to [link / reference]. Figures 13d-13g After the electrode 6 is implanted into the appropriate position through the bone hole 81, as Figure 13d As shown, the clamping tool 4 is used to insert the locking assembly 2 into the first through hole 31 of the bone hole base 3. The second buckle 35 on the bone hole base 3 engages with the top surface of the first locking member 21 or the third groove 219 of the locking assembly 2, and the fixing block 218 or the flange of the third groove 219 on the first locking member 21 of the locking assembly 2 restricts the entire locking assembly 2 from rotating in the bone hole base 3. Figure 13e As shown, rotating the clamping tool 4 causes the first slider 221 on the second locking member 22 to move in the first groove 212 of the first locking member 21, and the second slider 223 to move in the second groove 231 of the third locking member 23, thereby moving the entire structure of the second locking member 22. The second boss 222 in the second locking member 22 and the third boss 237 in the third locking member 23 engage to lock the position of the second locking member 22. At this time, the electrode 6 is pre-fixed by the combined surface of the second clamping surface 224 of the second locking member 22, the first clamping surface 213, and the third clamping surface 233. Then, the electrode 6 is pushed out from the appropriate groove among the four first grooves 33 around the bone hole base 3. Figure 13e As shown.

[0050] Step S3, as follows Figure 13gAs shown, after confirming the implantation position of electrode 6, the bone hole cover 1 is put on. The first buckle 12 on the bone hole cover 1 cooperates with the first slot 34 on the bone hole base 3. The electrode 6 can be completely fixed by the compression of the bone hole cover body 11 and the first groove 33 on the bone hole base 3.

[0051] Step S4: If, after completing the above procedures, the doctor finds that the implantation position of electrode 6 is not as expected and rework is required, then the accompanying operating tools need to be used to... Figure 14a Pry open the bone hole cover 1 at the first groove 33 position on the bone hole base 3 shown (the position indicated by the circle in the figure).

[0052] Step S5: After prying open the bone hole cover 1, the pre-fixation state of electrode 6 needs to be released. This requires using the attached operating tool to pry it open. Figure 14b The position indicated by the arrow represents the pre-fixed state of the gap between the second clamping surface 224 and the first clamping surface 213 on the second locking member 22, which releases the electrode 6.

[0053] Step S6: After unlocking the pre-fixed state of electrode 6, the locking component 2 needs to be pried out. This requires the use of the attached operating tool. Figure 14c Pry out the locking component 2 at the position of the first groove 33 indicated by the middle circle, and repeat the above steps S2 and S3.

[0054] In another embodiment, the other steps are the same as in the previous embodiment, except that in step S2, the locking component 2 is placed first, as follows: Figure 15 As shown, using an operating tool to push the protrusion 225 in the second locking member 22, the second slider 223 of the second locking member 22 moves in the second slide groove 231 and the first slider 221 moves in the first slide groove 212, causing the second locking member 22 to move as a whole. The second boss 222 on the second locking member 22 cooperates with the third boss 237 of the third locking member 23 to lock the position of the second locking member 22. At this time, the combination surface of the second clamping surface 224 on the second locking member 22, the first clamping surface 213, and the third clamping surface 233 together squeezes the electrode 6 to achieve the purpose of pre-fixing with the electrode 6.

[0055] Although the present invention has been disclosed above with reference to preferred embodiments, it is not intended to limit the present invention. Any person skilled in the art can make some modifications and improvements without departing from the spirit and scope of the present invention. Therefore, the scope of protection of the present invention shall be defined by the claims.

Claims

1. An electrode fixing device, characterized in that, include: A bone hole base for placement within a bone hole in the skull, the bone hole base having an axially penetrating first through hole and at least one radially penetrating first groove, the first groove being used to place the electrode; A locking assembly, used in conjunction with a clamping tool, the clamping tool including a gripping part and a clamping part, the bottom surface of the clamping part having a first boss and a fourth boss; the locking assembly is installed in a first through hole, the locking assembly including a first locking member, a second locking member, and a third locking member, the first locking member, the second locking member, and the third locking member being sequentially assembled axially, the first locking member having a first slot, a second slot, and a first sliding groove, the first slot having a first clamping surface, the second slot being used to engage with the first boss on the clamping tool, so that the clamping tool can clamp the locking assembly and install it to the bone hole base; the top surface of the second locking member having a first slider, the bottom surface of the second locking member having a second slider, the side surface of the second locking member having a second clamping surface formed by axially protruding relative to the top surface, and a protrusion formed by axially protruding relative to the top surface; the locking assembly is placed after being placed on the bone hole base. Rotating the clamping tool causes the fourth protrusion to press against the protrusion on the second locking member, moving the second clamping surface to lock the electrode; alternatively, the fourth protrusion limits the second locking member. The third locking member has a second sliding groove and a second slot, the second slot having a third clamping surface. The first clamping surface and the third clamping surface are flush to form a combined surface. The first locking member and the third locking member are snap-fitted together to axially fix the second locking member between the first locking member and the third locking member. The second clamping surface is located within the space formed by the first slot and the second slot. The second locking member controls the relative distance between the second clamping surface and the combined surface to lock or unlock the electrode by moving the first slider and the second slider in the first sliding groove and the second sliding groove. In the locked position, the second locking member engages with the third locking member or the first locking member. A bone hole cover is placed on the bone hole base to seal the first through hole.

2. The electrode fixing device as described in claim 1, characterized in that, The bone hole cover includes a bone hole cover body and a plurality of first buckles. One end of the first buckle is fixed to the bone hole cover body, and the other end of the first buckle is a free end with a radially outward protruding port. A plurality of first slots are matched on the bone hole base, and the free end of the first buckle is engaged in the first slot.

3. The electrode fixing device as described in claim 1, characterized in that, The first locking member has a second groove, which is disposed on the first clamping surface, so that the attached operating tool can pry the second locking member at the second groove to unlock the electrode.

4. The electrode fixing device as described in claim 1, characterized in that, The top surface of the first locking member is provided with multiple fixing blocks or multiple third grooves along the circumferential direction near the edge. The bone hole base includes a bone hole base body and multiple second buckles. One end of the second buckle is fixed to the bone hole base body, and the other end of the second buckle is a free end with a radially inward protruding port. The free end of the second buckle is engaged with the top surface between the fixing blocks or in the third groove.

5. The electrode fixing device as described in claim 1, characterized in that, The bottom surface of the first locking member is provided with a positioning post extending axially, and the third locking member is provided with a matching positioning hole, in which the positioning post is inserted; the bottom surface of the first locking member is provided with a third buckle, one end of which is fixed to the bottom surface of the first locking member, and the other end of which is a free end with a radially inward protruding port; the edge of the third locking member has a matching second clearance groove, and the free end of the third buckle passes through the second clearance groove and engages with the bottom surface of the third locking member, thereby axially fixing the second locking member between the first locking member and the third locking member.

6. The electrode fixing device as described in claim 1, characterized in that, The second locking member has a second protrusion on its bottom surface and a limiting block on one end of the second clamping surface. The third locking member has a first top surface and a second top surface at different heights. A space for the second locking member to move is formed between the second top surface at the lower position and the bottom surface of the first locking member. A third clearance groove is provided on the second top surface of the third locking member. A third protrusion is provided on the side of the third clearance groove near the second slot. The second protrusion and the third protrusion are matched and engaged. The second protrusion can slide in the third clearance groove and slide past the third protrusion to reach the locking position. The limiting block is limited by the first clamping surface or the third clamping surface. The second protrusion is limited by the third protrusion. At this time, the electrode is clamped by the combination surface of the second clamping surface and the first clamping surface and the third clamping surface.

7. The electrode fixing device as described in claim 4, characterized in that, The radial outer diameter of the bone hole base body is less than or equal to 25 mm.

8. A clamping tool, characterized in that, The clamping tool is used to clamp the locking component in the electrode fixing device according to any one of claims 1-7, including a gripping part and a clamping part. The bottom surface of the clamping part is provided with a first protrusion and a fourth protrusion. The first locking member has a second slot, and the third locking member is provided with a corresponding first clearance slot. The first clearance slot allows the first protrusion to extend and move. The first protrusion is installed in conjunction with the second slot. The clamping tool can clamp the locking component and install it with the bone hole base. After the locking component is placed on the bone hole base, the clamping tool is rotated so that the fourth protrusion abuts against the protrusion on the second locking member, causing the second clamping surface to move and thereby lock the electrode. Alternatively, the fourth protrusion can limit the second locking member.

9. The clamping tool as described in claim 8, characterized in that, The second slot is a combination of a circular slot and a long slot. The length of the first boss is less than the length of the long slot but greater than the diameter of the circular slot. The width of the first boss is less than the width of the long slot. The first clearance slot is a circular slot. The length of the first boss is less than the diameter of the first clearance slot.

10. The clamping tool as described in claim 8, characterized in that, The long axis of the gripping part is generally parallel to the protruding extension direction of the first boss. The third locking member has a first top surface and a second top surface of different heights. The first locking member at the second slot is located on the first top surface with a higher position. The third locking member has a first clearance groove corresponding to the first top surface, which allows the first boss to extend into and move. Alternatively, the long axis of the gripping part is generally perpendicular to the protruding extension direction of the first boss. The gripping part and the clamping part are connected by a transition section. A platform is provided near the gripping part. The third locking member has a first top surface and a second top surface of different heights. The first locking member at the second slot is located on the second top surface with a lower position.

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