Electrode fixation assembly and electrode implantation device

Abstract

The application provides an electrode fixing assembly and an electrode implanting device. The electrode fixing assembly is used for fixing a flexible electrode. The electrode fixing assembly comprises an electrode placing seat and a liquid containing structure. The electrode placing seat has an electrode placing surface, and a distal end portion of the flexible electrode is attached to the electrode placing surface. The liquid containing structure is arranged in a local recess of the electrode placing surface and / or on a region of a distal end of the electrode placing seat, and is used for containing liquid for adsorbing the distal end portion of the flexible electrode. When the flexible electrode is separated from the electrode placing surface, the liquid attached to the liquid containing structure can be used to prevent the flexible electrode from suddenly deforming and moving, so as to effectively reduce the risk of the flexible electrode falling off from a needle for assisting in implanting the flexible electrode into a target tissue.

Description

Technical Field

[0001] This application relates to the field of electrode implantation technology, and in particular to an electrode fixation component and an electrode implantation device. Background Technology

[0002] Existing implantable neural signalers can be implanted into patients to achieve targeted treatment of diseased areas and to collect relevant signals from those areas. For example, neurostimulators modulate neural activity by sending electrical stimulation pulses to the brain or spinal cord, thereby treating neurological disorders such as Parkinson's disease, epilepsy, depression, and pain. Brain-computer interface systems based on neural signal acquisition devices can collect neural electrical signals from the brain, enabling information interaction between the brain and external devices. Currently, electrode implantation devices typically employ the following procedure: electrode wires are pre-laid on an electrode support plate, then the implantation needle peels the electrode wires from the support plate and moves them to the target implantation point. After implantation, the electrode wire remains in the tissue, the implantation needle is withdrawn, and then the next electrode wire is implanted. However, during this process, the electrode wire is prone to detaching from the implantation needle as it is moved from the support plate to the implantation point, leading to inaccurate implantation. Summary of the Invention

[0003] In view of the above-mentioned technical problems existing in the related technologies, this application provides an electrode fixation component and an electrode implantation device.

[0004] This application provides an electrode fixing assembly for fixing a flexible electrode. The electrode fixing assembly includes an electrode placement seat and a liquid retention structure. The electrode placement seat has an electrode placement surface on which at least a portion of the distal end of the flexible electrode is attached. The liquid retention structure is located in a partial recess of the electrode placement surface and / or in a region of the electrode placement seat near the distal end. The liquid retention structure is used to contain liquid adsorbed onto the distal end of the flexible electrode.

[0005] In some embodiments, the upper part of the electrode placement seat has a groove configured as the liquid retention structure, a support plate is disposed in the groove, and a liquid retention area is formed on the side of the support plate facing the flexible electrode, for at least the distal end of the flexible electrode.

[0006] In some embodiments, a fluid flow gap is formed between the sidewall of the groove near the flexible electrode and the support plate.

[0007] In some embodiments, the electrode fixing assembly further includes a support plate, at least a portion of the distal end of the flexible electrode is fixed to a first plate surface of the support plate; the distal end of the flexible electrode is configured to overcome the fixing force with the support plate and detach from the support plate when subjected to a tensile force greater than or equal to a preset threshold.

[0008] In some embodiments, when the upper part of the electrode placement seat has a groove configured as the liquid retention structure, the support plate extends at least partially into the groove, and the first plate surface carries liquid supplied via the groove.

[0009] In some embodiments, the electrode placement surface has a transverse placement surface and an inclined placement surface arranged sequentially along the length direction of the flexible electrode, and the liquid retention structure is located in a local depression of the transverse placement surface.

[0010] In some embodiments, the liquid retention structure located on the lateral placement surface is used at least for attaching the front end and / or the middle portion of the distal end of the flexible electrode.

[0011] In some embodiments, a smooth arc surface is formed at the junction of the horizontal placement surface and the inclined placement surface.

[0012] In some embodiments, the electrode holder has a connecting portion on which a potting hole is formed.

[0013] In some embodiments, the electrode holder is provided with a plurality of calibration parts, which are used to calibrate the position of the electrode holder.

[0014] This application also provides an electrode implantation device, including the electrode fixation component described in any of the above embodiments, and further including a flexible electrode, at least a portion of which is attached to the electrode fixation component.

[0015] In some embodiments, the distal end of the flexible electrode includes at least a first segment and a second segment, the first segment being located at the distal end of the second segment; the liquid retention structure is provided at at least one of the following locations of the flexible electrode: the distal end of the second segment, the proximal end of the second segment, and the middle portion of the second segment.

[0016] In some embodiments, the distal end of the flexible electrode includes a plurality of filamentous portions, which are arranged in a predetermined manner on the electrode placement seat for supporting the distal end; the predetermined arrangement includes at least one of the following: parallel arrangement, stacked arrangement, and staggered arrangement along the length direction of the filamentous portions.

[0017] Compared with related technologies, the beneficial effects of the embodiments of this application are as follows: By setting an electrode placement surface on the electrode placement seat, at least part of the distal end of the flexible electrode is attached to the electrode placement surface. Simultaneously, a liquid retention structure located in a localized depression on the electrode placement surface and / or near the distal end region can contain and adsorb the liquid adsorbed from the distal end of the flexible electrode. At the instant the flexible electrode separates from the electrode placement surface, the solid-liquid interaction between the liquid adhering to the liquid retention structure and the flexible electrode can be utilized to prevent sudden deformation and movement of the flexible electrode. This effectively reduces the risk of the flexible electrode detaching from the auxiliary implantation needle that guides it into the target tissue, significantly improving the operational stability and success rate of the implantation surgery. Furthermore, the localized depression or distal region setting of the liquid retention structure can concentrate the liquid within a limited space, preventing excessive liquid diffusion and ensuring a concentrated and controllable adsorption effect, further improving the smoothness and reliability of the flexible electrode release process. Attached Figure Description

[0018] In drawings that are not necessarily drawn to scale, the same reference numerals may describe similar parts in different views. The drawings generally illustrate various embodiments by way of example rather than limitation and are used, together with the description and claims, to illustrate the disclosed embodiments. Where appropriate, the same reference numerals are used in all drawings to refer to the same or similar parts. Such embodiments are illustrative and not intended to be exhaustive or exclusive embodiments of the apparatus or method.

[0019] Figure 1 This is a schematic diagram of the electrode fixing assembly according to an embodiment of this application, showing a flexible electrode.

[0020] Figure 2 This is a structural schematic diagram of the electrode fixing assembly from another perspective in an embodiment of this application.

[0021] Figure 3 This is a schematic diagram of the electrode fixing assembly according to an embodiment of this application. The flexible electrode is not shown in the figure.

[0022] Figure 4 This is a schematic diagram of the structure of an electrode implantation device using the electrode fixation assembly of an embodiment of this application, showing the functional modules.

[0023] Figure 5 This is a schematic diagram of the structure of an electrode implantation device using the electrode fixation assembly of the present application embodiment. The functional modules are not shown in the figure.

[0024] The components indicated by the reference numerals in the figure: 1. Flexible electrode; 11. Distal end; 2. Electrode placement seat; 21. Electrode placement surface; 22. Groove; 23. Lateral placement surface; 24. Inclined placement surface; 25. Connecting part; 26. Potting hole; 27. First opening; 28. Second opening; 3. Liquid retention structure; 4. Support plate; 5. Functional module; 6. Mounting bracket. Detailed Implementation

[0025] To enable those skilled in the art to better understand the technical solutions of this application, the application will be described in detail below with reference to the accompanying drawings and specific embodiments. The embodiments of this application will be further described in detail below with reference to the accompanying drawings and specific examples, but these are not intended to limit the scope of this application.

[0026] The terms "first," "second," and similar words used in this application do not indicate any order, quantity, or importance, but are merely used to distinguish different parts. Words such as "including" or "contains" mean that the element preceding the word encompasses the element listed after it, and do not exclude the possibility of encompassing other elements as well. Terms such as "above," "below," "left," and "right" are used only to indicate relative positional relationships; when the absolute position of the described object changes, this relative positional relationship may also change accordingly.

[0027] In this application, when a specific device is described as being located between a first device and a second device, an intermediary device may or may not be present between the specific device and the first or second device. When a specific device is described as being connected to other devices, the specific device may be directly connected to the other devices without an intermediary device, or it may not be directly connected to the other devices but may have an intermediary device.

[0028] All terms used in this application (including technical or scientific terms) have the same meaning as understood by one of ordinary skill in the art to which this application pertains, unless otherwise specifically defined. It should also be understood that terms defined in general dictionaries should be interpreted as having a meaning consistent with their meaning in the context of the relevant art, and not as having an idealized or highly formalized meaning, unless expressly defined herein.

[0029] Techniques, methods, and equipment known to those skilled in the art may not be discussed in detail, but where appropriate, such techniques, methods, and equipment should be considered part of the specification.

[0030] This application provides an electrode fixing assembly for fixing a flexible electrode 1. Figures 1 to 3As shown, the electrode fixation assembly includes an electrode placement seat 2 and a liquid retention structure 3. The electrode placement seat 2 has an electrode placement surface 21 on which at least a portion of the distal end 11 of the flexible electrode 1 is attached. The liquid retention structure 3 is located in a partial recess of the electrode placement surface 21 and / or in a region of the electrode placement seat 2 near the end of the distal end 11. The liquid retention structure 3 is used to contain liquid (such as physiological saline or medical-grade solution) that adsorbs the distal end 11 of the flexible electrode 1.

[0031] like Figure 4 and Figure 5 As shown, the proximal end of the flexible electrode 1 can be electrically connected to the action module 5 of the electrode implantation device. The action module 5 may include a stimulation module and / or a acquisition module. When the action module 5 includes a stimulation module, the stimulation module can be electrically connected to the electrode site on the flexible electrode 1 of the electrode implantation device to apply electrical stimulation to the target tissue through the electrode site. When the action module 5 includes a acquisition module, the acquisition module can be electrically connected to the electrode site on the flexible electrode 1 of the electrode implantation device to acquire the potential signal of the target tissue through the electrode site.

[0032] The aforementioned flexible electrode 1 can be made of flexible materials (such as flexible insulating materials like polyimide, phenelzine, or silicone). The flexible materials used give the flexible electrode 1 good flexibility and biocompatibility, allowing it to better adapt to the shape and movement of nerve tissue, thereby reducing mechanical pressure and damage to surrounding tissues. Specifically, the aforementioned flexible electrode 1 can be constructed as a sheet-like structure.

[0033] like Figure 4 and Figure 5 As shown, the electrode implantation device using the above-mentioned electrode fixation assembly may further include a mounting frame 6, and the action module 5 may be detachably connected to the mounting frame 6. The mounting frame 6 is used for installing and releasing the action module 5.

[0034] The electrode implantation device using the above-described electrode fixation assembly may further include an auxiliary implantation needle. This auxiliary implantation needle applies a pulling force to first separate the distal end 11 of the flexible electrode 1 from the support plate 4, and then detach it from the cladding surface. In this way, the distal end 11 of the flexible electrode 1 can be safely and accurately transported and implanted into the target tissue via the auxiliary implantation needle. The rigidity of the auxiliary implantation needle provides the necessary thrust for implantation of the flexible electrode 1, enabling it to penetrate the tissue to the designated depth, thus compensating for the insufficient rigidity of the flexible electrode 1 itself.

[0035] The distal end 11 of the flexible electrode 1 is provided with an auxiliary implantation hole. The auxiliary implantation needle and the auxiliary implantation hole form a detachable insertion fit so as to apply a pulling force to the distal end 11 of the flexible electrode 1 through the auxiliary implantation hole.

[0036] The aforementioned auxiliary implantation needle can be a slender needle-like instrument made of high-rigidity medical metals (such as stainless steel or nickel-titanium alloy), with a diameter typically in the sub-millimeter range, in order to minimize puncture trauma to the target tissue.

[0037] The aforementioned electrode fixation assembly can be understood as an auxiliary device for temporarily fixing and maintaining the posture of the flexible electrode 1 during the implantation surgery. It is used to provide physical support and positioning reference for the flexible electrode 1, and its shape and size can be adapted to the specific shape of the distal end 11 of the flexible electrode 1.

[0038] The electrode placement surface 21 of the electrode placement base 2 is the surface area on the electrode placement base 2 used to directly contact and support the flexible electrode 1. At least a portion of the distal end 11 of the flexible electrode 1 is attached to the electrode placement surface 21. The term "attachment" can be understood as the distal end 11 of the flexible electrode 1 being physically attached to the electrode placement surface 21, rather than being fixed by chemical bonding methods such as adhesives. This attachment method is beneficial for achieving non-damaging separation of the flexible electrode 1 from the electrode fixation component after implantation.

[0039] The distal end 11 of the aforementioned flexible electrode 1 can be understood as the end of the flexible electrode 1 that is far from the action module 5 and enters the target tissue first. The distal end 11 needs to maintain a stable shape and precise orientation during implantation.

[0040] like Figure 1 As shown, Figure 1 The distal end 11 shown is the end of the distal end 11, and Figure 1 The liquid retention structure 3 shown below is located in a partial recess of the electrode placement surface 21, while the liquid retention structure 3 above is located in the region of the electrode placement seat 2 near the end of the distal end 11.

[0041] Understandably, the liquid retention structure 3 is used to contain and adsorb the liquid used to wet the distal end 11 of the flexible electrode 1. Specifically, the liquid retention structure 3 can be configured in two ways. The first configuration: the liquid retention structure 3 is located in a localized recess on the electrode placement surface 21, forming a depression area on the surface of the electrode placement surface 21 that is lower than the surrounding plane. This depression area can store a certain amount of liquid using its recessed spatial structure, and because the depression is lower than the surrounding surface, the liquid is less likely to leak outwards or diffuse excessively, thus forming a stable liquid retention area locally. The second configuration: the liquid retention structure 3 is located on the electrode placement base 2 near the end of the distal end 11, i.e., the liquid retention structure 3 is positioned on the electrode placement base 2 adjacent to the end of the distal end 11, thereby providing a liquid adsorption source near the end. These two configurations can be used individually or simultaneously to create a synergistic liquid adsorption effect at different locations.

[0042] This application provides an electrode placement surface 21 on the electrode placement base 2, allowing at least a portion of the distal end 11 of the flexible electrode 1 to adhere to the electrode placement surface 21. Simultaneously, a liquid retention structure 3 located in a localized recess on the electrode placement surface 21 and / or near the distal end 11 contains the liquid adsorbed from the distal end 11 of the flexible electrode 1. At the moment of separation between the flexible electrode 1 and the electrode placement surface 21, the solid-liquid interaction between the liquid adhering to the liquid retention structure 3 and the flexible electrode 1 prevents sudden deformation and movement of the flexible electrode 1, effectively reducing the risk of the flexible electrode 1 detaching from the auxiliary implantation needle that guides it into the target tissue. This significantly improves the operational stability and success rate of the implantation surgery. Furthermore, the localized recess or distal region of the liquid retention structure 3 allows for concentrated liquid retention within a limited space, preventing excessive liquid diffusion and ensuring a concentrated and controllable adsorption effect, further enhancing the smoothness and reliability of the release process of the flexible electrode 1. The solid-liquid interaction between the liquid and the flexible electrode 1 can be understood as the liquid-solid interface force between the liquid adhering to the liquid retention structure 3 and the flexible electrode 1.

[0043] In some embodiments, such as Figures 1 to 3 As shown, the upper part of the electrode placement seat 2 has a groove 22 with a liquid retention structure 3. A support plate 4 is provided in the groove 22. A liquid retention area is formed on the side of the support plate 4 facing the flexible electrode 1, so as to at least attach the end of the distal end 11 of the flexible electrode 1.

[0044] Thus, the groove 22 supports the distal end 11 of the flexible electrode 1, and the liquid in the groove 22 permeates into the support plate 4 to form a liquid retention area on the side facing the flexible electrode 1. This can form a stable adsorption force on the end when the flexible electrode 1 is released, effectively preventing the distal end 11 from lifting or detaching out of control, thereby improving the accuracy of the implanted end positioning.

[0045] The upper groove 22 of the electrode placement seat 2 can be understood as a specific physical realization of the liquid retention structure 3, which provides a storage and containment space for liquid through the recessed space. A support plate 4 is disposed within the groove 22. The support plate 4 directly supports and bears the distal end 11 of the flexible electrode 1, preventing the flexible electrode 1 from collapsing or curling due to its own flexibility. Specifically, the support plate 4 can be made of biomedical materials with excellent rigidity and bending resistance, such as medical-grade stainless steel, titanium alloy, or polyetheretherketone (PEEK), and its shape is generally a thin sheet structure. The main function of the support plate 4 is to provide a stable support base for the distal end 11 of the flexible electrode 1, which is not easily deformed by external forces, thereby ensuring the controllable posture of the electrode tip during loading and implantation.

[0046] On the surface of the support plate 4 facing the flexible electrode 1, liquid transferred from inside the groove 22 through a permeation pathway is distributed. The liquid gradually migrates and spreads evenly on this side surface of the support plate 4 by means of permeation, forming a thin liquid film of uniform thickness on it, thereby constructing a liquid retention area.

[0047] The support plate 4 can be further made of a release silicon wafer, which is made of a silicon-based material with low surface adhesion properties. This material property helps the liquid spread and form a film quickly on its surface, and also allows the flexible electrode 1 to separate smoothly from the surface of the support plate 4 when it needs to be detached, reducing separation resistance.

[0048] like Figure 3 As shown, the upper part of the groove 22 has a first opening 27 and a second opening 28 separated by phase. The first opening 27 is positioned close to the flexible electrode 1 relative to the second opening 28, and the support plate 4 is inserted into the groove 22 through the first opening 27. In this way, by setting the separated first opening 27 and second opening 28, stable positioning of the support plate 4 can be achieved.

[0049] In some embodiments, such as Figure 1 As shown, a fluid flow gap is formed between the side wall of the groove 22 near the flexible electrode 1 and the support plate 4.

[0050] In this way, by setting the liquid flow gap, it can be ensured that the liquid retention area is continuously filled with liquid, avoiding the decrease in adsorption force due to the inability to replenish the liquid after it is consumed, thereby improving the continuity and stability of the adsorption effect.

[0051] The aforementioned liquid flow gap allows the liquid to form a flow path between the bottom of the groove 22 and the liquid retention area of ​​the support plate 4. When the liquid in the liquid retention area decreases due to evaporation, gravity loss, or absorption by the flexible electrode 1, the liquid stored in the groove 22 can be replenished to the liquid retention area through the liquid flow gap, thereby maintaining the wet state and adsorption capacity of the liquid retention area.

[0052] In some embodiments, the electrode fixing assembly further includes a support plate 4, at least a portion of the distal end 11 of the flexible electrode 1 is fixed to the first plate surface of the support plate 4; the distal end 11 of the flexible electrode 1 is configured to overcome the fixing force with the support plate 4 and detach from the support plate 4 when subjected to a tensile force greater than or equal to a preset threshold.

[0053] Thus, by setting the support plate 4, a stable, flat and deformation-free attachment base can be provided for the distal end 11 of the flexible electrode 1 before implantation, avoiding the flexible electrode 1 from curling, wrinkling or shifting in position during the laying process due to its own flexibility. This ensures that the distal end 11 of the electrode always maintains the preset shape and spatial position accuracy before implantation, providing a reliable structural guarantee for the precise action of the subsequent auxiliary implantation needle.

[0054] The aforementioned support plate 4 can be made of materials with certain hardness and bending strength (such as silicon wafers, glass sheets, medical-grade stainless steel, titanium alloys, or polyetheretherketone, etc.). The support plate 4 can be in the form of a thin sheet, and its function is to provide a stable attachment base for the distal end 11 of the flexible electrode 1, which does not deform significantly with external force.

[0055] The aforementioned preset threshold can be set based on the fixing strength between the distal end 11 and the support plate 4. When the pulling force is less than the preset threshold, the distal end 11 is firmly fixed to the support plate 4 and will not move; when the pulling force is greater than or equal to the preset threshold, the fixing relationship between the distal end 11 and the support plate 4 is broken, and the distal end 11 can begin to detach from the support plate 4.

[0056] In some embodiments, when the upper part of the electrode placement seat 2 has a groove 22 configured as a liquid retention structure 3, the support plate 4 extends at least partially into the groove 22, and the first plate surface carries the liquid supplied through the groove 22.

[0057] Thus, by extending at least part of the support plate 4 into the groove 22 and supplying the liquid in the groove 22 to the first plate surface, a suitable amount of liquid can be continuously maintained on the first plate surface by utilizing the liquid storage function of the groove 22 and the guiding effect of the support plate 4 without adding an additional complex liquid supply structure.

[0058] In some embodiments, the support plate 4 is detachably mounted on the electrode fixing assembly, or the support plate 4 is integrally formed with the electrode fixing assembly.

[0059] In some embodiments, such as Figures 1 to 3 As shown, the electrode placement surface 21 has a transverse placement surface 23 and an inclined placement surface 24 arranged sequentially along the length direction of the flexible electrode 1, and the liquid retention structure 3 is located in a local depression of the transverse placement surface 23. Combined with... Figure 1 , Figure 1 The liquid retention structure 3 shown below is located in a partial recess of the transverse placement surface 23.

[0060] Thus, by setting the liquid retention structure 3 in a local depression of the transverse placement surface 23, the liquid can be concentrated in the transverse extension area of ​​the flexible electrode 1, which reduces the disorderly flow of the liquid while ensuring the adsorption effect, making the separation process between the flexible electrode 1 and the electrode placement surface 21 more stable and controllable.

[0061] The aforementioned support plate 4 can be tilted within the groove 22 so that the distal end 11 of the flexible electrode 1 attached thereto can obtain an orientation angle adapted to the implantation path of the target tissue. This tilting setting can flexibly adapt to the implantation operation requirements of different directions and angles in clinical applications, improving the adaptability of the device to different surgical scenarios.

[0062] The electrode placement surface 21 can be understood as a continuous surface area on the electrode placement base 2 used to support the flexible electrode 1, and is divided into a transverse placement surface 23 and an inclined placement surface 24 along the length of the flexible electrode 1. The transverse placement surface 23 is mainly used to support the relatively straight part of the distal end 11 of the flexible electrode 1, such as the front end and middle of the distal end 11 of the flexible electrode 1. The inclined placement surface 24 can be understood as a placement area set at a certain angle with the transverse placement surface 23, used to accommodate the bending or gradual change direction that the flexible electrode 1 may have at the distal end 11, so that the overall shape of the flexible electrode 1 can naturally conform to the contour of the electrode placement surface 21.

[0063] The liquid retention structure 3 is specifically set in a local depression of the transverse placement surface 23. The local depression refers to a depression area formed on the surface of the transverse placement surface 23 that is lower than the surrounding surface. This depression area can collect and contain liquid, making it difficult for the liquid to diffuse and leak to the surroundings.

[0064] In some embodiments, such as Figures 1 to 3 As shown, the liquid retention structure 3 located on the transverse placement surface 23 is used at least for attaching the front end and / or the middle part of the distal end 11 of the flexible electrode 1.

[0065] Thus, by using the liquid retention structure 3 to precisely adsorb the front end and / or middle part of the distal end 11, a stable constraint can be provided for the flexible electrode 1 during implantation, effectively preventing the flexible electrode 1 from shifting or wrinkling during puncture or advancement.

[0066] The distal end 11 of the aforementioned flexible electrode 1 can be divided into a front end, a middle end, and a terminal end along its length. The front end refers to the portion of the distal end 11 that is close to the proximal end of the flexible electrode 1, and the middle end refers to the intermediate section on the distal end 11 that connects the front end and the terminal end. The terminal end, middle end, and front end of the distal end 11 enter the target tissue in sequence.

[0067] In some embodiments, such as Figures 1 to 3As shown, a smooth arc surface is formed at the junction of the horizontal placement surface 23 and the inclined placement surface 24.

[0068] In this way, the smooth arc surface allows the flexible electrode 1 to transition naturally between the horizontal placement surface 23 and the inclined placement surface 24, avoiding local stress concentration or scratches caused by corners or sharp edges on the flexible electrode 1.

[0069] The horizontal placement surface 23 and the inclined placement surface 24 form a connecting boundary at their intersection due to their different orientations and angles. This connecting point is provided with a smooth arc surface, that is, the transition between the horizontal placement surface 23 and the inclined placement surface 24 is achieved in the form of an arc surface rather than a right angle or a sharp angle.

[0070] The radius of curvature of the aforementioned smooth arc surface can be set according to the bending stiffness and minimum bending radius of the flexible electrode 1 to ensure that the flexible electrode 1 can bend naturally without excessive elastic deformation when it is attached to the electrode placement surface 21. This smooth arc surface can, on the one hand, avoid forming sharp edges at the joint that would scratch the surface insulation layer or electrode sites of the flexible electrode 1, and on the other hand, eliminate the local stress concentration caused by the angle, preventing fatigue fracture of the flexible electrode 1 during long-term attachment or repeated assembly and disassembly.

[0071] In some embodiments, such as Figures 1 to 3 As shown, the electrode placement base 2 has a connecting portion 25, and a potting hole 26 is formed on the connecting portion 25.

[0072] In this way, the connecting part 25 can be glued and fixed to the external implantation tool through the glue hole 26, such as fixing it to the mounting bracket 6, which not only ensures the positional stability of the electrode placement seat 2 during the implantation operation, but also achieves a stable connection through glue bonding.

[0073] The aforementioned potting hole 26 can be a through-hole structure that penetrates or partially penetrates the wall of the connecting part 25, used to inject adhesive into the mating gap between the connecting part 25 and the mounting bracket 6 during assembly. After the adhesive enters the connecting area through the potting hole 26, it cures, thereby fixing the electrode placement seat 2 and the mounting bracket 6 together.

[0074] The diameter, number, and distribution of the aforementioned potting holes 26 can be optimized according to the requirements of connection strength and adhesive flowability, so as to balance connection reliability and ease of separation.

[0075] In some embodiments, the electrode placement base 2 is provided with a plurality of calibration parts (not shown in the figure), which are used to calibrate the position of the electrode placement base 2.

[0076] In this way, the spatial position and orientation of the electrode placement seat 2 can be confirmed in real time during the implantation surgery through the cooperation of multiple calibration units, providing a positioning reference for the surgical navigation system, thereby improving the accuracy of implantation path planning and surgical safety.

[0077] The aforementioned calibration section can be a marker structure with identifiable features disposed on the electrode placement base 2, with multiple calibration sections arranged in a predetermined spatial layout on the electrode placement base 2. The calibration sections can employ visual markers, magnetic markers, or other forms to adapt to surgical navigation and positioning systems based on different principles. When multiple calibration sections are used in conjunction, the surgical navigation system can identify the spatial coordinates of the multiple calibration sections, calculate and calibrate the precise position and orientation angle of the electrode placement base 2 in three-dimensional space, ensuring that the flexible electrode 1 enters the target tissue at the preset implantation angle and depth.

[0078] This application also provides an electrode implantation device, including the electrode fixation component of any of the above embodiments, and further including a flexible electrode 1, at least a portion of the flexible electrode 1 being attached to the electrode fixation component.

[0079] The flexible electrode 1, as an implant, has its proximal end used for electrical connection with the action module 5 of the electrode implantation system. When the action module 5 includes a stimulation module, the stimulation module can apply electrical stimulation signals to the target tissue through the electrode sites on the flexible electrode 1 to achieve neuromodulation. When the action module 5 includes a acquisition module, the acquisition module can acquire the potential signals of the target tissue through the electrode sites to achieve neural signal monitoring.

[0080] The flexible electrode 1 can be made of flexible materials (such as flexible insulating materials like polyimide, phenelzine, or silicone). This flexibility allows the flexible electrode 1 to adapt to the shape and movement of nerve tissue, reducing mechanical pressure and damage to surrounding tissues. By pre-attaching the flexible electrode 1 to the electrode fixation assembly, the electrode implantation device can be operated as a whole during the implantation surgery, avoiding the cumbersome process of loading and positioning the flexible electrode 1 on-site.

[0081] The aforementioned flexible electrode 1 can be specifically constructed as a layered structure, including at least a first insulating layer, a conductive layer, and a second insulating layer arranged sequentially. The connecting contact point, connecting lead, and electrode site are disposed in the conductive layer, and the connecting contact point and electrode site are exposed in the second insulating layer.

[0082] like Figure 4 and Figure 5 As shown, the electrode implantation device may also include a mounting frame 6, and the action module 5 may be detachably connected to the mounting frame 6. The mounting frame 6 is used for installing and releasing the action module 5.

[0083] The electrode implantation device may also include an auxiliary implantation needle, the distal end of which acts on the distal end 11 of the flexible electrode 1 to drive the distal end 11 of the flexible electrode 1 into the target tissue. Thus, the distal end 11 of the flexible electrode 1 can be safely and accurately transported and implanted into the target tissue via the auxiliary implantation needle. The rigidity of the auxiliary implantation needle provides the necessary thrust for implantation of the flexible electrode 1, enabling it to penetrate the tissue to reach the designated depth, thus compensating for the insufficient rigidity of the flexible electrode 1 itself.

[0084] The aforementioned auxiliary implantation needle can be a slender needle-like instrument made of high-rigidity medical metals (such as stainless steel or nickel-titanium alloy), with a diameter typically in the sub-millimeter range, in order to minimize puncture trauma to the target tissue.

[0085] The electrode implantation device employing the aforementioned electrode fixation assembly provides an electrode placement surface 21 on the electrode placement seat 2, allowing at least a portion of the distal end 11 of the flexible electrode 1 to adhere to this surface. Simultaneously, a liquid retention structure 3 located in a localized recess on the electrode placement surface 21 and / or near the distal end 11 contains the liquid adsorbed from the distal end 11 of the flexible electrode 1. At the moment of separation between the flexible electrode 1 and the electrode placement surface 21, the solid-liquid interaction between the liquid adhering to the liquid retention structure 3 and the flexible electrode 1 prevents sudden deformation and movement of the flexible electrode 1, effectively reducing the risk of the flexible electrode 1 detaching from the auxiliary implantation needle that guides it into the target tissue. This significantly improves the operational stability and success rate of the implantation surgery. Furthermore, the localized recess or distal region of the liquid retention structure 3 allows for concentrated liquid retention within a limited space, preventing excessive liquid diffusion and ensuring a concentrated and controllable adsorption effect, further enhancing the smoothness and reliability of the flexible electrode 1 release process.

[0086] In some embodiments, the distal end 11 of the flexible electrode 1 includes at least a first segment and a second segment, with the first segment located at the distal end of the second segment; the liquid retention structure 3 is disposed at at least one of the following locations corresponding to the flexible electrode 1: the distal end of the second segment, the proximal end of the second segment, and the middle portion of the second segment.

[0087] The aforementioned first segment can be understood as the part that is subjected to force, causing the flexible electrode 1 to move in the implantation direction. Specifically, the first segment is the region at the farthest end of the distal end 11 of the flexible electrode 1, which directly or indirectly receives the propulsive force from the auxiliary implantation needle. When the auxiliary implantation needle is advanced along the implantation direction (i.e., towards the interior of the target tissue), the propulsive force first acts on the first segment, and then is transmitted from the first segment to the entire flexible electrode 1, thereby driving the entire flexible electrode 1 to move along the implantation direction and enter the target tissue.

[0088] Of the three portions of the second segment, at least the distal end is attached to the electrode placement surface 21. As the farthest end of the flexible electrode 1, the force state it experiences at the moment of separation has the greatest impact on the overall risk of detachment. By ensuring that the distal end is at least supported by the electrode placement surface 21 and that the liquid retention area is set corresponding to the distal end of the second segment, the solid-liquid interaction between the liquid in the liquid retention area and the flexible electrode 1 can be used to avoid sudden deformation and movement of the flexible electrode 1, thereby effectively reducing the risk of the flexible electrode 1 detaching from the auxiliary implantation needle that carries it to the target tissue.

[0089] In some embodiments, at least a portion of the second segment of the flexible electrode 1 is fixed to the first plate surface of the support plate 4; the second segment is configured to overcome the fixing force between itself and the support plate 4 and detach from the support plate 4 when subjected to a tensile force greater than or equal to a preset threshold.

[0090] In some embodiments, the first segment is not adhered to the paving surface and is in a free state.

[0091] In this way, by keeping the first segment from being in contact with the electrode placement surface 21 and keeping the first segment in a free state, the auxiliary implantation needle can be prevented from being constrained or interfered with by the electrode placement surface 21 when it acts on the first segment. This allows the auxiliary implantation needle to freely approach and act on the first segment, ensuring that the propulsion force can be efficiently and smoothly transmitted to the first segment of the flexible electrode 1.

[0092] In some embodiments, the flexible electrode 1 is fabricated on a temporary processing substrate, and the support plate 4 is a portion of the temporary processing substrate retained after the processing of the flexible electrode 1 is completed.

[0093] In this way, by limiting the support plate 4 to a portion of the temporary processing base that is retained after the processing of the flexible electrode 1, the positioning function of the temporary processing base on the flexible electrode 1 can be fully utilized. Rigid support and precise positioning of the second section of the flexible electrode 1 can be achieved without the need to add an additional independent rigid base plate component. This simplifies the device structure, reduces the number of parts, and lowers manufacturing costs and assembly complexity.

[0094] A temporary processing substrate can be understood as a plate-shaped base component used to temporarily support and maintain the shape of the flexible electrode 1 during the manufacturing or assembly process. During the production or pre-processing stage of the flexible electrode 1, the flexible electrode 1 is typically fixed to the temporary processing substrate to facilitate subsequent processing, transportation, or intraoperative operations. The temporary processing substrate can be made of a material with a certain degree of rigidity and flatness, providing shape retention and positional stability for the flexible electrode 1. Peeling off the flexible electrode 1 can be understood as the action or process of separating the flexible electrode 1 from the temporary processing substrate.

[0095] In some embodiments, the temporary processing substrate is made of silicon wafer or glass sheet. Thus, by using silicon wafer or glass sheet as a temporary processing substrate, a reliable processing foundation can be provided for the high-precision fabrication of flexible electrode 1. At the same time, when the portion of silicon wafer or glass sheet retained after processing serves as support plate 4, its good rigidity and dimensional stability can meet the requirements for rigid support and precise positioning of the distal end 11 of flexible electrode 1 during implantation surgery.

[0096] In some embodiments, an adhesive layer is provided on the surface of the temporary processing substrate facing the flexible electrode 1, and the flexible electrode 1 is temporarily fixed to the support plate 4 by the adhesive layer; when the second segment is subjected to a tensile force greater than or equal to a preset threshold, the second segment overcomes the adhesive force of the adhesive layer and detaches from the support plate 4, so that the second segment of the flexible electrode 1 can be reliably held in a predetermined position on the support plate 4 by utilizing the adhesive force of the adhesive layer, preventing the flexible electrode 1 from shifting or falling off during processing, transportation and preoperative preparation.

[0097] In some embodiments, the adhesive layer is made of aluminum or titanium.

[0098] In some embodiments, such as Figures 1 to 3 As shown, the distal end 11 of the flexible electrode 1 includes multiple filamentous portions, which are arranged in a preset manner on the electrode placement seat 2 for supporting the distal end 11. The preset arrangement includes at least one of the following: parallel arrangement, stacked arrangement, and staggered arrangement along the length direction of the filamentous portions.

[0099] Thus, by increasing the contact points between the flexible electrode 1 and the target tissue, the stimulation or recording effect after implantation can be improved. At the same time, arranging these filamentous functional segments in a preset pattern on the distal electrode placement surface 21 helps to maintain the neatness and positional stability of each filamentous functional segment before implantation, facilitating the uniform operation of subsequent auxiliary implantation needles.

[0100] The aforementioned parallel arrangement can be understood as multiple filamentous functional segments being arranged on the electrode placement surface 21 in a manner that is generally parallel to each other, maintains a certain distance between them, and does not intertwine or entangle. By uniformly arranging the distal regions of multiple filamentous functional segments side by side on the electrode placement surface 21 used for attaching the distal regions, the positioning and constraint functions of the electrode placement surface 21 can be used to fix the relative positions of each filamentous functional segment during the pre-implantation preparation stage, thereby providing convenient conditions for the subsequent auxiliary implantation needle to be simultaneously aligned with and act on the filamentous functional segments.

[0101] The aforementioned layered arrangement can be understood as multiple filamentary functional segments being stacked sequentially along the thickness direction on the electrode placement surface 21, meaning that different filamentary functional segments occupy different height levels in the direction perpendicular to the electrode placement surface 21. By adopting a layered arrangement, a greater number of filaments can be accommodated within the limited area of ​​the electrode placement surface 21, thereby increasing the channel density of the flexible electrode 1 per unit area.

[0102] The aforementioned staggered arrangement along the length of the filamentous functional segments can be understood as follows: when multiple filamentous functional segments are arranged on the electrode placement surface 21, the distal ends of the second segment of each filamentous functional segment are not flush in the extension direction, but rather have a predetermined offset in the length direction, so that the distal ends of the second segment of each filamentous functional segment present a stepped or staggered distribution pattern along the implantation direction. This staggered arrangement allows each filamentous functional segment to reach different longitudinal depths within the tissue, facilitating simultaneous electrical stimulation or signal acquisition at different tissue levels and expanding the range of action of the flexible electrode 1 in the longitudinal dimension.

[0103] Furthermore, although exemplary embodiments have been described herein, their scope includes any and all embodiments based on this application that have equivalent elements, modifications, omissions, combinations (e.g., schemes involving intersections of various embodiments), adaptations, or alterations. Elements in the claims will be interpreted broadly based on the language used in the claims and are not limited to the examples described in this specification or during the implementation of this application, and such examples will be interpreted as non-exclusive.

[0104] The above description is intended to be illustrative and not restrictive. For example, the above examples (or one or more of them) can be used in combination with each other. Other embodiments can be used by those skilled in the art when reading the above description. Furthermore, in the above detailed description, various features may be grouped together to simplify the application. This should not be construed as an intention that a disclosed feature not claimed is necessary for any claim. Rather, the subject matter of the application may be less than all the features of a particular disclosed embodiment. Thus, the claims are incorporated herein by reference as examples or embodiments, wherein each claim is an independent, separate embodiment, and these embodiments are contemplated as being able to be combined with each other in various combinations or arrangements. The scope of this application should be determined by reference to the appended claims and the full scope of their equivalents.

[0105] The above embodiments are merely exemplary embodiments of this application and are not intended to limit this application. The scope of protection of this application is defined by the claims. Those skilled in the art can make various modifications or equivalent substitutions to this application within its substance and scope of protection, and such modifications or equivalent substitutions should also be considered to fall within the scope of protection of this application.

Claims

1. An electrode fixing assembly, characterized in that, For fixing a flexible electrode, the electrode fixing assembly includes: An electrode holder having an electrode placement surface on which at least a portion of the distal end of the flexible electrode is attached; A liquid containment structure is located in a partial recess on the electrode placement surface and / or in a region of the electrode placement seat near the distal end, the liquid containment structure being used to contain liquid adsorbed onto the distal end of the flexible electrode.

2. The electrode fixing assembly according to claim 1, characterized in that, The upper part of the electrode placement seat has a groove configured as the liquid retention structure, and a support plate is provided in the groove. The support plate has a liquid retention area on the side facing the flexible electrode, which is used to attach at least the distal end of the flexible electrode.

3. The electrode fixing assembly according to claim 2, characterized in that, A fluid flow gap is formed between the sidewall of the groove near the flexible electrode and the support plate.

4. The electrode fixing assembly according to claim 1 or 2, characterized in that, The electrode fixing assembly further includes a support plate, and at least a portion of the distal end of the flexible electrode is fixed to a first plate surface of the support plate; the distal end of the flexible electrode is configured to overcome the fixing force with the support plate and detach from the support plate when subjected to a tensile force greater than or equal to a preset threshold.

5. The electrode fixing assembly according to claim 4, characterized in that, When the upper part of the electrode placement seat has a groove configured as the liquid retention structure, the support plate extends at least partially into the groove, and the first plate surface carries the liquid supplied through the groove.

6. The electrode fixing assembly according to claim 1, characterized in that, The electrode placement surface has a transverse placement surface and an inclined placement surface arranged sequentially along the length direction of the flexible electrode, and the liquid retention structure is located in a local depression of the transverse placement surface.

7. The electrode fixing assembly according to claim 6, characterized in that, The liquid retention structure located on the lateral placement surface is used at least for attaching the front end and / or the middle part of the distal end of the flexible electrode.

8. The electrode fixing assembly according to claim 6, characterized in that, The junction between the horizontal and inclined placement surfaces forms a smooth arc surface.

9. The electrode fixing assembly according to claim 1, characterized in that, The electrode holder has a connecting portion, on which a potting hole is formed.

10. The electrode fixing assembly according to claim 1, characterized in that, The electrode holder is provided with multiple calibration parts, which are used to calibrate the position of the electrode holder.

11. An electrode implantation device, characterized in that, The device includes the electrode fixing assembly as described in any one of claims 1 to 10, and further includes a flexible electrode, at least a portion of which is attached to the electrode fixing assembly.

12. The electrode implantation device according to claim 11, characterized in that, The distal end of the flexible electrode includes at least a first segment and a second segment, wherein the first segment is located on the distal side of the second segment; the liquid retention structure is provided at at least one of the following locations corresponding to the flexible electrode: the distal end of the second segment, the proximal end of the second segment, and the middle portion of the second segment.

13. The electrode implantation device according to claim 11, characterized in that, The distal end of the flexible electrode includes multiple filamentous portions, which are arranged in a preset manner on the electrode placement seat for supporting the distal end. The preset arrangement includes at least one of the following: parallel arrangement, stacked arrangement, and staggered arrangement along the length direction of the filamentous portions.

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