An electrode implantation device

Abstract

The application provides an electrode implantation device. The electrode implantation device comprises a flexible electrode, an auxiliary implant, a sliding guide assembly and a kinetic energy releasing mechanism. The distal end of the auxiliary implant acts on the distal end of the flexible electrode. The sliding guide assembly comprises a sliding channel and a sliding member, and the extension direction of the sliding channel is the same as the implantation direction of the flexible electrode. The kinetic energy releasing mechanism has a first position away from the sliding member and a second position pushing the sliding member. When the kinetic energy releasing mechanism moves from the first position to the second position, the accumulated potential energy is transmitted to the sliding member, so that the sliding member moves in the sliding channel towards the auxiliary implant and acts on the proximal end of the auxiliary implant, so as to drive the auxiliary implant to carry the flexible electrode to implant the target tissue. The above structure can realize the release of potential energy by the kinetic energy releasing mechanism, so that the auxiliary implant obtains sufficient instantaneous speed in a very short time, thereby carrying the flexible electrode to cross the surface of the target tissue and directly penetrate into the target tissue.

Description

Technical Field

[0001] This application relates to the field of implantable medical device technology, and more particularly to an electrode implantation device. Background Technology

[0002] With the development of invasive brain-computer interfaces and high-resolution neuromodulation technologies, neural electrodes are evolving towards higher channel counts, smaller sizes, and longer-term stable operation. To improve long-term mechanical compatibility and reduce chronic tissue reactions, flexible electrodes are gaining increasing attention. However, compared to rigid electrode probes, flexible electrode wires have lower bending stiffness, making them prone to bending or deflection when entering soft tissues such as the brain, hindering reliable implantation in the intended direction and depth. While flexible electrodes currently offer advantages in long-term interfacial compatibility, the implantation process itself remains a core challenge in their engineering translation. Existing assisted implantation methods often rely on rigid support carriers, temporary stiffening layers (such as biodegradable polymers), or other structures, but the problem of flexible electrode wires being unable to directly enter soft tissues persists. Summary of the Invention

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

[0004] This application provides an electrode implantation device, which includes a flexible electrode, an auxiliary implant, a sliding guide assembly, and a kinetic energy release mechanism. The distal end of the auxiliary implant acts on the distal end of the flexible electrode. The sliding guide assembly includes a sliding channel and a slider slidably disposed within the sliding channel. The extending direction of the sliding channel is the same as the implantation direction of the flexible electrode, and the distal end of the slider corresponds to the proximal end of the auxiliary implant. The kinetic energy release mechanism has a first position away from the slider and a second position abutting the slider. When the kinetic energy release mechanism moves from the first position to the second position, it transfers the accumulated potential energy to the slider, causing the slider to move towards the auxiliary implant within the sliding channel and act on the proximal end of the auxiliary implant, thereby driving the auxiliary implant to implant the flexible electrode into the target tissue.

[0005] In some embodiments, the kinetic energy release mechanism includes an impact channel and an impact load member located within the impact channel. The impact channel is connected to the sliding channel, and the impact load member is used to apply an impact force to the sliding member when it moves from the first position to the second position within the impact channel.

[0006] In some embodiments, the distal end of the auxiliary implant is detachably connected to the distal end of the flexible electrode to drive the flexible electrode into the target tissue, and the auxiliary implant is used to detach from the flexible electrode when it is withdrawn in a direction opposite to the implantation direction, so that the flexible electrode remains in the target tissue.

[0007] In some embodiments, the kinetic energy release mechanism further includes a first limiting member disposed on the impact channel, the first limiting member being used to limit the maximum impact stroke of the impact load member moving toward the slider.

[0008] In some embodiments, the first limiting member has a plurality of first stop positions arranged sequentially along the extending direction of the sliding channel within the impact channel, and the impact load member abuts against one of the first limiting members located at one of the plurality of first stop positions.

[0009] In some embodiments, the sliding guide assembly further includes a second limiting member disposed on the sliding channel, the second limiting member being used to limit the maximum sliding stroke of the slider toward the auxiliary implant.

[0010] In some embodiments, the second limiting member has a plurality of second stop positions arranged sequentially along the extending direction of the sliding channel within the sliding channel. The sliding member abuts against one of the second limiting members located at one of the plurality of second stop positions, so as to change the maximum sliding stroke of the sliding member by adjusting the position of the second limiting member, thereby changing the implantation depth of the auxiliary implant.

[0011] In some embodiments, when the kinetic energy release mechanism further includes a first limiting member disposed on the impact channel, the first limiting member and the second limiting member are disposed independently of each other.

[0012] In some embodiments, when the kinetic energy release mechanism further includes a first limiting member disposed on the impact channel, at least one of the first limiting member and the second limiting member is provided with a buffer structure.

[0013] In some embodiments, the sliding guide assembly further includes a rebound suppression structure located within the sliding channel and / or on the slider, for suppressing the rebound movement of the slider away from the auxiliary implant.

[0014] In some embodiments, the rebound suppression structure includes at least one of a pawl and ratchet structure, a wedge structure, a friction locking structure, a magnetic holding structure, and a one-way snap-fit ​​structure disposed in the sliding channel; and / or, the rebound suppression structure includes at least one of an elastic damping element, a viscous damping element, and a friction damping element located on the sliding member.

[0015] In some embodiments, the kinetic energy release mechanism further includes a trigger structure disposed on the impact channel, the trigger structure being used to lock the impact load member in the first position and to release the impact load member to move the impact load member to the second position.

[0016] In some embodiments, the potential energy stored in the kinetic energy release mechanism includes at least gravitational potential energy, and the kinetic energy release mechanism is located above the slider to apply a downward impact force to the slider under the action of gravity after release.

[0017] In some embodiments, the kinetic energy release mechanism includes an impact channel and an impact load member located within the impact channel. The impact load member is used to apply an impact force to the slider when it moves from the first position to the second position within the impact channel. The mass of the impact load member is greater than the total mass of the slider and the auxiliary implant.

[0018] In some embodiments, the kinetic energy release mechanism further includes an elastic energy storage element for accumulating elastic potential energy in the first position, the elastic energy storage element being used to apply an elastic force to the impact load member, causing the impact load member to move from the first position to the second position.

[0019] In some embodiments, the kinetic energy release mechanism includes an impact channel, an impact load member, and an elastic energy storage element. The impact load member is located within the impact channel, and the elastic energy storage element is used to accumulate elastic potential energy at the first position. The elastic energy storage element acts on the impact load member, causing the impact load member to transfer both the gravitational potential energy and the elastic potential energy to the sliding member.

[0020] In some embodiments, the flexible electrode includes at least one flexible electrode wire, and the distal end of the auxiliary implant is disposed in a one-to-one correspondence with the distal end of the flexible electrode wire.

[0021] In some embodiments, the flexible electrode wires are multiple, and the multiple flexible electrode wires are arranged in at least one of the following ways: a straight line arrangement, a matrix arrangement, a ring circumferential arrangement, and an arc array arrangement.

[0022] In some embodiments, the proximal ends of the plurality of auxiliary implants are all disposed corresponding to the distal ends of the same slider, so as to act on the proximal ends of the plurality of auxiliary implants via the same slider; or, the proximal ends of the plurality of auxiliary implants are respectively disposed corresponding to the distal ends of independently disposed sliders, so as to act on the proximal ends of the plurality of auxiliary implants via the independent sliders respectively; wherein, the independent sliders respectively correspond to different sliding channels; or, the plurality of auxiliary implants are divided into multiple groups, and the auxiliary implants in the same group are at least disposed corresponding to the distal ends of the same slider, so as to act on the proximal ends of the auxiliary implants in the same group via the same slider.

[0023] In some embodiments, the proximal ends of a plurality of the assistive implants are all connected to a consistency-maintaining structure, and the distal end of the slider is configured to correspond to the proximal end of the assistive implant through the consistency-maintaining structure.

[0024] In some embodiments, the distal surface of the consistency-maintaining structure is a curved surface adapted to the surface of the target tissue.

[0025] In some embodiments, the flexible electrode wire includes at least a first insulating layer, a conductive layer, and a second insulating layer stacked sequentially along the thickness direction, and the distal end of the flexible electrode wire is provided with at least one electrode site, the electrode site being exposed through the first insulating layer and / or the second insulating layer, and the electrode site being used to collect electrophysiological signals of the target tissue and / or apply electrical stimulation to the target tissue.

[0026] In some embodiments, the distal end of the flexible electrode wire is provided with an auxiliary implantation hole, and the distal end of the auxiliary implant is detachably connected to the distal end of the flexible electrode wire through the auxiliary implantation hole.

[0027] In some embodiments, the electrode implantation device further includes an encapsulated implant that is electrically connected to the flexible electrode. The encapsulated implant includes a sealed housing and a processing module disposed inside the sealed housing. The processing module is at least used to process and transmit electrophysiological signals acquired by the flexible electrode, and / or to generate an electrical stimulation signal to be delivered to the flexible electrode.

[0028] Compared with related technologies, the beneficial effects of the embodiments of this application are as follows: This application uses the distal end of the slider to correspond to the proximal end of the auxiliary implant. When the kinetic energy release mechanism moves from the first position to the second position, it can transfer the accumulated potential energy to the slider, so that the slider moves towards the auxiliary implant in the sliding channel and acts on the proximal end of the auxiliary implant to drive the auxiliary implant to drive the flexible electrode to be implanted into the target tissue. The potential energy released by the kinetic energy release mechanism enables the auxiliary implant to obtain sufficient instantaneous speed in a very short time, thereby carrying the flexible electrode across the surface of the target tissue and directly piercing the target tissue. This effectively overcomes the technical problem that the flexible electrode itself has insufficient rigidity, is prone to bending and bending due to tissue resistance, and is difficult to directly puncture into the target tissue. Attached Figure Description

[0029] 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.

[0030] Figure 1 This is a schematic diagram of the electrode implantation device according to an embodiment of this application. The auxiliary implant shown in the figure is in the initial position.

[0031] Figure 2 This is an exploded view of the electrode implantation device according to an embodiment of this application.

[0032] Figure 3 This is a partial structural schematic diagram of the electrode implantation device according to an embodiment of this application, with the auxiliary implant shown in the figure in its initial position.

[0033] Figure 4 This is another partial structural schematic diagram of the electrode implantation device according to an embodiment of this application, showing the auxiliary implant in the initial position.

[0034] Figure 5 This is a schematic diagram of the electrode implantation device according to an embodiment of this application. The auxiliary implant shown in the figure is between the initial position and the implantation position.

[0035] Figure 6 This is a partial structural schematic diagram of the electrode implantation device according to an embodiment of this application. The auxiliary implant shown in the figure is between the initial position and the implantation position.

[0036] Figure 7 This is a schematic diagram of the electrode implantation device according to an embodiment of this application. The auxiliary implant shown in the figure is in the implantation position.

[0037] Figure 8 This is a schematic diagram of the electrode implantation device according to the application embodiment, showing the auxiliary implant in the retracted and separated position.

[0038] The components indicated by the reference numerals in the figure: 1. Flexible electrode; 11. Flexible electrode wire; 2. Auxiliary implant; 3. Sliding guide assembly; 31. Sliding channel; 32. Sliding component; 33. Second limiting component; 4. Kinetic energy release mechanism; 41. Impact channel; 42. Impact load component; 43. First limiting component; 44. Trigger structure; 5. Consistency maintenance structure; 6. Encapsulated implant; 7. Base. Detailed Implementation

[0039] 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.

[0040] 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.

[0041] 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.

[0042] 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.

[0043] 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.

[0044] The terms “proximal” and “distal” refer to the direction closer to or further away from the operator (e.g., surgeon, physician, nurse, technician, etc.) who will insert the medical device into the patient, with the tip (i.e., distal or distal) of the device inserted into the patient. Therefore, for example, “proximal direction” refers to the direction towards the operator, while “distal direction” refers to the direction away from the operator towards the tip or distal end of the medical device. The same applies to “distal” and “proximal” in the following text, and will not be elaborated upon further.

[0045] This application provides an electrode implantation device. For example... Figures 1 to 8 As shown, the electrode implantation device includes a flexible electrode 1, an auxiliary implant 2, a sliding guide assembly 3, and a kinetic energy release mechanism 4. The distal end of the auxiliary implant 2 acts on the distal end of the flexible electrode 1. The sliding guide assembly 3 includes a sliding channel 31 and a slider 32 slidably disposed within the sliding channel 31. The extending direction of the sliding channel 31 is the same as the implantation direction of the flexible electrode 1, and the distal end of the slider 32 corresponds to the proximal end of the auxiliary implant 2. The kinetic energy release mechanism 4 has a first position away from the slider 32 and a second position that pushes against the slider 32. When the kinetic energy release mechanism 4 moves from the first position to the second position, it transfers the accumulated potential energy to the slider 32, causing the slider 32 to move towards the auxiliary implant 2 within the sliding channel 31 and act on the proximal end of the auxiliary implant 2, thereby driving the auxiliary implant 2 to implant the flexible electrode 1 into the target tissue. The target tissue is the biological tissue region where the flexible electrode 1 is to be implanted.

[0046] The aforementioned flexible electrode 1 can be made of a flexible material. Specifically, the flexible material used can have good conductivity and biocompatibility, ensuring stable operation of the flexible electrode 1 for a long time, and also has a certain degree of flexibility so that the flexible electrode 1 can deform with the movement of human tissue after being implanted. Of course, the aforementioned flexible electrode 1 can be made of metallic materials, non-metallic materials, or a combination of non-metallic and metallic materials. This application does not specifically limit the material used for the flexible electrode 1.

[0047] During implantation, the aforementioned auxiliary implant 2 applies a force toward the distal end of the flexible electrode 1, guiding the distal end of the flexible electrode 1 to a predetermined depth in the target tissue. After the distal end of the flexible electrode 1 reaches the predetermined depth in the target tissue, the auxiliary implant 2 can be separated from the flexible electrode 1 and removed from the target tissue, leaving the distal end of the flexible electrode 1 at the predetermined depth in the target tissue.

[0048] The hardness of the aforementioned auxiliary implant 2 is greater than that of the flexible electrode 1. The auxiliary implant 2 serves as a temporary rigid carrier during the implantation of the flexible electrode 1, providing axial support and pushing force to overcome the puncture resistance of the target tissue surface. Once the auxiliary implant 2, carrying the flexible electrode 1, reaches the preset depth of the target tissue, it retracts in the opposite direction to the implantation direction. The flexible electrode 1, due to its flexibility, remains within the target tissue, while the auxiliary implant 2 detaches from the flexible electrode 1 and exits the body.

[0049] The aforementioned auxiliary implant 2 has an initial position (pre-implantation position), an implantation placement position, and a retraction separation position, which occur sequentially. Before the implantation process begins, the auxiliary implant 2 is in the initial position. At this time, the kinetic energy release mechanism 4 is in the first position, the distal end of the auxiliary implant 2 is connected to the distal end of the flexible electrode 1, and the auxiliary implant 2 has not yet entered the target tissue; it is in a state of readiness to be triggered. The implantation placement position is the position where the auxiliary implant 2 moves distally after receiving the impact force applied by the kinetic energy release mechanism 4, and drives the flexible electrode 1 to the preset depth of the target tissue. At this time, the kinetic energy release mechanism 4 is in the second position, and the distal end of the flexible electrode 1 has entered the target depth within the target tissue along with the auxiliary implant 2. The retraction separation position is the position where the auxiliary implant 2 retracts proximally after implantation and is completely detached from the flexible electrode 1. At this time, the flexible electrode 1 remains within the target tissue, and the auxiliary implant 2 is withdrawn from the body, completing the entire implantation process. (Specific details can be found in conjunction with...) Figure 1 as well as Figures 2 to 8 , Figure 1 , Figure 3 as well as Figure 4 The auxiliary implant 2 shown is in its initial position. Figure 5 as well as Figure 6 The auxiliary implant 2 shown is between the initial position and the implantation position. Figure 7 The auxiliary implant 2 shown in the image is in the implantation position. Figure 8 The auxiliary implant 2 shown is in the retracted separation position.

[0050] The distal end of the aforementioned slider 32 can be in direct contact with the proximal end of the auxiliary implant 2, or there can be a gap between the distal end of the slider 32 and the proximal end of the auxiliary implant 2. The distal end of the slider 32 can move toward the auxiliary implant 2 within the sliding channel 31, thereby driving the auxiliary implant 2 to move the flexible electrode 1 distally.

[0051] The movement stroke of the aforementioned slider 32 is positively correlated with the implantation depth of the flexible electrode 1 into the target tissue. That is, the greater the movement stroke of the slider 32, the deeper the auxiliary implant 2 carries the flexible electrode 1 into the target tissue; conversely, the smaller the movement stroke of the slider 32, the shallower the implantation depth of the flexible electrode 1. Therefore, the implantation depth of the flexible electrode 1 can be precisely adjusted by controlling the movement stroke of the slider 32. This quantitative relationship allows the operator to pre-set the stroke parameters of the slider 32 according to different depth requirements of the target tissue, improving the controllability of the implantation depth.

[0052] The aforementioned electrode implantation device may further include a base 7, which provides mounting support for the sliding guide assembly 3 and / or the kinetic energy release mechanism 4, and establishes a stable geometric reference system above the target tissue. The base 7 can be any of the following: a flat base 7, a ring base 7, a tripod base 7, a stereotactic adapter base 7, or a robotic arm end-effector mounting base 7, and its material is selected from at least one of stainless steel, titanium alloy, PEEK, carbon fiber reinforced composite material, or high-strength engineering plastics. For brain-computer interface craniotomy implantation scenarios, the base 7 is preferably configured to connect to a stereotactic frame, surgical robotic arm, cranial fixation clamp, or micromanipulator. The effective support span of the base 7 can be from 10mm to 150mm, and the connection stiffness between the base 7 and the sliding guide assembly 3 must meet the requirement that the displacement does not exceed 0.01mm to 0.2mm under an external force of 0.1N to 5N. Through the base 7, the electrode implantation device can form a stable spatial positioning reference above the target tissue, which is of great significance for repeated implantation, array implantation, and precise alignment under image guidance.

[0053] Through the cooperation of the kinetic energy release mechanism 4 and the sliding guide component 3, the instantaneous velocity of the auxiliary implant 2 when it contacts the target tissue surface is 0.5 m / s to 10 m / s. For some brain tissue implantation scenarios, the instantaneous velocity is preferably set to not less than 2 m / s to improve the ability of the auxiliary implant 2 to overcome the collapse stage of the target tissue surface. After the flexible electrode 1 reaches the target depth, the auxiliary implant 2 withdraws from the target tissue in the opposite direction of implantation, and the flexible electrode 1 separates from the auxiliary implant 2 and remains in the target tissue.

[0054] The material of the aforementioned sliding member 32 can be at least one of medical-grade stainless steel, PEEK, PEI, titanium alloy, or aluminum alloy. The overall length of the sliding member 32 can be from 3mm to 60mm, and the mass of the sliding member 32 can be from 20mg to 5g. The sliding member 32 is positioned corresponding to the proximal end of the auxiliary implant 2. The sliding member 32 and the auxiliary implant 2 can be detachably connected, or they can be not connected, or the sliding member 32 and the auxiliary implant 2 can be integrally formed. The sliding member 32 can move distally with the auxiliary implant 2. The length of the sliding channel 31 can be from 1mm to 50mm. The sliding channel 31 adopts a linear groove, a sleeve guide hole, or other channel design to constrain the sliding member 32 to move in an approximately linear manner along the implantation direction.

[0055] The potential energy stored in the aforementioned kinetic energy release mechanism 4 may include at least one of gravitational potential energy and elastic potential energy. When the potential energy includes gravitational potential energy, the kinetic energy release mechanism 4 is located above the slider 32, and after release, the kinetic energy release mechanism 4 applies an impact force to the slider 32 under its own gravity. When the potential energy includes elastic potential energy, the kinetic energy release mechanism 4 may be in a deformable energy storage state before release and move towards the slider 32 after release. When the potential energy includes both gravitational potential energy and elastic potential energy, the slider 32 may move towards the auxiliary implant 2 and act on the proximal end of the auxiliary implant 2 under the combined action of gravitational potential energy and elastic potential energy. The kinetic energy release mechanism 4 will be described in detail below, and will not be repeated here.

[0056] This application uses a sliding member 32 with its distal end corresponding to the proximal end of the auxiliary implant 2. The kinetic energy release mechanism 4 can transfer the accumulated potential energy to the sliding member 32 when it moves from the first position to the second position. This causes the sliding member 32 to move towards the auxiliary implant 2 within the sliding channel 31 and act on the proximal end of the auxiliary implant 2, thereby driving the auxiliary implant 2 to implant the flexible electrode 1 into the target tissue. This allows the auxiliary implant 2 to obtain sufficient instantaneous speed in a very short time by releasing potential energy through the kinetic energy release mechanism 4, thereby carrying the flexible electrode 1 across the surface of the target tissue and directly piercing the target tissue. This effectively overcomes the technical problem that the flexible electrode 1 itself has insufficient rigidity, is prone to bending and bending due to tissue resistance, and is difficult to directly puncture into the target tissue.

[0057] In some embodiments, such as Figures 1 to 8 As shown, the kinetic energy release mechanism 4 includes an impact channel 41 and an impact load member 42 located in the impact channel 41. The impact channel 41 is connected to the sliding channel 31. The impact load member 42 is used to apply an impact force to the sliding member 32 when it moves from the first position to the second position in the impact channel 41.

[0058] In this way, the potential energy accumulated by the impact load component 42 can be efficiently transferred to the sliding component 32, thereby driving the auxiliary implant component 2 to complete the implantation action. The connection design between the impact channel 41 and the sliding channel 31 ensures the linearity and directional consistency of the impact force transmission.

[0059] The impact channel 41 and the sliding channel 31 can be axially aligned. The effective length of the impact channel 41 can be from 2 mm to 100 mm, and the inner surface roughness Ra of the impact channel 41 is ≤ 1.6 μm to reduce the motion resistance and attitude disturbance of the impact load member 42. The impact load member 42 is a cylindrical, spherical, or block-shaped component, and its mass is from 50 mg to 20 g. The impact load member 42 has an initial energy storage state and a release state. In the initial energy storage state, the impact load member 42 is located at the position where potential energy is stored (at this time, the auxiliary implant 2 is in the initial position), and the impact load member 42 and the sliding member 32 are axially spaced apart. In the release state, the impact load member 42 converts the stored potential energy into kinetic energy and moves along the impact channel 41 towards the sliding member 32.

[0060] After the aforementioned impact load member 42 moves along the impact channel 41 in the released state, it collides with the sliding member 32, enabling the auxiliary implant 2 to obtain sufficient instantaneous velocity in a very short time, thereby carrying the flexible electrode 1 across the indentation stage of the target tissue surface and piercing the target tissue. The impact load member 42 is a block-shaped or columnar component that can reciprocate within the impact channel 41, and it has a first position in the energy storage state and a second position when releasing energy.

[0061] The aforementioned kinetic energy release mechanism 4 can be a device capable of storing and instantaneously releasing potential energy to drive the movement of other components. The impact channel 41 is a cavity structure that guides the movement of the impact load member 42, and its internal contour is adapted to the external shape of the impact load member 42.

[0062] In some embodiments, such as Figures 1 to 8 As shown, the distal end of the auxiliary implant 2 is detachably connected to the distal end of the flexible electrode 1 to drive the flexible electrode 1 into the target tissue. When the auxiliary implant 2 is withdrawn in the opposite direction to the implantation direction, it is disengaged from the flexible electrode 1, so that the flexible electrode 1 remains in the target tissue.

[0063] Thus, the connection between the auxiliary implant 2 and the flexible electrode 1 ensures that the flexible electrode 1 can advance synchronously with the auxiliary implant 2 during implantation, preventing bending or displacement of the flexible electrode 1 when penetrating the tissue. When the auxiliary implant 2 is retracted, it automatically detaches from the flexible electrode 1, allowing the flexible electrode 1 to remain stably within the target tissue without being pulled out. This solves the problem of the flexible electrode 1 being difficult to directly enter soft tissue and avoids the mechanical mismatch caused by the auxiliary implant 2 remaining in the tissue for a long time when assisting rigid puncture. Furthermore, this detachable connection structure simplifies the operation process and improves the implantation success rate.

[0064] The aforementioned auxiliary implant 2 can be a slender component for delivering the flexible electrode 1 to the target tissue, with its distal end being the end closest to the target tissue.

[0065] The connection between the auxiliary implant 2 and the flexible electrode 1 is structured as follows: when the auxiliary implant 2 moves along the implantation direction, it maintains a stable connection with the flexible electrode 1, thereby driving the flexible electrode 1 to synchronously enter the target tissue; when the auxiliary implant 2 retracts in the opposite direction to the implantation direction, it disengages from the flexible electrode 1, leaving the flexible electrode 1 within the target tissue. In this way, when the auxiliary implant 2 moves along the implantation direction, it can drive the flexible electrode 1 distally. After the flexible electrode 1 is implanted into the target tissue, the auxiliary implant 2 retracts in the opposite direction to the implantation direction, at which point it disengages from the flexible electrode 1.

[0066] The detachable connection between the aforementioned auxiliary implant 2 and the flexible electrode 1 can be understood as a temporary connection method, including but not limited to snap-fit, friction fit or magnetic adsorption, so that the flexible electrode 1 can be separated from the auxiliary implant 2 when the auxiliary implant 2 is retracted.

[0067] In some embodiments, such as Figure 3 and Figure 4 As shown, the kinetic energy release mechanism 4 also includes a first limiting member 43 disposed on the impact channel 41. The first limiting member 43 is used to limit the maximum impact stroke of the impact load member 42 moving toward the sliding member 32. The maximum impact stroke can be understood as the maximum distance that the impact load member 42 travels from its starting position to being stopped by the first limiting member 43.

[0068] Thus, the first limiting member 43 can prevent the impact load member 42 from exceeding the preset position at the end of the impact stroke, avoiding it from leaving the impact channel 41 and causing equipment damage. By limiting the maximum impact stroke by the first limiting member 43, the end position of each impact can be kept consistent, thereby improving the repeatability and stability of the impact process. At the same time, the first limiting member 43 also helps to protect the sliding member 32 from excessive impact.

[0069] The aforementioned first limiting member 43 can be understood as a blocking structure set on the impact channel 41, which is located on the movement path of the impact load member 42.

[0070] The first limiting member 43 can be disposed at the end, side wall, or shoulder position of the impact channel 41 that cooperates with the impact load member 42. The material of the first limiting member 43 can be at least one of stainless steel, titanium alloy, PEEK, zirconia ceramic, or other materials with impact resistance.

[0071] The thickness of the first limiting member 43 along the axial direction of the impact channel 41 can be from 0.2 mm to 10 mm. The contact surface between the first limiting member 43 and the impact load member 42 is a flat surface, an arc surface, or a composite surface with a buffer layer. This application does not make specific limitations on this. The first limiting member 43 can not only limit the maximum impact stroke of the impact load member 42, but also prevent the impact load member 42 from continuously moving forward or leaving the impact channel 41.

[0072] In some embodiments, the first limiting member 43 has a plurality of first stop positions arranged sequentially along the extension direction of the sliding channel 31 within the impact channel 41, and the impact load member 42 abuts against one of the first limiting members 43 located in the plurality of first stop positions.

[0073] Thus, by setting multiple first stop positions, the maximum impact stroke of the impact load component 42 can be flexibly adjusted according to different implantation needs to cope with different scenarios where different target tissues have different requirements for implantation impact energy.

[0074] The aforementioned impact load member 42 abuts against the first limiting member 43, which is located at the selected first stop position, thereby stopping the forward movement at that position.

[0075] Specifically, the position adjustment of the first limiting member 43 can be achieved using kinetic energy release mechanisms 4 of different specifications. For example, multiple kinetic energy release mechanisms 4 can be set up, each corresponding to a different first stop position. The operator can select and use the appropriate kinetic energy release mechanism 4. Alternatively, the position adjustment of the first limiting member 43 can be achieved on a single kinetic energy release mechanism 4, i.e., a single kinetic energy release mechanism 4 can be configured with multiple first stop positions corresponding to the first limiting member 43. In this case, the first limiting member 43 can adopt any of the following structural forms: threaded adjustment stop, sliding groove locking stop, shim adjustment stop, slotted multi-position stop, or micrometer head adjustment stop. The single adjustment range of the first limiting member 43 can be 0.01mm to 0.1mm, and the total adjustment range of the first limiting member 43 is 0.2mm to 20mm. By adjusting the position of the first limiting member 43 on the impact channel 41, the impact stroke of the impact load member 42 from its initial position to the maximum impact endpoint can be changed, thereby adjusting the magnitude of the impact energy released by the impact load member 42. This structure allows the same implantation device to be adapted to different target tissues, different sizes of auxiliary implants 2, and different implantation resistance conditions of flexible electrodes 1.

[0076] In some embodiments, such as Figure 3 and Figure 4 As shown, the sliding guide assembly 3 also includes a second limiting member 33 disposed on the sliding channel 31. The second limiting member 33 is used to limit the maximum sliding stroke of the slider 32 toward the auxiliary implant 2. The maximum sliding stroke is the maximum distance that the slider 32 travels from its starting position to the point where it is blocked and stopped by the second limiting member 33.

[0077] Thus, the second limiting member 33 can control the forward distance of the sliding member 32, preventing the auxiliary implant 2 from exceeding the preset depth and damaging the target tissue. The second limiting member 33 mechanically constrains the depth of each implantation, improving the controllability and consistency of the implantation depth. During repeated operations, the second limiting member 33 can ensure that multiple implantations have the same depth, meeting the clinical requirements for implantation accuracy.

[0078] The aforementioned second limiting member 33 can be understood as a blocking member disposed on the sliding channel 31, located in front of the movement path of the slider 32. The second limiting member 33 can be disposed on the far end, near end, or side wall of the sliding channel 31, and cooperate with the end face, side, or other parts of the slider 32 to limit the maximum sliding stroke of the slider 32.

[0079] In some embodiments, the second limiting member 33 has a plurality of second stop positions arranged sequentially along the extension direction of the sliding channel 31 within the sliding channel 31. The sliding member 32 abuts against one of the second limiting members 33 located in the plurality of second stop positions, so as to change the maximum sliding stroke of the sliding member 32 by adjusting the position of the second limiting member 33, thereby changing the implantation depth of the auxiliary implant 2.

[0080] Thus, multiple second stop positions provide adjustable implantation depth, allowing the operator to pre-set the implantation stroke according to the target depth of different target areas. This enhances the adaptability of the electrode implantation device to target tissues in different locations, enabling implantation depth adjustment without replacing any parts. In actual operation, the operator only needs to move the second limiting member 33 to the corresponding second stop position to change the maximum sliding stroke of the sliding member 32, thereby changing the implantation depth of the auxiliary implant 2.

[0081] The aforementioned second stop position is the position point where the second limiting member 33 can be fixed within the sliding channel 31, and multiple second stop positions are arranged along the extending direction of the sliding channel 31. The sliding member 32 abuts against the second limiting member 33 at the selected second stop position, thereby stopping the sliding member 32 from moving forward at that position.

[0082] Specifically, the position adjustment of the second limiting member 33 can be achieved using sliding guide components 3 of different specifications. For example, multiple sliding guide components 3 can be set up, each corresponding to a different second stop position. The operator can select and use the appropriate sliding guide component 3. Alternatively, the position adjustment of the second limiting member 33 can be achieved on a single sliding guide component 3, i.e., a single sliding guide component 3 can be configured with multiple second stop positions corresponding to the second limiting member 33. In this case, the second limiting member 33 can adopt a micro-adjustment head, a threaded adjustment component, a shim-type limiting block, a magnetic limiting sleeve, a slot-type multi-position structure, or other structures. For precise implantation scenarios of brain-computer interfaces, a threaded fine-tuning or micro-adjustment head is preferred, with a single adjustment resolution of 0.01mm to 0.1mm and a total adjustment range preferably of 0.2mm to 20mm.

[0083] The contact surface between the second limiting member 33 and the sliding member 32 is preferably a hard contact limiting or semi-hard limiting to reduce the final implantation depth error caused by elastic deformation at the impact end. By setting the second limiting member 33 as an adjustable structure, the operator can first determine the target implantation depth based on image planning or preoperative depth calculation, and then independently adjust the corresponding stroke, without having to rely entirely on personal experience.

[0084] In some embodiments, such as Figure 3 and Figure 4As shown, when the kinetic energy release mechanism 4 also includes a first limiting member 43 disposed on the impact channel 41, the first limiting member 43 and the second limiting member 33 are disposed independently of each other.

[0085] Thus, the first limiting member 43 and the second limiting member 33 are independent of each other, allowing the impact stroke of the impact load member 42 and the sliding stroke of the sliding member 32 to be controlled separately without affecting each other. This decoupling design allows the operator to independently adjust the impact energy by adjusting the position of the first limiting member 43 and independently adjust the implantation depth by adjusting the position of the second limiting member 33, improving the flexibility and accuracy of parameter adjustment. In actual operation, the impact force or implantation depth can be adjusted individually as needed without recalibrating the other parameter.

[0086] The aforementioned independent first limiting member 43 and second limiting member 33 are structurally unrelated and each has its own independent installation, adjustment, and fixing methods. The impact stroke of the impact load member 42 is individually constrained by the first limiting member 43, and the sliding stroke of the sliding member 32 is individually constrained by the second limiting member 33.

[0087] In some embodiments, when the kinetic energy release mechanism 4 further includes a first limiting member 43 disposed on the impact channel 41, at least one of the first limiting member 43 and the second limiting member 33 is provided with a buffer structure (not shown in the figure).

[0088] Thus, the buffer structure can absorb the excess kinetic energy generated by the impact load member 42 and / or the sliding member 32 at the end of the movement, reduce the impact load on the first limiting member 43 and / or the second limiting member 33, and prevent the sliding member 32 or the impact load member 42 from being displaced in the opposite direction due to impact rebound, which is beneficial to maintaining the positional stability of the auxiliary implant 2 and the flexible electrode 1 after implantation.

[0089] The aforementioned buffer structure is an elastic energy-absorbing component disposed on the first limiting member 43 and / or the second limiting member 33, which can be made of rubber, silicone, springs, or other materials with buffering properties. Specifically, the buffer structure can be made of medical-grade silicone, polyurethane elastomer, medical rubber, fluororubber, thermoplastic elastomer, microporous damping material, or a composite buffer pad structure with a thin layer of metal support. The silicone can be room temperature vulcanizing silicone, liquid injection molded silicone, or platinum-catalyzed medical silicone rubber, with a compression set preferably less than 20% and a thickness preferably between 0.1 mm and 1.5 mm. The polyurethane can be medical-grade thermoplastic polyurethane or cast polyurethane, suitable for buffer structures requiring high wear resistance and tear resistance. The medical rubber can be medical-grade elastic rubber or synthetic rubber. Using the above-mentioned medical-grade elastic buffer materials helps to achieve residual impact energy absorption, mechanical rebound suppression, and improved intraoperative safety while maintaining structural simplicity.

[0090] The thickness of the aforementioned buffer structure is preferably between 0.05 mm and 3 mm, and the Shore hardness is preferably between Shore A 10 and Shore D 70, which can be configured according to the impact energy level and the required degree of rebound suppression. When the buffer structure is provided on the first limiting member 43, it mainly functions to absorb the remaining kinetic energy of the impact load member 42 when it reaches the end position, reducing its rebound. When the buffer structure is provided on the second limiting member 33, it mainly functions to absorb the residual energy of the sliding member 32 when it reaches the end of the forward implantation stroke, reducing the tendency of the auxiliary implant member 2 to rebound in the opposite direction after insertion.

[0091] In some embodiments, the sliding guide assembly 3 further includes a rebound suppression structure (not shown in the figure), which is located in the sliding channel 31 and / or on the slider 32, for suppressing the rebound movement of the slider 32 in a direction away from the auxiliary implant 2.

[0092] Thus, the rebound suppression structure prevents the slider 32 from rebounding after completing the forward implantation stroke, avoiding the auxiliary implant 2 from pulling back and causing the flexible electrode 1 to partially detach from the target tissue. This structure makes the retention state of the flexible electrode 1 more stable and reliable after implantation, reducing the adverse effects of rebound on the retention state of the flexible electrode 1. At the same time, rebound suppression also helps to reduce additional damage to surrounding tissues caused by repeated vibration.

[0093] The aforementioned rebound suppression structure can be disposed on the inner wall of the sliding channel 31 and / or the outer surface of the slider 32, which can restrict its backward movement in the opposite direction to the implantation direction. Rebound motion is the phenomenon that the slider 32 undergoes reverse displacement due to collision or inertia after completing its forward stroke.

[0094] In some embodiments, the rebound suppression structure includes at least one of a pawl and ratchet structure, a wedge structure, a friction locking structure, a magnetic holding structure, and a one-way snap-fit ​​structure disposed in the sliding channel 31; and / or, the rebound suppression structure includes at least one of an elastic damping element, a viscous damping element, and a friction damping element located on the sliding member 32.

[0095] Thus, the above-mentioned various rebound suppression structures can be flexibly selected according to actual application scenarios to adapt to different structural sizes and reusability requirements. By selecting different damping methods, the rebound speed and locking force of the sliding member 32 can be effectively controlled. This diversified selection enables the electrode implantation device to achieve better anti-rebound effect under different working conditions.

[0096] The aforementioned ratchet and pawl structure, wedge structure, friction locking structure, magnetic holding structure, and one-way latching structure allow the slider 32 to pass through when it moves forward, while providing one-way restriction when it tends to rebound. Specifically, the wedge structure can be understood as a component that uses the self-locking principle of a wedge surface to prevent reverse movement. The friction locking structure can be understood as a device that suppresses reverse movement by increasing frictional resistance. The magnetic holding structure can be understood as a component that uses magnetic force to hold the slider 32 in the forward position. The one-way latching structure can be understood as an engaging component that allows unidirectional passage and prevents reverse retraction.

[0097] For example, if a ratchet structure is used, the ratchet pitch is preferably 0.01 mm to 0.5 mm, which can be designed according to the required implantation depth resolution; if a wedge structure is used, the wedge angle is preferably 3° to 20° to balance self-locking capability and unlocking requirements; if a friction locking structure is used, the contact material can be PEEK / metal, ceramic / metal, or a combination of high-friction coefficient elastomer / metal; if a magnetic holding structure is used, a micro permanent magnet can be used in conjunction with a soft magnetic component, and the magnetic attraction force is preferably 0.01 N to 2 N; if a one-way snap-fit ​​structure is used, one-way limiting can be formed by the cooperation of elastic claws, protrusions, or slots.

[0098] The aforementioned elastic damping element can be understood as a component that absorbs rebound energy through elastic deformation. The aforementioned viscous damping element can be understood as a device that consumes rebound energy using the resistance of viscous fluid. The aforementioned frictional damping element can be understood as a component that consumes rebound energy through sliding friction. The damping force generated by different damping elements can be designed to be from 0.005N to 1N to suppress pullback without significantly increasing forward resistance.

[0099] In some embodiments, such as Figures 1 to 3 as well as Figure 5 As shown, the kinetic energy release mechanism 4 also includes a trigger structure 44 disposed on the impact channel 41. The trigger structure 44 is used to lock the impact load member 42 in a first position and to release the impact load member 42 to move the impact load member 42 to a second position.

[0100] Thus, the trigger structure 44 allows the impact load component 42 to be reliably locked in the first position, preventing safety risks caused by accidental release. When the operator needs to release it, the trigger structure 44 can accurately control the release timing, ensuring that the impact action and the implantation operation are coordinated. This dual function of locking and releasing improves the controllability and safety of the electrode implantation device during the implantation process.

[0101] The aforementioned triggering structure 44 can be a switch assembly disposed on the impact channel 41, having a locked state and a released state. In the locked state, the triggering structure 44 forms a stop with the impact load member 42, keeping the impact load member 42 in a first position. In the released state, the triggering structure 44 releases the constraint on the impact load member 42, allowing the impact load member 42 to move along the impact channel 41 to a second position.

[0102] The aforementioned triggering structure 44 can be a mechanical button, lever, knob release mechanism, sliding unlock mechanism, foot trigger mechanism, electromagnetic release mechanism, or a remote trigger mechanism amplified by mechanical transmission. For microsurgery and stereotactic surgery scenarios, a mechanical button or sliding unlock mechanism is preferred, with a trigger stroke preferably between 0.2 mm and 5 mm and a trigger force preferably between 0.1 N and 20 N, to balance accidental triggering protection and operator feel.

[0103] To improve intraoperative safety, the triggering structure 44 may include a dual-safety structure, namely, disarming the safety device before triggering, so as to stabilize the impact load member 42 when the electrode implantation device has been aligned but is not yet ready for implantation, and to implement controlled release after the surgeon confirms the microscope field of view, the surface condition of the target tissue and the distal position of the auxiliary implant 2.

[0104] The potential energy stored in the aforementioned kinetic energy release mechanism 4 may include gravitational potential energy and / or elastic potential energy.

[0105] The potential energy stored in the kinetic energy release mechanism 4 includes gravitational potential energy, as described below. In some embodiments, such as Figures 1 to 7 As shown, the potential energy stored in the kinetic energy release mechanism 4 includes at least gravitational potential energy. The kinetic energy release mechanism 4 is located above the slider 32 so that it can exert a downward impact force on the slider 32 under the action of gravity after release.

[0106] Thus, in embodiments that use only gravitational potential energy as the driving force, there is no need to set up additional elastic energy storage elements or power devices, making the overall mechanism simpler and more reliable. After release, the kinetic energy release mechanism 4 (such as the impact load component 42) falls naturally under the action of gravity and impacts the sliding component 32, achieving instantaneous drive; this free-fall structure reduces manufacturing difficulty and cost, while improving the reliability and consistency of the impact action.

[0107] The aforementioned gravitational potential energy is the potential energy possessed by the kinetic energy release mechanism 4 due to its location above the sliding member 32. Its magnitude depends on the mass of the kinetic energy release mechanism 4 (such as the impact load member 42 of the kinetic energy release mechanism 4) and the height difference between it and the sliding member 32. For example, the impact load member 42 is entirely positioned above the sliding member 32, causing it to fall vertically or approximately vertically after release. The sliding member 32 receives the impact force from the impact load member 42 below the impact channel 41 and transmits this force to the auxiliary implant 2.

[0108] The mass of the impact load member 42 is preferably from 0.1g to 10g, and the distance between the impact load member 42 and the sliding member 32 is preferably from 2mm to 300mm. The impact channel 41 that accommodates the impact load member 42 can be designed as a vertical straight channel.

[0109] For example, when the impact load 42 has a mass of 1g and a drop height of 20mm, a theoretical gravitational potential energy of approximately 0.196mJ can be obtained. In the scenario of implanting the microcortical flexible electrode wire 11, this energy level can be used for puncture of relatively superficial brain tissue. The gravity-based approach is particularly suitable for laboratory research and development stages, animal experiment stages, and scenarios where sterilization and maintenance requirements are high but the drive structure needs to be simplified as much as possible.

[0110] In some embodiments, such as Figures 3 to 7 As shown, the kinetic energy release mechanism 4 includes an impact channel 41 and an impact load member 42 located within the impact channel 41. The impact load member 42 is used to apply an impact force to the sliding member 32 when it moves from a first position to a second position within the impact channel 41. The mass of the impact load member 42 is greater than the total mass of the sliding member 32 and the auxiliary implant 2. The impact channel 41 is connected to the sliding channel 31, and the impact load member 42 is used to apply an impact force to the sliding member 32 when it moves from the first position to the second position within the impact channel 41.

[0111] In this way, the impact load member 42 can more effectively transfer momentum to the sliding member 32 during the collision, which is conducive to driving the auxiliary implant 2 to complete the insertion action. Specifically, when the impact load member 42 hits the sliding member 32, the larger mass can ensure that the momentum transfer is more sufficient, so that the sliding member 32 can obtain enough kinetic energy to drive the auxiliary implant 2 to complete the insertion action.

[0112] The mass ratio of the impact load component 42 to the total mass of the sliding component 32 and all auxiliary implants 2 can be from 1.1:1 to 50:1. For implantation scenarios involving extremely fine single flexible electrode wires 11, the total mass of the sliding component 32 and all auxiliary implants 2 is typically small. Therefore, it is advisable to moderately increase the mass of the impact load component 42 to obtain more stable momentum output. However, the mass of the impact load component 42 should not be increased excessively, otherwise it will lead to an increase in the overall device size, excessive terminal impact, and increased buffering requirements. Designing the mass of the impact load component 42 to be greater than the total mass of the sliding component 32 and all auxiliary implants 2 allows the sliding component 32 to start up rapidly in a short time, reducing the system's sensitivity to contact friction, assembly micro-errors, and individual tissue differences.

[0113] The potential energy stored in the kinetic energy release mechanism 4 includes elastic potential energy. In some embodiments, the kinetic energy release mechanism 4 further includes an elastic energy storage element (not shown in the figure) for storing elastic potential energy in a first position. The elastic energy storage element is used to apply an elastic force to the impact load member 42, causing the impact load member 42 to move from the first position to the second position.

[0114] In this way, a more compact kinetic energy release mechanism 4 can be achieved through elastic energy storage and release, and the layout flexibility of the kinetic energy release mechanism 4 can be improved. Furthermore, the elastic release process is rapid and controllable, which can provide stable acceleration for the impact load component 42 and ensure the repeatability of the impact force.

[0115] The aforementioned elastic energy storage element is a component capable of elastic deformation and storing energy, such as a compression spring, tension spring, disc spring, elastic sheet, rubber energy storage component, or other components capable of storing elastic potential energy. In the first position, the elastic energy storage element is in a deformed state, thereby accumulating elastic potential energy. When the impact load component 42 is released, the elastic energy storage element returns to its original shape and applies an elastic force to the impact load component 42, driving the impact load component 42 from the first position to the second position.

[0116] The aforementioned elastic energy storage element can directly contact the impact load member 42, or it can contact the impact load member 42 through other transmission components. This application does not impose specific limitations on this, as long as it can ensure that the elastic energy storage element stably applies an elastic force to the impact load member 42. The elastic coefficient of the elastic energy storage element is preferably from 10 N / m to 5000 N / m, and the pre-compression amount or deformation is preferably from 0.5 mm to 20 mm. By adjusting the elastic coefficient and pre-compression amount, repeatable output of impact energy can be achieved within a small volume. Using an elastic energy storage element eliminates the need for a significant drop height space, allowing the entire kinetic energy release mechanism 4 to be made shorter and more compact, thus improving the scenario adaptability of the electrode implantation device.

[0117] The potential energy stored in the kinetic energy release mechanism 4 includes gravitational potential energy and elastic potential energy. In some embodiments, the kinetic energy release mechanism 4 includes an impact channel 41, an impact load member 42, and an elastic energy storage element (not shown in the figure). The impact load member 42 is located within the impact channel 41. The elastic energy storage element is used to store elastic potential energy in a first position, and the elastic energy storage element acts on the impact load member 42, so that the impact load member 42 transfers both gravitational potential energy and elastic potential energy to the sliding member 32.

[0118] In this way, both gravitational potential energy and elastic potential energy are utilized as driving forces, enabling the impact load component 42 to obtain greater total kinetic energy and improving its driving capability over the sliding component 32. The superposition of gravitational potential energy and elastic potential energy can achieve a stronger implantation driving force without increasing the overall size of the electrode implantation device. Furthermore, the two configuration methods increase the adjustment flexibility of the kinetic energy release mechanism 4, allowing the deformation of the elastic energy storage element to be adjusted as needed to change the total impact energy.

[0119] The aforementioned elastic energy storage element can be coaxially arranged with the impact channel 41, or it can contact the impact load element 42 through other transmission components. In the initial energy storage state, the elastic energy storage element undergoes compression deformation to store elastic potential energy; in the release state, the elastic energy storage element releases elastic potential energy and converts it into the kinetic energy of the impact load element 42. When the elastic energy storage element is a spring, the wire diameter of the spring is preferably 0.05mm to 2mm, the outer diameter is preferably 0.5mm to 20mm, and the free length is preferably 2mm to 80mm. Using a spring as the elastic energy storage element has advantages such as mature structure, convenient processing, stable energy output, and ease of miniaturization integration.

[0120] In some embodiments, such as Figures 1 to 8 As shown, the flexible electrode 1 includes at least one flexible electrode wire 11, and the distal end of the auxiliary implant 2 is provided in a one-to-one correspondence with the distal end of the flexible electrode wire 11.

[0121] In this way, the one-to-one correspondence setting allows each auxiliary implant 2 to independently drive the corresponding flexible electrode wire 11 to complete the implantation, avoiding mutual interference between multiple flexible electrode wires 11, and achieving more precise and reliable cooperation between each auxiliary implant 2 and the corresponding flexible electrode wire 11 during the implantation process.

[0122] The aforementioned flexible electrode wire 11 can be understood as a thin filamentous electrode with conductivity and flexibility. The auxiliary implant 2 can be a thin needle-like component for delivering the flexible electrode wire 11 into the target tissue, with its distal end corresponding to the distal end of the flexible electrode wire 11, that is, each auxiliary implant 2 is connected to one flexible electrode wire 11.

[0123] Specifically, the flexible electrode 1 may include N flexible electrode wires 11, where N≥2. N auxiliary implants 2 are correspondingly provided, with the distal end of each auxiliary implant 2 corresponding to the distal end of the corresponding flexible electrode wire 11 and detachably assembled.

[0124] The number N of the aforementioned flexible electrode wires 11 is preferably from 2 to 256. The number of auxiliary implants 2 is the same as the number of flexible electrode wires 11, and each auxiliary implant 2 corresponds one-to-one with a corresponding flexible electrode wire 11 and can be detached and assembled. Multiple auxiliary implants 2 can have the same length, or they can be set to different lengths according to the curvature of the target tissue surface or the difference in target depth. By setting a one-to-one correspondence between the distal end of the auxiliary implant 2 and the distal end of the flexible electrode wire 11, multiple flexible electrode wires 11 can obtain temporary rigid support, which facilitates subsequent synchronous or group implantation.

[0125] The aforementioned flexible electrode wire 11 can be a monofilament structure, a strip structure, a strip structure formed by microprocessing, or a slender fiber structure. Its outer diameter or equivalent lateral dimension is preferably 5μm to 150μm, and its total length can be set to 2mm to 150mm according to different target areas. For shallow cortical recording / stimulation scenarios, the effective brain penetration length is preferably 0.5mm to 8mm. For deep brain regions, peripheral nerves, or spinal cord related scenarios, it can be extended to 10mm to 80mm.

[0126] The aforementioned flexible electrode wire 11 can also be a linear structure or a curved structure with strain redundancy. The curved structure can be helical, serpentine, or other configurations that provide a certain degree of mechanical redundancy, facilitating the adaptation of the flexible electrode wire 11 to tissue movement after implantation. When the flexible electrode wire 11 adopts a linear structure, it is suitable for scenarios where the implantation path and final site requirements are relatively clear and tissue micro-movement is relatively small. When the flexible electrode wire 11 adopts a curved structure, the curved structure can be a helical, serpentine, wavy, zigzag, racetrack-shaped, or other structure that provides axial, lateral, or local strain redundancy. For a helical structure, the pitch is preferably 20 μm to 5 mm, and the outer diameter is preferably 10 μm to 2 mm; for a wavy or serpentine structure, the peak-to-peak amplitude is preferably 5 μm to 2 mm, and the period is preferably 20 μm to 10 mm. Using a curved structure with strain redundancy can absorb the relative displacement caused by brain tissue pulsation, changes in body position, or chronic micro-movement after implantation, thereby reducing the direct stress concentration near the electrode site on the flexible electrode wire 11 and improving long-term mechanical compatibility.

[0127] The aforementioned auxiliary implant 2 is a rigid structure, which can be made of tungsten, tungsten-rhenium alloy, 316L stainless steel, nickel-titanium alloy, titanium alloy, hard ceramic, or high-modulus carbon-based material. Its outer diameter or maximum lateral dimension is preferably 15μm to 300μm, and its length is preferably 3mm to 100mm. The tip can be constructed as a conical, beveled, triangular pyramidal, or blade-shaped structure, and the tip angle is preferably 8° to 30° to minimize the tissue cutting area while ensuring sufficient puncture capability. The distal end of the auxiliary implant 2 is detachably assembled with the distal end of the flexible electrode wire 11. The axial distance between the assembly position and the distal tip of the auxiliary implant 2 is preferably 0.1mm to 5mm to balance the puncture guidance capability and the stability of disengagement during post-implantation withdrawal.

[0128] In some embodiments, there are multiple flexible electrode wires 11, and the multiple flexible electrode wires 11 adopt at least one of the following arrangements: a straight line arrangement, a matrix arrangement, a ring circumferential arrangement, and an arc array arrangement. Figure 1 The flexible electrode wire 11 shown in the figure adopts a straight line arrangement as an example.

[0129] Thus, the multiple arrangement methods of the flexible electrode wire 11 enable it to adapt to target tissue regions of different shapes and locations, thereby expanding the application range of the device. Different arrangement methods correspond to different electrode coverage patterns, allowing the selection of the most suitable spatial distribution based on clinical needs. This diverse arrangement provides multiple feasible solutions from single-point implantation to multi-point array implantation.

[0130] The aforementioned linear arrangement can be achieved by arranging multiple flexible electrode wires 11 along a straight line. A matrix arrangement can be achieved by arranging multiple flexible electrode wires 11 in rows and columns along two mutually perpendicular directions. A circular circumferential arrangement can be achieved by distributing multiple flexible electrode wires 11 evenly or non-uniformly along a circumference. An arc-shaped array arrangement can be achieved by arranging multiple flexible electrode wires 11 along an arc.

[0131] When multiple flexible electrode wires 11 are arranged in a straight line, the center-to-center distance between adjacent flexible electrode wires 11 is preferably 20 μm to 3000 μm.

[0132] In some embodiments, the proximal ends of multiple auxiliary implants 2 are all disposed corresponding to the distal end of the same slider 32, so as to act on the proximal ends of the multiple auxiliary implants 2 via the same slider 32; or, The proximal ends of multiple auxiliary implants 2 are respectively positioned corresponding to the distal ends of independently configured sliders 32, so as to act on the proximal ends of the multiple auxiliary implants 2 via the independent sliders 32; wherein, the independent sliders 32 respectively correspond to different sliding channels 31; or, Multiple auxiliary implants 2 are divided into multiple groups, and the auxiliary implants 2 in the same group are at least located at the distal end of the same slider 32 so as to act on the proximal end of the auxiliary implants 2 in the same group via the same slider 32. Figures 1 to 8 The proximal ends of the multiple auxiliary implants 2 shown in the figure all correspond to the distal ends of the same slider 32.

[0133] In this way, the corresponding settings of the auxiliary implant 2 and the slider 32 can be flexibly selected according to the implantation strategy, realizing diversified implantation control of the flexible electrode wire 11. For scenarios requiring synchronous implantation, multiple auxiliary implants 2 are driven simultaneously through the same slider 32 to ensure consistent action. For scenarios requiring step-by-step or differentiated implantation, independent sliders 32 can control different auxiliary implants 2 separately to meet complex implantation needs.

[0134] The independently configured sliders 32 are located in different sliding channels 31, and each slider 32 moves independently and drives its corresponding auxiliary implant 2.

[0135] Multiple auxiliary implants 2 are divided into multiple groups. The auxiliary implants 2 in the same group are driven by the same slider 32, and the groups can be driven by the same or different sliders 32, so as to meet the synchronous implantation structure of the auxiliary implants 2 in the same group and the implantation difference requirements of the auxiliary implants 2 in different groups.

[0136] There are N auxiliary implants 2, and M independent sliders 32, where 1 ≤ M ≤ N. It is understood that M is one when multiple auxiliary implants 2 act on their proximal ends via the same slider 32; M equals N when multiple auxiliary implants 2 act on their proximal ends via independent sliders 32; and M is less than N when multiple auxiliary implants 2 within the same group act on their proximal ends via the same slider 32.

[0137] The aforementioned multiple independent sliding elements 32 can be arranged in parallel, in sections, on a turntable, or in series, and can be driven by independent triggering, group triggering, or sequential triggering. The reason for using step-by-step impact implantation is that the distribution of blood vessels, tissue surface height, predetermined depth, or target functional area boundaries may differ in different regions. If all flexible electrode wires 11 are implanted simultaneously at one time, it is not conducive to confirming and fine-tuning area by area. Step-by-step impact allows the surgeon to check the microscopic field of view and adjust the position or depth of the next flexible electrode wire 11 after completing the implantation of one or a group of flexible electrode wires 11, and then continue implantation, thus balancing efficiency and controllability.

[0138] The aforementioned flexible electrode wires 11 can be arranged in a three-dimensional matrix, with a preferred horizontal row-to-column spacing of 50 μm to 5000 μm and a preferred vertical interlayer spacing of 50 μm to 5000 μm, and a total number of wires ranging from 4 to 1024. This approach is particularly suitable for scenarios requiring the establishment of high-density three-dimensional sampling points within a certain volume, such as cortical columnar structure sampling, subcortical local volume sampling, or experimental high-throughput flexible neural interface implantation.

[0139] In some embodiments, such as Figures 1 to 8 As shown, the proximal ends of multiple auxiliary implants 2 are all connected to the consistency retention structure 5, and the distal end of the slider 32 is set to correspond to the proximal end of the auxiliary implant 2 through the consistency retention structure 5.

[0140] Thus, the consistency-maintaining structure 5 effectively limits the relative pose deviation between the auxiliary implants 2, ensuring that multiple auxiliary implants 2 maintain their predetermined relative positions and orientations during implantation. This structure helps improve the consistency of the implantation depth of multiple flexible electrode wires 11 and reduces the uneven depth caused by misalignment of multiple auxiliary implants 2 during array implantation. At the same time, the consistency-maintaining structure 5 also enhances the overall rigidity when multiple auxiliary implants 2 are implanted simultaneously, making the force on multiple auxiliary implants 2 more uniform.

[0141] The aforementioned consistency-maintaining structure 5 can be understood as a positioning component connected to the proximal end of multiple auxiliary implants 2, which is used to maintain the relative position and orientation between each auxiliary implant 2. The consistency-maintaining structure 5 cooperates with multiple auxiliary implants 2 to limit the relative pose deviation between each auxiliary implant 2 during the impact implantation process, thereby improving the consistency of the implantation depth of multiple flexible electrode wires 11.

[0142] The aforementioned consistency-maintaining structure 5 is preferably arranged at the proximal, middle, or near-distal guide position of the auxiliary implant 2, and can form a sleeve fit, lateral limiting fit, plate hole guide fit, or elastic holding fit with multiple auxiliary implants 2. The thickness of the consistency-maintaining structure 5 is preferably 0.05 mm to 5 mm.

[0143] In some embodiments, the distal surface of the consistency-maintaining structure 5 is a curved surface adapted to the surface of the target tissue.

[0144] Thus, the curved surface design of the consistency-maintaining structure 5 can still improve the alignment and consistency of the multiple auxiliary implants 2 during the implantation process even when the target tissue surface is not an ideal plane. This allows the consistency-maintaining structure 5 to fit well with the tissue surface when approaching the target tissue, reducing the deviation of the auxiliary implants 2 caused by surface curvature mismatch.

[0145] The aforementioned consistency-maintaining structure 5 can be a plate structure, and the lower surface of the plate structure can be curved to adapt to the curvature of the target tissue surface. The consistency-maintaining structure 5 uses a thin metal plate, PEEK plate, alumina plate, or photolithography / micromachining plate with a thickness of 0.1mm to 3mm, and has holes that correspond one-to-one with the auxiliary implant 2 to uniformly define the position of the auxiliary implant 2 in the initial state.

[0146] The aforementioned consistency-maintaining structure 5 can be configured as a compliant clamping element, such as being formed using medical silicone, polyurethane elastomer, or a flexible film, to conform to and clamp the surface of the target tissue.

[0147] In some embodiments, the flexible electrode wire 11 includes at least a first insulating layer, a conductive layer and a second insulating layer stacked sequentially along the thickness direction, and the distal end of the flexible electrode wire 11 is provided with at least one electrode site, which is exposed through the first insulating layer and / or the second insulating layer, and the electrode site is used to collect electrophysiological signals of the target tissue and / or apply electrical stimulation to the target tissue.

[0148] In this way, the conductive layer can be covered and protected by the first and second insulating layers, and the electrophysiological signals of the target tissue can be collected and / or electrical stimulation can be applied to the target tissue through the locally exposed electrode sites, so that the flexible electrode wire 11 can have one or both of the functions of recording and stimulation.

[0149] The aforementioned flexible electrode wire 11 includes at least one electrode site at its distal end. The electrode site can be a dotted, ring-shaped, strip-shaped, island-shaped, or multi-point array structure, and its exposure area can be designed according to recording and stimulation requirements. For single-neuron recording or local field potential recording scenarios, the exposure area of ​​a single site is preferably 50 μm² to 20000 μm²; for microstimulation or local modulation scenarios, the exposure area is preferably 500 μm² to 0.5 mm². The number of electrode sites can be 1 to 256, and the spacing between adjacent sites along the length of the flexible electrode wire 11 can be 10 μm to 10 mm. This design allows the same flexible electrode wire 11 to perform single-channel or multi-channel recording / stimulation functions after entering the tissue, thereby improving the information acquisition or modulation capabilities of the electrode implantation device.

[0150] The aforementioned electrode sites can be exposed by forming openings, thinning areas, or localized removal areas on the first and / or second insulating layers, thereby enabling the conductive layer to form electrical contact with the target tissue at a predetermined location. The flexible electrode wire 11 can be a micro-fabricated thin film structure, a flexible strip structure, or a multilayer composite structure, with a preferred total thickness of 2 μm to 200 μm, a preferred conductive layer thickness of 0.1 μm to 20 μm, and preferred single-layer thicknesses of the first and second insulating layers of 0.5 μm to 50 μm, respectively. Through this layered structure, the overall flexibility of the flexible electrode wire 11 can be ensured while the conductive layer is insulated and protected, and the electrode sites can be stably exposed at the target location.

[0151] The conductive layer can be made of at least one of gold, platinum, iridium, or a platinum-iridium alloy. Thus, a material with good electrical conductivity and biocompatibility can be used to construct the conductive portion of the flexible electrode wire 11.

[0152] The aforementioned conductive layer can be a single-layer metal layer, a multi-layer metal composite layer, or a patterned metal conductor layer, and its material can be at least one of gold, platinum, iridium, or platinum-iridium alloys. Gold, platinum, iridium, and platinum-iridium alloys possess good conductivity, corrosion resistance, and electrochemical stability, making them particularly suitable for long-term implantation environments.

[0153] The materials used for the first and / or second insulating layers described above can be the same or different. Specifically, the first and / or second insulating layers can be made of at least one of polyimide, parylene, polyurethane, and silicone. This allows for the use of common flexible insulating materials to insulate the conductive layer, thus achieving a balance between flexibility, electrical insulation properties, and biocompatibility.

[0154] For example, if the first insulating layer and / or the second insulating layer is made of polyimide, the thickness of a single layer is preferably 1 μm to 20 μm; if it is made of parylene, the thickness is preferably 0.5 μm to 10 μm; if it is made of polyurethane, the thickness is preferably 2 μm to 50 μm; and if it is made of silicone, the thickness is preferably 5 μm to 200 μm.

[0155] In some embodiments, the distal end of the flexible electrode wire 11 is provided with an auxiliary implantation hole, and the distal end of the auxiliary implant 2 is detachably connected to the distal end of the flexible electrode wire 11 through the auxiliary implantation hole.

[0156] Thus, the auxiliary implantation hole provides a simple and reliable mating method, allowing the auxiliary implant 2 to stably drive the flexible electrode wire 11 forward. After implantation, the auxiliary implant 2 can be smoothly withdrawn from the auxiliary implantation hole, while the flexible electrode wire 11 remains within the target tissue. This hole-fitting structure is easy to process and reliably connected, facilitating large-scale manufacturing and assembly.

[0157] The aforementioned auxiliary implantation hole can be a round hole, an elliptical hole, an oblong hole, a slit hole, or an irregularly shaped hole. It can be arranged through the thickness direction of the flexible electrode wire 11, or it can be formed as a local opening structure for the distal end of the auxiliary implant 2 to pass through or be attached to. The diameter or equivalent width of the auxiliary implantation hole is preferably 5 μm to 300 μm, and preferably larger than the local diameter of the distal end of the auxiliary implant 2 by 1 μm to 100 μm, so as to facilitate the distal end of the auxiliary implant 2 to pass through, be attached to, or temporarily constrain the distal end of the flexible electrode wire 11. Through this auxiliary implantation hole, the auxiliary implant 2 can reliably drive the flexible electrode wire 11 into the target tissue during the impact implantation phase; when the auxiliary implant 2 is withdrawn, the distal end of the auxiliary implant 2 can detach from the auxiliary implantation hole, thereby leaving the flexible electrode wire 11 in the target tissue.

[0158] In some embodiments, such as Figure 1 and Figure 2 As shown, the electrode implantation device also includes an encapsulated implant 6 electrically connected to the flexible electrode 1. The encapsulated implant 6 includes a sealed housing and a processing module disposed inside the sealed housing. The processing module is used at least to process and transmit the electrophysiological signals collected by the flexible electrode 1, and / or to generate an electrical stimulation signal to be delivered to the flexible electrode 1.

[0159] Thus, the encapsulated implant 6 provides signal processing and transmission capabilities for the flexible electrode 1, enabling subsequent recording, transmission, and integration with functional modules. The sealed housing protects the internal processing module from the humid environment within the body, ensuring long-term reliability. The signal processing function of the processing module allows for effective amplification, filtering, and transmission of the acquired electrophysiological signals, providing high-quality data for subsequent diagnosis or treatment.

[0160] The aforementioned encapsulated implant 6 can be made of titanium alloy, ceramic, titanium-ceramic composite, or high-barrier polymer. Its internal processing module may include a front-end amplifier, filter, analog-to-digital converter, multiplexer, stimulation pulse generation module, control module, wireless transceiver module, or power management module. For animal experiments or early prototypes, the encapsulated implant 6 can be configured as an externally extended processing module; for long-term implantation, the sealing shell preferably uses a laser-welded titanium shell, a brazed ceramic shell, or a glass-metal sealing structure. Its dimensions can range from 5mm×5mm×1mm to 80mm×80mm×20mm, depending on the number of channels and functional complexity. The processing module can be used to process and transmit the electrophysiological signals acquired by the flexible electrode wire 11, and / or to generate and deliver electrical stimulation signals to the flexible electrode wire 11.

[0161] The implantation method of the electrode implantation device is described below: First, the distal end of at least one flexible electrode wire 11 is detachably assembled with the distal end of the corresponding auxiliary implant 2 to complete the pre-assembly of the device. Then, the impact load member 42 is adjusted to the first position, i.e., the initial energy storage position, to accumulate potential energy; then, the distal end of the auxiliary implant 2 is aligned with the preset implantation site of the target tissue; subsequently, the impact load member 42 is released, and the impact load member 42 converts the accumulated potential energy into kinetic energy, moves along the impact channel 41 and impacts the sliding member 32, driving the auxiliary implant 2 to carry the flexible electrode wire 11 into the target tissue; finally, the auxiliary implant 2 is driven to withdraw from the target tissue in the opposite direction of implantation, so that the flexible electrode wire 11 separates from the auxiliary implant 2 and remains in the target tissue.

[0162] When the flexible electrode 1 includes multiple flexible electrode wires 11, multiple auxiliary implants 2 can be synchronously driven by the same slider 32 to complete the synchronous implantation of multiple flexible electrode wires 11; alternatively, multiple independent sliders 32 can be used to drive the corresponding auxiliary implants 2 in an independent, grouped, or sequential manner to complete the independent, grouped, or stepwise implantation of multiple flexible electrode wires 11. After the implantation of one or a group of flexible electrode wires 11 is completed, the implantation position and depth of the next flexible electrode wire or the next group of flexible electrode wires 11 can be adjusted according to the target site, and then the steps of energy storage, alignment, release, implantation, and retraction separation can continue to be performed.

[0163] 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.

[0164] 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.

[0165] 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 implantation device, characterized in that, include: Flexible electrodes; An auxiliary implant, the distal end of which acts on the distal end of the flexible electrode; A sliding guide assembly includes a sliding channel and a slider slidably disposed within the sliding channel. The extending direction of the sliding channel is the same as the implantation direction of the flexible electrode, and the distal end of the slider is correspondingly disposed to the proximal end of the auxiliary implant. The kinetic energy release mechanism has a first position away from the slider and a second position that pushes against the slider. The kinetic energy release mechanism is used to transfer the accumulated potential energy to the slider when it moves from the first position to the second position, so that the slider moves toward the auxiliary implant in the sliding channel and acts on the proximal end of the auxiliary implant to drive the auxiliary implant to drive the flexible electrode to be implanted into the target tissue.

2. The electrode implantation device according to claim 1, characterized in that, The kinetic energy release mechanism includes an impact channel and an impact load member located within the impact channel. The impact channel is connected to the sliding channel. The impact load member is used to apply an impact force to the sliding member when it moves from the first position to the second position within the impact channel.

3. The electrode implantation device according to claim 1, characterized in that, The distal end of the auxiliary implant is detachably connected to the distal end of the flexible electrode to drive the flexible electrode into the target tissue. When the auxiliary implant is withdrawn in the opposite direction to the implantation direction, it disengages from the flexible electrode, leaving the flexible electrode in the target tissue.

4. The electrode implantation device according to claim 2, characterized in that, The kinetic energy release mechanism further includes a first limiting member disposed on the impact channel, the first limiting member being used to limit the maximum impact stroke of the impact load member moving toward the sliding member.

5. The electrode implantation device according to claim 4, characterized in that, The first limiting member has a plurality of first stop positions arranged sequentially along the extension direction of the sliding channel within the impact channel, and the impact load member abuts against one of the first limiting members located in the plurality of first stop positions.

6. The electrode implantation device according to claim 4, characterized in that, The sliding guide assembly further includes a second limiting member disposed on the sliding channel, the second limiting member being used to limit the maximum sliding stroke of the sliding member toward the auxiliary implant.

7. The electrode implantation device according to claim 6, characterized in that, The second limiting member has a plurality of second stop positions arranged sequentially along the extension direction of the sliding channel within the sliding channel. The sliding member abuts against one of the second limiting members located in the plurality of second stop positions, so as to change the maximum sliding stroke of the sliding member by adjusting the position of the second limiting member, thereby changing the implantation depth of the auxiliary implant.

8. The electrode implantation device according to claim 6, characterized in that, In the case where the kinetic energy release mechanism further includes a first limiting member disposed on the impact channel, the first limiting member and the second limiting member are disposed independently of each other.

9. The electrode implantation device according to claim 6, characterized in that, When the kinetic energy release mechanism further includes a first limiting member disposed on the impact channel, at least one of the first limiting member and the second limiting member is provided with a buffer structure.

10. The electrode implantation device according to claim 1, characterized in that, The sliding guide assembly further includes a rebound suppression structure located within the sliding channel and / or on the slider, for suppressing the rebound movement of the slider away from the auxiliary implant.

11. The electrode implantation device according to claim 10, characterized in that, The rebound suppression structure includes at least one of the following: a pawl and ratchet structure, a wedge structure, a friction locking structure, a magnetic holding structure, and a one-way snap-fit ​​structure disposed within the sliding channel; and / or The rebound suppression structure includes at least one of an elastic damping element, a viscous damping element, and a friction damping element located on the sliding element.

12. The electrode implantation device according to claim 2, characterized in that, The kinetic energy release mechanism further includes a trigger structure disposed on the impact channel, the trigger structure being used to lock the impact load member in the first position and to release the impact load member so that the impact load member moves to the second position.

13. The electrode implantation device according to claim 1 or 2, characterized in that, The potential energy stored in the kinetic energy release mechanism includes at least gravitational potential energy. The kinetic energy release mechanism is located above the slider so that, after release, it applies a downward impact force to the slider under the action of gravity.

14. The electrode implantation device according to claim 13, characterized in that, The kinetic energy release mechanism includes an impact channel and an impact load member located within the impact channel. The impact load member is used to apply an impact force to the sliding member when it moves from the first position to the second position within the impact channel. The mass of the impact load member is greater than the total mass of the sliding member and the auxiliary implant.

15. The electrode implantation device according to claim 2, characterized in that, The kinetic energy release mechanism further includes an elastic energy storage element for accumulating elastic potential energy in the first position. The elastic energy storage element is used to apply an elastic force to the impact load member, causing the impact load member to move from the first position to the second position.

16. The electrode implantation device according to claim 13, characterized in that, The kinetic energy release mechanism includes an impact channel, an impact load member, and an elastic energy storage element. The impact load member is located within the impact channel. The elastic energy storage element is used to accumulate elastic potential energy at the first position, and the elastic energy storage element acts on the impact load member, so that the impact load member transfers both the gravitational potential energy and the elastic potential energy to the sliding member.

17. The electrode implantation device according to claim 1, characterized in that, The flexible electrode includes at least one flexible electrode wire, and the distal end of the auxiliary implant is disposed in a one-to-one correspondence with the distal end of the flexible electrode wire.

18. The electrode implantation device according to claim 17, characterized in that, The flexible electrode wires are multiple, and the multiple flexible electrode wires are arranged in at least one of the following ways: a straight line arrangement, a matrix arrangement, a ring circumferential arrangement, and an arc array arrangement.

19. The electrode implantation device according to claim 17, characterized in that, The proximal ends of the plurality of said auxiliary implants are all disposed corresponding to the distal end of the same said slider, so as to act on the proximal ends of the plurality of said auxiliary implants via the same said slider; or, The proximal ends of the plurality of auxiliary implants are respectively disposed corresponding to the distal ends of the independently disposed sliders, so as to act on the proximal ends of the plurality of auxiliary implants via the independently disposed sliders; wherein, the independently disposed sliders correspond to different sliding channels; or, The multiple auxiliary implants are divided into multiple groups, and the auxiliary implants in the same group are disposed at least at the distal end of the same slider so as to act on the proximal end of the auxiliary implants in the same group via the same slider.

20. The electrode implantation device according to claim 17, characterized in that, The proximal ends of the plurality of auxiliary implants are all connected to a consistency-maintaining structure, and the distal end of the slider is configured to correspond to the proximal end of the auxiliary implant through the consistency-maintaining structure.

21. The electrode implantation device according to claim 20, characterized in that, The distal surface of the consistency-maintaining structure is a curved surface adapted to the surface of the target tissue.

22. The electrode implantation device according to claim 17, characterized in that, The flexible electrode wire includes at least a first insulating layer, a conductive layer, and a second insulating layer stacked sequentially along its thickness direction. The distal end of the flexible electrode wire is provided with at least one electrode site, which is exposed through the first insulating layer and / or the second insulating layer. The electrode site is used to collect electrophysiological signals from the target tissue and / or to apply electrical stimulation to the target tissue.

23. The electrode implantation device according to claim 17, characterized in that, The distal end of the flexible electrode wire is provided with an auxiliary implantation hole, and the distal end of the auxiliary implant is detachably connected to the distal end of the flexible electrode wire through the auxiliary implantation hole.

24. The electrode implantation device according to claim 1 or 22, characterized in that, The electrode implantation device further includes a packaged implant that is electrically connected to the flexible electrode. The packaged implant includes a sealed housing and a processing module disposed inside the sealed housing. The processing module is at least used to process and transmit the electrophysiological signals collected by the flexible electrode, and / or to generate an electrical stimulation signal to be delivered to the flexible electrode.

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