Electrode implant assembly and neuromodulation system

Abstract

The application provides an electrode implanting assembly and a neuromodulation system. The electrode implanting assembly comprises a flexible electrode and an auxiliary implanting assembly. The flexible electrode comprises a proximal contact portion, a lead connecting portion and a distal electrode portion, the distal electrode portion comprises an electrode wire, a distal end of the electrode wire is provided with an auxiliary implanting portion, and the flexible electrode further comprises an auxiliary mounting structure located on a non-electric functional area of the flexible electrode. The auxiliary implanting assembly comprises an implanting member base and an auxiliary implanting needle arranged on the implanting member base, a distal needle tip of the auxiliary implanting needle is detachably connected with the auxiliary implanting portion, and the implanting member base is detachably connected with the auxiliary mounting structure, so that the electrode wire is driven to implant into a target tissue via the auxiliary implanting assembly at least when the flexible electrode is implanted. In the process that the electrode wire enters the target tissue, the two detachable connections and the flexible electrode are kept connected, and the position and load distribution of the flexible electrode relative to the auxiliary implanting assembly are jointly defined.

Description

Technical Field

[0001] This application relates to the field of neural electrode implantation technology, specifically to an electrode implantation component and a neural modulation system. Background Technology

[0002] Flexible electrodes, with their advantages of minimal damage to biological tissues and excellent biocompatibility, have been applied in medical and research fields such as implantable brain-computer interfaces, implantable neurostimulation, and electrophysiological signal monitoring. However, existing flexible electrode implantation techniques still have significant drawbacks: on the one hand, the electrode wires used for implantation into target brain tissue, spinal cord, or other soft tissues have extremely low bending stiffness and are prone to bending deformation when implanted alone, making it difficult to accurately reach the target tissue depth; on the other hand, the current auxiliary implantation tools (such as auxiliary implantation needles) and electrode wires have relatively simple mating structures, mostly relying on single-point fixation at the distal end of the auxiliary implantation needle and the distal end of the electrode wire. Therefore, the electrode wire and auxiliary implantation needle are prone to relative slippage or accidental detachment during transportation, alignment, or implantation, making it difficult to guarantee the reliability of electrode transportation and implantation. Summary of the Invention

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

[0004] This application provides an electrode implantation assembly, which includes a flexible electrode and an auxiliary implantation component. The flexible electrode includes a proximal contact portion, a lead wire connection portion, and a distal electrode portion arranged sequentially from proximal to distal along its length. The distal electrode portion includes at least one independently disposed electrode wire, and the distal end of the electrode wire has at least one auxiliary implantation portion. The flexible electrode also includes an auxiliary mounting structure located on a non-electrical functional area of ​​the flexible electrode. The auxiliary implantation component includes at least one implant base and at least one auxiliary implantation needle disposed on the implant base. The distal tip of the auxiliary implantation needle is detachably connected to the auxiliary implantation portion, and the implant base is detachably connected to the auxiliary mounting structure. This allows the electrode wire to be implanted into the target tissue via the auxiliary implantation component, at least during the implantation of the flexible electrode. The detachable connection between the auxiliary implantation needle and the auxiliary implantation portion, and the detachable connection between the implant base and the auxiliary mounting structure, remain connected during the electrode wire's entry into the target tissue, jointly constraining the relative position of the flexible electrode and the auxiliary implantation component.

[0005] In some embodiments, the constraint formed between the implant substrate and the flexible electrode by the auxiliary mounting structure is released after the flexible electrode is implanted, prior to the detachable connection between the auxiliary implantation needle and the auxiliary implantation part, so that the electrode wire remains in the target tissue.

[0006] In some embodiments, the implant substrate is attached to the auxiliary mounting structure via a hook structure.

[0007] In some embodiments, there are at least two auxiliary mounting structures, which are spaced apart along the length of the flexible electrode, and the distal electrode portion is located between the at least two auxiliary mounting structures.

[0008] In some embodiments, there are at least two auxiliary mounting structures, which are spaced apart along the width direction of the flexible electrode, and the distal electrode portion is located at the distal end of the at least two auxiliary mounting structures.

[0009] In some embodiments, the constraint formed between the implant substrate and the flexible electrode by the auxiliary mounting structure is released by at least one of the following: the auxiliary mounting structure or the connection between the auxiliary mounting structure and the flexible electrode is deformed and / or disconnected; the connection structure between the auxiliary mounting structure and the implant substrate undergoes relative displacement and / or is unlocked.

[0010] In some embodiments, the auxiliary mounting structure and / or the auxiliary implantation portion is a through hole extending through the thickness direction of the flexible electrode.

[0011] In some embodiments, the auxiliary mounting structure is a hook structure, which is provided in the non-electrical functional areas corresponding to the proximal contact portion and / or lead wire connection portion.

[0012] In some embodiments, the hook structure includes a combination of one or more of the following structures: a hook structure, a columnar structure, and a slot structure.

[0013] In some embodiments, the auxiliary implantation component further includes a release mechanism that acts on the hook structure and is used at least to separate the hook structure from the auxiliary installation structure through rotational and / or translational movements.

[0014] In some embodiments, the auxiliary implantation assembly further includes a retaining structure disposed on the implant substrate and acting on the auxiliary implantation needle. The retaining structure is used to adjust and / or retain at least one of the following parameters of one or more of the auxiliary implantation needles: a spacing parameter, a position parameter, and an orientation parameter.

[0015] In some embodiments, the electrode wire is a linear structure and / or a curved structure with strain redundancy.

[0016] In some embodiments, the electrode wire is in a planar state before being implanted by the auxiliary implantation needle, and the electrode wire in the planar state has at least a curved structure, which is at least one of a spiral structure, a racetrack structure, or a polygonal structure.

[0017] In some embodiments, the flexible electrode includes a first insulating layer, a first conductive layer and a second insulating layer stacked along its thickness direction, and the electrode wire has at least one conductive site for electrical signal acquisition and / or electrical stimulation, the conductive site being disposed in the first conductive layer and exposed to the second insulating layer.

[0018] In some embodiments, the auxiliary implantation portion is configured as a through-hole penetrating the first insulating layer and the second insulating layer.

[0019] In some embodiments, the auxiliary mounting structure is configured as a through hole penetrating the first and second insulating layers.

[0020] In some embodiments, the electrode implantation assembly includes a plurality of flexible electrodes and a plurality of auxiliary implantation components, wherein the plurality of flexible electrodes are configured in a one-to-one correspondence with the plurality of auxiliary implantation components; and / or, there are a plurality of electrode wires, wherein the plurality of electrode wires are configured in a one-to-one correspondence with a plurality of auxiliary implantation needles.

[0021] In some embodiments, the implantation assistance component is configured to drive multiple electrode wires to be implanted into the target tissue in parallel or sequentially via the corresponding implantation assistance needle.

[0022] This application also provides a neuromodulation system, including the electrode implantation assembly described in any of the above embodiments, and further including at least one of the following target devices: an external signal acquisition device, an electrical stimulation device, and a wireless fully implantable device, wherein the target device is electrically connected to the proximal contact portion of the flexible electrode.

[0023] Compared with related technologies, the beneficial effects of the embodiments of this application are as follows: This application forms a dual constraint relationship distributed along the length direction of the flexible electrode by detachably connecting the distal tip of the auxiliary implantation needle with the auxiliary implantation part (first detachable assembly relationship) and detachably connecting the implantation substrate with the auxiliary installation structure (second detachable assembly relationship). This dual constraint relationship jointly defines the position and load distribution of the flexible electrode relative to the auxiliary implantation component. Compared with the current single-point fixing method of the distal end of the auxiliary implantation needle and the distal end of the electrode wire, it avoids the concentration of all loads at the single-point connection between the distal tip of the auxiliary implantation needle and the auxiliary implantation part, thereby reducing the risk of the flexible electrode buckling, slippage or accidental detachment due to stress concentration. Furthermore, after the flexible electrode is implanted, the constraint formed on the flexible electrode by the implant substrate through the auxiliary installation structure can be released first, and then the detachable connection between the auxiliary implant needle and the auxiliary implant part can be released. That is, the second detachable assembly relationship is released before the first detachable assembly relationship, thereby realizing step-by-step release. The release action logically follows the order of the implant substrate constraint being released first and the distal needle tip being withdrawn later, thereby reducing disturbance to the implanted flexible electrode. Attached Figure Description

[0024] 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.

[0025] Figure 1 This is a front view of the electrode implantation assembly according to an embodiment of this application.

[0026] Figure 2 This is a three-dimensional structural diagram of the electrode implantation assembly according to an embodiment of this application. The electrode wire shown in the figure is a linear structure.

[0027] Figure 3 This is a partial disassembly diagram of the electrode implantation assembly according to an embodiment of this application.

[0028] Figure 4 This is a front view of the electrode implantation assembly according to an embodiment of this application. The electrode wire shown in the figure has a curved structure with strain redundancy.

[0029] Figure 5 This is a three-dimensional structural diagram of the electrode implantation assembly according to an embodiment of this application. The electrode wire shown in the figure is a curved structure with strain redundancy and is in a planar state.

[0030] Figure 6This is a three-dimensional structural diagram of the electrode implantation assembly according to an embodiment of this application. The electrode wire shown in the figure is a curved structure with strain redundancy, and the electrode wire is in an unfolded state.

[0031] Figure 7 This is a schematic diagram of the implantation process of the electrode implantation assembly according to an embodiment of this application. The flexible electrode shown in the figure is in the first position before implantation.

[0032] Figure 8 This is a schematic diagram of the implantation process of the electrode implantation assembly according to an embodiment of this application. The flexible electrode shown in the figure is in the second position after implantation, and neither the first detachable assembly relationship nor the second detachable assembly relationship has been disassembled.

[0033] Figure 9 This is a schematic diagram of the implantation process of the electrode implantation assembly according to an embodiment of this application. The flexible electrode shown in the figure is in the second position after implantation, the second detachable assembly relationship has been disassembled and the first detachable assembly relationship has not been disassembled.

[0034] Figure 10 for Figure 9 Enlarged view of part A in the middle.

[0035] Figure 11 This is a schematic diagram of the implantation process of the electrode implantation assembly according to an embodiment of this application. The first and second detachable assembly relationships shown in the figure have both been disassembled.

[0036] Figure 12 This is an exploded view of the flexible electrode of the electrode implantation assembly according to an embodiment of this application.

[0037] Figure 13 This is a schematic diagram of the electrical connection between a flexible electrode and a target device in a neural modulation system according to an embodiment of this application. The connecting lines in the diagram are used to indicate the electrical connection relationship rather than the signal transmission direction. The flexible electrode can be electrically connected to one or more of the target devices shown.

[0038] The components indicated by the reference numerals in the figure: 100. Target device; 101. External signal acquisition device; 102. Electrical stimulation device; 103. Wireless fully implantable device; 1. Flexible electrode; 11. Non-electrical functional area; 12. First insulating layer; 13. First conductive layer; 14. Second insulating layer; 2. Proximal contact portion; 21. Conductive contact; 3. Lead wire connection portion; 31. Conductive interconnecting lead wire; 4. Distal electrode portion; 41. Electrode wire; 42. Auxiliary implantation portion; 43. Conductive site; 5. Auxiliary mounting structure; 6. Implant substrate; 7. Auxiliary implantation needle; 8. Hook structure; 9. Retention structure. 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 of insertion of a medical device into a patient, either near or far from the operator (e.g., surgeon, physician, nurse, technician, etc.).

[0045] This application provides an electrode implantation assembly. For example... Figures 1 to 6As shown, the electrode implantation assembly includes a flexible electrode 1 and an auxiliary implantation assembly. The flexible electrode 1 includes a proximal contact portion 2, a lead wire connection portion 3, and a distal electrode portion 4 arranged sequentially from near to far along the length of the flexible electrode 1. The distal electrode portion 4 includes at least one independently arranged electrode wire 41, and at least one auxiliary implantation portion 42 is provided at the distal end of the electrode wire 41. The flexible electrode 1 also includes an auxiliary mounting structure 5, which is located on the non-electrical functional area 11 of the flexible electrode 1. The auxiliary implantation component includes at least one implant base 6 and at least one auxiliary implantation needle 7 disposed on the implant base 6. The distal tip of the auxiliary implantation needle 7 is detachably connected to the auxiliary implantation part 42. The implant base 6 is detachably connected to the auxiliary mounting structure 5 so as to drive the electrode wire 41 into the target tissue via the auxiliary implantation component at least when the flexible electrode 1 is implanted. The detachable connection between the auxiliary implantation needle 7 and the auxiliary implantation part 42, and the detachable connection between the implant base 6 and the auxiliary mounting structure 5, are maintained during the process of the electrode wire 41 entering the target tissue, so as to jointly constrain the relative position of the flexible electrode 1 and the auxiliary implantation component.

[0046] The aforementioned flexible electrode 1 has an overall elongated thin-film structure, with a length ranging from 5 mm to 80 mm and an overall thickness ranging from 5 μm to 300 μm, to balance flexibility, processability, and tissue compliance after implantation. The flexible electrode 1 is divided into a proximal contact portion 2, a lead wire connection portion 3, and a distal electrode portion 4 along its length from proximal to distal. The proximal contact portion 2 may be provided with one or more conductive contacts 21 for connection to an external signal acquisition device 101, an electrical stimulation device 102, or a wireless fully implantable device 103; the lead wire connection portion 3 is used to provide conductive interconnecting leads 31, electrically connecting the conductive contacts 21 of the proximal contact portion 2 to the conductive sites 43 of the distal electrode portion 4; the distal electrode portion 4 is used to enter the target tissue and carry at least one electrode wire 41.

[0047] The number of electrode wires 41 in the aforementioned distal electrode section 4 can be from 1 to 256. When multiple electrode wires 41 are provided, the spacing between adjacent electrode wires 41 can be from 50 μm to 2000 μm to adapt to the acquisition and stimulation needs of different brain regions, cortical depths, nerve bundles, or soft tissue target areas. The width of each electrode wire 41 can be from 10 μm to 300 μm, and the length can be from 0.5 mm to 50 mm.

[0048] The aforementioned non-electrical functional region 11 can be understood as the region on the flexible electrode 1 that does not perform the functions of electrical signal transmission, acquisition, or stimulation. The non-electrical functional region 11 is spatially separated from electrical functional structures such as conductive contacts 21, conductive interconnecting leads 31, and conductive sites 43. Specifically, the insulating substrate region in the proximal contact portion 2 other than the conductive contacts 21 (as described below, the first insulating layer 12 and the second insulating layer 14 correspond to the partial regions of the proximal contact portion 2), the insulating substrate region in the lead connection portion 3 other than the conductive interconnecting leads 31 (as described below, the first insulating layer 12 and the second insulating layer 14 correspond to the partial regions of the lead connection portion 3), and the insulating region in the distal electrode portion 4 other than the conductive sites 43 (as described below, the first insulating layer 12 and the second insulating layer 14 correspond to the partial regions of the distal electrode portion 4), can all belong to the non-electrical functional region 11 of the flexible electrode 1, provided that the aforementioned electrical functional structures are avoided. The auxiliary mounting structure 5 is placed in this area to ensure that it only serves mechanical limiting and temporary assembly functions, avoiding interference with the electrical functional structure. This ensures that the electrical performance of the flexible electrode 1 is not affected during assembly, implantation, and release. It also facilitates the removal of the second detachable assembly relationship after implantation by cutting or detachment without damaging the electrical function of the flexible electrode 1. The aforementioned non-electrical functional area 11 does not include the insulating area covering only the surface of the conductive contact 21, conductive interconnect lead 31, or conductive point 43; the auxiliary mounting structure 5 and its predetermined disconnection position should avoid the aforementioned electrical functional structure.

[0049] In some embodiments, the auxiliary mounting structure 5 can be located on the non-implanted portion of the flexible electrode 1 (the portion of the flexible electrode 1 that remains outside the target tissue and does not enter the target tissue after implantation). The proximal contact portion 2 and at least part of the lead connection portion 3 are the non-implanted portions of the flexible electrode 1. Of course, in the scenario where only part of the distal electrode portion 4 is implanted, not the entire distal electrode portion 4 enters the target tissue, but only a portion of its distal electrode wire 41 is implanted into the target tissue. In this case, part of the distal electrode portion 4, along with all of the proximal contact portion 2 and the lead connection portion 3, belong to the non-implanted portion of the flexible electrode 1. By placing the auxiliary mounting structure 5 on the non-implanted portion of the flexible electrode 1, the second detachable assembly relationship can remain in an easily operable and observable position after implantation, facilitating the surgeon or release mechanism to disconnect the implant base 6 from the auxiliary mounting structure 5. It also avoids the auxiliary mounting structure 5 occupying the space in the distal electrode portion 4 that needs to enter the target tissue, reducing interference with the implantation path and electrical functional area of ​​the electrode wire 41. In this embodiment, "non-implanted portion" refers only to the portion that does not enter the target tissue and does not limit this portion to being located outside the body.

[0050] The aforementioned auxiliary implantation needle 7 can be made of tungsten, titanium alloy, stainless steel, platinum-iridium alloy, nickel-titanium alloy, or other medical rigid materials, and its outer diameter can be from 20 μm to 500 μm. The tip of the auxiliary implantation needle 7 can be conical, beveled, triangular pyramidal, or micro-beveled, with a tip angle of 10° to 45°, in order to reduce excessive tissue cutting while providing puncture capability.

[0051] The detachable connection between the distal tip of the aforementioned auxiliary implantation needle 7 and the auxiliary implantation part 42 can form a first detachable assembly relationship, which is used to guide and support the distal end of the electrode wire 41. The detachable connection between the implant base 6 and the auxiliary mounting structure 5 can form a second detachable assembly relationship, which is used to provide main body limitation and posture constraint for the flexible electrode 1. The two work together to prevent the flexible electrode 1 from axially slipping, laterally shifting, twisting, and accidentally detaching during pre-implantation loading, intraoperative movement, and entry into the target tissue.

[0052] The detachable connection between the implant base 6 and the auxiliary mounting structure 5 can be achieved through one or more combinations of the following methods: hook-and-loop connection, pin-and-loop connection, snap-fit ​​connection, clamping connection, magnetic connection, etc. Taking hook-and-loop connection as an example, the implant base 6 has a hook structure 8 such as a hook, column, or slot, and the auxiliary mounting structure 5 has a hanging ear, through hole, or crossbeam. The connection is achieved through hooking, looping, snapping, or limiting, allowing the hook to rotate, move, or retract to disengage. Taking pin-and-loop connection as an example, the implant base 6 has a removable limiting pin, and the auxiliary mounting structure 5 is a through hole. The pin passes through the through hole to form a limit; removing the pin disengages the connection. Taking snap-fit ​​connection as an example, the implant base 6 has an elastic snap, tongue, or claw, and the auxiliary mounting structure 5 has a groove or hole. Snapping into the hole forms a lock; pressing, pushing, or rotating releases the snap. Taking clamping connection as an example, the implant base 6 has a claw; releasing or lifting the claw disengages the connection. The above methods can be used individually or in combination, but all must ensure that the second detachable assembly relationship has sufficient connection strength and attitude constraint capability before and during implantation. The second detachable assembly relationship will be explained in detail below, and will not be repeated here.

[0053] This application establishes a dual constraint relationship along the length of the flexible electrode 1 through a detachable connection between the distal tip of the auxiliary implantation needle 7 and the auxiliary implantation part 42 (first detachable assembly relationship), and a detachable connection between the implantation substrate 6 and the auxiliary mounting structure 5 (second detachable assembly relationship). This dual constraint relationship jointly defines the position and load distribution of the flexible electrode 1 relative to the auxiliary implantation assembly. Compared with the current single-point fixation method of the distal end of the auxiliary implantation needle 7 and the distal end of the electrode wire 41, this avoids the concentration of all loads at the single-point connection between the distal tip of the auxiliary implantation needle 7 and the auxiliary implantation part 42, thereby reducing the risk of buckling, slippage or accidental detachment of the flexible electrode 1 due to stress concentration. Furthermore, after the flexible electrode 1 is implanted, the constraint formed on the flexible electrode 1 by the implant substrate 6 through the auxiliary installation structure 5 can be released first, and then the detachable connection between the auxiliary implantation needle 7 and the auxiliary implantation part 42 can be released. That is, the second detachable assembly relationship is released before the first detachable assembly relationship, thereby realizing step-by-step release. The release action logically follows the order of the limitation of the implant substrate 6 being released first and the distal needle tip being withdrawn later, thereby reducing the disturbance to the implanted flexible electrode 1.

[0054] In some embodiments, such as Figures 7 to 11 As shown, the constraint formed between the implant base 6 and the flexible electrode 1 by the auxiliary installation structure 5 is released before the detachable connection between the auxiliary implant needle 7 and the auxiliary implant part 42 after the flexible electrode 1 is implanted, so that the electrode wire 41 remains in the target tissue.

[0055] Thus, by placing the release sequence of the second detachable assembly relationship before the first detachable assembly relationship, the limiting position between the flexible electrode 1 and the implant substrate 6 is released first, and then the auxiliary implant needle 7 is withdrawn. This reduces the pulling force on the flexible electrode 1 when the auxiliary implant needle 7 is withdrawn, reduces the disturbance to the implanted electrode wire 41, and improves the final positional accuracy and working stability of the electrode wire 41.

[0056] like Figures 7 to 11 As shown, Figure 7 The flexible electrode 1 shown is in the first position before implantation. Figure 8 The flexible electrode 1 shown is in the second position after implantation. Figure 8 Neither the first nor the second detachable assembly relationship was disassembled. Figure 9 The flexible electrode 1 shown is in the second position after implantation. Figure 9 and Figure 10 The second detachable assembly relationship has been disassembled while the first detachable assembly relationship has not been disassembled (i.e., the implant base 6 is detached from the auxiliary installation structure 5, and the auxiliary implant needle 7 is not detached from the auxiliary implant part 42). Figure 11The first and second detachable assembly relationships shown in the figure have both been disassembled (i.e., the auxiliary implant needle 7 is disassembled from the auxiliary implant part 42, and the implant base 6 is disassembled from the auxiliary mounting structure 5).

[0057] It is understandable that in the scenario of flexible electrode 1 implantation, the step of separating the auxiliary implantation component from the flexible electrode 1 after reaching the target depth can also easily affect the final positional accuracy of the electrode wire 41. If the release action is not controlled or the release sequence is not designed reasonably, it may cause traction, pull-back, or displacement of the flexible electrode 1 that has already entered the tissue when the auxiliary implantation needle 7 is withdrawn, thereby affecting the final position and working stability of the electrode. This application places the release sequence of the second detachable assembly relationship before the first detachable assembly relationship, so that the release action logically follows the sequence of "the main body of the flexible electrode 1 is released first, and the distal needle tip is withdrawn later", thereby reducing the disturbance to the implanted electrode wire 41. In this way, when the auxiliary implantation needle 7 is withdrawn, the flexible electrode 1 is no longer restrained by the implantation component base 6, thereby reducing the risk of traction and pull-back transmitted to the electrode wire 41 through the flexible electrode 1 by the needle withdrawal action.

[0058] In some embodiments, such as Figures 1 to 6 As shown, the implant substrate 6 is connected to the auxiliary installation structure 5 via the hook structure 8.

[0059] Thus, by hooking the implant base 6 to the auxiliary installation structure 5 via the hook structure 8, a second detachable assembly relationship is formed. This hooking method facilitates the quick release of the restriction between the implant base 6 and the auxiliary installation structure 5 through the unhooking operation after implantation, which is beneficial to achieving the requirement of releasing the second detachable assembly relationship first in the step-by-step release process.

[0060] The hook structure 8 described above can adopt a combination of one or more of the following structures: a bent hook structure, a columnar structure, etc. The bent hook structure achieves hook positioning by inserting its hook portion into or engaging with the auxiliary mounting structure 5, such as a lug or through hole. The columnar structure can form a shaft-hole fit for positioning by inserting into the through hole of the auxiliary mounting structure 5. Furthermore, the contact edges of the hook structure 8 can be rounded or blunted to prevent scratching or tearing of the flexible electrode 1 during assembly and release.

[0061] In some embodiments, such as Figure 4 and Figure 5 As shown, there are at least two auxiliary mounting structures 5, which are spaced apart along the length of the flexible electrode 1, and the distal electrode portion 4 is located between the at least two auxiliary mounting structures 5.

[0062] Thus, by arranging at least two auxiliary mounting structures 5 at intervals along the length direction of the flexible electrode 1, and with the distal electrode portion 4 located between the at least two auxiliary mounting structures 5, the auxiliary mounting structures 5 can cooperatively limit the distal electrode portion 4 in the length direction, thereby reducing the risk of axial slippage or local warping of the flexible electrode 1 relative to the auxiliary implantation components during implantation.

[0063] In some preferred embodiments, the auxiliary mounting structures 5 are spaced apart along the length direction, with at least two auxiliary mounting structures 5 arranged front-to-back along the length direction of the flexible electrode 1, and the distal electrode portion 4 located between the at least two auxiliary mounting structures 5. The spacing between the two auxiliary mounting structures 5 can be from 0.2 mm to 20 mm. The auxiliary mounting structure 5 located at the proximal end can be used to limit the axial rearward movement of the flexible electrode 1 relative to the implant substrate 6, while the auxiliary mounting structure 5 located at the distal end can be used to limit the warping or wobbling of the distal electrode portion 4. By arranging them front-to-back at intervals, the distal electrode portion 4 is positioned between two assembly constraints, which is beneficial for maintaining the alignment relationship between the electrode wire 41 and the auxiliary implantation needle 7 during implantation and reduces the risk of slippage of the flexible electrode 1 along the length direction.

[0064] In some embodiments, such as Figures 1 to 5 As shown, there are at least two auxiliary mounting structures 5, which are spaced apart along the width direction of the flexible electrode 1, and the distal electrode portion 4 is located at the distal end of the at least two auxiliary mounting structures 5.

[0065] Thus, by arranging at least two auxiliary mounting structures 5 at intervals along the width direction of the flexible electrode 1, and with the distal electrode portion 4 located at the distal end of at least two auxiliary mounting structures 5, the auxiliary mounting structures 5 can constrain the flexible electrode 1 from both sides in the width direction, thereby maintaining good lateral stability of the distal electrode portion 4 before and during implantation, thereby reducing the risk of the flexible electrode 1 swaying or twisting.

[0066] For example, such as Figures 1 to 3 As shown in the figure, there are two auxiliary mounting structures 5, and the two auxiliary mounting structures 5 are spaced apart along the width direction of the flexible electrode 1.

[0067] In some preferred embodiments, such as Figure 4 and Figure 5 As shown, at least two auxiliary mounting structures 5 are spaced apart along the length and width directions of the flexible electrode 1, so that the auxiliary mounting structures 5 can cooperate in limiting the distal electrode portion 4 in the length and width directions.

[0068] In some embodiments, such as Figures 7 to 11As shown, the constraint formed between the implant substrate 6 and the flexible electrode 1 by the auxiliary mounting structure 5 is released by at least one of the following methods: the auxiliary mounting structure 5 or the connection between the auxiliary mounting structure 5 and the flexible electrode 1 is deformed and / or disconnected; the connection structure between the auxiliary mounting structure 5 and the implant substrate 6 is relatively displaced and / or unlocked.

[0069] Thus, by deforming and / or breaking the auxiliary mounting structure 5 or the connection between the auxiliary mounting structure 5 and the flexible electrode 1, or by causing relative displacement and / or unlocking of the connection structure between the auxiliary mounting structure 5 and the implant substrate 6, multiple ways to release the second detachable assembly relationship can be achieved, providing multiple optional implementation methods for releasing the second detachable assembly relationship first in the step-by-step release after implantation.

[0070] The aforementioned deformation and / or disconnection can be understood as the auxiliary mounting structure 5 or the connection between the auxiliary mounting structure 5 and the flexible electrode 1 releasing the constraint of the implant substrate 6 on the flexible electrode 1 through shape change and / or structural destruction after implantation. Deformation of the auxiliary mounting structure 5 can be understood as the auxiliary mounting structure 5 bending, torsion, stretching, or locally yielding under stress, causing it to disengage from its mating position with the hook structure 8, thereby releasing the constraint. This method usually does not damage the integrity of the auxiliary mounting structure 5. Disconnection of the auxiliary mounting structure 5 can be understood as the auxiliary mounting structure 5 itself or the breakable connection between the auxiliary mounting structure 5 and the body of the flexible electrode 1 breaking, for example, being sheared or pulled along a pre-fabricated incision, narrow neck structure, thin bridge structure, or locally thinned structure, causing the auxiliary mounting structure 5 to separate from the body of the flexible electrode 1 or detach from the implant substrate 6. When the breakable connection is cut, the auxiliary mounting structure 5 may still remain on the implant substrate 6, but the constraint formed by the implant substrate 6 on the flexible electrode 1 through the auxiliary mounting structure 5 has been released.

[0071] The relative displacement and / or unlocking of the connection structure between the auxiliary mounting structure 5 and the implant base 6 can be understood as the release of the second detachable assembly relationship through the movement or change of the locking state of the connection structure between the two. Relative displacement can be understood as the occurrence of relative movements such as sliding, rotation, pulling, or misalignment between the auxiliary mounting structure 5 and the implant base 6, causing the originally mating hooks, latches, pins, or limiting structures to disengage from their mating positions. For example, a hook may slide out of a through hole, a latch may exit a slot, or a limiting pin may be pulled out, thereby releasing the connection. Unlocking can be understood as the release of the connection structure that was originally locked, such as by rotating a locking element to loosen it or unscrewing a screw, so that the connection structure is no longer locked, thus allowing the auxiliary mounting structure 5 to separate from the implant base 6.

[0072] It is understood that both the auxiliary mounting structure 5 and the connecting structure are preferably disposed on the non-electrical functional area 11 of the flexible electrode 1. The breakable connecting structure can be a narrow neck structure, a thin bridge structure, a locally thinned structure, a pre-fabricated incision structure, or a low-strength connecting segment, with a width ranging from 20 μm to 500 μm and a thickness ranging from 20% to 80% of the thickness of the adjacent main body area of ​​the flexible electrode 1. Through this design, the auxiliary mounting structure 5 can provide sufficient assembly strength before and during implantation, and when release is required, the second detachable assembly relationship can be released by cutting the connecting structure without affecting the electrical function of the flexible electrode 1.

[0073] In some embodiments, such as Figures 1 to 6 As shown, the auxiliary mounting structure 5 and / or the auxiliary implantation part 42 are through holes that penetrate the thickness direction of the flexible electrode 1.

[0074] Thus, by setting the auxiliary mounting structure 5 and / or the auxiliary implantation part 42 as a through hole penetrating the thickness direction of the flexible electrode 1, the distal tip of the auxiliary implantation needle 7 can penetrate into the auxiliary implantation part 42 to form a first detachable assembly relationship, while the mating part on the implant base 6 can pass through or partially enter the auxiliary mounting structure 5 to form a second detachable assembly relationship, and smoothly detach after implantation.

[0075] The aforementioned through-holes can be formed by laser drilling, reactive ion etching, mechanical punching, die cutting, or wet etching. The diameter of the through-holes can range from 30 μm to 1000 μm. Preferably, the edges of the through-holes can be rounded or locally thickened to reduce stress concentration during connection and decrease the risk of tearing of the flexible electrode 1.

[0076] In some preferred embodiments, the auxiliary implantation portion 42 is a through-hole extending through the thickness direction of the flexible electrode 1, formed at the distal end of each electrode wire 41. The outer diameter or maximum outer contour dimension of the auxiliary implantation portion 42 can be 50 μm to 800 μm, and the inner diameter can be 20 μm to 600 μm. Preferably, the inner diameter of the auxiliary implantation portion 42 is slightly larger than the outer diameter of the distal tip of the auxiliary implantation needle 7, for example, maintaining an assembly gap of 5 μm to 80 μm between them, so that the distal tip of the auxiliary implantation needle 7 can smoothly penetrate the auxiliary implantation portion 42, while avoiding excessive gap that would cause shaking during implantation. The function of the auxiliary implantation portion 42 is to provide a temporary fulcrum and guide for the distal end of the electrode wire 41, enabling the auxiliary implantation needle 7 to drive the distal end of the electrode wire 41 to synchronously enter the target tissue, and to smoothly withdraw after implantation.

[0077] In some embodiments, such as Figures 1 to 6 As shown, the auxiliary mounting structure 5 is a hook structure, which is provided in the non-electrical functional area 11 corresponding to the near-end contact part 2 and / or the lead wire connection part 3.

[0078] Thus, by setting the auxiliary installation structure 5 as an ear-like structure and setting it in the non-electrical functional area 11 of the flexible electrode 1, the auxiliary installation structure 5 can form a second detachable assembly relationship with the implant substrate 6 in the non-electrical functional area 11, avoiding any impact on the electrical function of the flexible electrode 1. At the same time, the ear-like structure facilitates the hook-and-hook engagement with the hook structure 8, which is beneficial to the structural stability.

[0079] The aforementioned ear-like structure can engage with the hook structure 8 to achieve a reliable temporary assembly between the auxiliary installation structure 5 and the implant substrate 6. The ear-like structure can be formed by extending outward from the side edge of the flexible electrode 1, with an outward extension length of 0.1 mm to 3 mm and an ear width of 0.1 mm to 2 mm.

[0080] The auxiliary installation structure 5 can also be a slit hook structure, which can be set in the non-electrical functional area 11. The slit length can be 0.1mm to 3mm and the width can be 20μm to 500μm, and it is used to cooperate with the implant substrate 6 with a sheet-like hook, micro-clamp tongue or lateral insertion structure.

[0081] In some embodiments, the hook structure 8 includes a combination of one or more of the following structures: a hook structure, a columnar structure, and a slot structure. For example... Figures 1 to 6 As shown in the figure, the hook structure 8 is a bent hook structure.

[0082] In this way, the auxiliary installation structure 5 can form a second detachable assembly relationship with the hook structure 8 through various limiting and matching methods, providing a variety of assembly forms to adapt to the needs of auxiliary installation structures 5 with different structures and different implantation scenarios.

[0083] The hook structure 8 described above can be a curved hook structure, with an outer diameter or width of 50μm to 1000μm, used to insert into or fasten the lug structure. The hook structure 8 can also be a columnar structure, which can be inserted into the through hole of the auxiliary mounting structure 5 to form a limiting position. The hook structure 8 can also be a slot structure, allowing the lug structure to be embedded in the slot to form a locking mechanism.

[0084] In some embodiments, the auxiliary implantation component further includes a release mechanism (not shown in the figure) that acts on the hook structure 8 and is used at least to separate the hook structure 8 from the auxiliary installation structure 5 by rotational and / or translational motion.

[0085] Thus, by setting a release mechanism to act on the hook structure 8, and by rotating and / or translating the hook structure 8 to separate from the auxiliary installation structure 5, the second detachable assembly relationship can be quickly released in a controllable mechanical manner, providing an operational basis for releasing the second detachable assembly relationship first after implantation.

[0086] Understandably, the release mechanism is a mechanical component used to drive the hook structure 8, which can cause the hook structure 8 to rotate and / or translate, thereby disengaging it from its mating position with the auxiliary mounting structure 5. Rotational motion can be understood as the hook structure 8 rotating around an axis, for example, the hook portion of the hook structure 8 turning away from the auxiliary mounting structure 5. Translational motion can be understood as the hook structure 8 moving along a straight line, for example, the columnar structure being axially pulled out of the through hole of the auxiliary mounting structure 5. Thus, through rotation and / or translation, the hook structure 8 no longer constrains the auxiliary mounting structure 5, and the second detachable assembly relationship is released.

[0087] The aforementioned release mechanism can be located on the proximal end, side, or movable part connected to the hook structure 8 of the implant base 6. Its stroke can be from 0.2mm to 20mm, which can ensure sufficient release range without causing additional traction on the implanted electrode wire 41 due to excessive stroke.

[0088] In some preferred embodiments, the release mechanism may include a latch, a snap-fit, a sliding locking plate, or a rotary locking element. In the assembled state, the release mechanism keeps the hook structure 8 in the locked position and forms a stable engagement with the auxiliary mounting structure 5; during release, the lock is released by pushing the sliding plate, pressing the release button, or rotating the release element, thereby disengaging the hook structure 8 from the auxiliary mounting structure 5.

[0089] In some preferred embodiments, the release mechanism may also employ a pull-out release method. For example, the release mechanism may include a pull rod, a release line, or other structures. In the assembled state, the release mechanism holds the hook structure 8 in a position that mates with the auxiliary mounting structure 5. During release, the release mechanism is pulled out from the proximal end, causing the hook structure 8 to move along a preset direction and disengage the second detachable assembly relationship.

[0090] In some embodiments, such as Figures 1 to 6 As shown, the auxiliary implantation component also includes a retaining structure 9, which is disposed on the implantation substrate 6 and acts on the auxiliary implantation needle 7. The retaining structure 9 is used to adjust and / or retain at least one of the following parameters of the single or multiple auxiliary implantation needles 7: spacing parameter, position parameter, and orientation parameter.

[0091] Thus, by maintaining the structure 9 on the implant substrate 6 and acting on the auxiliary implant needle 7, the spacing, position, and orientation parameters of the auxiliary implant needle 7 can be adjusted and / or maintained; in the adjustable embodiment, at least some of the auxiliary implant needles 7 can be adjusted individually or in groups and maintained in the adjusted position, thereby taking into account both the individualized setting of the implantation path and the stability of the implantation process.

[0092] The aforementioned retaining structure 9 can be located at the distal end, middle part, or connection point of the implant base 6 with the auxiliary implant needle 7 and the implant base 6.

[0093] Specifically, the retaining structure 9 can be constructed as a fixed plate structure or an adjustable plate structure. A fixed plate structure means that the retaining structure 9 itself is a plate with multiple positioning holes arranged in a preset pattern. Multiple auxiliary implantation needles 7 are installed by passing through the corresponding positioning holes, thus being positioned and retained according to a fixed spacing, position, and posture. This structure is suitable for scenarios where the arrangement of the auxiliary implantation needles 7 is already determined and does not require intraoperative adjustment, and has the advantages of simple structure, high positioning accuracy, and good overall rigidity. An adjustable plate structure means that the plate has adjustment grooves, slide rails, or movable needle seats. At least some of the auxiliary implantation needles 7 are installed on the movable needle seats. The movable needle seats can move along the adjustment grooves or slide rails and can be adjusted and locked using screws or other adjusting or locking components, thereby changing the spacing, position, and posture between adjacent auxiliary implantation needles 7. Each auxiliary implantation needle 7 can be adjusted individually or in groups simultaneously. This structure is suitable for scenarios requiring individualized adjustments based on the target tissue's target point distribution, blood vessel location, or other needs, taking into account the flexibility and adjustability of the implantation path.

[0094] In some embodiments, such as Figures 1 to 6 As shown, electrode wire 41 has a linear structure and / or a curved structure with strain redundancy.

[0095] Thus, by setting the electrode wire 41 as a linear structure and / or a curved structure with strain redundancy, the electrode wire 41 can accommodate certain displacement changes and local strains during assembly, implantation and release, which helps to reduce the risk of excessive local stress in the electrode wire 41 due to tension, bending or small displacement differences.

[0096] Specifically, each electrode wire 41 of the distal electrode section 4 can be a straight structure, suitable for implantation scenarios with short target paths, small tissue displacement, and high requirements for structural compactness. The electrode wire 41 can also be a curved structure with strain redundancy. Strain redundancy can be understood as the electrode wire 41 having a certain amount of bending, winding, or unfolding margin in its geometry, allowing it to absorb displacement differences through the unfolding, contraction, or local bending of the curved structure during assembly, implantation, withdrawal of the assisted implantation needle 7, and tissue micromovement. This structure is particularly suitable for target tissues with micromovement or soft deformation, such as brain tissue, spinal cord, or peripheral nerves, and helps reduce mechanical traction and interface stress after long-term implantation.

[0097] In some embodiments, such as Figures 4 to 6 As shown, the electrode wire 41 is in a planar state before being implanted by the auxiliary implantation needle 7. The electrode wire 41 in the planar state has at least a curved structure, which is at least one of a spiral structure, a racetrack structure, or a polygonal structure.

[0098] Thus, the electrode wire 41 is in a planar state before being implanted by the auxiliary implantation needle 7, and the electrode wire 41 in the planar state has at least one of the following curved structures: a spiral structure, a racetrack structure, or a polygonal structure. This allows the electrode wire 41 to have additional deformation margin in a limited space, resulting in better compliance during implantation and placement. This helps to reduce the traction effect caused by tissue micromovement or the withdrawal of the auxiliary implantation needle 7.

[0099] The aforementioned helical structure can be understood as being formed by electrode wire 41 extending in a spiral or approximately spiral shape around a local centerline, with a pitch ranging from 50 μm to 2000 μm and an outer diameter ranging from 50 μm to 1000 μm. For example... Figures 4 to 6 As shown, Figure 4 and Figure 5 The electrode wire 41 with a spiral structure shown is in a planar state. Figure 6 The auxiliary implantation needle 7 shown acts on the spiral structure of the electrode wire 41, causing the electrode wire 41 to switch from a planar state to an unfolded state.

[0100] The aforementioned runway structure can be understood as consisting of two approximately straight segments and two curved segments at both ends, which is suitable for providing a large expansion margin within a limited width.

[0101] The aforementioned polygonal structure can be understood as being composed of multiple broken lines, such as sawtooth, serpentine, or zigzag paths, which are easy to fabricate using planar micromachining processes.

[0102] The aforementioned curved structure can be set individually, or it can be set by any two or more of the spiral structure, racetrack structure and polygon structure, or it can be set in combination with straight line segments. The purpose is to provide the electrode wire 41 with controllable deformation capability, so that it can naturally adapt to the slight positional changes in the tissue after the auxiliary implantation needle 7 is withdrawn, thereby reducing the risk of electrode wire 41 breaking, dislocation or continuous traction on the tissue.

[0103] In some embodiments, such as Figures 1 to 6 as well as Figure 12 As shown, the flexible electrode 1 includes a first insulating layer 12, a first conductive layer 13 and a second insulating layer 14 stacked along its thickness direction. The electrode wire 41 has at least one conductive site 43 for electrical signal acquisition and / or electrical stimulation. The conductive site 43 is disposed in the first conductive layer 13 and exposed to the second insulating layer 14.

[0104] Thus, by including a first insulating layer 12, a first conductive layer 13 and a second insulating layer 14 stacked along its thickness direction, and the conductive sites 43 of the electrode wire 41 being disposed on the first conductive layer 13 and exposed to the second insulating layer 14, the flexible electrode 1 maintains overall flexibility while protecting the first conductive layer 13 through the first insulating layer 12 and the second insulating layer 14, thereby reducing the risk of leakage and short circuit.

[0105] The first insulating layer 12 can serve as the bottom substrate of the flexible electrode 1, and its thickness can be from 2 μm to 100 μm. The first conductive layer 13 can be disposed on the first insulating layer 12, and its thickness can be from 50 nm to 10 μm. The second insulating layer 14 covers the non-exposed area of ​​the first conductive layer 13, and its thickness can be from 1 μm to 50 μm. The conductive site 43 is formed by exposing the first conductive layer 13 through an opening in the second insulating layer 14, and the diameter or equivalent diameter of the conductive site 43 can be from 10 μm to 1000 μm. Specifically, the conductive contact 21 in the proximal contact portion 2, the conductive interconnecting lead 31 in the lead connection portion 3, and the conductive site 43 in the distal electrode portion 4 can all be patterned from the first conductive layer 13.

[0106] For brain-computer interface acquisition scenarios, smaller conductive sites 43 are advantageous for achieving higher spatial resolution; for electrical stimulation scenarios, larger conductive sites 43 can be selected based on the safe charge injection capability and the target tissue range. The aforementioned stacked structure of the flexible electrode 1 maintains the overall flexibility of the flexible electrode 1 and protects the conductive interconnect leads 31 through the first insulating layer 12 and the second insulating layer 14, reducing the risk of leakage and short circuit in non-target areas.

[0107] The first insulating layer 12 and / or the second insulating layer 14 can be made of polyimide, parylene, polyurethane, or silicone. Polyimide is suitable for forming a thin-film, high-precision flexible electrode 1; parylene has good biocompatibility and uniform coating; and polyurethane and silicone have good softness and elasticity. Depending on the implantation scenario, a single material or a combination of multiple materials can be selected to balance microfabrication precision, flexibility, insulation stability, and long-term implantation reliability.

[0108] The first conductive layer 13 can be made of gold, platinum, iridium, or their alloys, or it can be a platinum-iridium alloy, a titanium / platinum composite layer, a titanium / gold composite layer, an iridium oxide coating, or other conductive materials suitable for implantation electrodes. Gold has good conductivity and processability, platinum and platinum-iridium alloys have good biocompatibility and electrostimulation stability, and iridium or iridium oxide is suitable for improving charge injection capability. Through the above material selection, the flexible electrode 1 can balance conductivity, biocompatibility, and electrochemical stability in the implantation environment.

[0109] In some embodiments, such as Figures 1 to 6 as well as Figure 12 As shown, the auxiliary implantation part 42 is constructed as a through hole penetrating the first insulating layer 12 and the second insulating layer 14.

[0110] Thus, by constructing the auxiliary implantation part 42 as a through hole penetrating the first insulating layer 12 and the second insulating layer 14, the auxiliary implantation part 42 forms a clear penetration space in the thickness direction of the flexible electrode 1, so as to form a stable first detachable assembly relationship with the tip of the auxiliary implantation needle 7, and smoothly detach after implantation.

[0111] The aforementioned auxiliary implantation portion 42, with a through-hole, penetrates the first insulating layer 12 and the second insulating layer 14, while avoiding the conductive interconnect lead 31. The auxiliary implantation portion 42 can be formed by laser drilling, reactive ion etching, wet etching, mechanical punching, or die-cutting. Preferably, the edges of the auxiliary implantation portion 42 can be rounded or locally thickened to reduce stress concentration during the insertion or withdrawal of the auxiliary implantation needle 7, thus reducing the risk of tearing. The aperture of the auxiliary implantation portion 42 should match the outer diameter of the auxiliary implantation needle 7, and an appropriate assembly clearance should be maintained to facilitate smooth disengagement after implantation.

[0112] In some embodiments, such as Figures 1 to 6 as well as Figure 12 As shown, the auxiliary mounting structure 5 is constructed as a through hole penetrating the first insulating layer 12 and the second insulating layer 14.

[0113] Thus, by constructing the auxiliary mounting structure 5 as a through hole penetrating the first insulating layer 12 and the second insulating layer 14, the auxiliary mounting structure 5 forms a clear hooking or limiting space in the thickness direction of the flexible electrode 1, so as to form a stable second detachable assembly relationship with the implant substrate 6 and smoothly detach upon release.

[0114] The hook structure 8, located on the implant substrate 6, can pass through or partially enter the auxiliary mounting structure 5, which is configured as a through hole, to achieve stable positioning between the two. The diameter of the hole in the auxiliary mounting structure 5 should match that of the hook structure 8, and an appropriate assembly clearance should be maintained to allow for smooth disengagement upon release. Preferably, the edges of the hole in the auxiliary mounting structure 5 can be rounded, thickened, or locally reinforced to improve its tear resistance during assembly and implantation.

[0115] In some embodiments, the electrode implantation assembly includes a plurality of flexible electrodes 1 and a plurality of auxiliary implantation components, wherein the plurality of flexible electrodes 1 are configured in a one-to-one correspondence with the plurality of auxiliary implantation components; and / or, there are a plurality of electrode wires 41, wherein the plurality of electrode wires 41 are configured in a one-to-one correspondence with a plurality of auxiliary implantation needles 7.

[0116] Thus, by setting multiple flexible electrodes 1 in a one-to-one correspondence with multiple auxiliary implantation components, and / or setting multiple electrode wires 41 in a one-to-one correspondence with multiple auxiliary implantation needles 7, independent assembly units can be formed between the flexible electrodes 1 and the auxiliary implantation components, and / or between the electrode wires 41 and the auxiliary implantation needles 7, so as to adapt to multi-target brain-computer interface or multi-regional neuromodulation applications.

[0117] The aforementioned flexible electrodes 1 can be two, four, or more in number. Multiple flexible electrodes 1 are assembled one-to-one with multiple auxiliary implantation components, thus forming multiple sets of dual detachable assembly relationships. Each set of dual detachable assembly relationships includes a first detachable assembly relationship between the auxiliary implantation part 42 at the distal end of the electrode wire 41 and the corresponding auxiliary implantation needle 7, and a second detachable assembly relationship between the auxiliary mounting structure 5 of the flexible electrode 1 and the corresponding implant base 6. Through this configuration, independent assembly units can be formed between multiple implantation paths or multiple target regions to adapt to multi-target brain-computer interfaces or multi-regional neuromodulation applications.

[0118] Multiple independent flexible electrodes 1 can be implanted simultaneously or in stages. In some preferred embodiments, multiple independent flexible electrodes 1 can be simultaneously inserted into the target tissue under the guidance of their respective auxiliary implantation components, thus suitable for scenarios where multiple target points are at similar depths, have the same entry direction, or require rapid deployment of multiple sets. In other embodiments, multiple independent flexible electrodes 1 can also be implanted in stages, for example, the first flexible electrode 1 can be implanted and released first, and then the angle, position, or depth can be adjusted before implanting the second flexible electrode 1. Staged independent implantation is suitable for scenarios where the spatial relationship between multiple target points is complex, the curvature of the tissue surface is different, or it is necessary to avoid structures such as blood vessels, sulci, and nerve bundles.

[0119] Each flexible electrode 1 is provided with multiple electrode wires 41, and is assembled one-to-one with multiple auxiliary implantation needles 7 to form multiple pairs of first detachable assembly relationships. In some preferred embodiments, each flexible electrode 1 may be provided with multiple electrode wires 41, for example, 2 to 256 electrode wires 41, and is assembled one-to-one with multiple auxiliary implantation needles 7 to form multiple pairs of first detachable assembly relationships. The multiple auxiliary implantation needles 7 may be arranged on the implant substrate 6 with the same or adapted spacing and arrangement as the multiple electrode wires 41, and the relative position and spacing of at least some of the auxiliary implantation needles 7 may be adjusted according to the target location, blood vessel distribution or other avoidance requirements to ensure that each auxiliary implantation needle 7 can cooperate with the auxiliary implantation part 42 of the corresponding electrode wire 41.

[0120] Specifically, the auxiliary implantation component is configured to drive multiple electrode wires 41 to be implanted into the target tissue in parallel or sequentially via corresponding auxiliary implantation needles 7. Multiple auxiliary implantation needles 7 can be implanted simultaneously or independently in stages. Multiple auxiliary implantation needles 7 can be synchronously driven by the same implantation substrate 6, allowing multiple electrode wires 41 to enter the target tissue simultaneously, thereby improving implantation efficiency and maintaining the relative position and implantation direction of each auxiliary implantation needle 7 and its corresponding electrode wire 41 after adjustment. In other embodiments, multiple auxiliary implantation needles 7 can also be implanted independently in stages, for example, through group driving, group release, group advancement, or needle-by-needle advancement, allowing different electrode wires 41 to enter the tissue according to the target tissue morphology, implantation depth, or avoidance requirements. Synchronous implantation is suitable for array-style implantation scenarios with consistent paths; independent step-by-step implantation is suitable for scenarios with uneven tissue surfaces, different target depths, or where blood vessels need to be avoided.

[0121] This application also provides a neural modulation system. For example... Figure 13 As shown, the neuromodulation system includes the electrode implantation assembly of any of the above embodiments, and further includes at least one target device 100 of the following: an external signal acquisition device 101, an electrical stimulation device 102, and a wireless fully implantable device 103. The target device 100 is electrically connected to the proximal contact portion 2 of the flexible electrode 1. The auxiliary implantation assembly is used to assist in the implantation of the flexible electrode 1 and can be separated from the flexible electrode 1 after implantation, without needing to remain in the target tissue.

[0122] This application utilizes at least one target device 100 from among the external signal acquisition device 101, electrical stimulation device 102, and wireless fully implantable device 103 included in the neuromodulation system. The target device 100 is electrically connected to the proximal contact portion 2 of the flexible electrode 1, enabling the flexible electrode 1 to acquire electrophysiological signals, output electrical stimulation, or a combination of both within the target tissue. It can also be used in conjunction with the wireless fully implantable device 103 depending on the application scenario. Furthermore, the neuromodulation system employing the aforementioned electrode implantation assembly forms a dual constraint relationship along the length of the flexible electrode 1 through a detachable connection between the distal tip of the auxiliary implantation needle 7 and the auxiliary implantation part 42 (first detachable assembly relationship), and a detachable connection between the implantation base 6 and the auxiliary mounting structure 5 (second detachable assembly relationship). This dual constraint relationship jointly defines the positional relationship of the flexible electrode 1 relative to the auxiliary implantation assembly and optimizes the load distribution during implantation. Compared to the current single-point fixation method of the distal end of the auxiliary implantation needle 7 and the distal end of the electrode wire 41, it avoids concentrating all the load at the single-point connection between the distal tip of the auxiliary implantation needle 7 and the auxiliary implantation part 42, thereby reducing the risk of the flexible electrode 1 buckling, slipping, or accidentally detaching due to stress concentration. Furthermore, after the flexible electrode 1 is implanted, the constraint formed on the flexible electrode 1 by the implant substrate 6 through the auxiliary installation structure 5 can be released first, and then the detachable connection between the auxiliary implantation needle 7 and the auxiliary implantation part 42 can be released. That is, the second detachable assembly relationship is released before the first detachable assembly relationship, thereby realizing step-by-step release. The release action logically follows the order of the limitation of the implant substrate 6 being released first and the distal needle tip being withdrawn later, thereby reducing the disturbance to the implanted flexible electrode 1.

[0123] The aforementioned flexible electrode 1 can be electrically connected to an external signal acquisition device 101 and / or an electrical stimulation device 102 to achieve intraoperative testing, acute electrophysiological recording, short-term neurostimulation, or functional localization. The external signal acquisition device 101 and / or the electrical stimulation device 102 can be connected to the proximal contact portion 2 of the flexible electrode 1 via a proximal connector, pad, flexible cable, or adapter cable.

[0124] The aforementioned flexible electrode 1 can be electrically connected to the wireless fully implantable device 103 to form a long-term implantable brain-computer interface or neuromodulation system. The wireless fully implantable device 103 can be equipped with a signal acquisition module, a stimulation output module, a wireless communication module, a power supply module, and a packaging shell. Thus, the flexible electrode 1 can serve both signal acquisition and stimulation verification during surgery or experimental stages, and neural signal acquisition, neural stimulation, or closed-loop modulation in long-term implantation scenarios.

[0125] In some preferred embodiments, the proximal contact portion 2 of the flexible electrode 1 may be provided with connecting pads, metal contacts, flexible connecting tails, connecting plugs, or other electrical connection structures for connection to external signal acquisition device 101 and / or electrical stimulation device 102. The size of the connecting pads may be from 50 μm to 2000 μm to accommodate welding, crimping, anisotropic conductive film connection, or micro-connector connection. In other embodiments, the flexible electrode 1 may be directly or indirectly connected to the wireless fully implantable device 103, for example, via flexible ribbon cables, metal leads, micro-connectors, or solder joints within the package. The wireless fully implantable device 103 may be positioned on the outer table of the skull, subcutaneously, near a bone window, or in other suitable locations for fixation, and may achieve long-term operation through sealed encapsulation.

[0126] The assembly and implantation method of the electrode implantation assembly are described below: First, the auxiliary implantation part 42 at the distal end of each electrode wire 41 of the flexible electrode 1 is matched one by one with the tip of the auxiliary implantation needle 7 to form a first detachable assembly relationship; then, at least two auxiliary mounting structures 5 of the flexible electrode 1 are matched with the corresponding implant base 6 to form a second detachable assembly relationship; subsequently, under the combined action of the first and second detachable assembly relationships, the auxiliary implantation needle 7 is manipulated to drive the electrode wire 41 into the target tissue; after the electrode wire 41 reaches the target position, the second detachable assembly relationship is first released; after the second detachable assembly relationship is released, the auxiliary implantation needle 7 is retracted, so that the needle tip exits the auxiliary implantation part 42 and the first detachable assembly relationship is released, thereby leaving the electrode wire 41 in the target tissue and completing the implantation.

[0127] Specifically, the auxiliary implantation needle 7 can be operated by hand or by a mechanical drive. Hand operation is suitable for simple and direct operating scenarios; operating the auxiliary implantation needle 7 by a mechanical drive can improve the stability, repeatability and accuracy of the advancement process.

[0128] 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.

[0129] The above description is 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 may be used by those skilled in the art upon 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 possible 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.

[0130] 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 assembly, characterized in that, include: A flexible electrode includes a proximal contact portion, a lead wire connection portion, and a distal electrode portion arranged sequentially from near to far along the length of the flexible electrode. The distal electrode portion includes at least one independently arranged electrode wire, and the distal end of the electrode wire is provided with at least one auxiliary implantation portion. The flexible electrode also includes an auxiliary mounting structure, which is located on the non-electrical functional area of ​​the flexible electrode. An auxiliary implantation assembly includes at least one implant base and at least one auxiliary implantation needle disposed on the implant base. The distal tip of the auxiliary implantation needle is detachably connected to the auxiliary implantation portion. The implant base is detachably connected to the auxiliary mounting structure so as to drive the electrode wire into the target tissue via the auxiliary implantation assembly, at least when the flexible electrode is implanted. The detachable connection between the auxiliary implantation needle and the auxiliary implantation portion, and the detachable connection between the implant base and the auxiliary mounting structure, remain connected during the entry of the electrode wire into the target tissue to jointly constrain the relative position of the flexible electrode and the auxiliary implantation assembly.

2. The electrode implantation assembly according to claim 1, characterized in that, The constraint formed between the implant substrate and the flexible electrode by the auxiliary mounting structure is released after the flexible electrode is implanted, prior to the detachable connection between the auxiliary implant needle and the auxiliary implant part, so that the electrode wire remains in the target tissue.

3. The electrode implantation assembly according to claim 1, characterized in that, The implant substrate is attached to the auxiliary installation structure via a hook structure.

4. The electrode implantation assembly according to any one of claims 1 to 3, characterized in that, The auxiliary mounting structure is at least two, and the at least two auxiliary mounting structures are spaced apart along the length direction of the flexible electrode, with the distal electrode portion located between the at least two auxiliary mounting structures.

5. The electrode implantation assembly according to any one of claims 1 to 3, characterized in that, The auxiliary mounting structure is at least two, and the at least two auxiliary mounting structures are spaced apart along the width direction of the flexible electrode, with the distal electrode portion located at the distal end of the at least two auxiliary mounting structures.

6. The electrode implantation assembly according to any one of claims 1 to 3, characterized in that, The constraint formed between the implant substrate and the flexible electrode by the auxiliary mounting structure is released by at least one of the following methods: The auxiliary mounting structure or the connection between the auxiliary mounting structure and the flexible electrode is deformed and / or disconnected; The connection structure between the auxiliary installation structure and the implant substrate undergoes relative displacement and / or unlocking.

7. The electrode implantation assembly according to any one of claims 1 to 3, characterized in that, The auxiliary mounting structure and / or the auxiliary implantation part are through holes that penetrate the thickness direction of the flexible electrode.

8. The electrode implantation assembly according to any one of claims 1 to 3, characterized in that, The auxiliary installation structure is a hook structure, which is set in the non-electrical functional area corresponding to the proximal contact part and / or lead wire connection part.

9. The electrode implantation assembly according to claim 3, characterized in that, The hook structure includes a combination of one or more of the following structures: a hook structure, a columnar structure, and a slot structure.

10. The electrode implantation assembly according to claim 3 or 9, characterized in that, The auxiliary implantation component also includes a release mechanism that acts on the hook structure and is used to separate the hook structure from the auxiliary installation structure through rotational and / or translational movements.

11. The electrode implantation assembly according to any one of claims 1 to 3, characterized in that, The auxiliary implantation component further includes a retaining structure disposed on the implant substrate and acting on the auxiliary implantation needle. The retaining structure is used to adjust and / or retain at least one of the following parameters of one or more of the auxiliary implantation needles: spacing parameter, position parameter, and posture parameter.

12. The electrode implantation assembly according to any one of claims 1 to 3, characterized in that, The electrode wire has a linear structure and / or a curved structure with strain redundancy.

13. The electrode implantation assembly according to claim 12, characterized in that, The electrode wire is in a planar state before being implanted by the auxiliary implantation needle. The electrode wire in the planar state has at least a curved structure, which is at least one of a spiral structure, a racetrack structure, or a polygonal structure.

14. The electrode implantation assembly according to any one of claims 1 to 3, characterized in that, The flexible electrode includes a first insulating layer, a first conductive layer and a second insulating layer stacked along its thickness direction. The electrode wire has at least one conductive site for electrical signal acquisition and / or electrical stimulation. The conductive site is disposed in the first conductive layer and exposed to the second insulating layer.

15. The electrode implantation assembly according to claim 14, characterized in that, The auxiliary implantation part is constructed as a through hole penetrating the first insulating layer and the second insulating layer.

16. The electrode implantation assembly according to claim 14, characterized in that, The auxiliary installation structure is constructed as a through hole penetrating the first and second insulating layers.

17. The electrode implantation assembly according to any one of claims 1 to 3, characterized in that, The electrode implantation assembly includes a plurality of flexible electrodes and a plurality of auxiliary implantation components, wherein the plurality of flexible electrodes and the plurality of auxiliary implantation components are configured in a one-to-one correspondence; and / or, There are multiple electrode wires, and each of the multiple electrode wires is configured in a one-to-one correspondence with one of the multiple auxiliary implantation needles.

18. The electrode implantation assembly according to claim 17, characterized in that, The auxiliary implantation component is configured to drive multiple electrode wires to be implanted into the target tissue in parallel or sequentially via the corresponding auxiliary implantation needle.

19. A neural modulation system, characterized in that, The electrode implantation assembly, as described in any one of claims 1 to 18, further includes at least one target device: an external signal acquisition device, an electrical stimulation device, and a wireless fully implantable device, said target device being electrically connected to the proximal contact portion of the flexible electrode.

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