A flexible neural electrode assembly

Abstract

The present application provides a flexible neural electrode assembly. The flexible neural electrode assembly includes a flexible electrode, a traction member, an auxiliary fixing assembly, and an elastic seal. The flexible electrode includes a proximal contact portion, a lead connection portion, a distal electrode portion, and an auxiliary implantation portion. The flexible electrode and the traction member are both inserted through the auxiliary fixing assembly for implantation into a target tissue. The elastic seal is sleeved outside the flexible electrode and the traction member, and the elastic seal is configured to abut against the auxiliary fixing assembly at least after the distal electrode portion is implanted into the target tissue to a preset depth, and deform under the action of the auxiliary fixing assembly to squeeze the flexible electrode, so that the distal electrode portion of the flexible electrode is fixed at the preset depth, and the flexible electrode is hermetically connected to the auxiliary fixing assembly through the elastic seal. Through the cooperative action of the elastic seal and the auxiliary fixing assembly, the present application effectively limits the implantation depth of the flexible electrode and can effectively seal the wound where the flexible electrode is implanted.

Description

Technical Field

[0001] This application relates to the technical field of biomedical engineering, and specifically, to a flexible nerve electrode assembly. Background Art

[0002] Flexible nerve electrodes have important application values in neuroscience research and nerve electrostimulation therapy. In the prior art, in order to achieve precise implantation of flexible nerve electrodes, a traction member or an auxiliary fixing part is usually used in cooperation. However, there are still some deficiencies in these technical solutions in practical applications. For example, the prior art has less consideration for the design of the seal of flexible nerve electrodes, which easily leads to leakage or contamination risks of body fluids (such as blood, cerebrospinal fluid, etc.) or gases, further increasing the probability of postoperative complications for patients. In addition, the problem of unstable fixation of flexible nerve electrodes after implantation has not been fully solved. Especially in a dynamic environment, flexible nerve electrodes may shift, affecting the treatment effect. In particular, there is a lack of effective limitation on the implantation depth of flexible nerve electrodes during the implantation process, which easily causes the flexible nerve electrodes to be too deep or deviate from the target area. Summary of the Invention

[0003] In view of the above technical problems existing in the prior art, this application provides a flexible nerve electrode assembly, which can effectively limit the implantation depth of the flexible electrode through the synergistic effect of an elastic seal and an auxiliary fixing component, and can effectively seal the wound where the flexible electrode is implanted.

[0004] This application provides a flexible nerve electrode assembly. The flexible nerve electrode assembly includes a flexible electrode, a traction member, an auxiliary fixing component, and an elastic seal. The flexible electrode is made of a flexible material and includes a proximal contact part, a lead connection part, a distal electrode part, and an auxiliary implantation part that are sequentially connected along the length direction of the flexible electrode. The distal electrode part and the auxiliary implantation part are used for implanting into a target tissue, and the distal electrode part includes at least one electrode site, and the electrode site is used for applying an electrical stimulation to the target tissue and / or collecting the potential signal of the target tissue. The traction member acts on the auxiliary implantation part to implant the flexible electrode into the target target area via the auxiliary implantation part. The auxiliary fixing component is connected to the surface of the target tissue and / or the affiliated organism of the target tissue, and both the flexible electrode and the traction member pass through the auxiliary fixing component to be implanted into the target tissue. The elastic seal is sleeved outside the flexible electrode and the traction member, and the elastic seal is configured to abut against the auxiliary fixing component at least after the distal electrode part is implanted into the target tissue to a preset depth, and deform under the action of the auxiliary fixing component to squeeze the flexible electrode, so that the distal electrode part of the flexible electrode is fixed at the preset depth, and the flexible electrode is hermetically connected to the auxiliary fixing component through the elastic seal.

[0005] In some embodiments, the auxiliary fixing component includes a first fixing member, the first fixing member is connected to the surface of the target tissue and / or the accessory organism of the target tissue, and a first through-channel is provided on the first fixing member. The flexible electrode and the traction member are both implanted into the target tissue through the first through-channel, and the elastic seal abuts against the proximal end of the first fixing member.

[0006] In some embodiments, the elastic seal has a second through-channel for passing through the flexible electrode, and the second through-channel is configured to deform in the direction of the flexible electrode under the action of the auxiliary fixing component so as to abut against the flexible electrode.

[0007] In some embodiments, the elastic seal further has a third through-channel for passing through the traction member, and the second through-channel and the third through-channel are connected or independently provided.

[0008] In some embodiments, the elastic seal is configured to move relative to the flexible electrode along the length direction of the flexible electrode when a force exceeding a first threshold is applied.

[0009] In some embodiments, the shape of the second through-channel and / or the third through-channel is slit-shaped.

[0010] In some embodiments, the second through-channel of the elastic seal is configured to apply a first frictional force to the inserted flexible electrode. When the force on the elastic seal exceeds the first frictional force, the elastic seal moves relative to the flexible electrode along the length direction of the flexible electrode. The third through-channel of the elastic seal is configured to apply a second frictional force to the inserted traction member. When the force on the elastic seal exceeds the second frictional force, the elastic seal moves relative to the traction member along the length direction of the traction member.

[0011] In some embodiments, the difference between the first frictional force and the second frictional force is within a preset range, and the force of the first threshold is configured to be able to overcome the first frictional force and the second frictional force and move relative to the flexible electrode and the traction member synchronously after the elastic seal is stressed.

[0012] In some embodiments, the auxiliary fixing component further includes a second fixing member, the second fixing member is movably connected to the first fixing member, the elastic seal is disposed between the first fixing member and the second fixing member, and the second fixing member is used to move in the direction of the first fixing member to apply a force to the elastic seal to make it abut against the first fixing member.

[0013] In some embodiments, the first fixing member and the second fixing member are used to cooperate to apply an extrusion force exceeding a second threshold to the elastic seal, so that the elastic seal can deform to extrude the flexible electrode.

[0014] In some embodiments, the first fixing member and the second fixing member are snap-connected, and / or the first fixing member and the second fixing member are locked and connected.

[0015] In some embodiments, one of the first fixing member and the second fixing member is provided with a recess, and the other is provided with a protrusion matching the recess. The protrusion is snapped into the recess to achieve the snap connection between the first fixing member and the second fixing member.

[0016] In some embodiments, the elastic seal has a second through-channel for passing through the flexible electrode, and the second fixing member has a fourth through-channel for passing through the flexible electrode. The first through-channel, the second through-channel, and the fourth through-channel are aligned along the length direction of the flexible electrode during the connection process of the second fixing member and the first fixing member.

[0017] In some embodiments, the flexible electrode includes a first insulating layer, a first conductive layer, and a second insulating layer laminated along the thickness direction of the flexible electrode. The electrode site is formed on the first conductive layer, and the first insulating layer and / or the second insulating layer are not provided outside the part of the first conductive layer corresponding to the electrode site.

[0018] In some embodiments, a traction portion is formed at the distal end of the traction member. The traction portion acts on the auxiliary implantation portion. The traction member is used to separate the traction portion from the auxiliary implantation portion when a force is applied to the proximal contact portion of the flexible electrode.

[0019] Compared with the prior art, the beneficial effects of the embodiments of the present application are as follows: Through the synergistic effect of the elastic seal and the auxiliary fixing assembly, the elastic seal can abut against the auxiliary fixing assembly after the distal electrode portion of the flexible electrode is implanted into the preset depth of the target tissue, so that the elastic seal can apply a squeezing force to the flexible electrode at the preset depth, achieving the purpose of keeping the distal electrode portion of the flexible electrode at the position of the preset depth, effectively limiting the implantation depth of the flexible electrode, improving the implantation stability of the flexible electrode, and avoiding the problems of the implantation depth of the flexible electrode being too deep or deviating from the target position. Moreover, the elastic seal can abut against the auxiliary fixing assembly and deform to achieve the sealed connection between the elastic seal and the auxiliary fixing assembly, thereby realizing the sealing of the wound where the flexible electrode is implanted, reducing the risk of leakage or contamination of body fluids (such as blood, cerebrospinal fluid, etc.) or gas, and providing important technical support for the precise implantation and long-term stable use of the flexible electrode. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] In the drawings, which are not necessarily drawn to scale, the same reference numerals may describe similar components in different views. The drawings generally illustrate, by way of example and not limitation, various embodiments, and are used together with the description and the claims to explain the disclosed embodiments. Where appropriate, the same reference numerals are used throughout the drawings to refer to the same or similar parts. Such embodiments are illustrative and are not intended to be an exhaustive or exclusive embodiment of the apparatus or method.

[0021] Figure 1 This is a schematic three-dimensional structure diagram of the flexible neural electrode assembly according to an embodiment of the present application.

[0022] Figure 2 This is a schematic diagram of the installation process of the flexible neural electrode assembly according to an embodiment of the present application.

[0023] Figure 3 This is a schematic diagram of the installation process of the flexible neural electrode assembly during the implantation process according to an embodiment of the present application.

[0024] Figure 4 This is a schematic diagram of the installation process of the flexible neural electrode assembly implanted in the brain according to an embodiment of the present application.

[0025] Components represented by the reference numerals in the figure:

[0026] 1. Flexible electrode; 11. Proximal contact part; 12. Lead connection part; 13. Distal electrode part; 14. Auxiliary implantation part; 2. Traction member; 21. Traction part; 3. Auxiliary fixing assembly; 31. First fixing member; 32. Second fixing member; 33. Recessed part; 34. Protruding part; 4. Elastic seal. Detailed implementation manners

[0027] To enable those skilled in the art to better understand the technical solutions of the present application, the present application will be described in detail below in conjunction with the accompanying drawings and specific implementation manners. The embodiments of the present application will be further described in detail below in conjunction with the accompanying drawings and specific embodiments, but this is not a limitation to the present application.

[0028] The "first", "second" and similar terms used in the present application do not indicate any order, quantity or importance, but are only used to distinguish different parts. Words such as "including" or "comprising" mean that the elements before this word cover the elements listed after this word, and do not exclude the possibility of also covering other elements. "Upper", "lower", "left", "right", etc. are only used to represent relative positional relationships, and when the absolute position of the object being described changes, the relative positional relationship may also change accordingly.

[0029] In the present application, when it is described that a specific device is located between a first device and a second device, there may or may not be an intermediate device between the specific device and the first device or the second device. When it is described that a specific device is connected to other devices, the specific device may be directly connected to the other devices without an intermediate device, or may not be directly connected to the other devices but have an intermediate device.

[0030] All terms used in this application (including technical or scientific terms) have the same meaning as understood by those of ordinary skill in the art to which this application pertains, unless otherwise specifically defined. It should also be understood that terms defined in, for example, a general dictionary should be interpreted as having a meaning consistent with their meaning in the context of the relevant art, and should not be interpreted in an idealized or overly formal sense, unless specifically defined as such here.

[0031] Technologies, methods, and devices known to those of ordinary skill in the relevant art may not be discussed in detail, but where appropriate, such technologies, methods, and devices should be regarded as part of the specification.

[0032] In this application, the term "proximal" is intended to denote the end closer to the operator (such as a doctor) performing the implantation operation, while the term "distal" is intended to denote the side closer to the target area of the implantable neural signal device to be implanted.

[0033] All terms used in this application (including technical or scientific terms) have the same meaning as understood by those of ordinary skill in the art to which this application pertains, unless otherwise specifically defined. It should also be understood that terms defined in, for example, a general dictionary should be interpreted as having a meaning consistent with their meaning in the context of the relevant art, and should not be interpreted in an idealized or overly formal sense, unless specifically defined as such here. Technologies, methods, and devices known to those of ordinary skill in the relevant art may not be discussed in detail, but where appropriate, such technologies, methods, and devices should be regarded as part of the specification.

[0034] An embodiment of this application provides a flexible neural electrode assembly, which can be used in the medical field and the like. The following will introduce in detail a flexible neural electrode assembly according to an embodiment of this application with reference to the accompanying drawings.

[0035] As Figures 1 to 4As shown, the flexible neural electrode assembly includes a flexible electrode 1, a traction member 2, an auxiliary fixing member 3 and an elastic sealing member 4. The flexible electrode 1 is made of a flexible material, and includes a proximal contact portion 11, a lead connection portion 12, a distal electrode portion 13 and an auxiliary implantation portion 14 connected in sequence along the length direction of the flexible electrode 1. The distal electrode portion 13 and the auxiliary implantation portion 14 are used to be implanted into the target tissue, and the distal electrode portion 13 includes at least one electrode site, and the electrode site is used to apply electrical stimulation to the target tissue and / or collect the potential signal of the target tissue. The traction member 2 acts on the auxiliary implantation portion 14 to implant the flexible electrode 1 into the target area via the auxiliary implantation portion 14. The auxiliary fixing member 3 is connected to the surface of the target tissue and / or the attached organism of the target tissue, and the flexible electrode 1 and the traction member 2 are both penetrated through the auxiliary fixing member 3 to be implanted into the target tissue. The elastic seal 4 is sleeved outside the flexible electrode 1 and the traction member 2. The elastic seal 4 is constructed to abut against the auxiliary fixing component 3 at least after the distal electrode portion 13 is implanted to a preset depth of the target tissue, and deform under the action of the auxiliary fixing component 3 to squeeze the flexible electrode 1, so that the distal electrode portion 13 of the flexible electrode 1 is fixed at a preset depth, and the flexible electrode 1 is sealed and connected to the auxiliary fixing component 3 through the elastic seal 4.

[0036] The flexible material used in the flexible electrode 1 may have good electrical conductivity and biocompatibility, which can ensure that the flexible electrode 1 can work stably for a long time, and also have a certain flexibility so that the flexible electrode 1 can deform with the movement of the human tissue after being implanted in the human tissue. Of course, the flexible electrode 1 may be made of metal material, or non-metal material, or a combination of non-metal material and metal material. This application does not specifically limit the material used in the flexible electrode 1.

[0037] The above-mentioned flexible electrode 1 can be shaped as a long sheet structure, and the proximal contact part 11, the lead connection part 12, the distal electrode part 13 and the auxiliary implant part 14 are connected in sequence along the length direction of the flexible electrode 1, wherein the proximal contact part 11, the lead connection part 12 and the distal electrode part 13 are all shaped as long sheets, and the auxiliary implant part 14 can be constructed as a hole structure or a groove structure.

[0038] The diameter of the auxiliary implantation portion 14 constructed as a hole structure may range from 0.002 mm to 2 mm. The auxiliary implantation portion 14 can drive the flexible electrode 1 to be accurately implanted into the target tissue under the action of the traction member 2 .

[0039] The electrode sites of the distal electrode part 13 described above can be electrically connected to the proximal contact part 11 through the lead connection part 12. The number of electrode sites of the distal electrode part 13 ranges from 1 to 200. Among them, the number of electrode sites for collecting the potential signals of the target tissue can be from 1 to 2000. These electrode sites can be used to apply electrical stimulation to the target tissue or to collect the potential signals of the target tissue. The design of the number of the above electrode sites fully considers the electrical stimulation coverage and the resolution of the recorded signals to ensure its functionality in various application scenarios.

[0040] The width range of the above proximal contact part 11 can be from 100 micrometers to 10 millimeters, and the thickness is controlled below 0.2 millimeters. It can achieve signal interaction with external devices through electrical connection.

[0041] The width of the above lead connection part 12 can be different at different positions, and its structural design is specifically a stacked design, that is, formed by stacking multiple layers.

[0042] The above traction member 2 is used to apply a force towards the distal end during implantation to guide the distal electrode part 13 of the flexible electrode 1 to the preset depth of the target tissue. After the distal electrode part 13 of the flexible electrode 1 reaches the preset depth of the target tissue, the traction member 2 is separated from the auxiliary implantation part 14 of the flexible electrode 1, and the traction member 2 is removed from the target tissue, so that the distal electrode part 13 of the flexible electrode 1 is at the preset depth of the target tissue.

[0043] The surface of the above target tissue and / or the accessory organism of the target tissue can be understood as a biological structure located outside the target tissue and close to the target tissue. Specifically, it can be combined with Figure 4 , in the case where the target tissue is the brain tissue, the accessory organism of the target tissue can be understood as the skull.

[0044] The above auxiliary fixing component 3 can be made of biocompatible materials, such as polyetheretherketone (PEEK), titanium, titanium alloy, stainless steel or other medical-grade polymer materials, to ensure the stability of the fixing part during long-term use and its compatibility with tissues.

[0045] The above elastic seal 4 can be made of materials with high elasticity, high flexibility and biocompatibility, so that when the squeezing force applied by the auxiliary fixing component 3 is received, the elastic seal 4 can undergo appropriate deformation, such as silicone and rubber.

[0046] It can be understood that the deformed elastic seal 4 can not only closely fit with the auxiliary fixing component 3, but also deform and extrude the flexible electrode 1, enabling the flexible electrode 1 to be hermetically connected to the auxiliary fixing component 3 through the elastic seal 4, ensuring that the wound where the flexible electrode 1 is implanted can be sealed. After sealing, it can not only prevent the leakage of body fluids (such as blood, cerebrospinal fluid, etc.) or gases, but also effectively prevent external pollutants from entering the body. Moreover, the elastic seal 4 can also fix the distal electrode portion 13 of the flexible electrode 1 at a preset depth in the target tissue by extruding the flexible electrode 1, achieving precise limitation of the implantation depth of the flexible electrode 1, thereby ensuring the safety of the flexible electrode 1 during long-term use.

[0047] The length range of the cross-section of the above-mentioned elastic seal 4 can be from 0.2 mm to 200 mm, and the width range can be from 0.1 mm to 100 mm.

[0048] The size and shape of the above-mentioned elastic seal 4 can be adjusted according to the implantation requirements of the flexible electrode 1, so that after the elastic seal 4 deforms under force, it can apply an appropriate extrusion force to the flexible electrode 1, and on the basis of ensuring that the flexible electrode 1 is not damaged, limit the implantation depth of the flexible electrode 1.

[0049] In this application, through the synergistic effect of the elastic seal 4 and the auxiliary fixing component 3, wherein, after the distal electrode portion 13 of the flexible electrode 1 is implanted to the preset depth in the target tissue, the elastic seal 4 can abut against the auxiliary fixing component 3, enabling the elastic seal 4 to apply an extrusion force to the flexible electrode 1 at the preset depth, achieving the purpose of keeping the distal electrode portion 13 of the flexible electrode 1 at the position of the preset depth, effectively limiting the implantation depth of the flexible electrode 1, improving the implantation stability of the flexible electrode 1, and avoiding the problems of the implantation depth of the flexible electrode 1 being too deep or deviating from the target position. Moreover, the elastic seal 4 can abut against the auxiliary fixing component 3 and deform to realize the hermetic connection between the elastic seal 4 and the auxiliary fixing component 3, thereby realizing the sealing of the wound where the flexible electrode 1 is implanted, reducing the risk of leakage or contamination of body fluids (such as blood, cerebrospinal fluid, etc.) or gases, and providing important technical support for the precise implantation and long-term stable use of the flexible electrode 1.

[0050] In some embodiments, as Figures 1 to 4 shown, the auxiliary fixing component 3 includes a first fixing member 31, the first fixing member 31 is connected to the surface of the target tissue and / or the attached organism of the target tissue, and the first fixing member 31 is provided with a first through-channel. Both the flexible electrode 1 and the traction member 2 pass through the first through-channel and are implanted into the target tissue, and the elastic seal 4 abuts against the proximal end of the first fixing member 31.

[0051] In this way, the first fixing member 31 can be fixed to the surface of the target tissue and / or the attached organism of the target tissue, which is beneficial to the accurate implantation of the subsequent flexible electrode 1. Moreover, the first fixing member 31 after being fixed in position abuts against the elastic seal 4, and can apply a stable acting force to the elastic seal 4, improving the structural stability.

[0052] The above-mentioned first fixing member 31 can be connected to the surface of the target tissue and / or the attached organism of the target tissue by a detachable connection method, such as screw connection, snap connection, etc. Of course, it can also be connected to the surface of the target tissue and / or the attached organism of the target tissue by means of glue bonding. The present application does not make specific limitations on this, as long as the first fixing member 31 can be stably installed.

[0053] Exemplarily, as Figure 3 and Figure 4 shown, a threaded structure can be formed at the distal end of the first fixing member 31 to be connected to the surface of the target tissue and / or the attached organism of the target tissue through the threaded structure.

[0054] The cross-sectional dimension range of the above-mentioned first fixing member 31 is 0.1 mm to 20 mm, and the length range is 0.2 mm to 40 mm, so as to provide sufficient support area for the entire flexible nerve electrode assembly.

[0055] The cross-sectional dimension range of the above-mentioned first through-channel is 0.005 mm to 10 mm, so as to match the lead connection part 12 of the flexible electrode 1 and the traction member 2, thereby ensuring that the flexible electrode 1 can be smoothly implanted while the implantation path of the flexible electrode 1 can be accurately without deviation.

[0056] The shape of the distal end of the above-mentioned elastic seal 4 can be adapted to the shape of the proximal end of the first fixing member 31, so that the elastic seal 4 and the first fixing member 31 can stably abut against each other, and the contact tightness between the elastic seal 4 and the first fixing member 31 can be ensured.

[0057] Exemplarily, a first groove can be formed at the proximal end of the first fixing member 31, and the distal end of the elastic seal 4 can be at least partially embedded in the first groove to ensure the connection stability between the elastic seal 4 and the first fixing member 31.

[0058] In some embodiments, the elastic seal 4 has a second through-channel passing through the flexible electrode 1, and the second through-channel is configured to deform towards the flexible electrode 1 under the action of the auxiliary fixing assembly 3 so as to abut against the flexible electrode 1.

[0059] In this way, after the second through-channel deforms under the action of the first fixing member 31, a suitable force can be applied to the flexible electrode 1 through the deformed second through-channel. This can not only guide the stable implantation of the flexible electrode 1 via the second through-channel, but also press against the flexible electrode 1 through the deformed second through-channel to achieve a better sealing effect.

[0060] The cross-sectional dimension range of the above-mentioned second through-channel is from 0.005 mm to 50 mm.

[0061] The above-mentioned second through-channel is configured to enable the flexible electrode 1 to pass through smoothly and, at the same time, to press against the flexible electrode 1 after deformation for a sealed connection with the flexible electrode 1. Therefore, the size of the second through-channel should not be too large, and there should be a certain gap between it and the flexible electrode 1.

[0062] The shape of the above-mentioned second through-channel can be adapted to the shape of the flexible electrode 1. For example, when the shape of the flexible electrode 1 is sheet-like, the shape of the second through-channel can be rectangular.

[0063] The above-mentioned second through-channel pressing against the flexible electrode 1 can be understood as the inner wall of the second through-channel wrapping around the flexible electrode 1 and applying a suitable force to the flexible electrode 1 to ensure the sealing effect.

[0064] In some embodiments, the elastic seal 4 further has a third through-channel through which the traction member 2 passes, and the second through-channel and the third through-channel are connected or independently arranged.

[0065] In the case where the above-mentioned second through-channel and third through-channel are independently arranged, the passages through which the flexible electrode 1 and the traction member 2 pass can be made not to affect each other, so as to ensure the accuracy of the implantation of the flexible electrode 1 during the implantation process, avoid wear or misalignment of the flexible electrode 1 and the traction member 2 caused by mechanical deviation, and ensure the sealing between the second through-channel and the flexible electrode 1 through a separate passage design.

[0066] In the case where the above-mentioned second through-channel and third through-channel are connected, it is convenient to manufacture the elastic seal 4, and it is also convenient to pass through the flexible electrode 1 and the traction member 2, improving the operation convenience.

[0067] The length direction of the above-mentioned second through-channel and the length direction of the third through-channel can be parallel. The parallel distribution helps to maintain the overall symmetry of the elastic seal 4 and ensure the stable performance of the elastic seal 4 during sealing and limiting.

[0068] In some embodiments, the elastic seal 4 is configured to move relative to the flexible electrode 1 along the length direction of the flexible electrode 1 when subjected to a force exceeding the first threshold.

[0069] Thus, through the elastic seal 4 that can move relative to the flexible electrode 1, flexible adjustment of the implantation depth of the flexible electrode 1 can be achieved. After the distal electrode portion 13 is implanted to the preset depth of the target tissue, the elastic seal 4 abuts against the auxiliary fixing component 3 to ensure the accurate positioning of the flexible electrode 1.

[0070] It can be understood that the above-mentioned elastic seal 4 is configured such that it cannot move relative to the flexible electrode 1 along the length direction of the flexible electrode 1 when subjected to a force not exceeding the first threshold. At this time, the relative position between the elastic seal 4 and the flexible electrode 1 remains unchanged, that is, the elastic seal 4 can approach the first fixing member 31 as the flexible electrode 1 is implanted.

[0071] In some embodiments, the shape of the second through-channel and / or the third through-channel is slit-shaped. Thus, on the basis of ensuring that the flexible electrode 1 can pass smoothly through the slit-shaped second through-channel and / or third through-channel, a sealing effect on the flexible electrode 1 can be achieved through the slit-shaped structure, and the problem of ineffective sealing of the flexible electrode 1 due to an excessive gap between the second through-channel and the flexible electrode 1 will not occur. It can also prevent the flexible electrode 1 from being worn due to vibration or movement during implantation.

[0072] The cross-sectional shape of the above-mentioned slit-shaped second through-channel and / or third through-channel can be one or a combination of the following: broken line shape, straight line shape, and oval shape. Among them, the straight-line-shaped second through-channel and / or third through-channel can play a role in linear guiding, and the broken-line-shaped and oval-shaped second through-channels and / or third through-channels can better adapt to the complex movement requirements of the flexible electrode 1 and increase the fixing effect with the flexible electrode 1.

[0073] The above-mentioned third through-channel can be adapted to the shape and size of the traction member 2. For example, the shape of the third through-channel is hole-shaped.

[0074] In some embodiments, the second through-channel of the elastic seal 4 is configured to apply a first frictional force to the inserted flexible electrode 1. When the force on the elastic seal 4 exceeds the first frictional force, the elastic seal 4 moves relative to the flexible electrode 1 along the length direction of the flexible electrode 1. The third through-channel of the elastic seal 4 is configured to apply a second frictional force to the inserted traction member 2. When the force on the elastic seal 4 exceeds the second frictional force, the elastic seal 4 moves relative to the traction member 2 along the length direction of the traction member 2.

[0075] In this way, through the design of the first frictional force and the second frictional force, the elastic seal 4 can move relative to the flexible electrode 1 and the traction member 2 only after the acting force received reaches a certain threshold, improving the stability of the interaction between the elastic seal 4, the flexible electrode 1, and the traction member 2, and achieving the purpose that the flexible electrode 1 can be accurately implanted under the drive of the traction member 2.

[0076] It can be understood that when the force on the elastic seal 4 does not exceed the first frictional force, the elastic seal 4 is stationary relative to the flexible electrode 1; when the force on the elastic seal 4 does not exceed the second frictional force, the elastic seal 4 is stationary relative to the traction member 2.

[0077] It can be understood that the first frictional force exerted by the second through-channel of the elastic seal 4 on the penetrated flexible electrode 1 is achieved based on the parameter design of the second through-channel, including but not limited to the material design, size design, and shape design of the second through-channel.

[0078] It can be understood that the second frictional force exerted by the third through-channel of the elastic seal 4 on the penetrated traction member 2 is achieved based on the parameter design of the third through-channel, including but not limited to the material design, size design, and shape design of the second through-channel.

[0079] In some embodiments, the difference between the first frictional force and the second frictional force is within a preset range, and the acting force of the first threshold is configured to be able to overcome the first frictional force and the second frictional force and move relative to the flexible electrode 1 and the traction member 2 synchronously after the elastic seal 4 is stressed.

[0080] In this way, after the elastic seal 4 receives a force exceeding the first threshold, it can overcome the first frictional force and the second frictional force and slide on the flexible electrode 1 and the traction member 2 simultaneously, avoiding the problem that the frictional force between the elastic seal 4 and any one of the flexible electrode 1 and the traction member 2 is too large, resulting in uncoordinated movement of the elastic seal 4 or even pulling problems.

[0081] It can be understood that the difference between the first frictional force and the second frictional force should not be too large, and this preset range can enable the elastic seal 4 to slide synchronously and smoothly relative to the flexible electrode 1 and the traction member 2 after being stressed.

[0082] Specifically, one of the first frictional force and the second frictional force can be equal to the acting force of the first threshold, and the other can be less than or equal to the acting force of the first threshold.

[0083] In some embodiments, such as Figures 1 to 4As shown, the auxiliary fixing component 3 further includes a second fixing member 32. The second fixing member 32 is movably connected to the first fixing member 31. An elastic seal 4 is disposed between the first fixing member 31 and the second fixing member 32. The second fixing member 32 is configured to move in the direction of the first fixing member 31 to apply a force to the elastic seal 4 to make it abut against the first fixing member 31.

[0084] In this way, by the movement of the second fixing member 32 in the direction close to the first fixing member 31, the elastic seal 4 can be continuously squeezed, so that the elastic seal 4 gradually applies a force to the flexible electrode 1, ensuring the stability of the force applied by the auxiliary fixing component 3 to the elastic seal 4.

[0085] The shape of the proximal end of the elastic seal 4 described above can be adapted to the shape of the distal end of the second fixing member 32, so that the elastic seal 4 and the second fixing member 32 can stably abut against each other and ensure the contact sealing between the elastic seal 4 and the second fixing member 32.

[0086] Exemplarily, a second groove can be formed at the distal end of the second fixing member 32, and the proximal end of the elastic seal 4 can be at least partially embedded in the second groove to ensure the connection stability between the elastic seal 4 and the second fixing member 32.

[0087] The cross-sectional dimension of the second fixing member 32 described above ranges from 0.1 mm to 200 mm, and the length ranges from 0.2 mm to 40 mm, so that the second fixing member 32 can be stably connected to the first fixing member 31.

[0088] In some embodiments, the elastic seal 4 has a second through-channel passing through the flexible electrode 1, and the second fixing member 32 has a fourth through-channel passing through the flexible electrode 1. The first through-channel, the second through-channel, and the fourth through-channel are aligned along the length direction of the flexible electrode 1 during the connection of the second fixing member 32 and the first fixing member 31, so as to avoid squeezing or damaging the flexible electrode 1 due to the misalignment of the first through-channel, the second through-channel, and the fourth through-channel during the connection of the second fixing member 32 and the first fixing member 31, improving the implantation accuracy and service life of the flexible electrode 1.

[0089] The fourth through-channel described above can also be used to pass the traction member 2, so that the traction member 2 and the flexible electrode 1 can share the fourth through-channel to achieve the purpose of a compact structural design. Of course, the fourth through-channel may not be used to pass the traction member 2, and the second fixing member 32 may also have a fifth through-channel passing through the traction member 2.

[0090] In some embodiments, as Figures 1 to 4 shown, the first fixing member 31 and the second fixing member 32 are configured to cooperate to apply an extrusion force exceeding a second threshold to the elastic seal 4, so that the elastic seal 4 can deform to squeeze the flexible electrode 1.

[0091] In this way, during the connection process of the first fixing member 31 and the second fixing member 32, by applying an extrusion force exceeding the second threshold to the elastic seal 4, the elastic seal 4 can undergo sufficient deformation to squeeze the flexible electrode 1, so as to wrap around the outside of the flexible electrode 1, enabling the elastic seal 4 to be hermetically connected to the flexible electrode 1.

[0092] In some embodiments, the first fixing member 31 and the second fixing member 32 are snap-connected, and / or the first fixing member 31 and the second fixing member 32 are locked together. The connection manner between the first fixing member 31 and the second fixing member 32 is stable, which can effectively ensure the implantation stability of the flexible electrode 1.

[0093] It can be understood that the first fixing member 31 and the second fixing member 32 cannot rotate relative to each other under snap connection, and an axial fastening force is generated between the first fixing member 31 and the second fixing member 32 through relative rotation under locking connection.

[0094] When the connection manner between the first fixing member 31 and the second fixing member 32 includes snap connection and locking connection, the snap connection and the locking connection can occur sequentially or simultaneously. For example, the first fixing member 31 and the second fixing member 32 are first snap-connected and then locked together.

[0095] When the connection manner between the first fixing member 31 and the second fixing member 32 includes snap connection and locking connection, the first connection portion for snap connection and the second connection portion for locking connection provided on the first fixing member 31 can be integrally formed or separately provided independently. The second connection portion for snap connection and the second connection portion for locking connection provided on the second fixing member 32 can be integrally formed or separately provided independently. The present application does not make specific limitations on this. If an integrally formed design method is adopted, the number of parts can be reduced and the installation efficiency can be improved, which is suitable for implantation scenarios that require quick operation and a compact structure. If a separately provided design method is adopted, greater flexibility can be provided for the structural design of the first fixing member 31 and the second fixing member 32, which is applicable to complex implantation scenarios and situations where individual adjustment and replacement of the first fixing member 31 and the second fixing member 32 are required.

[0096] As Figures 2 to 4 shown, when the first fixing member 31 and the second fixing member 32 are snap-connected, one of the first fixing member 31 and the second fixing member 32 is provided with a recess 33, and the other is provided with a protrusion 34 that matches the recess 33. The protrusion 34 is snapped into the recess 33 to achieve the snap connection between the first fixing member 31 and the second fixing member 32.

[0097] AsFigures 2 to 4 As shown, when the first fixing member 31 and the second fixing member 32 are locked and connected, the first fixing member 31 may have a first locking structure, the second fixing member 32 may have a second locking structure, and the first locking structure and the second locking structure may be locked and connected. For example, the first locking structure and the second locking structure may be connected by threads, so as to generate an axial fastening force by rotating the second fixing member 32 relative to the first fixing member 31, making the overall structure of the auxiliary fixing assembly 3 stable.

[0098] When only a locking connection is used to connect between the first fixing member 31 and the second fixing member 32, the elastic seal 4 cannot rotate relative to the first fixing member 31 under the limitation of the first fixing member 31, so as to avoid the misalignment of the first through-channel, the second through-channel and the fourth through-channel during the installation of the first fixing member 31 and the second fixing member 32.

[0099] Specifically combined with Figure 2 , Figure 2 the installation process of the flexible neural electrode assembly shown in, in the leftmost first figure, the elastic seal 4, the first fixing member 31 and the second fixing member 32 are separated; in the leftmost second figure, the lower part of the elastic seal 4 abuts against the first fixing member 31; in the leftmost third figure, the protruding part 34 of the first fixing member 31 is snapped into the recessed part 33 of the second fixing member 32 to realize the snap connection between the first fixing member 31 and the second fixing member 32. At this time, the elastic seal 4 is squeezed between the first fixing member 31 and the second fixing member 32; in the leftmost fourth figure, the first fixing member 31 and the second fixing member 32 are locked and connected to complete the limitation of the flexible electrode 1 and enable the flexible electrode 1 to be hermetically connected to the auxiliary fixing assembly 3 through the elastic seal 4.

[0100] Combined with Figure 3 and Figure 4 , Figure 3 and Figure 4 both show the installation process of the flexible neural electrode assembly. The flexible neural electrode assemblies shown from left to right are in the first state, the second state, the third state and the fourth state respectively. Among them, in the first state, the first fixing member 31 is fixed on the surface of the target tissue and / or the attached organism of the target tissue; in the second state, the flexible electrode 1 is implanted to a preset depth of the target tissue through the first through-channel of the first fixing member 31 driven by the traction member 2; in the third state, the traction member 2 and the flexible electrode 1 are separated and the traction member 2 is taken out; in the fourth state, the first fixing member 31 and the second fixing member 32 are snap-connected and locked to complete the limitation of the flexible electrode 1 and enable the flexible electrode 1 to be hermetically connected to the auxiliary fixing assembly 3 through the elastic seal 4.

[0101] There are at least the following four ways to implant the flexible electrode 1 by the synergistic action of the above-mentioned auxiliary fixing component 3 and the elastic seal 4.

[0102] The first implantation method: When connecting the first fixing member 31 and the second fixing member 32 by one of the snap connection and the locking connection, first fix the first fixing member 31 of the auxiliary fixing component 3 on the surface of the target tissue and / or at the accessory organism of the target tissue to form an implantation channel for the flexible electrode 1. Subsequently, implant the distal electrode portion 13 of the flexible electrode 1 and the traction member 2 into the target tissue through the first through channel of the first fixing member 31 until the distal electrode portion 13 reaches the preset depth of the target tissue. The traction member 2 is separated from the auxiliary implantation portion 14 of the flexible electrode 1 by applying a force toward the proximal end and is removed, so that the distal electrode portion 13 of the flexible electrode 1 remains inside the target tissue, while the lead connection portion 12 and the proximal contact portion 11 remain outside the target tissue. The elastic seal 4 moves along the lead connection portion 12 of the flexible electrode 1 to the proximal end of the first fixing member 31. Next, snap-connect the second fixing member 32 of the auxiliary fixing component 3 to the first fixing member 31 to form a firm mechanical fixation. During the snap connection process, the elastic seal 4 is located between the first fixing member 31 and the second fixing member 32 and is subjected to sufficient extrusion force under the action of the second fixing member 32 to closely fit with the flexible electrode 1 and the auxiliary fixing component 3, thereby realizing the fixation of the flexible electrode 1 and the sealing of the wound.

[0103] The second synergistic mode: When one of the snap connection and the locking connection is adopted to connect between the first fixing member 31 and the second fixing member 32, and the elastic seal 4 is used to control the implantation depth of the flexible electrode 1, first fix the first fixing member 31 of the auxiliary fixing assembly 3 on the surface of the target tissue and / or at the affiliated organism of the target tissue to form an implantation channel for the flexible electrode 1. Move the elastic seal 4 along the lead connection portion 12 of the flexible electrode 1, so that the distal electrode portion 13 of the flexible electrode 1 is located at a preset depth in the target tissue after implantation. Subsequently, implant the distal electrode portion 13 of the flexible electrode 1 and the traction member 2 into the target tissue through the first through channel of the first fixing member 31 until the elastic seal 4 reaches the proximal end of the first fixing member 31. At this time, the distal electrode portion 13 of the flexible electrode 1 reaches the preset depth of the target tissue. The traction member 2 separates from the auxiliary implantation portion 14 of the flexible electrode 1 by applying a force towards the proximal end and is taken out, so that the distal electrode portion 13 of the flexible electrode 1 remains inside the target tissue, while the lead connection portion 12 and the proximal contact portion 11 remain outside the target tissue. Next, snap-connect the second fixing member 32 of the auxiliary fixing assembly 3 with the first fixing member 31 to form a firm mechanical fixation between the two. During the snap connection process, the elastic seal 4 is located between the first fixing member 31 and the second fixing member 32, and is subjected to sufficient extrusion force under the action of the second fixing member 32 to closely fit with the flexible electrode 1 and the auxiliary fixing assembly 3, thereby realizing the fixation of the flexible electrode 1 and the sealing of the wound.

[0104] The third synergy mode: When the first fixing member 31 and the second fixing member 32 of the auxiliary fixing assembly 3 are connected by snap connection and locking connection, first fix the first fixing member 31 of the auxiliary fixing assembly 3 on the surface of the target tissue and / or at the appendage organism of the target tissue to form an implantation channel for the flexible electrode 1. Subsequently, implant the distal electrode portion 13 of the flexible electrode 1 and the traction member 2 into the target tissue through the first through-channel of the first fixing member 31 until the distal electrode portion 13 reaches the preset depth of the target tissue. The traction member 2 is separated from the auxiliary implantation portion 14 of the flexible electrode 1 by applying a force towards the proximal end and is removed, so that the distal electrode portion 13 of the flexible electrode 1 is fixed inside the target tissue, and the lead connection portion 12 and the proximal contact portion 11 remain outside the target tissue. After the traction member 2 is removed, move the elastic seal 4 along the lead connection portion 12 of the flexible electrode 1 to the proximal end of the first fixing member 31. Move and fix the second fixing member 32 to the position proximal to the elastic seal 4. Next, snap-connect the second fixing member 32 of the auxiliary fixing assembly 3 to the first fixing member 31 to ensure that the elastic seal 4 and the lead connection portion 12 will not be damaged due to torsional forces during subsequent operations. Subsequently, the second fixing member 32 is further locked to the first fixing member 31 to continue to act on the elastic seal 4, so that the elastic seal 4 is subjected to a squeezing pressure exceeding the second threshold value and closely fits to the first fixing member 31 and the flexible electrode 1, thereby realizing the fixation of the flexible electrode 1 and the sealing of the wound.

[0105] The fourth synergy mode: When the first fixing member 31 and the second fixing member 32 are connected by snap connection and locking connection, and the elastic seal 4 is used to control the implantation depth of the flexible electrode 1, first fix the first fixing member 31 of the auxiliary fixing assembly 3 on the surface of the target tissue and / or at the accessory organism of the target tissue to form an implantation channel for the flexible electrode 1. Move the elastic seal 4 along the lead connection portion 12 of the flexible electrode 1, so that the distal electrode portion 13 of the flexible electrode 1 is located at a preset depth of the target tissue after implantation. Subsequently, implant the distal electrode portion 13 of the flexible electrode 1 and the traction member 2 into the target tissue through the first through channel of the first fixing member 31 until the elastic seal 4 reaches the proximal end of the first fixing member 31 and the distal electrode portion 13 of the flexible electrode 1 reaches the preset depth of the target tissue. The traction member 2 is separated from the auxiliary implantation portion 14 of the flexible electrode 1 by applying a force towards the proximal end and is removed, so that the distal electrode portion 13 of the flexible electrode 1 is fixed inside the target tissue, and the lead connection portion 12 and the proximal contact portion 11 remain outside the target tissue. Move the second fixing member 32 and fix it at the position proximal to the elastic seal 4. Next, snap-connect the second fixing member 32 of the auxiliary fixing assembly 3 with the first fixing member 31 to ensure that the elastic seal 4 and the lead connection portion 12 will not be damaged due to torsional force during subsequent operations. Subsequently, the second fixing member 32 is further locked to the first fixing member 31 to continue to act on the elastic seal 4, so that the elastic seal 4 is subjected to a squeezing pressure exceeding the second threshold value and closely fits the first fixing member 31 and the flexible electrode 1, thereby realizing the fixation of the flexible electrode 1 and the sealing of the wound.

[0106] In some embodiments, the flexible electrode 1 includes a first insulating layer, a first conductive layer, and a second insulating layer laminated along the thickness direction of the flexible electrode 1. Electrode sites are formed on the first conductive layer, and the first insulating layer and / or the second insulating layer are not provided outside the portion of the first conductive layer corresponding to the electrode sites.

[0107] The above-mentioned first insulating layer and second insulating layer play a role in protecting the first conductive layer, isolating the first conductive layer from the surrounding target tissue, thereby ensuring that electrical pulses can be accurately transmitted to the electrode sites, avoiding the loss of electrical pulses during transmission, and effectively improving the reliability of the flexible nerve electrode assembly.

[0108] The above-mentioned first insulating layer and second insulating layer are made of one or a combination of the following materials: SU-8 photoresist, parylene, fluorinated polymer, and polyimide. In this way, using the above-mentioned insulating materials for the first insulating layer and the second insulating layer can ensure the flexibility and biocompatibility of the flexible nerve electrode assembly.

[0109] The above-mentioned first conductive layer can be made of a metal material, which has good electrical conductivity and biocompatibility, so that the electrical pulses released by the external device can reach the electrode site. The above-mentioned first conductive layer can adopt metal materials such as gold, platinum, iridium, etc. to ensure the effective transmission of electrical signals.

[0110] In some embodiments, as Figures 1 to 4 shown, a traction portion 21 is formed at the distal end of the traction member 2. The traction portion 21 acts on the auxiliary implantation portion 14. The traction member 2 is used to separate the traction portion 21 from the auxiliary implantation portion 14 when a force is applied toward the proximal contact portion 11 of the flexible electrode 1.

[0111] In this way, the stable action on the flexible electrode 1 can be realized through the traction portion 21 of the traction member 2, ensuring that the flexible electrode 1 can be smoothly implanted into the target tissue.

[0112] An embodiment of the present application also provides an implantation method for a flexible nerve electrode assembly, which is used to implant the flexible nerve electrode assembly in the above-mentioned embodiment. The implantation method includes steps S101 to S106.

[0113] Step S101: Fix the first fixing member 31 of the auxiliary fixing assembly 3 on the surface of the target tissue and / or at the affiliated organism of the target tissue.

[0114] Step S102: Implant the distal electrode portion 13 of the flexible electrode 1 and the traction member 2 to a preset depth in the target tissue through the first through-channel of the first fixing member 31.

[0115] Step S103: Move the elastic seal 4 to the proximal end of the first fixing member 31 by applying a force exceeding the first threshold.

[0116] Step S104: Separate the traction member 2 from the flexible electrode 1 and remove the traction member 2.

[0117] Step S105: Leave the distal electrode portion 13 of the flexible electrode 1 at the preset depth in the target tissue.

[0118] Step S106: Connect the second fixing member 32 to the first fixing member 31 in a snap-fit connection or a locking connection manner, so that the extrusion force received by the elastic seal 4 exceeds the second threshold.

[0119] An embodiment of the present application also provides an implantation method for a flexible nerve electrode assembly, which is used to implant the flexible nerve electrode assembly in the above-mentioned embodiment. The implantation method includes steps S201 to S206.

[0120] Step S201: Fix the first fixing member 31 of the auxiliary fixing assembly 3 on the surface of the target tissue and / or at the affiliated organism of the target tissue.

[0121] Step S202: Move the elastic seal 4 along the length direction of the flexible electrode 1 by applying a force exceeding a first threshold, so that the distal electrode portion 13 of the flexible electrode 1 is located at a preset depth in the target tissue after implantation.

[0122] Step S203: Implant the distal electrode portion 13 of the flexible electrode 1 and the traction member 2 to a preset depth in the target tissue through the first through-channel of the first fixing member 31. At this time, the elastic seal 4 reaches the proximal end of the first fixing member 31.

[0123] Step S204: Separate the traction member 2 from the flexible electrode 1 and remove the traction member 2.

[0124] Step S205: Leave the distal electrode portion 13 of the flexible electrode 1 at the preset depth in the target tissue.

[0125] Step S206: Connect the second fixing member 32 to the first fixing member 31 in a snap-fit connection or a locking connection manner, so that the extrusion force received by the elastic seal 4 exceeds a second threshold.

[0126] In an embodiment of the present application, an implantation method for a flexible neural electrode assembly is further provided. The implantation method is used to implant the flexible neural electrode assembly in the above embodiment. The implantation method includes steps S301 to S307.

[0127] Step S301: Fix the first fixing member 31 of the auxiliary fixing assembly 3 on the surface of the target tissue and / or at an affiliated organism of the target tissue.

[0128] Step S302: Implant the distal electrode portion 13 of the flexible electrode 1 and the traction member 2 to a preset depth in the target tissue through the first through-channel of the first fixing member 31.

[0129] Step S303: Move the elastic seal 4 to the proximal end of the first fixing member 31 by applying a force exceeding a first threshold.

[0130] Step S304: Separate the traction member 2 from the flexible electrode 1 and remove the traction member 2.

[0131] Step S305: Leave the distal electrode portion 13 of the flexible electrode 1 at the preset depth in the target tissue.

[0132] Step S306: Connect the second fixing member 32 to the first fixing member 31 in a snap-fit manner.

[0133] Step S307: Connect the second fixing member 32 to the first fixing member 31 in a locking manner, so that the extrusion force received by the elastic seal 4 exceeds a second threshold.

[0134] In an embodiment of the present application, a method for implanting a flexible neural electrode assembly is further provided. This implantation method is used to implant the flexible neural electrode assembly in the above embodiment. The implantation method includes steps S401 to S407.

[0135] Step S401: Fix the first fixing member 31 of the auxiliary fixing assembly 3 on the surface of the target tissue and / or at the affiliated organism of the target tissue.

[0136] Step S402: By applying a force exceeding the first threshold, move the elastic seal 4 along the length direction of the flexible electrode 1, so that the distal electrode portion 13 of the flexible electrode 1 can be located at a preset depth of the target tissue after implantation.

[0137] Step S403: Insert the distal electrode portion 13 of the flexible electrode 1 and the traction member 2 into the preset depth of the target tissue through the first through-channel of the first fixing member 31. At this time, the elastic seal 4 reaches the proximal end of the first fixing member 31.

[0138] Step S404: Separate the traction member 2 from the flexible electrode 1 and remove the traction member 2.

[0139] Step S405: Leave the distal electrode portion 13 of the flexible electrode 1 at the preset depth of the target tissue.

[0140] Step S406: Snap-connect the second fixing member 32 with the first fixing member 31.

[0141] Step S407: Lock-connect the second fixing member 32 with the first fixing member 31, so that the extrusion force received by the elastic seal 4 exceeds the second threshold.

[0142] In addition, although exemplary embodiments have been described herein, their scope includes any and all embodiments based on the present application having equivalent elements, modifications, omissions, combinations (e.g., solutions that cross various embodiments), adaptations, or changes. The elements in the claims will be broadly interpreted based on the language used in the claims and are not limited to the examples described in this specification or during the implementation of the present application, and the examples will be interpreted as non-exclusive.

[0143] The above description is intended to be illustrative and not restrictive. For example, the above examples (or one or more aspects thereof) may be used in combination with each other. For example, other embodiments may be used by those of ordinary skill in the art upon reading the above description. Additionally, in the above detailed description, various features may be grouped together to simplify the present application. This should not be construed as an intention that a disclosed feature not claimed is necessary for any claim. On the contrary, the subject matter of the present application may be less than all of the features of a particular disclosed embodiment. Thus, the claims are hereby incorporated into the detailed description by way of example or embodiment, where each claim stands on its own as a separate embodiment, and these embodiments may be combined with each other in various combinations or permutations. The scope of the present application should be determined with reference to the appended claims and the full scope of equivalents to which those claims are entitled.

[0144] The above embodiments are only exemplary embodiments of the present application and are not used to limit the present application. The protection scope of the present application is defined by the claims. Those skilled in the art can make various modifications or equivalent replacements within the essence and protection scope of the present application, and such modifications or equivalent replacements should also be regarded as falling within the protection scope of the present application.

Claims

1. A flexible neural electrode assembly, characterized in that: include: A flexible electrode, which is made of a flexible material, comprising a proximal contact portion, a lead connection portion, a distal electrode portion and an auxiliary implant portion connected in sequence along the length direction of the flexible electrode, wherein the distal electrode portion and the auxiliary implant portion are used to be implanted into a target tissue, and the distal electrode portion comprises at least one electrode site, wherein the electrode site is used to apply electrical stimulation to the target tissue and / or collect a potential signal of the target tissue; a traction member, which acts on the auxiliary implantation portion to implant the flexible electrode into a target area via the auxiliary implantation portion; An auxiliary fixation component connected to the surface of the target tissue and / or an appendage of the target tissue, wherein the flexible electrode and the traction member are both inserted through the auxiliary fixation component to be implanted into the target tissue; An elastic seal is sleeved outside the flexible electrode and the traction member, and the elastic seal is configured to abut against the auxiliary fixing component at least after the distal electrode portion is implanted to a preset depth of the target tissue, and deform under the action of the auxiliary fixing component to squeeze the flexible electrode, so that the distal electrode portion of the flexible electrode is fixed at the preset depth, and the flexible electrode is sealed and connected to the auxiliary fixing component through the elastic seal.

2. The flexible neural electrode assembly according to claim 1, characterized in that: The auxiliary fixation component includes a first fixing member, which is connected to the surface of the target tissue and / or the attached organism of the target tissue, and the first fixing member is provided with a first through channel, the flexible electrode and the traction member are both implanted into the target tissue through the first through channel, and the elastic sealing member abuts against the proximal end of the first fixing member.

3. The flexible neural electrode assembly according to claim 1 or 2, characterized in that: The elastic sealing member has a second through-channel through which the flexible electrode is disposed. The second through-channel is configured to deform toward the flexible electrode under the action of the auxiliary fixing assembly so as to abut against the flexible electrode.

4. The flexible neural electrode assembly according to claim 3, characterized in that: The elastic sealing member further comprises a third through-channel penetrating the traction member, and the second through-channel and the third through-channel are connected to each other or are independently arranged.

5. The flexible neural electrode assembly according to claim 1, characterized in that: The elastic seal is configured to move relative to the flexible electrode along a length direction of the flexible electrode when subjected to a force exceeding a first threshold.

6. The flexible neural electrode assembly according to claim 4, characterized in that: The second through channel and / or the third through channel may be in a slit shape.

7. The flexible neural electrode assembly according to claim 5, characterized in that: The second through channel of the elastic seal is configured to apply a first friction force to the flexible electrode through which the elastic seal is disposed, and when the force applied to the elastic seal exceeds the first friction force, the elastic seal moves relative to the flexible electrode along the length direction of the flexible electrode; The third through channel of the elastic seal is configured to apply a second friction force to the traction member passing through the elastic seal. When the force applied to the elastic seal exceeds the second friction force, the elastic seal moves relative to the traction member along the length direction of the traction member.

8. The flexible neural electrode assembly according to claim 7, characterized in that: The difference between the first friction force and the second friction force is within a preset range, and the force of the first threshold is configured to overcome the first friction force and the second friction force and move synchronously relative to the flexible electrode and the traction member after the elastic seal is subjected to force.

9. The flexible neural electrode assembly according to claim 2, characterized in that: The auxiliary fixing assembly also includes a second fixing member, which is movably connected to the first fixing member. The elastic sealing member is arranged between the first fixing member and the second fixing member. The second fixing member is used to move in the direction of the first fixing member to apply a force to the elastic sealing member to make it press against the first fixing member.

10. The flexible neural electrode assembly according to claim 9, characterized in that: The first fixing member and the second fixing member are used to cooperate to apply a squeezing force exceeding a second threshold value to the elastic sealing member, so that the elastic sealing member can be deformed to squeeze the flexible electrode.

11. The flexible neural electrode assembly according to claim 9, characterized in that: The first fixing member and the second fixing member are snap-connected, and / or the first fixing member and the second fixing member are locked.

12. The flexible neural electrode assembly according to claim 11, characterized in that: One of the first fixing member and the second fixing member is provided with a recessed portion, and the other is provided with a protruding portion matching the recessed portion, and the protruding portion is snapped into the recessed portion to achieve snap-fit ​​connection between the first fixing member and the second fixing member.

13. The flexible neural electrode assembly according to claim 9 or 11, characterized in that: The elastic sealing member has a second through channel for penetrating the flexible electrode, and the second fixing member has a fourth through channel for penetrating the flexible electrode. The first through channel, the second through channel and the fourth through channel remain aligned along the length direction of the flexible electrode during the connection between the second fixing member and the first fixing member.

14. The flexible neural electrode assembly according to claim 1, characterized in that: The flexible electrode includes a first insulating layer, a first conductive layer and a second insulating layer stacked along the thickness direction of the flexible electrode, the electrode site is formed on the first conductive layer, and the first insulating layer and / or the second insulating layer are not arranged outside the part of the first conductive layer corresponding to the electrode site.

15. The flexible neural electrode assembly according to claim 1, characterized in that: A traction portion is formed at the distal end of the traction member, and the traction portion acts on the auxiliary implant portion. The traction member is used to separate the traction portion from the auxiliary implant portion when a force is applied to the proximal contact portion of the flexible electrode.

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