Flexible neural electrode assembly

Abstract

The invention provides a flexible neural electrode assembly. The flexible neural electrode assembly comprises a flexible electrode, a traction piece, an auxiliary fixing assembly and an elastic sealing piece. The flexible electrode comprises a near-end contact part, a lead connecting part, a far-end electrode part and an auxiliary implantation part. The flexible electrode and the traction piece penetrate through the auxiliary fixing assembly to be implanted into the target tissue. The flexible electrode and the traction piece are sleeved with the elastic sealing piece, and the elastic sealing piece is constructed to abut against the auxiliary fixing assembly at least after the far-end electrode part is implanted to the preset depth of the target tissue and deform under the action of the auxiliary fixing assembly to extrude the flexible electrode, so that the far-end electrode part of the flexible electrode is fixed to the preset depth; and the flexible electrode is in sealing connection with the auxiliary fixing assembly through the elastic sealing piece. Through the synergistic effect of the elastic sealing piece and the auxiliary fixing assembly, effective limitation of the implantation depth of the flexible electrode is achieved, and effective sealing of a wound where the flexible electrode is implanted can be achieved.

Description

Technical Field

[0001] The present application relates to the technical field of biomedical engineering, and in particular, to a flexible neural electrode assembly. Background Art

[0002] Flexible neural electrodes have important application value in neuroscience research and neural electrical stimulation therapy. In the prior art, in order to achieve precise implantation of flexible neural electrodes, traction devices or auxiliary fixation parts are usually used in combination. However, these technical solutions still have some shortcomings in practical applications. For example, the prior art has given little consideration to the design of flexible neural electrode sealing, which can easily lead to the risk of leakage or contamination of body fluids (such as blood, cerebrospinal fluid, etc.) or gases, further increasing the probability of postoperative complications in patients. In addition, the problem of unstable fixation of flexible neural electrodes after implantation has not been fully solved. In particular, in dynamic environments, flexible neural electrodes may shift, affecting the treatment effect. In particular, there is a lack of effective restrictions on the implantation depth of flexible neural electrodes during the implantation process, which can easily lead to the flexible neural electrodes being too deep or deviating from the target area. Summary of the invention

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

[0004] The present application provides a flexible neural electrode assembly. The flexible neural electrode assembly includes a flexible electrode, a traction member, an auxiliary fixation assembly and an elastic seal. The flexible electrode is made of a flexible material, and the flexible electrode includes a proximal contact portion, a lead connection portion, a distal electrode portion and an auxiliary implantation portion connected in sequence along the length direction of the flexible electrode, the distal electrode portion and the auxiliary implantation portion are used to be implanted in the target tissue, and the distal electrode portion 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 acts on the auxiliary implantation portion to implant the flexible electrode into the target target area via the auxiliary implantation portion. The auxiliary fixation assembly is connected to the surface of the target tissue and / or the appendage of the target tissue, and the flexible electrode and the traction member are both penetrated through the auxiliary fixation assembly to be implanted into the target tissue. The elastic seal is sleeved outside the flexible electrode and the traction member. The elastic seal is constructed 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 is deformed 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.

[0005] In some embodiments, the auxiliary fixation assembly includes a first fixing member, which is connected to the surface of the target tissue and / or an 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 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.

[0006] In some embodiments, the elastic sealing member has a second through-channel through which the flexible electrode is disposed, and 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.

[0007] In some embodiments, the elastic sealing member further has a third through-channel for penetrating the traction member, and the second through-channel and the third through-channel are connected to each other or are independently arranged.

[0008] In some embodiments, the resilient 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.

[0009] In some embodiments, 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 friction force to the flexible electrode through which it is inserted, and when the elastic seal is subjected to a force exceeding 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 through which it is inserted, and when the elastic seal is subjected to a force exceeding the second friction 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 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.

[0012] In some embodiments, the auxiliary fixing assembly also includes a second fixing member, which is movably connected to the first fixing member, and the elastic sealing member is arranged 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 sealing member to make it press against the first fixing member.

[0013] In some embodiments, the first fixing member and the second fixing member are used to cooperate to apply a squeezing force exceeding a second threshold to the elastic sealing member, so that the elastic sealing member can be deformed to squeeze 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.

[0015] In some embodiments, 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 a snap-fit ​​connection between the first fixing member and the second fixing member.

[0016] In some embodiments, the elastic sealing member has a second through channel for passing the flexible electrode, the second fixing member has a fourth through channel for passing the flexible electrode, and 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.

[0017] In some embodiments, 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 sites are 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 sites.

[0018] In some embodiments, a traction portion is formed at the distal end of the traction member, the traction portion acts on the auxiliary implant portion, and 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.

[0019] Compared with the prior art, the beneficial effect of the embodiments of the present application is that: the present application achieves the synergistic effect of an elastic seal and an auxiliary fixing component, wherein the elastic seal can be abutted against the auxiliary fixing component after the distal electrode portion of the flexible electrode is implanted to a preset depth of the target tissue, so that the elastic seal can apply an extrusion force to the flexible electrode at the preset depth, thereby achieving the purpose of keeping the distal electrode portion of the flexible electrode at a position at the preset depth, effectively limiting the implantation depth of the flexible electrode, improving the implantation stability of the flexible electrode, and avoiding the problem of the flexible electrode being implanted too deeply or deviating from the target position. In addition, the elastic seal can be deformed by abutting against the auxiliary fixing component to achieve a sealed connection between the elastic seal and the auxiliary fixing component, thereby achieving sealing of the wound in which the flexible electrode 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. 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 various embodiments by way of example and not limitation, and together with the description and claims, serve to illustrate the disclosed embodiments. When 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 exhaustive or exclusive embodiments of the present apparatus or method.

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

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

[0025] The components indicated by the reference numerals in the figures are: 1. Flexible electrode; 11. Proximal contact portion; 12. Lead connection portion; 13. Distal electrode portion; 14. Auxiliary implant portion; 2. Traction member; 21. Traction portion; 3. Auxiliary fixing assembly; 31. First fixing member; 32. Second fixing member; 33. Recessed portion; 34. Protruding portion; 4. Elastic sealing member. DETAILED DESCRIPTION

[0026] In order to enable those skilled in the art to better understand the technical solution of the present application, the present application is described in detail below in conjunction with the accompanying drawings and specific implementation examples. The embodiments of the present application are further described in detail below in conjunction with the accompanying drawings and specific implementation examples, but are not intended to limit the present application.

[0027] The words "first", "second" and similar words used in this application do not indicate any order, quantity or importance, but are only used to distinguish different parts. The words "include" or "comprise" and similar words mean that the elements before the word include the elements listed after the word, and do not exclude the possibility of including other elements. "Up", "down", "left", "right" and the like are only used to indicate relative positional relationships. When the absolute position of the described object changes, the relative positional relationship may also change accordingly.

[0028] In the present application, when a specific device is described as being 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 a specific device is described as being connected to other devices, the specific device may be directly connected to the other device without an intermediate device, or may not be directly connected to the other device but have an intermediate device.

[0029] All terms (including technical terms or scientific terms) used in this application have the same meaning as those understood by ordinary technicians in the field to which this application belongs, 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 technology, and should not be interpreted in an idealized or extremely formal sense, unless explicitly defined herein.

[0030] Technologies, methods, and equipment known to ordinary technicians in the relevant art may not be discussed in detail, but where appropriate, the technologies, methods, and equipment should be considered as part of the specification.

[0031] In the present application, the term "proximal end" is intended to mean the end closer to the operator (eg, doctor) who performs the implantation operation, and the term "distal end" is intended to mean the side closer to the target site of the implantable neural signaling device to be implanted.

[0032] All terms (including technical terms or scientific terms) used in this application have the same meaning as those understood by ordinary technicians in the field to which this application belongs, 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 technology, and should not be interpreted in an idealized or extremely formal sense, unless explicitly defined herein. Techniques, methods and equipment known to ordinary technicians in the relevant field may not be discussed in detail, but where appropriate, the techniques, methods and equipment should be considered as part of the specification.

[0033] A flexible neural electrode assembly is provided in an embodiment of the present application, and the flexible neural electrode assembly can be used in the medical field, etc. A flexible neural electrode assembly according to an embodiment of the present application will be described in detail below in conjunction with the accompanying drawings.

[0034] like 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.

[0035] 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.

[0036] 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.

[0037] 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 .

[0038] The electrode sites of the distal electrode portion 13 can be electrically connected to the proximal contact portion 11 through the lead connection portion 12. The number of electrode sites of the distal electrode portion 13 is 1 to 200, wherein the number of electrode sites for collecting potential signals of target tissues can be 1 to 2000, and the electrode sites can be used to apply electrical stimulation to the target tissues and can also be used to collect potential signals of the target tissues. The number of electrode sites is designed with full consideration of the coverage of electrical stimulation and the resolution of recorded signals to ensure its functionality in various application scenarios.

[0039] The width of the proximal contact portion 11 may range from 100 micrometers to 10 millimeters, and the thickness may be controlled below 0.2 millimeters. The proximal contact portion 11 may realize signal interaction with external devices through electrical connection.

[0040] The lead connection portion 12 may have different widths at different positions, and its structural design is specifically a stacked design, that is, formed by stacking multiple layers.

[0041] The traction member 2 is used to guide the distal electrode portion 13 of the flexible electrode 1 to a preset depth of the target tissue by applying a force toward the distal end during the implantation process. After 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, and the traction member 2 is removed from the target tissue, so that the distal electrode portion 13 of the flexible electrode 1 is at the preset depth of the target tissue.

[0042] The surface of the target tissue and / or the attached organism of the target tissue can be understood as the biological structure located outside the target tissue and close to the target tissue. Figure 4 , when the target tissue is brain tissue, the attached organism of the target tissue can be understood as the skull.

[0043] The auxiliary fixation 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 fixation part in long-term use and compatibility with tissues.

[0044] The elastic sealing member 4 may be made of a highly elastic, highly flexible and biocompatible material, such as silicone and rubber, so that the elastic sealing member 4 can be appropriately deformed when subjected to the extrusion force applied by the auxiliary fixing component 3 .

[0045] It is understandable that the deformed elastic seal 4 can not only fit tightly with the auxiliary fixing component 3, but also deform and squeeze the flexible electrode 1, so that the flexible electrode 1 can be sealed and connected with 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 gas, but also effectively prevent external contaminants from entering the body. In addition, the elastic seal 4 can also squeeze the flexible electrode 1 so that the distal electrode part 13 of the flexible electrode 1 is fixed at the preset depth of the target tissue, realizing the precise definition of the implantation depth of the flexible electrode 1, thereby ensuring the safety of the flexible electrode 1 in long-term use.

[0046] The cross section of the elastic sealing member 4 may have a length ranging from 0.2 mm to 200 mm, and a width ranging from 0.1 mm to 100 mm.

[0047] The size and shape of the elastic seal 4 can be adjusted according to the implantation requirements of the flexible electrode 1, so that the elastic seal 4 can apply a suitable extrusion force to the flexible electrode 1 after being deformed by force, thereby limiting the implantation depth of the flexible electrode 1 while ensuring that the flexible electrode 1 is not damaged.

[0048] The present application uses the synergistic effect of the elastic seal 4 and the auxiliary fixing component 3, wherein the elastic seal 4 can be against the auxiliary fixing component 3 after the distal electrode portion 13 of the flexible electrode 1 is implanted to the preset depth of the target tissue, so that the elastic seal 4 can apply an extrusion force to the flexible electrode 1 at the preset depth, so as to achieve the purpose of keeping the distal electrode portion 13 of the flexible electrode 1 at the preset depth, realize the effective limitation of the implantation depth of the flexible electrode 1, improve the implantation stability of the flexible electrode 1, and avoid the problem of the flexible electrode 1 being implanted too deep or deviating from the target position. In addition, the elastic seal 4 can be deformed against the auxiliary fixing component 3 to achieve a sealed connection between the elastic seal 4 and the auxiliary fixing component 3, thereby achieving 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.

[0049] In some embodiments, Figures 1 to 4 As shown, the auxiliary fixation component 3 includes a first fixing member 31, which is connected to the surface of the target tissue and / or the attached organism of the target tissue, and a first through channel is provided on the first fixing member 31. The flexible electrode 1 and the traction member 2 are both implanted into the target tissue through the first through channel, and the elastic sealing member 4 abuts against the proximal end of the first fixing member 31.

[0050] 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 subsequent precise implantation of the flexible electrode 1. After the position is fixed, the first fixing member 31 is abutted against the elastic sealing member 4, and a stable force can be applied to the elastic sealing member 4 to improve the structural stability.

[0051] 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 threaded 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 adhesive bonding. The present application does not make specific limitations on this, as long as the first fixing member 31 can be stably installed.

[0052] For example, Figure 3 and Figure 4 As shown, a thread structure may be formed at the distal end of the first fixing member 31 so as to be connected to the surface of the target tissue and / or an appendage of the target tissue through the thread structure.

[0053] The cross-sectional size of the first fixing member 31 is in the range of 0.1 mm to 20 mm, and the length is in the range of 0.2 mm to 40 mm, so as to provide sufficient supporting area for the entire flexible neural electrode assembly.

[0054] The cross-section of the first through channel has a size range of 0.005 mm to 10 mm to match the lead connection portion 12 and the traction member 2 of the flexible electrode 1, thereby ensuring that the flexible electrode 1 can be successfully implanted while the implantation path of the flexible electrode 1 can be accurate and without deviation.

[0055] The shape of the distal end of the 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 be stably abutted against each other and the contact sealing performance of the elastic seal 4 and the first fixing member 31 can be ensured.

[0056] Exemplarily, a first groove may be formed at the proximal end of the first fixing member 31 , and the distal end of the elastic sealing member 4 may be at least partially embedded in the first groove to ensure the connection stability between the elastic sealing member 4 and the first fixing member 31 .

[0057] In some embodiments, the elastic seal 4 has a second through-channel penetrating the flexible electrode 1 , and the second through-channel is configured to deform toward the flexible electrode 1 under the action of the auxiliary fixing assembly 3 so as to abut against the flexible electrode 1 .

[0058] In this way, after the second through channel is deformed by the force of the first fixing member 31, a more appropriate force can be applied to the flexible electrode 1 through the deformed second through channel, which can not only guide the flexible electrode 1 to be stably implanted through the second through channel, but also press against the flexible electrode 1 through the deformed second through channel to achieve a better sealing effect.

[0059] The cross-sectional size of the second through channel ranges from 0.005 mm to 50 mm.

[0060] The second through-channel is constructed to allow the flexible electrode 1 to pass smoothly and to abut against the flexible electrode 1 after deformation to be sealed with the flexible electrode 1. Therefore, the size of the second through-channel should not be too large, and a certain gap can be formed between it and the flexible electrode 1.

[0061] The shape of the second through-channel may be adapted to the shape of the flexible electrode 1 . For example, when the flexible electrode 1 is in the shape of a sheet, the shape of the second through-channel may be a rectangle.

[0062] The second through-channel abutting against the flexible electrode 1 can be understood as the inner wall of the second through-channel can be wrapped around the flexible electrode 1 and apply a suitable force to the flexible electrode 1 to ensure a sealing effect.

[0063] In some embodiments, the elastic sealing member 4 further has a third through-channel penetrating the traction member 2, and the second through-channel and the third through-channel are connected or independently arranged.

[0064] When the second through channel and the third through channel are independently arranged, the passages through which the flexible electrode 1 and the traction member 2 pass will not affect each other, so as to ensure the implantation accuracy of the flexible electrode 1 during the implantation process, avoid wear or dislocation of the flexible electrode 1 and the traction member 2 due to mechanical deviation, and ensure the sealing between the second through channel and the flexible electrode 1 through a separate passage design.

[0065] When the second through channel and the third through channel are connected, it is convenient to manufacture and process the elastic sealing member 4, and it is convenient to penetrate the flexible electrode 1 and the traction member 2, thereby improving the convenience of operation.

[0066] The length direction of the second through channel and the length direction of the third through channel may 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.

[0067] 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 a first threshold.

[0068] In this way, by means of the elastic seal 4 that can move relative to the flexible electrode 1, the implantation depth of the flexible electrode 1 can be flexibly adjusted. After the distal electrode portion 13 is implanted to a preset depth of the target tissue, the elastic seal 4 is abutted against the auxiliary fixing component 3 to ensure accurate positioning of the flexible electrode 1.

[0069] It is understandable that the elastic seal 4 is constructed so that it cannot move relative to the flexible electrode 1 along the length direction of the flexible electrode 1 when it is subjected to a force not exceeding a first threshold value. 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 be close to the first fixing member 31 as the flexible electrode 1 is implanted.

[0070] In some embodiments, the second through-channel and / or the third through-channel are slit-shaped. In this way, the slit-shaped second through-channel and / or the third through-channel can ensure that the flexible electrode 1 can pass smoothly, and the slit-shaped structure can achieve a sealing effect on the flexible electrode 1, so that the problem of being unable to effectively seal the flexible electrode 1 will not occur due to the large interval between the second through-channel and the flexible electrode 1, and the flexible electrode 1 can be prevented from being worn due to vibration or movement during implantation.

[0071] The cross-section of the slit-shaped second through-channel and / or the third through-channel may be one or more of the following combinations: a zigzag shape, a straight line shape, and an ellipse shape. The straight line-shaped second through-channel and / or the third through-channel may play a role of linear guidance, and the zigzag and ellipse-shaped second through-channel and / or the third through-channel may better meet the complex movement requirements of the flexible electrode 1 and increase the fixing effect with the flexible electrode 1.

[0072] The third through-channel may be adapted to the shape and size of the traction member 2 , for example, the shape of the third through-channel is a hole shape.

[0073] In some embodiments, the second through-channel of the elastic seal 4 is configured to apply a first friction force to the penetrated flexible electrode 1, and when the elastic seal 4 is subjected to a force exceeding the first friction 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 friction force to the penetrated traction member 2, and when the elastic seal 4 is subjected to a force exceeding the second friction force, the elastic seal 4 moves relative to the traction member 2 along the length direction of the traction member 2.

[0074] In this way, by designing the first friction force and the second friction force, the elastic seal 4 can move relative to the flexible electrode 1 and the traction member 2 only after the force applied to it reaches a certain threshold, thereby improving the stability of the interaction between the elastic seal 4, the flexible electrode 1 and the traction member 2, and achieving the purpose of precise implantation of the flexible electrode 1 driven by the traction member 2.

[0075] It is understandable that when the elastic seal 4 is subjected to a force not exceeding the first friction force, the elastic seal 4 is fixed relative to the flexible electrode 1 ; when the elastic seal 4 is subjected to a force not exceeding the second friction force, the elastic seal 4 is fixed relative to the traction member 2 .

[0076] The second through channel of the elastic seal 4 exerts the first friction force on the flexible electrode 1 passing therethrough, which can be understood as being realized 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.

[0077] The third through channel of the elastic seal 4 exerts the second friction force on the penetrating traction member 2, which can be understood as being 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.

[0078] In some embodiments, 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 1 and the traction member 2 after the elastic seal 4 is subjected to force.

[0079] In this way, after being subjected to a force exceeding the first threshold value, the elastic seal 4 can overcome the first friction force and the second friction force and slide on the flexible electrode 1 and the traction member 2 at the same time, thereby avoiding excessive friction between the elastic seal 4 and either the flexible electrode 1 or the traction member 2, which may lead to uncoordinated movement of the elastic seal 4 or even pulling problems.

[0080] It is understandable that the difference between the first friction force and the second friction force should not be too large, and the preset range enables the elastic sealing member 4 to slide synchronously and smoothly relative to the flexible electrode 1 and the traction member 2 after being subjected to force.

[0081] Specifically, one of the first friction force and the second friction force may be equal to a force of a first threshold, and the other may be less than or equal to the force of the first threshold.

[0082] In some embodiments, Figures 1 to 4As shown, the auxiliary fixing assembly 3 also includes a second fixing member 32, which is movably connected to the first fixing member 31, and the elastic sealing member 4 is arranged between the first fixing member 31 and the second fixing member 32. The second fixing member 32 is used to move in the direction of the first fixing member 31 to apply a force to the elastic sealing member 4 to make it press against the first fixing member 31.

[0083] In this way, the second fixing member 32 can be moved toward the first fixing member 31 to continuously squeeze the elastic seal 4, so that the elastic seal 4 gradually applies force to the flexible electrode 1, thereby ensuring the stability of the force applied by the auxiliary fixing component 3 to the elastic seal 4.

[0084] The shape of the proximal end of the elastic seal 4 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 be stably abutted against each other and the contact sealing performance of the elastic seal 4 and the second fixing member 32 can be ensured.

[0085] Exemplarily, a second groove may be formed at the distal end of the second fixing member 32 , and the proximal end of the elastic sealing member 4 may be at least partially embedded in the second groove to ensure the connection stability between the elastic sealing member 4 and the second fixing member 32 .

[0086] The cross-section of the second fixing member 32 has a size range of 0.1 mm to 200 mm, and a length range of 0.2 mm to 40 mm, so that the second fixing member 32 is stably connected to the first fixing member 31 .

[0087] In some embodiments, the elastic sealing member 4 has a second through channel for passing the flexible electrode 1, and the second fixing member 32 has a fourth through channel for passing the flexible electrode 1. The first through channel, the second through channel and the fourth through channel are kept aligned along the length direction of the flexible electrode 1 during the connection between the second fixing member 32 and the first fixing member 31, so as to avoid squeezing or damage to the flexible electrode 1 due to misalignment of the first through channel, the second through channel and the fourth through channel during the connection between the second fixing member 32 and the first fixing member 31, thereby improving the implantation accuracy and service life of the flexible electrode 1.

[0088] The fourth through channel 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, thereby achieving 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 that penetrates the traction member 2.

[0089] In some embodiments, Figures 1 to 4 As shown, the first fixing member 31 and the second fixing member 32 are used to cooperate to apply a squeezing force exceeding a second threshold to the elastic sealing member 4 , so that the elastic sealing member 4 can be deformed to squeeze the flexible electrode 1 .

[0090] In this way, during the connection process between the first fixing member 31 and the second fixing member 32, by applying an extrusion force exceeding the second threshold value to the elastic seal 4, the elastic seal 4 can be deformed sufficiently to squeeze the flexible electrode 1 so as to wrap around the outside of the flexible electrode 1, so that the elastic seal 4 can be sealed and connected to the flexible electrode 1.

[0091] In some embodiments, the first fixing member 31 and the second fixing member 32 are engaged and / or locked. The connection 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.

[0092] It is understandable that the first fixing member 31 and the second fixing member 32 in the snap connection may not rotate relative to each other, and the first fixing member 31 and the second fixing member 32 in the locking connection need to generate an axial tightening force through relative rotation.

[0093] When the connection method between the first fixing member 31 and the second fixing member 32 includes a snap connection and a locking connection, the snap connection and the locking connection may occur successively or simultaneously. For example, the first fixing member 31 and the second fixing member 32 are first snap-connected and then locked.

[0094] In the case where the connection method between the first fixing member 31 and the second fixing member 32 includes a snap-fit ​​connection and a locking connection, the first connection portion for the snap-fit ​​connection and the second connection portion for the locking connection provided on the first fixing member 31 can be integrally formed or independently provided, and the second connection portion for the snap-fit ​​connection and the second connection portion for the locking connection provided on the second fixing member 32 can be integrally formed or independently provided, and 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, the installation efficiency can be improved, and it is suitable for implantation scenarios that require quick operation and compact structure. If a design method of independently provided separately is adopted, greater flexibility can be provided for the structural design of the first fixing member 31 and the second fixing member 32, and it is suitable for complex implantation scenarios, and situations where the first fixing member 31 and the second fixing member 32 need to be adjusted and replaced separately.

[0095] like Figures 2 to 4 As shown, when the first fixing member 31 and the second fixing member 32 are snap-fitted together, one of the first fixing member 31 and the second fixing member 32 is provided with a recessed portion 33, and the other is provided with a protruding portion 34 matching the recessed portion 33, and the protruding portion 34 is snapped into the recessed portion 33 to achieve the snap-fitted connection between the first fixing member 31 and the second fixing member 32.

[0096] like Figures 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 that the second fixing member 32 rotates relative to the first fixing member 31 to generate an axial tightening force, so that the overall structure of the auxiliary fixing assembly 3 is stable.

[0097] When only a locking connection is used to connect the first fixing member 31 and the second fixing member 32, the elastic sealing member 4 cannot rotate relative to the first fixing member 31 under the limitation of the first fixing member 31, so as to avoid the first through channel, the second through channel and the fourth through channel being misaligned during the installation of the first fixing member 31 and the second fixing member 32.

[0098] Specific combination Figure 2 , Figure 2 The installation process of the flexible neural electrode assembly shown in the figure, the elastic seal 4, the first fixing member 31 and the second fixing member 32 shown in the first figure from the left are separated; the lower part of the elastic seal 4 shown in the second figure from the left is against the first fixing member 31; the protrusion 34 of the first fixing member 31 shown in the third figure from the left is snapped into the recessed portion 33 of the second fixing member 32, so as 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; the first fixing member 31 and the second fixing member 32 shown in the fourth figure from the left are locked and connected to complete the limitation of the flexible electrode 1 and enable the flexible electrode 1 to be sealed and connected with the auxiliary fixing assembly 3 through the elastic seal 4.

[0099] Recombination Figure 3 and Figure 4 , Figure 3 and Figure 4 All of them show the installation process of the flexible neural electrode assembly. The flexible neural electrode assemblies shown from left to right are respectively in the first state, the second state, the third state and the fourth state, wherein, in the first state, the first fixing member 31 is fixed to 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 sealed and connected to the auxiliary fixing assembly 3 through the elastic sealing member 4.

[0100] There are at least four ways to implant the flexible electrode 1 by using the synergistic effect of the auxiliary fixing component 3 and the elastic sealing member 4 .

[0101] The first implantation method: When the first fixing member 31 and the second fixing member 32 are connected by a snap connection and a locking connection, the first fixing member 31 of the auxiliary fixing assembly 3 is first fixed to the surface of the target tissue and / or the attached organism of the target tissue to form an implantation channel for the flexible electrode 1. Subsequently, the distal electrode portion 13 of the flexible electrode 1 and the traction member 2 are implanted 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 sealing member 4 moves along the lead connection portion 12 of the flexible electrode 1 to the proximal end of the first fixing member 31. Next, the second fixing member 32 of the auxiliary fixing assembly 3 is snap-connected with the first fixing member 31 to form a firm mechanical fixation. During the clamping process, the elastic sealing member 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 fit tightly with the flexible electrode 1 and the auxiliary fixing component 3, thereby fixing the flexible electrode 1 and sealing the wound.

[0102] The second synergistic mode: when the first fixing member 31 and the second fixing member 32 are connected by a snap connection and a locking connection, and the elastic seal 4 is used to control the implantation depth of the flexible electrode 1, the first fixing member 31 of the auxiliary fixing assembly 3 is first fixed to the surface of the target tissue and / or the attached organism of the target tissue to form an implantation channel for the flexible electrode 1. The elastic seal 4 is moved 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, the distal electrode portion 13 of the flexible electrode 1 and the traction member 2 are implanted 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 which time 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 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. Next, the second fixing member 32 of the auxiliary fixing assembly 3 is engaged with the first fixing member 31 to form a firm mechanical fixation between the two. During the engagement process, the elastic sealing member 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 fit tightly with the flexible electrode 1 and the auxiliary fixing assembly 3, thereby achieving fixation of the flexible electrode 1 and sealing of the wound.

[0103] The third synergistic mode: When the first fixing member 31 and the second fixing member 32 are connected by a snap connection and a locking connection, the first fixing member 31 of the auxiliary fixing assembly 3 is first fixed to the surface of the target tissue and / or the attached organism of the target tissue to form an implantation channel for the flexible electrode 1. Subsequently, the distal electrode portion 13 of the flexible electrode 1 and the traction member 2 are implanted 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 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, the elastic seal 4 is moved along the lead connection portion 12 of the flexible electrode 1 to the proximal end of the first fixing member 31. The second fixing member 32 is moved and fixed to the proximal position of the elastic seal 4. Next, the second fixing member 32 of the auxiliary fixing assembly 3 is engaged with the first fixing member 31 to ensure that the elastic seal 4 and the lead connection portion 12 will not be damaged by the torsional force in subsequent operations. Subsequently, the second fixing member 32 is further locked and connected with the first fixing member 31 to continue to act on the elastic seal 4, so that the elastic seal 4 is subjected to an extrusion force exceeding the second threshold value and is closely attached to the first fixing member 31 and the flexible electrode 1, thereby achieving the fixation of the flexible electrode 1 and the sealing of the wound.

[0104] The fourth synergistic mode: when the first fixing member 31 and the second fixing member 32 are connected by a snap connection and a locking connection, and the implantation depth of the flexible electrode 1 is controlled by the elastic seal 4, the first fixing member 31 of the auxiliary fixing assembly 3 is first fixed to the surface of the target tissue and / or the attached organism of the target tissue to form an implantation channel for the flexible electrode 1. The elastic seal 4 is moved 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, the distal electrode portion 13 of the flexible electrode 1 and the traction member 2 are implanted 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 toward 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. The second fixing member 32 is moved and fixed to the position near the elastic seal 4. Next, the second fixing member 32 of the auxiliary fixing assembly 3 is engaged 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 the torsional force in subsequent operations. Subsequently, the second fixing member 32 is further locked and connected with the first fixing member 31 to continue to act on the elastic seal 4, so that the elastic seal 4 is subjected to an extrusion force exceeding the second threshold value and is tightly attached to the first fixing member 31 and the flexible electrode 1, thereby achieving the fixation of the flexible electrode 1 and the sealing of the wound.

[0105] In some embodiments, the flexible electrode 1 includes a first insulating layer, a first conductive layer, and a second insulating layer stacked along the thickness direction of the flexible electrode 1, the electrode sites are 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 sites.

[0106] The first insulating layer and the second insulating layer protect the first conductive layer, isolating the first conductive layer from the surrounding target tissue, thereby ensuring that the electric pulses can be accurately transmitted to the electrode sites, avoiding the loss of electric pulses during the transmission process, and effectively improving the reliability of the flexible neural electrode assembly.

[0107] The first insulating layer and the second insulating layer are made of one or a combination of the following materials: SU-8 photoresist, polyparaxylene, fluorinated polymer and polyimide. Thus, the first insulating layer and the second insulating layer are made of the above insulating materials to ensure the flexibility and biocompatibility of the flexible neural electrode assembly.

[0108] The first conductive layer can be made of a metal material having good conductivity and biocompatibility so that the electric pulse released by the external device can reach the electrode site. The first conductive layer can be made of metal materials such as gold, platinum, iridium, etc. to ensure effective transmission of electrical signals.

[0109] In some embodiments, Figures 1 to 4 As shown, a traction portion 21 is formed at the distal end of the traction member 2, and the traction portion 21 acts on the auxiliary implant portion 14. The traction member 2 is used to separate the traction portion 21 from the auxiliary implant portion 14 when a force is applied to the proximal contact portion 11 of the flexible electrode 1.

[0110] In this way, the traction portion 21 of the traction member 2 can be used to stabilize the flexible electrode 1, thereby ensuring that the flexible electrode 1 can be successfully implanted into the target tissue.

[0111] The present application also provides a method for implanting a flexible neural electrode assembly, which is used to implant the flexible neural electrode assembly in the above embodiment. The implantation method includes steps S101 to S106.

[0112] Step S101: fix the first fixing member 31 of the auxiliary fixing assembly 3 to the surface of the target tissue and / or the appendage of the target tissue.

[0113] Step S102: implanting the distal electrode portion 13 of the flexible electrode 1 and the traction member 2 to a preset depth of the target tissue through the first through channel of the first fixing member 31.

[0114] Step S103: Move the elastic sealing member 4 to the proximal end of the first fixing member 31 by applying a force exceeding a first threshold value.

[0115] Step S104: Separate the traction member 2 from the flexible electrode 1 and take out the traction member 2.

[0116] Step S105: leaving the distal electrode portion 13 of the flexible electrode 1 at a preset depth in the target tissue.

[0117] Step S106: Connect the second fixing member 32 to the first fixing member 31 in a snap-fitting or locking manner, so that the extrusion force on the elastic sealing member 4 exceeds the second threshold.

[0118] The present application also provides a method for implanting a flexible neural electrode assembly, which is used to implant the flexible neural electrode assembly in the above embodiment. The implantation method includes steps S201 to S206.

[0119] Step S201: fix the first fixing member 31 of the auxiliary fixing assembly 3 to the surface of the target tissue and / or the appendage of the target tissue.

[0120] Step S202: by applying a force exceeding a first threshold, the elastic seal 4 is moved along the length direction 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.

[0121] Step S203 : implanting the distal electrode portion 13 of the flexible electrode 1 and the traction member 2 to a preset depth of the target tissue through the first through channel of the first fixing member 31 , and at this time, the elastic sealing member 4 reaches the proximal end of the first fixing member 31 .

[0122] Step S204: separate the traction member 2 from the flexible electrode 1 and take out the traction member 2.

[0123] Step S205: leaving the distal electrode portion 13 of the flexible electrode 1 at a preset depth of the target tissue.

[0124] Step S206: Connect the second fixing member 32 to the first fixing member 31 in a snap-fitting or locking manner, so that the squeezing force on the elastic sealing member 4 exceeds the second threshold.

[0125] The present application also provides a method for implanting a flexible neural electrode assembly, which is used to implant the flexible neural electrode assembly in the above embodiment. The implantation method includes steps S301 to S307.

[0126] Step S301: fix the first fixing member 31 of the auxiliary fixing assembly 3 to the surface of the target tissue and / or the appendage of the target tissue.

[0127] Step S302 : implanting the distal electrode portion 13 of the flexible electrode 1 and the traction member 2 to a preset depth of the target tissue through the first through-channel of the first fixing member 31 .

[0128] Step S303 : moving the elastic sealing member 4 to the proximal end of the first fixing member 31 by applying a force exceeding a first threshold value.

[0129] Step S304: separate the traction member 2 from the flexible electrode 1 and take out the traction member 2.

[0130] Step S305: leaving the distal electrode portion 13 of the flexible electrode 1 at a preset depth of the target tissue.

[0131] Step S306 : Engage and connect the second fixing member 32 with the first fixing member 31 .

[0132] Step S307: The second fixing member 32 is locked and connected with the first fixing member 31, so that the squeezing force on the elastic sealing member 4 exceeds the second threshold value.

[0133] The present application also provides a method for implanting a flexible neural electrode assembly, which is used to implant the flexible neural electrode assembly in the above embodiment. The implantation method includes steps S401 to S407.

[0134] Step S401: fix the first fixing member 31 of the auxiliary fixing assembly 3 to the surface of the target tissue and / or the appendage of the target tissue.

[0135] Step S402: by applying a force exceeding a first threshold, the elastic seal 4 is moved 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.

[0136] Step S403 : implanting the distal electrode portion 13 of the flexible electrode 1 and the traction member 2 to a preset depth of the target tissue through the first through channel of the first fixing member 31 , and at this time, the elastic sealing member 4 reaches the proximal end of the first fixing member 31 .

[0137] Step S404: separate the traction member 2 from the flexible electrode 1 and take out the traction member 2.

[0138] Step S405: leaving the distal electrode portion 13 of the flexible electrode 1 at a preset depth of the target tissue.

[0139] Step S406 : Engage and connect the second fixing member 32 with the first fixing member 31 .

[0140] Step S407: The second fixing member 32 is locked and connected with the first fixing member 31, so that the squeezing force on the elastic sealing member 4 exceeds the second threshold value.

[0141] In addition, although exemplary embodiments have been described herein, the scope includes any and all embodiments based on the present application with equivalent elements, modifications, omissions, combinations (e.g., schemes that cross various embodiments), adaptations or changes. The 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 practice of the present application, and the examples will be interpreted as non-exclusive.

[0142] The above description is intended to be illustrative rather than restrictive. For example, the above examples (or one or more schemes thereof) may be used in combination with each other. For example, a person of ordinary skill in the art may use other embodiments when reading the above description. In addition, in the above-mentioned specific embodiments, various features may be grouped together to simplify the present application. This should not be interpreted as an intention that a disclosed feature that is not required to be protected is necessary for any claim. On the contrary, the subject matter of the present application may be less than all the features of a particular disclosed embodiment. Thus, the claims are incorporated herein as examples or embodiments in the specific embodiments, wherein each claim is independently a separate embodiment, and it is considered that these embodiments may be combined with each other in various combinations or arrangements. The scope of the present application should be determined with reference to the attached claims and the full scope of equivalent forms granted by these claims.

[0143] The above embodiments are only exemplary embodiments of the present application and are not intended to limit the present application. The protection scope of the present application is defined by the claims. Those skilled in the art may make various modifications or equivalent substitutions to the present application within the essence and protection scope of the present application, and such modifications or equivalent substitutions shall also be deemed to fall 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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