Flexible neural electrode assembly and method of making a flexible neural electrode

Abstract

The application discloses a flexible neural electrode assembly and a preparation method of the flexible neural electrode. The flexible neural electrode assembly comprises a flexible neural electrode and a traction piece. A first fixing hole and a second fixing hole are arranged on a lead connecting part of the flexible neural electrode. The traction piece comprises a sleeve and an auxiliary implant needle. A side wall of the sleeve is provided with a first limiting opening and a second limiting opening. A side surface of the auxiliary implant needle is provided with a first fixing structure and a second fixing structure. The inside of the sleeve is a cavity, and the auxiliary implant needle is inserted into the inside of the sleeve. The first fixing structure of the auxiliary implant needle is connected with the first fixing hole through the first limiting opening, and the second fixing structure of the auxiliary implant needle is connected with the second fixing hole through the second limiting opening. Between the first fixing structure and the second fixing structure, the flexible neural electrode spirally coils on the outside of the sleeve. The application can significantly improve the stability and long-term reliability of the flexible neural electrode.

Description

Technical Field

[0001] This application relates to the field of electrode technology, and in particular to a flexible neural electrode assembly and a method for preparing a flexible neural electrode. Background Technology

[0002] Neurostimulation and recording technology has significant applications in the treatment of neurological diseases, pain relief, and functional recovery. Traditional neural electrodes are typically implanted invasively, directly fixing the stimulation or recording site to the nerve or target tissue. However, conventionally designed neural electrodes face numerous challenges after implantation. Due to the continuous movement of the target tissue, especially during physiological activities such as respiration, muscle contraction, and vascular pulsation, the neural electrodes are susceptible to traction and stress, leading to displacement or damage. This displacement and material fatigue can not only affect the electrical connection stability of the neural electrode but also reduce its reliability during long-term use, even requiring a second surgery for replacement, increasing patient risks and medical costs.

[0003] Existing neural electrodes typically lack flexible structures or have limited flexibility, making them ill-suited to physiological stress. Therefore, with technological advancements, flexible neural electrodes have gained widespread attention. Flexible neural electrodes can better conform to the target tissue, reducing mechanical stimulation during implantation.

[0004] However, although the flexibility of the flexible neural electrode itself can adapt to some stress, after the flexible neural electrode is implanted into the target tissue, it may still face the problem of stress concentration due to insufficient deformation margin, which leads to poor stability of the flexible neural electrode. Summary of the Invention

[0005] The purpose of this application is to provide a flexible neural electrode and a method for preparing a flexible neural electrode, so as to solve the problem that after the flexible neural electrode is implanted into the tissue, it may face stress concentration due to insufficient deformation margin, which leads to poor stability of the flexible neural electrode.

[0006] In a first aspect, embodiments of this application provide a flexible neural electrode assembly, including: a flexible neural electrode and a traction member;

[0007] The flexible neural electrode includes a proximal contact portion, a lead wire connection portion, a distal electrode portion, and an auxiliary implantation portion; the proximal contact portion includes at least one contact point, the distal electrode portion includes at least one electrode site, and the lead wire connection portion is provided with a first fixation hole and a second fixation hole.

[0008] The traction device includes a cannula and an auxiliary implantation needle; the side wall of the cannula is provided with a first limiting opening and a second limiting opening; the side of the auxiliary implantation needle is provided with a first fixing structure and a second fixing structure.

[0009] The inside of the cannula is a cavity, which helps the implantation needle to be inserted into the cannula;

[0010] The first fixing structure of the auxiliary implantation needle is engaged with the first fixing hole through the first limiting opening, and the second fixing structure of the auxiliary implantation needle is engaged with the second fixing hole through the second limiting opening;

[0011] Between the first and second fixation structures, a flexible neural electrode is spirally coiled on the outside of the cannula.

[0012] Secondly, embodiments of this application provide a method for preparing a flexible neural electrode, applicable to a flexible neural electrode assembly as described above. The method for preparing the flexible neural electrode includes:

[0013] A sacrificial layer is prepared on a carrier;

[0014] A first flexible insulating layer is formed on the side of the sacrificial layer away from the carrier;

[0015] The pattern of contact and electrode sites on the first surface is defined by photolithography, and the first flexible insulating layer in the corresponding area is removed by etching to obtain the hollow area of ​​contact and electrode sites on the first surface.

[0016] A metallic conductive layer is formed on the side of the first flexible insulating layer away from the carrier, and contact and electrode sites are formed on the first surface in the hollowed-out area;

[0017] A second flexible insulating layer is formed on the side of the metal conductive layer away from the carrier;

[0018] The pattern of contact and electrode sites on the second surface is defined using photolithography and / or hard mask coating processes, and the second flexible insulating layer in the corresponding area is removed using an etching process to obtain the contact and electrode sites on the second surface. The pattern of the auxiliary implantation part is defined using photolithography processes, and the first and second flexible insulating layers in the corresponding areas are removed using an etching process to obtain the auxiliary implantation part.

[0019] The sacrificial layer is removed by an etching process to release flexible neural electrodes.

[0020] A first fixing hole and a second fixing hole are formed on the first flexible insulating layer and the second flexible insulating layer of the lead connection portion of the flexible neural electrode, and no metal conductive layer is provided at the first fixing hole and the second fixing hole in the thickness direction of the lead connection portion.

[0021] This application provides a flexible neural electrode assembly, including a flexible neural electrode and a traction component. The traction component includes a cannula and an auxiliary implantation needle. Two fixing structures are provided on the auxiliary implantation needle. Two limiting openings are provided on the side wall of the cannula. Two fixing holes are provided on the lead connection portion of the flexible neural electrode. The two fixing structures on the auxiliary implantation needle are engaged with the two fixing holes of the flexible neural electrode through the two limiting openings on the side wall of the cannula, thereby allowing the flexible neural electrode to spirally coiled outside the cannula before and during implantation. In other words, this application embodiment uses the spiral coiling structure of the flexible neural electrode to disperse stress after implantation into the target tissue, maintaining the stability of the flexible neural electrode and avoiding displacement and material fatigue caused by target tissue movement, thus improving the stability of the flexible neural electrode. Attached Figure Description

[0022] Figure 1 This is a schematic diagram of the overall structure of a flexible neural electrode assembly provided in an embodiment of this application;

[0023] Figure 2 An exploded view of a flexible neural electrode assembly provided in an embodiment of this application;

[0024] Figure 3 A schematic diagram of a multilayer structure of a flexible neural electrode provided in an embodiment of this application;

[0025] in, Figure 3 (a) A schematic diagram of the structure of a flexible neural electrode provided in an embodiment of this application;

[0026] Figure 3 (b) is Figure 3 (a) is a schematic diagram of the multilayer structure of the flexible neural electrodes;

[0027] Figure 4 This application provides a schematic diagram illustrating the process of detachment between an auxiliary implantation needle and the first and second fixation holes of a flexible neural electrode.

[0028] in, Figure 4 (a) Schematic diagram of applying force to the proximal end of the auxiliary implantation needle to disengage the traction portion from the flexible neuroelectrode;

[0029] Figure 4 (b) Schematic diagram showing the separation of the fixation structure of the auxiliary implantation needle from the fixation hole of the flexible neuroelectrode in order to apply force to the proximal end of the auxiliary implantation needle;

[0030] Figure 4 (c) Schematic diagram showing the traction portion of the auxiliary implantation needle disengaging from the auxiliary implantation portion of the flexible neuroelectrode as force continues to be applied to the proximal end of the auxiliary implantation needle.

[0031] Figure 4 (d) Schematic diagram of the cannula disengaging from the flexible neuroelectrode as force continues to be applied to the proximal end of the assist implantation needle;

[0032] Figure 5 This is a schematic flowchart illustrating a method for preparing a flexible neural electrode according to an embodiment of this application.

[0033] Figure Identification

[0034] 1- Flexible neural electrode;

[0035] 11-Proximal contact portion, 111-Contact;

[0036] 12-lead connection part, 121-first fixing hole, 122-second fixing hole, 123-auxiliary fixing part, 124-first flexible insulating layer, 125-second flexible insulating layer, 126-third flexible insulating layer, 127-first metal conductive layer, 128-second metal conductive layer, 129-fourth flexible insulating layer;

[0037] 13-Distal electrode portion, 131-Electrode site, 132-Stimulation site, 133-Recording site;

[0038] 14-Auxiliary implantation section, 141-Auxiliary implantation port;

[0039] 2-Traction component;

[0040] 21-Sleeve, 211-First limiting opening, 212-Second limiting opening, 213-Traction opening;

[0041] 22-Auxiliary implantation needle, 221-Traction part, 224-First fixation structure, 225-Second fixation structure. Detailed Implementation

[0042] Various embodiments and features of this application are described herein with reference to the accompanying drawings.

[0043] It should be understood that various modifications can be made to the embodiments described herein. Therefore, the above description should not be considered as limiting, but merely as an example of embodiments. Other modifications within the scope and spirit of this application will be apparent to those skilled in the art.

[0044] The accompanying drawings, which are included in and form part of this specification, illustrate embodiments of the present application and, together with the general description of the present application given above and the detailed description of the embodiments given below, serve to explain the principles of the present application.

[0045] These and other features of this application will become apparent from the following description of preferred forms of embodiments given as non-limiting examples, with reference to the accompanying drawings.

[0046] It should also be understood that although this application has been described with reference to some specific examples, those skilled in the art can certainly implement many other equivalent forms of this application.

[0047] The above and other aspects, features and advantages of this application will become more apparent when taken in conjunction with the accompanying drawings and in view of the following detailed description.

[0048] Specific embodiments of this application are described thereafter with reference to the accompanying drawings; however, it should be understood that the claimed embodiments are merely examples of this application, which can be implemented in various ways. Well-known and / or repeated functions and structures are not described in detail to avoid unnecessary or redundant details that could obscure the application. Therefore, the specific structural and functional details claimed herein are not intended to be limiting, but merely serve as the basis and representative basis for the claims to teach those skilled in the art to use this application in a variety of substantially any suitable detailed structures.

[0049] This specification may use the phrases “in one embodiment,” “in another embodiment,” “in yet another embodiment,” or “in other embodiments,” all of which may refer to one or more of the same or different embodiments according to this application.

[0050] While existing flexible neural electrodes possess the flexibility to adapt to some stress, they may still face stress concentration issues after implantation due to insufficient deformation margin, leading to electrode breakage or failure. Furthermore, most existing flexible neural electrodes employ a linear design, making them susceptible to stretching and deviation from the target area during and after implantation, increasing the difficulty and complexity of implantation.

[0051] To address these issues, several improved designs have emerged in recent years, such as the coiled or helical structure of flexible neural electrodes to provide some flexibility and distribute external stress after implantation. However, these designs still have shortcomings in terms of fixation and post-implantation stability of the flexible neural electrodes. In particular, the helical structure of the flexible neural electrode is easily affected in terms of retention and stability within the target tissue during implantation. Furthermore, traditional implantation methods often lack specialized auxiliary implantation components, resulting in low implantation accuracy of the flexible neural electrode in complex tissue structures and increasing the possibility of post-operative displacement. For example, some stretchable flexible neural electrodes are designed with tensile deformation adaptability to match the dynamics of the target tissue. However, this approach fails to provide effective deformation margin absorption when facing stress concentration caused by tissue activity after implantation. Especially after repeated stretching and rebound, the flexible neural electrode may face the risk of morphological failure or fatigue damage.

[0052] Therefore, this application provides a flexible neural electrode assembly to solve the problem that after the flexible neural electrode is implanted into the tissue, it may face stress concentration due to insufficient deformation margin, which leads to poor stability of the flexible neural electrode.

[0053] The technical solution of this application and how the technical solution of this application solves the above-mentioned technical problems are described in detail below with specific embodiments. These specific embodiments can be combined with each other, and the same or similar concepts or processes may not be described again in some embodiments. The embodiments of this application will now be described with reference to the accompanying drawings.

[0054] This application provides an embodiment of a flexible neural electrode assembly, combined with... Figure 1 and Figure 2 As shown, the flexible neural electrode assembly includes: a flexible neural electrode 1 and a traction element 2;

[0055] The flexible neural electrode 1 includes a proximal contact portion 11, a lead wire connection portion 12, a distal electrode portion 13, and an auxiliary implantation portion 14; the proximal contact portion 11 includes at least one contact 111, the distal electrode portion 13 includes at least one electrode site 131, and the lead wire connection portion 12 is provided with a first fixing hole 121 and a second fixing hole 122.

[0056] The traction component 2 includes a cannula 21 and an auxiliary implantation needle 22; the side wall of the cannula 21 is provided with a first limiting opening 211 and a second limiting opening 212; the side of the auxiliary implantation needle 22 is provided with a first fixing structure 224 and a second fixing structure 225.

[0057] The inside of the cannula 21 is a cavity used to accommodate the auxiliary implantation needle 22 and guide the auxiliary implantation needle 22 to be inserted longitudinally into the inside of the cannula 21; the auxiliary implantation needle 22 is inserted into the inside of the cannula 21;

[0058] The first fixing structure 224 of the auxiliary implantation needle 22 is engaged with the first fixing hole 121 through the first limiting opening 211, and the second fixing structure 225 of the auxiliary implantation needle 22 is engaged with the second fixing hole 122 through the second limiting opening 212.

[0059] Between the first fixing structure 224 and the second fixing structure 225, the flexible neural electrode 1 is spirally coiled on the outside of the cannula 21.

[0060] This application provides a flexible neural electrode assembly, including a flexible neural electrode and a traction component. The traction component includes a cannula and an auxiliary implantation needle. Two fixing structures are provided on the auxiliary implantation needle. Two limiting openings are provided on the side wall of the cannula. Two fixing holes are provided on the lead connection portion of the flexible neural electrode. The two fixing structures on the auxiliary implantation needle are engaged with the two fixing holes of the flexible neural electrode through the two limiting openings on the side wall of the cannula, thereby allowing the flexible neural electrode to spirally coiled outside the cannula before and during implantation. In other words, this application embodiment uses the spiral coiling structure of the flexible neural electrode to disperse stress after implantation into the target tissue, maintaining the stability of the flexible neural electrode and avoiding displacement and material fatigue caused by target tissue movement, thus improving the stability of the flexible neural electrode.

[0061] This application provides a flexible neural electrode with a unique helical design that effectively alleviates stress concentration and maintains stability in the target area during and after implantation. Specifically, the lead connection of the flexible neural electrode is designed in a helical shape and coiled outside the cannula of the traction device. After implantation, it forms a helical shape within the target tissue to absorb physiological stress and avoid fatigue and displacement of the flexible neural electrode material caused by stress concentration. The traction device includes an auxiliary implantation needle and a cannula. The traction device guides the flexible neural electrode for precise implantation while maintaining its helical shape to disperse stress during implantation, thus significantly improving the stability and long-term reliability of the flexible neural electrode. This design not only improves the adaptability and stability of the flexible neural electrode but also enhances implantation accuracy and ease of operation in complex clinical applications.

[0062] For example, the width of the proximal contact portion 11, the lead connection portion 12, the distal electrode portion 13, and the auxiliary implantation portion 14 of the flexible neural electrode can be from 100 micrometers to 10 millimeters, and the thickness is controlled to be less than 0.2 millimeters to ensure the flexibility of the flexible neural electrode and its ability to adapt to the movement of the target tissue. The width of the flexible neural electrode can be varied according to the needs of different sites to increase the anchoring effect in the target area. It should be noted that the above-mentioned range values ​​of width and thickness can be adjusted in a timely manner according to actual conditions, and this application does not impose specific limitations.

[0063] For example, electrode site 131 includes at least one of stimulation site 132 and recording site 133; wherein stimulation site 132 is used to deliver stimulation pulses to target tissue, and recording site 133 is used to record neural signals of target tissue.

[0064] The stimulation site 132 has a maximum diameter of no less than 50 micrometers, and the number of stimulation sites 132 can reach 200, ensuring sufficient coverage of the electrical stimulation range; the recording site 133 has a maximum diameter of no more than 200 micrometers, and the number can reach 2000, to meet various neural recording needs. This designed flexible neural electrode can be widely used for electrical stimulation and recording, while reducing the risk of material fatigue and breakage caused by target tissue movement. It should be noted that the above-mentioned maximum diameter and number ranges can be adjusted as needed based on actual conditions, and this application does not impose specific limitations.

[0065] Exemplarily, the diameter of the first fixing hole 121 and the second fixing hole 122 can range from 0.01 mm to 2 mm. The diameters of the first fixing hole 121 and the second fixing hole 122 can be the same or different. The first fixing hole 121 includes at least one first sub-fixing hole, and the second fixing hole 122 includes at least one second sub-fixing hole. The diameters of the multiple first sub-fixing holes can all be the same, partially the same, or all different, and the number of each sub-fixing hole can be from 2 to 100. Each sub-fixing hole is used to cooperate with the fixing structure of the traction member to ensure that the flexible neural electrode maintains its spiral shape during implantation. It should be noted that the above-mentioned range of hole diameters and numbers can be adjusted as needed according to actual circumstances, and this application does not impose specific limitations.

[0066] For example, the diameter of the auxiliary implantation needle 22 can range from 0.001 mm to 3 mm to provide sufficient rigidity during the implantation of the flexible neural electrode into the target tissue and to guide the implantation of the flexible neural electrode. Of course, the diameter range of the auxiliary implantation needle 22 can be adjusted as needed, and this application does not impose a specific limitation.

[0067] For example, the diameter of the cannula 21 can range from 0.002 mm to 5 mm to ensure that the auxiliary implantation needle 22 can pass through smoothly. Of course, the diameter range of the cannula 21 can be adjusted as needed according to the actual situation, and this application does not impose a specific limitation.

[0068] The auxiliary implantation needle 22 has 2 to 100 sub-fixation structures on its side, with a length ranging from 0.1 mm to 5 mm. The number and length of the sub-fixation structures can be adjusted as needed, and this application does not impose specific limitations.

[0069] The outer side of the cannula 21 has 2 to 100 sub-limiting openings with a diameter between 0.01 mm and 3 mm, allowing the auxiliary implantation needle 22 to mate with the sub-fixation holes of the flexible nerve electrode at these sub-limiting openings. The lead wire connection 12 of the flexible nerve electrode 1 is spirally wound around the outer side of the cannula 21 to ensure the stability of the flexible nerve electrode during implantation. The number and diameter range of the limiting openings can be adjusted as needed, and this application does not impose specific limitations.

[0070] In some embodiments, the first fixing structure 224 and the second fixing structure 225 are made of flexible materials; the flexible materials include at least one or more combinations of parylene, silicone rubber and polyimide.

[0071] In some embodiments, see Figure 2 As shown, the first fixing structure 224 and the second fixing structure 225 are spike-like structures;

[0072] The thorn-like structure extends in a direction away from the auxiliary implantation needle 22;

[0073] The thorn-like structure is inclined relative to the auxiliary implantation needle 22 towards the proximal end or the distal end of the auxiliary implantation needle 22;

[0074] The proximal end and the distal end of the auxiliary implantation needle 22 are positioned relative to each other.

[0075] In some embodiments, combined with Figure 1 and Figure 4 As shown, the auxiliary implantation part 14 and the lead wire connection part 12 form an L-shaped shape in the longitudinal direction; a traction opening 213 is provided at the top or side of the distal end of the cannula 21.

[0076] The cannula 21 abuts against the auxiliary implantation part 14 of the flexible nerve electrode 1 at the traction opening 213, and the cannula 21 and the auxiliary implantation part 14 form a physical connection structure.

[0077] In some embodiments, the auxiliary implantation part 14 includes an auxiliary implantation hole 141;

[0078] The diameter of the traction opening 213 of the cannula 21 is larger than the diameter of the auxiliary implantation hole 141.

[0079] For example, the diameter of the auxiliary implantation hole 141 can range from 0.002 mm to 2 mm to accommodate the connection requirements with the traction device, thereby achieving stable implantation of the flexible neural electrode. The diameter range of the auxiliary implantation hole 141 can be adjusted as needed according to actual circumstances, and this application does not impose a specific limitation.

[0080] In some embodiments, combined with Figure 1 and Figure 4As shown, the auxiliary implantation needle 22 is provided with a traction part 221, which passes through the traction opening 213 of the sleeve 21 and exits from the auxiliary implantation hole 141 of the auxiliary implantation part 14.

[0081] Specifically, the auxiliary implantation hole 141 is used to cooperate with the traction portion 221 of the auxiliary implantation needle 22. The traction structure of the traction member 2 may include a traction opening 213 provided at the top or side of the distal end of the cannula 21. The auxiliary implantation needle 22 forms a physical connection mechanism with the auxiliary implantation portion 14 of the flexible nerve electrode 1 through the traction opening 213, thereby realizing the stable implantation of the flexible nerve electrode 1 into the target tissue. During the implantation of the flexible nerve electrode 1, the sidewall of the traction opening 213 at the distal end of the cannula 21 contacts the auxiliary implantation portion 14 of the flexible nerve electrode 1, and the stable implantation of the flexible nerve electrode 1 is achieved by pressing and limiting.

[0082] In some embodiments, see Figure 3 As shown, the flexible neural electrode 1 is constructed as a stacked structure along its thickness direction, comprising a first flexible insulating layer 124, a second flexible insulating layer 125, and a metal conductive layer located between the two. The materials of the first flexible insulating layer 124 and the second flexible insulating layer 125 may be made of one or more combinations of SU-8 photoresist, phenelzine, parylene, fluorinated polymers, or polyimide.

[0083] In some embodiments, see Figure 3 As shown, the metal conductive layer includes a first metal conductive layer 127 that is attached to the first flexible insulating layer 124 and a second metal conductive layer 128 that is attached to the second flexible insulating layer 125. The lead wire connection portion 12 also has a third flexible insulating layer 126 along its thickness direction, and the third flexible insulating layer 126 is disposed between the first metal conductive layer 127 and the second metal conductive layer 128.

[0084] In some embodiments, there are multiple first metal conductive layers 127, which are arranged in parallel, and a fourth flexible insulating layer 129 is provided between adjacent first metal conductive layers 127; and / or, there are multiple second metal conductive layers 128, which are arranged in parallel, and a fourth flexible insulating layer 129 is provided between adjacent second metal conductive layers 128.

[0085] In this embodiment, by providing multiple first metallic conductive layers and / or multiple second metallic conductive layers, the flexible neural electrode can provide multiple independent electrode sites. These electrode sites can contact different regions of the nerve tissue respectively, achieving independent signal acquisition and stimulation functions. A third flexible insulating layer is provided between the metallic conductive layers to avoid mutual interference between them, ensuring accurate signal transmission. At the same time, the third flexible insulating layer enhances the mechanical strength and stability of the flexible neural electrode, thereby improving its long-term reliability.

[0086] Multiple first and second conductive metal layers are arranged side-by-side to meet the requirements of different electrode sites. A fourth flexible insulating layer is provided between each pair of adjacent conductive metal layers to isolate different electrode sites. This design ensures the independence of each electrode site during operation, thereby avoiding signal interference between adjacent electrode sites, while ensuring the stability and electrical performance of the entire flexible neural electrode structure.

[0087] In specific embodiments, the spiral implantable flexible neural electrode assembly of this application can be designed in various ways according to different application scenarios and tissue environments to meet specific implantation needs. Several embodiments are as follows:

[0088] In some embodiments, the flexible neural electrode 1 between the first fixing hole 121 and the second fixing hole 122 is in a spiral shape;

[0089] The length of the lead wire connection portion 12 between the first fixing hole 121 and the second fixing hole 122 is the first length;

[0090] The length between the first fixing structure 224 and the second fixing structure 225 is the second length;

[0091] The first length is greater than the second length.

[0092] In some embodiments, the lead wire connection portion 12 is further provided with an auxiliary fixing portion 123; the auxiliary fixing portion 123 has a barbed structure and / or a hollow structure;

[0093] The first fixing hole 121 is close to the distal electrode portion 13, and the second fixing hole 122 is far away from the distal electrode portion 13;

[0094] The auxiliary fixing part 123 is located between the distal electrode part 13 and the first fixing hole 121; and / or,

[0095] The auxiliary fixing part 123 is located near the second fixing hole 122.

[0096] In some embodiments, the auxiliary fixing portion 123 is formed on the first flexible insulating layer and / or the second flexible insulating layer.

[0097] The spike-like structure extends away from the lead wire connection portion 12 and is inclined relative to the lead wire connection portion 12, while the hollow structure is located on the side and / or surface of the lead wire connection portion 12. The auxiliary fixation portion 123 may be formed on the first flexible insulating layer and / or the second flexible insulating layer to enhance the implantation stability of the flexible neural electrode.

[0098] For example, the tilting direction of the spike-like structure can be opposite to the longitudinal direction, that is, the spike-like structure of the auxiliary fixing part 123 is barbed (e.g. Figures 1 to 4 As shown, the barbed structure effectively increases the contact area and friction with the target tissue. Furthermore, this design helps reduce resistance during implantation, allowing the flexible neural electrode to be firmly fixed in the target tissue, enabling it to reach the target tissue smoothly and conveniently.

[0099] For example, the length of the spike-like structure of the auxiliary fixation part 123 can be from 0.1 mm to 5 mm, and it can be inserted into the tissue of the target area, thereby increasing the fixation effect of the flexible nerve electrode after implantation. It should be noted that the range of values ​​for the length of the spike-like structure of the auxiliary fixation part 123 can be adjusted in a timely manner according to the actual situation, and this application does not make a specific limitation.

[0100] Exemplarily, the hollow structure of the auxiliary fixation part 123 enhances the embedding effect between the tissue and the flexible neural electrode. The number of auxiliary fixation parts 123 can be from 1 to 100, and the diameter of each hollow structure unit ranges from 0.1 mm to 10 mm. It should be noted that the range of the number of auxiliary fixation parts 123 can be adjusted as needed, and this application does not impose a specific limitation. The range of the diameter of each hollow structure unit can also be adjusted as needed, and this application does not impose a specific limitation.

[0101] In one embodiment, such as Figure 1As shown, the flexible neural electrode 1 has two fixing holes (i.e., the first fixing hole 121 and the second fixing hole 122) on its proximal lead connection portion 12 to define the helical structure of the flexible neural electrode. These two fixing holes are located on the lead connection portion 12 and are 3 to 4 centimeters apart. During implantation, the flexible neural electrode 1 is spirally wound around the outside of the cannula 21 of the traction member 2, forming a helical segment with deformation allowance. The total length of this helical segment when unwound is approximately 3 to 4 centimeters (i.e., the first length). Through the two fixing holes of the lead connection portion 12 of the flexible neural electrode 1 and the two fixing structures on the auxiliary implantation needle 22, the helical segment of the flexible neural electrode is compressed to approximately 1 centimeter in length (i.e., the second length) after fixation. The two fixing structures of the auxiliary implantation needle 22 cooperate with the two limiting openings on the side wall of the cannula 21 to keep the helical structure stable during implantation into the target tissue. The distal electrode portion 13 of the flexible neural electrode remains straight and without a spiral, facilitating stable application of electrical stimulation or recording within the target area.

[0102] In another embodiment, the flexible neural electrode 1 is designed without auxiliary fixation, and a helical structure is directly constructed on the lead connection portion 12 of the flexible neural electrode 1. In this embodiment, the lead connection portion 12 at the proximal end of the flexible neural electrode is designed with two fixation holes, the distance between the two fixation holes being 4 cm to 5 cm, used to define the position of the helical segment. The total length of the flexible neural electrode before helical formation is 4 cm to 5 cm (i.e., the first length), and after helical formation, it is compressed to a length of approximately 2 cm (i.e., the second length). The two fixation structures on the auxiliary implantation needle 22 cooperate with the two limiting openings on the side wall of the cannula 21 to ensure the positioning of the flexible neural electrode in the helical segment. The distal electrode portion 13 of the flexible neural electrode in this design is also kept straight and without a helix to provide stable electrical stimulation or signal recording function after implantation.

[0103] The first and second lengths in the above embodiments are only examples, and can be set to other length values ​​according to actual needs. This application does not limit them.

[0104] Through these embodiments, this application demonstrates the various effects of different helical segment lengths, auxiliary fixation designs, and fixation structures on the stability of flexible neural electrodes, enabling flexible neural electrodes to be flexibly adapted to various application scenarios and ensuring the mechanical stability and electrical performance of flexible neural electrodes in complex physiological environments.

[0105] In the implementation of this application, in order to ensure that the flexible neural electrode 1 is stably maintained within the target area, the removal of the auxiliary implantation needle 22 is designed to be carried out in stages, gradually detaching the physical connection between the auxiliary implantation needle and the flexible neural electrode 1, and finally completing the stable implantation of the flexible neural electrode.

[0106] In some embodiments, when the proximal end of the auxiliary implantation needle 22 is subjected to a force in the direction opposite to the longitudinal direction, the first fixing structure 224 is disengaged from the first fixing hole 121, the second fixing structure 225 is disengaged from the second fixing hole 122, and the traction part 221 is disengaged from the auxiliary implantation part 14.

[0107] In this embodiment, after implantation, a force is applied towards the proximal end of the auxiliary implantation needle 22 to separate the auxiliary implantation needle 22 from the auxiliary implantation portion 14 of the flexible neural electrode 1. Then, the auxiliary implantation needle 22 is gradually withdrawn, causing it to sequentially detach from the first fixation hole 121 and the second fixation hole 122 of the flexible neural electrode 1. Alternatively, after implantation, a force is applied towards the proximal end of the auxiliary implantation needle 22, and the auxiliary implantation needle 22 is gradually withdrawn, causing it to sequentially detach from the first fixation hole 121 and the second fixation hole 122 of the flexible neural electrode 1. Then, the auxiliary implantation needle 22 is withdrawn from the auxiliary implantation portion 14 of the flexible neural electrode 1, ultimately achieving stable implantation of the flexible neural electrode 1 into the target tissue. The order in which the auxiliary implantation needle 22 detaches from the fixation hole of the flexible neural electrode 1 and from the auxiliary implantation portion 14 is determined by the pre-set mechanical structure of the flexible neural electrode assembly. This application does not impose specific limitations here.

[0108] In some embodiments, when the lengths of the first fixing structure 224 and the second fixing structure 225 of the auxiliary implantation needle 22 are greater than a preset length, and when the proximal end of the auxiliary implantation needle 22 is subjected to a force in the direction opposite to the longitudinal direction, the traction part 221 is first disengaged from the auxiliary implantation part 14, and then the first fixing structure 224 is disengaged from the first fixing hole 121 and the second fixing structure 225 is disengaged from the second fixing hole 122.

[0109] In some embodiments, a first mark and a second mark are sequentially provided on the proximal side of the auxiliary implantation needle 22 in the longitudinal direction from proximal to distal; wherein, the proximal side of the auxiliary implantation needle 22 is the portion of the auxiliary implantation needle close to its proximal end, such as... Figure 2 As shown.

[0110] When the traction unit 221 separates from the auxiliary implantation unit 14, the first mark is exposed;

[0111] The second mark is exposed when the first fixing structure 224 disengages from the first fixing hole 121 and the second fixing structure 225 disengages from the second fixing hole 122.

[0112] That is, when the first pre-set mark is exposed, it indicates that the traction part 221 and the auxiliary implantation part 14 have been separated; when the second pre-set mark is exposed, it indicates that the first fixation structure 224 and the first fixation hole 121 have been separated and the second fixation structure 225 and the second fixation hole 122 have been separated.

[0113] It should be noted that when the traction part 221 disengages from the auxiliary implantation part 14, and when the first fixation structure 224 disengages from the first fixation hole 121 and the second fixation structure 225 disengages from the second fixation hole 122, the position of the cannula 21 remains fixed. Only when a force continues to be applied to the proximal end of the auxiliary implantation needle 22 will the cannula 21 disengage from the flexible neuroelectrode 1 (e.g., ...). Figure 4 (d) thus keeping the flexible neural electrode in the target area.

[0114] In other embodiments, when the lengths of the first fixing structure 224 and the second fixing structure 225 of the auxiliary implantation needle 22 are not greater than a preset length, and when the proximal end of the auxiliary implantation needle 22 is subjected to a force in the direction opposite to the implantation direction, the first fixing structure 224 is disengaged from the first fixing hole 121 and the second fixing structure 225 is disengaged from the second fixing hole 122, and then the traction part 221 is disengaged from the auxiliary implantation part 14.

[0115] In some embodiments, see Figure 4 , Figure 4 (a) Schematic diagram of applying force to the proximal end of the auxiliary implantation needle to disengage the traction portion from the flexible neuroelectrode; Figure 4 (b) Schematic diagram showing the separation of the fixation structure of the auxiliary implantation needle from the fixation hole of the flexible neuroelectrode in order to apply force to the proximal end of the auxiliary implantation needle; Figure 4 (c) Schematic diagram showing the traction portion of the auxiliary implantation needle disengaging from the auxiliary implantation portion of the flexible neuroelectrode as force continues to be applied to the proximal end of the auxiliary implantation needle. Figure 4 (d) Schematic diagram of the cannula disengaging from the flexible neuroelectrode as force continues to be applied to the proximal end of the assist implantation needle.

[0116] The proximal side of the auxiliary implantation needle 22 is marked with a third and a fourth mark sequentially from proximal to distal in the longitudinal direction; wherein, the proximal side of the auxiliary implantation needle 22 is the portion of the auxiliary implantation needle closest to the proximal end of the auxiliary implantation needle 22, such as... Figure 2 As shown.

[0117] The third mark is exposed when the first fixing structure 224 disengages from the first fixing hole 121 and the second fixing structure 225 disengages from the second fixing hole 122;

[0118] When the traction unit 221 separates from the auxiliary implantation unit 14, the fourth mark is exposed.

[0119] That is, when the pre-set third mark is exposed, it indicates that the first fixing structure 224 has been separated from the first fixing hole 121 and the second fixing structure 225 has been separated from the second fixing hole 122.

[0120] When the pre-set fourth mark is exposed, it indicates that the traction unit 221 has detached from the assisted implantation unit 14.

[0121] It should be noted that when the traction part 221 disengages from the auxiliary implantation part 14, and when the first fixation structure 224 disengages from the first fixation hole 121 and the second fixation structure 225 disengages from the second fixation hole 122, the position of the cannula 21 remains fixed. Only when a force continues to be applied to the proximal end of the auxiliary implantation needle 22 will the cannula 21 disengage from the flexible neuroelectrode 1 (e.g., ...). Figure 4 (d)).

[0122] Optionally, if the length of the first fixing structure 224 is less than the length of the second fixing structure 225, the first fixing structure 224 is disengaged from the first fixing hole 121 first, and then the second fixing structure 225 is disengaged from the second fixing hole 122.

[0123] Optionally, if the length of the first fixing structure 224 is greater than the length of the second fixing structure 225, the second fixing structure 225 is disengaged from the second fixing hole 122 first, and then the first fixing structure 224 is disengaged from the first fixing hole 121.

[0124] In one specific embodiment, the proximal side of the auxiliary implantation needle 22 is provided with a first mark, a second mark, and a third mark in the longitudinal direction from proximal to distal.

[0125] First, when the auxiliary implantation needle 22 is withdrawn in the opposite direction to the longitudinal direction and the first marker located proximal to the auxiliary implantation needle 22 is exposed, the traction portion of the auxiliary implantation needle 22 disengages from the auxiliary implantation portion of the flexible neuroelectrode 1. The initial connection between the auxiliary implantation needle and the flexible neuroelectrode is released, allowing the flexible neuroelectrode to maintain basic positioning within the target area. This disengagement allows the flexible neuroelectrode to remain stable within the target tissue, while simultaneously preparing for subsequent disengagement from the first and second fixation holes.

[0126] Next, the auxiliary implantation needle 22 continues to move in the opposite direction to the longitudinal direction until the second mark located proximal to the auxiliary implantation needle 22 is exposed. At this point, the first fixation structure 224 of the auxiliary implantation needle 22 disengages from the first fixation hole 121 of the flexible neuroelectrode 1, further releasing part of the helical structure of the flexible neuroelectrode and further enhancing the stability of the flexible neuroelectrode within the target tissue. This disengagement process ensures that part of the helical segment of the flexible neuroelectrode can maintain its predetermined shape without external force interference, thereby mitigating the stress effects caused by tissue activity.

[0127] Next, the auxiliary implantation needle 22 continues to move in the opposite direction to the longitudinal direction until the third marker located proximal to the auxiliary implantation needle 22 is exposed. At this point, the second fixation structure 225 of the auxiliary implantation needle 22 disengages from the second fixation hole 122 of the flexible neuroelectrode 1. This complete disengagement of the auxiliary implantation needle 22 from the flexible neuroelectrode 1 allows the flexible neuroelectrode 1 to achieve its final fixed state within the target tissue. In this state, the helical structure of the flexible neuroelectrode 1 is completely released, enabling it to adapt to the movement of surrounding tissues without displacement, thus ensuring a stable implantation effect over a long period.

[0128] Next, after the auxiliary implantation needle 22 is completely detached from the flexible neural electrode 1, the cannula 21 can be withdrawn in the opposite direction to the longitudinal direction to complete the complete removal of the traction element 2. At this time, the flexible neural electrode 1 is stably fixed in the target area, and its helical segment still maintains an appropriate amount of deformation margin to adapt to the minute movements within the target tissue, reducing the risk of displacement or material fatigue caused by stress concentration after implantation.

[0129] This multi-stage decoupling design gradually reduces the connection strength between the flexible neural electrode 1 and the traction element 2, allowing the flexible neural electrode to be gradually released during implantation, thereby achieving safe and precise implantation and maintaining the structural integrity and stability of the flexible neural electrode after complete implantation.

[0130] In some embodiments, the first fixing structure 224 includes at least one first sub-fixing structure, and the second fixing structure 225 includes a second sub-fixing structure;

[0131] The first limiting opening 211 includes at least one first sub-limiting opening, and the second limiting opening 212 includes at least one second sub-limiting opening;

[0132] The first fixing hole 121 includes at least one first sub-fixing hole, and the second fixing hole 122 includes at least one second sub-fixing hole;

[0133] The first sub-fixing structure, the first sub-limiting opening, and the first sub-fixing hole correspond one-to-one;

[0134] The second sub-fixing structure, the second sub-limiting opening, and the second sub-fixing hole correspond one-to-one.

[0135] In this embodiment, by setting multiple sub-fixation structures, multiple sub-limiting openings, and multiple sub-fixation holes, a more uniform fixation effect and step-by-step release control can be provided according to the structural needs of the flexible neural electrode and the specific requirements of the implantation location.

[0136] In this embodiment, when the auxiliary implantation needle is withdrawn in the direction opposite to the longitudinal direction, the connection with the auxiliary implantation part is first released; as the auxiliary implantation needle continues to be withdrawn, the connection with the first fixation hole is gradually released. The first fixation hole may include multiple first sub-fixation holes distributed at different positions of the lead wire connection part to further improve the stability of the helical segment. The multiple first sub-fixation holes work together to further ensure the maintenance of the flexible neural electrode helical structure during implantation.

[0137] As the auxiliary implantation needle continues to withdraw, the multiple sub-fixation holes of the second fixation hole gradually detach from the auxiliary implantation needle, allowing the helical segment of the flexible neural electrode to fully unfold in its final position. At this point, the distribution of the second fixation hole is farther than that of the first fixation hole, ensuring that the implanted flexible neural electrode maintains optimal stability and stress dispersion within the target area.

[0138] Furthermore, in practical applications, a specific design can be used to achieve a step-by-step release effect based on the adaptation requirements of the flexible neural electrode in the target tissue. The auxiliary implantation needle can gradually detach from more sub-fixation holes, thereby achieving precise control of the helical flexible neural electrode structure. Each detachment operation ensures a smooth transition of the flexible neural electrode during implantation, while minimizing the stress impact on the flexible neural electrode.

[0139] The first and second fixation structures of the auxiliary implantation needle in this application are spiky structures that extend away from the auxiliary implantation needle and are inclined relative to the proximal and / or distal end of the auxiliary implantation needle. When the auxiliary implantation needle is withdrawn in the direction opposite to the longitudinal direction, the limiting opening of the spiky structure on the sidewall of the cannula retracts into the cannula under the applied force, thereby achieving separation from the first and second fixation holes of the flexible neural electrode. This design ensures the stability of the flexible neural electrode during implantation and simplifies the removal of the traction device.

[0140] In the extraction method of the auxiliary implantation needle in the embodiments of this application, when the length of the first fixing structure and the second fixing structure of the auxiliary implantation needle is not greater than the preset length, it can be understood that when the interaction length between the fixing structure of the auxiliary implantation needle and the fixing hole of the flexible nerve electrode is short, the proximal end of the auxiliary implantation needle, under the action of a force in the direction opposite to the implantation direction, will cause the first fixing structure to detach from the first fixing hole and the second fixing structure to detach from the second fixing hole first, and then the traction part will detach from the auxiliary implantation part.

[0141] When the lengths of the first and second fixation structures of the auxiliary implantation needle exceed a preset length, it can be understood that when the interaction length between the fixation structure of the auxiliary implantation needle and the fixation hole of the flexible neural electrode is long, the proximal end of the auxiliary implantation needle, under a force acting in the opposite direction to the implantation direction, will cause the traction part to detach from the auxiliary implantation part first. Then, the first fixation structure will detach from the first fixation hole, and the second fixation structure will detach from the second fixation hole. The order in which the auxiliary implantation needle detaches from the fixation hole of the flexible neural electrode and from the auxiliary implantation part is determined by the pre-set mechanical structure of the flexible neural electrode assembly. This flexible design is suitable for different types of implantation needs and can optimize the release sequence and stability of the flexible neural electrode according to the structural length of the traction component.

[0142] Furthermore, when the third marker of the auxiliary implantation needle is exposed, its flexible fixation structure disengages from the fixation hole of the flexible neuroelectrode, allowing the helical segment of the flexible neuroelectrode to be gradually released. As the auxiliary implantation needle continues to be withdrawn, when the fourth marker is exposed, the auxiliary implantation needle completely detaches from the auxiliary implantation portion of the flexible neuroelectrode. During this process, the flexible retraction capability of the fixation structure of the auxiliary implantation needle ensures the smoothness of the withdrawal process and avoids damage to the flexible neuroelectrode or surrounding tissues due to excessive mechanical force.

[0143] Finally, after the auxiliary implantation needle has completely detached from the flexible neural electrode, the cannula can be further withdrawn to remove the traction device. At this point, the helical structure of the flexible neural electrode is fully released and stably fixed in the target area. The thorn-like fixation structure of the auxiliary implantation needle and the helical shape of the flexible neural electrode itself work together to further enhance the mechanical stability and long-term reliability after implantation.

[0144] The design of multiple fixation holes in the auxiliary implantation needle ensures the stability of the flexible neural electrode at different implantation depths through stepwise disengagement, and maintains the desired spiral shape after reaching the target position. In practice, this design can also flexibly adjust the number and distribution of fixation holes according to the physiological characteristics of different tissue regions, thereby achieving the best implantation stability and further enhancing the long-term reliability and adaptability of the flexible neural electrode.

[0145] The flexible neural electrode assembly provided in this application has advantages such as strong stress dispersion and high stability after implantation, and has broad application potential in the fields of nerve stimulation, nerve recording, pain relief and treatment of related nervous system diseases.

[0146] Based on the same inventive concept, this application provides a method for preparing a flexible neural electrode 1, which is applied to the flexible neural electrode assembly provided in any of the above embodiments. See also... Figure 5 As shown, the fabrication method of the flexible neural electrode 1 includes:

[0147] S101, Prepare a sacrificial layer on the support;

[0148] S102, a first flexible insulating layer is formed on the side of the sacrificial layer away from the carrier;

[0149] S103, the pattern of the contact and electrode sites on the first surface is defined by photolithography, and the first flexible insulating layer in the corresponding area is removed by etching to obtain the hollow area of ​​the contact and electrode sites on the first surface.

[0150] S104, a metallic conductive layer is formed on the side of the first flexible insulating layer away from the carrier, and contact points and electrode sites are formed on the first surface in the hollow area.

[0151] S105, a second flexible insulating layer is formed on the side of the metal conductive layer away from the carrier;

[0152] S106, the pattern of the contact and electrode sites on the second surface is defined by photolithography and / or hard mask coating process, and the second flexible insulating layer in the corresponding area is removed by etching process to obtain the contact and electrode sites on the second surface. The pattern of the auxiliary implantation part is defined by photolithography process, and the first flexible insulating layer and the second flexible insulating layer in the corresponding area are removed by etching process to obtain the auxiliary implantation part.

[0153] S107, the sacrificial layer is removed by an etching process to release a flexible neural electrode;

[0154] S108, a first fixing hole and a second fixing hole are formed on the first flexible insulating layer and the second flexible insulating layer of the lead connection portion of the flexible nerve electrode, and no metal conductive layer is provided at the first fixing hole and the second fixing hole in the thickness direction of the lead connection portion.

[0155] In some embodiments, see Figure 3The metal conductive layer includes a first metal conductive layer 127 that is attached to the first flexible insulating layer 124 and a second metal conductive layer 128 that is attached to the second flexible insulating layer 125. The lead wire connection portion 12 also has a third flexible insulating layer 126 along its thickness direction. The third flexible insulating layer 126 is disposed between the first metal conductive layer 127 and the second metal conductive layer 128.

[0156] In some embodiments, there are multiple first metal conductive layers 127, which are arranged in parallel, and a fourth flexible insulating layer 129 is provided between adjacent first metal conductive layers 127; and / or, there are multiple second metal conductive layers 128, which are arranged in parallel, and a fourth flexible insulating layer 129 is provided between adjacent second metal conductive layers 128.

[0157] Specifically, the fabrication method of this flexible neural electrode includes the following steps: First, a sacrificial layer is formed on a carrier by photolithography and film deposition; then, a first flexible insulating layer is spin-coated and baked on the side of the carrier where the sacrificial layer has been formed; next, the pattern of electrode sites and contacts on the first surface is defined on the first flexible insulating layer using photolithography, and the corresponding areas of the first flexible insulating layer are removed by etching, forming hollow areas of electrode sites and contacts on the first surface; subsequently, a metal conductive layer is deposited on the side of the first flexible insulating layer away from the carrier by photolithography and film deposition, and contacts and electrode sites on the first surface are formed in the hollow areas, and the thickness and performance of the metal conductive layer can be further enhanced by electroplating. On the side of the metal conductive layer away from the carrier, a second flexible insulating layer is formed by spin-coating and baking. On the second flexible insulating layer, the pattern of electrode sites and contacts on the second surface is defined by photolithography, and the corresponding areas of the second flexible insulating layer are removed by etching, forming electrode sites and contacts on the second surface. Furthermore, the overall outline of the flexible neural electrode and the pattern of the auxiliary implantation portion are defined on the second flexible insulating layer by photolithography. The first and second flexible insulating layers in the corresponding areas are then removed by etching, thereby forming a complete flexible neural electrode outline and auxiliary implantation portion. Next, the sacrificial layer is removed by wet etching to release the flexible neural electrode. Finally, a first fixing hole and a second fixing hole are formed on the first and second flexible insulating layers of the lead connection portion of the flexible neural electrode, and no metal conductive layer is provided at the first and second fixing holes in the thickness direction of the lead connection portion.

[0158] To simplify the process, the steps of defining electrode sites and contacts on the second flexible insulating layer can be combined with the steps of defining the overall outline of the flexible neural electrode and other components, thereby improving production efficiency and reducing manufacturing complexity.

[0159] In some embodiments, the pattern on the second flexible insulating layer can be defined using photolithography and hard mask coating techniques. The application of a hard mask further improves pattern accuracy, especially in the fabrication of key components such as electrode sites and auxiliary implantation parts of the flexible neural electrode, ensuring high precision and reliability of each functional component.

[0160] In the fabrication method of flexible neural electrodes, hard mask technology is introduced to further improve processing accuracy. Specifically, during the formation of the first and second flexible insulating layers, hard mask deposition technology is used to ensure more precise patterns of electrode sites and contacts on the flexible neural electrodes. This step simplifies and improves the manufacturing process of flexible neural electrodes, while also reducing quality issues caused by mask inaccuracies. Especially in the fabrication of key functional components of flexible neural electrodes (such as electrode sites), processing accuracy is further enhanced through photolithography and hard mask deposition technology. The application of hard masks ensures clear edges and precise shapes of components, making it particularly suitable for flexible neural electrode components requiring complex structures.

[0161] The above embodiments are merely exemplary embodiments of this application and are not intended to limit this application. The scope of protection of this application is defined by the claims. Those skilled in the art can make various modifications or equivalent substitutions to this application within its substance and scope of protection, and such modifications or equivalent substitutions should also be considered to fall within the scope of protection of this application.

Claims

1. A flexible neural electrode assembly, characterized in that, include: Flexible neural electrodes and traction devices; The flexible neural electrode includes a proximal contact portion, a lead wire connection portion, a distal electrode portion, and an auxiliary implantation portion; The proximal contact portion includes at least one contact point, the distal electrode portion includes at least one electrode site, and the lead wire connection portion is provided with a first fixing hole and a second fixing hole to define the helical structure of the flexible neural electrode. The traction device includes a cannula and an auxiliary implantation needle; the side wall of the cannula is provided with a first limiting opening and a second limiting opening; the side of the auxiliary implantation needle is provided with a first fixing structure and a second fixing structure. The inside of the cannula is a cavity, and the auxiliary implantation needle is inserted into the inside of the cannula; The first fixing structure of the auxiliary implantation needle is engaged with the first fixing hole through the first limiting opening, and the second fixing structure of the auxiliary implantation needle is engaged with the second fixing hole through the second limiting opening; Between the first fixing structure and the second fixing structure, the flexible neural electrode is spirally coiled on the outside of the cannula; The flexible neural electrode between the first fixing hole and the second fixing hole is spiral in shape; The length of the lead wire connection between the first fixing hole and the second fixing hole is the first length; The length between the first fixing structure and the second fixing structure is the second length; The first length is greater than the second length; The first fixing structure and the second fixing structure are made of flexible materials; the first fixing structure and the second fixing structure have flexible retraction capability; After the flexible neural electrode is implanted, the removal process of the auxiliary implantation needle includes: gradually detaching the physical connection between the auxiliary implantation needle and the flexible neural electrode in stages, specifically including: After the flexible neural electrode is implanted, a force is applied towards the proximal end of the auxiliary implantation needle to separate the auxiliary implantation needle from the auxiliary implantation portion of the flexible neural electrode. Then, the auxiliary implantation needle is gradually withdrawn to sequentially detach from the first fixation hole and the second fixation hole of the flexible neural electrode. Alternatively, after the flexible neural electrode is implanted, a force is applied towards the proximal end of the auxiliary implantation needle, and the auxiliary implantation needle is gradually withdrawn to sequentially detach from the first fixation hole and the second fixation hole of the flexible neural electrode. Then, the auxiliary implantation needle is withdrawn to detach from the auxiliary implantation portion of the flexible neural electrode.

2. The flexible neural electrode assembly according to claim 1, characterized in that, The first fixing structure includes at least one first sub-fixing structure, and the second fixing structure includes a second sub-fixing structure; The first limiting opening includes at least one first sub-limiting opening, and the second limiting opening includes at least one second sub-limiting opening; The first fixing hole includes at least one first sub-fixing hole, and the second fixing hole includes at least one second sub-fixing hole; The first sub-fixing structure, the first sub-limiting opening, and the first sub-fixing hole correspond one-to-one; The second sub-fixing structure, the second sub-limiting opening, and the second sub-fixing hole correspond one-to-one.

3. The flexible neural electrode assembly according to claim 1, characterized in that, The flexible material includes one or more of parylene, silicone rubber, and polyimide.

4. The flexible neural electrode assembly according to claim 3, characterized in that, The first fixing structure and the second fixing structure are spike-like structures; The thorn-like structure extends in a direction away from the auxiliary implantation needle; The thorn-like structure is inclined relative to the auxiliary implantation needle in the direction of the proximal end or the distal end of the auxiliary implantation needle. The proximal end and the distal end of the auxiliary implantation needle are positioned opposite each other.

5. The flexible neural electrode assembly according to claim 1, characterized in that, The auxiliary implantation part and the lead wire connection part form an L-shaped shape in the longitudinal direction; a traction opening is provided on the top or side of the distal end of the cannula; The cannula abuts against the auxiliary implantation part of the flexible nerve electrode at the traction opening, forming a physical connection structure with the auxiliary implantation part.

6. The flexible neural electrode assembly according to claim 5, characterized in that, The auxiliary implantation unit includes an auxiliary implantation port; The diameter of the traction opening of the cannula is larger than the diameter of the auxiliary implantation hole.

7. The flexible neural electrode assembly according to claim 6, characterized in that, The auxiliary implantation needle is provided with a traction part, which passes through the traction opening of the cannula and exits from the auxiliary implantation hole of the auxiliary implantation part.

8. The flexible neural electrode assembly according to claim 7, characterized in that, When the proximal end of the auxiliary implantation needle is subjected to a force in the opposite direction to the longitudinal direction, it causes the first fixing structure to detach from the first fixing hole, the second fixing structure to detach from the second fixing hole, and the traction part to detach from the auxiliary implantation part.

9. The flexible neural electrode assembly according to claim 8, characterized in that, When the lengths of the first and second fixing structures of the auxiliary implantation needle are greater than the preset length, and the proximal end of the auxiliary implantation needle is subjected to a force in the opposite direction to the longitudinal direction, the traction part is first disengaged from the auxiliary implantation part, and then the first fixing structure is disengaged from the first fixing hole and the second fixing structure is disengaged from the second fixing hole.

10. The flexible neural electrode assembly according to claim 9, characterized in that, The proximal side of the auxiliary implantation needle is marked with a first mark and a second mark in the longitudinal direction from proximal to distal; When the traction part detaches from the auxiliary implantation part first, the first mark is exposed; The second mark is exposed when the first fixing structure detaches from the first fixing hole and the second fixing structure detaches from the second fixing hole.

11. The flexible neural electrode assembly according to claim 8, characterized in that, When the lengths of the first and second fixing structures of the auxiliary implantation needle are not greater than a preset length, and when the proximal end of the auxiliary implantation needle is subjected to a force in the opposite direction to the implantation direction, the first fixing structure is disengaged from the first fixing hole and the second fixing structure is disengaged from the second fixing hole. Then, the traction part is disengaged from the auxiliary implantation part.

12. The flexible neural electrode assembly according to claim 11, characterized in that, The third and fourth marks are sequentially arranged from proximal to distal along the longitudinal direction on the proximal side of the auxiliary implantation needle; The third mark is exposed when the first fixing structure disengages from the first fixing hole and the second fixing structure disengages from the second fixing hole; The fourth mark is exposed when the traction part disengages from the auxiliary implantation part.

13. The flexible neural electrode assembly according to claim 1, characterized in that, The lead wire connection part is also provided with an auxiliary fixing part; the auxiliary fixing part has a barbed structure and / or a hollow structure; The first fixing hole is close to the distal electrode portion, and the second fixing hole is far away from the distal electrode portion; The auxiliary fixing part is located between the distal electrode part and the first fixing hole; and / or The auxiliary fixing part is located near the second fixing hole.

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