Flexible neural electrode assembly and preparation method of flexible neural electrode

Abstract

The invention discloses a flexible neural electrode assembly and a preparation method of a 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 formed in a lead connecting part of the flexible neural electrode; the traction piece comprises a sleeve and an auxiliary implantation needle; a first limiting opening and a second limiting opening are formed in the side wall of the sleeve; a first fixing structure and a second fixing structure are arranged on the side surface of the auxiliary implantation needle; the interior of the sleeve is a cavity, and the auxiliary implantation needle is inserted into the sleeve; the first fixing structure of the auxiliary implantation needle is clamped with the first fixing hole through the first limiting opening, and the second fixing structure of the auxiliary implantation needle is clamped 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 coiled on the outer side of the sleeve in a spiral manner. By adopting the flexible neural electrode, the stability and the long-term use reliability of the flexible neural electrode can be remarkably improved.

Description

Technical Field

[0001] The present 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 Art

[0002] Neural electrical stimulation and recording technology has important application value in the treatment of neurological diseases, pain relief and functional recovery. Traditional neural electrodes are usually implanted invasively, with the stimulation or recording site of the neural electrode directly fixed on the nerve or target tissue. However, traditionally designed neural electrodes face many challenges after implantation. Due to the constant movement of the target tissue, especially under physiological activities such as breathing, muscle contraction and blood vessel pulsation, the neural electrode is easily pulled and stressed, resulting in displacement or damage of the neural electrode. This displacement and material fatigue may not only affect the electrical connection stability of the neural electrode, but also reduce its reliability during long-term use, and may even require a secondary surgery for replacement, increasing the risk and medical costs for patients.

[0003] Existing neural electrodes usually lack flexible structures or have limited flexibility, and they are often difficult to adapt to physiological stress. Therefore, with the development of technology, flexible neural electrodes have begun to attract widespread attention. Flexible neural electrodes can better fit the target tissue and reduce the mechanical stimulation of the target tissue 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 in the target tissue, it may still face stress concentration problems due to the lack of sufficient deformation margin, resulting in poor stability of the flexible neural electrode. Summary of the invention

[0005] The purpose of the embodiments of the present application is to provide a flexible neural electrode and a method for preparing a flexible neural electrode, so as to solve the problem of stress concentration caused by lack of sufficient deformation margin after the flexible neural electrode is implanted in the tissue, thereby causing the flexible neural electrode to have poor stability.

[0006] In a first aspect, an embodiment of the present application provides a flexible neural electrode assembly, including: a flexible neural electrode and a traction member; The flexible neural electrode comprises a proximal contact portion, a lead connection portion, a distal electrode portion and an auxiliary implant portion; the proximal contact portion comprises at least one contact point, the distal electrode portion comprises at least one electrode site, and the lead connection portion is provided with a first fixing hole and a second fixing hole; The traction member includes a sleeve and an auxiliary implantation needle; the side wall of the sleeve is provided with a first limiting opening and a second limiting opening; the side wall of the auxiliary implantation needle is provided with a first fixing structure and a second fixing structure; The interior of the cannula is a cavity, and the auxiliary implantation needle is inserted into the interior of the cannula; The first fixing structure of the auxiliary implant needle is clamped with the first fixing hole through the first limiting opening, and the second fixing structure of the auxiliary implant needle is clamped with the second fixing hole through the second limiting opening; The flexible neural electrode is spirally wound around the outer surface of the sleeve between the first fixing structure and the second fixing structure.

[0007] In a second aspect, an embodiment of the present application provides a method for preparing a flexible neural electrode, which is applied to a flexible neural electrode of the flexible neural electrode assembly as described above, and the method for preparing the flexible neural electrode comprises: preparing a sacrificial layer on the carrier; forming a first flexible insulating layer on a side of the sacrificial layer away from the carrier; Defining the pattern of the contact points and electrode sites on the first surface by using a photolithography process, and removing the first flexible insulating layer in the corresponding area by using an etching process to obtain a hollow area of ​​the contact points and electrode sites on the first surface; Forming a metal conductive layer on a side of the first flexible insulating layer away from the carrier, and forming contacts and electrode sites located on the first surface in the hollowed-out area; forming a second flexible insulating layer on a side of the metal conductive layer away from the carrier; Defining the pattern of the contacts and electrode sites on the second surface by using photolithography and / or hard mask coating process, and removing the second flexible insulating layer in the corresponding area by using etching process to obtain the contacts and electrode sites on the second surface, and defining the pattern of the auxiliary implant part by using photolithography process, and removing the first flexible insulating layer and the second flexible insulating layer in the corresponding area by using etching process to obtain the auxiliary implant part; The sacrificial layer is removed by etching process to release the flexible neural electrode; 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 connecting part of the flexible nerve electrode, and no metal conductive layer is arranged at the first fixing hole and the second fixing hole in the thickness direction of the lead connecting part.

[0008] The embodiment of the present application provides a flexible neural electrode assembly, including a flexible neural electrode and a traction member, the traction member including a sleeve and an auxiliary implantation needle, two fixing structures are arranged on the auxiliary implantation needle, the side wall of the sleeve is provided with two limiting openings, and the lead connection part of the flexible neural electrode is provided with two fixing holes, and the two fixing structures on the auxiliary implantation needle are connected with the two fixing holes of the flexible neural electrode through the two limiting openings on the side wall of the sleeve in a one-to-one correspondence, so that the flexible neural electrode is spirally coiled on the outside of the sleeve before and during implantation. That is, the embodiment of the present application disperses stress after implantation into the target tissue through the spiral winding structure of the flexible neural electrode, maintains the stability of the flexible neural electrode, avoids displacement and material fatigue problems caused by the activity of the target tissue, and thus improves the stability of the flexible neural electrode. BRIEF DESCRIPTION OF THE DRAWINGS

[0009] Figure 1 A schematic diagram of the overall structure of a flexible neural electrode assembly provided in an embodiment of the present application; Figure 2 A schematic diagram of the exploded structure of a flexible neural electrode assembly provided in an embodiment of the present application; Figure 3 A schematic diagram of a multi-layer structure of a flexible neural electrode provided in an embodiment of the present application; in, Figure 3 (a) is a schematic diagram of the structure of a flexible neural electrode provided in an embodiment of the present application; Figure 3 (b) Figure 3 (a) Schematic diagram of the multilayer structure of the flexible neural electrode; Figure 4 A schematic diagram of the process of disengaging an auxiliary implant needle from a first fixing hole and a second fixing hole of a flexible nerve electrode is provided for an embodiment of the present application; in, Figure 4 (a) is a schematic diagram of applying force to the proximal end of the auxiliary implant needle to separate the traction part from the flexible neural electrode; Figure 4 (b) Schematic diagram of applying a force to the proximal end of the auxiliary implant needle and first separating the fixing structure of the auxiliary implant needle from the fixing hole of the flexible neural electrode; Figure 4 (c) A schematic diagram of the traction portion of the auxiliary implant needle and the auxiliary implant portion of the flexible nerve electrode being separated after the force is continuously applied to the proximal end of the auxiliary implant needle; Figure 4 (d) Schematic diagram of the cannula being separated from the flexible neural electrode in order to continue applying force to the proximal end of the auxiliary implant needle; Figure 5 A schematic flow chart of a method for preparing a flexible neural electrode provided in an embodiment of the present application.

[0010] Description of the accompanying drawings 1- Flexible neural electrodes; 11-proximal contact portion, 111-contact; 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; 13-distal electrode part, 131-electrode site, 132-stimulation site, 133-recording site; 14- auxiliary implantation portion, 141- auxiliary implantation hole; 2- traction piece; 21-sleeve, 211-first limiting opening, 212-second limiting opening, 213-traction opening; 22 - auxiliary implantation needle, 221 - traction part, 224 - first fixing structure, 225 - second fixing structure. DETAILED DESCRIPTION

[0011] Various aspects and features of the present application are described herein with reference to the accompanying drawings.

[0012] It should be understood that various modifications may be made to the embodiments of the present application. Therefore, the above description should not be considered as limiting, but only as an example of an embodiment. Other modifications within the scope and spirit of the present application will occur to those skilled in the art.

[0013] The accompanying drawings, which are incorporated in and constitute a part of the 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.

[0014] These and other characteristics of the present application will become apparent from the following description of a preferred form of embodiment given as a non-limiting example with reference to the accompanying drawings.

[0015] It should also be understood that although the present application has been described with reference to some specific examples, those skilled in the art will be able to readily implement many other equivalent forms of the present application.

[0016] The above and other aspects, features and advantages of the present application will become more apparent in view of the following detailed description when taken in conjunction with the accompanying drawings.

[0017] Specific embodiments of the present application are described hereinafter with reference to the accompanying drawings; however, it should be understood that the embodiments applied for are merely examples of the present application, which may be implemented in a variety of ways. Well-known and / or repeated functions and structures are not described in detail to avoid unnecessary or redundant details that obscure the present application. Therefore, the specific structural and functional details applied for herein are not intended to be limiting, but merely serve as a basis and representative basis for the claims to teach those skilled in the art to use the present application in a variety of ways with substantially any suitable detailed structure.

[0018] 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 the present application.

[0019] Although the flexibility of existing flexible neural electrodes can adapt to some stress, they may still face stress concentration problems after implantation due to lack of sufficient deformation margin, which may lead to fracture or failure of the flexible neural electrodes. In addition, existing flexible neural electrodes are mostly designed in a straight line shape, which is easily pulled and deviated from the target area during and after implantation, which increases the difficulty of implantation and the complexity of operation.

[0020] In order to solve these problems, some improved designs have emerged in recent years, such as curling or spiraling the flexible neural electrode to provide a certain deformation margin so that it can disperse external stress after implantation. However, these designs still have shortcomings in the fixation of flexible neural electrodes and the stability after implantation, especially the spiral structure of the flexible neural electrode is easily affected by its retention and stability inside the target tissue during implantation. In addition, traditional implantation methods usually lack special auxiliary implantation components, resulting in low implantation accuracy of flexible neural electrodes in complex tissue structures, increasing the possibility of postoperative displacement of flexible neural electrodes. For example, some stretchable flexible neural electrodes are designed to focus on the tensile deformation adaptability of flexible neural electrodes to match the dynamics of target tissues. However, this solution fails to provide an effective deformation margin absorption design when facing the stress concentration problem caused by tissue activity after the implantation of flexible neural electrodes. Especially after multiple stretching rebounds, the flexible neural electrodes may face the risk of morphological failure or fatigue damage.

[0021] Therefore, an embodiment of the present application provides a flexible neural electrode assembly to solve the problem of stress concentration after the flexible neural electrode is implanted in the tissue due to lack of sufficient deformation margin, thereby causing poor stability of the flexible neural electrode.

[0022] The technical solution of the present application and how the technical solution of the present application solves the above-mentioned technical problems are described in detail below with specific embodiments. The following specific embodiments can be combined with each other, and the same or similar concepts or processes may not be repeated in some embodiments. The embodiments of the present application will be described below in conjunction with the accompanying drawings.

[0023] A flexible neural electrode assembly according to an embodiment of the present application, combined with Figure 1 and Figure 2 As shown, the flexible neural electrode assembly includes: a flexible neural electrode 1 and a traction member 2; The flexible neural electrode 1 includes a proximal contact portion 11, a lead 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 connection portion 12 is provided with a first fixing hole 121 and a second fixing hole 122; The traction member 2 includes a sleeve 21 and an auxiliary implantation needle 22; the side wall of the sleeve 21 is provided with a first limiting opening 211 and a second limiting opening 212; the side wall of the auxiliary implantation needle 22 is provided with a first fixing structure 224 and a second fixing structure 225; The interior of the sleeve 21 is a cavity for accommodating the auxiliary implantation needle 22 and guiding the auxiliary implantation needle 22 to be longitudinally inserted into the interior of the sleeve 21; the auxiliary implantation needle 22 is inserted into the interior of the sleeve 21; The first fixing structure 224 of the auxiliary implant needle 22 is clamped with the first fixing hole 121 through the first limiting opening 211, and the second fixing structure 225 of the auxiliary implant needle 22 is clamped with the second fixing hole 122 through the second limiting opening 212; Between the first fixing structure 224 and the second fixing structure 225 , the flexible neural electrode 1 is spirally wound around the outer surface of the sleeve 21 .

[0024] The embodiment of the present application provides a flexible neural electrode assembly, including a flexible neural electrode and a traction member, the traction member including a sleeve and an auxiliary implantation needle, two fixing structures are arranged on the auxiliary implantation needle, the side wall of the sleeve is provided with two limiting openings, and the lead connection part of the flexible neural electrode is provided with two fixing holes, and the two fixing structures on the auxiliary implantation needle are connected with the two fixing holes of the flexible neural electrode through the two limiting openings on the side wall of the sleeve in a one-to-one correspondence, so that the flexible neural electrode is spirally coiled on the outside of the sleeve before and during implantation. That is, the embodiment of the present application disperses stress after implantation into the target tissue through the spiral winding structure of the flexible neural electrode, maintains the stability of the flexible neural electrode, avoids displacement and material fatigue problems caused by the activity of the target tissue, and thus improves the stability of the flexible neural electrode.

[0025] The embodiment of the present application provides a flexible neural electrode with a unique spiral design, which can effectively relieve stress concentration and maintain stability in the target area during and after implantation. That is, the embodiment of the present application designs the lead connection part of the flexible neural electrode into a spiral shape, and makes it spiral outside the sleeve of the traction member, so that a spiral shape is formed in the target tissue after implantation to absorb physiological stress and avoid the risk of fatigue and displacement of the flexible neural electrode material caused by stress concentration. The traction member includes an auxiliary implantation needle and a sleeve, which guides the flexible neural electrode to achieve precise implantation through the traction member, while maintaining the spiral shape of the flexible neural electrode during the implantation process to disperse stress, thereby significantly improving the stability of the flexible neural electrode and the reliability of long-term use. This design not only improves the adaptability and stability of the flexible neural electrode, but also improves the implantation accuracy and ease of operation in complex clinical applications.

[0026] Exemplarily, the width of the proximal contact portion 11, the lead connection portion 12, the distal electrode portion 13 and the auxiliary implant portion 14 of the flexible neural electrode can be 100 microns to 10 mm, and the thickness is controlled below 0.2 mm to ensure the flexibility of the flexible neural electrode and adapt to the movement of the target tissue. The width of the flexible neural electrode can be changed according to the needs of different parts to increase the anchoring effect in the target area. It should be noted that the range values ​​of the above width and thickness can be adjusted in time according to actual conditions, and this application does not make specific limitations.

[0027] Exemplarily, the electrode site 131 includes at least one of a stimulation site 132 and a recording site 133; wherein the stimulation site 132 is used to deliver stimulation pulses to the target tissue, and the recording site 133 is used to record neural signals of the target tissue.

[0028] Among them, the maximum diameter of the stimulation site 132 is not less than 50 microns, and the number of stimulation sites 132 can reach 200, ensuring that a sufficient range of electrical stimulation is covered; the maximum diameter of the recording site 133 is not greater than 200 microns, and the number can reach 2000 to meet a variety of neural recording needs. Flexible neural electrodes designed in this way can be widely used in electrical stimulation and recording, while reducing the risk of material fatigue and fracture caused by target tissue activity. It should be noted that the range values ​​of the above maximum diameter and number can be adjusted in time according to actual conditions, and this application does not make specific limitations.

[0029] Exemplarily, the aperture range of the first fixing hole 121 and the second fixing hole 122 can be 0.01 mm to 2 mm, and the apertures 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 apertures of multiple first sub-fixing holes can be the same, partially the same, or different, and the number of each sub-fixing hole can be 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 a spiral shape during the implantation process. It should be noted that the range values ​​of the above-mentioned aperture and number can be adjusted in time according to actual conditions, and this application does not make specific limitations.

[0030] For example, the diameter of the auxiliary implantation needle 22 may range from 0.001 mm to 3 mm, so as to provide sufficient rigidity during the process of implanting the flexible neural electrode into the target tissue and guiding the implantation of the flexible neural electrode. Of course, the diameter range of the auxiliary implantation needle 22 may be adjusted in a timely manner according to actual conditions, and this application does not make specific limitations.

[0031] For example, the diameter of the cannula 21 may range from 0.002 mm to 5 mm, ensuring that the auxiliary implantation needle 22 can pass smoothly. Of course, the diameter range of the cannula 21 can be adjusted in time according to actual conditions, and this application does not make specific limitations.

[0032] The side of the auxiliary implant needle 22 is provided with 2 to 100 sub-fixing structures, and the length can be between 0.1 mm and 5 mm. The number and length range of the sub-fixing structures can be adjusted in time according to the actual situation, and this application does not make specific restrictions.

[0033] The outer side of the sleeve 21 is provided with 2 to 100 sub-limit openings, the diameter of which can be between 0.01 mm and 3 mm, so that the auxiliary implantation needle 22 cooperates with the sub-fixing hole of the flexible neural electrode at these sub-limit openings, and the lead connection part 12 of the flexible neural electrode 1 is spirally wound around the outer side of the sleeve 21 to ensure the stability of the flexible neural electrode during implantation. The number of limit openings and the range of diameters can be adjusted in time according to actual conditions, and this application does not make specific restrictions.

[0034] In some embodiments, the materials of the first fixing structure 224 and the second fixing structure 225 are flexible materials; the flexible material includes a combination of at least one or more of polyparaxylene, silicone rubber, and polyimide.

[0035] In some embodiments, see Figure 2 As shown, the first fixing structure 224 and the second fixing structure 225 are thorn-like structures; The thorn-like structure extends in a direction away from the auxiliary implantation needle 22; The thorn-like structure is arranged obliquely relative to the auxiliary implantation needle 22 toward the proximal end of the auxiliary implantation needle 22 or the distal end of the auxiliary implantation needle 22; The proximal end of the auxiliary implantation needle 22 and the distal end of the auxiliary implantation needle 22 are arranged opposite to each other.

[0036] In some embodiments, in combination Figure 1 and Figure 4 As shown, the auxiliary implantation portion 14 and the lead connection portion 12 form an L-shape in the longitudinal direction; a traction opening 213 is provided at the top or side of the distal end of the sleeve 21; The sleeve 21 abuts against the auxiliary implantation portion 14 of the flexible nerve electrode 1 at the traction opening 213 , and the sleeve 21 and the auxiliary implantation portion 14 form a physical connection structure.

[0037] In some embodiments, the auxiliary implantation portion 14 includes an auxiliary implantation hole 141; The diameter of the traction opening 213 of the sleeve 21 is larger than the diameter of the auxiliary implantation hole 141 .

[0038] For example, the diameter of the auxiliary implant hole 141 may range from 0.002 mm to 2 mm to meet the connection requirements with the traction member so as to achieve stable implantation of the flexible neural electrode. The diameter range of the auxiliary implant hole 141 may be adjusted in due course according to actual conditions, and this application does not make any specific limitation.

[0039] In some embodiments, in combination Figure 1 and Figure 4 As shown, the auxiliary implantation needle 22 is provided with a traction portion 221 , which passes through the traction opening 213 of the sleeve 21 and comes out from the auxiliary implantation hole 141 of the auxiliary implantation portion 14 .

[0040] Specifically, the auxiliary implantation hole 141 is used to cooperate with the traction part 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 sleeve 21, and the auxiliary implantation needle 22 forms a physical connection mechanism with the auxiliary implantation part 14 of the flexible neural electrode 1 through the traction opening 213, thereby realizing the stable implantation of the flexible neural electrode 1 into the target tissue. The side wall of the traction opening 213 at the distal end of the sleeve 21 contacts the auxiliary implantation part 14 of the flexible neural electrode 1 during the implantation process of the flexible neural electrode 1, and the stable implantation of the flexible neural electrode 1 is realized by pressing and limiting.

[0041] In some embodiments, see Figure 3As shown, the flexible neural electrode 1 is constructed as a stacked structure along the thickness direction, including a first flexible insulating layer 124, a second flexible insulating layer 125 and a metal conductive layer located therebetween. The materials of the first flexible insulating layer 124 and the second flexible insulating layer 125 can be made of one or more combinations of SU-8 photoresist, parylene, polyparaxylene, fluorinated polymer or polyimide.

[0042] In some embodiments, see Figure 3 As shown, the metal conductive layer includes a first metal conductive layer 127 arranged in contact with the first flexible insulating layer 124 and a second metal conductive layer 128 arranged in contact with the second flexible insulating layer 125. The lead connecting portion 12 also has a third flexible insulating layer 126 along its thickness direction, and the third flexible insulating layer 126 is placed between the first metal conductive layer 127 and the second metal conductive layer 128.

[0043] In some embodiments, there are multiple first metal conductive layers 127, the multiple first metal conductive layers 127 are arranged in parallel, and a fourth flexible insulating layer 129 is arranged between adjacent first metal conductive layers 127; and / or, there are multiple second metal conductive layers 128, the multiple second metal conductive layers 128 are arranged in parallel, and a fourth flexible insulating layer 129 is arranged between adjacent second metal conductive layers 128.

[0044] In this embodiment, multiple first metal conductive layers and / or multiple second metal conductive layers are provided to ensure that the flexible neural electrode can provide multiple independent electrode sites. These electrode sites can contact different areas of the neural tissue respectively to achieve independent signal acquisition and stimulation functions. A third flexible insulating layer is provided between the metal conductive layers to avoid mutual interference between the metal conductive layers and ensure accurate signal transmission. At the same time, the provision of the third flexible insulating layer enhances the mechanical strength and stability of the flexible neural electrode, thereby improving the long-term reliability of the flexible neural electrode.

[0045] Multiple first metal conductive layers and multiple second metal conductive layers are arranged in parallel to meet the requirements of different electrode sites. A fourth flexible insulating layer is arranged between each pair of adjacent metal conductive layers to isolate different electrode sites. This design can ensure 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.

[0046] In a specific embodiment, the spiral implantable flexible neural electrode assembly of the present application can be designed in a variety of ways according to different application scenarios and tissue environments to meet specific implantation requirements. The following are several embodiments: In some embodiments, the shape of the flexible neural electrode 1 between the first fixing hole 121 and the second fixing hole 122 is a spiral shape; The length of the lead connection portion 12 between the first fixing hole 121 and the second fixing hole 122 is a first length; The length between the first fixed structure 224 and the second fixed structure 225 is the second length; The first length is greater than the second length.

[0047] In some embodiments, the lead connection portion 12 is further provided with an auxiliary fixing portion 123; the auxiliary fixing portion 123 has a thorn-like structure and / or a hollow structure; 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 ; The auxiliary fixing portion 123 is located between the distal electrode portion 13 and the first fixing hole 121; and / or, The auxiliary fixing portion 123 is located near the second fixing hole 122 .

[0048] In some embodiments, the auxiliary fixing portion 123 is formed on the first flexible insulating layer and / or the second flexible insulating layer.

[0049] The thorn-like structure extends in a direction away from the lead connection portion 12 and is arranged obliquely relative to the lead connection portion 12, while the hollow structure is located on the side and / or surface of the lead connection portion 12. The auxiliary fixing portion 123 can 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.

[0050] For example, the inclination direction of the thorn-like structure may be opposite to the longitudinal direction, that is, the thorn-like structure of the auxiliary fixing portion 123 is in the shape of a barb (eg Figures 1 to 4 As shown in FIG. 1 ), the barbed thorn structure can effectively increase the contact area and friction with the target tissue. Moreover, such a design can also help reduce resistance during implantation, so that the flexible neural electrode can be firmly fixed to the target tissue position, so that the flexible neural electrode can smoothly and conveniently reach the target tissue.

[0051] Exemplarily, the length of the thorn-like structure of the auxiliary fixing portion 123 can be 0.1 mm to 5 mm, which can be inserted into the tissue of the target area, thereby increasing the fixation effect of the flexible neural electrode after implantation. It should be noted that the range of the length of the thorn-like structure of the auxiliary fixing portion 123 can be adjusted in time according to actual conditions, and this application does not make specific limitations.

[0052] Exemplarily, the hollow structure of the auxiliary fixing part 123 enhances the embedding effect of the tissue and the flexible neural electrode. The number of auxiliary fixing parts 123 can be 1 to 100, and the diameter of each hollow structural unit ranges from 0.1 mm to 10 mm. It should be noted that the range of the number of auxiliary fixing parts 123 can be adjusted in time according to actual conditions, and this application does not make specific restrictions. The range of the diameter of each hollow structural unit can also be adjusted in time according to actual conditions, and this application does not make specific restrictions.

[0053] In one embodiment, Figure 1 As shown, the flexible nerve electrode 1 is designed with two fixing holes (i.e., a first fixing hole 121 and a second fixing hole 122) on its proximal lead connection part 12 to define the spiral structure of the flexible nerve electrode. The two fixing holes are located on the lead connection part 12, 3 cm to 4 cm apart. During the implantation process, the flexible nerve electrode 1 is spirally wound around the outer side of the sleeve 21 of the traction member 2 to form a spiral segment with a deformation margin. The total length of the spiral segment is about 3 cm to 4 cm (i.e., the first length) when not coiled. The two fixing holes of the lead connection part 12 of the flexible nerve electrode 1 cooperate with the two fixing structures on the auxiliary implantation needle 22, so that the flexible nerve electrode spiral segment is fixed and compressed to a length of about 1 cm (i.e., the second length). The two fixing structures of the auxiliary implantation needle 22 cooperate with the two limiting openings on the side wall of the sleeve 21 to keep the spiral structure stable during the implantation process of the target tissue. The distal electrode part 13 of the flexible nerve electrode remains in a straightened state without a spiral, so as to facilitate stable application of electrical stimulation or recording in the target target area.

[0054] In another embodiment, the flexible nerve electrode 1 is designed without an auxiliary fixing portion, and a spiral structure is directly constructed on the lead connection portion 12 of the flexible nerve electrode 1. In this embodiment, the lead connection portion 12 at the proximal end of the flexible nerve electrode is designed with two fixing holes, and the distance between the two fixing holes is 4 cm to 5 cm, which is used to define the position of the spiral segment. The total length of the flexible nerve electrode before the spiral is formed is 4 cm to 5 cm (i.e., the first length), and is compressed to a length of about 2 cm (i.e., the second length) after the spiral is formed. The two fixing structures on the auxiliary implant needle 22 are used in conjunction with the two limiting openings on the side wall of the sleeve 21 to ensure the positioning of the flexible nerve electrode in the spiral segment. The distal electrode portion 13 of the flexible nerve electrode of this design is also kept in a straightened state without a spiral to provide a stable electrical stimulation or signal recording function after implantation.

[0055] The first length and the second length in the above embodiments are only examples and may be set to other length values ​​according to actual needs, which are not limited in this application.

[0056] Through these embodiments, the present application demonstrates the various effects of different spiral segment lengths, auxiliary fixation designs, and fixation structures on the stability of flexible neural electrodes, enabling flexible neural electrodes to be flexibly adapted to a variety of application scenarios and ensuring the mechanical stability and electrical performance of flexible neural electrodes in complex physiological environments.

[0057] During the implementation of the present application, in order to ensure that the flexible neural electrode 1 remains stably within the target area, the removal of the auxiliary implant needle 22 is designed to be carried out in stages, gradually releasing the physical connection between the auxiliary implant needle and the flexible neural electrode 1, and finally completing the stable implantation of the flexible neural electrode.

[0058] In some embodiments, when the proximal end of the auxiliary implant needle 22 is subjected to a force in a direction opposite to the longitudinal direction, the first fixing structure 224 is driven to disengage from the first fixing hole 121, the second fixing structure 225 is driven to disengage from the second fixing hole 122, and the traction portion 221 is driven to disengage from the auxiliary implant portion 14.

[0059] In the embodiment of the present application, after the implantation is completed, the auxiliary implant needle 22 is separated from the auxiliary implant part 14 of the flexible neural electrode 1 by applying a force toward the proximal end of the auxiliary implant needle 22, and then the auxiliary implant needle 22 is separated from the first fixing hole 121 and the second fixing hole 122 of the flexible neural electrode 1 in sequence by gradually withdrawing. Of course, it is also possible that after the implantation is completed, the auxiliary implant needle 22 is separated from the first fixing hole 121 and the second fixing hole 122 of the flexible neural electrode 1 in sequence by applying a force toward the proximal end of the auxiliary implant needle 22, and then the auxiliary implant needle 22 is separated from the auxiliary implant part 14 of the flexible neural electrode 1 by withdrawing, and finally the flexible neural electrode 1 is stably implanted into the target tissue. The order of separating the auxiliary implant needle 22 from the fixing hole of the flexible neural electrode 1 and the auxiliary implant needle 22 from the auxiliary implant part 14 is determined according to the pre-set mechanical structure of the flexible neural electrode assembly. This application does not make specific limitations here.

[0060] In some embodiments, when the length of the first fixing structure 224 and the second fixing structure 225 of the auxiliary implant needle 22 is greater than a preset length, and the proximal end of the auxiliary implant needle 22 is subjected to a force in a direction opposite to the longitudinal direction, the traction part 221 is driven to separate from the auxiliary implant part 14 first, and then the first fixing structure 224 is separated from the first fixing hole 121 and the second fixing structure 225 is separated from the second fixing hole 122.

[0061] In some embodiments, the proximal side of the auxiliary implant needle 22 is provided with a first mark and a second mark in sequence from near to far in the longitudinal direction; wherein the proximal side of the auxiliary implant needle 22 is a portion of the auxiliary implant needle close to the proximal end of the auxiliary implant needle 22, such as Figure 2 shown.

[0062] When the traction portion 221 is first separated from the auxiliary implant portion 14, the first mark is exposed; When the first fixing structure 224 is separated from the first fixing hole 121 and the second fixing structure 225 is separated from the second fixing hole 122 , the second mark is exposed.

[0063] That is, when the pre-set first mark is exposed, it indicates that the traction part 221 and the auxiliary implant part 14 have been detached; when the pre-set second mark is exposed, it indicates that the first fixing structure 224 and the first fixing hole 121 have been detached and the second fixing structure 225 and the second fixing hole 122 have been detached.

[0064] It should be noted that when the traction portion 221 is separated from the auxiliary implant portion 14, the first fixing structure 224 is separated from the first fixing hole 121, and the second fixing structure 225 is separated from the second fixing hole 122, the position of the sleeve 21 is fixed and unchanged. Only when the force is continuously applied to the proximal end of the auxiliary implant needle 22, the sleeve 21 is separated from the flexible neural electrode 1 (such as Figure 4 (d)), thereby keeping the flexible neural electrode in the target area.

[0065] In other embodiments, when the length of the first fixed structure 224 and the second fixed structure 225 of the auxiliary implant needle 22 is not greater than the preset length, and the proximal end of the auxiliary implant needle 22 is subjected to a force in a direction opposite to the implantation direction, the first fixed structure 224 and the first fixed hole 121 and the second fixed structure 225 and the second fixed hole 122 are first separated, and then the traction part 221 is separated from the auxiliary implant part 14.

[0066] In some embodiments, see Figure 4 , Figure 4 (a) is a schematic diagram of applying force to the proximal end of the auxiliary implant needle to separate the traction part from the flexible neural electrode; Figure 4 (b) Schematic diagram of applying a force to the proximal end of the auxiliary implant needle and first separating the fixing structure of the auxiliary implant needle from the fixing hole of the flexible neural electrode; Figure 4 (c) A schematic diagram of the traction portion of the auxiliary implant needle and the auxiliary implant portion of the flexible nerve electrode being separated after the force is continuously applied to the proximal end of the auxiliary implant needle; Figure 4 (d) Schematic diagram of the cannula being detached from the flexible nerve electrode to continue applying force to the proximal end of the auxiliary implant needle.

[0067] The proximal side of the auxiliary implant needle 22 is provided with a third mark and a fourth mark in sequence from near to far in the longitudinal direction; wherein the proximal side of the auxiliary implant needle 22 is a part of the auxiliary implant needle close to the proximal end of the auxiliary implant needle 22, such as Figure 2 shown.

[0068] When the first fixing structure 224 is separated from the first fixing hole 121 and the second fixing structure 225 is separated from the second fixing hole 122, the third mark is exposed; When the traction portion 221 and the auxiliary implant portion 14 are separated first, the fourth mark is exposed.

[0069] That is, when the preset third mark is exposed, it indicates that the first fixing structure 224 is separated from the first fixing hole 121 and the second fixing structure 225 is separated from the second fixing hole 122 .

[0070] When the preset fourth mark is exposed, it indicates that the traction part 221 and the auxiliary implant part 14 have been separated.

[0071] It should be noted that when the traction portion 221 is separated from the auxiliary implant portion 14, the first fixing structure 224 is separated from the first fixing hole 121, and the second fixing structure 225 is separated from the second fixing hole 122, the position of the sleeve 21 is fixed and unchanged. Only when the force is continuously applied to the proximal end of the auxiliary implant needle 22, the sleeve 21 is separated from the flexible neural electrode 1 (such as Figure 4 (d)).

[0072] Optionally, if the length of the first fixing structure 224 is smaller than the length of the second fixing structure 225 , the first fixing structure 224 is firstly disengaged from the first fixing hole 121 , and then the second fixing structure 225 is disengaged from the second fixing hole 122 .

[0073] 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 firstly disengaged from the second fixing hole 122 , and then the first fixing structure 224 is disengaged from the first fixing hole 121 .

[0074] In a 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 sequence from proximal to distal in the longitudinal direction.

[0075] First, when the auxiliary implant needle 22 is pulled away in the direction opposite to the longitudinal direction and the first mark disposed on the proximal side of the auxiliary implant needle 22 is exposed, the traction portion of the auxiliary implant needle 22 is separated from the auxiliary implant portion of the flexible nerve electrode 1, and the initial connection between the auxiliary implant needle and the flexible nerve electrode is released, so that the flexible nerve electrode can maintain basic positioning in the target area. The purpose of this separation is to allow the flexible nerve electrode to remain in a stable state in the target tissue, while providing preparation for the subsequent separation process from the first fixing hole and the second fixing hole.

[0076] Next, the auxiliary implant needle 22 continues to move in the direction opposite to the longitudinal direction until the second mark set on the proximal side of the auxiliary implant needle 22 is exposed. At this time, the first fixing structure 224 of the auxiliary implant needle 22 is separated from the first fixing hole 121 of the flexible nerve electrode 1, further releasing part of the spiral structure of the flexible nerve electrode, so that the stability of the flexible nerve electrode in the target tissue is further improved. This separation process ensures that the part of the spiral segment of the flexible nerve electrode can maintain a predetermined shape without external interference, so as to alleviate the stress caused by tissue activity.

[0077] Next, the auxiliary implant needle 22 continues to move in the direction opposite to the longitudinal direction until the third mark disposed on the proximal side of the auxiliary implant needle 22 is exposed. At this time, the second fixing structure 225 of the auxiliary implant needle 22 is disengaged from the second fixing hole 122 of the flexible neural electrode 1. At this time, the auxiliary implant needle 22 is completely disengaged from the flexible neural electrode 1, so that the flexible neural electrode 1 reaches the final fixed state in the target tissue. In this state, the spiral structure of the flexible neural electrode 1 is completely released and can adapt to the movement of the surrounding tissue without displacement, thereby ensuring a long-term stable implantation effect.

[0078] Then, after the auxiliary implant needle 22 is completely separated from the flexible nerve electrode 1, the sleeve 21 can be further withdrawn in the direction opposite to the longitudinal direction to complete the complete removal of the traction member 2. At this time, the flexible nerve electrode 1 is stably fixed in the target area, and its spiral segment still maintains an appropriate amount of deformation margin to adapt to the micro-movement in the target tissue, reducing the risk of displacement or material fatigue caused by stress concentration after implantation.

[0079] This multi-stage detachment design gradually reduces the connection strength between the flexible nerve electrode 1 and the traction member 2, allowing the flexible nerve electrode to be gradually released during the implantation process to achieve a safe and precise implantation operation and maintain the structural integrity and stability of the flexible nerve electrode after complete implantation.

[0080] 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; 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; 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 first sub-fixing structure, the first sub-limiting opening and the first sub-fixing hole correspond to each other one by one; The second sub-fixing structure, the second sub-limiting opening and the second sub-fixing hole correspond to each other one by one.

[0081] In this embodiment, by providing multiple sub-fixing structures, multiple sub-limiting openings, and multiple sub-fixing holes, a more uniform fixing effect and step-by-step release control can be provided according to the structural requirements of the flexible neural electrode and the specific requirements of the implantation position.

[0082] In this embodiment, when the auxiliary implant needle is withdrawn in the direction opposite to the longitudinal direction, the connection with the auxiliary implant part is first released; as the auxiliary implant needle continues to be withdrawn, the connection with the first fixing hole is gradually released. The first fixing hole may include a plurality of first sub-fixing holes, which are distributed at different positions of the lead connection part to further improve the stability of the spiral segment. The plurality of first sub-fixing holes work together to further ensure the maintenance of the spiral structure of the flexible neural electrode during the implantation process.

[0083] As the auxiliary implant needle continues to be withdrawn, the multiple sub-fixation holes of the second fixing hole gradually separate from the auxiliary implant needle, so that the spiral segment of the flexible neural electrode is fully unfolded in the final position. At this time, the distribution position of the second fixing hole is farther than the first fixing hole, so that the implanted flexible neural electrode maintains the best stability and stress dispersion effect in the target area.

[0084] In addition, in specific 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 implant needle can be gradually detached from more sub-fixation holes to achieve precise control of the spiral flexible neural electrode structure. Each detachment operation will ensure a smooth transition of the flexible neural electrode during implantation while minimizing the stress impact on the flexible neural electrode.

[0085] The first fixing structure and the second fixing structure of the auxiliary implant needle of the present application are thorn-like structures, which extend in a direction away from the auxiliary implant needle and are inclined relative to the proximal and / or distal directions of the auxiliary implant needle. When the auxiliary implant needle is pulled out in a direction opposite to the longitudinal direction, the limiting opening of the thorn-like structure on the side wall of the sleeve retracts into the interior of the sleeve under the applied force, thereby achieving separation from the first fixing hole and the second fixing hole of the flexible neural electrode. This design ensures the stability of the flexible neural electrode during the implantation process, while simplifying the removal operation of the traction member.

[0086] In the method of withdrawing the auxiliary implant needle in the embodiment of the present application, when the length of the first fixing structure and the second fixing structure of the auxiliary implant needle is not greater than the preset length, it can be understood that when the interaction length between the fixing structure of the auxiliary implant needle and the fixing hole of the flexible nerve electrode is short, the proximal end of the auxiliary implant needle, under the condition of being subjected to a force in a direction opposite to the implantation direction, drives the first fixing structure and the first fixing hole and the second fixing structure and the second fixing hole to separate first, and then the traction part separates from the auxiliary implant part.

[0087] In the case where the length of the first fixing structure and the second fixing structure of the auxiliary implant needle is greater than the preset length, it can be understood that when the interaction length between the fixing structure of the auxiliary implant needle and the fixing hole of the flexible neural electrode is longer, the proximal end of the auxiliary implant needle, under the condition of being subjected to a force in the direction opposite to the implantation direction, drives the traction part and the auxiliary implant part to separate first, and then the first fixing structure separates from the first fixing hole and the second fixing structure separates from the second fixing hole. The order in which the auxiliary implant needle separates from the fixing hole of the flexible neural electrode and the auxiliary implant needle separates from the auxiliary implant part is determined according to the pre-set mechanical structure of the flexible neural electrode assembly. This flexible design is suitable for different types of implantation requirements and can optimize the order and stability of the release of the flexible neural electrode according to the structural length of the traction member.

[0088] Furthermore, when the third mark of the auxiliary implant needle is exposed, its flexible fixing structure is separated from the fixing hole of the flexible neural electrode, so that the spiral section of the flexible neural electrode is gradually released; the auxiliary implant needle is continued to be withdrawn, and when the fourth mark is exposed, the auxiliary implant needle is completely separated from the auxiliary implant part of the flexible neural electrode. In this process, the flexible retraction ability of the fixing structure of the auxiliary implant needle ensures the smoothness of the auxiliary implant needle withdrawal process and avoids damage to the flexible neural electrode or surrounding tissues due to excessive mechanical force.

[0089] Finally, after the auxiliary implant needle is completely separated from the flexible nerve electrode, the cannula can be further pulled out to complete the removal of the traction member. At this time, the spiral structure of the flexible nerve electrode is completely released and stably fixed in the target area. The thorn-like fixing structure of the auxiliary implant needle and the spiral shape of the flexible nerve electrode itself work together to further improve the mechanical stability and long-term reliability after implantation.

[0090] The design of multiple fixing holes in the auxiliary implant needle ensures the stability of the flexible neural electrode at different implant depths by gradually detaching, and enables the flexible neural electrode to maintain the desired spiral shape after reaching the target position. In actual operation, the design can also flexibly adjust the number and distribution of fixing holes according to the physiological characteristics of different tissue areas, thereby achieving the best implant stability effect, further enhancing the long-term reliability and adaptability of the flexible neural electrode.

[0091] The flexible neural electrode assembly provided by the embodiment of the present application has the advantages of strong stress dispersion and high stability after implantation, and has broad application potential in the fields of neural stimulation, neural recording, pain relief and treatment of related neurological diseases.

[0092] Based on the same inventive concept, the present application embodiment provides a method for preparing a flexible neural electrode 1, which is applied to a flexible neural electrode 1 of a flexible neural electrode assembly as provided in any of the above embodiments, see Figure 5As shown, the preparation method of the flexible neural electrode 1 includes: S101, preparing a sacrificial layer on a carrier; S102, forming a first flexible insulating layer on a side of the sacrificial layer away from the carrier; S103, defining the pattern of the contact points and electrode sites on the first surface by using a photolithography process, and removing the first flexible insulating layer in the corresponding area by using an etching process to obtain a hollow area of ​​the contact points and electrode sites on the first surface; S104, forming a metal conductive layer on a side of the first flexible insulating layer away from the carrier, and forming contacts and electrode sites located on the first surface in the hollow area; S105, forming a second flexible insulating layer on a side of the metal conductive layer away from the carrier; S106, defining the pattern of the contacts and electrode sites on the second surface by using a photolithography and / or hard mask coating process, and removing the second flexible insulating layer in the corresponding area by using an etching process to obtain the contacts and electrode sites on the second surface, and defining the pattern of the auxiliary implant part by using a photolithography process, and removing the first flexible insulating layer and the second flexible insulating layer in the corresponding area by using an etching process to obtain the auxiliary implant part; S107, removing the sacrificial layer through an etching process to release the flexible neural electrode; S108, forming a first fixing hole and a second fixing hole on the first flexible insulating layer and the second flexible insulating layer of the lead connecting part 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 connecting part.

[0093] In some embodiments, see Figure 3 The metal conductive layer includes a first metal conductive layer 127 arranged in contact with the first flexible insulating layer 124 and a second metal conductive layer 128 arranged in contact with the second flexible insulating layer 125. The lead connecting portion 12 also has a third flexible insulating layer 126 along its thickness direction. The third flexible insulating layer 126 is arranged between the first metal conductive layer 127 and the second metal conductive layer 128.

[0094] In some embodiments, there are multiple first metal conductive layers 127, the multiple first metal conductive layers 127 are arranged in parallel, and a fourth flexible insulating layer 129 is arranged between adjacent first metal conductive layers 127; and / or, there are multiple second metal conductive layers 128, the multiple second metal conductive layers 128 are arranged in parallel, and a fourth flexible insulating layer 129 is arranged between adjacent second metal conductive layers 128.

[0095] Specifically, the preparation method of the flexible neural electrode includes the following steps: first, a sacrificial layer is formed on a carrier by photolithography and coating; then, a first flexible insulating layer is spin-coated and baked on one side of the carrier where the sacrificial layer is formed; then, a pattern of electrode sites and contacts located on the first surface is defined on the first flexible insulating layer by photolithography, and the first flexible insulating layer in the corresponding area is removed by etching to form a hollow area of ​​electrode sites and contacts located on the first surface; then, a metal conductive layer is deposited on the side of the first flexible insulating layer away from the carrier by photolithography and coating, and contacts and electrode sites located on the first surface are formed in the hollow area, 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, a pattern of electrode sites and contacts located on the second surface is defined by photolithography, and the second flexible insulating layer in the corresponding area is removed by etching to form electrode sites and contacts located on the second surface. In addition, the overall outline of the flexible neural electrode and the pattern of the auxiliary implantation part are further defined on the second flexible insulating layer by photolithography, and the first flexible insulating layer and the second flexible insulating layer in the corresponding area are removed by etching process, thereby forming a complete flexible neural electrode outline and auxiliary implantation part. Then, the sacrificial layer is removed by wet etching process to release the flexible neural electrode. Finally, the first fixing hole and the second fixing hole are formed on the first flexible insulating layer and the second flexible insulating layer of the lead connection part 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 part.

[0096] 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 contour of the flexible neural electrode and other components, thereby improving production efficiency and reducing manufacturing complexity.

[0097] In some embodiments, the second flexible insulating layer can be patterned using photolithography and hard mask coating techniques. The use of hard masks can further improve pattern accuracy, especially in the production of key components such as electrode sites and auxiliary implants of flexible neural electrodes, ensuring high accuracy and reliability of each functional component.

[0098] In the preparation method of the flexible neural electrode, the processing accuracy is further improved by introducing hard mask technology. Specifically, in the process of forming the first flexible insulating layer and the second flexible insulating layer, the hard mask coating technology is used to ensure that the pattern of the electrode sites and contacts of the flexible neural electrode is more accurate. The introduction of this step makes the manufacturing process of the flexible neural electrode more concise and efficient, while also reducing the quality problems caused by inaccurate masks. In particular, in the production of key functional components of flexible neural electrodes (such as electrode sites), the processing accuracy is further improved through photolithography and hard mask coating technology. The application of hard masks can ensure that the edges of the components are clear and the shapes are precise, which is particularly suitable for flexible neural electrode components that require complex structures.

[0099] 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: Flexible neural electrodes and traction devices; The flexible neural electrode comprises a proximal contact portion, a lead 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 connection portion is provided with a first fixing hole and a second fixing hole; The traction member includes a sleeve and an auxiliary implantation needle; the side wall of the sleeve 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 interior of the sleeve is a cavity, and the auxiliary implantation needle is inserted into the interior of the sleeve; The first fixing structure of the auxiliary implant needle is engaged with the first fixing hole through the first limiting opening, and the second fixing structure of the auxiliary implant needle is engaged with the second fixing hole through the second limiting opening; The flexible neural electrode is spirally wound around the outer surface of the sleeve between the first fixing structure and the second fixing structure.

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 to each other one by one; The second sub-fixing structure, the second sub-limiting opening and the second sub-fixing hole correspond to each other one by one.

3. The flexible neural electrode assembly according to claim 1, characterized in that: The materials of the first fixing structure and the second fixing structure are flexible materials; the flexible materials include a combination of at least one or more of polyparaxylene, 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 thorn-shaped structures; The thorn-like structure extends in a direction away from the auxiliary implantation needle; The thorn-like structure is arranged obliquely relative to the auxiliary implant needle toward the proximal end of the auxiliary implant needle or the distal end of the auxiliary implant needle; The proximal end of the auxiliary implantation needle and the distal end of the auxiliary implantation needle are arranged opposite to each other.

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

6. The flexible neural electrode assembly according to claim 5, characterized in that: The auxiliary implantation portion includes an auxiliary implantation hole; The diameter of the traction opening of the sleeve 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 portion, which passes through the traction opening of the sleeve and comes out from the auxiliary implantation hole of the auxiliary implantation portion.

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 a direction opposite to the longitudinal direction, the first fixing structure is driven to separate from the first fixing hole, the second fixing structure is driven to separate from the second fixing hole, and the traction part is driven to separate from the auxiliary implantation part.

9. The flexible neural electrode assembly according to claim 8, characterized in that: When the lengths of the first fixing structure and the second fixing structure of the auxiliary implant needle are greater than the preset lengths, and the proximal end of the auxiliary implant needle is subjected to a force in a direction opposite to the longitudinal direction, the traction part and the auxiliary implant part are driven to separate first, and then the first fixing structure separates from the first fixing hole and the second fixing structure separates 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 provided with a first mark and a second mark in sequence from proximal to distal in the longitudinal direction; When the traction part and the auxiliary implant part are separated first, the first mark is exposed; When the first fixing structure is detached from the first fixing hole and the second fixing structure is detached from the second fixing hole, the second mark is exposed.

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

12. The flexible neural electrode assembly according to claim 11, characterized in that: The proximal side of the auxiliary implantation needle is provided with a third mark and a fourth mark in sequence from proximal to distal in the longitudinal direction; When the first fixing structure is detached from the first fixing hole and the second fixing structure is detached from the second fixing hole, the third mark is exposed; When the traction portion and the auxiliary implant portion are separated first, the fourth mark is exposed.

13. The flexible neural electrode assembly according to claim 1, characterized in that: The shape of the flexible neural electrode between the first fixing hole and the second fixing hole is a spiral shape; The length of the lead connection portion between the first fixing hole and the second fixing hole is a first length; The length between the first fixed structure and the second fixed structure is a second length; The first length is greater than the second length.

14. The flexible neural electrode assembly according to claim 13, characterized in that: The lead connection portion is also provided with an auxiliary fixing portion; the auxiliary fixing portion has a thorn-like 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 portion is located between the distal electrode portion and the first fixing hole; and / or, The auxiliary fixing portion is located on the proximal side of the second fixing hole.

15. A method for preparing a flexible neural electrode, characterized in that: A flexible neural electrode used in a flexible neural electrode assembly as claimed in any one of claims 1 to 14, wherein the preparation method comprises: preparing a sacrificial layer on the carrier; forming a first flexible insulating layer on a side of the sacrificial layer away from the carrier; Defining the pattern of the contact points and the electrode sites on the first surface by using a photolithography process, and removing the first flexible insulating layer in the corresponding area by using an etching process to obtain a hollow area of ​​the contact points and the electrode sites on the first surface; forming a metal conductive layer on a side of the first flexible insulating layer away from the carrier, and forming the contact points and the electrode sites located on the first surface in the hollow area; forming a second flexible insulating layer on a side of the metal conductive layer away from the carrier; Defining the pattern of the contact points and the electrode sites on the second surface by using a photolithography and / or hard mask coating process, and removing the second flexible insulating layer in the corresponding area by using an etching process to obtain the contact points and the electrode sites on the second surface, and defining the pattern of the auxiliary implant part by using a photolithography process, and removing the first flexible insulating layer and the second flexible insulating layer in the corresponding area by using an etching process to obtain the auxiliary implant part; Removing the sacrificial layer through an etching process to release the flexible neural electrode; The first fixing hole and the second fixing hole are formed on the first flexible insulating layer and the second flexible insulating layer of the lead connecting part of the flexible nerve electrode, and the metal conductive layer is not arranged at the first fixing hole and the second fixing hole in the thickness direction of the lead connecting part.

16. The method for preparing a flexible neural electrode according to claim 15, characterized in that: The metal conductive layer includes a first metal conductive layer arranged in contact with the first flexible insulating layer and a second metal conductive layer arranged in contact with the second flexible insulating layer. The lead connecting portion also has a third flexible insulating layer along its thickness direction, and the third flexible insulating layer is arranged between the first metal conductive layer and the second metal conductive layer.

17. The method for preparing a flexible neural electrode according to claim 16, characterized in that: There are multiple first metal conductive layers, the multiple first metal conductive layers are arranged in parallel, and a fourth flexible insulating layer is arranged between adjacent first metal conductive layers; and / or there are multiple second metal conductive layers, the multiple second metal conductive layers are arranged in parallel, and the fourth flexible insulating layer is arranged between adjacent second metal conductive layers.

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