A linear flexible electrode for peripheral nerves and a manufacturing method thereof

Abstract

The present disclosure relates to a linear flexible electrode for peripheral nerves and a manufacturing method thereof. A linear flexible electrode for peripheral nerves is provided, the flexible electrode comprising an implantation portion and a fixing portion, at least a portion of the implantation portion being capable of being implanted into a peripheral nerve bundle, the fixing portion being configured to fix the flexible electrode to a muscle surrounding the peripheral nerve bundle, wherein: the flexible electrode comprises a first insulating layer and a second insulating layer and a wire layer located between the first insulating layer and the second insulating layer; and the implantation portion comprises one or more electrode sites, each electrode site being electrically coupled to one of the wires in the wire layer, and contacting the peripheral nerve after the flexible electrode is implanted into the peripheral nerve bundle, so as to collect electrical signals from the peripheral nerve and transmit the collected electrical signals through the wire, or apply the electrical signals received through the wire to the peripheral nerve.

Description

Technical Field

[0001] The present disclosure relates to the field of life science technology, and more specifically to a linear flexible electrode for peripheral nerves and a manufacturing method thereof. Background Art

[0002] The peripheral nervous system (PNS) is derived from the central nervous system and directed to various parts of the human body. It can be divided into the somatic nervous system and the autonomic nervous system. The peripheral nervous system is responsible for communicating with various parts of the body and plays the role of transmitting and receiving information. Studies have shown that electrical stimulation can promote the regeneration of axons and functional rehabilitation of peripheral nerve injuries, and can also relieve neuropathic pain. Peripheral nerve stimulation (PNS) can apply low-level electrical pulses to painful nerves, thereby producing pain interference. The stimulation of these non-pain sensory pathways seems to attenuate input from nearby pain pathways. PNS can be applied with superficial electrodes, such as for the sciatic nerve to treat leg pain. As an alternative, subcutaneous electrodes can be placed in the general area of ​​pain, such as low back pain. PNS has been used for a wide range of pain conditions, including complex regional pain syndrome, diabetic peripheral neuropathy, ilioinguinal neuralgia, intercostal neuralgia, lateral femoral cutaneous neuropathy (meralgia paresthesia), low back pain, neck pain, nerve injury, peripheral neuropathy, post-amputation stump pain, postherpetic neuralgia, post-hernia surgery pain, post-thoracotomy syndrome, trigeminal neuralgia, and other types of pain.

[0003] Common neural electrodes currently include extra-fascicular neural electrodes implanted outside the nerve bundle and intra-fascicular neural electrodes implanted inside the nerve bundle. Extra-fascicular neural electrodes are wrapped around the outside of the peripheral nerve bundle when used. Commonly used extra-fascicular electrodes such as Cuff electrodes and FINE electrodes are assembled on the inner wall of a silicone hose or a flat catheter when used, and then the silicone hose or flat catheter is wrapped around the outside of the nerve bundle.

[0004] Linear intrafascicular electrodes arrange the electrode recording ends on a long strip base and insert the base into the nerve bundle when used. Summary of the invention

[0005] A brief overview of the disclosure is given below in order to provide a basic understanding of some aspects of the disclosure. However, it should be understood that this overview is not an exhaustive overview of the disclosure. It is not intended to identify the key or important parts of the disclosure, nor is it intended to limit the scope of the disclosure. Its purpose is simply to give some concepts of the disclosure in a simplified form as a prelude to a more detailed description given later.

[0006] According to a first aspect of the present disclosure, a linear flexible electrode for peripheral nerves is provided, the flexible electrode comprising an implantation part and a fixing part, at least a part of the implantation part being capable of being implanted into a peripheral nerve bundle, the fixing part being configured to fix the flexible electrode to the peripheral nerve bundle or other tissues near the peripheral nerve bundle, wherein: the flexible electrode comprises a first insulating layer and a second insulating layer and a wire layer located between the first insulating layer and the second insulating layer; and the implantation part comprises one or more electrode sites, each electrode site being electrically coupled to one of the wires in the wire layer, and contacting the peripheral nerve after the flexible electrode is implanted into the peripheral nerve bundle, so as to collect electrical signals from the peripheral nerve and transmit the collected electrical signals through the wires, or apply the electrical signals received through the wires to the peripheral nerves.

[0007] According to a second aspect of the present disclosure, a method for manufacturing a linear flexible electrode for peripheral nerves is provided, wherein the flexible electrode is the flexible electrode according to the first aspect of the present disclosure, and the method comprises: manufacturing a first insulating layer, a wire layer, a second insulating layer and an electrode site on a substrate; and separating the flexible electrode from the substrate; wherein a through hole is manufactured at a position corresponding to the electrode site in at least one of the first insulating layer and the second insulating layer by patterning.

[0008] Other features and advantages of the present disclosure will become more apparent from the following detailed description of exemplary embodiments of the present disclosure with reference to the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0009] The accompanying drawings, which constitute a part of the specification, illustrate embodiments of the present disclosure and, together with the description, serve to explain the principles of the present disclosure.

[0010] The present disclosure may be more clearly understood from the following detailed description with reference to the accompanying drawings, in which:

[0011] Figure 1 A schematic diagram showing at least a portion of a linear flexible electrode for peripheral nerves according to an embodiment of the present disclosure;

[0012] Figure 2 A schematic diagram showing an implantation position of a linear flexible electrode for peripheral nerves according to an embodiment of the present disclosure;

[0013] Figure 3 An exploded view of at least a portion of a linear flexible electrode for peripheral nerves according to an embodiment of the present disclosure is shown;

[0014] Figure 4 A flow chart showing a method for manufacturing a linear flexible electrode for peripheral nerves according to an embodiment of the present disclosure;

[0015] Figure 5 A schematic diagram showing a method for manufacturing a linear flexible electrode for peripheral nerves according to an embodiment of the present disclosure is shown. DETAILED DESCRIPTION

[0016] The following detailed description is made with reference to the accompanying drawings, and the following detailed description is provided to assist in a comprehensive understanding of the various exemplary embodiments of the present disclosure. The following description includes various details to assist in understanding, but these details are considered to be examples only and not to limit the present disclosure, which is defined by the appended claims and their equivalents. The words and phrases used in the following description are only used to enable a clear and consistent understanding of the present disclosure. In addition, for the sake of clarity and brevity, descriptions of well-known structures, functions, and configurations may be omitted. Those of ordinary skill in the art will recognize that various changes and modifications may be made to the examples described herein without departing from the spirit and scope of the present disclosure.

[0017] The following description of at least one exemplary embodiment is in fact merely illustrative and is in no way intended to limit the present disclosure and its application or use. That is, the structures and methods herein are shown in an exemplary manner to illustrate different embodiments of the structures and methods in the present disclosure. However, those skilled in the art will appreciate that they merely illustrate exemplary ways of the present disclosure that can be implemented, rather than exhaustive ways. In addition, the drawings need not be drawn to scale, and some features may be enlarged to illustrate the details of specific components.

[0018] Technologies, methods, and apparatus known to ordinary technicians in the relevant field may not be discussed in detail, but where appropriate, such technologies, methods, and apparatus should be considered part of the authorization specification.

[0019] In all examples shown and discussed herein, any specific values ​​should be interpreted as merely exemplary and not as limiting. Therefore, other examples of the exemplary embodiments may have different values.

[0020] When in use, the silicone hose wrapped around the outside of the nerve of the extrafascicular nerve electrode may be displaced relative to the nerve bundle. On the other hand, the resolution of the signal sensed by the extrafascicular nerve electrode is low due to its implantation position. During long-term use, the friction between the hard catheter of the extrafascicular nerve electrode and the nerve bundle will cause nerve damage, and the scar formed on the nerve will affect the sensing and stimulation of the signal. In terms of sensing signals, the extrafascicular nerve electrode can only sense compound action potential signals or perform large-scale nerve stimulation. The sensing and stimulation accuracy is far from meeting the needs of fine control.

[0021] Intrafascicular neural interfaces can build a window for peripheral nerves to interact with the outside world through electrodes. On the one hand, electrodes can collect neural information (e.g., electrical signals from peripheral nerves) for controlling external devices, and on the other hand, they can feed back external information to peripheral nerves through stimulation (e.g., electrical stimulation to be applied to peripheral nerves). Currently, intrafascicular neural interface technology is increasingly being used as an auxiliary technology to help restore or enhance cognitive and sensorimotor functions impaired by disease or trauma, especially for the rehabilitation of people with severe neuromuscular disabilities.

[0022] Existing rigid intrafascicular neural electrodes will cause severe long-term immune responses after implantation due to the mismatch in mechanical properties between the rigid electrodes and the soft neural tissue, which results in the inability of the electrodes to perform long-term stable signal sensing and stimulation.

[0023] The present disclosure provides a flexible electrode for sensing and stimulating electrophysiological signals of the peripheral nervous system. The flexible electrode has a linear structure and can be used for both collecting electrical signals of the peripheral nerves and applying functional electrical stimulation to the peripheral nerves after being implanted in the nerve bundle. By reducing the thickness of the electrode, the bending stiffness of the electrode can be reduced, thereby improving the problem of mechanical property mismatch between the electrode and the peripheral nerve tissue, and providing a long-term stable electrical signal sensing and stimulation interface. And by proportionally increasing or reducing the size of the electrode plate, the electrode array can be made suitable for different human bodies or other vertebrates. Compared with the extra-fascicular nerve electrode that can only record local field potential signals, the flexible electrode disclosed in the present disclosure can simultaneously record action potentials and local field potential signals. Electrodes with different numbers of layers, different numbers of contacts, different sizes and shapes, and contact distributions can be designed according to different needs, which are of great significance in the research of neuroscience and the application of rehabilitation medicine.

[0024] Figure 1 FIG. 2 shows an exploded view of at least a portion of a linear flexible electrode 100 for peripheral nerves according to an embodiment of the present disclosure. Figure 1 As shown, the flexible electrode 100 may include a linear implant portion 110, at least a portion of which can be implanted inside a peripheral nerve bundle, so that the neural electrical signals within the peripheral nerve bundle and the deep and surface of the peripheral nerve bundle can be sensed and stimulated at the same time. Specifically, the implant portion 110 can be implanted perpendicular to the nerve bundle, implanted parallel to the nerve bundle, or implanted at other angles to the nerve bundle. In an embodiment according to the present disclosure, the flexible electrode 100 may also include a rear end portion 120, which can be implanted subcutaneously and can be used to join the flexible electrode 100 and the rear end circuit for rear end switching. The implant portion 110 extends from the rear end portion 120, and the flexible electrode 100 may also include a connecting portion 130 located between the implant portion 110 and the rear end portion 120.

[0025] After implantation, the flexible electrodes for peripheral nerves are in an in vivo environment that is subject to long-term movement and change. Limb movement, external force, and the like may cause relative displacement between the flexible electrode and the nerve bundle. In the present disclosure, the flexible electrode cannot generate a force to counteract the relative displacement through its own deformation due to its inherent flexibility. In order to counteract this relative displacement and ensure that the flexible electrode can accurately sense the electrical signals at the same position of the peripheral nerve and apply electrical stimulation at the same position of the peripheral nerve after implantation, the flexible electrode 100 may further include a fixing portion 140, which may be configured to fix the flexible electrode 100 to the peripheral nerve bundle or other tissues near the peripheral nerve bundle (such as but not limited to muscles, bones, and the like near the peripheral nerve bundle). Figure 1 As shown, the fixing portion 140 may include a hole in the flexible electrode 100, through which a fixing device (such as a surgical thread, etc.) can pass and be attached to the peripheral nerve bundle or other tissue near the peripheral nerve bundle to reliably fix the flexible electrode 100. In an embodiment according to the present disclosure, the fixing portion 140 may be thicker than other portions of the flexible electrode 100 (such as the implant portion 110, the rear end portion 120, the connecting portion 130, etc.) to provide higher mechanical strength. Figure 1 In the embodiment shown in FIG. 1 , the flexible electrode 100 includes a pair of fixing portions 140 located on both sides of the rear end portion 120 and a pair of fixing portions 140 located on both sides of the connecting portion 130. However, it should be understood that the flexible electrode according to the present disclosure is not limited thereto, but may include more or fewer fixing portions. For example, the flexible electrode 100 may not include a pair of fixing portions 140 located on both sides of the connecting portion 130. For example, the flexible electrode 100 includes multiple pairs of fixing portions 140 located on both sides of the rear end portion 120.

[0026] In an embodiment according to the present disclosure, the implantation part 110 may also have a mounting hole (not shown), through which the electrode implantation device can be attached to the flexible electrode 100 and drive the flexible electrode 100 through the mounting hole during implantation, thereby guiding the flexible electrode 100 to complete the implantation process.

[0027] Figure 1 The flexible electrode 100 shown in FIG. 1 includes an implantation portion 110 having an elongated needle shape, a linear rear end portion 120 and a connection portion 130, and a semi-annular fixing portion 140, but it should be understood that Figure 1 The illustration is merely a non-limiting example, and the flexible electrode for peripheral nerve bundles may have an implant portion 110 , a rear end portion 120 , a connection portion 130 , and a fixing portion 140 of different shapes and sizes as required.

[0028] Figure 2FIG. 1 is a schematic diagram showing the implantation position of a linear flexible electrode for peripheral nerves according to an embodiment of the present disclosure. Figure 2 As shown, at least a portion of the implantable portion of the flexible electrode is implanted inside the vagus nerve, and a surgical thread passing through the hole of the fixed portion of the flexible electrode is sutured to the muscle tissue around the vagus nerve to fix the flexible electrode to the muscle tissue.

[0029] Figure 3 FIG. 2 shows an exploded view of at least a portion of a linear flexible electrode 300 for peripheral nerves according to an embodiment of the present disclosure. Figure 3 It can be clearly seen that the flexible electrode 300 is a multi-layer structure, specifically, including a bottom insulating layer 301, a top insulating layer 302, a wire layer 303, an electrode site layer 304, a rear site layer 306, a flexible separation layer 308, etc. It should be understood that Figure 3 The various layers of the flexible electrode 300 shown in the figure are merely non-limiting examples, and the flexible electrode in the present disclosure may omit one or more layers thereof, for example, may include only a bottom insulating layer, a top insulating layer and a wire layer, or may include more other layers.

[0030] The flexible electrode 300 may include an insulating layer 301 at the bottom and an insulating layer 302 at the top. Figure 3 As shown, the implantation part 310, the rear end part 320, the connection part 330 and the fixing part 340 of the flexible electrode 300 may all include insulating layers 301 and 302. The insulating layer in the flexible electrode may refer to the outer surface layer in the electrode that plays an insulating role. Since the insulating layer of the flexible electrode needs to contact the peripheral nerve after implantation, the material of the insulating layer is required to have good insulation and good biocompatibility. In the embodiment of the present disclosure, the materials of the insulating layers 301 and 302 may include polyimide (PI), polydimethylsiloxane (PDMS), polyparaxylene (Parylene), epoxy resin, polyamideimide (PAI), SU-8 photoresist, silicone, silicone rubber, etc. In the embodiment according to the present disclosure, in order to make the flexible electrode further have biodegradable properties, the materials of the insulating layers 301 and 302 may also include polylactic acid, polylactic acid-glycolic acid copolymer, etc. In addition, the insulating layers 301 and 302 are also the main parts that provide strength in the flexible electrode 300. If the insulating layer is too thin, the strength of the electrode will be reduced, and if the insulating layer is too thick, the flexibility of the electrode will be reduced. In addition, the implantation of an electrode including an overly thick insulating layer will cause greater damage to the organism. In an embodiment according to the present disclosure, the thickness of the insulating layers 301 and 302 may be 100 nm to 300 μm, preferably 300 nm to 20 μm.

[0031] The flexible electrode 300 may further include one or more wires spaced apart from each other in a wire layer 303 between the bottom insulating layer 301 and the top insulating layer 302. Figure 3 As shown, the implantation part 310, the rear end part 320 and the connection part 330 of the flexible electrode 300 may all include a wire layer 303. In an embodiment according to the present disclosure, each wire in the wire layer 303 may extend to the implantation part 310 along the rear end part 320 and the connection part 330, and extend to the electrode site located in the implantation part 310 in the implantation part 310. In an embodiment according to the present disclosure, the flexible electrode 300 may include one or more wires in the same wire layer 303, wherein each wire may be electrically coupled to an electrode site in the electrode site layer 304 and electrically coupled to a rear end site in the rear end site layer 306. In an embodiment according to the present disclosure, the thickness of the wire layer 303 and each wire therein may be 5nm to 200μm. The spacing between each wire may be as low as 10nm, for example. The line width of the wire and the spacing between each wire may be, for example, 10nm to 500μm, for example, preferably 300nm to 3μm. It should be understood that the size of the wire, etc. is not limited to the range listed above, but may vary according to design requirements.

[0032] In an embodiment according to the present disclosure, the wire in the wire layer 303 may be a thin film structure including multiple layers stacked in the thickness direction. The materials of these layers may be materials that can enhance the wire's adhesion, ductility, conductivity, etc. As a non-limiting example, the wire layer 303 may be a metal film including three layers stacked, wherein the first layer and the second layer that are in contact with the insulating layers 301 and 302, respectively, are adhesion layers, which may be metal adhesion materials or non-metal adhesion materials such as titanium (Ti), titanium nitride (TiN), chromium (Cr), tantalum (Ta) or tantalum nitride (TaN), and the third layer between the first layer and the second layer is a conductive layer, which may be gold (Au), platinum (Pt), iridium (Ir), tungsten (W), platinum-iridium alloy, titanium alloy, graphite, carbon nanotubes, PEDOT, etc., which have good conductivity. In an embodiment according to the present disclosure, in order to make the flexible electrode further have biodegradable properties, the conductive layer may also be made of materials such as magnesium (Mg), molybdenum (Mo) and their alloys. It should be understood that the wire layer can be made of other conductive metal materials or non-metal materials, or can be made of polymer conductive materials and composite conductive materials. In the embodiment according to the present disclosure, the thickness of the adhesion layer can be 1 nm to 50 nm.

[0033] The flexible electrode 300 may also include one or more electrode sites in the top electrode site layer 304, each electrode site is electrically coupled to one of the wires in the wire layer 303, and contacts the peripheral nerves after the flexible electrode 300 is implanted to collect electrical signals from the peripheral nerves and transmit the collected electrical signals through the wires, or apply the electrical signals received through the wires to the peripheral nerves. Figure 3 In the flexible electrode 300 shown in FIG, the electrode sites in the implanted portion 110 that are located on the surface of the peripheral nerve after implantation can be used to apply or collect electrical signals on the surface of the peripheral nerve, and the electrode sites that are located inside the peripheral nerve after implantation can be used to apply or collect electrical signals inside the peripheral nerve. In addition, since each electrode site is coupled to its corresponding wire, when the flexible electrode 300 is used as a stimulation electrode, each electrode site can synchronously or asynchronously apply the same or different electrical signals at different locations deep and / or on the surface of the peripheral nerve; and when the flexible electrode 300 is used as a sensing electrode, these electrode sites can simultaneously and finely collect electrical signals at different locations deep and / or on the surface of the peripheral nerve.

[0034] The electrode sites in the top electrode site layer 304 can be electrically coupled to the corresponding wires in the wire layer through the through holes at the positions corresponding to the electrode sites in the top insulating layer 302. In the case where the flexible electrode includes multiple wires, the flexible electrode can correspondingly include multiple electrode sites in the top electrode site layer 304, and each of these electrode sites is electrically coupled to one of the multiple wires through the corresponding through holes in the top insulating layer 302. In an embodiment according to the present disclosure, the electrode sites in the top electrode site layer 304 can be a thin film structure including multiple layered layers stacked in the thickness direction. The material of the adhesion layer close to the wire layer 303 in the multiple layers can be a material that can enhance the adhesion of the electrode site to the wire, and the thickness of the adhesion layer can be 1nm to 50nm. As a non-limiting example, the electrode site layer 304 can be a metal film including two superimposed layers, wherein the first layer close to the wire layer 303 is Ti, TiN, Cr, Ta or TaN, and the second layer of the electrode site layer 304 exposed to the outside is Au. It should be understood that the electrode site layer can also be similar to the wire layer and made of other conductive metal materials or non-metallic materials, such as Pt, Ir, W, Mg, Mo, platinum-iridium alloy, titanium alloy, graphite, carbon nanotubes, PEDOT, etc.

[0035] Each electrode site may have a planar size of micrometers and a thickness of nanometers. In the embodiments according to the present disclosure, the shape of the electrode site may be set to various regular or irregular shapes as needed, the number may be one or more, the maximum side length or diameter may be 1 μm to 500 μm, the spacing between each electrode site may be 1 μm to 5 mm, and the thickness may be 5 nm to 200 μm. It should be understood that the shape, number, size, spacing, etc. of the electrode site may be selected according to the situation of the peripheral nerve area to be sensed or stimulated.

[0036] In an embodiment according to the present disclosure, the surface of the electrode site that is exposed to the outside and in contact with the surrounding nerve tissue may also have a surface modification layer to improve the electrochemical properties of the electrode site. As a non-limiting example, the surface modification layer may be obtained by using an electro-induced polymerization coating of PEDOT:PSS, a sputtered iridium oxide film, and the like, and is used to reduce impedance (such as electrochemical impedance at a working frequency of 1kHz) when the flexible electrode collects electrical signals, and to improve charge injection capability when the flexible electrode applies electrical signal stimulation, thereby improving interaction efficiency.

[0037] exist Figure 3In the embodiment shown in , the top electrode site layer 304 is located above the top insulating layer 302. It should be understood that the electrode site layer 304 can be located outside at least one of the bottom insulating layer 301 and the top insulating layer 302, so that the electrode site is located on the outer surface of the flexible electrode 300 to facilitate contact with the nerve bundle. For example, in an embodiment according to the present disclosure, the flexible electrode may also include an electrode site in a bottom electrode site layer 305 located below the bottom insulating layer 301. After the flexible electrode is implanted, the electrode site in the bottom electrode site layer 305 may contact the surrounding nerve tissue to directly collect or apply electrical signals. Similar to the electrode site in the top electrode site layer 304, in the flexible electrode 300, the electrode site in the bottom electrode site layer 305 can be electrically coupled to the corresponding wire in the wire layer through a through hole at a position corresponding to the electrode site in the bottom insulating layer 301. In an embodiment according to the present disclosure, the electrode sites in the bottom electrode site layer 305 may be located at relative positions on both the top and bottom sides of the flexible electrode 300 as the electrode sites in the top electrode site layer 304, and electrically coupled to the same wire in the wire layer 303 as the electrode sites in the top electrode site layer 304 located at relative positions. In an embodiment according to the present disclosure, the electrode sites in the bottom electrode site layer 305 may also be located at different positions on both the top and bottom sides of the flexible electrode 300 as the electrode sites in the top electrode site layer 304, so as to collect or apply electrical signals in different areas of the peripheral nerve; and in an embodiment according to the present disclosure, the electrode sites in the bottom electrode site layer 305 may also be electrically coupled to wires in the wire layer 303 that are different from the electrode sites in the top electrode site layer 304.

[0038] It should be understood that the bottom electrode site layer 305 is an optional but not necessary part of the flexible electrode. For example, the flexible electrode in the present disclosure may only include the top electrode site layer 304 but not the bottom electrode site layer 305. The shape, size, material, etc. of the bottom electrode site may be similar to that of the top electrode site and will not be described in detail here.

[0039] By including an electrode site layer different from the wire layer 303 in the flexible electrode 300, that is, separating the electrode sites and the wires in the flexible electrode 300 in different layers, the size of the electrode can be advantageously reduced to provide a more integrated electrode. However, in an embodiment according to the present disclosure, a separate electrode site layer may not be included. In this case, the electrode sites and the wires of the flexible electrode may both be located in the wire layer, and the electrode sites are exposed to the outer surface of the flexible electrode through the through holes in at least one of the bottom insulating layer and the top insulating layer, so that the electrode sites can be in direct contact with the surrounding nerve tissue.

[0040] In an embodiment of the present disclosure, the flexible electrode may further include an additional wire layer, that is, the flexible electrode in the present disclosure may include one or more wire layers. The size, material, manufacturing method, etc. of the additional wire layer may be similar to the wire layer 303, and will not be described in detail here. In the case where the flexible electrode includes an additional wire layer, these wire layers may be spaced apart by an additional insulating layer, and each wire layer includes a plurality of wires spaced apart from each other. The size, material, and manufacturing method of the additional insulating layer may be similar to the bottom insulating layer 301 and / or the top insulating layer 302, and will not be described in detail here. One or more wires in these additional wire layers may be electrically coupled to an electrode site located below the bottom insulating layer or above the top insulating layer through a through hole in one or more layers of the bottom insulating layer, the top insulating layer, and the additional insulating layer. By including multiple wire layers in the flexible electrode, the number and accuracy of signals transmitted through the flexible electrode can be increased under the same cross-sectional width, that is, a high-precision and multi-channel electrode is provided, which is conducive to achieving high-throughput interaction.

[0041] In an embodiment according to the present disclosure, the rear end portion 320 of the flexible electrode 300 may include a rear end site in the rear end site layer 306, and the rear end site may be electrically coupled to one of the wires ( Figure 3 Each back-end site in the back-end site layer 306 is electrically coupled to a metal ring at the end of one of the wires in the wire layer 303) and is exposed to the outer surface of the flexible electrode through a through hole in at least one of the bottom insulating layer 301 and the top insulating layer 302, so that when the back-end portion is connected to the back-end circuit, bidirectional signal transmission between the electrode site electrically coupled to the wire and the back-end circuit can be achieved. In an embodiment according to the present disclosure, the back-end site can be located between at least one of the top insulating layer and the bottom insulating layer and the wire layer, and exposed through a through hole in the other of the top insulating layer and the bottom insulating layer. For example, Figure 3As shown, the rear end site is located between the wire layer 303 and the bottom insulating layer 301, and the rear end site can be electrically coupled to the rear end circuit through the metal ring of the wire layer 303 and the through hole in the top insulating layer 302. This arrangement does not place the rear end site on the outer surface of the flexible electrode 300, which is conducive to the stable connection between the flexible electrode 300 and the rear end circuit. Here, the rear end circuit may refer to a circuit at the rear end of the flexible electrode, such as a signal recording circuit, a signal processing circuit, a signal generating circuit, etc. associated with the signal of the flexible electrode. In an embodiment according to the present disclosure, the flexible electrode can be coupled to the rear end circuit in a connection manner. Specifically, the ball grid array (BGA) packaging site as the rear end site can be transferred to a commercial signal recording system through a printed circuit board (PCB), a flexible printed circuit (FPC), etc., and the connection method includes ball implantation patch and anisotropic conductive film bonding (ACF Bonding), etc. After the flexible electrode is made, the flexible electrode can be separated from the substrate on which it is made (such as by removing its flexible separation layer), and then the flexible electrode can be connected (for example, welded) to the back-end circuit. In an embodiment according to the present disclosure, the flexible electrode and the back-end circuit connected to the back-end portion can be encapsulated together by any one of epoxy resin and polydimethylsiloxane or a combination thereof to improve their strength. In an embodiment according to the present disclosure, the gap between the back-end portion and the back-end circuit is coated with a high-viscosity waterproof glue to ensure the waterproofness of the connection between the flexible electrode and the back-end circuit after implantation.

[0042] The back-end site may have a planar size of micrometer level and a thickness of nanometer level. As a non-limiting example, the back-end site may be a BGA package site with a diameter of 50 μm to 2000 μm, or may be a circular, elliptical, rectangular, rounded rectangular, chamfered rectangular site with a side length of 50 μm to 2000 μm, and the back-end site layer 306 and the back-end sites therein may have a thickness of 5nm to 200 μm. It should be understood that the shape, size, etc. of the back-end site are not limited to the ranges listed above, but may vary according to design requirements.

[0043] The back-end site in a connected manner may include multiple layers in the thickness direction, the material of the adhesion layer close to the wire layer 303 in the multiple layers may be a material that can enhance the adhesion between the electrode site and the wire, the material of the soldering layer in the middle of the multiple layers may be a soldering material, the conductive layer in the multiple layers may be other metal materials or non-metal materials with conductivity as described above for the wire layer, and the outermost layer in the multiple layers that may be exposed through the insulating layers 301 and 302 is a protective layer for oxidation prevention. As a non-limiting example, the back-end site layer 306 may be a metal film including three superimposed layers, wherein the first layer close to the wire layer 303 may be a nano-scale adhesion layer to improve the adhesion between the back-end site layer 306 and the wire layer 303, the second layer as the soldering layer may be nickel (Ni), Pt or palladium (Pd), and the third layer as the conductive layer may be Au, Pt, Ir, W, Mg, Mo, platinum-iridium alloy, titanium alloy, graphite, carbon nanotubes, PEDOT, etc. It should be understood that the back-end site layer may also be made of other metal materials or non-metal materials with conductivity. Figure 3 The back-end site layer 306 is the part connected to the back-end processing system or chip, and the size, spacing, shape, etc. of its sites can be changed and designed according to different connection methods of the back-end.

[0044] In an embodiment according to the present disclosure, the flexible electrode 300 and the rear end circuit connected to the rear end portion 320 can be packaged together by any one of epoxy resin and polydimethylsiloxane or a combination thereof to improve their strength. After packaging, the flexible electrode 300 can be immersed in a biocompatible adhesive (such as but not limited to low modulus silicone) to play a waterproof role. After the flexible electrode 300 is coated with the biocompatible adhesive, the flexible electrode 300 can be implanted.

[0045] In an embodiment according to the present disclosure, the flexible electrode may not include a rear end site layer. In this case, the rear end site for switching in the rear end portion of the flexible electrode may be a portion in the wire layer, electrically coupled to the corresponding wire in the wire layer, and exposed to the outer surface of the electrode through a corresponding through hole in at least one of the top insulating layer and the bottom insulating layer.

[0046] In an embodiment according to the present disclosure, the flexible electrode 300 may further include a flexible separation layer 308 . Figure 3The flexible separation layer 308 of the flexible electrode 300 in the figure is shown as being located at the bottom layer of the entire flexible electrode, i.e., but it should be understood that the position of the flexible separation layer is not limited thereto, and the flexible electrode may include one or more flexible separation layers located at different positions. Preferably, the flexible separation layer can be manufactured between the substrate and the bottom insulating layer. The flexible separation layer can be made of a material that can be removed by a specific substance (such as a solution) to separate the two parts of the flexible electrode above and below the flexible separation layer while avoiding damage to the flexible electrode. Specifically, the flexible separation layer can be used to separate the entire electrode or only the flexible part of the electrode from the substrate, to separate the flexible substrate from the hard substrate, to separate the part with too strong adhesion that needs to be separated, etc. In an embodiment of the present disclosure, the material of the flexible separation layer can be a metal or non-metallic material such as Ni, Cr, aluminum (Al), etc.

[0047] Figure 4 4 shows a flow chart of a method 400 for manufacturing a flexible electrode according to an embodiment of the present disclosure. In the present disclosure, a manufacturing method based on a micro-electro mechanical system (MEMS) process can be adopted to manufacture a nano-scale flexible electrode. Figure 4 As shown, method 400 may include: at S41, manufacturing a first insulating layer, a wire layer, and a second insulating layer on a substrate, wherein a through hole is manufactured at a position corresponding to the electrode site of at least one of the first insulating layer and the second insulating layer by patterning; and at S42, separating the flexible electrode from the substrate. Figure 5 The steps of manufacturing each layer of the flexible electrode at S41 are described in detail.

[0048] Figure 5 FIG. 5 is a schematic diagram of a method 500 for manufacturing a flexible electrode according to an embodiment of the present disclosure. Figure 5 The manufacturing process and structure of the flexible separation layer, bottom insulating layer, wire layer, top insulating layer, electrode site layer and other parts of the flexible electrode are described in more detail.

[0049] Figure 5 The view (A) shows the substrate of the electrode. In the embodiment according to the present disclosure, a hard substrate such as glass, quartz, silicon wafer, etc. can be used. In the embodiment of the present disclosure, other soft materials can also be used as the substrate, such as the same material as the insulating layer.

[0050] Figure 5 The view (B) shows the step of manufacturing a flexible separation layer on the substrate. The flexible separation layer can be removed by applying a specific substance, thereby facilitating the separation of the flexible part of the electrode from the hard substrate. Figure 5The embodiment shown in uses Ni as the material of the flexible separation layer, and other materials such as Cr and Al may also be used. In an embodiment according to the present disclosure, when manufacturing a flexible separation layer on a substrate by evaporation, a portion of the exposed substrate may be etched first, thereby improving the flatness of the entire substrate after evaporation. It should be understood that the flexible separation layer is an optional but not necessary part of the flexible electrode. Depending on the characteristics of the selected material, the flexible electrode can also be conveniently separated without a flexible separation layer. In an embodiment according to the present disclosure, the flexible separation layer may also have a mark, which can be used for alignment of subsequent layers.

[0051] Figure 5 View (C) shows the manufacture of the bottom insulating layer on top of the flexible separation layer. As a non-limiting example, in the case where the insulating layer is made of polyimide material, the manufacture of the bottom insulating layer may include steps such as film forming process, film curing and enhanced curing to manufacture a thin film as the insulating layer. The film forming process may include coating polyimide on the flexible separation layer, such as spin coating a layer of polyimide at a segmented speed. Film curing may include gradually heating to a higher temperature and keeping the temperature to form a film, so as to perform subsequent processing steps. Enhanced curing may include multi-gradient temperature increases before manufacturing subsequent layers, preferably heating in a vacuum or nitrogen atmosphere, and baking for several hours. It should be understood that the above-mentioned manufacturing process is only a non-limiting example of the manufacturing process of the bottom insulating layer, and one or more steps may be omitted, or more other steps may be included.

[0052] It should be noted that the above manufacturing process is directed to an embodiment of manufacturing a bottom insulating layer in a flexible electrode without a bottom electrode site layer and the bottom insulating layer does not have a through hole corresponding to the electrode site. If the flexible electrode includes a bottom electrode site layer, the bottom electrode site layer can be manufactured on the flexible separation layer before manufacturing the bottom insulating layer. For example, Au and Ti can be sequentially evaporated on the flexible separation layer. The patterning step of the bottom electrode site will be described in detail later with respect to the top electrode site. Accordingly, in the case where the flexible electrode includes a bottom electrode site, in the process of manufacturing the bottom insulating layer, in addition to the above steps, a patterning step can also be included for etching a through hole at a position corresponding to the bottom electrode site in the bottom insulating layer. The patterning step of the insulating layer will be described in detail later with respect to the top insulating layer.

[0053] Figure 5Views (D) to (G) show the manufacture of a conductor layer on the bottom insulating layer. As shown in view (D), a photoresist and a mask can be applied on top of the bottom insulating layer. It should be understood that other photolithography methods can also be used to prepare patterned films, such as laser direct writing and electron beam lithography. In an embodiment according to the present disclosure, for a metal film such as a conductor layer, a double layer of glue can be applied to facilitate the manufacture (evaporation or sputtering) and peeling of the patterned film. By setting the pattern of the mask associated with the conductor layer, for example, the pattern of the conductor layer described above can be achieved, such as, Figure 3 The pattern of the conductor layer 303 can be obtained. Then, exposure and development can be performed to obtain the structure shown in view (E). In an embodiment according to the present disclosure, the exposure can be carried out by contact lithography, and the mask and the structure are exposed in a vacuum contact mode. In an embodiment according to the present disclosure, different developers and their concentrations can be used for graphics of different sizes. In an embodiment according to the present disclosure, this step can also include alignment between layers. Then, film formation can be performed on the structure shown in view (E), such as by using processes such as evaporation and sputtering to deposit metal film materials, such as Au, to obtain a structure shown in view (F). Then, stripping can be performed to separate the film in the non-patterned area from the film in the patterned area by removing the photoresist in the non-patterned area, to obtain the structure shown in view (G), that is, the conductor layer is manufactured. In an embodiment according to the present disclosure, after stripping, stripping can be performed again to further remove the residual glue on the surface of the structure.

[0054] In the embodiment according to the present disclosure, before manufacturing the wire layer, a back-end site layer may also be manufactured. As a non-limiting example, the manufacturing process of the back-end site layer may be similar to the manufacturing process of the metal film described above with respect to the wire layer.

[0055] Figure 5Views (H) to (K) show the manufacture of the top insulating layer. For photosensitive films, patterning can generally be achieved directly through patterned exposure and development, while for non-photosensitive materials used in the insulating layer, patterning cannot be achieved by exposing and developing them themselves. Therefore, a sufficiently thick patterned anti-etching layer can be manufactured on the layer, and then the film in the area not covered by the anti-etching layer is removed by dry etching (the anti-etching layer will also become thinner, so it is necessary to ensure that the anti-etching layer is thick enough), and then the anti-etching layer is removed to achieve the patterning of the non-photosensitive layer. As a non-limiting example, the manufacture of the insulating layer can use photoresist as the anti-etching layer. The manufacture of the top insulating layer can include the steps of film forming process, film forming and curing, patterning, enhanced curing, etc., wherein view (H) shows the structure obtained after the top insulating layer is formed, view (I) shows the application of photoresist and mask on the top insulating layer after film formation, view (J) shows the structure of the anti-etching layer obtained after exposure and development, and view (K) shows the structure of the prepared top insulating layer. The film forming process, film curing and enhanced curing have been described in detail in the previous article about the bottom insulating layer, and are omitted here for the sake of brevity. The patterning step can be performed after film curing or after enhanced curing. After enhanced curing, the insulating layer has a stronger etching resistance. Specifically, in view (I), a sufficiently thick layer of photoresist is manufactured on the insulating layer through steps such as coating and baking. By setting the pattern of the mask related to the top insulating layer, for example, Figure 3 The pattern of the top insulating layer 302 shown in FIG. 3 , that is, the contours of the implanted portion 310, the rear end portion 320, the connecting portion 330 and the fixing portion 340 of the flexible electrode 300 and the contours of the through holes realized at positions corresponding to the electrode sites and the rear end sites in the top insulating layer 302. In view (J), the pattern is transferred to the photoresist on the insulating layer through exposure, development and other steps to obtain an etch-resistant layer, wherein the portion to be removed from the top insulating layer is exposed. The exposed portion of the top insulating layer can be removed by oxygen plasma etching, and after flood exposure, the remaining photoresist on the top insulating layer is removed with a developer or acetone to obtain the structure shown in view (K).

[0056] In an embodiment according to the present disclosure, the top insulating layer may be subjected to an adhesion enhancement treatment before being manufactured to improve the bonding force between the bottom insulating layer and the top insulating layer.

[0057] Figure 5 View (L) shows the fabrication of a top electrode site layer above the top insulating layer.

[0058] In the embodiment of the present disclosure, in the process of manufacturing the flexible electrode, in order to make the thickness of the fixed part of the flexible electrode greater than the thickness of other parts of the flexible electrode, the top insulating layer and / or the bottom insulating layer of the fixed part can be made thicker than the top insulating layer and / or the bottom insulating layer of other parts of the flexible electrode. Specifically, for example, in the case where the top insulating layer of the fixed part needs to be made thicker than the top insulating layer of other parts, before manufacturing the top electrode site layer (such as, Figure 5 After view (K) in the figure and before view (L) in the figure), a portion of the thickness of the insulating layer of the flexible electrode other than the fixed portion can be removed. This can be achieved by the following steps (not shown): applying a layer of photoresist and a mask to protect the fixed portion on the top insulating layer of the structure shown in view (K); transferring the pattern to the photoresist on the top insulating layer through exposure, development and other steps to obtain an anti-etching layer, wherein the portion to be removed from the top insulating layer is exposed; removing the anti-etching layer and a portion of the thickness of the top insulating layer other than the fixed portion that is exposed through etching. Since this method requires the removal of part of the top insulating layer, in order to ensure that the top insulating layer of the flexible electrode still has a normal thickness to ensure the strength of the flexible electrode, when manufacturing the top insulating layer (such as, Figure 5 (H) in FIG. 1 ), the top insulating layer can be made thicker than the top insulating layer in a conventional case (ie, without making the fixed portion thicker than other portions).

[0059] The present disclosure provides a linear flexible electrode for peripheral nerves and a method for manufacturing the same. The flexible electrode uses a flexible material to replace a hard silicon-based electrode, uses a high molecular polymer as an insulating layer to wrap a conductive material, and reduces the thickness of the electrode to reduce its bending stiffness so as to improve the mechanical property mismatch between the electrode and the tissue, and ultimately provide a long-term stable electrical signal sensing and stimulation interface. The flexible electrode adopts a linear design and can be implanted in a peripheral nerve bundle and directly contact a single nerve axon, so it has a much higher selectivity and number of channels than an extra-bundle nerve electrode. This electrode has the characteristics of less trauma and is suitable for use in some minimally invasive scenarios to achieve good peripheral nerve signal sensing and stimulation functions.

[0060] The words "front", "rear", "top", "bottom", "above", "below", etc., if present, in the specification and claims are used for descriptive purposes and are not necessarily used to describe invariant relative positions. It should be understood that the words so used are interchangeable under appropriate circumstances, such that the embodiments of the disclosure described herein, for example, are capable of operation in other orientations than those illustrated or otherwise described herein.

[0061] As used herein, the word "exemplary" means "serving as an example, instance, or illustration," rather than as a "model" to be exactly copied. Any implementation described as an example herein is not necessarily to be construed as preferred or advantageous over other implementations. Furthermore, the present disclosure is not limited by any expressed or implied theory given in the above technical field, background technology, summary of the invention, or detailed description.

[0062] As used herein, the term "substantially" is intended to include any minor variations due to design or manufacturing imperfections, device or component tolerances, environmental influences, and / or other factors. The term "substantially" also allows for deviations from a perfect or ideal situation due to parasitic effects, noise, and other practical considerations that may exist in actual implementations.

[0063] The terms "first", "second" and the like may be used herein for reference purposes only and are not intended to be limiting. For example, the terms "first", "second" and other such numerical terms referring to structures or elements do not imply a sequence or order unless the context clearly indicates otherwise.

[0064] It should also be understood that when the term “include / comprises” is used in this document, it indicates the presence of the specified features, integers, steps, operations, units and / or components, but does not exclude the presence or addition of one or more other features, integers, steps, operations, units and / or components and / or their combinations.

[0065] As used herein, the term "and / or" includes any and all combinations of one or more of the associated listed items. The terms used herein are for the purpose of describing specific embodiments only and are not intended to limit the present disclosure. As used herein, the singular forms "a", "an", and "the" are also intended to include the plural forms, unless the context clearly indicates otherwise.

[0066] Those skilled in the art will appreciate that the boundaries between the above operations are merely illustrative. Multiple operations may be combined into a single operation, a single operation may be distributed in additional operations, and operations may be performed at least partially overlapping in time. Moreover, alternative embodiments may include multiple instances of a particular operation, and the order of operations may be changed in other various embodiments. However, other modifications, variations, and replacements are equally possible. Therefore, this specification and accompanying drawings should be considered illustrative, not restrictive.

[0067] Although some specific embodiments of the present disclosure have been described in detail by way of example, it should be understood by those skilled in the art that the above examples are for illustration only and are not intended to limit the scope of the present disclosure. The various embodiments disclosed herein may be combined in any manner without departing from the spirit and scope of the present disclosure. It should also be understood by those skilled in the art that various modifications may be made to the embodiments without departing from the scope and spirit of the present disclosure. The scope of the present disclosure is defined by the appended claims.

Claims

1. A linear flexible electrode for peripheral nerves, the flexible electrode comprising an implantation portion and a fixing portion, at least a portion of the implantation portion being capable of being implanted into a peripheral nerve bundle, the fixing portion being configured to fix the flexible electrode to the peripheral nerve bundle or other tissues near the peripheral nerve bundle, wherein: The flexible electrode comprises a first insulating layer, a second insulating layer and a wire layer located between the first insulating layer and the second insulating layer; as well as The implantable portion includes one or more electrode sites, each of which is electrically coupled to one of the wires in the wire layer and contacts the peripheral nerve after the flexible electrode is implanted in the peripheral nerve bundle, so as to collect electrical signals from the peripheral nerve and transmit the collected electrical signals through the wire, or apply the electrical signals received through the wire to the peripheral nerve. Wherein, the fixing portion comprises a hole in the flexible electrode, and a fixing device can pass through the hole and be attached to the peripheral nerve bundle or the other tissue to fix the flexible electrode to the peripheral nerve bundle or the other tissue.

2. The flexible electrode according to claim 1, wherein: The flexible electrode includes a plurality of wire layers, the plurality of wire layers are separated by additional insulating layers, and each wire layer includes a plurality of wires separated from each other.

3. The flexible electrode according to claim 1 or 2, wherein: The other tissues include muscles or bones near the peripheral nerve bundles.

4. The flexible electrode according to claim 1 or 2, wherein: The fixing portion is thicker than other portions of the flexible electrode to provide higher mechanical strength.

5. The flexible electrode according to claim 1 or 2, wherein: The electrode sites are located outside at least one of the first insulating layer and the second insulating layer, and are electrically coupled to the wires in the wire layer through through holes in the at least one layer.

6. The flexible electrode according to claim 5, wherein: The electrode site includes a conductive layer, and the material of the conductive layer is any one of gold, platinum, iridium, tungsten, magnesium, molybdenum, platinum-iridium alloy, titanium alloy, graphite, carbon nanotube, PEDOT or a combination thereof.

7. The flexible electrode according to claim 6, wherein: The electrode site further includes an adhesion layer adjacent to the wire layer, wherein the adhesion layer is made of a material capable of enhancing adhesion between the electrode site and the wire layer.

8. The flexible electrode according to claim 1 or 2, wherein: The electrode sites are located in the conductive line layer and exposed through through holes in at least one of the first insulating layer and the second insulating layer.

9. The flexible electrode according to claim 1 or 2, wherein: The shape of the electrode sites is set as required, and the number is one or more. The maximum side length or diameter of the electrode sites is 1 micron to 500 microns, the spacing between each electrode site is 1 micron to 5 millimeters, and the thickness is 5 nanometers to 200 microns.

10. The flexible electrode according to claim 1 or 2, further comprising a rear end portion, wherein the rear end portion is implanted subcutaneously and fixed by the fixing portion, wherein: The back end portion includes a back end site coupled to one of the wires in the wire layer and a back end circuit to achieve bidirectional signal transmission between an electrode site electrically coupled to one of the wires and the back end circuit.

11. The flexible electrode according to claim 10, wherein: The flexible electrode includes a pair of fixing portions located at both sides of the rear end portion.

12. The flexible electrode according to claim 11, wherein: The flexible electrode further includes a pair of fixing portions located at both sides of a connecting portion of the flexible electrode, wherein the connecting portion is a portion of the flexible electrode located between the implanting portion and the rear end portion.

13. The flexible electrode according to claim 10, wherein: The back end site is located in the conductor layer and is exposed through a through hole in at least one of the first insulating layer and the second insulating layer.

14. The flexible electrode according to claim 10, wherein: The rear end site is located between at least one of the first insulating layer and the second insulating layer and the conductor layer, and is exposed through a through hole in the other of the first insulating layer and the second insulating layer.

15. The flexible electrode according to claim 14, wherein: The back-end site includes a conductive layer, and the material of the conductive layer is any one of gold, platinum, iridium, tungsten, magnesium, molybdenum, platinum-iridium alloy, titanium alloy, graphite, carbon nanotubes, PEDOT, or a combination thereof.

16. The flexible electrode according to claim 14, wherein: The thickness of the back end site is 5 nanometers to 200 micrometers.

17. The flexible electrode according to claim 14, wherein: The back-end site also includes an adhesion layer close to the wire layer, and the material of the adhesion layer is any one of chromium, tantalum, tantalum nitride, titanium, titanium nitride, or a combination thereof.

18. The flexible electrode according to claim 10, wherein: The flexible electrode and the rear end circuit connected to the rear end portion are packaged together by any one of epoxy resin and polydimethylsiloxane or a combination thereof.

19. The flexible electrode according to claim 18, wherein: The flexible electrodes are coated with a biocompatible adhesive after packaging.

20. The flexible electrode according to claim 1 or 2, wherein: The conductor layer includes a conductive layer, and the material of the conductive layer is any one of gold, platinum, iridium, tungsten, platinum-iridium alloy, titanium alloy, graphite, carbon nanotube, PEDOT or a combination thereof.

21. The flexible electrode according to claim 20, wherein: The thickness of the conductive layer is 5 nanometers to 200 micrometers.

22. The flexible electrode according to claim 14, wherein: The wire layer includes a conductive layer and an adhesion layer close to any one of the electrode site and the rear end site, and the material of the adhesion layer is any one of chromium, tantalum, tantalum nitride, titanium, titanium nitride, or a combination thereof.

23. The flexible electrode according to claim 1 or 2, wherein: The thickness of the first insulating layer and the second insulating layer is 100 nanometers to 300 micrometers.

24. The flexible electrode according to claim 1 or 2, wherein: The materials of the first insulating layer and the second insulating layer are any one of polyimide, polydimethylsiloxane, polyparaxylene, epoxy resin, polyamide-imide, SU-8 photoresist, silica gel, and silicone rubber, or a combination thereof.

25. The flexible electrode according to claim 1 or 2, further comprising a flexible separation layer, wherein: The flexible separation layer can be removed by a specific substance to separate parts of the flexible electrode and avoid damage to the flexible electrode.

26. The flexible electrode according to claim 25, wherein: The material of the flexible separation layer is any one of nickel, chromium, and aluminum, or a combination thereof.

27. The flexible electrode according to claim 25, wherein: The flexible separation layer further includes an adhesion layer, the material of which is chromium, tantalum, tantalum nitride, titanium or titanium nitride.

28. The flexible electrode according to claim 1 or 2, wherein: The implantation portion includes a mounting hole through which an electrode implantation device is attached to the flexible electrode for implantation.

29. The flexible electrode according to claim 1 or 2, wherein: The material of the wire layer is any one of magnesium, molybdenum and their alloys or a combination thereof, and the material of the first insulating layer and the second insulating layer is any one of polylactic acid and polylactic acid-glycolic acid copolymer or a combination thereof, so that the flexible electrode is biodegradable.

30. The flexible electrode according to claim 1 or 2, wherein: The implantation portion has a mounting hole, and the electrode implantation device is attached to the flexible electrode through the mounting hole for implantation.

31. A method for manufacturing a linear flexible electrode for peripheral nerves, the flexible electrode being the flexible electrode according to any one of claims 1 to 30, the method comprising: fabricating a first insulating layer, a conductive line layer, a second insulating layer, and electrode sites on a substrate; as well as separating the flexible electrode from the substrate; Wherein, through holes are manufactured at positions corresponding to the electrode sites in at least one of the first insulating layer and the second insulating layer by patterning.

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