Mri compatible implantable electrode and method of manufacturing the same

Abstract

This invention relates to the field of medical devices, specifically to an MRI-compatible implantable electrode and its manufacturing method. A base layer and a shielding mesh are disposed on the outer periphery of the catheter. The shielding mesh is formed by patterning a metal layer and is thinner than existing braided shielding sleeves. Along the axial direction of the catheter, the elastic modulus of the shielding mesh is less than that of the base layer, and the elastic limit elongation of the shielding mesh is greater than that of the base layer. The shielding mesh is more flexible than the base layer and can withstand greater stretching and bending. The base layer protects the shielding mesh from external forces, making it less prone to breakage. The elastic modulus of the base layer is less than that of the catheter. Overall, the shielding layer has greater ductility than the catheter, and is more elastic than the catheter.

Description

Technical Field

[0001] This invention relates to the field of medical devices, and more particularly to MRI-compatible implantable electrodes and methods for manufacturing the same. Background Technology

[0002] Currently, magnetic resonance imaging (MRI) technology has significant advantages over other imaging techniques (such as X-rays and CT scans): MRI images are clearer, have high resolution for soft tissues, and do not cause ionizing radiation damage to the human body. Therefore, MRI technology is widely used in clinical diagnosis in modern medicine.

[0003] When an MRI machine is operating, it utilizes a high-intensity, uniform static magnetic field, a gradient magnetic field adjustable to any direction, and a radiofrequency (RF) magnetic field used to excite the nuclear magnetic resonance (MRI) signal. In common MRI setups with a static magnetic field B0 of 1.5T or 3.0T, the RF magnetic field frequencies are approximately 64MHz and 128MHz, respectively. If a patient has implanted medical devices, such as pacemakers, defibrillators, vagus nerve stimulators, spinal cord stimulators, or deep brain stimulators, these three magnetic fields can pose significant risks to the patient's health and safety. For example, during MRI scans, patients with these implanted medical devices may experience severe temperature rises at the points where the slender conductive structures contact the tissue, which can cause serious harm.

[0004] To overcome the above problems, existing technologies involve weaving a metal mesh sleeve onto the outer surface of a slender conductive structure. However, due to the slender nature of the conductive structure, the installation of the metal mesh sleeve is complex and time-consuming. To ensure structural stability during assembly and use, the metal mesh sleeve cannot be made very thin, resulting in poor elasticity and easy breakage, thus significantly increasing the diameter of the slender conductive structure. Summary of the Invention

[0005] In view of this, a first aspect of the present invention provides an MRI-compatible implantable electrode, comprising:

[0006] catheter;

[0007] A shielding layer is disposed on the outer periphery of the conduit, comprising a base layer and a shielding mesh. The shielding mesh is formed by patterning the metal layer disposed on the base layer through etching or laser cutting processes, and the shielding mesh comprises multiple wavy metal mesh wires.

[0008] Along the axial direction of the conduit, the elastic modulus of the shielding mesh, the base layer, and the conduit increase sequentially, while the elastic limit elongation decreases sequentially.

[0009] Preferably, in some embodiments of the present invention, the coverage of the shielding mesh is 80%-95%, and the shielding mesh is in the form of a grid or an axially extending spiral on the conduit.

[0010] Preferably, in some embodiments of the present invention, the thickness of the substrate layer is 5μm-20μm, and the thickness of the shielding mesh is 1μm-10μm.

[0011] Preferably, in some embodiments of the present invention, the shielding layer further includes a thin film layer, the thin film layer covering the shielding mesh, and the thin film layer being bonded to the substrate layer;

[0012] Along the axial direction of the conduit, the elastic modulus of the thin film layer is greater than that of the shielding mesh, and the elastic limit elongation is less than that of the shielding mesh.

[0013] Preferably, in some embodiments of the present invention, the metal layer is made of one or more of the following biocompatible materials: platinum, platinum alloy, iridium, iridium alloy, titanium, titanium alloy, stainless steel, nickel-titanium alloy, and cobalt-based alloy.

[0014] A second aspect of the present invention provides a method for manufacturing an MRI-compatible implantable electrode, comprising:

[0015] S01 provides a catheter;

[0016] S02. A base layer is prepared on the outer periphery of the catheter, wherein the elastic modulus of the base layer is less than that of the catheter.

[0017] S03 deposits a metal layer in the substrate layer;

[0018] S04 The metal layer is patterned to form a shielding mesh, the shielding mesh comprising a plurality of wavy extended metal mesh wires. In the axial direction of the conduit, the elastic modulus of the shielding mesh is less than the elastic modulus of the base layer, and the elastic limit elongation of the shielding mesh is greater than the elastic limit elongation of the base layer.

[0019] S05 prepares a thin film layer to cover the shielding mesh.

[0020] Preferably, in some embodiments of the present invention, S02, which involves preparing a base layer on the peripheral side of the catheter, further includes:

[0021] A shielding area is provided on the outer periphery of the conduit;

[0022] A base layer with a thickness of 5μm-20μm is deposited in the shielded area.

[0023] Preferably, in some embodiments of the present invention, depositing a metal layer on the substrate layer includes:

[0024] A metal layer with a thickness of 1μm-10μm is formed using a vapor deposition process.

[0025] Preferably, in some embodiments of the present invention, S04 patterning the metal layer to form a shielding mesh further includes:

[0026] The metal layer is patterned using etching or laser cutting processes;

[0027] The shielding mesh has a coverage of 80%-95%, and the shielding mesh is in the form of a grid or an axially extending spiral on the duct.

[0028] Preferably, in some embodiments of the present invention, the metal layer is formed by a deposition process from one or more of the following materials that are biocompatible: platinum, platinum alloys, iridium, iridium alloys, titanium, titanium alloys, stainless steel, nickel-titanium alloys, and cobalt-based alloys.

[0029] The beneficial effects of this invention include:

[0030] This invention provides an MRI-compatible implantable electrode and its manufacturing method. A base layer and a shielding mesh are disposed on the outer periphery of the catheter of the implantable electrode. The shielding mesh is formed by patterning a metal layer, which simplifies the processing of the shielding mesh and allows for a very small metal layer thickness. The shielding mesh is thinner than existing woven mesh sleeves. In the axial direction of the catheter, the elastic modulus of the shielding mesh is less than that of the base layer, and the elastic limit elongation of the shielding mesh is greater than that of the base layer. The shielding mesh is more flexible than the base layer and can withstand greater tension and bending without breaking. The base layer protects the shielding mesh and withstands more external forces. The elastic modulus of the base layer is less than that of the catheter, making the shielding layer more ductile than the catheter. Attached Figure Description

[0031] The above and other objects, features and advantages of the present invention will become clearer from the following description of embodiments of the invention with reference to the accompanying drawings, in which:

[0032] Figure 1 This is a schematic diagram of the electrode wires in an embodiment of the present invention.

[0033] Figure 2 This is a schematic diagram of the extension wire in an embodiment of the present invention.

[0034] Figure 3 This is a schematic diagram of the shielding layer in an embodiment of the present invention.

[0035] Figure 4 This is a partial schematic diagram of the spiral shielding mesh in an embodiment of the present invention.

[0036] Figure 5 This is a partial schematic diagram of two different forms of shielding mesh in an embodiment of the present invention.

[0037] Figure 6 This is a partial schematic diagram of the mesh-like shielding net in an embodiment of the present invention.

[0038] Figure 7-10 This is a schematic diagram of the shielding layer processing flow in an embodiment of the present invention.

[0039] Explanation of reference numerals in the attached figures:

[0040] 100 - Electrode lead; 110 - Connector; 120 - Connector; 130 - Stimulation end; 140 - Contact; 150 - Catheter; 160 - Shielding layer;

[0041] 161 - Base layer; 162 - Metal layer; 163, 163A, 163B, 163C, 163D - Shielding mesh; 164 - Thin film layer;

[0042] 200 - Extension wire; 210 - Connector; Detailed Implementation

[0043] The present invention is described below based on embodiments, but the invention is not limited to these embodiments. In the detailed description of the invention below, certain specific details are described in detail. Those skilled in the art will fully understand the invention even without these details. To avoid obscuring the essence of the invention, well-known methods, processes, flows, elements, and circuits are not described in detail.

[0044] Furthermore, those skilled in the art should understand that the accompanying drawings provided herein are for illustrative purposes and are not necessarily drawn to scale. Unless the context explicitly requires it, the terms "comprising," "including," and similar terms throughout the application should be interpreted as encompassing rather than exclusive or exhaustive; that is, meaning "including but not limited to." In the description of this invention, it should be understood that the terms "first," "second," etc., are used for descriptive purposes only and should not be construed as indicating or implying relative importance. Furthermore, in the description of this invention, unless otherwise stated, "a plurality of" means two or more.

[0045] This invention provides an MRI-compatible implantable electrode and its manufacturing method. A shielding mesh is directly fabricated on the catheter, and the inner and outer sides of the shielding mesh are sandwiched by a polymer layer, forming a shielding layer. The shielding mesh is composed of several wavy, extending metal wires, and the elastic limit elongation of the shielding mesh is greater than that of the polymer layer. When the shielding layer is subjected to tensile force, the polymer layer can withstand more external force than the shielding mesh, and the polymer layer covers and protects the shielding mesh, preventing it from breaking. In this invention, the elastic limit elongation of the polymer layer is greater than that of the catheter, while its elastic modulus is smaller, making the overall shielding layer more elastic than the catheter. Compared with existing technologies, the step of assembling the braided mesh with the electrode is eliminated, allowing the polymer layer and shielding mesh to be thinner and more flexible, solving the problems of existing shielding sleeves being thick, having poor elasticity, and being prone to breakage. This also reduces the diameter of the lead wire, facilitating electrode implantation.

[0046] Implantable electrodes include integrated and separate structures. Integrated electrodes use a continuous wire connection from contact 140 to the stimulator. Separate electrodes, such as... Figure 1-2 The device includes an electrode lead 100 and an extension lead 200. One end of the extension lead 200 is used to connect to a stimulator, and the other end of the extension lead 200 is provided with a connector 210, which is plugged into the electrode lead 100. The electrode lead 100 includes a connecting end 110 and a stimulation end 130. The connecting end 110 is provided with multiple connectors 120, which are used to electrically connect to the connector 210 of the extension lead 200. The stimulation end 130 is used to output stimulation signals and is provided with multiple contacts 140. The connectors 120 and contacts 140 are connected one-to-one by wires. The number of contacts 140 can be one, two, four, eight, sixteen, thirty-two, etc. For deep brain stimulation, it can also be a directional electrode, that is, including multiple contacts 140 spaced apart in a circumferential direction. In the illustration of this invention, the number of contacts 140 is four. In other embodiments, the implantable electrode may also be a cuff electrode for vagus nerve stimulation, an electrode for spinal cord stimulation or sacral nerve stimulation, or, in addition to a stimulation function, an implantable electrode for other functions, such as physiological signal acquisition.

[0047] The contacts 140 of the electrode wire 100 are made of platinum or its alloys, iridium or its alloys, titanium or its alloys, tungsten, stainless steel, carbon nanotubes, carbon fibers, or conductive polymer materials. The wires are used to transmit various functional electrical signals between the contacts 140 and the connector 120. The wires are made of platinum, iridium or its alloys, stainless steel, carbon nanotubes, carbon fibers, or conductive polymer materials. The wires can be straight, spiral, or stranded.

[0048] like Figure 3-6The implantable electrode includes a catheter 150, which is made of one or more materials selected from biocompatible polyurethane, silicone rubber, and nylon. A shielding area is provided on the outer periphery of the catheter 150, and the shielding area of ​​the extension wire 200 covers the connector 210. A shielding layer 160 is provided in the shielding area, covering the catheter 150 within the shielding area. The shielding layer 160 includes a base layer 161, a shielding mesh 163, and a thin film layer 164 covering the shielding mesh 163. The base layer 161 and the thin film layer 164 are polymer layers. The base layer 161 is bonded to the catheter 150, and the thin film layer 164 is bonded to both the shielding mesh 163 and the base layer 161. The shielding mesh 163 is sandwiched between the base layer 161 and the thin film layer 164, and the base layer 161 and the thin film layer 164 provide protection for the shielding mesh 163. The substrate layer 161 can be formed on the conduit 150 through processes such as deposition and coating. Then, a metal layer 162 is deposited on the substrate layer 161 using physical vapor deposition. The patterned metal layer 162 serves as a shielding mesh 163 through etching or laser cutting. Along the axial direction of the conduit 150, the elastic modulus of the shielding mesh 163 is lower than that of the substrate layer 161. The shielding mesh 163 is more flexible than the substrate layer 161, and its elongation at its elastic limit is greater than that of the substrate layer 161. This allows the shielding mesh 163 to withstand greater tension and bending without breaking. The substrate layer 161 withstands more tensile force to protect the shielding mesh 163, thus allowing for the use of a thinner shielding mesh 163. The lower elastic modulus and greater elongation at its elastic limit compared to the conduit 150 make the shielding layer 160 as a whole elastic relative to the conduit 150, making it less prone to breakage under prolonged and significant bending.

[0049] like Figure 4 The shielding mesh 163A is composed of multiple wavy, extending metal mesh wires. These wavy wires improve the elastic limit elongation of the shielding mesh 163A, resulting in better elasticity and structural stability. The metal mesh wires extend spirally on the conduit 150, giving the shielding mesh 163A a spiral shape. The spiral angle of the spirally extending metal mesh wires is between 30° and 60°. A larger spiral angle (e.g., >60°) will lead to a decrease in the axial elastic limit elongation of the shielding mesh 163A, resulting in poorer elasticity. A smaller spiral angle (e.g., <30°) reduces the number of spiral turns, leading to poor stability of the shielding mesh 163A.

[0050] like Figure 5 Multiple wavy metal mesh wires extend and intersect on the conduit 150. The shielding mesh 163B is grid-like, with an irregular quadrilateral grid, and the metal mesh wires on the four sides of the grid extend in a wavy pattern. Figure 6The shielding mesh 163C includes multiple metal mesh wires extending only along the axial direction of the conduit 150, or the spacing between the crests and troughs of the wavy lines is adjusted to form reciprocating bending lines. The shielding mesh 163D includes multiple reciprocating bending lines extending along the axial direction of the conduit 150. Preferably, the extension direction of the metal mesh wires is not perpendicular to the axial direction of the conduit 150, ensuring the elastic limit elongation of the metal mesh wires in the axial direction of the conduit 150, so that the shielding mesh 163 can withstand greater tension and bending. The thickness of the film layer 164 is 10μm-50μm. The film layer 164 is made of the same material as the base layer 161, using a biocompatible material. The elastic modulus of the film layer 164 is greater than that of the shielding mesh 163 but less than that of the conduit 150. The elastic limit elongation of the film layer 164 is less than that of the shielding mesh 163 but greater than that of the conduit 150.

[0051] The coverage of the shielding mesh 163 is 80%-95% to ensure good electromagnetic compatibility and safety. The thickness of the shielding mesh 163 is 1μm-10μm, that is, the thickness of the metal layer 162 is between 1μm and 10μm. In this invention, the width of the metal mesh wires is 2-10 times the thickness, and it is sheet-like, which is beneficial to improving the coverage and structural strength of the shielding mesh 163, and also allows for the use of thinner shielding mesh 163. The material of the shielding mesh 163 is one or more of the following biocompatible materials: platinum, platinum alloy, iridium, iridium alloy, titanium, titanium alloy, stainless steel, nickel-titanium alloy, and cobalt-based alloy.

[0052] The thickness of the base layer 161 is between 5 μm and 20 μm. If the base layer 161 is less than 5 μm, it is too thin and prone to breakage; if the base layer 161 is greater than 20 μm, it will result in an excessively large diameter of the implantable electrode wires, which is not conducive to implantation. Preferably, the thickness of the base layer 161 is 15 μm. The base layer 161 is made of a biocompatible polymer material, preferably silicone rubber.

[0053] This invention also provides a method for manufacturing an MRI-compatible implantable electrode, used to manufacture the aforementioned implantable electrode, comprising:

[0054] S01 provides catheter 150;

[0055] Specifically, the conduit 150 can be a conduit for the electrode wire 100 or a conduit for the extension wire 200. The conduit 150 contains wires, and a shielding area is provided on its outer periphery. For example... Figure 1 One end of the electrode wire 100 is provided with a connector 120, and the other end is provided with a contact 140. The contact 140 is connected to the connector 120 via a wire, and the shielding area of ​​the electrode wire 100 is located between the connector 120 and the contact 140. The contact 140 and the connector 120 are connected to the wire by one or more methods such as crimping, screw fixing, bundling, bonding, laser welding, resistance welding, brazing, and ultrasonic welding. Figure 2One end of the extension wire 200 is provided with a connector 210, which is used for electrical connection with the connector 120 of the electrode wire 100. The shielding area of ​​the extension wire 200 covers the connector 210.

[0056] S02 deposits basal layer 161 on the outer periphery of duct 150;

[0057] like Figure 7 A base layer 161 is prepared within the shielded area using a vacuum deposition process, and the base layer 161 is bonded to the outer periphery of the catheter 150. The thickness of the base layer 161 is between 5 μm and 20 μm. A base layer 161 thinner than 5 μm is prone to breakage, while a base layer thicker than 20 μm would result in an excessively large diameter of the implantable electrode, which is not conducive to implantation. Preferably, the thickness of the base layer 161 is 15 μm. The base layer 161 is made of a biocompatible polymer material, preferably silicone rubber. The elastic modulus of the base layer 161 is lower than that of the catheter 150, and the elastic limit elongation is greater than that of the catheter 150. The base layer 161 has better elastic properties than the catheter 150, can withstand greater bending, and is less prone to breakage.

[0058] S03 deposits a metal layer 162 on the substrate 161;

[0059] like Figure 8 A physical vapor deposition metal layer 162 is used, which uniformly covers the substrate layer 161. The thickness of the metal layer 162 is between 1 μm and 10 μm. The metal layer 162 is made of one or more of the following materials that are biocompatible: platinum, platinum alloy, iridium, iridium alloy, titanium, titanium alloy, stainless steel, nickel-titanium alloy, and cobalt-based alloy.

[0060] S04 The metal layer 162 is patterned to form a shielding mesh 163. The shielding mesh 163 includes multiple wavy extended metal mesh wires. In the axial direction of the conduit 150, the elastic modulus of the shielding mesh 163 is less than the elastic modulus of the base layer 161, and the elastic limit elongation of the shielding mesh 163 is greater than the elastic limit elongation of the base layer 161.

[0061] like Figure 4-69. The metal layer 162 is patterned using etching or femtosecond laser cutting. The patterned metal layer 162 serves as the shielding mesh 163, with a coverage rate of 80%-95%. The thickness of the shielding mesh 163 is the same as that of the metal layer 162, between 1μm and 10μm. The shielding mesh 163 is composed of multiple wavy metal wires extending in a non-perpendicular direction to the axial direction of the conduit 150. The wavy metal wires improve the elastic limit elongation of the shielding mesh 163, resulting in better elasticity and structural stability. The width of the metal wires is 2-10 times their thickness, forming a sheet-like structure, which helps improve the coverage and structural strength of the shielding mesh 163 and allows for the use of thinner shielding meshes. The metal wires extend spirally on the conduit 150, resulting in a spiral-shaped shielding mesh 163A. The metal mesh wires extend and cross on the conduit 150, and the shielding mesh 163B is a grid pattern with irregular quadrilaterals, the metal mesh wires on the four sides extending in a wavy shape. For example... Figure 6 The shielding mesh 163C includes multiple metal mesh wires that extend only along the axial direction of the conduit 150, or the spacing between the peaks and troughs of the wavy lines is adjusted to form a reciprocating bend line. The shielding mesh 163D includes multiple reciprocating bend lines that extend along the axial direction of the conduit 150.

[0062] S05 prepares a thin film layer 164 to cover the shielding mesh 163;

[0063] like Figure 10 A thin film layer 164 is formed on the outer periphery of the shielding mesh 163 through a deposition process. The thin film layer 164 is bonded to the shielding mesh 163 and the base layer 161, with the shielding mesh 163 sandwiched between the base layer 161 and the thin film layer 164. The thickness of the thin film layer 164 is 10μm-50μm, and the thin film layer 164 is made of a biocompatible material. In this invention, the thin film layer 164 and the base layer 161 are made of the same material. The elastic modulus of the thin film layer 164 is greater than that of the shielding mesh 163 but less than that of the conduit 150. The elastic limit elongation of the thin film layer 164 is less than that of the shielding mesh 163 but greater than that of the conduit 150. The thin film layer 164 is used to protect the shielding mesh 163.

[0064] In summary, this invention provides an MRI-compatible implantable electrode and its manufacturing method. A metal layer is disposed on a catheter, and this metal layer is patterned using etching or laser cutting to form a shielding mesh composed of wavy metal wires. The shielding mesh is wrapped by a polymer layer (base layer and thin film layer), forming a shielding layer together. The elastic limit elongation of the shielding mesh is greater than that of the base layer and the thin film layer. When the shielding layer is subjected to tensile force, the base layer and the thin film layer can withstand more force than the shielding mesh, preventing wear and breakage of the shielding mesh, thus protecting it. In this invention, the elastic limit elongation of the base layer and the thin film layer is greater than that of the catheter, while their elastic modulus is lower, making the shielding layer more elastic and less prone to breakage than the catheter.

[0065] The above description is merely a preferred embodiment of the present invention and is not intended to limit the invention. For those skilled in the art, the present invention can be modified and varied in various ways, and the contents of each embodiment can be combined with each other without conflict. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principle of the present invention should be included within the protection scope of the present invention.

[0066] Unless otherwise expressly specified and limited, the terms "installation," "connection," "linking," and "fixing," etc., should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components, unless otherwise expressly limited. Those skilled in the art can understand the specific meaning of the above terms in this invention according to the specific circumstances.

[0067] For ease of explanation, spatially related terms such as “inside,” “outside,” “below,” “below,” “lower,” “above,” “upper,” etc., are used herein to describe the relationship between one element or feature illustrated in the figure and another. It will be understood that spatially related terms may be intended to encompass different orientations of the device in use or operation besides those depicted in the figure. For example, if the device in the figure is flipped, an element described as “below” or “below” another element or feature would then be positioned “above” that other element or feature. Thus, the exemplified term “below” can encompass both above and below orientations. The device may be oriented in other ways (rotated 90 degrees or in other orientations), and the spatially related descriptive terms used herein should be interpreted accordingly.

Claims

1. An MRI-compatible implantable electrode, characterized in that, include: catheter; A shielding layer is disposed on the outer periphery of the conduit, comprising a base layer and a shielding mesh. The shielding mesh is formed by patterning a metal layer disposed on the base layer through etching or laser cutting processes. The shielding mesh comprises multiple wavy metal mesh wires. Along the axial direction of the conduit, the elastic modulus of the shielding mesh, the base layer, and the conduit increase sequentially, while the elastic limit elongation decreases sequentially.

2. The implantable electrode according to claim 1, characterized in that, The shielding mesh has a coverage of 80%-95%, and the shielding mesh is in the form of a grid or an axially extending spiral on the duct.

3. The implantable electrode according to claim 2, characterized in that, The thickness of the base layer is 5μm-20μm, and the thickness of the shielding mesh is 1μm-10μm.

4. The implantable electrode according to claim 2, characterized in that, The shielding layer further includes a thin film layer that covers the shielding mesh and is bonded to the base layer; Along the axial direction of the conduit, the elastic modulus of the thin film layer is greater than that of the shielding mesh, and the elastic limit elongation is less than that of the shielding mesh.

5. The implantable electrode according to claim 2, characterized in that, The metal layer is made of one or more of the following materials that are biocompatible: platinum, platinum alloy, iridium, iridium alloy, titanium, titanium alloy, stainless steel, nickel-titanium alloy, and cobalt-based alloy.

6. A method for manufacturing an MRI-compatible implantable electrode, characterized in that, include: S01 provides a catheter; S02. A base layer is prepared on the outer periphery of the catheter, wherein the elastic modulus of the base layer is less than that of the catheter. S03 deposits a metal layer in the substrate layer; S04 The metal layer is patterned to form a shielding mesh, the shielding mesh comprising a plurality of wavy extended metal mesh wires. In the axial direction of the conduit, the elastic modulus of the shielding mesh is less than the elastic modulus of the base layer, and the elastic limit elongation of the shielding mesh is greater than the elastic limit elongation of the base layer. S05 prepares a thin film layer to cover the shielding mesh.

7. The method for manufacturing an implantable electrode according to claim 6, characterized in that, S02 prepares a base layer on the peripheral side of the catheter, and also includes: A shielding area is provided on the outer periphery of the conduit; A base layer with a thickness of 5μm-20μm is deposited in the shielded area.

8. The method for manufacturing an implantable electrode according to claim 6, characterized in that, Depositing a metal layer in the substrate includes forming a metal layer with a thickness of 1 μm to 10 μm using a vapor deposition process.

9. The method for manufacturing an implantable electrode according to claim 6, characterized in that, S04 patterning the metal layer to form a shielding mesh further includes: The metal layer is patterned using etching or laser cutting processes; The shielding mesh has a coverage of 80%-95%, and the shielding mesh is in the form of a grid or an axially extending spiral on the duct.

10. The method for manufacturing an implantable electrode according to claim 6, characterized in that, The metal layer is formed by a deposition process from one or more of the following materials that are biocompatible: platinum, platinum alloys, iridium, iridium alloys, titanium, titanium alloys, stainless steel, nickel-titanium alloys, and cobalt-based alloys.

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