Mri compatible implantable electrode and method of manufacturing the same

Abstract

This invention relates to the field of medical devices, providing an MRI-compatible implantable electrode and its manufacturing method. The implantable electrode includes multiple contacts and multiple core wires, each core wire being electrically connected to one of the contacts. Each core wire includes an electrical conductor and a shielding layer and an isolation layer covering the electrical conductor. The shielding layer includes a first conductor layer and a second conductor layer formed by a patterning process. The first and second conductor layers each include multiple wavy, extending metal wires. The isolation layer electrically isolates the first conductor layer, the second conductor layer, and the electrical conductor. In this invention, the double-layer shielded electrical conductors generate an anti-phase magnetic field through the eddy current effect to counteract the external radio frequency magnetic field, reducing the influence of the external radio frequency magnetic field on the internal electrical conductor, reducing the temperature rise at the contact point with tissue, and suppressing the thermal effect generated by the radio frequency magnetic field.

Description

Technical Field

[0001] This invention relates to the field of medical devices, and more particularly to an MRI-compatible implantable electrode and its manufacturing method. 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] During MRI, 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) work together. In common MRI scans 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, the three magnetic fields used during MRI 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. Summary of the Invention

[0004] In view of this, the present invention provides an MRI-compatible implantable electrode and a method for manufacturing the same, for reducing, suppressing or eliminating the problem of heating of the contacts of slender electrodes in the radio frequency magnetic field of MRI.

[0005] An MRI-compatible implantable electrode, comprising:

[0006] Multiple contacts;

[0007] Multiple core wires, each of which is electrically connected to one of the contacts;

[0008] The core wire includes an electrical conductor and a shielding layer and an isolation layer covering the electrical conductor. The shielding layer includes a first conductor layer and a second conductor layer formed by a patterning process. The first conductor layer and the second conductor layer each include a plurality of wavy-shaped metal wires. The isolation layer is used to electrically isolate the first conductor layer, the second conductor layer and the electrical conductor.

[0009] Preferably, in some embodiments of the present invention, the plurality of metal wires in the first conductor layer and / or the second conductor layer form a mesh or a spiral around the electrical conductor;

[0010] The elastic modulus of the first conductor layer and the second conductor layer is less than that of the insulating layer, and the axial elastic limit elongation is greater than that of the insulating layer.

[0011] Preferably, in some embodiments of the present invention, the isolation layer includes a protective layer, a first base layer, a second base layer, and a thin film layer;

[0012] The protective layer covers the electrical conductor, the first base layer is disposed between the protective layer and the first conductor layer, the second base layer is disposed between the first conductor layer and the second conductor layer, and the thin film layer covers the second conductor layer.

[0013] Preferably, in some embodiments of the present invention, the thickness of the protective layer is 10μm-500μm, and the thickness of the first base layer and the second base layer is 10μm-200μm.

[0014] Preferably, in some embodiments of the present invention, the isolation layer includes a protective layer, a patterned substrate layer, and a thin film layer;

[0015] The protective layer covers the electrical conductor, the base layer has a wavy groove that extends spirally around the electrical conductor, and a spirally extending protrusion is provided between two adjacent grooves. The first conductor layer is disposed at the bottom of the groove, the second conductor layer is disposed on the protrusion, and the thin film layer covers the first conductor layer and the second conductor layer.

[0016] A second aspect of the present invention provides a method for manufacturing an MRI-compatible implantable electrode, comprising:

[0017] Provide multiple electrical conductors;

[0018] A patterning process is used to form a double-layer shielded conductor that is electrically isolated by an isolation layer on the outer periphery of the electrical conductor;

[0019] Prepare a thin film layer to cover the shielding conductor to form a core wire with a double-layer shielding conductor;

[0020] The insulator is prepared by processing multiple core wires into a conductor.

[0021] Preferably, in some embodiments of the present invention, the formation of a double-layer shielded conductor electrically isolated by an isolation layer on the outer periphery of the electrical conductor using a patterning process includes:

[0022] A protective layer is prepared to surround the electrical conductor, and a first base layer is prepared on the outer periphery of the protective layer;

[0023] A patterned first conductor layer is formed on the first substrate layer using deposition and etching processes;

[0024] Prepare a second substrate layer to cover the first conductor layer;

[0025] A patterned second conductor layer is formed on the second substrate layer using deposition and etching processes.

[0026] Preferably, in some embodiments of the present invention, the formation of a double-layer shielded conductor electrically isolated by an isolation layer on the outer periphery of the electrical conductor using a patterning process includes:

[0027] A protective layer is prepared to surround the electrical conductor, and a base layer is prepared on the outer periphery of the protective layer;

[0028] The substrate layer is patterned, and wavy grooves that extend spirally around the electrical conductor axis are etched out. Spiral protrusions are formed between adjacent grooves, and the depth of the grooves is less than the depth of the substrate layer.

[0029] A metal pattern is deposited on the bottom of the groove and the protrusion using a deposition process. The continuously spirally extending metal pattern on the bottom of the groove and the protrusion forms a double layer of shielding conductor.

[0030] Preferably, in some embodiments of the present invention, the formation of a double-layer shielded conductor electrically isolated by an isolation layer on the outer periphery of the electrical conductor using a patterning process includes:

[0031] A shielding conductor composed of multiple wavy metal wires is fabricated using a patterning process. The shielding conductor is either mesh-like or spiral-shaped around the electrical conductor. The elastic modulus of the shielding conductor is less than that of the insulating layer, and the axial elastic limit elongation is greater than that of the insulating layer.

[0032] Preferably, in some embodiments of the present invention, the preparation of the insulator involves processing multiple core wires into a conductor, including:

[0033] Provide an insulating tube;

[0034] Multiple core wires are wound onto an insulating tube;

[0035] An insulator is formed on the radially outer side of the multiple core wires, and the insulating tube, multiple core wires and insulator are formed as one unit.

[0036] The beneficial effects of the MRI-compatible implantable electrode and its manufacturing method provided by this invention include:

[0037] The implantable electrode consists of multiple core wires, each of which is equipped with a double-layer shielded conductor. The double-layer shielded conductors generate an anti-phase magnetic field through the eddy current effect to counteract the external radio frequency magnetic field, reduce the influence of the external radio frequency magnetic field on the internal conductor, reduce the temperature rise at the contact point with the tissue, and suppress the thermal effect generated by the radio frequency magnetic field. Attached Figure Description

[0038] 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:

[0039] Figure 1 This is a schematic diagram of the split structure of the implantable electrode in an embodiment of the present invention.

[0040] Figure 2 This is a schematic diagram of a wire structure in an embodiment of the present invention.

[0041] Figure 3 This is a schematic diagram of another structure of the wire in an embodiment of the present invention.

[0042] Figure 4 This is a schematic diagram of the core wire processing steps in an embodiment of the present invention.

[0043] Figure 5 This is a schematic diagram of another set of processing steps for the core wire in an embodiment of the present invention.

[0044] Figure 6 This is a schematic diagram of the core wire structure in an embodiment of the present invention.

[0045] Figure 7 This is a schematic diagram of another core wire structure in an embodiment of the present invention.

[0046] Explanation of reference numerals in the attached figures:

[0047] 1-Electrode wire;

[0048] 11-Stimulation end; 111-Contact; 12-Connection end; 121-Connector;

[0049] 2-Extension cable; 21-Connecting plug;

[0050] 3 - Core wire; 4, 4A - Insulator; 5 - Conductor;

[0051] 31-Electrical conductor; 32-Protective layer; 33-First substrate layer; 34, 34A-First conductor layer; 35-Second substrate layer; 36, 36A-Second conductor layer; 37-Thin film layer; 38-Substrate layer; 381-Groove; 382-Protrusion. Detailed Implementation

[0052] 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.

[0053] 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.

[0054] Figure 1 This is a schematic diagram of the split structure of the implantable electrode in an embodiment of the present invention.

[0055] like Figure 1 The implantable electrode includes both integrated and split structures. The split electrode consists of an electrode lead 51 and an extension lead 52. One end of the extension lead 52 is used to connect to the stimulator, and the other end of the extension lead 52 is provided with a connector 21 for insertion and mating with the electrode lead 51. The electrode lead 51 includes a connecting end 12 and a stimulating end 11. The connecting end 12 is provided with multiple connectors 121 for electrical connection with the connector 21 of the extension lead 52. The stimulating end 11 is used to transmit stimulation signals and is provided with multiple contacts 111. The connectors 121 and contacts 111 are connected one-to-one via the lead 5.

[0056] In other embodiments, the implanted electrode may be an electrode for vagus nerve stimulation, spinal cord stimulation, or sacral nerve stimulation. Besides stimulation, it may include other functions, such as physiological signal acquisition. Multiple contacts 111 may be fixed as a single unit or distributed as independent individuals as needed. The type of contact 111 is not limited to annular or sheet-like. Contacts 111 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 number of contacts 111 can be one, two, four, eight, sixteen, thirty-two, etc. Electrodes used for deep brain stimulation include directional electrodes, i.e., multiple spaced contacts 111 arranged in a circumferential direction.

[0057] like Figure 1-3The MRI-compatible implantable electrode provided by this invention includes a lead wire 5, which comprises multiple core wires 3. Typically, the number of core wires 3 corresponds to the number of contacts 111. One end of each core wire 3 is connected to a contact 111, and the other end is connected to a connector 121. The core wires 3 connect the contacts 111 and the connectors 121 accordingly, transmitting various functional electrical signals between the contacts 111 and the connectors. The core wires 3 can be connected to the contacts 111 and the connectors 121 through one or more methods such as crimping, screw fixing, bundling, bonding, laser welding, resistance spot welding, brazing, and ultrasonic welding.

[0058] The core wire 3 includes an electrical conductor 31, which is composed of one or more metal conductors twisted together, with a central metal conductor and the remaining metal conductors spirally extending around the central metal conductor. The number of metal conductors ranges from 1 to 50, preferably 5 to 10, and each metal conductor has the same or different diameters. Typically, the metal conductors have a diameter of 1 μm to 50 μm, and the diameter and number of metal conductors can be designed according to size and conductivity requirements. Preferably, the diameter of the metal conductors is between 15 μm and 25 μm.

[0059] refer to Figure 4-7 In this invention, a shielding layer and an isolation layer are provided on the outer periphery of the electrical conductor 31. The shielding layer is used to shield the internal electrical conductor 31. In the MRI radio frequency magnetic field, the shielding layer generates an induced electromotive force, thereby forming eddy currents that generate a high-frequency reverse magnetic field. This magnetic field cancels out part of the MRI radio frequency magnetic field, reducing, suppressing, or eliminating the heating of the electrode contacts 111 in the MRI radio frequency magnetic field.

[0060] The shielding layer can be a single-layer shielding structure formed by a patterning process or a double-layer shielding structure. In this embodiment, the shielding layer includes a first conductor layer 34 and a second conductor layer 36 formed by a patterning process. The first conductor layer 34 and the second conductor layer 36 are coaxially arranged and electrically isolated by an isolation layer. The first conductor layer 34 and the second conductor layer 36 each include a plurality of wavy-shaped metal wires. The plurality of metal wires form a mesh or a spiral around the electrical conductor 31. The shapes of the first conductor layer 34 and the second conductor layer 36 may be the same or different. Designing the mesh size or the spacing of the spiral-shaped metal wires according to the wavelength of the MRI radio frequency magnetic field in the human body can improve the shielding effect.

[0061] Preferably, the extension direction of the metal wire is not perpendicular to the axial direction (length direction) of the core wire 3. The wavy extension design of the metal wire increases the elastic properties of the first conductor layer 34 and the second conductor layer 36, improves the axial elastic modulus, and makes the first conductor layer 34 and the second conductor layer 36 less prone to breakage. The insulating layer covers the electrical conductor 31, and the first conductor layer 34 and the second conductor layer 36 are disposed inside the insulating layer. The elastic modulus of the first conductor layer 34 and the second conductor layer 36 is less than that of the insulating layer, and the axial elastic limit elongation is greater than that of the insulating layer. The conductor layer is elastic relative to the insulating layer.

[0062] The isolation layer includes a protective layer 32, a first base layer 33, a second base layer 35, and a thin film layer 37. The protective layer 32 covers the electrical conductor 31, serving as an outer sheath for the conductor 31. The elastic modulus of the protective layer 32 is slightly greater than that of the base layer 38 and the thin film layer 37, allowing it to withstand greater forces when the core wire 3 is bent or stretched. The first base layer 33 and the second base layer 35 serve as the base for the conductor layer in the patterning process. The thin film layer 37 is disposed on the outermost side of the core wire 3, covering the second conductor layer 36. The thicknesses of the first base layer 33, the second base layer 35, and the thin film layer 37 may be the same or different, and the material may be silicone rubber. The thicknesses of the first base layer 33, the second base layer 35, and the thin film layer 37 are between 10 μm and 200 μm, while the thickness of the protective layer 32 is between 10 μm and 500 μm. In some other embodiments, the protective layer 32 may be omitted, and the first base layer 33 may be directly disposed on the outer periphery of the electrical conductor 31, thereby reducing the diameter of the core wire 3.

[0063] In other embodiments of the present invention, the isolation layer includes a protective layer 32, a patterned substrate layer 38A, and a thin film layer 37. The protective layer 32 has the same structure as described above and is used to cover the electrical conductor 31. The patterned substrate layer 38A includes a wavy groove 381 that extends spirally around the electrical conductor 31 and a protrusion 382 that extends spirally between adjacent grooves 381. A first conductor layer 34A is deposited at the bottom of the groove 381, and a second conductor layer 36A is deposited on the protrusion 382. The thin film layer 37 covers the first conductor layer 34A and the second conductor layer 36A.

[0064] The present invention also provides a method for manufacturing an MRI-compatible implantable electrode, comprising:

[0065] S01 provides multiple electrical conductors 31;

[0066] S02 uses a patterning process to form a double-layer shielded conductor that is electrically isolated by an isolation layer on the outer periphery of the electrical conductor 31;

[0067] The isolation layer includes a protective layer 32, a first base layer 33, a second base layer 35, and a thin film layer 37. For example... Figure 4In step A, a protective layer 32 can be applied to the outside of the electrical conductor 31 using an extruder. The thickness of the protective layer 32 is between 10 μm and 500 μm, preferably between 50 μm and 200 μm. The patterning process includes deposition, exposure, development, and etching. In this embodiment of the invention, a double-layer patterned metal layer is prepared using a patterning process, and the patterned metal layer serves as a shielding conductor.

[0068] Figure 4 This is a schematic diagram of the core wire processing steps in an embodiment of the present invention.

[0069] Specifically, such as Figure 4 In steps B, C, D, E, F, and G, a first substrate layer 33 and a photoresist layer are deposited on the outer periphery of the protective layer 32 using a deposition process. The photoresist layer is exposed, and the exposed photoresist layer is developed to form a photoresist pattern, exposing the first substrate layer 33. A metal layer is deposited using a physical / chemical vapor deposition process, with some metal located on the photoresist and some metal deposited on the first substrate layer 33 through the pattern. In this embodiment, the exposed first substrate layer 33 is composed of multiple wavy lines forming a grid or spiral shape, thus making the metal layer deposited on the first substrate layer 33 mesh or spiral. The thickness of the metal layer is 1μm-10μm, preferably 2μm-5μm. The photoresist is etched away to remove the photoresist, thereby stripping the metal layer on the photoresist, and the remaining metal layer deposited on the first substrate layer 33 serves as a shielding conductor. A second substrate layer 35 is deposited on the shielding conductor, and the processing method for the shielding conductor on the second substrate layer 35 is the same as described above. In this invention, the thickness of the first base layer 33, the second base layer 35 and the thin film layer 37 is between 10μm and 200μm. The shielding conductor located on the inner side is the first conductor layer 34, and the shielding conductor located on the outer side is the second conductor layer 36. The first conductor layer 34 and the second conductor layer 36 form a double-layer shielding conductor.

[0070] Figure 5 This is a schematic diagram of another set of processing steps for the core wire in an embodiment of the present invention.

[0071] like Figure 5 In steps A1, B1, C1, and D1, in some embodiments of the present invention, the fabrication of the double-layer shielded conductor using a patterning process further includes:

[0072] T1 prepares a base layer 38A to cover the protective layer 32, the thickness of the base layer 38A being close to the sum of the thicknesses of the first base layer 33 and the second base layer 35.

[0073] T2 patterns the substrate 38A and etches a wavy groove 381 that spirals around the electrical conductor 31. A protrusion 382 is formed between adjacent grooves 381. The depth of the etched grooves 381 is controlled by controlling the etching time and etching rate. The depth of the grooves 381 is less than the thickness of the substrate 38.

[0074] T3 employs a highly directional physical vapor deposition (PVD) process to deposit metal layers on the bottom of groove 381 and protrusion 382. A dielectric layer is formed within the metal layer using this highly directional deposition process, making the dielectric layer on the bottom of groove 381 and protrusion 382 thicker than the dielectric layer on the sidewalls of groove 381. A less directional etching process is then used, with controlled etching time and rate, to remove the dielectric layer on the sidewalls of groove 381, while leaving a certain thickness of dielectric layer on the bottom of groove 381 and protrusion 382. This less directional etching process removes the exposed metal layer on the sidewalls of groove 381, preventing electrical connection between the metal layer at the bottom of groove 381 and the metal layer on protrusion 382. The metal layer on the bottom of groove 381 and protrusion 382 remains unaffected due to the dielectric layer protection. Finally, the remaining dielectric layer on protrusion 382 and the bottom of groove 381 is removed, forming a continuously spiraling double-layer shielded conductor.

[0075] S03 prepares a thin film layer 37 to cover the shielding conductor, forming a core wire 3 with a double-layer shielding conductor;

[0076] like Figure 4 H steps Figure 5 In step E1, a thin film layer 37 is deposited to cover the conductor layer. The thin film layer 37, the first substrate layer 33, the second substrate layer 35, the first conductor layer 34, and the second conductor layer 36 form an integral structure. The thin film layer 37 is used to protect the conductor layer. The thickness of the thin film layer 37, the first substrate layer 33, and the second substrate layer 35 may be the same or different, and the material is the same, optionally silicone rubber.

[0077] S04 Insulator preparation 4 Processing multiple core wires 3 into conductors 5;

[0078] For details, please refer to Figure 1 An insulating tube is provided, and multiple core wires 3 are wound onto the insulating tube. An insulator 4 is then formed to cover the radially outer side of the multiple core wires 3. The insulating tube, the multiple core wires 3, and the insulator 4 are formed as a single unit. In some other embodiments, refer to... Figure 2 Multiple core wires are distributed in three circumferential intervals and are formed into one piece by being covered by insulator 4A through extrusion processing.

[0079] In this invention, elastic properties refer to the ability of an object to return to its original shape and size after being subjected to external force. The elastic modulus refers to the proportionality between stress and strain during the elastic deformation stage. The elastic limit elongation refers to the ratio of elongation to the original length when the material reaches its elastic limit.

[0080] 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. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principle of the present invention should be included within the scope of protection of the present invention.

[0081] For ease of explanation, spatially related terms such as “inside” and “outside” 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 “under” 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: Multiple contacts (111); Multiple core wires (3), each of the core wires (3) being electrically connected to one of the contacts (111); The core wire (3) includes an electrical conductor (31) and a shielding layer and an isolation layer covering the electrical conductor (31). The shielding layer includes a first conductor layer (34, 34A) and a second conductor layer (36, 36A) formed by a patterning process. The first conductor layer (34, 34A) and the second conductor layer (36, 36A) each include a plurality of wavy-shaped metal wires. The isolation layer is used to electrically isolate the first conductor layer (34, 34A), the second conductor layer (36, 36A) and the electrical conductor (31).

2. The MRI-compatible implantable electrode of claim 1, wherein, The plurality of metal wires in the first conductor layer (34, 34A) and / or the second conductor layer (36, 36A) form a mesh or a spiral around the electrical conductor (31); The elastic modulus of the first conductor layer (34, 34A) and the second conductor layer (36, 36A) is less than that of the insulating layer, and the axial elastic limit elongation is greater than that of the insulating layer.

3. The MRI-compatible implantable electrode of claim 1, wherein, The isolation layer includes a protective layer (32), a first base layer (33), a second base layer (35), and a thin film layer (37); The protective layer (32) covers the electrical conductor (31), the first base layer (33) is disposed between the protective layer (32) and the first conductor layer (34, 34A), the second base layer (35) is disposed between the first conductor layer (34, 34A) and the second conductor layer (36, 36A), and the thin film layer (37) covers the second conductor layer (36, 36A).

4. The MRI-compatible implantable electrode of claim 3, wherein, The thickness of the protective layer (32) is 10μm-500μm, and the thickness of the first base layer (33) and the second base layer (35) is 10μm-200μm.

5. The MRI-compatible implantable electrode of claim 1, wherein, The isolation layer includes a protective layer (32), a patterned base layer (38), and a thin film layer (37); The protective layer (32) covers the electrical conductor (31), the base layer (38) is provided with a wavy groove (381) that extends spirally around the electrical conductor (31) axially, and a spirally extending protrusion (382) is provided between two adjacent grooves (381). The first conductor layer (34, 34A) is provided at the bottom of the groove (381), and the second conductor layer (36, 36A) is provided on the protrusion (382). The thin film layer (37) covers the first conductor layer (34, 34A) and the second conductor layer (36, 36A).

6. A method of manufacturing an MRI-compatible implantable electrode, characterized by, include: Provide multiple electrical conductors (31); A double-layer shielded conductor, electrically isolated by an isolation layer, is formed on the outer periphery of the electrical conductor (31) using a patterning process; Prepare a thin film layer (37) to cover the shielding conductor to form a core wire (3) with a double-layer shielding conductor; The insulator is prepared by processing multiple core wires (3) into conductors (5).

7. The method of manufacturing an MRI-compatible implantable electrode according to claim 6, wherein, The process of forming a double-layer shielded conductor electrically isolated by an isolation layer on the outer periphery of the electrical conductor (31) using a patterning process includes: A protective layer (32) is prepared to surround the electrical conductor (31), and a first base layer (33) is prepared on the outer periphery of the protective layer (32); A patterned first conductor layer (34, 34A) is formed on the first substrate layer (33) using deposition and etching processes; A second substrate layer (35) is prepared to cover the first conductor layer (34, 34A); A patterned second conductor layer (36, 36A) is formed on the second substrate layer (35) using deposition and etching processes.

8. The method of manufacturing an MRI-compatible implantable electrode according to claim 6, wherein, The process of forming a double-layer shielded conductor electrically isolated by an isolation layer on the outer periphery of the electrical conductor (31) using a patterning process includes: A protective layer (32) is prepared to surround the electrical conductor (31), and a base layer (38) is prepared on the outer periphery of the protective layer (32); The substrate layer (38) is patterned and etched with wavy grooves (381) that spirally extend around the electrical conductor (31) axially. Spiral protrusions (382) are formed between adjacent grooves (381). The depth of the grooves (381) is less than the depth of the substrate layer (38). A metal pattern is deposited on the bottom of the groove (381) and the protrusion (382) using a deposition process. The continuously spirally extending metal pattern on the bottom of the groove (381) and the protrusion (382) forms a double layer of the shielding conductor.

9. The MRI-compatible implantable electrode manufacturing method of claim 6, wherein, The process of forming a double-layer shielded conductor electrically isolated by an isolation layer on the outer periphery of the electrical conductor (31) using a patterning process includes: A shielding conductor composed of multiple wavy metal wires is fabricated using a patterning process. The shielding conductor is either mesh-like or spiral-shaped around the electrical conductor (31). The elastic modulus of the shielding conductor is less than that of the isolation layer, and the axial elastic limit elongation is greater than that of the isolation layer.

10. The MRI compatible implantable electrode manufacturing method of claim 6, wherein, The preparation of the insulator involves processing multiple core wires (3) into conductors (5), including: Provide an insulating tube; Multiple core wires (3) are wound onto an insulating tube; An insulator is formed on the radially outer side of the multiple core wires (3), and the insulating tube, the multiple core wires (3) and the insulator are formed as one unit.

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