High-flux bidirectional temperature sensing flexible electrode and preparation method and application thereof

Abstract

The invention belongs to the technical field of biomedical engineering, and provides a preparation method of a high-flux bidirectional temperature sensing flexible electrode. The preparation method comprises the following steps: sequentially stacking a flexible substrate, a wire layer and an insulating layer on a substrate; patterning the insulating layer to expose an electrode region, a temperature sensing window and a circuit connection region of the wire layer; forming an electrode contact connected with the wire layer in the electrode area; a temperature sensing unit connected with the wire layer is formed in the temperature sensing window; forming micro salient points which are connected with the wire layer and are used for connecting a circuit in the circuit connection area; and removing part of the substrate to obtain the flexible electrode. According to the method, the width of the flexible electrode can be reduced, the number of channels is increased, and high-density electrode array processing and batch production are achieved; a temperature sensing unit is integrated on the neural electrode, so that the temperature change of tissues under different stimulation parameters can be accurately monitored, and the working state of the electrode can be adjusted in time. According to the deep stimulation electrode assembly based on the flexible electrode, the hard needle drives the soft needle to enter the brain tissue, so that the electrode implantation damage is reduced.

Description

Technical Field

[0001] The present invention belongs to the technical field of biomedical engineering, and in particular relates to a high-throughput bidirectional temperature sensing flexible electrode and a preparation method and application thereof. Background Art

[0002] The number of channels of existing deep brain stimulation electrodes is generally 4, 8, or 16 channels. The processing technology mainly involves welding the electrode contacts and wires and encapsulating them in silicone or polyurethane tubes. This can achieve programmable controllable stimulation of deep brain nuclei, thereby achieving the purpose of treating neurological diseases such as Parkinson's disease and epilepsy.

[0003] The traditional processing and manufacturing method of deep brain stimulation electrodes requires delicate manual skills, and it is difficult to process high-density array electrodes. Because the lead wire of each electrode point is an independent wire, as the number of electrode contacts increases, the connecting wire composed of each independent wire will be very thick, resulting in the final electrode implanted deep in the brain being large in size, poor in biocompatibility, and prone to brain tissue damage. Therefore, the number of electrode channels in existing products is limited. In addition, the manual processing method has poor repeatability and is difficult to mass produce.

[0004] In addition, most of the current implantable deep brain stimulation electrodes only have stimulation functions. Some neural electrodes have further added recording functions, which can also collect signals from specific nuclei. However, the above two types of neural electrodes cannot monitor the state of the brain in real time from other dimensions and make timely adjustments to the electrodes. Summary of the invention

[0005] The purpose of the present invention is to overcome the problems of existing deep brain stimulation electrodes having a small number of channels, only unidirectional stimulation, great damage, and inability to monitor changes near the electrodes.

[0006] To this end, the present invention provides a method for preparing a high-throughput bidirectional temperature sensing flexible electrode, comprising the following steps:

[0007] A flexible substrate, a conductor layer and an insulating layer are sequentially stacked on the base;

[0008] The insulating layer is patterned to expose the electrode area, the temperature sensing window and the circuit connection area of ​​the conductor layer;

[0009] forming an electrode contact in the electrode region, wherein the electrode contact is connected to the wire layer;

[0010] Depositing a temperature sensitive material on the temperature sensing window to form a temperature sensing unit, wherein the temperature sensing unit is connected to the wire layer;

[0011] Forming micro-bumps for connecting the circuit in the circuit connection area, and the micro-bumps are connected to the wire layer;

[0012] The substrate is thinned to partially expose the flexible substrate, thereby obtaining the high-throughput bidirectional temperature sensing flexible electrode.

[0013] Specifically, the preparation method further includes: before thinning the substrate, forming a hydrophobic layer along the stacking direction, and patterning the hydrophobic layer to expose the electrode contacts, micro-bumps and temperature sensing units.

[0014] Specifically, a hydrophobic material is deposited along the stacking direction to form a hydrophobic layer.

[0015] Specifically, a biocompatible material is deposited in the electrode region to form an electrode contact; the biocompatible material includes gold, platinum / platinum-iridium, iridium oxide, titanium nitride, and PEDOT.

[0016] Specifically, the temperature sensitive material includes nano-platinum and graphene.

[0017] Specifically, indium pillars are evaporated in the circuit connection area, and copper and tin form micro bumps.

[0018] The present invention also provides a high-throughput bidirectional temperature sensing flexible electrode, comprising a flexible substrate; a conductive layer is formed on the flexible substrate; an insulating layer is coated on the conductive layer; electrode contacts, micro-bumps and a temperature sensing unit are provided on the insulating layer; the micro-bumps, the electrode contacts and the temperature sensing unit are all connected to the conductive layer.

[0019] Specifically, a hydrophobic layer is formed on the insulating layer, and the electrode contacts, the micro-bumps, and the surface of the temperature sensing unit are all exposed outside the hydrophobic layer.

[0020] The present invention also provides a high-density bidirectional deep stimulation electrode assembly, comprising a hard needle and the above-mentioned high-flux bidirectional temperature sensing flexible electrode; the flexible electrode is detachably connected to the hard needle.

[0021] Specifically, the head end of the hard needle is provided with a first hook; the head end of the flexible electrode is provided with a first positioning hanging rope; the flexible electrode is detachably connected to the hard needle through the first positioning hanging rope and the first hook.

[0022] Compared with the prior art, the present invention has the following advantages and beneficial effects:

[0023] The preparation method of the high-throughput bidirectional temperature-sensing flexible electrode provided by the present invention is based on micro-nano processing technology, and multiple temperature sensing units are integrated on the neural electrode. The temperature of different positions during the implantation process can be monitored, and the temperature changes of the electrode during the patient's nuclear magnetic resonance or electrical stimulation after the electrode is implanted can be accurately judged, and timely adjustments can be made. The width of the flexible electrode can be 0.4mm-1.2mm, and the number of channels can reach 4 / 8 / 16 / 32 / 64 / 128, realizing high-density electrode array processing and mass production. The high-throughput bidirectional temperature-sensing flexible electrode prepared by this method has the characteristics of high channel, bidirectional, low power consumption, and ultra-fine electrode, and can be implanted into deep brain nuclei to reduce tissue damage.

[0024] The high-density bidirectional deep stimulation electrode assembly provided by the present invention enters the brain tissue through a hard needle with a soft needle, and finally only the flexible electrode is left in the brain tissue. This structure can reduce the damage to the brain tissue, and the flexible electrode can remain in the brain for a long time, realizing real-time collection and stimulation of neurological diseases such as Parkinson's disease, depression, Alzheimer's disease, and depression.

[0025] The present invention will be further described in detail below with reference to the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] Figure 1 It is a flow chart of the preparation method of high-throughput bidirectional temperature sensing flexible electrode.

[0027] Figure 2 It is a schematic diagram of the structure of a high-density bidirectional deep stimulation electrode assembly.

[0028] Figure 3 It is a schematic diagram of the structure of the flexible electrode and the hard needle head end.

[0029] Figure 4 It is a schematic diagram of the structure of the flexible electrode and the hard needle end.

[0030] Figure 5 The diagram is a schematic diagram of a first hook structure in an implementation manner.

[0031] Figure 6 It is a schematic diagram of the second hook structure in an implementation manner.

[0032] Figure numerals: 1. hard needle; 2. first hook; 2-1. first hook body; 2-2. first hook groove; 3. first positioning rope; 4. electrode contact; 5. flexible electrode; 6. temperature sensing unit; 7. second hook; 7-2. second hook body; 7-2. second hook groove; 8. second positioning rope; 9. CMOS circuit; 10. electrode assembly. DETAILED DESCRIPTION

[0033] The technical scheme in the present invention will be clearly and completely described below in conjunction with the embodiments. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all the embodiments. Although the representative embodiments of the present invention have been described in detail, it will be understood by those skilled in the art that various modifications and changes can be made to the present invention without departing from the scope of the present invention. Therefore, the scope of the present invention should not be limited to the embodiments, but should be limited by the attached claims and their equivalents.

[0034] Reference Figure 1 The present invention provides a method for preparing a high-throughput bidirectional temperature-sensing flexible electrode, comprising the following steps: stacking a flexible substrate, a wire layer and an insulating layer on a substrate in sequence; patterning the insulating layer to expose the electrode area, the temperature-sensing window and the circuit connection area of ​​the wire layer; forming an electrode contact 4 in the electrode area, and the electrode contact 4 is connected to the wire layer; depositing a temperature-sensitive material in the temperature-sensing window to form a temperature-sensing unit 6, and the temperature-sensing unit 6 is connected to the wire layer; forming a micro-bump for connecting the circuit in the circuit connection area, and the micro-bump is connected to the wire layer; thinning the substrate, partially exposing the flexible substrate, and obtaining the high-throughput bidirectional temperature-sensing flexible electrode 5. The thinning position and thickness of the substrate are designed according to actual needs, preferably retaining the substrate support at the bottom of the micro-bump, and the wire part is flexibly released to remove all the substrate. The flexible electrode 5 is combined with the CMOS circuit 9 to realize the collection and stimulation of deep nucleus information, and programmable directional stimulation can be realized.

[0035] Optionally, the substrate is a silicon substrate, preferably prepared by RCA cleaning a silicon wafer of suitable size. Flexible substrate materials include but are not limited to polymer materials such as polyimide / polyurethane, parylene C, SU8, etc. The electrode contact 4 material is a biocompatible material, including but not limited to gold, platinum / platinum iridium, iridium oxide, titanium nitride, and PEDOT. Temperature-sensitive materials include but are not limited to nano-platinum and graphene. These temperature-sensitive materials have the characteristics of high sensitivity and rapid response, and the controllable regulation of the stimulation current during electrode stimulation can be achieved by temperature monitoring. Micro-bump materials include but are not limited to indium, gold, copper tin, preferably indium.

[0036] In a detailed implementation, the flexible substrate, the wire layer and the insulating layer are stacked in sequence on the substrate as follows: a polymer material is spin-coated and hard-baked on the substrate to form a flexible substrate; a metal layer is deposited on the flexible substrate, and the metal can be selected from aluminum, gold or other conductive metal materials as needed; photoresist is spin-coated on the metal layer, and a desired pattern is formed by photolithography and development, and the metal layer is etched according to the pattern to form a wire layer, and then the photoresist is removed; a polymer is coated on the wire layer along the stacking direction to form an insulating layer, and the insulating layer and the flexible substrate form an enclosure structure to wrap the wire layer inside to protect the wire layer.

[0037] Furthermore, before the base is formed into a flexible substrate, a sacrificial layer may be formed on the base, and then a polymer is spin-coated and hard-baked on the sacrificial layer to form the flexible substrate. The sacrificial layer material is preferably silicon dioxide.

[0038] Reference Figure 1 The insulating layer is patterned as follows: a second photoresist layer is formed on the insulating layer, photolithography is performed, and the insulating layer is patterned to expose the electrode area, temperature sensing window and circuit connection area of ​​the wire layer which are subsequently connected to the electrode contacts 4, micro-bumps and temperature sensing units 6, and then the second photoresist layer is removed.

[0039] In an optimized implementation, referring to Figure 1 , the specific steps of electrode contact 4, temperature sensing unit 6, and micro-bump are: spin-coating photoresist on the insulating layer, patterning the photoresist layer, and exposing the electrode area. Deposit biocompatible metal material to form a conductive layer, and after the conductive layer is subjected to a stripping process, obtain electrode contacts 4 for collecting neuron signals in the electrode area, the electrode contacts 4 are connected to the wire layer, and the photoresist is removed. Spin-coating photoresist along the stacking direction again, and patterning is performed to expose a temperature sensing window, and temperature-sensitive materials are deposited in the temperature sensing window to form a temperature sensing unit 6, the temperature sensing unit 6 is connected to the wire layer, and the photoresist is removed. Spin-coating photoresist along the stacking direction again, and patterning is performed to expose a circuit connection area, and indium, gold, or copper-tin columns are evaporated in the connection area to form micro-bumps, the indium columns are connected to the wire layer, and the photoresist is finally removed. Micro-bumps are used for subsequent connection with circuits, and programmable recording and stimulation can be performed on any contact through CMOS circuit 9 and host computer software. The number of electrode contacts 4 of the flexible electrode 5 prepared by this method can reach 8 / 16 / 32 / 64 or more.

[0040] In order to increase the biocompatibility of the electrode and reduce the adhesion of glial cells, after the electrode contacts 4, the temperature sensing units 6, and the micro-bumps are formed, a hydrophobic layer is formed on the flexible electrode 5 along the stacking direction, and the hydrophobic layer is patterned to expose the electrode contacts 4, the micro-bumps, and the temperature sensing units 6, so as to facilitate sensing or connection with the circuit. The hydrophobic layer material includes polytetrafluoroethylene, silica gel, parylene C, fluorinated polymers, etc., preferably parylene C.

[0041] Specifically, the steps for preparing the hydrophobic layer are: depositing parylene C along the stacking direction to form a hydrophobic layer; spin coating photoresist on the hydrophobic layer, patterning the hydrophobic layer after photolithography and development to expose the electrode contacts 4, micro-bumps and temperature sensing units 6, and then removing the photoresist.

[0042] In the present invention, photolithography or other feasible processes can be used for patterning. The deposition method of each material can be selected according to actual conditions, such as PECVD, PVD, CVD and the like. Based on the above preparation method, the present invention also provides a high-throughput bidirectional temperature sensing flexible electrode, including a flexible substrate; a conductive layer is formed on the flexible substrate; an insulating layer is coated on the conductive layer; an electrode contact 4, a micro-bump and a temperature sensing unit 6 are provided on the insulating layer; the micro-bump, the electrode contact 4 and the temperature sensing unit 6 are all connected to the conductive layer. Based on micro-nano processing technology, the width of the flexible electrode 5 can be 0.4mm-1.2mm, and the number of channels is 4 / 8 / 16 / 32 / 64 / 128. The number of electrode channels can be selected according to the actual indications, including but not limited to Parkinson's disease, depression, Alzheimer's disease, epilepsy and other neurological diseases.

[0043] Specifically, a hydrophobic layer is formed on the insulating layer, and the surfaces of the electrode contacts 4, the micro-bumps, and the temperature sensing unit 6 are all exposed outside the hydrophobic layer.

[0044] Furthermore, the bottom of the flexible substrate of the flexible electrode 5 and the corresponding part of the micro-bumps are connected to a base for support.

[0045] Reference Figure 2-4 The present invention also provides a high-density bidirectional deep stimulation electrode assembly 10, comprising a hard needle 1 and the above-mentioned high-throughput bidirectional temperature-sensing flexible electrode 5; the flexible electrode 5 is detachably connected to the hard needle 1. The size of the electrode assembly 10 can be designed as needed, the width is generally 0.5-1.2mm, and the length is generally 150-200mm. When in use, a conventional surgical robot or stereotaxic instrument is used to determine the surgical path, perform craniotomy and positioning, and drive the flexible electrode 5 to be implanted into the deep brain nucleus through the hard needle 1. Then, the connection between the flexible electrode 5 and the hard needle 1 is released, and the hard needle 1 is slowly pulled out. The implanted flexible electrode 5 is externally fixed to complete the implantation of the flexible deep brain electrode. The material of the hard needle 1 is not limited to high Young's modulus materials such as stainless steel, titanium alloy, polycrystalline silicon, and tungsten steel. The hard needle 1 is chamfered as a whole and polished to meet the requirements for implantation in the human body, thereby reducing damage to micro-blood vessels.

[0046] Specifically, Figure 3As shown, the first end of the hard needle 1 is provided with a first hook 2; the first end of the flexible electrode 5 is provided with a first positioning rope 3; the flexible electrode 5 is hung on the first hook 2 through the first positioning rope 3 to achieve a detachable connection with the hard needle 1. The opening direction of the first hook 2 is preferably away from the length extension direction of the hard needle 1 to facilitate subsequent extraction. The external groove structure combining the hard needle 1 and the flexible electrode 5 can realize the implantation of the hard needle 1 with the flexible electrode 5 into the deep nucleus of the brain, realize self-detachment, and reduce damage to brain tissue.

[0047] In an optimized implementation, referring to Figure 3-4 The first and second hooks 2 and 7 are provided at the head and tail of the hard needle 1, respectively, and the opening directions of the first hook 2 and the second hook 7 are opposite to each other; the first and second positioning ropes 3 and 8 are provided at the head and tail of the flexible electrode 5, respectively; the two ends of the flexible electrode 5 are detachably connected to the first hook 2 and the second hook 7 through the positioning ropes. The electrode assembly 10 is implanted into the deep brain nucleus, the first positioning rope 3 is loosened, and the hard needle 1 is slowly pulled out.

[0048] The hook processing method is not limited to laser cutting, mechanical grinding, wire cutting, etc., and can hang the lower edge of the flexible electrode 5. The material of the positioning lanyard can be a degradable biomaterial or a biocompatible polymer, not limited to silk protein, polyimide, parylene C and other materials.

[0049] In order to facilitate the separation of the hard needle 1 and the flexible electrode 5 after implantation, and also to prevent the positioning rope from being separated from the corresponding hook during implantation, the hooks at the head and tail of the hard needle 1 are specially designed with barbs. Figure 5 As shown, the first hook 2 includes a first hook body 2-1 and a first hook groove 2-2 formed between the first hook body 2-1 and the body of the hard needle 1. The first hook body 2-1 is preferably a conical triangle with a taper of 15-45°, and the first hook groove 2-2 is a groove structure of 15-30°. When the hard needle 1 is pulled out, the first positioning rope 3 can be smoothly withdrawn under this conical structure, so that the flexible electrode 5 is separated from the hard needle 1, and the flexible electrode 5 is retained inside the nucleus. During the assembly process with the hard needle 1, the first positioning rope 3 can be smoothly fixed to the hard needle 1 along the groove taper according to the groove design of the first hook groove 2-2, and because of the tapered design, the first positioning rope 3 will not easily slip out of the groove, avoiding the first positioning rope 3 from being separated from the first hook 2 during the implantation process.

[0050] Further, the second hook 7 includes a second hook body 7-1 and a second hook groove 7-2, referring to Figure 6 The second hook body 7-1 and the second hook groove 7-2 are preferably comma-shaped structures, and the second positioning rope 8 is tightly connected to the hard needle 1 through the circular comma-shaped barb structure. The protruding rounded barb structure can also make it difficult for the second positioning rope 8 to be withdrawn after being fixed to the groove, thereby ensuring the tight connection between the hard needle 1 and the flexible electrode 5.

[0051] Reference Figure 4 The tail end of the flexible electrode 5 is packaged with a circuit, preferably a CMOS circuit 9, to realize on-site processing of the collected deep brain nucleus information, and has a stimulation function to achieve two-way regulation of the deep brain nuclei with low energy loss.

[0052] The materials of CMOS circuit 9 include but are not limited to silicon, polyimide and other materials, and the internal circuit is processed by integrated circuit technology to amplify, filter and ADC circuits. The width is generally 0.4-0.8mm and the length is generally 0.5-2mm.

[0053] In order to improve the tight fixation of the flexible electrode 5 and the brain tissue, a micro barb structure is provided around the flexible electrode 5. After implantation, the barb structure fixes the flexible electrode 5 to the surrounding brain tissue to prevent the electrode position from shifting.

[0054] The following is a study of a high-throughput bidirectional temperature-sensing flexible electrode 5 of the present invention and its preparation method and application effects through specific embodiments.

[0055] Embodiment 1:

[0056] Reference Figure 1 This embodiment provides a high-throughput bidirectional temperature sensing flexible electrode, which is prepared by the following steps:

[0057] (1) Perform RCA cleaning on the silicon wafer to prepare the silicon substrate.

[0058] (2) Using PECVD to deposit silicon dioxide on a silicon substrate to form a sacrificial layer.

[0059] (3) Spin coating and hard baking polyimide on the sacrificial layer to form a flexible substrate.

[0060] (4) Deposit metallic gold on the flexible substrate using PVD process.

[0061] (5) Spin-coat photoresist to form a first photoresist layer, and then expose and develop the layer.

[0062] (6) Dry-etching the aluminum wire to form a conductor layer and removing the first photoresist layer.

[0063] (7) Polyimide is coated on the conductor layer to form an insulating layer. The insulating layer and the flexible substrate form an enclosure structure to wrap the conductor layer inside to protect the aluminum wire.

[0064] (8) Spin-coat photoresist on the insulating layer to form a second photoresist layer. After photolithography and development, pattern the insulating layer to partially expose the area where the aluminum wire is subsequently connected to the electrode contact 4, micro-bump, and temperature sensing unit 6, and remove the second photoresist layer.

[0065] (9) Continue to spin-coat the photoresist along the stacking direction to form a third photoresist layer, and perform patterning on the third photoresist layer to expose the electrode region.

[0066] (10) Use PVD to deposit Au to form a conductive layer.

[0067] (11) After the conductive layer is stripped, an electrode contact 4 for collecting neuron signals is obtained in the electrode region, the electrode contact 4 is connected to the wire layer, and the third photoresist layer is removed.

[0068] (12) Spin-coat the photoresist again to form a fourth photoresist layer, and perform patterning to expose the temperature-sensitive window.

[0069] (13) Depositing nano-platinum material on the temperature sensing window to form a temperature sensing unit 6, wherein the temperature sensing unit 6 is connected to the wire layer, and removing the fourth photoresist layer.

[0070] (14) Spin-coat the photoresist again along the stacking direction to form a fifth photoresist layer, and pattern the fifth photoresist layer to expose the connection area of ​​the CMOS circuit 9.

[0071] (15) Indium columns are evaporated in the CMOS electrical connection area to form micro bumps, the indium columns are connected to the wire layer, and finally the fifth photoresist layer is removed.

[0072] (16) Depositing parylene C along the stacking direction to form a hydrophobic layer; spin coating photoresist on the hydrophobic layer to form a sixth photoresist layer, patterning the hydrophobic layer after photolithography and development to expose the electrode contacts 4, micro bumps and temperature sensing units 6, and then removing the sixth photoresist layer.

[0073] (17) Thinning the silicon substrate, retaining the silicon substrate support at the bottom of the micro-bump, and flexibly releasing the wire part to remove all the silicon substrate and sacrificial layer to obtain the high-throughput bidirectional temperature sensing flexible electrode 5.

[0074] Embodiment 2:

[0075] This embodiment provides a high-density bidirectional deep stimulation electrode assembly 10, comprising a hard needle 1 and a high-throughput bidirectional temperature-sensing flexible electrode 5 prepared in Example 1.

[0076] The first hook 2 and the second hook 7 are respectively provided at the head and tail ends of the hard needle 1, and the opening directions of the first hook 2 and the second hook 7 are opposite to each other. The first and the tail ends of the flexible electrode 5 are respectively provided with a first positioning hanging rope 3 and a second positioning hanging rope 8. There are micro barb structures around the flexible electrode 5. The tail end of the flexible electrode 5 is packaged with a CMOS circuit 9. Figure 3-4 As shown, the first positioning hanging rope 3 and the second positioning hanging rope 8 are hung on the first hook 2 and the second hook 7 respectively.

[0077] When in use, a conventional surgical robot or stereotaxic instrument is used to determine the surgical path, perform craniotomy and positioning, and use the hard needle 1 to drive the flexible electrode 5 to be implanted into the deep brain nucleus. The barb structure of the flexible electrode 5 is tightly fixed to the brain tissue. Then, the second positioning rope is loosened, and the hard needle 1 is slowly pulled out to separate it from the first positioning rope. The hard needle 1 is pulled out, and the implanted flexible electrode 5 is externally fixed to complete the implantation of the flexible deep brain electrode.

[0078] The above examples are merely illustrative of the present invention and do not constitute a limitation on the protection scope of the present invention. All designs that are the same or similar to the present invention fall within the protection scope of the present invention.

Claims

1. A method for preparing a high-throughput bidirectional temperature sensing flexible electrode, characterized in that: The following steps are involved: A flexible substrate, a conductor layer and an insulating layer are sequentially stacked on the base; The insulating layer is patterned to expose the electrode area, the temperature sensing window and the circuit connection area of ​​the conductor layer; forming an electrode contact in the electrode region, wherein the electrode contact is connected to the wire layer; Depositing a temperature sensitive material on the temperature sensing window to form a temperature sensing unit, wherein the temperature sensing unit is connected to the wire layer; Forming micro-bumps for connecting the circuit in the circuit connection area, and the micro-bumps are connected to the wire layer; The substrate is thinned to partially expose the flexible substrate, thereby obtaining the high-throughput bidirectional temperature sensing flexible electrode.

2. The method for preparing a high-throughput bidirectional temperature sensing flexible electrode according to claim 1, characterized in that: Before thinning the substrate, the method also includes: forming a hydrophobic layer along the stacking direction, patterning the hydrophobic layer, and exposing electrode contacts, micro-bumps and temperature sensing units.

3. The method for preparing a high-throughput bidirectional temperature sensing flexible electrode according to claim 2, characterized in that: A hydrophobic material is deposited along the stacking direction to form a hydrophobic layer.

4. The method for preparing a high-throughput bidirectional temperature sensing flexible electrode according to claim 1, characterized in that: A biocompatible material is deposited in the electrode region to form an electrode contact; the biocompatible material includes gold, platinum / platinum-iridium, iridium oxide, titanium nitride, and PEDOT.

5. The method for preparing a high-throughput bidirectional temperature sensing flexible electrode according to claim 1, characterized in that: The temperature sensitive material includes nano-platinum and graphene.

6. The method for preparing a high-throughput bidirectional temperature sensing flexible electrode according to claim 1, characterized in that: Indium pillars and copper-tin are evaporated in the circuit connection area to form micro bumps.

7. A high-throughput bidirectional temperature sensing flexible electrode, characterized in that: It comprises a flexible substrate; a conductive layer is formed on the flexible substrate; an insulating layer is coated on the conductive layer; electrode contacts, micro-bumps and a temperature sensing unit are arranged on the insulating layer; the micro-bumps, the electrode contacts and the temperature sensing unit are all connected to the conductive layer.

8. The high-throughput bidirectional temperature sensing flexible electrode according to claim 7, characterized in that: A hydrophobic layer is formed on the insulating layer, and the electrode contacts, the micro-bumps, and the surface of the temperature sensing unit are all exposed outside the hydrophobic layer.

9. A high-density bidirectional deep stimulation electrode assembly, characterized in that: It comprises a hard needle and a high-throughput bidirectional temperature-sensing flexible electrode as described in any one of claims 7 to 8; the flexible electrode is detachably connected to the hard needle.

10. The high-density bidirectional deep stimulation electrode assembly according to claim 9, characterized in that: The head end of the hard needle is provided with a first hook; the head end of the flexible electrode is provided with a first positioning hanging rope; the flexible electrode is detachably connected to the hard needle through the first positioning hanging rope and the first hook.

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