Fabrication methods of implantable detection devices, implantable detection devices and systems

Abstract

This application provides a method for fabricating an implantable detection device, an implantable detection device, and a system. The method includes: forming an insulating layer on a first surface of a wafer; forming at least one electrode group on the insulating layer; insulatingly encapsulating the electrode group to form an insulating encapsulation layer covering the electrode group, wherein openings are provided in the insulating encapsulation layer opposite to a counter electrode, a working electrode, a reference electrode, and an electrode terminal block; thinning the wafer on a second surface of the wafer; coating a flexible reinforcement layer on the thinned second surface of the wafer; and dicing the wafer to obtain at least one semiconductor device, wherein each semiconductor device includes an electrode group; and forming a functional film layer on the insulating encapsulation layer of the at least one semiconductor device to obtain at least one implantable detection device. The method for fabricating the implantable detection device provided in this application offers a simple process and low cost.

Description

Technical Field

[0001] This application relates to the field of electrochemical technology, and more particularly to a method for manufacturing an implantable detection device, the implantable detection device, and a system. Background Technology

[0002] As people's living standards improve, the incidence of diabetes is also increasing, and blood glucose testing is receiving more and more attention. As an important means of comprehensive diabetes management, blood glucose testing plays an extremely important role in diabetes diagnosis, diabetes control, and diabetes treatment. Long-term continuous dynamic blood glucose testing can effectively reduce or delay the occurrence of diabetic complications and improve patients' quality of life.

[0003] Currently, implantable minimally invasive blood glucose detectors are being implanted into the human body to enable long-term, continuous dynamic blood glucose monitoring.

[0004] However, existing implantable minimally invasive blood glucose detectors are based on organic flexible substrates, which have a complex manufacturing process and a low yield rate. Summary of the Invention

[0005] In view of this, embodiments of this application provide a method for manufacturing an implantable detection device, an implantable detection device, and a system to at least partially solve the above-mentioned problems.

[0006] According to a first aspect of the present application, a method for fabricating an implantable detection device is provided, comprising: forming an insulating layer on a first surface of a wafer; forming at least one electrode group on the insulating layer, wherein the electrode group includes a counter electrode, a working electrode, and a reference electrode, the counter electrode, the working electrode, and the reference electrode being connected to different electrode terminals via metal leads; insulatingly encapsulating the electrode group to form an insulating encapsulation layer covering the electrode group, wherein an opening is provided on the insulating encapsulation layer at a position opposite to the counter electrode, the working electrode, the reference electrode, and the electrode terminals; thinning the wafer on a second surface of the wafer, wherein the second surface is opposite to the first surface; forming a flexible reinforcement layer on the second surface of the thinned wafer, and then dicing the wafer to obtain at least one semiconductor device, wherein each semiconductor device includes one of the electrode groups; forming a functional film layer on the insulating encapsulation layer of the at least one semiconductor device to obtain at least one implantable detection device, wherein the functional film layer is in contact with the counter electrode, the working electrode, and the reference electrode.

[0007] In one possible implementation, forming an insulating layer on the first surface of the wafer includes: forming a silicon dioxide layer on the first surface, wherein the thickness of the silicon dioxide layer is [20nm, 100nm], and the thickness of the wafer is [100μm, 200μm].

[0008] In one possible implementation, forming at least one electrode group on the insulating layer includes: depositing a first metal layer on the insulating layer, wherein the first metal layer comprises a chromium metal layer or a titanium metal layer, and the thickness of the first metal layer is [10nm, 50nm]; depositing a second metal layer on the first metal layer, wherein the second metal layer comprises a gold metal layer or a copper metal layer, and the thickness of the second metal layer is [50nm, 300nm]; and depositing a third metal layer on the second metal layer to form at least one electrode group, wherein the counter electrode, the working electrode, the reference electrode, and the electrode terminal block all comprise the first metal layer, the second metal layer, and the third metal layer, wherein the third metal layer comprises a platinum metal layer or a gold metal layer, and the thickness of the third metal layer is [50nm, 400nm].

[0009] In one possible implementation, the metal lead includes a first metal layer and a second metal layer, the length of the metal lead is [5mm, 20mm], and the width of the metal lead is [0.01mm, 0.05mm].

[0010] In one possible implementation, in a plane perpendicular to the axis of the wafer, the area of ​​the counter electrode is larger than the area of ​​the working electrode, and the area of ​​the working electrode is larger than the area of ​​the reference electrode.

[0011] In one possible implementation, the counter electrode, the working electrode, the reference electrode, and the electrode terminal block are rectangular structures; the length of the counter electrode is [1mm, 2mm], and the width of the counter electrode is [0.1mm, 0.5mm]; the length of the working electrode is [0.8mm, 1.8mm], and the width of the working electrode is [0.1mm, 0.4mm]; the length of the reference electrode is [0.6mm, 1.6mm], and the width of the reference electrode is [0.1mm, 0.3mm]; the length of the electrode terminal block is [1mm, 2mm], and the width of the electrode terminal block is [0.4mm, 1mm].

[0012] In one possible implementation, the method further includes: forming a silver metal layer on the bottom electrode corresponding to the reference electrode, wherein the thickness of the silver metal layer is [2μm, 6μm], the area of ​​the silver metal layer is less than or equal to the area of ​​the bottom electrode, and the bottom electrode is formed by the first metal layer, the second metal layer and the third metal layer; chlorinating the surface of the silver metal layer to form a silver chloride layer, so that the bottom electrode, the silver metal layer and the silver chloride layer form the reference electrode, wherein the thickness of the silver chloride layer is [1μm, 3μm].

[0013] In one possible implementation, the insulating encapsulation layer is made of photosensitive polyimide and has a thickness of [8μm, 10μm].

[0014] In one possible implementation, the thinning process on the second surface of the wafer includes: forming a protective layer on the insulating encapsulation layer, wherein the protective layer includes a water-soluble protective adhesive and the thickness of the protective layer is [6μm, 8μm]; and thinning the wafer on the second surface of the wafer, wherein the thickness of the wafer after the thinning process is [20μm, 50μm].

[0015] In one possible implementation, after coating the second surface of the thinned wafer with a flexible reinforcement layer, the wafer is cut to obtain at least one semiconductor device, which includes: after coating the second surface of the thinned wafer with a flexible reinforcement layer, the wafer is cut from the first surface of the wafer to the second surface, wherein the thickness of the flexible reinforcement layer is [25μm, 100μm]; after cutting the wafer, the water-soluble protective adhesive is removed to obtain at least one semiconductor device.

[0016] In one possible implementation, the functional membrane layer includes: a reaction catalyst, an anti-interference membrane, and an analyte permeation membrane.

[0017] In one possible implementation, the reaction catalyst includes glucose oxidase.

[0018] In one possible implementation, the reaction catalyst includes a dopamine reaction catalyst.

[0019] According to a second aspect of the present application, an implantable detection device is provided, comprising: a substrate, an insulating layer, an electrode assembly, an insulating encapsulation layer, a flexible reinforcement layer, and a functional film layer; the substrate is formed by dicing a wafer; the insulating layer is formed on a first surface of the substrate; the electrode assembly is formed on the insulating layer, wherein the electrode assembly includes a counter electrode, a working electrode, and a reference electrode, the counter electrode, the working electrode, and the reference electrode being connected to different electrode terminals via metal leads; the insulating layer covers the electrode assembly, wherein an opening is provided on the insulating encapsulation layer at a position opposite to the counter electrode, the working electrode, the reference electrode, and the electrode terminal; the flexible reinforcement layer is formed on a second surface of the substrate; the functional film layer is formed on the insulating layer, wherein the functional film layer is in contact with the counter electrode, the working electrode, and the reference electrode.

[0020] According to a third aspect of the embodiments of this application, an implantable detection system is provided, comprising: an implantable detection device and a detection terminal as described in the second aspect of the embodiments of this application; the detection terminal is electrically connected to the electrode terminal block of the implantable detection device; the detection terminal includes a processing unit, a power supply unit, and a communication unit; the power supply unit is used to supply power to the detection terminal and the implantable detection device; the processing unit is used to process the detection data of the implantable detection device; and the communication unit is used to send the detection results generated by the processing unit to a user terminal.

[0021] According to the method for fabricating an implantable detector device provided in this application, an insulating layer is formed on one surface of a wafer through an insulating treatment. Then, at least one electrode group is formed on the insulating layer and the electrode group is insulated and encapsulated, thereby obtaining a wafer including the electrode group. The other surface of the wafer is thinned, thereby giving the wafer a certain degree of flexibility. After forming a flexible reinforcement layer on the surface of the thinned wafer, the wafer is cut to obtain multiple semiconductor devices, and a functional film layer is formed on the semiconductor devices to obtain an implantable detector device. Since the implantable detector device is formed on a wafer, i.e., a rigid material, the process is simpler than the prior art of fabricating implantable detector devices based on organic flexible substrates. After the device is fabricated, the electrode group and the thinned single-crystal silicon are a whole, and there is no need to separate the electrode group. Therefore, the yield is higher and the cost is lower. Furthermore, due to the coating of the flexible reinforcement layer, the flexibility and biocompatibility of the thinned wafer can be improved, and the breakage and chipping of the implantable detector device during repeated bending in the implanted body can be avoided, thus improving the practicality of the implantable detector device. Attached Figure Description

[0022] To more clearly illustrate the technical solutions in the embodiments of this application or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments recorded in the embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings.

[0023] Figure 1 This is a flowchart illustrating a method for manufacturing an implantable detection device according to an embodiment of this application;

[0024] Figure 2 This is a top view of an electrode assembly provided in an embodiment of this application;

[0025] Figure 3 This is a top view of an insulating encapsulation layer provided in an embodiment of this application;

[0026] Figure 4 This is a cross-sectional view of an insulating encapsulation layer provided in an embodiment of this application;

[0027] Figure 5 This is a schematic diagram of an insulating layer provided in an embodiment of this application;

[0028] Figure 6 This is a cross-sectional view of an electrode assembly provided in an embodiment of this application;

[0029] Figure 7 This is a cross-sectional view of another electrode assembly provided in an embodiment of this application;

[0030] Figure 8 This is a top view of another electrode assembly provided in an embodiment of this application;

[0031] Figure 9 This is a top view of another electrode assembly provided in the embodiments of this application;

[0032] Figure 10 This is a cross-sectional view of an electrode assembly including a silver chloride layer provided in an embodiment of this application;

[0033] Figure 11 This is a cross-sectional view of an electrode assembly including a protective layer provided in an embodiment of this application;

[0034] Figure 12 This is a cross-sectional view of a semiconductor device including a flexible reinforcement layer provided in an embodiment of this application;

[0035] Figure 13 This is a schematic diagram of a wafer provided in an embodiment of this application;

[0036] Figure 14 This is a cross-sectional view of an implantable detection device provided in an embodiment of this application;

[0037] Figure 15 This is a schematic diagram of an implantable detection system provided in an embodiment of this application. Detailed Implementation

[0038] To enable those skilled in the art to better understand the technical solutions in the embodiments of this application, the technical solutions in the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this application, and not all embodiments. Based on the embodiments of this application, all other embodiments obtained by those skilled in the art should fall within the protection scope of the embodiments of this application.

[0039] The terminology used in this application is for the purpose of describing particular embodiments only and is not intended to be limiting of the application. The singular forms “a,” “the,” and “the” used in this application and the appended claims are also intended to include the plural forms unless the context clearly indicates otherwise. It should also be understood that the term “and / or” as used herein refers to and includes any or all possible combinations of one or more of the associated listed items.

[0040] It should be understood that although the terms first, second, third, etc., may be used in this application to describe various information, such information should not be limited to these terms. These terms are only used to distinguish information of the same type from one another. For example, without departing from the scope of this application, first information may also be referred to as second information, and similarly, second information may also be referred to as first information. Depending on the context, the word "if" as used herein may be interpreted as "when," "when," or "in response to determination."

[0041] As mentioned earlier, with the improvement of people's living standards, the incidence of diabetes is also increasing, and blood glucose monitoring is receiving more and more attention. Blood glucose testing, as an important means of comprehensive diabetes management, plays an extremely important role in the diagnosis, control, and treatment of diabetes. Long-term continuous dynamic blood glucose monitoring can effectively reduce or delay the occurrence of diabetic complications and improve patients' quality of life. Currently, by implanting an extremely fine flexible probe into the subcutaneous tissue of the human body using a transmitter, a minimally invasive implantable blood glucose detector on the probe can achieve continuous 24 / 7 monitoring of blood glucose concentration. This probe is virtually undetectable by the human body and will not affect people's daily lives. It has advantages such as minimal invasiveness, low price, high sensitivity, and strong anti-interference. However, existing implantable minimally invasive blood glucose detectors are based on organic flexible substrates, which are relatively complex to manufacture and have a low yield rate.

[0042] This application provides a method for fabricating an implantable detection device. An insulating layer is formed on one surface of a wafer through an insulating treatment. Then, at least one electrode assembly is formed on the insulating layer, and the electrode assembly is insulated and encapsulated, thereby obtaining a wafer including the electrode assembly. The other surface of the wafer is thinned to give it a certain degree of flexibility. A flexible reinforcement layer is formed on the surface of the thinned wafer. The wafer is then cut to obtain multiple semiconductor devices, and a functional film layer is formed on the semiconductor devices to obtain the implantable detection device. Since the implantable detection device is formed on a wafer, i.e., a rigid material, the process is simpler compared to the prior art of fabricating implantable detection devices based on organic flexible substrates. Furthermore, after device fabrication, the electrode assembly and the thinned single-crystal silicon are a single unit, eliminating the need to separate the electrode assembly. Therefore, the yield rate is higher and the cost is lower. Moreover, the coating with a flexible reinforcement layer improves the flexibility and biocompatibility of the thinned wafer and prevents breakage and chipping during repeated bending within the implanted body, thus improving the practicality of the implantable detection device.

[0043] The following examples illustrate the insulation layer processing method provided in this application.

[0044] Figure 1 This is a flowchart illustrating a method for manufacturing an implantable detection device according to an embodiment of this application, such as... Figure 1 As shown, the method for manufacturing this implantable detection device includes the following steps 101 to 106:

[0045] Step 101: Form an insulating layer on the first surface of the wafer.

[0046] An insulating layer is formed on the first surface of a single-crystal silicon wafer.

[0047] Step 102: Form at least one electrode group on the insulating layer.

[0048] Figure 2 This is a top view of an electrode assembly provided in an embodiment of this application, such as... Figure 2 As shown, the electrode group is formed on the insulating layer 201. The electrode group includes a counter electrode 202, a working electrode 203 and a reference electrode 204. The counter electrode 202, the working electrode 203 and the reference electrode 204 are respectively connected to different electrode terminals 206 through metal leads 205.

[0049] Step 103: Insulate and encapsulate the electrode assembly to form an insulating encapsulation layer covering the electrode assembly.

[0050] Figure 3 This is a top view of an insulating encapsulation layer provided in an embodiment of this application. Figure 4 This is a cross-sectional view of an insulating encapsulation layer provided in an embodiment of this application, such as... Figure 3 and Figure 4 As shown, openings are provided on the insulating encapsulation layer 301 at positions opposite to the counter electrode 202, working electrode 203, reference electrode 204, and electrode terminal block 206. It should be understood that all positions except the counter electrode 202, working electrode 203, reference electrode 204, and electrode terminal block 206 are insulated and encapsulated, that is, the insulating layer 201 around the electrode group is also encapsulated within the insulating encapsulation layer 301.

[0051] Step 104: Thin the wafer on the second surface of the wafer.

[0052] Thinning treatment is performed on the second surface of the single-crystal silicon wafer. The second surface is opposite to the first surface, that is, the second surface is the surface where the insulating layer 201 is not formed. Thinning treatment means reducing the thickness of the wafer. It should be understood that when the thickness of the wafer is reduced, the wafer changes from rigid to having a certain degree of flexibility.

[0053] Step 105: After forming a flexible reinforcement layer on the second surface of the thinned wafer, the wafer is cut to obtain at least one semiconductor device.

[0054] Multiple semiconductor devices are formed on a wafer at one time. Therefore, the electrode group formed on the insulating layer 201 is multiple electrode groups. After forming a flexible reinforcement layer on the second surface of the thinned wafer, the wafer is cut to obtain at least one semiconductor device. Each semiconductor device includes an electrode group, namely, a counter electrode 202, a working electrode 203 and a reference electrode 204.

[0055] Step 106: Form a functional film layer on the insulating encapsulation layer of at least one semiconductor device to obtain at least one implantable detection device.

[0056] A functional film is coated on the insulating layer 201 of each semiconductor device. The functional film can perform specific functions, such as filtering some substances in the blood to detect specific substances. When the functional film is formed on the insulating layer 201, the functional film is in contact with the counter electrode 202, the working electrode 203 and the reference electrode 204, and the functional film is not in contact with the electrode terminal block 206 to ensure that the implantable detection device can be connected to the outside.

[0057] In this embodiment, an insulating layer 201 is formed on one surface of a wafer by performing an insulating treatment. Then, at least one electrode group is formed on the insulating layer 201 and the electrode group is insulated and encapsulated, thereby obtaining a wafer including the electrode group. The other surface of the wafer is thinned, thereby giving the wafer a certain degree of flexibility. After forming a flexible reinforcement layer on the surface of the thinned wafer, the wafer is cut to obtain multiple semiconductor devices, and a functional film layer is formed on the semiconductor devices to obtain an implantable detector device. Since the implantable detector device is formed on a wafer, i.e., a rigid material, the process is simpler than the prior art of fabricating implantable detector devices based on organic flexible substrates. After the device is fabricated, the electrode group and the thinned single crystal silicon are a whole, and there is no need to separate the electrode group. Therefore, the yield is higher and the cost is lower. Furthermore, due to the coating of the flexible reinforcement layer, the flexibility and biocompatibility of the thinned wafer can be improved, and the breakage and chipping of the implantable detector device during repeated bending in the implanted body can be avoided, thus improving the practicality of the implantable detector device.

[0058] Figure 5 This is a schematic diagram of an insulating layer provided in an embodiment of this application, such as... Figure 5 As shown, when an insulating layer 201 is formed on the first surface of the wafer 200, a silicon dioxide layer can be generated on the first surface, wherein the thickness of the silicon dioxide layer is [20nm, 100nm], and the thickness of the wafer 200 is [100μm, 200μm].

[0059] It should be understood that when generating the silicon dioxide layer, an insulating layer 201 can be formed on the surface of the wafer 200 by methods such as thermal oxidation or chemical vapor deposition. The specific generation method is not limited in the embodiments of this application. It should also be understood that in order to balance the insulation performance and the flexibility of the implantable detection device, the thickness of the insulating layer 201, i.e., the silicon dioxide layer, is [20nm, 100nm].

[0060] In this embodiment, a silicon dioxide layer is formed on the first surface of the wafer 200, thereby achieving insulation between the electrode group and the wafer 200. Furthermore, using the silicon dioxide layer as the insulating layer 201 is a relatively simple and low-cost process, reducing the complexity of the process for generating the implantable detector device.

[0061] Figure 6 This is a cross-sectional view of an electrode assembly provided in an embodiment of this application, such as... Figure 6 As shown, the electrode assembly includes a first metal layer 601, a second metal layer 602, and a third metal layer 603.

[0062] When forming at least one electrode group on the insulating layer 201, a first metal layer 601 may be deposited on the insulating layer 201, wherein the first metal layer 601 includes a chromium metal layer or a titanium metal layer and the thickness of the first metal layer 601 is [10nm, 50nm]. A second metal layer 602 may be deposited on the first metal layer 601, wherein the second metal layer 602 includes a gold metal layer or a copper metal layer and the thickness of the second metal layer 602 is [50nm, 300nm]. A third metal layer 603 may be deposited on the second metal layer 602 to form at least one electrode group, wherein the counter electrode 202, the working electrode 203, the reference electrode 204 and the electrode terminal block 206 all include the first metal layer 601, the second metal layer 602 and the third metal layer 603, wherein the third metal layer 603 includes a platinum metal layer or a gold metal layer and the thickness of the third metal layer 603 is [50nm, 400nm].

[0063] The metal layer deposition process on the insulating layer 201 includes, but is not limited to, sputtering, evaporation, and screen printing. The electrode pattern fabrication process includes, but is not limited to, dry etching, wet etching, and metal stripping. It should be understood that the three metal layers can be fabricated using the same process, different processes, or a combination of the above processes. For example, the first metal layer 601 can be fabricated using sputtering, the second metal layer 602 can be fabricated using evaporation, and the third metal layer 603 can be fabricated using screen printing, etc. Optionally, three metal layers can be deposited using sputtering to improve step coverage.

[0064] It should be understood that the first metal layer 601 can ensure the adhesion of the second metal layer 602 and the third metal layer 603. The second metal layer 602 mainly plays a conductive role, while the third metal layer 603 is a special metal layer that can react with or catalyze the reaction of the object to be detected in order to achieve the corresponding electrode function.

[0065] In one example, in order to balance the flexibility of the first metal layer 601, the second metal layer 602 and the required functions, the thickness of the first metal layer 601 is preferably [20nm, 40nm], the thickness of the second metal layer 602 is preferably [100nm, 200nm], and the thickness of the third metal layer 603 is preferably [100nm, 250nm].

[0066] In this embodiment, a first metal layer 601, a second metal layer 602, and a third metal layer 603 are sequentially deposited on the insulating layer 201, thereby forming an electrode assembly. Since the first metal layer 601, the second metal layer 602, and the third metal layer 603 are relatively thin, the flexibility of the metal layers can be improved. While fulfilling the electrode function, the overall flexibility of the implantable detection device is ensured. Moreover, the process of depositing the metal layers is relatively simple, reducing the process complexity of generating the implantable detection device.

[0067] In one possible implementation, the metal lead 205 includes a first metal layer 601 and a second metal layer 602, the length of the metal lead 205 is [5mm, 20mm], and the width of the metal lead 205 is [0.01mm, 0.05mm].

[0068] Figure 7 This is a cross-sectional view of another electrode assembly provided in an embodiment of this application, such as... Figure 7 As shown, the metal lead 205 includes only the first metal layer 601 and the second metal layer 602. Since the first metal layer 601 is for fixing, the second metal layer 602 plays the main role in conduction, and the third metal layer 603 is a special metal layer that completes the electrode function, the metal lead 205 includes the first metal layer 601, the second metal layer 602 and the third metal layer 603. The conductivity is not much different from that of the metal lead 205 which only includes the first metal layer 601 and the second metal layer 602. Therefore, since the metal lead 205 has a high flexibility requirement, including only the first metal layer 601 and the second metal layer 602 can prevent the metal wire from breaking and improve the service life of the implantable detection device.

[0069] It should be understood that, in order to balance the flexibility and conductivity of the metal lead 205, the length of the metal lead 205 is [5mm, 20mm], and the width of the metal lead 205 is [0.01mm, 0.05mm].

[0070] It should be noted that when depositing the first metal layer 601, the second metal layer 602, and the third metal layer 603, the area above the metal lead 205 can be covered with photoresist or a mask, so that only the first metal layer 601 and the second metal layer 602 are deposited, and the third metal layer 603 is not deposited. This allows the metal lead 205 to include only the first metal layer 601 and the second metal layer 602.

[0071] In this embodiment, the metal lead 205 includes a first metal layer 601 and a second metal layer 602, which can improve the flexibility of the metal lead 205, prevent the metal lead 205 from breaking when it is bent with the implantable probe, and improve the service life of the implantable probe.

[0072] In one possible implementation, in a plane perpendicular to the axis of the wafer, the area of ​​the counter electrode 202 is larger than the area of ​​the working electrode 203, and the area of ​​the working electrode 203 is larger than the area of ​​the reference electrode 204.

[0073] In the embodiments of this application, the counter electrode 202 and the working electrode 203 form a polarization circuit to transport electrons. The working electrode 203 and the reference electrode 204 form a measurement circuit for testing the electrochemical reaction process. The area of ​​the counter electrode 202 is larger than the area of ​​the working electrode 203, and the area of ​​the working electrode 203 is larger than the area of ​​the reference electrode 204, thereby ensuring the normal operation of the implantable detection device.

[0074] In one possible implementation, such as Figure 2 As shown, the counter electrode 202, working electrode 203, reference electrode 204, and electrode terminal block 206 are rectangular structures. The length of the counter electrode 202 is [1mm, 2mm], and the width of the counter electrode 202 is [0.1mm, 0.5mm]. The length of the working electrode 203 is [0.8mm, 1.8mm], and the width of the working electrode 203 is [0.1mm, 0.4mm]. The length of the reference electrode 204 is [0.6mm, 1.6mm], and the width of the reference electrode 204 is [0.1mm, 0.3mm].

[0075] It should be understood that, in order to balance the working performance of the electrode assembly and the overall size of the implantable detection device, the length of the counter electrode 202 is [1mm, 2mm], the width of the counter electrode 202 is [0.1mm, 0.5mm], the length of the working electrode 203 is [0.8mm, 1.8mm], the width of the working electrode 203 is [0.1mm, 0.4mm], the length of the reference electrode 204 is [0.6mm, 1.6mm], and the width of the reference electrode 204 is [0.1mm, 0.3mm]. It should also be understood that the area of ​​the counter electrode 202 is larger than the area of ​​the working electrode 203, and the area of ​​the working electrode 203 is larger than the area of ​​the reference electrode 204.

[0076] Correspondingly, the length of the electrode terminal block 206 is [1mm, 2mm], and the width of the electrode terminal block 206 is [0.4mm, 1mm].

[0077] In one example, Figure 8 This is a top view of another electrode assembly provided in an embodiment of this application, such as... Figure 8 As shown, the counter electrode 202, working electrode 203, and reference electrode 204 can be irregularly shaped. Figure 9 This is a top view of another electrode assembly provided in the embodiments of this application, such as... Figure 9 As shown, the counter electrode 202, working electrode 203 and reference electrode 204 can be a ring structure. It should be understood that the shapes of the counter electrode 202, working electrode 203 and reference electrode 204 can be set as needed, as long as the area of ​​the counter electrode 202 is greater than the area of ​​the working electrode 203 and the area of ​​the working electrode 203 is greater than the area of ​​the reference electrode 204.

[0078] In this embodiment, the counter electrode 202, working electrode 203, reference electrode 204, and electrode connector are rectangular structures. The counter electrode 202 has a length of [1mm, 2mm] and a width of [0.1mm, 0.5mm]. The working electrode 203 has a length of [0.8mm, 1.8mm] and a width of [0.1mm, 0.4mm]. The reference electrode 204 has a length of [0.6mm, 1.6mm] and a width of [0.1mm, 0.3mm]. The electrode connector has a length of [1mm, 2mm] and a width of [0.4mm, 1mm]. This balances the working performance and area occupied by the electrode assembly, reducing the overall size of the implantable detection device.

[0079] In one possible implementation, the method for fabricating the implantable detection device further includes forming a silver metal layer 1001 on the bottom electrode 1003 corresponding to the reference electrode 204, wherein the thickness of the silver metal layer 1001 is [2μm, 6μm], the area of ​​the silver metal layer 1001 is less than or equal to the area of ​​the bottom electrode 1003, the bottom electrode 1003 is formed by a first metal layer 601, a second metal layer 602 and a third metal layer 603, and the surface of the silver metal layer 1001 is chlorinated to form a silver chloride layer 1002, so that the bottom electrode 1003, the silver metal layer 1001 and the silver chloride layer 1002 form the reference electrode 204, wherein the thickness of the silver chloride layer 1002 is [1μm, 3μm].

[0080] Figure 10 This is a cross-sectional view of an electrode assembly including a silver chloride layer provided in an embodiment of this application, as shown below. Figure 10 As shown, a silver metal layer 1001 covers the bottom electrode 1003. The bottom electrode 1003 is formed by a first metal layer 601, a second metal layer 602 and a third metal layer 603. A silver chloride layer 1002 is formed on the silver metal layer 1001. Thus, the bottom electrode 1003, the silver metal layer 1001 and the silver chloride layer 1002 form a reference electrode 204.

[0081] The deposition methods for the silver metal layer 1001 include, but are not limited to, sputtering, vapor deposition, screen printing, and electroplating, with sputtering being preferred. The electrode pattern fabrication process includes, but is not limited to, dry etching, wet etching, and metal stripping, with metal stripping being preferred.

[0082] When the length of the bottom electrode 1003 is [0.6mm, 1.6mm] and the width of the bottom electrode 1003 is [0.1mm, 0.3mm], the length of the silver metal layer 1001 is [0.6mm, 1.6mm] and the width of the silver metal layer 1001 is [0.1mm, 0.3mm]. Preferably, the length of the silver metal layer 1001 is [0.5mm, 1.5mm] and the width of the silver metal layer 1001 is [0.05mm, 0.2mm]. It should be noted that the area of ​​the silver metal layer 1001 needs to be less than or equal to the area of ​​the bottom electrode 1003.

[0083] The method for converting part of the silver metal layer 1001 into the silver chloride layer 1002 includes, but is not limited to, electroconversion and chemical conversion, with chemical conversion being preferred. The conversion solution includes, but is not limited to, FeCl3 solution, KCl solution and NaClO solution, with a solution concentration of 0.1 to 3 mol / L, preferably 1 mol / L.

[0084] In this embodiment of the application, the method for fabricating the implantable detector further includes forming a silver metal layer 1001 on the bottom electrode 1003 and chlorinating the surface of the silver metal layer 1001 to form a silver chloride layer 1002. This allows the bottom electrode 1003, the silver metal layer 1001, and the silver chloride layer 1002 to form a reference electrode 204. The silver chloride layer 1002 and the silver metal layer 1001 can form a known potential that is close to an ideal non-polarized electrode, thereby providing a stable potential. This ensures that the potential of the reference electrode 204 is stable and known.

[0085] In one possible implementation, the insulating encapsulation layer 301 is made of photosensitive polyimide, and the thickness of the insulating encapsulation layer 301 is [8μm, 10μm].

[0086] The insulating encapsulation layer 301 can be formed by processes including but not limited to spin coating and blade coating. The insulating encapsulation layer 301 needs to have a low Young's modulus, good biocompatibility, and good corrosion resistance, and is preferably a photosensitive polyimide or its derivative. The openings on the insulating encapsulation layer 301 corresponding to the positions of the counter electrode 202, working electrode 203, reference electrode 204, and electrode terminal block 206 are formed by processes including but not limited to laser ablation and photolithography. The thickness of the insulating encapsulation layer 301 is [8μm, 10μm], and the length and width of each opening are the same as or slightly smaller than the size of the metal electrode below it.

[0087] In this embodiment, the insulating encapsulation layer 301 is made of photosensitive polyimide, and the thickness of the insulating encapsulation layer 301 is [8μm, 10μm]. This ensures the insulation of the implantable detection device, as well as its low Young's modulus, good biocompatibility, and good corrosion resistance, thereby improving the service life of the implantable detection device.

[0088] In one possible implementation, when the wafer is thinned on the second surface of the wafer, a protective layer 1101 can be formed on the insulating encapsulation layer 301, wherein the protective layer 1101 includes a water-soluble protective adhesive and the thickness of the protective layer 1101 is [6μm, 8μm]. The wafer is thinned on the second surface of the wafer, wherein the thickness of the wafer after the thinning treatment is [20μm, 50μm].

[0089] Figure 11 This is a cross-sectional view of an electrode assembly including a protective layer provided in an embodiment of this application, such as... Figure 11 As shown, a protective layer 1101 is formed on the insulating encapsulation layer 301, which covers the entire protective layer 1101 and the electrode assembly. The material of the protective layer 1101 is preferably a high-temperature resistant water-soluble protective adhesive.

[0090] After forming the protective layer 1101, the second surface of the wafer 200 is thinned. The thinning process includes, but is not limited to, mechanical polishing, reactive ion etching, etc. The thickness of the wafer 200 after the thinning process is [20μm, 50μm], which is lower than the thickness of the wafer 200 before the thinning process [100μm, 200μm], thus reducing rigidity and increasing flexibility.

[0091] In this embodiment, a protective layer 1101 is formed on the insulating encapsulation layer 301, thereby protecting the electrode assembly and other structures during the thinning process of the second surface of the wafer 200, preventing oxidation or damage to the electrode assembly. After the protective layer 1101 is formed, the second surface of the wafer 200 is thinned, thereby reducing the rigidity of the wafer 200 and increasing its flexibility, ensuring the flexibility of the implantable detection device.

[0092] In one possible implementation, after forming a flexible reinforcement layer on the second surface of the thinned wafer, the wafer is cut to obtain at least one semiconductor device. This can be achieved by coating the flexible reinforcement layer 1201 on the second surface of the thinned wafer 200, and then cutting the wafer 200 from the first surface to the second surface. The thickness of the flexible reinforcement layer 1201 is [25μm, 100μm]. After cutting the wafer 200, the water-soluble protective adhesive is removed to obtain at least one semiconductor device.

[0093] Figure 12 This is a cross-sectional view of a semiconductor device including a flexible reinforcement layer provided in an embodiment of this application, such as... Figure 12 As shown, the semiconductor device includes a flexible reinforcement layer 1201.

[0094] The formation process of the flexible reinforcing layer 1201 includes, but is not limited to, laminating an adhesive dry film, spin-coating a liquid organic polymer and curing it. The flexible reinforcing layer 1201 needs to have a low Young's modulus, good biocompatibility and corrosion resistance. The preferred materials are polymethyl methacrylate, polyimide, polyethylene terephthalate, polyethylene naphthalate, etc. When coating the flexible reinforcing layer 1201 on the second surface of the wafer 200, the above-mentioned materials can be spin-coated in liquid form, or pressure-sensitive adhesive can be directly processed on its dry film and then bonded to the thinned wafer 200.

[0095] After the wafer 200 including the flexible reinforcement layer 1201 is cut from the side including the protective layer 1101, the water-soluble protective adhesive is removed. In one example, the device can be placed in deionized water to remove the water-soluble protective adhesive. Then, the device with the protective layer 1101 removed is placed in an inert atmosphere and dried at low temperature to obtain a semiconductor device.

[0096] Figure 13 This is a schematic diagram of a wafer provided in an embodiment of this application, as shown below. Figure 13 As shown, after the wafer 200 is cut, at least one semiconductor device 300 can be obtained.

[0097] Optionally, the substrate of the semiconductor device 300 is designed to be slightly larger than the size of the electrode group, and preferably, a space of [20μm, 50μm] is left between the edge of each electrode group and the edge of the cut substrate.

[0098] In this embodiment, after the flexible reinforcement layer 1201 is coated on the second surface of the thinned wafer 200, the wafer 200 is cut and the protective layer 1101 is removed from the cut wafer 200 to obtain multiple semiconductor devices 300. Since the flexible reinforcement layer 1201 is coated, the flexibility and biocompatibility of the thinned wafer 200 can be improved, and the breakage and chipping of the wafer can also be avoided when the implantable detection device is repeatedly bent in the body.

[0099] In one possible implementation, the functional membrane layer includes: a reaction catalyst, an anti-interference membrane, and an analyte permeation membrane.

[0100] In the embodiments of this application, the functional membrane layer includes: a reaction catalyst, an anti-interference membrane, and an analyte permeation membrane, thereby ensuring that the substance to be detected is filtered and reacted, and ensuring that the implantable detection device can detect the corresponding substance to be detected.

[0101] In one possible implementation, the reaction catalyst includes glucose oxidase.

[0102] In the embodiments of this application, the reaction catalyst includes glucose oxidase, thereby enabling the implantable detection device to detect the glucose content in the human body, realizing long-term continuous dynamic blood glucose monitoring.

[0103] In one possible implementation, the reaction catalyst includes a dopamine reaction catalyst.

[0104] In the embodiments of this application, the reaction catalyst includes a dopamine reaction catalyst, thereby enabling the implantable detection device to detect the dopamine content in the human body, realizing long-term continuous dynamic dopamine monitoring of the human body.

[0105] Figure 14 This is a cross-sectional view of an implantable detection device provided in an embodiment of this application, such as... Figure 14 As shown, the implantable device includes: a substrate 2001, an insulating layer 201, an electrode assembly, an insulating encapsulation layer 301, a flexible reinforcement layer 1201, and a functional film layer 1401.

[0106] The substrate 2001 is formed by cutting a wafer 200. An insulating layer 201 is formed on the first surface of the substrate 2001. An electrode group is formed on the insulating layer 201, wherein the electrode group includes a counter electrode 202, a working electrode 203, and a reference electrode 204. The counter electrode 202, the working electrode 203, and the reference electrode 204 are respectively connected to different electrode terminals 206 through metal leads 205. The insulating layer 201 covers the electrode group. An opening is provided on the insulating encapsulation layer 301 at a position opposite to the counter electrode 202, the working electrode 203, the reference electrode 204, and the electrode terminal 206. A flexible reinforcement layer 1201 is formed on the second surface of the substrate 2001. A functional film layer 1401 is formed on the insulating layer 201, wherein the functional film layer 1401 is in contact with the counter electrode 202, the working electrode 203, and the reference electrode 204.

[0107] It should be noted that the above-mentioned implantable detection device can be manufactured by the implantable detection device manufacturing method in any of the above embodiments. Since it is based on the same concept as the above-mentioned implantable detection device manufacturing method embodiments, the specific details can be found in the descriptions in the above-mentioned implantable detection device manufacturing method embodiments, and will not be repeated here.

[0108] Figure 15 This is a schematic diagram of an implantable detection system provided in an embodiment of this application, as shown below. Figure 15 As shown, the implantable detection system includes the implantable detection device 400 and the detection terminal 500 in the above embodiments.

[0109] The detection terminal 500 is electrically connected to the electrode terminal block of the implantable detection device 400. The detection terminal 500 includes a processing unit 1502, a power supply unit 1501, and a communication unit 1503. The power supply unit 1501 can supply power to the detection terminal 500 and the implantable detection device 400. The processing unit 1502 can process the detection data of the implantable detection device 400. The communication unit 1503 can send the detection results generated by the processing unit 1502 to the user terminal.

[0110] Optionally, the communication unit 1503 can send the detection results to the user terminal via a wireless network, which is not limited in this embodiment.

[0111] In this embodiment of the application, the implantable detection system can dynamically detect the human body through the implantable detection device 400, and the detection terminal 500 can power the implantable detection device 400 and send the detection results to the user terminal, thereby realizing dynamic detection of the human body.

[0112] It should be noted that, depending on the implementation needs, the various components / steps described in the embodiments of this application can be broken down into more components / steps, or two or more components / steps or parts of the operation of components / steps can be combined into new components / steps to achieve the purpose of the embodiments of this application.

[0113] Those skilled in the art will recognize that the units and method steps of the various examples described in conjunction with the embodiments disclosed herein can be implemented in electronic hardware, or a combination of computer software and electronic hardware. Whether these functions are implemented in hardware or software depends on the specific application and design constraints of the technical solution. Those skilled in the art can use different methods to implement the described functions for each specific application, but such implementation should not be considered beyond the scope of the embodiments of this application.

[0114] The above embodiments are only used to illustrate the embodiments of this application, and are not intended to limit the embodiments of this application. Those skilled in the art can make various changes and modifications without departing from the spirit and scope of the embodiments of this application. Therefore, all equivalent technical solutions also fall within the scope of the embodiments of this application, and the patent protection scope of the embodiments of this application should be defined by the claims.

Claims

1. A method for manufacturing an implantable detection device, characterized in that, include: An insulating layer is formed on the first surface of the wafer; At least one electrode group is formed on the insulating layer, wherein the electrode group includes a counter electrode, a working electrode and a reference electrode, and the counter electrode, the working electrode and the reference electrode are respectively connected to different electrode terminals via metal leads; The electrode assembly is insulated and encapsulated to form an insulating encapsulation layer covering the electrode assembly, wherein the insulating encapsulation layer has an opening at a position opposite to the counter electrode, the working electrode, the reference electrode and the electrode terminal block; The wafer is thinned on a second surface, wherein the second surface is opposite to the first surface; After forming a flexible reinforcement layer on the second surface of the thinned wafer, the wafer is cut to obtain at least one semiconductor device, wherein each semiconductor device includes one of the electrode groups; A functional film layer is formed on the insulating encapsulation layer of the at least one semiconductor device to obtain at least one implantable detector device, wherein the functional film layer is in contact with the counter electrode, the working electrode and the reference electrode.

2. The method according to claim 1, characterized in that, The formation of an insulating layer on the first surface of the wafer includes: A silicon dioxide layer is formed on the first surface, wherein the thickness of the silicon dioxide layer is [20nm, 100nm], and the thickness of the wafer is [100μm, 200μm].

3. The method according to claim 1, characterized in that, The formation of at least one electrode group on the insulating layer includes: A first metal layer is deposited on the insulating layer, wherein the first metal layer comprises a chromium metal layer or a titanium metal layer, and the thickness of the first metal layer is [10nm, 50nm]. A second metal layer is deposited on the first metal layer, wherein the second metal layer comprises a gold metal layer or a copper metal layer, and the thickness of the second metal layer is [50nm, 300nm]. A third metal layer is deposited on the second metal layer to form at least one of the electrode groups, wherein the counter electrode, the working electrode, the reference electrode and the electrode terminal block all include the first metal layer, the second metal layer and the third metal layer, the third metal layer includes a platinum metal layer or a gold metal layer, and the thickness of the third metal layer is [50nm, 400nm].

4. The method according to claim 3, characterized in that, The metal lead includes a first metal layer and a second metal layer, the length of the metal lead is [5mm, 20mm], and the width of the metal lead is [0.01mm, 0.05mm].

5. The method according to claim 1, characterized in that, In a plane perpendicular to the axis of the wafer, the area of ​​the counter electrode is larger than the area of ​​the working electrode, and the area of ​​the working electrode is larger than the area of ​​the reference electrode.

6. The method according to claim 5, characterized in that, The counter electrode, the working electrode, the reference electrode, and the electrode terminal block are rectangular in structure; The length of the counter electrode is [1mm, 2mm], and the width of the counter electrode is [0.1mm, 0.5mm]. The length of the working electrode is [0.8mm, 1.8mm], and the width of the working electrode is [0.1mm, 0.4mm]. The length of the reference electrode is [0.6mm, 1.6mm], and the width of the reference electrode is [0.1mm, 0.3mm]. The length of the electrode terminal block is [1mm, 2mm], and the width of the electrode terminal block is [0.4mm, 1mm].

7. The method according to claim 3, characterized in that, The method further includes: A silver metal layer is formed on the bottom electrode corresponding to the reference electrode, wherein the thickness of the silver metal layer is [2μm, 6μm], the area of ​​the silver metal layer is less than or equal to the area of ​​the bottom electrode, and the bottom electrode is formed by the first metal layer, the second metal layer and the third metal layer; The surface of the silver metal layer is subjected to chlorination treatment to form a silver chloride layer, thereby forming the reference electrode from the bottom electrode, the silver metal layer, and the silver chloride layer, wherein the thickness of the silver chloride layer is [1 μm, 3 μm].

8. The method according to claim 1, characterized in that, The insulating encapsulation layer is made of photosensitive polyimide, and the thickness of the insulating encapsulation layer is [8μm, 10μm].

9. The method according to claim 1, characterized in that, The thinning process on the second surface of the wafer includes: A protective layer is formed on the insulating encapsulation layer, wherein the protective layer comprises a water-soluble protective adhesive and the thickness of the protective layer is [6μm, 8μm]; The wafer is thinned on the second surface of the wafer, wherein the thickness of the wafer after thinning is [20μm, 50μm].

10. The method according to claim 9, characterized in that, After forming a flexible reinforcement layer on the second surface of the thinned wafer, the wafer is cut to obtain at least one semiconductor device, including: After the wafer is thinned, a flexible reinforcement layer is coated on the second surface of the wafer. The wafer is then cut from the first surface to the second surface. The thickness of the flexible reinforcement layer is [25 μm, 100 μm]. After the wafer is cut, the water-soluble protective adhesive is removed to obtain at least one semiconductor device.

11. The method according to claim 1, characterized in that, The functional membrane layer includes: a reaction catalyst, an anti-interference membrane, and an analyte permeation membrane.

12. The method according to claim 11, characterized in that, The reaction catalyst includes glucose oxidase.

13. The method according to claim 11, characterized in that, The reaction catalyst includes a dopamine reaction catalyst.

14. An implantable detection device, characterized in that, include: Substrate, insulating layer, electrode assembly, insulating encapsulation layer, flexible reinforcement layer, and functional film layer; The substrate is formed by cutting a wafer; The insulating layer is formed on the first surface of the substrate; The electrode assembly is formed on the insulating layer, wherein the electrode assembly includes a counter electrode, a working electrode, and a reference electrode, and the counter electrode, the working electrode, and the reference electrode are respectively connected to different electrode terminals via metal leads; The insulating layer covers the electrode assembly, wherein the insulating encapsulation layer has an opening at a position opposite to the counter electrode, the working electrode, the reference electrode and the electrode terminal block; The flexible reinforcement layer is formed on the second surface of the substrate; The functional film is formed on the insulating layer, wherein the functional film is in contact with the counter electrode, the working electrode and the reference electrode.

15. An implantable detection system, characterized in that, include: The implantable detection device and detection terminal as described in claim 14; The detection terminal is electrically connected to the electrode terminal block of the implanted detection device; The detection terminal includes a processing unit, a power supply unit, and a communication unit; The power supply unit is used to supply power to the detection terminal and the implanted detection device; The processing unit is used to process the detection data of the implanted detection device; The communication unit is used to send the detection results generated by the processing unit to the user terminal.

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