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WO2025060041A1 - Capteur d'analyte structurellement amélioré à substrat multiple - Google Patents

Capteur d'analyte structurellement amélioré à substrat multiple Download PDF

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Publication number
WO2025060041A1
WO2025060041A1 PCT/CN2023/120616 CN2023120616W WO2025060041A1 WO 2025060041 A1 WO2025060041 A1 WO 2025060041A1 CN 2023120616 W CN2023120616 W CN 2023120616W WO 2025060041 A1 WO2025060041 A1 WO 2025060041A1
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WIPO (PCT)
Prior art keywords
electrode
substrate
sensor
layer
electrodes
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Application number
PCT/CN2023/120616
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English (en)
Inventor
Cuijun YANG
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Medtrum Technologies Inc
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Medtrum Technologies Inc
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Priority to PCT/CN2023/120616 priority Critical patent/WO2025060041A1/fr
Publication of WO2025060041A1 publication Critical patent/WO2025060041A1/fr
Pending legal-status Critical Current
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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
    • A61B5/1468—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue using chemical or electrochemical methods, e.g. by polarographic means
    • A61B5/1486—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue using chemical or electrochemical methods, e.g. by polarographic means using enzyme electrodes, e.g. with immobilised oxidase
    • A61B5/14865—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue using chemical or electrochemical methods, e.g. by polarographic means using enzyme electrodes, e.g. with immobilised oxidase invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0002—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
    • A61B5/0015—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network characterised by features of the telemetry system
    • A61B5/002—Monitoring the patient using a local or closed circuit, e.g. in a room or building
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
    • A61B5/14532—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue for measuring glucose, e.g. by tissue impedance measurement

Definitions

  • the invention mainly relates to the field of medical devices, in particular to a structurally enhanced analyte sensor with multi substrate.
  • the pancreas in a normal human body can automatically monitor the layer of glucose in the human blood and automatically secrete the required insulin/glucagon.
  • the pancreas does not function properly and cannot produce the insulin the body needs. Therefore, diabetes is a metabolic disease caused by abnormal pancreatic function, and diabetes is a lifelong disease. At present, there is no cure for diabetes with medical technology. The occurrence and development of diabetes and its complications can only be controlled by stabilizing blood glucose.
  • Diabetics need to have their blood glucose measured before they inject insulin into the body. At present, most of the testing methods can continuously measure blood glucose and send the data to a remote device in real time for the user to view. This method is called Continuous Glucose Monitoring (CGM) .
  • CGM Continuous Glucose Monitoring
  • the method requires the device to be attached to the skin and the probe it carries is penetrated into the tissue fluid beneath the skin.
  • the substrate material is usually coated layer by layer on the mold, and then electrodes, wires, and PADs are set.
  • the substrate material coated layer by layer may have insufficient curing, which increases the risk of substrate embrittlement in subsequent use. Once the substrate embrittlement occurs, the electrodes, wires, and PADs may be short circuited or damaged to each other, affecting the reliability of sensor detection.
  • the embodiment of the invention discloses a structurally enhanced analyte sensor with multi substrate. After the substrate is prefabricated, it is combined into a whole by pasting, which can avoid insulation failure caused by insufficient solidification of the substrate material, leading to brittle cracking, and further causing crosstalk between electrical signals between wires or electrodes, resulting in noise in the detection signal, at the same time, at least one protective layer is set on the surface of the substrate, covering at least the edge of the electrode, increasing the adhesion between the edge of the electrode and the substrate, preventing the edge of the electrode from curling, bubbling, and detaching. At the same time, the protective layer can also increase the mechanical strength of the substrate of sensor, extend the service life of the sensor, and improve the detection reliability of the sensor.
  • the invention discloses an analyte sensor, comprising: at least one layer of substrate, the substrate comprising an in vivo part and an in vitro part. At least two electrodes, located on the surface of the in vivo part, are used to penetrate subcutaneously to obtain analyte parameter information. And PADs, which are set on the surface of the in vitro part and electrically connected to the corresponding electrodes through wires. Wherein, at least two layers of substrate are combined into a whole by pasting after prefabrication. Wherein, at least one protective layer is set on the surface of the substrate, and the protective layer covers at least the edge of the electrode.
  • the electrode is an electrode array composed of electrode units.
  • At least two electrodes are arranged on substrates of different layers.
  • At least one electrode is disposed on the reverse side of the substrate.
  • the PADs corresponding to the electrodes set on the reverse side of the substrate are set on the reverse side of the substrate.
  • a secondary-PAD corresponding to the PAD is also provided on the obverse side of the substrate.
  • the PADs are electrically connected to the secondary-PADs through the side of the substrate.
  • obverse side and/or reverse side of the substrate further comprises at least two layers of secondary-substrate, with at least two electrodes arranged on different layers of secondary-substrates.
  • the electrodes are distributed on the substrate surface in a predetermined manner to avoid areas where the substrate is easy to bend.
  • the electrode comprises at least one group of electrodes with the same name.
  • the analyte sensor disclosed in the invention after prefabricating each layer or each side of the substrate is combined into a whole by pasting, which can avoid insulation failure caused by insufficient solidification of the substrate material, resulting in brittle cracking, and further leading to crosstalk between the electrical signals between the conductor or electrode, and noise in the detection signal.
  • install at least one protective layer on the substrate of sensor covering at least the edge of the electrode and avoiding the central area of the electrode to prevent edge warping, bubbling, or detaching, increasing the mechanical strength of the substrate of sensor, extending the service life of the sensor, and reducing signal noise caused by irregular edge warping, thereby improving the detection reliability of the sensor.
  • the electrode is an electrode array composed of electrode units.
  • the original entire electrode is made into smaller electrode units and laid on wires, which can prevent the entire electrode from being bent or even broken when the sensor repeatedly bends with the muscle after piercing into the subcutaneous tissue, extending the service life of the electrode and improving the detection reliability of the sensor.
  • the substrate includes at least two layers of secondary-substrates. At least two electrodes are arranged on the secondary-substrates of different layers. The electrodes are located on the secondary-substrates of different layers, which can avoid the wire routing. The electrodes can be made larger, increase the contact area with analytes, enhance the electrode reaction sensitivity, and improve the detection reliability of the sensor.
  • At least one of the multiple electrodes is located on the reverse side of the substrate, and the area of the electrode can be set on the single-sided substrate is limited. Setting one or more electrodes on the reverse side of the substrate can make full use of the two sides of the substrate, so the electrode on each side can be set to a larger area, increasing the contact area with the analyte, improving the electrode reaction sensitivity and improving the detection reliability of the sensor.
  • the area of one side of the PAD-area on the substrate is limited. At least one PAD is set on the reverse side of the substrate to facilitate the electrical connection with the electrode on the reverse side of the substrate through the wire. At the same time, the PAD on the single side of the substrate can be larger, and the PAD with larger area can be better electrically connected with the circuit, making the current conduction more stable and improving the detection reliability of the sensor.
  • the secondary-PAD corresponding to the PAD can also be set on the obverse side of the substrate.
  • the secondary-PAD can be connected to the circuit together with the PAD on the obverse side of the substrate, without additional circuit design for the PAD on the reverse side of the substrate, simplifying the complexity of the circuit.
  • the PAD on the reverse side of the substrate and the secondary-PAD corresponding to the obverse side of the substrate are connected by conductive materials on the side of the substrate, the PADs on the opposite side and the secondary-PADs can be electrically connected.
  • the scheme of punching holes on the substrate to electrically connect the PADs on the opposite side are electrically connected on the side of the substrate without aligning the PADs on the opposite side on the substrate, which simplifies the difficulty of the manufacturing process and improves the yield of the sensor.
  • the depth at which the sensor penetrates into the subcutaneous area is fixed, and the substrate is fixed in the area where it repeatedly bends with muscle peristalsis.
  • the electrodes are distributed in a predetermined manner on the substrate of sensor, avoiding areas on the substrate of sensor that are easy to bend, thereby avoiding repeated bending of the substrate, which can lead to electrode breakage or damage, prolongs the service life of the electrode and improves the detection reliability of the sensor.
  • the senor can be equipped with multiple electrodes with the same name, such as two or more working electrodes, two or more counter electrodes, and two or more reference electrodes, to achieve different functions, such as multiple analyte detection, redundant detection, electrode relay use, enhancing electrode detection signal, reducing detection signal noise, and improving the detection reliability of the sensor.
  • multiple electrodes with the same name, such as two or more working electrodes, two or more counter electrodes, and two or more reference electrodes, to achieve different functions, such as multiple analyte detection, redundant detection, electrode relay use, enhancing electrode detection signal, reducing detection signal noise, and improving the detection reliability of the sensor.
  • Fig. 1 is a top view of a planar structure of the sensor according to the embodiment of the invention.
  • Fig. 2 is side A view of the planar structure of the sensor as an embodiment of Fig. 1.
  • Fig. 3 is a sectional view of an electrode according to an embodiment of the invention.
  • Fig. 4 is a schematic diagram of function realization according to the embodiment of the invention.
  • Fig. 5 is a top view of the sensor with a stepped structure according to the embodiment of the invention.
  • Fig. 6 is side A view of the sensor with a stepped structure as an embodiment of Fig. 5.
  • Fig. 7 is a schematic diagram of the sensor having a cylindrical structure according to the embodiment of the invention.
  • Fig. 8 shows a V-V’ section view of the transducer with a cylindrical structure as an embodiment of Fig. 7.
  • Fig. 9 is a schematic diagram of a continuous analyte monitoring device according to an embodiment of the invention.
  • Fig. 10a-Fig. 10m are schematic diagrams of different sensors according to the embodiment of the invention.
  • the substrate material is usually coated layer by layer on the mold, and then the electrodes, wires, and PADs are set.
  • the substrate material coated layer by layer may have insufficient curing, which increases the risk of substrate embrittlement in subsequent use.
  • the electrodes, wires, and PADs may be short circuited or damaged to each other, affecting the reliability of sensor detection.
  • the invention provides a structurally enhanced analyte sensor with multi substrate. After the substrate is prefabricated, it is combined into a whole by pasting, which can avoid insulation failure caused by insufficient solidification of the substrate material, leading to brittle cracking, and further causing crosstalk between electrical signals between wires or electrodes, resulting in noise in the detection signal.
  • At least one protective layer is set on the surface of the substrate, the protective layer at least covers the edge of the electrode, increasing the adhesion between the edge of the electrode and the substrate, preventing the edge of the electrode from curling, bubbling, and detaching.
  • the protective layer can also increase the mechanical strength of the substrate of sensor, extend the service life of the sensor, and improve the detection reliability of the sensor.
  • one or more method steps referred to in the invention do not exclude the possibility that other method steps may exist before and after the combined steps or that other method steps may be penetrated between such explicitly mentioned steps, unless otherwise stated.
  • the combination connection between one or more devices/devices referred to in the invention does not preclude the existence of other devices/devices before and after the said combination devices/devices or the insertion of other devices/devices between the two specifically mentioned devices/devices, unless otherwise stated.
  • Fig. 1 is a top view of a planar structure of the sensor according to the embodiment of the invention.
  • Fig. 2 is side A view of the planar structure of the sensor as an embodiment of Fig. 1.
  • the sensor 11 comprises a substrate 111, which is divided into an in vitro part X and an in vivo part Y by the dotted line shown in Fig. 1.
  • the in vivo part Y is paved with electrodes, comprising at least one working electrode 1131 and at least one additional electrode.
  • the additional electrode comprises a counter electrode 1231 and a reference electrode 1331, thus forming a three-electrode system.
  • the counter electrode 1231 is the other electrode relative to the working electrode 1131, forming a closed loop with the working electrode 1131, so that the current on the electrode can be normally conducted, the reference electrode 1331 is used to provide the reference potential of the working electrode 1131, so the detection potential can be effectively controlled.
  • the additional electrode can also only comprise the counter electrode 1231, thus forming a two-electrode system.
  • the effective area of the working electrode 1131 and the counter electrode 1231 can be increased on the limited area of the in vivo part Y, thereby extending the service life of the electrode.
  • the processing process is simpler, however, the working electrode 1131 does not have the detection potential of the reference electrode as a reference, and the reliability of the analyte detection information will be reduced.
  • the in vitro part X is paved with PADs, which correspond to the electrode one-by-one and are electrically connected through wires, that is, the working PAD 1111 corresponding to the working electrode 1131 is electrically connected through wire 1121.
  • the counter PAD 1211 corresponding to the counter electrode 1231 is electrically connected through wire 1221.
  • reference PAD 1311 corresponding to reference electrode 1331 which is electrically connected through wire 1321.
  • Different PADs, wires and electrodes are insulated from each other to prevent electrical signals from interfering.
  • the sensor 11 is the planar structure, there are two opposite sides, obverse side A and reverse side B.
  • the working electrode 1131, counter electrode 1231 and reference electrode 1331 are laid as one electrode-group on the obverse side A of the sensor.
  • another electrode-group is laid on the reverse side B of the sensor.
  • the electrode-group can be a two-electrode system, a three-electrode system or a double working electrode.
  • it is consistent with the electrode-group on the obverse side A, comprising working electrode 1132, counter electrode 1232 and reference electrode 1332.
  • PADs are also laid on the side B.
  • the electrode with the same name on side B can take over and enter the working state, improving the reliability of the parameter data of the detected analyte and extending the service life of the sensor.
  • the PADs, wires and electrodes laid on the side A And side B of the sensor can be symmetrically or asymmetrically arranged.
  • the corresponding PADs, wires and electrodes are laid on the same side or on different sides.
  • the corresponding PADs, wires and electrodes are laid on the same side for the convenience of wire routing.
  • the working electrode 1131 on the side A can be replaced with the counter electrode 1231, or the counter electrode 1231 on the side A can be replaced with the reference electrode 1332 on the side B.
  • the planar structure sensor only has the side A And side B, it can also increase the number of electrode-groups by increasing the sensor area or reducing the electrode-area, so as to further increase the service life of the sensor.
  • too large sensor area may increase the host’s rejection response and cause host discomfort.
  • Too small electrode-area will reduce the sensitivity of electrode and reduce the reliability of detection parameters.
  • Too many electrode-groups will also increase the complexity of the processing process, such as the wiring of the wire will become very dense. Therefore, it is preferred that the number of electrode-groups is two.
  • each electrode-group can also be distributed on the same side of the sensor, such as side A or side B, which is not limited here.
  • the substrate 111 is a material with excellent insulation performance, mainly from inorganic non-metallic ceramics, silica glass, organic Polymers, etc. at the same time, considering the application environment of the implanted electrode, the substrate material is also required to have high impermeability and mechanical strength.
  • the substrate material is selected from one or more combinations of Teflon, PE, PVC, aBS, PMMA, PC, PI, etc.
  • Fig. 3 is a sectional view of the electrode.
  • the working electrode (auxiliary electrode) , counter electrode and reference electrode comprise at least an electron conduction layer a, an anti-interference layer b, an enzyme layer c, an adjustment layer d and a biocompatible layer e.
  • the electron conduction layer a adopts a material with good conductivity and hardening inertia.
  • the working electrode and counter electrode are selected from one of graphite electrode, glassy carbon electrode, noble metal and other materials, and the reference electrode is selected from one of Ag/AgCl or calomel.
  • noble metal electrodes such as gold electrode, platinum electrode and silver electrode have become better choices.
  • both working electrode and counter electrode are platinum electrodes.
  • the anti-interference layer b is located between the enzyme layer and the electron conduction layer.
  • Interferents are molecules or substances that will undergo electrochemical reduction or electrochemical oxidation directly or indirectly through electron transfer agents on the electrode surface, thus generating an error signal that interferes with the detection of analytes.
  • common interferents in the body comprise urea, ascorbic acid, paracetamol, and so on.
  • the anti-interference layer b can prevent one or more interferents from penetrating into the electrolyte around the electrode.
  • the anti-interference layer b will allow the analytes (e.g., hydrogen peroxide) to be measured on the electrode to pass, while at the same time preventing the passage of other substances (e.g., potential interfering substances) .
  • the anti-interference layer b can be a very thin film designed to limit the diffusion of substances with molecular weight greater than 34Da.
  • the anti-interference layer b may be an organic Polymer, which may be made from organosilane and a hydrophilic copolymer.
  • the hydrophilic copolymers more preferably Poly-ethylene glycol (PEG) , Poly-methacrylic acid, 2-hydroxyethyl ester and Poly-lysine.
  • the thickness range of the anti-interference layer b may be 0.1um or less to 10um or more. The more preferred thickness range is 0.5um to 5um.
  • the enzyme layer c is coated with active enzyme, and the corresponding active enzyme is coated according to the type of analyte to be detected.
  • the active enzyme can make the analyte to be detected produce some chemical reactions and generate electrons. According to different concentrations of analyte to be detected, the number of electrons generated is different, and the electrons are collected by the electron conduction layer, thus forming different current intensities. Therefore, the current intensity information can be used to characterize the analyte parameter information.
  • the enzyme layer c is coated with glucose oxidase (Gox) .
  • Gox glucose oxidase
  • the adjustment layer d is located above the enzyme layer.
  • the regulating layer d is mainly used to regulate the transmittance of oxygen and glucose transmitted to the enzyme layer.
  • the glucose content (molar concentration) in body fluid is one order of magnitude higher than that of oxygen.
  • excess oxygen needs to be supplied to ensure that oxygen does not become a limiting substance, so that the sensor can respond linearly to changes in glucose concentration without being affected by oxygen partial pressure.
  • oxygen content becomes a limiting factor, the linear range of glucose oxygen monitoring reaction cannot reach the expected concentration range.
  • the upper limit of the linear response of the sensor to glucose can only reach about 40mg/dL.
  • the upper limit of linear response of blood glucose layer needs to reach about 500mg/dL.
  • the regulating layer d mainly functions as a semipermeable membrane to regulate the amount of oxygen and glucose transmitted to the enzyme layer. More specifically, excess oxygen becomes a non-restrictive factor.
  • the upper limit of the linear response to glucose of the sensor with an adjustment layer can reach a higher layer than that without an adjustment layer.
  • the ratio of oxygen glucose transmittance of the regulating layer d can reach 200: 1, which can ensure that there is enough oxygen for the enzymatic reaction for various glucose and oxygen concentrations that may occur under the skin.
  • the adjustment layer d may be an organic Polymer, which may be manufactured from organosilane and a hydrophilic copolymer. Hydrophilic copolymers, more preferably copolymerized or grafted Poly-ethylene glycol (PEG) . Other hydrophilic copolymers that may be used comprise but are not limited to other diols, such as propylene glycol, esters, amides, carbonates, and Polypropylene glycol. The use of silicone Polymers can significantly improve oxygen transport and effectively control glucose permeation.
  • the thickness range of the adjustment layer d can be 1um or less to 50um or more, and the more preferred thickness range is 1um to 10um.
  • the biocompatible layer e is located at the outermost part of the electrode, aiming to eliminate the body’s rejection of foreign bodies and reduce the formation of a shielding cell layer around the implanted electrode.
  • the biocompatible layer e can be manufactured from organosilane and a hydrophilic copolymer.
  • Hydrophilic copolymers more preferably copolymerized or grafted Poly-ethylene glycol (PEG) .
  • PEG Poly-ethylene glycol
  • Other hydrophilic copolymers comprising but not limited: diols, such as propylene glycol, esters, amides, carbonates, and Polypropylene glycol.
  • the thickness range of the biocompatible layer e may be 1um or less to 100um or more. The more preferred thickness range is 10um to 30um.
  • the thickness of the substrate 11 is 0.01 ⁇ 0.8mm
  • the electrodes are rectangular
  • the width of each electrode is 0.01 ⁇ 1mm
  • the area is 0.1 ⁇ 2mm 2 .
  • the surface of each electrode is also provided with a carbon nanotube layer modification layer.
  • a carbon nanotube layer modification layer Taking advantage of the unique mechanical strength, high specific obverse side Area, rapid electron transfer effect and chemical stability of carbon nanotubes, carbon nanotubes are modified to the electrode surface by physical adsorption, embedding or covalent bonding on the formed electrode surface to improve the electron transfer speed.
  • carbon nanotubes due to its large specific obverse side Area, carbon nanotubes can be used as an excellent catalyst (enzyme) carrier.
  • the carbon nanotube layer modified layer can be fixed on the electrode surface by Nafion solution dispersion method, covalent fixation method, etc.
  • Fig. 4 is the schematic diagram of the function realization of the embodiment of the invention.
  • the in vivo circuit applies voltage to the PAD, and the electrode corresponding to the PAD is activated to enter the working state.
  • the effective working time of the electrode after being activated is 1-14 days. After 14 days, the enzyme activity on the electrode decreases and enters the failure state. At the same time, there may be reasons such as electrode damage or processing errors, and the activated electrode will enter the failure state in advance. If a single group of electrodes is set on the sensor, once a certain electrode enters the failure state, the sensor will fail, and the user needs to replace the sensor, which reduces the user experience and increases the user’s use cost.
  • the in vivo circuit will apply voltage to the PAD corresponding to the electrode with the same name of other electrode-groups, activate the electrode with the same name, make it enter the working state, replace the failed electrode, and make the sensor continue to work normally.
  • the working PAD 1111, the counter PAD 1211 and the reference PAD 1311 on side A are preferentially applied with voltage by the in vivo circuit.
  • the working electrode 1131, the counter electrode 1231 and the reference electrode 1331 on side A enter the working state.
  • the in vivo circuit switches the PAD object to which the voltage is applied, for example, when the working electrode 1131 fails in advance, the in vivo circuit switches to apply voltage to the fourth PAD 1112 on the side B, activates the working electrode 1132 on the side B, and combines it with the counter electrode 1231 and the reference electrode 1331 that have not yet failed to form a new electrode-group to detect the analyte to be tested, thus avoiding the early failure of the sensor 11.
  • the user does not need to replace the sensor because of the early failure of the working electrode 1131, which enhances the user experience, it also reduces the cost of replacing sensors.
  • the above embodiment is not limited to the failure of the working electrode, other electrodes such as the counter electrode and the reference electrode fail, or two or three-electrodes fail at the same time.
  • the method of using the same name electrode to replace the failed electrode in the above embodiment can be adopted.
  • the electrode fails after 14 days in the normal working state, and the preset time t is 2 days.
  • the first electrode-group is energized and activated, after working for 2 days, switch to the second electrode-group, the second electrode-group is activated, and the first electrode-group is no longer energized and enters the sleep state.
  • the second electrode-group works for 2 days, other electrode-groups can be activated or the first electrode-group can be activated again. This cycle is activated until the service life of all electrode-groups ends and all electrode-groups enter the failure state. In this mode, the service life of multiple electrode-groups is superimposed, thus extending the service life of the sensor.
  • the preset time t can be any day within 14 days. If the service life of the electrode is extended to n (n>14) days due to process improvement or other reasons, the preset time t can be any day within n days.
  • Fig. 5 is a top view of the sensor with a stepped structure in the embodiment of the invention.
  • Fig. 6 is side A view of the step structure of the sensor in the embodiment of Fig. 5.
  • the sensor 21 of the step structure comprises side A and side B, and each side is divided into the in vitro part X and the in vivo part Y with the dotted line as the dividing line.
  • the in vivo part Y comprises a first substrate 211, a second substrate 221 and a third substrate 231, forming a step structure with each other.
  • the number and layers of the substrate are consistent with the number of electrodes on the surface. For example, when there is a three-electrode system on the substrate, the substrate is a three-layer step structure. When the side A is a two-electrode system, the substrate is a two-layer step structure.
  • each electrode is electrically connected with the corresponding PAD through the wires distributed on one substrate (such as the third substrate) , that is, a part of the wire is in contact with the electrode, and the main part of the wire is located under the substrate, which can effectively protect the wire.
  • the electrodes are distributed on different layers of substrates.
  • the spacing of electrodes is enlarged, which reduces the influence of the microenvironment on the electrode surface.
  • the electrode distribution of the step structure can effectively inhibit the interference of human response on the electrode response.
  • the width of the whole sensor can be further reduced on the premise that the effective area of each electrode is unchanged.
  • the width of step structure sensor can be reduced by about half on the basis of plane structure sensor.
  • side B and side A are symmetrical step structures.
  • the in vitro part X is paved with PADs, which correspond to the electrode one-by-one and are electrically connected through the wire, that is, the working PAD 2111 corresponding to the working electrode 2131 is electrically connected through the wire 2121.
  • the counter PAD 2211 corresponding to the counter electrode 2231 is electrically connected through wire 2221.
  • the reference PAD 2311 corresponding to the reference electrode 2331 which is electrically connected through wire 2321.
  • Different PADs, wires and electrodes are insulated from each other to prevent electrical signals from interfering.
  • the working electrode 2131, counter electrode 2231 and reference electrode 2331 are laid as an electrode-group on the obverse side A of the sensor.
  • another electrode-group is laid on the reverse side B of the sensor.
  • the electrode-group can be a two-electrode system, a three-electrode system or a double working electrode.
  • it is consistent with the electrode-group on the obverse side A, comprising the working electrode 2132, counter electrode 2232 and reference electrode 2332.
  • PADs are also laid on the side B.
  • the PADs correspond to the electrodes on the side B one-by-one and are electrically connected through wires, that is, the fourth PAD 2112 corresponding to the working electrode 2132 is electrically connected through wires 2122.
  • the fifth PAD 2212 corresponding to the counter electrode 2232 is electrically connected through wire 2222.
  • the sixth PAD 2312 corresponding to the reference electrode 2332 which is electrically connected through wire 2322.
  • the PADs, wires and electrodes laid on the side A And side B of the sensor can be symmetrically or asymmetrically arranged.
  • the corresponding PADs, wires and electrodes are laid on the same side or on different sides.
  • the corresponding PADs, wires and electrodes are laid on the same side for the convenience of wire routing.
  • the working electrode 2131 on the side A can be replaced with the counter electrode 2231, or the counter electrode 2231 on the side A can be replaced with the reference electrode 2332 on the side B.
  • the step structure sensor although the step structure sensor only has the opposite side A and side B, it can also increase the number of electrode-groups by increasing the sensor area or reducing the electrode-area, so as to further increase the service life of the sensor.
  • too large sensor area may increase the host’s rejection response and cause host discomfort.
  • Too small electrode-area will reduce the sensitivity of electrode and reduce the reliability of detection parameters.
  • Too many electrode-groups will also increase the complexity of the processing process, such as the wiring of the wire will become very dense. Therefore, it is preferred that the number of electrode-groups is two.
  • each electrode-group can also be distributed on the same side of the sensor, such as side A or side B, which is not limited here.
  • the first substrate 211, the second substrate 221 and the third substrate 231 are materials with excellent insulation properties, mainly from inorganic non-metallic ceramics, silica glass and organic Polymers.
  • the substrate material is also required to have high water permeability and mechanical strength.
  • the material of the substrate is selected from one or more combinations of Poly-tetrafluoroethylene (Teflon) , Poly-ethylene (PE) , Poly-vinyl chloride (PVC) , acrylonitrile butadiene styrene copolymer (ABS) , Poly-methyl methacrylate (PMMA) , Poly-carbonate (PC) , Poly-imide (PI) , etc.
  • Teflon Poly-tetrafluoroethylene
  • PE Poly-ethylene
  • PVC Poly-vinyl chloride
  • ABS acrylonitrile butadiene styrene copolymer
  • PMMA Poly-methyl methacrylate
  • PC Poly-carbonate
  • PI Poly-imide
  • the working electrode (auxiliary electrode) , counter electrode and reference electrode at least comprise an electron conduction layer a’, an anti-interference layer b’, an enzyme layer c’, an adjustment layer d’ and a biocompatible layer e’, the properties of each layer and their related descriptions can be seen in embodiment 1, and will not be repeated here.
  • Fig. 7 is a schematic diagram of the cylindrical structure of the sensor in the embodiment of the invention.
  • Fig. 8 is the V-V’ sectional view of the cylindrical structure of the sensor in the embodiment of Fig. 7.
  • the columnar sensor 31 is divided by the dotted line on the figure, and its substrate 311 is divided into the in vitro part X and the in vivo part Y.
  • the in vitro part X is planar or cylindrical, preferably planar.
  • the in vivo part Y comprises the substrate 311, which is cylindrical, and each electrode is surrounded on the surface of the substrate. Compared with the planar electrode, the electrode with ring structure does not have sharp edges, which reduces the irritation to human tissues and human rejection reaction, which is conducive to achieving implantable long-term detection and improving the service life of the sensor.
  • the in vivo part Y comprises at least one working electrode 3131 and at least one additional electrode.
  • the additional electrode comprises a counter electrode 3231 and a reference electrode 3331, thereby forming a three-electrode system.
  • the counter electrode 3231 is the other electrode relative to the working electrode 3131, forming a closed loop with the working electrode 3131, so that the current on the electrode can be normally conducted.
  • the reference electrode 3331 is used to provide the reference potential of the working electrode 3131, therefore, the detection potential can be effectively controlled.
  • the additional electrode can also only comprise the counter electrode 3231, thus forming a two-electrode system.
  • the effective area of the working electrode 3131 and the counter electrode 3231 can be increased on the limited area of the in vivo part Y, thereby extending the service life of the electrode. Moreover, because there is less one electrode, the processing process is simpler, however, the working electrode 3131 does not have the detection potential of the reference electrode as a reference, and the reliability of the analyte detection information will be reduced.
  • there are two working electrodes 3131 one of which is used to detect the response signal of the interferents or background solution in the host body fluid by electro redox reaction with the analyte to be detected, and the other electrode is the auxiliary electrode.
  • the in vitro part X is paved with PADs, which correspond to the electrode one-by-one and are electrically connected through wires, that is, the working PAD 3111 corresponding to the working electrode 3131 is electrically connected through wire 3121.
  • the counter PAD 3211 corresponding to the counter electrode 3231 is electrically connected through wire 3221.
  • the reference PAD 3311 corresponding to the reference electrode 3331 are electrically connected through the wire 3321.
  • the working electrode 3131, the counter electrode 3231 and the reference electrode 3331 form an electrode-group. Different PADs, wires and electrodes are insulated from each other to prevent electrical signals from being disturbed.
  • each electrode is laid on the in vivo part Y in a semi surrounded manner, so there can be two electrodes at the same place to form an enclosure for the in vivo part Y.
  • the reference electrodes 3331 and 3332 are semicircular rings, respectively, whose inner diameter is equal to the outer diameter of the in vivo part Y, and are in insulated contact with each other, maximizing the obverse side Area of the in vivo part Y.
  • the working electrode 3131 or counter electrode 3231 of the same electrode-group, or the working electrode (not shown in the figure) or counter electrode (not shown in the figure) of other electrode-groups can form an enclosure with the reference electrode 3331, so that in the case of termination or early failure of any electrode, its corresponding electrode of the same name can take over and enter the working state, improve the reliability of the parameter data of the detected analytes and extend the service life of the sensor.
  • the sequence and position of the PADs, wires and electrodes laid on the substrate 311 are not limited.
  • the PADs, wires and electrodes can be symmetrically or asymmetrically arranged. No matter how the order and position of the PADs, wires and electrodes change, it is only necessary to make the PADs, wires and electrodes have a one-to-one correspondence and insulation relationship with each other.
  • the number of electrode-groups can also be increased by increasing the sensor area or reducing the electrode-area, thereby further increasing the service life of the sensor.
  • too large sensor area may increase the host’s rejection response and cause host discomfort.
  • Too small electrode-area will reduce the sensitivity of electrode and reduce the reliability of detection parameters.
  • Too many electrode-groups will also increase the complexity of the processing process, such as the wiring of the wire will become very dense. Therefore, it is preferred that the number of electrode-groups is two.
  • the substrate 311 is a material with excellent insulation performance, mainly from inorganic non-metallic ceramics, silica glass, organic Polymers, etc. at the same time, considering the application environment of the implanted electrode, the substrate material is also required to have high impermeability and mechanical strength.
  • the material of the substrate is selected from one or more combinations of Poly-tetrafluoroethylene (Teflon) , Poly-ethylene (PE) , Poly-vinyl chloride (PVC) , acrylonitrile butadiene styrene copolymer (ABS) , Poly-methyl methacrylate (PMMA) , Poly-carbonate (PC) , Poly-imide (PI) , etc.
  • the outer diameter of the in vivo part Y of the substrate 311 and the inner diameter of the electrode are 0.01 ⁇ 100um, preferably 10 ⁇ 50um.
  • the electrode can be a half ring, a 1/3 ring, a 1/4 ring or other proportion of the ring.
  • the working electrode (auxiliary electrode) , counter electrode and reference electrode at least comprise an electron conduction layer a”, an anti-interference layer b”, an enzyme layer c”, an adjustment layer d”, and a biocompatible layer e”, the properties of each layer and their related descriptions can be seen in embodiment 1, and will not be repeated here.
  • the in vivo part Y of the sensor is not necessarily limited to the shape of the above three embodiments.
  • it can be circular, semi-circular, conical, spiral and other shapes, and the shape of the electrode arranged on it also changes based on the shape of the in vivo part Y.
  • the electrode can be easily laid on the in vivo part Y, there is no limitation here.
  • Fig. 9 is a schematic diagram of a continuous analyte detection device 100 according to an embodiment of the invention.
  • the continuous analyte detection device 100 comprises a bottom shell 101 for mounting on the surface of the host skin.
  • the sensor unit 102 comprises a substrate 1021 and a micro analyte sensor 11 (21/31) as previously described.
  • the micro analyte sensor 11 (21/31) is fixed on the substrate, and the sensor unit 102 is installed on the bottom shell 101 through the substrate.
  • the transmitter unit 103 comprises an in vivo circuit 1031, a transmitter 1032, and an electrical connection area 1033.
  • the electrical connection area 1033 is electrically connected with the sensor unit 102.
  • the in vivo circuit 1031 stores the predetermined conditions for switching electrodes described above.
  • the transmitter 1032 is used to send analyte parameter information to the outside world.
  • the battery 104 is used to provide electric energy.
  • the receiver 105 which is used to receive analyte parameter information and indicate
  • Fig. 10a to Fig. 10m are the schematic diagrams of different schemes of the sensor in the embodiment of the invention.
  • Fig. 10a in order to easily and clearly show the structural characteristics of the sensor 41, the length, width, thickness and curve characteristics of the sensor are expressed in exaggerated form in Fig. 10a.
  • the actual length, width, thickness and curve characteristics of the sensor may be different from those shown in the figure.
  • the length, width, thickness and curve characteristics of the sensor are expressed in the same exaggerated form.
  • the actual length, width, thickness and curve characteristics of the sensor may be different from those in the illustration, and will not be repeated below.
  • wires, PADs and electrodes described earlier and later are also expressed in the figure in exaggerated form.
  • the wires, PADs and electrodes in the figure are only used as auxiliary examples to express the scheme of the invention, and are not completely equivalent to the wires, PADs and wires in the actual sensor.
  • the wire in the actual sensor is a flat wire with a certain width, which is shown in the form of lines in the illustration.
  • the substrate 411 of the sensor 41 is generally a flexible material, such as one or more combinations selected from Poly-tetrafluoroethylene, Poly-ethylene, Poly-vinyl chloride, acrylonitrile butadiene styrene copolymer, Poly-methyl-methacrylate, Poly-carbonate, Poly-imide, which has good electrical insulation characteristics, and the electrode and electrode, wire and wire set on it can be insulated from each other.
  • the substrate 411 is made of Poly-imide, which has good adaptability to human physiology and will not suffer from excessive rejection due to penetration into the subcutaneous skin.
  • the senor 41 adopts a three-electrode system, including a working electrode 4141, a counter electrode 4241 and a reference electrode 4341, and their corresponding working PAD 4111, counter PAD 4211 and reference PAD 4311, as well as wires 4121/4221/4321 connecting each PAD and electrode.
  • the sensor 41 can also adopt a two-electrode system, which does not include the reference electrode 4341 and the corresponding PADs and wires. This is a common general knowledge in the art and will not be described here.
  • the wires 4121/4221/4321 can be set on the surface or inner layer of the substrate 411 through etching, laser welding and other processes.
  • the wires 4121/4221/4321 are arranged on the inner layer of the substrate 411 and are electrically connected with the PADs or electrodes arranged on the surface of the substrate 411, holes 4141/4241/4341 are opened at the corresponding positions of the electrical connection on the substrate 411, and the electrical connection ends of the wires 4121/4221/4321 are led out to the surface of the substrate 411 through holes 4141/4241/4341 to establish electrical connections with the electrodes 4131/4231/4331 respectively.
  • wire 4121/4221/4321 is electrically connected with PAD 4111/4211/4311 through the corresponding hole (not shown in the figure) .
  • the substrate 411 can provide insulation protection for each wire to avoid signal loss or instability caused by short circuit between each wire, but the processing technology is relatively complex.
  • a protective layer 412 can also be set on the substrate 411.
  • the protective layer 412 can cover the entire substrate 411 or a certain area of the substrate 411, but avoid the central area of PAD 4111/4211/4311 and electrode 4131/4231/4331 and cover the edges of PAD 4111/4211/4311 and electrode 4131/4231/4331.
  • the protective layer 412 can enhance the mechanical strength of the substrate 411 and prolong the time when the substrate 411 is damaged.
  • the protective layer 412 covers the edges of PADs 4111/4211/4311 and electrodes 4131/4231/4331 to prevent irregular edges from being exposed to cause signal noise and improve the stability of the detection signal.
  • the electron conduction layer a of electrode 4131/4231/4331 is fixed on the substrate 411. Because the substrate 411 is repeatedly bent during use, the metal film of electron conduction layer a is inevitably separated from the substrate 411 and appears edge warping, bubbling or even detaching. After setting the protective layer 412, the protective layer 412 can also enhance the adhesion between the metal film of electron conduction layer a and the substrate 411, avoid edge warping and bubbling of the metal film, and improve the detection reliability of the sensor.
  • the electrode 4131/4231/4331 is more valuable than the PAD 4111/4211/4311 for the sensor 41, and belongs to a sensitive component. It may be given priority to set the protective layer 412 to cover the edge of the electrode 4131/4231/4331, that is, the protective layer 412 does not cover all of the substrate 411, but covers a part of the substrate 411.
  • the protective layer 412 has a thicker thickness than the electrode 4131/4231/4331, such as 0.1 ⁇ 500um. After coating the protective layer 412, pits are formed on the electrode 4131/4231/4331. The anti-interference layer, enzyme layer, adjusting layer, biocompatible layer and other structural layers of the electrode 4131/4231/4331 are located in the pits. The pits can accommodate more anti-interference layer, enzyme layer, adjusting layer and biocompatible layer, the sensitivity of electrode 4131/4231/4331 was improved.
  • the thickness of the protective layer 412 is 0.1 ⁇ 200um. In a further preferred embodiment of the invention, the thickness of the protective layer 412 is 1 ⁇ 50um. The excessively thick protective layer 412 will reduce the softness of the substrate 411 and increase the user’s discomfort after penetrating into the user’s skin, while the excessively thin protective layer 412 is easy to be damaged.
  • the protective layer 412 can be a multi-layer structure, which can be set on the substrate 411, or the multi-layer protective layer 412 can be set on the substrate 411.
  • the overall thickness of the multi-layer protective layer 412 is still referred to the thickness mentioned above. When the multi-layer protective layer 412 is set, the thickness of each protective layer will become thinner.
  • the protective layer 412 is made of one or more combinations of Poly-tetrafluoroethylene, Poly-ethylene, Poly-vinyl chloride, acrylonitrile butadiene styrene copolymer, Poly-methyl methacrylate, Poly-carbonate and Poly-imide.
  • the material of the protective layer 412 is Poly-imide. After the Poly-imide is properly heated to form a liquid, it is coated on the substrate 411 which is also Poly-imide material, and the protective layer 412 can be formed after curing.
  • the protective layer 412 of the same material has the same physical characteristics as the substrate 411, which can prevent the protective layer 412 from being damaged or detaching due to uneven stress or stress concentration on the substrate 411.
  • the substrate 411 is a single-layer plane as shown in Fig. 10a.
  • the substrate 411 may also be a multilayer plane as shown in Fig. 10b.
  • the substrate 411 can be composed of multiple layers of secondary-substrates, such as the first secondary-substrate 411d, the second secondary-substrate 411e, and/or the third secondary-substrate 411f.
  • At least one electrode and at least one wire can be arranged on each layer of secondary-substrate 411d/411e/411f.
  • the electrodes 4131/4231/4331 are respectively set on the secondary-substrates 411d/411e/411f of different layers. On the one hand, it can increase the distance between electrodes, reduce the signal interference between electrodes, and improve the detection reliability.
  • the electrode on the substrate of each layer can be made larger, and the electrode with larger area can contact the body fluid more fully, the signal is more stable, and the detection reliability can be improved.
  • the wires 4121/4221/4321 electrically connected with the electrode can also be routed on different secondary-substrates, so the secondary-substrate can also electrically insulate the wires 4121/4221/4321. Based on this, the wires 4121/4221/4321 can be routed on the surface of the secondary-substrates 411d/411e/411f at all layers, simplifying the wire processing technology.
  • the wires 4121/4221/4321 can be laid on the surface of the secondary-substrate 411d/411e/411f of different layers, once the substrate of a certain layer is damaged, the wires of the adjacent two layers may contact and short circuit. Therefore, when laying the wires 4121/4221/4321 on the secondary-substrate 411d/411e/411f, the wires 4121/4221/4321 can be staggered as shown in the top view of Fig. 10b to form a stepped distribution of wires, even if the substrate of a certain layer is damaged, the wires of two adjacent layers will not be short circuited due to contact, which improves the detection reliability.
  • the substrate composed of multi-layer secondary-substrate has higher mechanical strength, is not easy to be broken or damaged, and extends and improves the detection reliability.
  • the use of a multi-layer secondary-substrate will inevitably increase the overall thickness of the sensor 41, which may increase the user’s discomfort after penetration into the subcutaneous layer.
  • each electrode on the secondary-substrate is not fixed.
  • the reference electrode 4331 can be set on the secondary-substrate 411f of the top layer.
  • the cost of the reference electrode 4331 is higher than that of the working electrode 4131 and the counter electrode 4231.
  • the reference electrode 4331 on the secondary-substrate 411f of the top layer is prepared in the final process, which can protect the reference electrode 4331 from damage.
  • the reference electrode 4331 can also be set on the secondary-substrate 411d of the bottom layer.
  • the reference electrode 4331 is thicker than the working electrode and the counter electrode 4231, and is located on the secondary-substrate 411d of the bottom layer, which can improve the thickness consistency of the sensor 41 without making the sensor 41 have too large thickness difference, which is convenient for the storage and use of the sensor 41.
  • the thicknesses of the secondary-substrates 411d/411e/411f and electrodes 4131/4231/4331 of each layer are expressed in exaggerated form. It is understandable that this does not affect the description of this scheme.
  • the secondary-substrates 411d/411e/411f of each layer can be prepared layer by layer, that is, after the bottom layer secondary-substrate 411d is prepared, the middle layer secondary-substrate 411e is prepared on the basis of the bottom layer secondary-substrate 411d. Similarly, after the middle layer secondary-substrate 411e is prepared, the top layer secondary-substrate 411f is prepared.
  • the secondary-substrate materials such as Poly-imide, are coated on the mold layer by layer after heating to form a complete secondary-substrate after curing.
  • the substrate will be brittle during subsequent use, which will cause the electrodes, wires and PADs on the substrate to be short circuited to each other or even damaged, affecting the detection reliability of the sensor.
  • the secondary-substrates 411d/411e/411f of each layer can be prefabricated first.
  • the prefabrication completion refers to that after the substrate material of each layer of secondary-substrates 411d/411e/411f is fully cured, the electrodes, wires or PADs are processed on the substrate.
  • the electrodes, wires or PADs set on the substrate of each layer The wires or PADs may or may not be the same.
  • the secondary-substrates 411d/411e/411f of each layer are combined into a whole by pasting.
  • the precursor of Poly-imide can be used to paste the secondary-substrates 411d/411e/411f of each layer, and finally a complete substrate of sensor can be obtained. Since the secondary-substrates 411d/411e/411f of each layer are pasted as a whole after being fully cured, it can not only avoid the embrittlement problem caused by insufficient curing of materials in the substrate of the same layer, but also avoid the embrittlement problem caused by insufficient curing of materials between secondary-substrates of different layers, which improves the detection reliability of the sensor. In addition, since the secondary-substrates 411d/411e/411f of each layer can be prefabricated independently and then assembled into a whole, the manufacturing efficiency of the sensor 41 can also be increased in the manufacturing process.
  • the PADs 4111/4211/4311 corresponding to each electrode 4131/4231/4331 also need to be prefabricated to make the function of the sensor 41 complete.
  • the wires on the secondary-substrate 411d/411e are led to the secondary-substrate 411f of the top layer by drilling to establish an electrical connection with the PADs on the secondary-substrate 411f.
  • the protective layer 412 when preparing the secondary-substrates 411d/411e/411f, can also be set on the secondary-substrates 411d/411e/411f at all layers.
  • the protective layer 412 can protect the electrode edges on the substrates at all layers and the PAD edges on the substrates 411f at the top layer. The specific principle has been described previously and will not be repeated here.
  • the thickness of each layer of secondary-substrate 411d/411e/411f can be 0.1 ⁇ 200um, which is different from the scheme of single-layer substrate shown in Fig. 10a.
  • Each layer of secondary-substrate 411d/411e/411f may need to be made thinner. Otherwise, the superposition of several layers of base is too thick as a whole, and there is not enough softness, which increases the discomfort when stabbing into the user’s skin. Therefore, it is preferred that the thickness of each layer of the secondary-substrate 411d/411e/411f is 0.1 ⁇ 20um.
  • each layer of the secondary-substrate 411d/411e/411f is about 10um, and the thickness of the whole is about 25 ⁇ 35um. This thickness will not be easily damaged or broken because it is too thin, nor will it increase the user’s discomfort because it is too thick. Those skilled in the art can understand that the actual thickness of the secondary-substrate 411d/411e/411f of each layer may deviate due to the error of the processing technology.
  • the material of the secondary-substrates 411d/411e/411f at all layers is preferably Poly-imide.
  • the bonding material can preferably be Poly-imide precursor. After curing, the Poly-imide precursor and Poly-imide can maintain the consistency of physical properties. Such a bonding method can prevent the secondary-substrates 411d/411e/411f at all layers from peeling off or even detaching due to stress concentration or uneven stress.
  • a protective layer 412 can still be set on the surface of the substrate to protect its electrodes or PADs.
  • the thickness and the number of layers of the protective layer 412 are the same as those previously described, and will not be repeated here.
  • At least one electrode may be set on the reverse side B of the substrate 411.
  • a protective layer 412 can be set on both the obverse side A and the reverse side B of the substrate 411 to protect the electrode located on the opposite side of the substrate 411.
  • the protective layer 412 on the reverse side B should also avoid the central area of the electrode on the reverse side B and cover at least its edge.
  • the electrode arranged on the reverse side B of the substrate 411 may be a counter electrode 4231.
  • Setting the counter electrode 4231 on the reverse side B of the substrate 411 can increase the relative distance between the counter electrode 4231 and the working electrode 4131, reduce the current crosstalk between the counter electrode 4231 and the working electrode 4131, and reduce the noise.
  • the area of the counter electrode 4231 can be maximized, so as to reduce the electrochemical polarization and improve the accuracy and sensitivity of the detection signal.
  • the electrode arranged on the reverse side B of the substrate 411 may be a reference electrode 4331.
  • the reference electrode 4331 is set on the reverse side B of the substrate 411.
  • the reference electrode 4331 can be prepared separately, which will not affect the working electrode 4131 and the counter electrode 4231, improving the yield of finished products.
  • it can reduce the circuit risk caused by the migration of Ag/Cl material of reference electrode 4331 and improve the detection reliability.
  • the electrode arranged on the reverse side B of the substrate 411 may be the working electrode 4131.
  • the working electrode 4131 is set at the reverse side B of the substrate 411. If the counter electrode 4231 is short circuited with the reference electrode 4331, the three-electrode system will become a two-electrode system, which will not affect the detection current, and the detection signal will not change suddenly, improving the detection stability.
  • the obverse side and reverse side of the substrate 411 need to be processed to set electrodes, wires, etc., which will inevitably cause damage to the other side in the processing process.
  • the obverse side and reverse side of the substrate 411 can be processed separately, that is, the obverse side A and reverse side B of the substrate 411 are processed respectively, and then the obverse side A and reverse side B are assembled into a whole, forming a complete sensor can improve the integrity of the double-sided substrate.
  • electrodes, wires and PADs are processed on the substrate 411a of obverse side A, while electrodes and wires are processed on the substrate 411b of reverse side B.
  • the setting positions of the above electrodes, wires and PADs on the substrate 411a and substrate 411b are not limited.
  • at least one protective layer can be processed after the electrodes, wires and PADs are processed.
  • the protective layer can be set as described above, avoiding the central area of the PADs and electrodes and covering the edges of the PADs and electrodes.
  • the substrate 411a and the substrate 411b can be combined into a whole by pasting.
  • the materials of the substrate 411a and the substrate 411b are Poly-imide, and the substrate 411a and the substrate 411b are pasted together using the precursor material of Poly-imide. Refer to Fig. 10c and its description for relevant technical details.
  • the mechanical strength of the substrate 411 can be enhanced by setting a protective layer 412 on the substrate 411, so as to reduce the possibility of electrode damage, in actual use, with the increase of the user’s movement and other reasons, the substrate 411 may be repeatedly bent more than expected, and the electrode may still be damaged. Therefore, some necessary measures can be taken to prevent the electrode from being damaged.
  • the electron conduction layer is a hard layer and other structural layers are soft layers
  • the working electrode 4131 when the working electrode 4131 is damaged due to bending, the probability is that the electron conduction layer is bent and broken. Therefore, the working electrode unit 4131a can make the original whole electron conduction layer into an electron conduction layer unit with a smaller area.
  • These electron conduction layer units share an anti-interference layer, an enzyme layer, an adjustment layer and a biocompatible layer.
  • each working electrode unit 4131a can independently realize the detection function, that is, each working electrode unit 4131a contains an independent electron conduction layer, an anti-interference layer, an enzyme layer, a regulation layer, and a biocompatible layer.
  • the electrode unit is a cubic structure as shown in Fig. 10f, which has dimensions of length (L) about 10 ⁇ 100um, width (K) about 1 ⁇ 50um, thickness (H) about 0.05 ⁇ 10um, and the adjacent two electrode units are arranged at intervals of 1 ⁇ 20um.
  • each electrode may contain 10-500 electrode units, which depends on the area of the electrode, the area of the single electrode unit and the spacing of the electrode units.
  • the specific number of electrode units in each electrode is not specially limited here.
  • the area of each electrode in the sensor 41 is different, and there are different numbers of electrode units in the working electrode array, counter electrode array and reference electrode array. For example, there can be 25-120 working electrode units in the working electrode array, 50-150 counter electrode units in the counter electrode array and 15-75 reference electrode units in the reference electrode array.
  • the electrode unit can be other three-dimensional structures, such as cylinder structure, prism structure, cone structure, etc.
  • the length*width*thickness of the electrode unit is 50um*30um*0.2um
  • there are 75 working electrode units 4131 in the working electrode array 110 counter electrode units 4231 in the counter electrode array, 35 reference electrode units 4331 in the reference electrode array, and the spacing of each electrode unit is 10um. If more advanced laser etching technology is adopted, the area of electrode units and the spacing between electrode units can be made smaller, so that the possibility of electrode units being damaged becomes smaller and the detection performance is better.
  • the approximate size of each electrode array is: the length*width*thickness of the working electrode array is 1.08mm*0.18mm*0.2um, the length*width*thickness of the counter electrode array is 1.52mm*0.18mm*0.2um, and the length*width*thickness of the reference electrode array is 0.51mm*0.18mm*0.2um.
  • the protective layer 412 protecting the electrode units and the edge of the PADs can still be set in the corresponding area on the substrate 411. Different from the protective layer 412 set previously, the protective layer 412 covers the edge of the electrode unit, so that the protective layer 412 can fill the spacing area of adjacent electrode units, that is, the protective layer 412 can be partially set in the central area of the whole electrode without affecting its detection performance.
  • the electrode unit array can be shown in Fig. 10b.
  • the substrate 411 can include a multi-layer secondary-substrate, and the electrode unit array is respectively set on the secondary-substrates of different layers.
  • the electrode unit array when the electrode unit array is respectively set on the secondary-substrates of different layers, as shown in Fig. 10c, the secondary-substrates of each layer can be prefabricated first and then combined into a whole.
  • the electrode unit array can be set on the obverse side A and the reverse side B of the substrate 411, respectively, as shown in Fig. 10d.
  • the obverse side A of substrate 411a and the reverse side B of substrate 411b can also be prefabricated first and then combined into a whole as shown in Fig. 10e.
  • the electrodes located on the substrate 411 can be distributed in a predetermined way to avoid the easy-bending-area 413, so as to prevent the electrodes from being damaged.
  • the easy-bending-area 413 is not limited to one easy-bending-area 413 shown in Fig. 10g, but there may also be multiple easy-bending-areas, which are mainly determined by the material of the substrate 411 and the depth of penetration into the subcutaneous skin. Secondly, it is also related to the location of the substrate penetration into the user’s subcutaneous skin, the user’s movement mode, the thickness of the substrate and other reasons. Generally speaking, for the same substrate material, the penetration depth, the areas with large bending amplitude on the substrate 411 are fixed, and the electrodes should be set away from these easy-bending-areas.
  • the easy-bending-area 413 is the middle section of the in vivo part Y.
  • the easy-bending-area 413 is about 2.5mm away from the end of the substrate 411.
  • the easy-bending-area 413 may be an area 2.1 ⁇ 2.8mm away from the end of the in vivo part Y. The above values are for illustrative purposes only.
  • the substrate 411 when the substrate 411 includes a multi-layer secondary-substrate or a double-sided substrate, there will also be some easy-bending-areas, which should be avoided when setting electrodes. In some embodiments of the invention, when at least one electrode is arranged on the reverse side of the substrate 411, the electrode arranged on the reverse side of the substrate 411 also avoids these easy-bending-areas.
  • the protective layer 412 protecting the electrode and the edge of the PAD can still be set on the substrate 411.
  • the setting method and setting area have been described in detail previously, and will not be described here.
  • the PAD 4111/4211/4311 corresponding to the electrode 4131/4231/4331 may be set on the reverse side B of the substrate 411, while the electrode 4131/4231/4331 is still set on the obverse side A of the substrate 411, or the PAD 4111/4211/4311 is set on the obverse side A of the substrate 411, and the electrode 4131/4231/4331 is set on the reverse side B of the substrate 411, that is, electrode 4131/4231/4331 and PAD 4111/4211/4311 are respectively set on the opposite side of substrate 411.
  • the in vitro part X may have different bending directions relative to the in vivo part Y.
  • the PADs 4111/4211/4311 are set on the reverse side B of the substrate 411, the in vitro part X is bent clockwise relative to the in vivo part Y, the way of bending makes the sensor 41 need to be installed in the analyte detection device in a flip chip manner.
  • the flip chip of the sensor 41 see the public patent pct/cn2022/0845, and will not be repeated here.
  • protective layers can be set on the obverse side A and reverse side B of the substrate 411 to cover the edges of the electrodes 4131/4231/4331 and PADs 4111/4211/4311, respectively.
  • the setting method and setting area have been described in detail above, and will not be repeated here.
  • not all PADs are located on the obverse side A or reverse side B of the substrate 411, but some PADs are located on the obverse side A of the substrate 411, while the rest PADs are located on the reverse side B of the substrate 411.
  • the number of PADs on one side of the substrate 411 can be reduced, so as to increase the area of a single PAD.
  • the PADs with larger area are better electrically connected with the circuit, the detection reliability of the sensor is improved.
  • the PAD corresponding to this electrode should also be set on the reverse side B of the substrate 411, so that the wire can run on the reverse side B of the substrate 411.
  • the PADs are located on the opposite sides of the substrate 411, for the circuit, it is necessary to design the electrical connection area for the PADs on the two sides of the substrate 411, which will increase the complexity of the circuit.
  • the PADs of the reverse side B can still be guided to the obverse side A (reverse side B) of the substrate 411, it is connected to the circuit with other PADs on the obverse side A (reverse side B) to simplify the complexity of the circuit.
  • the counter PAD 4211 corresponding to the counter electrode 4231 and the reference PAD 4311 corresponding to the reference electrode 4331 are set on the obverse side A of the substrate 411, while the working PAD 4111 corresponding to the working electrode 4131 is set on the reverse side B of the substrate 411.
  • the first secondary-PAD 4111’ corresponding to the working PAD 4111 is also set on the obverse side A of the substrate 411, the first secondary-PAD 4111’ is connected to the circuit instead of the working PAD 4111 to simplify the complexity of the circuit, or the working PAD 4111 and the first secondary-PAD 4111’ are connected to the circuit at the same time to improve the reliability of the electrical connection between the PAD and the circuit.
  • the working PAD 4111 and the first secondary-PAD 4111’ need to establish an electrical connection to connect the working electrode 4131 to the circuit.
  • the area covered by the first secondary-PAD 4111’ and the working PAD 4111 at the same time on the substrate 411 is punched (not shown in the figure) , and conductive material is coated or sprayed in the hole.
  • the first secondary-PAD 4111’ and the working PAD 4111 can be electrically connected, but this process requires that the first secondary-PAD 4111’ and the working PAD 4111 be aligned on the substrate 411, at least a part of the first secondary-PAD 4111’ and the working PAD 4111 coincide on the substrate 411, otherwise the conductive material in the hole cannot contact the first secondary-PAD 4111’ and the working PAD 4111 at the same time, resulting in the failure of the fabrication of the sensor 41, which is common in the fabrication process of the sensor 41.
  • conductive material 4111 is arranged on the surface of the substrate 411 to establish an electrical connection between the first secondary-PAD 4111’ and the working PAD 4111, without the need for drilling holes on the substrate 411.
  • the conductive material 4111” is set on the obverse side A and reverse side B of the substrate 411 through coating, spraying, and other processes, and the conductive material 4111” on the obverse side A and reverse side B is connected through the side edges of the substrate 411.
  • the conductive material 4111” located on the obverse side A is electrically connected to the first secondary-PAD 4111’, and the conductive material 4111” on the reverse side B is electrically connected to the working PAD 4111, this establishes an electrical connection between PAD 4111 ‘and working PAD 4111 for the first time.
  • this scheme there is no need to align the first secondary-PAD 4111’and the working PAD 4111 when machining, which simplifies the production difficulty of sensor 41 and improves the production yield of sensor 41.
  • the conductive material 4111” located on the obverse side A of the substrate 411 and the conductive material 4111” located on the reverse side B are connected through the "side edge” of the substrate 411, where the "side edge” refers to any edge of the substrate 411.
  • conductive material 4111 can be some common solder, such as solder, or some conductive metal or alloy, such as copper zinc alloy, platinum, etc.
  • the obverse side A and reverse side B of the substrate 411 can be prefabricated first and then combined into a whole. Specifically, on the obverse side A of substrate 411, the specific production plan has been described in detail earlier and will not be repeated here.
  • one or more of the working electrode 4131, counter electrode 4231, and reference electrode 4331 may have additional electrodes with the same name, for example, the working electrode 4131 includes the first working electrode 4131 ⁇ and the second working electrode 4131 ⁇ .
  • the working electrode 4131 includes the first working electrode 4131 ⁇ and the second working electrode 4131 ⁇ at the same time
  • the counter electrode 4231 also includes the first counter electrode 4231 ⁇ and the second counter electrode 4231 ⁇ .
  • each electrode may have multiple electrodes with the same name, which can enrich and improve the functions of the sensor 41.
  • the first working electrode 4131 ⁇ and the second working electrode 4131 ⁇ can be used relay when the first working electrode 4131 ⁇ the second working electrode 4131 ⁇ as a redundant electrode, it can replace the first working electrode 4131 ⁇ by connecting the circuit and continuing the detection function, the service life of the sensor 41 is extended and the detection reliability is improved.
  • the first working electrode 4131 ⁇ and the second working electrode 4131 ⁇ can be different enzyme layers to detect different analytes in the user’s body, such as blood glucose and blood ketone.
  • the first working electrode 4131 ⁇ and the second working electrode 4131 ⁇ can be connected to the circuit at the same time, and its detection data are calibrated with each other, which improves the detection reliability.
  • the first working electrode 4131 ⁇ and the second working electrode 4131 ⁇ can be used alternately, reducing the consumption of each electrode enzyme layer during use, and can extend the first working electrode 4131 ⁇ and the second working electrode 4131 ⁇ and further, the service life of sensor 41 is extended.
  • the first working electrode 4131 ⁇ and the second working electrode 4131 ⁇ be connected to the circuit at the same time, and the analyte parameter signal is detected at the same time. After the detection signals of the two electrodes are superimposed, a stronger signal can be obtained, which enhances the anti-interference of the signal and improves the detection reliability.
  • each electrode has at least one electrode with the same name.
  • the first working electrode, the first counter electrode, and the first reference electrode form the first electrode-group
  • the second working electrode, the second counter electrode, and the second reference electrode form the second electrode-group.
  • the electrode with the same name is added on the substrate 411, which means that the corresponding PAD is also added.
  • the first working PAD 4111 ⁇ the second working PAD 4111 ⁇ the counter PAD 4211 and the reference PAD 4311 are set on the PAD-area a.
  • the area of PAD-area a is limited, and the larger the number of PADs means the smaller the area of each PAD, which will affect the reliability of the electrical connection between the PAD and the circuit.
  • part of the PADs are set on the reverse side B of the substrate 411, effectively using the limited area of the obverse side A and the reverse side B of the PAD-area a.
  • the first working PAD 4111 ⁇ and the second working PAD 4111 ⁇ are simultaneously connected to the circuit.
  • the first working PAD 4111 ⁇ and the second working PAD 4111 ⁇ can establish electrical connection on the sensor 41 directly, and the circuit only needs to connect with one of the first working PAD 4111 ⁇ and the second working PAD 4111 ⁇ to achieve the function of the sensor 41, which will reduce the complexity of the circuit.
  • the electrical connection between the first working PAD 4111 ⁇ and the second working PAD 4111 ⁇ should refer to Fig. 10i and its corresponding description, and will not be repeated here.
  • the first working electrode 4131 ⁇ and the second working electrode 4131 ⁇ share the PAD.
  • the first working electrode 4131 ⁇ and the second working electrode 4131 ⁇ electrically connect with the working PAD 4111 through wire 4121 ⁇ and wire 4121 ⁇ respectively, and the detection signals of the first working electrode 4131 ⁇ and the second working electrode 4131 ⁇ are transmitted through the working PAD 4111, which can realize the function of signal enhancement.
  • the first working electrode 4131 ⁇ and the second working electrode 4131 ⁇ share the wire.
  • the first working electrode 4131 ⁇ and the second working electrode 4131 ⁇ are electrically connected with the working PAD 4111 through the wire 4121, and the detection signals of the first working electrode 4131 ⁇ and the second working electrode 4131 ⁇ are transmitted through wire 4121 and PAD 4111, which can realize the function of signal enhancement.
  • the first working electrode 4131 ⁇ shares the wire 4121 with the second working electrode 4131 ⁇ can reduce the number of wires set on the substrate 411, reduce the possibility of short circuit between wires, and improve the detection reliability.
  • electrodes with the same name can be set on the same side of the substrate 411, which can reduce the manufacturing process steps and complexity.
  • electrodes with the same name can be set on the opposite surface of substrate 411 to reduce signal interference between electrodes with the same name.
  • the limited area of the obverse side A of the substrate 411 limits the area of the electrodes. Therefore, it is also necessary to set some of the electrodes on the reverse side B of the substrate 411. For example, setting the first working electrode 4131 ⁇ and the counter electrode 4231 on the reverse side B not only achieves detection function, but also reduces the possibility of short circuit between the counter electrode 4231 and the reference electrode 4331.
  • a protective layer 412 can be set on the substrate 411 to cover the edges of the electrodes or PADs.
  • the setting of the protective layer 412 is not necessary, and without the protective layer 412, sensor 41 can still achieve its detection function.
  • the shape of the protective layer 412 on the substrate 411 is not limited to those shown in Fig. 10a to 10m.
  • the figures are only for illustration, and any simple shape transformation, position transformation, material transformation, quantity transformation, layer number transformation, size transformation, etc. should be included in the scope of protection of the invention.
  • void the area where PADs and electrodes are located can refer to avoiding the structural areas that require electrical conductivity such as PADs and electrodes, or to the surface area where PADs and electrodes are set on the substrate in some embodiments of the invention.
  • the schemes involved in different illustrations may be applicable to each other, such as the electrode unit array scheme in Fig. 10f, which can be applied to the double-sided electrode scheme in Fig. 10e or other schemes, without limitation.
  • the invention provides a structurally enhanced analyte sensor with multi substrate. After the substrate is prefabricated, it is combined into a whole by pasting, which can avoid insulation failure caused by insufficient solidification of the substrate material, leading to brittle cracking, and further causing crosstalk between electrical signals between wires or electrodes, resulting in noise in the detection signal.
  • At least one protective layer is set on the surface of the substrate, the protective layer at least covers the edge of the electrode, increasing the adhesion between the edge of the electrode and the substrate, preventing the edge of the electrode from curling, bubbling, and detaching.
  • the protective layer can also increase the mechanical strength of the substrate of sensor, extend the service life of the sensor, and improve the detection reliability of the sensor.

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Abstract

L'invention concerne un capteur d'analyte structurellement amélioré (41) à substrat (411a,411b,411d,411e,411f) multiple. Après que le substrat (411a,411b,411d,411e,411f) est préfabriqué, il est combiné dans un ensemble par collage, ce qui peut éviter une défaillance d'isolation provoquée par une solidification insuffisante du matériau de substrat, conduisant à une fissuration fragile, et provoquant en outre une diaphonie entre les signaux électriques entre les fils ou les électrodes, ce qui entraîne un bruit dans le signal de détection, en même temps, au moins une couche de protection (412) est placée sur la surface du substrat (411), recouvrant au moins le bord de l'électrode (4131,4231,4331), augmentant l'adhérence entre le bord de l'électrode (4131,4231,4331) et le substrat (411), empêchant le bord de l'électrode (4131,4231,4331) de s'enrouler, de faire des bulles et de se détacher. En même temps, la couche de protection (412) peut également augmenter la résistance mécanique du substrat (411) du capteur (41), prolonger la durée de vie du capteur (41), et améliorer la fiabilité de détection du capteur (41).
PCT/CN2023/120616 2023-09-22 2023-09-22 Capteur d'analyte structurellement amélioré à substrat multiple Pending WO2025060041A1 (fr)

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Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20130211219A1 (en) * 2010-08-24 2013-08-15 Micro CHIPS ,Inc. Implantable Biosensor Device and Methods of Use Thereof
CN205458703U (zh) * 2015-11-12 2016-08-17 三诺生物传感股份有限公司 一种柔性植入电极
US20160235346A1 (en) * 2015-02-16 2016-08-18 Verily Life Sciences Llc Electrochemical Sensor for a Bandage Type of Continuous Glucose Monitoring System
WO2018046404A1 (fr) * 2016-09-09 2018-03-15 Robert Bosch Gmbh Bande de test jetable pour réaliser une détection d'analytes sanguins multiples chez soi
US20210077001A1 (en) * 2017-05-17 2021-03-18 Samsung Electronics Co., Ltd. Bio-sensor and manufacturing method therefor
CN115590509A (zh) * 2021-07-08 2023-01-13 上海移宇科技股份有限公司（Cn） 微型分析物传感器

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20130211219A1 (en) * 2010-08-24 2013-08-15 Micro CHIPS ,Inc. Implantable Biosensor Device and Methods of Use Thereof
US20160235346A1 (en) * 2015-02-16 2016-08-18 Verily Life Sciences Llc Electrochemical Sensor for a Bandage Type of Continuous Glucose Monitoring System
CN205458703U (zh) * 2015-11-12 2016-08-17 三诺生物传感股份有限公司 一种柔性植入电极
WO2018046404A1 (fr) * 2016-09-09 2018-03-15 Robert Bosch Gmbh Bande de test jetable pour réaliser une détection d'analytes sanguins multiples chez soi
US20210077001A1 (en) * 2017-05-17 2021-03-18 Samsung Electronics Co., Ltd. Bio-sensor and manufacturing method therefor
CN115590509A (zh) * 2021-07-08 2023-01-13 上海移宇科技股份有限公司（Cn） 微型分析物传感器

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