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WO2025060046A1 - Capteur d'analyte avec réseau d'électrodes - Google Patents

Capteur d'analyte avec réseau d'électrodes Download PDF

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Publication number
WO2025060046A1
WO2025060046A1 PCT/CN2023/120627 CN2023120627W WO2025060046A1 WO 2025060046 A1 WO2025060046 A1 WO 2025060046A1 CN 2023120627 W CN2023120627 W CN 2023120627W WO 2025060046 A1 WO2025060046 A1 WO 2025060046A1
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WO
WIPO (PCT)
Prior art keywords
electrode
substrate
layer
sensor
electrodes
Prior art date
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Pending
Application number
PCT/CN2023/120627
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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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Publication date
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Priority to PCT/CN2023/120627 priority Critical patent/WO2025060046A1/fr
Publication of WO2025060046A1 publication Critical patent/WO2025060046A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

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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
    • 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
    • A61B5/14503—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 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
    • A61B5/145—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 an analyte sensor with electrode array.
  • 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 electrode of the sensor may break as the substrate repeatedly bends, affecting the service life of the sensor and reducing its detection reliability.
  • the embodiment of the invention discloses an analyte sensor with electrode array, which makes a whole electrode into a smaller electrode unit.
  • At least one protective layer is set on the surface of the substrate, which covers at least the edge of the electrode, increases the adhesion between the edge of the electrode and the substrate, and prevents the edge of the electrode from warping bubbling and detaching, while 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, which comprises: at least one layer of substrate, the substrate comprises an in vivo part and an in vitro part. At least two electrodes are arranged on the surface of the in vivo part for penetrating into the subcutaneous to obtain analyte parameter information. And PADs, which are arranged on the surface of the in vitro part and are electrically connected with the corresponding electrodes through wires.
  • the electrode is an array composed of electrode units.
  • at least one protective layer is arranged on the surface of substrate, and the protective layer at least covers the edge of the electrode.
  • each electrode unit includes an independent electron conduction layer, anti-interference layer, enzyme layer, adjustment layer, and biocompatible layer.
  • the electrode unit shares an anti-interference layer, an enzyme layer, an adjustment layer, and a biocompatible layer.
  • the electrode unit is a three-dimensional structure with a length of 10-100um, a width of 1-50um, and a thickness of 0.05-10um.
  • the electrode units are arranged at intervals of 1-20 ⁇ m.
  • the electrode comprises 10 to 500 electrode units.
  • the substrate comprises at least two layers of secondary-substrate, with at least two electrodes arranged on secondary-substrates of different layers.
  • each layer of secondary-substrate is prefabricated and pasted into a whole.
  • At least one electrode is disposed on the reverse side of the substrate.
  • At least one PAD is provided 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.
  • the obverse side and reverse side of the substrate are prefabricated and pasted as a whole.
  • the 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.
  • each layer of secondary-substrate is prefabricated and pasted into a whole.
  • 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 is made of a whole electrode into a smaller electrode unit.
  • 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, and 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 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.
  • the secondary-substrates of different layers can be prefabricated first, that is, the electrodes, wires and PADs are prefabricated on each layer of substrate, and then pasted and combined into a whole to form a complete sensor.
  • the conventional layer by layer coating process it can avoid insulation failure due to insufficient consolidation of the substrate material, resulting in embrittlement, further causing crosstalk between the electrical signals of the wires or electrodes, and noise in the detection signal, the detection reliability of the sensor is improved.
  • 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.
  • 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 electrodes of sensors in existing technologies may break as the substrate repeatedly bends during use, affecting the service life of the sensor and reducing its detection reliability.
  • the invention provides an analyte sensor with electrode array, which makes a whole electrode into a smaller electrode unit.
  • At least one protective layer is set on the surface of the substrate, which covers at least the edge of the electrode, increases the adhesion between the edge of the electrode and the substrate, and prevents 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.
  • 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 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 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 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 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.
  • 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 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 discloses an analyte sensor with electrode array, which makes a whole electrode into a smaller electrode unit.
  • the substrate is repeatedly bent, the possibility of electrode breakage is reduced, and 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, and 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.

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Abstract

L'invention concerne un capteur d'analyte (41) comprenant : au moins une couche de substrat (411), le substrat (411) comprenant une partie in vivo et une partie in vitro ; au moins deux électrodes (4131, 4231, 4331) disposées sur la surface de la partie in vivo pour pénétrer dans la sous-cutanée et obtenir des informations de paramètre d'analyte ; et au moins deux PAD (4111, 4211, 4311) disposés sur la surface de la partie in vitro et électriquement connectés aux électrodes (4131, 4231, 4331) correspondantes par l'intermédiaire de fils ; chacune des électrodes (4131, 4231, 4331) étant un réseau composé d'unités d'électrode (4131a, 4231a, 4331a) ; au moins une couche de protection étant disposée sur la surface du substrat (411), et la couche de protection recouvrant au moins les bords des électrodes (4131, 4231, 4331).
PCT/CN2023/120627 2023-09-22 2023-09-22 Capteur d'analyte avec réseau d'électrodes Pending WO2025060046A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/CN2023/120627 WO2025060046A1 (fr) 2023-09-22 2023-09-22 Capteur d'analyte avec réseau d'électrodes

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/CN2023/120627 WO2025060046A1 (fr) 2023-09-22 2023-09-22 Capteur d'analyte avec réseau d'électrodes

Publications (1)

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WO2025060046A1 true WO2025060046A1 (fr) 2025-03-27

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Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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
CN111670006A (zh) * 2018-02-08 2020-09-15 美敦力泌力美公司 葡萄糖传感器电极设计
CN115462787A (zh) * 2022-11-15 2022-12-13 北京深纳普思人工智能技术有限公司 基于微电极阵列的传感器
WO2023279312A1 (fr) * 2021-07-08 2023-01-12 Medtrum Technologies Inc. Capteur de micro-analyte
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
WO2023010539A1 (fr) * 2021-08-06 2023-02-09 Medtrum Technologies Inc. Capteur de micro-analyte
CN115704799A (zh) * 2021-08-06 2023-02-17 上海移宇科技股份有限公司 微型分析物传感器

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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
CN111670006A (zh) * 2018-02-08 2020-09-15 美敦力泌力美公司 葡萄糖传感器电极设计
WO2023279312A1 (fr) * 2021-07-08 2023-01-12 Medtrum Technologies Inc. Capteur de micro-analyte
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
WO2023010539A1 (fr) * 2021-08-06 2023-02-09 Medtrum Technologies Inc. Capteur de micro-analyte
CN115704799A (zh) * 2021-08-06 2023-02-17 上海移宇科技股份有限公司 微型分析物传感器
CN115462787A (zh) * 2022-11-15 2022-12-13 北京深纳普思人工智能技术有限公司 基于微电极阵列的传感器

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