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WO2025134124A1 - Procédés, systèmes et dispositifs pour la surveillance d'un analyte en continu - Google Patents

Procédés, systèmes et dispositifs pour la surveillance d'un analyte en continu Download PDF

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Publication number
WO2025134124A1
WO2025134124A1 PCT/IL2024/051207 IL2024051207W WO2025134124A1 WO 2025134124 A1 WO2025134124 A1 WO 2025134124A1 IL 2024051207 W IL2024051207 W IL 2024051207W WO 2025134124 A1 WO2025134124 A1 WO 2025134124A1
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WO
WIPO (PCT)
Prior art keywords
signals
electrode
electrodes
analyte
enzyme
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Pending
Application number
PCT/IL2024/051207
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English (en)
Inventor
Lior Shtram
Ofer Yodfat
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Tingo Medical Ltd
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Tingo Medical Ltd
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Publication of WO2025134124A1 publication Critical patent/WO2025134124A1/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
    • A61B5/14532—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
    • 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
    • A61B5/1495—Calibrating or testing of in-vivo probes
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/40—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/60—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
    • G16H40/63—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for local operation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2560/00—Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
    • A61B2560/02—Operational features
    • A61B2560/0223—Operational features of calibration, e.g. protocols for calibrating sensors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/12—Manufacturing methods specially adapted for producing sensors for in-vivo measurements
    • A61B2562/125—Manufacturing methods specially adapted for producing sensors for in-vivo measurements characterised by the manufacture of electrodes
    • 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

Definitions

  • the embodiments of the disclosure generally relate to systems and methods for real time continuous monitoring of glucose. More specifically, the embodiments of the disclosure relate to a device for continuous glucose monitoring (CGM), that includes subcutaneous electrochemical sensor, electronics, and algorithms to improve ease of use and welfare of people with diabetes.
  • CGM continuous glucose monitoring
  • Continuous glucose monitoring (CGM) systems play a critical role in diabetes management by enabling real-time tracking of glucose levels.
  • Current CGM technologies often face challenges related to accuracy, calibration, longevity, and interference from non-glucose analytes. These challenges often result in substantial costs during manufacturing, or else provide sub-optimal products to end-users.
  • This invention addresses at least one and/or other challenge by introducing an advanced sensing system utilizing multi - electrode electrochemical configuration and real-time signal processing algorithms.
  • a system for continuously monitoring glucose concentration (hereinafter “CGM system” or “system”) in the subcutaneous tissue is provided.
  • the system includes a skin adhered sensor patch that comprises an electronic assembly having a battery, a processor, and a bi-directional communication with a monitor and a planar probe ("sensor", or “electrochemical sensor”) for insertion within a subject.
  • the planar probe includes a side A and a side B.
  • the electrochemical sensor can comprise, in some embodiments, a plurality of working electrodes, a reference electrode, and a counter electrode.
  • the processor has access to computer instructions which when operated thereon, cause the processor to determine glucose concentration based on information (which in some embodiments, are one or more signals) generated by the planar probe.
  • each working electrode includes a base sheet, a conductive metal layer, and one of multiple glucose sensitive enzymes (and in some embodiments, at least one), other analytes sensitive enzymes, or inactive enzymes.
  • Each working electrode is coated or not coated with glucose limiting membrane (GLM) or any other analyte limiting membrane.
  • GLM glucose limiting membrane
  • all electrodes that are coated with GLM are positioned on one side of the planar probe.
  • each triad of working electrode, reference electrode, and counter electrode form an electrochemical cell (EC).
  • each electrochemical cell generates an electrical current (j) by enzymatic oxidizing of glucose (or another analyte) by a glucose (analyte) sensitive enzyme deposited on the working electrode.
  • a plurality of electrochemical cells is provided, e.g., EC-1, EC- 2, EC-3 ... EC-n, which generate currents j 1 , j 2 , J 3 , ... jn, respectively.
  • the processor receives these current signals from one or more electrochemical cells, analyses the signals (in some embodiments, via a glucose determination algorithm), and provides output - i.e., a glucose concentration (g).
  • the processor receives current signals from two (2) electrochemical cells (EC 1, comprising a working electrode with glucose sensitive enzyme and GLM, and EC 2, comprising a working electrode with the same enzyme without GLM), analyses the signals (in some embodiments, using a dedicated algorithm) and provides output (glucose level(s)).
  • EC 1 comprising a working electrode with glucose sensitive enzyme and GLM
  • EC 2 comprising a working electrode with the same enzyme without GLM
  • analyses the signals in some embodiments, using a dedicated algorithm
  • provides output glucose level(s)
  • the glucose levels are accurate immediately after insertion and throughout use time, and in some embodiments, include a short warm-up time and/or a short step response time.
  • the glucose concentration is not dependent on calibration.
  • i is the time index; is the glucose concentration in the bulk solution; and are constants describing the linear relationship of the signal received at EC-1 and the glucose concentration
  • the constants and shall be estimations of using a linear regression such as least squares estimation.
  • glucose concentration at any given time can be given by:
  • C giucose is the concentration of glucose in the bulk solution where the electrode is present and is the interesting signal to measure
  • f() is a non-linear function of the form [2]
  • a EC-2 and b EC-2 are constants that are calculated in real-time from the relationship between the average signal received by EC-1 and the average of the signal received by EC -2. This estimation of the calibration constants of EC-2 is performed given the constraint:
  • the additional information provided by one or more additional electrodes is used to improve the sensor specificity by subtraction of signals correlating to interferences.
  • An algorithm is used to process the signals from additional electrodes, which are not sensitive to glucose, but are sensitive to interferences, estimate the effect of the interferences and subtract from the signal of the primary glucose-sensitive electrode.
  • Manufacturing parameters may cause minor differences in gain properties of the measured interferences (e.g., the signal is directly proportional to electrode area which will include manufacturing variance). It is possible to estimate the gain difference between EC-1 and the additional electrode by calculating the correlation of the two signals, and account for this gain in the subtraction.
  • FIG. 1 shows a CGM system that includes a sensor patch and a monitor, according to some embodiments
  • FIG. 2 shows a cross-section view of a skin adhered sensor patch and a subcutaneous electrochemical sensor, according to some embodiments, where glucose that oxidized on the sensor is converted to gluconic acid and a generated electrical current is conducted to the PCB/A;
  • FIGs. 3a-f show an exploded view of a sensor patch according to some embodiments, where the sensor patch 3a-b includes electronic assembly 3c and probe assembly 3d, and the probe assembly includes a probe 3e having a contacts plate and a tip (magnified view 3f).
  • FIG. 4a-b show detailed views of an electronic assembly 4a and a probe assembly 4b according to some embodiments
  • FIG. 5a-e show a view of a probe for a continuous glucose monitoring system, illustrating a top-level view, side A (5a), and side B (5b), spatial view (5c), and cross section views of electrodes (5d-e), according to some embodiments;
  • FIGs. 6a-e shows a production process of electrodes on side A of a planar probe - adhesion of 2 nd polyimide sheets (top level view 6a) to 1 st polyimide sheet (cross section view - 6b), electrodes base sheet and conductive layer (cross section view 6c), deposition of enzyme (bio-dotting) 6d, and coating of GLM 6e, according to some embodiments;
  • FIGs. 7a-e shows a top-level view, a side A (7a) and a side B (7b), a spatial view (7c), and cross section views of the electrodes (7d-e), for a planar probe according to some embodiments;
  • FIGs. 8a-e shows a production process of electrodes on side A of a planar probe - adhesion of 2 nd polyimide sheets (top level view 8a) to 1 st polyimide sheet (cross section view - 8b), electrodes base sheet and conductive layer (cross section view 8c), deposition of enzymes (bio-dotting) 8d, and GLM coating 8e, according to some embodiments;
  • FIGs. 9a-c shows a calibration curve of electrochemical cells - typical calibration curve of a single electrochemical cell (9a), different calibration curves (1 and 2) of 2 electrochemical cells of 2 sensors from same lot (9b), calibration curves of a single electrochemical cell without GLM (9c- 1) and with GLM (9c-2) according to some embodiments;
  • FIG. 10 a characteristic stability curve after insertion of a sensor without GLM (line 1) and with GLM (line 2), according to some embodiments;
  • FIG. 11 shows a step addition test (chronoamperometry) of a single electrochemical cell for a probe for glucose monitoring, at day 1 (11-1) and day 13 (11-2), where response time is the distance between diamonds, according to some embodiments;
  • FIG. 12 shows a step addition test (chronoamperometry) of a single electrochemical cell for a probe for glucose monitoring, at day 1, 5, 9, and 16 (12-1, 2, 3, and 4), where response time is the distance between diamonds, according to some embodiments;
  • FIG. 13 shows a step addition test (chronoamperometry) of a single electrochemical cell (working electrode without GLM) for a probe for glucose monitoring, at days 1, 5, 9, and 16 (FIGs. 12-1, 2, 3, and 4), according to some embodiments;
  • FIG. 14 shows a step addition test (chronoamperometry) of a calibrated electrochemical cell (working electrode with GLM) for a probe for glucose monitoring, at day 1 (14-1) and day 11 (14-2), after implementing an algorithm that considers signals from another electrochemical cell (working electrode without GLM), according to some embodiments.
  • glucose within the subcutaneous tissue 300 is oxidized to gluconic acid by a glucose specific enzyme and the generated electrons are conducted, via the prob tip 10, to the PCB/A 24. Accordingly, given a non-linear correlation between glucose concentration and the generated current, an algorithm operating on PCB/A 24 processor converts the current (signal) to glucose readings.
  • the enzyme is glucose specific, oxygen independent, cellobiose dehydrogenase (CDH), and electrons are transferred from the enzyme to the electrode.
  • Example 26 The method of Example 25, where the specificity of the EC-1 electrode is increased by subtraction of the one or more signals correlating to interferences.
  • Example 27 The method of any of Examples 24-26, where the one or more additional EC-n electrodes are not sensitive to analyte.
  • Example 28 The method of any of Examples 24-26, where the one or more additional EC-n electrodes are sensitive to interferences.
  • Example 29 The method of any of Examples 26 and 28, where an effect of the interferences is subtracted from the one or more signals of EC-1 electrode.
  • Example 30 A continuous analyte sensor comprising at least a first electrode and a second electrode, where: the first electrode (EC-1) includes a covering comprising an analyte limiting membrane (GLM); and at least one second electrode (EC-2) configured without a GLM covering and configured for calibrating a signal of EC 1.
  • the first electrode includes a covering comprising an analyte limiting membrane (GLM); and at least one second electrode (EC-2) configured without a GLM covering and configured for calibrating a signal of EC 1.
  • Example 31 An analyte sensor including at least two electrodes including a first electrode with an active enzyme and a second electrode with inactive enzyme, optionally the at least two electrodes include one or more additional electrodes each of which includes a different variant enzyme, the sensor being configured so as to suppress the interference of signals.
  • a reference to "A and/or B", when used in conjunction with open-ended language such as “comprising” can refer, in one embodiment, to A only (optionally including elements other than B); in another embodiment, to B only (optionally including elements other than A); in yet another embodiment, to both A and B (optionally including other elements); etc.
  • the phrase "at least one,” in reference to a list of one or more elements, should be understood to mean at least one element selected from any one or more of the elements in the list of elements, but not necessarily including at least one of each and every element specifically listed within the list of elements and not excluding any combinations of elements in the list of elements.
  • This definition also allows that elements may optionally be present other than the elements specifically identified within the list of elements to which the phrase "at least one" refers, whether related or unrelated to those elements specifically identified.
  • At least one of A and B can refer, in one embodiment, to at least one, optionally including more than one, A, with no B present (and optionally including elements other than B); in another embodiment, to at least one, optionally including more than one, B, with no A present (and optionally including elements other than A); in yet another embodiment, to at least one, optionally including more than one, A, and at least one, optionally including more than one, B (and optionally including other elements); etc.
  • determining encompasses a wide variety of actions and, therefore, “determining” can include calculating, computing, processing, deriving, investigating, looking up (e.g., looking up in a table, a database or another data structure), ascertaining and the like. Also, “determining” can include receiving (e.g., receiving information), accessing (e.g., accessing data in a memory) and the like. Also, “determining” can include resolving, selecting, choosing, establishing and the like.
  • Hardware modules can include, for example, a general-purpose processor, a field programmable gate array (FPGA), and/or an application specific integrated circuit (ASIC).
  • FPGA field programmable gate array
  • ASIC application specific integrated circuit
  • one or more of the aspects and embodiments described herein can be conveniently implemented using one or more machines (e.g., one or more computing devices that are utilized as a user computing device for an electronic document, one or more server devices, such as a document server, etc.) programmed according to the teachings of the present specification.
  • a machine can be provided on as wholly or partially part of a processor of a sensor patch.
  • Examples of a computing device include, but are not limited to, an electronic book reading device, a computer workstation, a terminal computer, a server computer, a handheld device (e.g., a tablet computer, a smartphone, etc.), a web appliance, a network router, a network switch, a network bridge, any machine capable of executing a sequence of instructions that specify an action to be taken by that machine, and any combinations thereof.
  • a computing device can include and/or be included in a kiosk.
  • the computing device can comprise a processor on a sensor patch for analyte monitoring.
  • processor should be interpreted broadly to encompass a general -purpose processor, a central processing unit (CPU), a microprocessor, a digital signal processor (DSP), a controller, a microcontroller, a state machine and so forth.
  • a “processor” can refer to an application specific integrated circuit (ASIC), a programmable logic device (PLD), a field programmable gate array (FPGA), etc.
  • ASIC application specific integrated circuit
  • PLD programmable logic device
  • FPGA field programmable gate array
  • processor can refer to a combination of processing devices, e.g., a combination of a DSP and a microprocessor, multiple microprocessors, one or more microprocessors in conjunction with a DSP core or any other such configuration.
  • memory should be interpreted broadly to encompass any electronic component capable of storing electronic information.
  • the term memory can refer to various types of processor-readable media such as random-access memory (RAM), read-only memory (ROM), non-volatile random-access memory (NVRAM), programmable read-only memory (PROM), erasable programmable read only memory (EPROM), electrically erasable PROM (EEPROM), flash memory, magnetic or optical data storage, registers, etc.
  • RAM random-access memory
  • ROM read-only memory
  • NVRAM non-volatile random-access memory
  • PROM programmable read-only memory
  • EPROM erasable programmable read only memory
  • EEPROM electrically erasable PROM
  • flash memory magnetic or optical data storage, registers, etc.
  • Such software can be a computer program product that employs a machine-readable storage medium.
  • a machine-readable storage medium can be any medium that is capable of storing and/or encoding a sequence of instructions for execution by a machine (e.g., a computing device) and that causes the machine to perform any one of the methodologies and/or embodiments described herein.
  • Examples of a machine-readable storage medium include, but are not limited to, a magnetic disk, an optical disc (e.g., CD, CD-R, DVD, DVD-R, etc.), a magneto-optical disk, a read-only memory "ROM” device, a random-access memory “RAM” device, a magnetic card, an optical card, a solid-state memory device, an EPROM, an EEPROM, and any combinations thereof.
  • a machine-readable medium, as used herein, is intended to include a single medium as well as a collection of physically separate media, such as, for example, a collection of compact discs or one or more hard disk drives in combination with a computer memory.
  • a machine-readable storage medium does not include transitory forms of signal transmission.
  • Such software can also include information (e.g., data) carried as a data signal on a data carrier, such as a carrier wave.
  • a data carrier such as a carrier wave.
  • machine-executable information can be included as a data-carrying signal embodied in a data carrier in which the signal encodes a sequence of instruction, or portion thereof, for execution by a machine (e.g., a computing device) and any related information (e.g., data structures and data) that causes the machine to perform any one of the methodologies and/or embodiments described herein.
  • instructions and “code” should be interpreted broadly to include any type of computer-readable statement(s).
  • the terms “instructions” and “code” can refer to one or more programs, routines, sub-routines, functions, procedures, etc.
  • “Instructions” and “code” can comprise a single computer-readable statement or many computer-readable statements.
  • modules can be, for example, distinct but interrelated units from which a program may be built up or into which a complex activity may be analyzed.
  • a module can also be an extension to a main program dedicated to a specific function.
  • a module can also be code that is added in as a whole or is designed for easy reusability.
  • Some embodiments described herein relate to a computer storage product with a non- transitory computer-readable medium (also can be referred to as a non-transitory processor- readable medium) having instructions or computer code thereon for performing various computer-implemented operations.
  • the computer-readable medium or processor-readable medium
  • the media and computer code can be those designed and constructed for the specific purpose or purposes.
  • non-transitory computer-readable media include, but are not limited to, magnetic storage media such as hard disks, floppy disks, and magnetic tape; optical storage media such as Compact Disc/Digital Video Discs (CD/DVDs), Compact Disc-Read Only Memories (CD-ROMs), and holographic devices; magneto-optical storage media such as optical disks; carrier wave signal processing modules; and hardware devices that are specially configured to store and execute program code, such as Application-Specific Integrated Circuits (ASICs), Programmable Logic Devices (PLDs), Read-Only Memory (ROM) and Random-Access Memory (RAM) devices.
  • ASICs Application-Specific Integrated Circuits
  • PLDs Programmable Logic Devices
  • ROM Read-Only Memory
  • RAM Random-Access Memory
  • Other embodiments described herein relate to a computer program product, which can include, for example, the instructions and/or computer code discussed herein.

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Abstract

Des modes de réalisation de la divulgation concernent de manière générale des systèmes et des procédés pour la surveillance du glucose en continu en temps réel. Plus précisément, les modes de réalisation de la divulgation concernent un dispositif pour la surveillance du glucose en continu (COM), qui comprend un capteur électrochimique sous-cutané, de l'électronique et des algorithmes pour améliorer la facilité de fabrication, l'utilisation et, plus important, le bien-être de personnes souffrant de diabète.
PCT/IL2024/051207 2023-12-19 2024-12-19 Procédés, systèmes et dispositifs pour la surveillance d'un analyte en continu Pending WO2025134124A1 (fr)

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US202363612343P 2023-12-19 2023-12-19
US63/612,343 2023-12-19

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WO2025134124A1 true WO2025134124A1 (fr) 2025-06-26

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20110319739A1 (en) * 2003-12-05 2011-12-29 Dexcom, Inc. Calibration techniques for a continuous analyte sensor
US20120265035A1 (en) * 2011-04-15 2012-10-18 Dexcom, Inc Advanced analyte sensor calibration and error detection
CN104825171A (zh) * 2009-02-26 2015-08-12 雅培糖尿病护理公司 改进的分析物传感器及其制造和使用方法
US20230140651A1 (en) * 2015-09-10 2023-05-04 Dexcom. Inc. Transcutaneous analyte sensors and monitors, calibration thereof, and associated methods

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20110319739A1 (en) * 2003-12-05 2011-12-29 Dexcom, Inc. Calibration techniques for a continuous analyte sensor
CN104825171A (zh) * 2009-02-26 2015-08-12 雅培糖尿病护理公司 改进的分析物传感器及其制造和使用方法
US20120265035A1 (en) * 2011-04-15 2012-10-18 Dexcom, Inc Advanced analyte sensor calibration and error detection
US20230140651A1 (en) * 2015-09-10 2023-05-04 Dexcom. Inc. Transcutaneous analyte sensors and monitors, calibration thereof, and associated methods

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