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KR-20260065861-A - Sensor assembly and sensor assembly wake-up method

KR20260065861AKR 20260065861 AKR20260065861 AKR 20260065861AKR-20260065861-A

Abstract

A sensor assembly is proposed comprising at least one analyte sensor (110) configured to detect at least one analyte transdermally. The analyte sensor (110) comprises at least two electrodes (116, 118). The sensor assembly (124) comprises at least one electronic unit (126) that can be connected to the analyte sensor (110). The electronic unit (126) comprises at least one wake-up unit (128) configured to determine the conductivity of the analyte sensor (110) and trigger the wake-up of the sensor assembly (124) according to the determined conductivity of the analyte sensor (110).

Inventors

  • 슬리오츠베르크 키릴
  • 베호브스키 프레드리끄

Assignees

  • 로셰 다이어비티즈 케어 게엠베하

Dates

Publication Date
20260511
Application Date
20240909
Priority Date
20230912

Claims (15)

  1. A sensor assembly (124) comprising at least one analyte sensor (110) configured to detect at least one analyte transdermally, wherein the analyte sensor (110) comprises at least two electrodes (116, 118), and the sensor assembly (124) comprises at least one electronic device unit (126) connectable to the analyte sensor (110), and the electronic device unit (126) comprises at least one wake-up unit (128) configured to determine the conductivity of the analyte sensor (110) and trigger the wake-up of the sensor assembly (124) according to the determined conductivity of the analyte sensor (110).
  2. A sensor assembly (124) in which, in claim 1, a wake-up is triggered when a change in conductivity from an initial conductivity value is determined, and a wake-up is triggered when the change in conductivity exceeds at least one predefined limit.
  3. In paragraph 2, the electronic device unit (126) includes at least one microcontroller unit (132) configured to control the operation of the analyte sensor (110), the wake-up unit (128) is configured to generate at least one wake-up signal according to a determined conductivity and provide the wake-up signal to the microcontroller unit (132), and the microcontroller unit (132) is configured to switch the state of the sensor assembly (124) from an inactive state to an active mode upon receiving the wake-up signal.
  4. A sensor assembly (124) in which, in any one of claims 1 to 3, the conductivity of the analyte sensor (110) is determined using at least one DC and/or AC measurement.
  5. A sensor assembly (124) wherein, in any one of claims 1 to 4, the conductivity of the analyte sensor (110) is determined using at least one impedance measurement, the wake-up unit (128) includes at least one signal generator device, the wake-up unit (128) includes at least one reference resistor connected to the signal generator device and connected in series with the analyte sensor (110), the wake-up unit (128) is configured to apply an AC voltage signal to the reference resistor and the analyte sensor (110) connected in series, the wake-up unit (128) is configured to determine a voltage distribution across the analyte sensor (110) and the reference resistor during the AC voltage signal, and the wake-up unit (128) is configured to activate the sensor assembly (124) when the change in the voltage distribution reaches at least a predefined amount.
  6. In claim 5, the signal generator device comprises at least one pulse generator (134) configured to generate a rapid transient voltage signal, and the wake-up unit (128) comprises at least one reference resistor R connected to the pulse generator (134) and connected in series with the analyte sensor (110), and the impedance measurement comprises applying a rapid transient voltage signal to the reference resistor R and the analyte sensor (110) connected in series, and the wake-up unit (128) is configured to determine a voltage distribution across the analyte sensor (110) and the reference resistor R during the rapid transient voltage signal, and the wake-up unit (128) is configured to activate the sensor assembly (124) when the change in the voltage distribution reaches at least a predefined amount.
  7. A sensor assembly (124) according to claim 6, wherein the rapid transient voltage signal comprises a single pulse or a series of pulses, and the duration of each pulse is ≤ 20 μs, preferably ≤ 10 μs.
  8. In any one of claims 1 to 7, the conductivity of the analyte sensor (110) is determined using at least one DC resistance measurement, and the wake-up unit (128) includes at least one reference resistor R1 connected in series with the analyte sensor (110), the DC resistance measurement includes distributing a DC voltage to the analyte sensor (110) and the reference resistor R1 and measuring at least one voltage distribution across the analyte sensor (110) and the reference resistor R1, and the wake-up unit (128) is configured to activate the sensor assembly (124) when the change in the voltage distribution reaches at least a predefined amount.
  9. In any one of claims 1 to 8, the sensor assembly (124) is configured such that the wake-up unit (128) detects the insertion of the analyte sensor (110).
  10. A sensor assembly (124) wherein, in any one of claims 1 to 9, the analyte sensor (110) is a 2-electrode sensor or a 3-electrode sensor.
  11. A method for waking up a sensor assembly (124) according to any one of claims 1 to 10, wherein the method A step of determining the conductivity of the above-mentioned analyte sensor (110), and A step of triggering the wake-up of the sensor assembly (124) according to the conductivity of the determined analyte sensor (110). A method including
  12. In claim 11, the conductivity of the analyte sensor (110) is determined using at least one DC resistance or AC impedance measurement.
  13. In claim 11 or 12, the conductivity of the analyte sensor (110) is determined using at least one AC impedance measurement, and the method is, i) a step of generating and applying at least one AC voltage signal, such as at least one rapid transient voltage signal, using at least one signal generator device of the wake-up unit (128), and Herein, the wake-up unit (128) comprises at least one reference resistor connected to the signal generator device and connected in series with the analyte sensor (110), step ii) measuring at least one voltage distribution across the analyte sensor (110) and the reference resistor during the AC voltage signal, iii) activating the sensor assembly (124) when the change in voltage distribution reaches at least a predefined amount A method including
  14. In any one of claims 11 to 13, the conductivity of the analyte sensor (110) is determined using at least one DC resistance measurement, and the method is a) a step of distributing the DC voltage to the analyte sensor (110) and a reference resistor connected in series with the analyte sensor (110); b) a step of measuring at least one voltage distribution across the analyte sensor (110) and the reference resistor; c) Activating the sensor assembly (124) when the change in voltage distribution reaches at least a predefined amount A method including
  15. In paragraph 14, the method wherein the DC voltage is removed after activating the sensor assembly (124).

Description

Sensor assembly and sensor assembly wake-up method The present invention relates to a sensor assembly and a method for waking up the sensor assembly. The sensor assembly may be configured to detect at least one analyte in the body fluid of a subject, in particular. The devices may be applied in the field of continuous monitoring of analytes, particularly in the field of home care and professional care, such as hospitals. However, other applications are also possible. Monitoring the concentration of one or more analytes, such as one or more metabolites, in the body fluids of a subject plays an important role in the prevention and treatment of various diseases. Such analytes may include, for example, but not limited to, glucose, lactic acid, cholesterol, or other types of analytes and metabolites. Without limiting additional applicability, the present invention will be described below with reference to glucose monitoring. However, additionally or alternatively, the present invention may be applied to other types of analytes. Continuous monitoring (CM) is gradually establishing itself as an important method for managing, monitoring, and controlling diabetes. Transdermal CM systems typically include a sensor inserted into the patient's skin and an electronic module that controls the sensor and collects data. Since the system must be waterproof, the electronic components, including the battery, are sealed within a case; consequently, there is no way to mechanically separate the battery from the electronic components to prevent discharge during the storage period, which is typically about one year. Therefore, various methods are being developed to conserve battery charge by keeping the electronic components in a low-power consumption mode during storage. To maintain the electronic components in a low-power consumption mode, certain processes and signal sources are required to activate them when the system is applied and measurements are to begin. Methods for activating a CM system are disclosed, for example, in EP3515287B1, US11350857B2, and US20170172472A1. Various other methods are described, for example, a method of activating system electronic devices by transmitting power via NFC using an NFC antenna and an external NFC reader. Another method involves using electronic components that detect magnetic fields. These components are placed on the system's PCBA, and magnets are embedded in external components that are removed during CM system insertion. The electronic devices are manufactured and programmed to check the external magnetic field at specific periodicities during storage. However, existing methods always require additional components, such as NFC antennas or some magnetic field sensors. Therefore, it is necessary to reduce the number of components to make the device simpler, cheaper, and smaller. Additional optional features and embodiments will be disclosed in more detail in conjunction with dependent claims, preferably in the subsequent description of the embodiments. Herein, such optional features may be implemented not only independently but also in any feasible combination, as will be recognized by a person skilled in the art. The scope of the invention is not limited by preferred embodiments. Embodiments are schematically depicted in the drawings. In these drawings, the same reference numerals refer to the same or functionally comparable elements. In the drawing: Figure 1 schematically shows the biological end of the analyte sensor; FIG. 2 shows two simulated impedance spectra of an analyte sensor represented by a Randall circuit in a frequency range of 10 m Hz to 100 kHz; FIG. 3 shows a sensor assembly for determining conductivity using AC measurement; and Figure 4 shows a sensor assembly for determining conductivity using DC measurement. The upper portion of FIG. 1 is an analyte sensor (110) schematically showing the biological end of the insertable portion. The analyte sensor (110) is an element of the sensor assembly (124) as shown in FIG. 3 and FIG. 4. The analyte sensor (110) may be configured to detect at least one analyte transdermally. In the embodiment of FIG. 1, the analyte sensor (110) is an amperometric sensor and includes two electrodes. The analyte sensor (110) may include a carrier, such as a substrate (114). The substrate (114) may have an elongated shape, such as a strip and/or a rod. The substrate (114) may include an electrical insulating material, such as a plastic foil, for example, as shown in FIG. 1. Each side of the substrate (114) may be coated with a certain conductive layer (115), such as carbon. The electrode comprises at least one working electrode (WE, 116) and at least one additional electrode (CE/RE, 118), such as a counter electrode and/or reference electrode or a combined counter electrode/reference electrode. In FIG. 1, one side is the working electrode (116) and the other side is the combined counter electrode-reference electrode (118). A sensing chemical (11