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WO2025090609A1 - Systèmes, dispositifs et procédés de surveillance d'analytes - Google Patents

Systèmes, dispositifs et procédés de surveillance d'analytes Download PDF

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Publication number
WO2025090609A1
WO2025090609A1 PCT/US2024/052567 US2024052567W WO2025090609A1 WO 2025090609 A1 WO2025090609 A1 WO 2025090609A1 US 2024052567 W US2024052567 W US 2024052567W WO 2025090609 A1 WO2025090609 A1 WO 2025090609A1
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WO
WIPO (PCT)
Prior art keywords
analyte
sensor
analyte level
user
display
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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Application number
PCT/US2024/052567
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English (en)
Inventor
Harri E. BRADBEER
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Abbott Diabetes Care Inc
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Abbott Diabetes Care Inc
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Filing date
Publication date
Application filed by Abbott Diabetes Care Inc filed Critical Abbott Diabetes Care Inc
Publication of WO2025090609A1 publication Critical patent/WO2025090609A1/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
    • A61B5/0002—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
    • 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
    • A61B5/74—Details of notification to user or communication with user or patient; User input means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/74—Details of notification to user or communication with user or patient; User input means
    • A61B5/742—Details of notification to user or communication with user or patient; User input means using visual displays

Definitions

  • the subject matter described herein relates generally to systems, devices, and methods for in vivo analyte monitoring.
  • analyte levels such as glucose, ketones, lactate, oxygen, hemoglobin AIC, or the like
  • analyte levels can be vitally important to the overall health of a person, particularly for an individual having diabetes.
  • Patients suffering from diabetes mellitus can experience complications including loss of consciousness, cardiovascular disease, retinopathy, neuropathy, and nephropathy.
  • Persons with diabetes are generally required to monitor their glucose levels to ensure that they are being maintained within a clinically safe range, and may also use this information to determine if and/or when insulin is needed to reduce glucose levels in their bodies, or when additional glucose is needed to raise the level of glucose in their bodies.
  • Growing clinical data demonstrates a strong correlation between the frequency of glucose monitoring and glycemic control. Despite such correlation, however, many individuals diagnosed with a diabetic condition do not monitor their glucose levels as frequently as they should due to a combination of factors including convenience, testing discretion, pain associated with glucose testing, and cost.
  • a sensor control device may be worn on the body of an individual who requires analyte monitoring.
  • the sensor control device may have a small form-factor, and can be assembled and applied by the individual with a sensor applicator.
  • the application process includes inserting a sensor, such as an analyte sensor that senses a user’s analyte level in a bodily fluid, using an applicator or insertion mechanism, such that the sensor comes into contact with a bodily fluid.
  • the sensor control device may also be configured to transmit analyte data to another device, from which the individual or her health care provider (“HCP”) can review the data and make therapy decisions.
  • HCP her health care provider
  • Continuous glucose monitoring relies on the use of a mobile device (cell phone or designated reader) to retrieve and display glucose signals to the user. This requirement may preclude those with limited access to power, smartphone technology, or technological literacy. [0007] Thus, a need exists for a continuous analyte monitoring system that provides a display or output of analyte levels on the sensor control device, and is economical to manufacture.
  • a sensor control device can be provided that includes a sensor control device or on- body unit that includes a display configured to qualitatively or quantitively display a measured analyte level.
  • a simple, low-powered system includes a sensor control device with an on-board display.
  • a sensor control device may include a semi- quantitative analogue display that employs an ammeter actuated by the current generated by the glucose response.
  • alternative qualitative and quantitative designs using microchip-powered LED displays are described.
  • Systems, devices and methods are provided for measurement of an analyte level in a bodily fluid of a subject.
  • sensor control devices include a display.
  • the display may be on or in the housing of the on-body unit.
  • the display may be directly electronically coupled to the analyte sensor or may be indirectly electronically coupled to the analyte sensor through the sensor electronics.
  • FIG. 1 is a system overview of a sensor applicator, reader device, monitoring system, network, and remote system.
  • FIG. 2A is a block diagram depicting an example embodiment of a reader device.
  • FIGS. 2B and 2C are block diagrams depicting example embodiments of sensor control devices.
  • FIGS. 2D-2H are block diagrams depicting example embodiments of sensor control devices with displays.
  • FIG. 3 A is a side view depicting an example embodiment of an applicator device coupled with a cap.
  • FIG. 4C is a side cross-sectional view depicting an example embodiment of a housing.
  • FIG. 5A is a side view depicting an example embodiment of a sheath.
  • FIG. 5B is a perspective view depicting an example embodiment of a proximal end of a sheath.
  • FIG. 5C is a close-up perspective view depicting an example embodiment of a distal side of a detent snap of a sheath.
  • FIG. 5D is a side view depicting an example embodiment of features of a sheath.
  • FIG. 5E is an end view of an example embodiment of a proximal end of a sheath.
  • FIG. 6A is a proximal perspective view depicting an example embodiment of a device carrier.
  • FIG. 6B is a distal perspective view depicting an example embodiment of a device carrier.
  • FIG. 7 is a proximal perspective view of an example embodiment of a sharp carrier.
  • FIG. 8 is a side cross-section depicting an example embodiment of a sharp carrier.
  • FIG. 9 is a top view of an exemplary sensor control device with a display.
  • FIGS. 10A-10C are exemplary embodiments of sensor control devices with an ammeter.
  • FIGS. 10D-10E are exemplary embodiments of housings of sensor control devices with portions of an ammeter.
  • FIGS. 11 A-l IB are exemplary displays with at least one light.
  • FIG. 12 is an exemplary digital display.
  • FIGS. 13A-13E illustrate cross-sectional views depicting an example embodiment of an applicator during various stages of deployment.
  • embodiments of the present disclosure include systems, devices, and methods for the use of analyte sensor insertion applicators for use with in vivo analyte monitoring systems.
  • An applicator can be used to position the sensor control device on a human body with an analyte sensor in contact with the wearer’s bodily fluid.
  • the embodiments provided herein are improvements to reduce the likelihood that a sensor is improperly inserted or damaged, or elicits an adverse physiological response. Other improvements and advantages are provided as well.
  • the various configurations of these devices are described in detail by way of the embodiments which are only examples.
  • inventions include in vivo analyte sensors structurally configured so that at least a portion of the sensor is, or can be, positioned in the body of a user to obtain information about at least one analyte of the body. It should be noted, however, that the embodiments disclosed herein can be used with in vivo analyte monitoring systems that incorporate in vitro capability, as well as purely in vitro or ex vivo analyte monitoring systems, including systems that are entirely non-invasive.
  • sensor control devices are disclosed and these devices can have one or more sensors, analyte monitoring circuits (e.g., an analog circuit), memories (e.g., for storing instructions), power sources, communication circuits, transmitters, receivers, processors and/or controllers (e.g., for executing instructions) that can perform any and all method steps or facilitate the execution of any and all method steps.
  • analyte monitoring circuits e.g., an analog circuit
  • memories e.g., for storing instructions
  • power sources e.g., for storing instructions
  • communication circuits e.g., transmitters, receivers, processors and/or controllers
  • transmitters e.g., for executing instructions
  • processors and/or controllers e.g., for executing instructions
  • Continuous Analyte Monitoring systems
  • Continuous Glucose Monitoring can transmit data from a sensor control device to a reader device continuously without prompting, e.g., automatically according to a schedule.
  • Flash Analyte Monitoring systems (or “Flash Glucose Monitoring” systems or simply “Flash” systems), as another example, can transfer data from a sensor control device in response to a scan or request for data by a reader device, such as with a Near Field Communication (NFC) or Radio Frequency Identification (RFID) protocol.
  • NFC Near Field Communication
  • RFID Radio Frequency Identification
  • In vivo analyte monitoring systems can also operate without the need for finger stick calibration.
  • In vivo analyte monitoring systems can be differentiated from “in vitro” systems that contact a biological sample outside of the body (or “ex vivo”) and that typically include a meter device that has a port for receiving an analyte test strip carrying bodily fluid of the user, which can be analyzed to determine the user’s blood sugar level.
  • In vivo monitoring systems can include a sensor that, while positioned in vivo, makes contact with the bodily fluid of the user and senses the analyte levels contained therein.
  • the sensor can be part of the sensor control device that resides on the body of the user and contains the electronics and power supply that enable and control the analyte sensing.
  • the sensor control device and variations thereof, can also be referred to as a “sensor control unit,” an “on-body electronics” device or unit, an “on-body” device or unit, or a “sensor data communication” device or unit, to name a few.
  • In vivo monitoring systems may also include a device that receives sensed analyte data from the sensor control device and processes and/or displays that sensed analyte data, in any number of forms, to the user.
  • This device and variations thereof, can be referred to as a “handheld reader device,” “reader device” (or simply a “reader”), “handheld electronics” (or simply a “handheld”), a “portable data processing” device or unit, a “data receiver,” a “receiver” device or unit (or simply a “receiver”), or a “remote” device or unit, to name a few.
  • Other devices such as personal computers have also been utilized with or incorporated into in vivo and in vitro monitoring systems.
  • FIG. l is a conceptual diagram depicting an example embodiment of an analyte monitoring system 100 that includes a sensor applicator 150, a sensor control device 102, and a reader device 120.
  • Sensor applicator 150 can be used to deliver sensor control device 102 to a monitoring location on a user’s skin where a sensor 104 is maintained in position for a period of time by an adhesive patch 105.
  • Sensor control device 102 is further described in FIGS. 2B and 2C, and can communicate with reader device 120 via a communication path 140 using a wired or wireless technique.
  • Example wireless protocols include Bluetooth, Bluetooth Low Energy (BLE, BTLE, Bluetooth SMART, etc.), Near Field Communication (NFC) and others.
  • Reader device 120 can communicate with local computer system 170 via a communication path 141 using a wired or wireless technique.
  • Local computer system 170 can include one or more of a laptop, desktop, tablet, phablet, smartphone, set-top box, video game console, or other computing device and wireless communication can include any of a number of applicable wireless networking protocols including Bluetooth, Bluetooth Low Energy, Wi-Fi or others.
  • Local computer system 170 can communicate via communications path 143 with a network 190 similar to how reader device 120 can communicate via a communications path 142 with network 190, by wired or wireless technique as described previously.
  • Network 190 can be any of a number of networks, such as private networks and public networks, local area or wide area networks, and so forth.
  • a trusted computer system 180 can include a server and can provide authentication services and secured data storage and can communicate via communications path 144 with network 190 by wired or wireless technique.
  • FIG. 2A is a block diagram depicting an example embodiment of a reader device configured as a smartphone.
  • reader device 120 can include a display 122, input component 121, and a processing core 206 including a communications processor 222 coupled with memory 223 and an applications processor 224 coupled with memory 225.
  • a processing core 206 including a communications processor 222 coupled with memory 223 and an applications processor 224 coupled with memory 225.
  • Also included can be separate memory 230, RF transceiver 228 with antenna 229, and power supply 226 with power management module 238.
  • a multi-functional transceiver 232 which can communicate over Wi-Fi, NFC, Bluetooth, BTLE, and GPS with an antenna 234. As understood by one of skill in the art, these components are electrically and communicatively coupled in a manner to make a functional device.
  • Exemplary Sensor Control Devices are electrically and communicatively coupled in a manner to make a functional device.
  • FIGS. 2B and 2C are block diagrams depicting example embodiments of sensor control device 102 having analyte sensor 104 and sensor electronics 160 (including analyte monitoring circuitry) that can have the majority of the processing capability for rendering endresult data suitable for display to the user.
  • a single semiconductor chip 161 is depicted that can be a custom application specific integrated circuit (ASIC). Shown within ASIC
  • AFE 161 are certain high-level functional units, including an analog front end (AFE) 162, power management (or control) circuitry 164, processor 166, and communication circuitry 168 (which can be implemented as a transmitter, receiver, transceiver, passive circuit, or otherwise according to the communication protocol).
  • AFE 162 and processor 166 are used as analyte monitoring circuitry, but in other embodiments either circuit can perform the analyte monitoring function.
  • Processor 166 can include one or more processors, microprocessors, controllers, and/or microcontrollers, each of which can be a discrete chip or distributed amongst (and a portion of) a number of different chips.
  • a memory 163 is also included within ASIC 161 and can be shared by the various functional units present within ASIC 161, or can be distributed amongst two or more of them. Memory 163 can also be a separate chip. Memory 163 can be volatile and/or non-volatile memory.
  • ASIC 161 is coupled with power source 172, which can be a coin cell battery, or the like.
  • AFE 162 interfaces with in vivo analyte sensor 104 and receives measurement data therefrom and outputs the data to processor 166 in digital form, which in turn processes the data to arrive at the end-result glucose discrete and trend values, etc. This data can then be provided to communication circuitry 168 for sending, by way of antenna 171, to reader device 120 (not shown), for example, where minimal further processing is needed by the resident software application to display the data.
  • FIG. 2C is similar to FIG. 2B but instead includes two discrete semiconductor chips
  • AFE 162 and 174 which can be packaged together or separately.
  • AFE 162 is resident on ASIC 161.
  • Processor 166 is integrated with power management circuitry 164 and communication circuitry 168 on chip 174.
  • AFE 162 includes memory 163 and chip 174 includes memory 165, which can be isolated or distributed within.
  • AFE 162 is combined with power management circuitry 164 and processor 166 on one chip, while communication circuitry 168 is on a separate chip.
  • both AFE 162 and communication circuitry 168 are on one chip, and processor 166 and power management circuitry 164 are on another chip. It should be noted that other chip combinations are possible, including three or more chips, each bearing responsibility for the separate functions described, or sharing one or more functions for fail-safe redundancy.
  • analyte sensor 104 e.g., a glucose sensor
  • a proximal portion configured to be positioned above a user’s skin and to be electrically coupled with electronics disposed in the electronics housing of the sensor control device.
  • a distal portion of the sensor 104 is configured to be transcutaneously positioned through the user’s skin and in contact with a bodily fluid of the user.
  • the distal portion of the sensor 104 is configured to detect an analyte in the bodily fluid.
  • the bodily fluid is interstitial fluid.
  • the sensor control device 102 or on-body unit may include a housing 107.
  • Sensor electronics may be disposed within the housing 107 when present.
  • the housing 107 may be coupled to an adhesive patch 105 that is adapted to adhere the housing 107 to skin of the user.
  • the housing 107 may include an opening 109 configured to receive the sensor 104 and sharp.
  • the housing 107 may include a display 200 that indicates a measured analyte level (e.g., glucose level) of the user.
  • the display 200 may be a qualitative or quantitative display. In some embodiments, as seen in FIGS. 10A-10E, the display 200 may be an ammeter 210. In other embodiments, the display 200 may be a digital or a qualitative display. For example, the display 200 may be a qualitative low-high series of LED lights. Alternatively, the display 200 may be fully qualitative LCD or, alternatively, a 7-segment display that displays the glucose levels determined by the sensor electronics.
  • the ammeter 210 may be in an opening of the housing 107 and include a printed scale 212 beneath a needle 214, and encased under a clear window that allows the user to read an analyte level according to the position of the needle 214 on the scale 212.
  • the needle 214 may be actuated directly by current produced on a working electrode of the sensor.
  • the display 200 e.g., ammeter 210) may be directly coupled to the electrodes from the sensor 104. As seen in FIG. 2D, the display 200 may be in series with or replace the sensor electronics 160.
  • the sensor control devices 102 may also include sensor electronics.
  • the sensor electronics may additionally enable the communication of measured and/or determined analyte levels to a reader device.
  • FIGS. 2E and 2F are block diagrams depicting example embodiments of sensor control device 102 having analyte sensor 104 and sensor electronics 160 (including analyte monitoring circuitry) where the display 200 is directly coupled to the analyte sensor 104.
  • the display 200 may be an ammeter 210 that includes a needle 214 that is actuated directly by current produced on a working electrode of the sensor. In some embodiments, as seen in FIG.
  • a single semiconductor chip 161 is depicted that can be a custom application specific integrated circuit (ASIC). Shown within ASIC 161 are certain high-level functional units, including an analog front end (AFE) 162, power management (or control) circuitry 164, processor 166, and communication circuitry 168 (which can be implemented as a transmitter, receiver, transceiver, passive circuit, or otherwise according to the communication protocol). In this embodiment, both AFE 162 and processor 166 are used as analyte monitoring circuitry, but in other embodiments either circuit can perform the analyte monitoring function. Processor 166 can include one or more processors, microprocessors, controllers, and/or microcontrollers, each of which can be a discrete chip or distributed amongst (and a portion of) a number of different chips.
  • a memory 163 is also included within ASIC 161 and can be shared by the various functional units present within ASIC 161, or can be distributed amongst two or more of them. Memory 163 can also be a separate chip. Memory 163 can be volatile and/or non-volatile memory.
  • ASIC 161 is coupled with power source 172, which can be a coin cell battery, or the like.
  • AFE 162 interfaces with in vivo analyte sensor 104 and receives measurement data therefrom and outputs the data to processor 166 in digital form, which in turn processes the data to arrive at the end-result glucose discrete and trend values, etc.
  • FIG. 2F is similar to FIG. 2E in that the display 200 is directly coupled to the analyte sensor 104.
  • the embodiment of FIG. 2F instead includes two discrete semiconductor chips 162 and 174, which can be packaged together or separately.
  • AFE 162 is resident on ASIC 161.
  • Processor 166 is integrated with power management circuitry 164 and communication circuitry 168 on chip 174.
  • AFE 162 includes memory 163 and chip 174 includes memory 165, which can be isolated or distributed within.
  • AFE 162 is combined with power management circuitry 164 and processor 166 on one chip, while communication circuitry 168 is on a separate chip.
  • both AFE 162 and communication circuitry 168 are on one chip, and processor 166 and power management circuitry 164 are on another chip. It should be noted that other chip combinations are possible, including three or more chips, each bearing responsibility for the separate functions described, or sharing one or more functions for fail-safe redundancy.
  • the display 200 may be coupled or electrically coupled to the sensor electronics 160. As seen in FIGS. 2G and 2H, the display may be coupled to the sensor electronics and the one or more processors of the sensor electronics may display a determined analyte level on the display 200.
  • the analyte sensor 104, the sensor electronics 160, and the AFE 162 and memory 163, may interact as described with respect to FIGS. 2B-2C.
  • the sensor electronics 160 may convert electrical signals, e.g., analog signals, from the electrodes to digital signal in the ASIC and the one or more processors may determine an analyte level, which can then be displayed on the display 200 and may also optionally be communicated to a reader device 120, server, network 190, or cloud.
  • the display may include one or more lights, e.g., one or more LED lights.
  • a pattern of lights displayed can convey a relative analyte level of the user.
  • an illumination pattern of the lights may indicate whether or not the user is in a target analyte range.
  • a color displayed of lights may convey a relative analyte level of the user, e.g., whether the user’s analyte level is below a target range (e.g., red), within a target range (e.g., green), or above a target range (e.g., yellow or orange).
  • the display may include a plurality of lights, and each light of the plurality of lights may be associated with an analyte range, and the one or more processors may illuminate the light associated with a measured analyte level. For example, as seen in FIG.
  • display 240 may illuminate light 242 when the user’s measured analyte level is below a target range, light 244 when the user’s measured analyte level is within a target range, and light 246 when the user’s measured analyte level is above a target range.
  • lights 242, 244, 246 may also be different colors, as mentioned with respect to other embodiments.
  • a brightness of the one or more lights may convey a relative analyte level of the user, e.g., whether the user’s analyte level is below a target range, within a target range, or above a target range.
  • the display 200 may be a 7-segment display or other digital display that can display a numerical value of a measured analyte level.
  • FIG. 3 A is a side view depicting an example embodiment of an applicator device 150 coupled with screw cap 708. This is one example of how applicator 150 is shipped to and received by a user, prior to assembly by the user with a sensor. In other embodiments, applicator 150 can be shipped to the user with the sensor and sharp contained therein.
  • FIG. 3B is a side perspective view depicting applicator 150 and cap 708 after being decoupled.
  • FIG. 3C is a perspective view depicting an example embodiment of a distal end of an applicator device 150 with electronics housing 706 and adhesive patch 105 removed from the position they would have retained within device carrier 710 of sheath 704, when cap 708 is in place.
  • FIG. 4A is a side view depicting an example embodiment of the applicator housing 702 that can include an internal cavity with support structures for applicator function.
  • a user can push housing 702 in a distal direction to activate the applicator assembly process and then also to cause delivery of sensor control device 102, after which the cavity of housing 702 can act as a receptacle for a sharp.
  • various features are shown including housing orienting feature 1302 for orienting the device during assembly and use.
  • Tamper ring groove 1304 can be a recess located around an outer circumference of housing 702, distal to a tamper ring protector 1314 and proximal to a tamper ring retainer 1306.
  • Tamper ring groove 1304 can retain a tamper ring so users can identify whether the device has been tampered with or otherwise used.
  • Housing threads 1310 can secure housing 702 to complimentary threads on cap 708 (FIGS. 3A and 3B) by aligning with complimentary cap threads and rotating in a clockwise or counterclockwise direction.
  • a side grip zone 1316 of housing 702 can provide an exterior surface location where a user can grip housing 702 in order to use it.
  • Grip overhang 1318 is a slightly raised ridge with respect to side grip zone 1316 which can aid in ease of removal of housing 702 from cap 708.
  • a shark tooth 1320 can be a raised section with a flat side located on a clockwise edge to shear off a tamper ring (not shown), and can hold the tamper ring in place after a user has unscrewed cap 708 and housing 702.
  • four shark teeth 1320 are used, although more or less can be used as desired.
  • FIG. 4B is a perspective view depicting a distal end of housing 702.
  • three housing guide structures (or “guide ribs”) 1321 are located at a 120 degree angles with respect to each other, and at 60 degree angles with respect to locking structures (or “locking ribs”) 1340, of which there are also three at 120 degree angles with respect to each other.
  • Other angular orientations either symmetric or asymmetric, can be used, as well as any number of one or more structures 1321 and 1340.
  • each structure 1321 and 1340 is configured as a planar rib, although other shapes can be used.
  • Each guide rib 1321 includes a guide edge (also called a “sheath guide rail”) 1326 that can pass along a surface of sheath 704 (e.g., guide rail 1418 described with respect to FIG. 5 A).
  • An insertion hard stop 1322 can be a flat, distally facing surface of housing guide rib 1321 located near a proximal end of housing guide rib 1321. Insertion hard stop 1322 provides a surface for a sensor electronics carrier travel limiter face 1420 of a sheath 704 (FIG. 5B) to abut during use, preventing sensor electronics carrier travel limiter face 1420 from moving any further in a proximal direction.
  • a carrier interface post 1327 passes through an aperture 1510 (FIG. 6A) of device carrier 710 during an assembly.
  • a device carrier interface 1328 can be a rounded, distally facing surface of housing guide ribs 1321 which interfaces with device carrier 710.
  • FIG. 4C is a side cross-section depicting an example embodiment of a housing.
  • Locking rib 1340 includes sheath snap lead-in feature 1330 near a distal end of locking rib 1340 which flares outward from central axis 1346 of housing 702 distally.
  • Each sheath snap lead-in feature 1330 causes detent snap round 1404 of detent snap 1402 of sheath 704 as shown in FIG. 5C to bend inward toward central axis 1346 as sheath 704 moves towards the proximal end of housing 702.
  • detent snap 1402 of sheath 704 is locked into place in locked groove 1332.
  • detent snap 1402 cannot be easily moved in a distal direction due to a surface with a near perpendicular plane to central axis 1346, shown as detent snap flat 1406 in FIG. 5C.
  • housing 702 moves further in a proximal direction toward the skin surface, and as sheath 704 advances toward the distal end of housing 702, detent snaps 1402 shift into the unlocked grooves 1334, and applicator 150 is in an “armed” position, ready for use.
  • detent snap 1402 passes over firing detent 1344.
  • deflected detent snaps 1402 This begins a firing sequence due to release of stored energy in the deflected detent snaps 1402, which travel in a proximal direction relative to the skin surface, toward sheath stopping ramp 1338 which is slightly flared outward with respect to central axis 1346 and slows sheath 704 movement during the firing sequence.
  • the next groove encountered by detent snap 1402 after unlocked groove 1334 is final lockout groove 1336 which detent snap 1402 enters at the end of the stroke or pushing sequence performed by the user.
  • Final lockout recess 1336 can be a proximally-facing surface that is perpendicular to central axis 1346 which, after detent snap 1402 passes, engages a detent snap flat 1406 and prevents reuse of the device by securely holding sheath 704 in place with respect to housing 702. Insertion hard stop 1322 of housing guide rib 1321 prevents sheath 704 from advancing proximally with respect to housing 702 by engaging sensor electronics carrier travel limiter face 1420.
  • FIGS. 5A and 5B are a side view and perspective view, respectively, depicting an example embodiment of sheath 704.
  • sheath 704 can stage sensor control device 102 above a user’s skin surface prior to application.
  • Sheath 704 can also contain features that help retain a sharp in a position for proper application of a sensor, determine the force required for sensor application, and guide sheath 704 relative to housing 702 during application.
  • Detent snaps 1402 are near a proximal end of sheath 704, described further with respect to FIG. 5C below.
  • Sheath 704 can have a generally cylindrical cross section with a first radius in a proximal section (closer to top of figure) that is shorter than a second radius in a distal section (closer to bottom of figure). Also shown are a plurality of detent clearances 1410, three in the example embodiment. Sheath 704 can include one or more detent clearances 1410, each of which can be a cutout with room for sheath snap lead-in feature 1330 to pass distally into until a distal surface of locking rib 1340 contacts a proximal surface of detent clearance 1410.
  • Guide rails 1418 are disposed between sensor electronics carrier traveler limiter face 1420 at a proximal end of sheath 704 and a cutout around lock arms 1412. Each guide rail 1418 can be a channel between two ridges where the guide edge 1326 of housing guide rib 1321 can slide distally with respect to sheath 704.
  • Lock arms 1412 are disposed near a distal end of sheath 704 and can include an attached distal end and a free proximal end, which can include lock arm interface 1416. Lock arms 1412 can lock device carrier 710 to sheath 704 when lock arm interface 1416 of lock arms 1412 engage lock interface 1502 of device carrier 710. Lock arm strengthening ribs 1414 can be disposed near a central location of each lock arm 1412 and can act as a strengthening point for an otherwise weak point of each lock arm 1412 to prevent lock arm 1412 from bending excessively or breaking.
  • Detent snap stiffening features 1422 can be located along the distal section of detent snaps 1402 and can provide reinforcement to detent snaps 1402.
  • Alignment notch 1424 can be a cutout near the distal end of sheath 704, which provides an opening for user alignment with sheath orientation feature of platform 808.
  • Stiffening ribs 1426 can include buttresses, that are triangularly shaped here, which provide support for detent base 1436.
  • Housing guide rail clearance 1428 can be a cutout for a distal surface of housing guide rib 1321 to slide during use.
  • FIG. 5C is a close-up perspective view depicting an example embodiment of detent snap 1402 of sheath 704.
  • Detent snap 1402 can include a detent snap bridge 1408 located near or at its proximal end. Detent snap 1402 can also include a detent snap flat 1406 on a distal side of detent snap bridge 1408. An outer surface of detent snap bridge 1408 can include detent snap rounds 1404 which are rounded surfaces that allow for easier movement of detent snap bridge 1408 across interior surfaces of housing 702 such as, for example, locking rib 1340.
  • FIG. 5D is a side view depicting an example embodiment of sheath 704.
  • alignment notch 1424 can be relatively close to detent clearance 1410.
  • Detent clearance 1410 is in a relatively proximal location on distal portion of sheath 704.
  • Rotation limiter 1506 can be a proximally extending relatively short protrusion on a proximal surface of device carrier 710 which limits rotation of carrier 710.
  • Sharp carrier lock arms 1524 can interface with sharp carrier 1102 as described with reference to FIGS. 7 and 8 below.
  • a sensor 4104 is supported within sharp 4030, just above the skin 1104 of the user.
  • the sheath 704 is held by detents 1344 within the applicator 150 such that appropriate downward force along the longitudinal axis of the applicator 150 will cause the resistance provided by the detents 1344 to be overcome so that sharp 4030 and sensor control device 102 can translate along the longitudinal axis into (and onto) skin 1104 of the user.
  • deflectable sharp carrier lock arms 1524 of device carrier 710 engage the sharp retraction assembly 1024 to maintain the sharp 4030 in a position relative to the sensor control device 102.
  • sensor 4104 and sharp 4030 have reached full insertion depth.
  • the deflectable sharp carrier lock arms 1524 clear the inner diameter of sheath 704.
  • the compressed force of the coil return spring 1118 drives retention features 1526 radially outward, releasing force to drive the sharp carrier 1102 or 4102 of the sharp retraction assembly 1024 to pull the (slotted or otherwise configured) sharp 4030 out of the user and off of the sensor 4104 as indicated by the arrow R in FIG. 13D.
  • the sheath 704 comprises a final locking feature 1120. Subsequently, the spent applicator assembly 150 is removed from the insertion site, leaving behind the sensor control device 102, and with the sharp 4030 secured safely inside the applicator assembly 150. The spent applicator assembly 150 is now ready for disposal.
  • Operation of the applicator 150 when applying the sensor control device 102 is designed to provide the user with a sensation that both the insertion and retraction of the sharp 4030 is performed automatically by the internal mechanisms of the applicator 150.
  • the present invention avoids the user experiencing the sensation that he is manually driving the sharp 4030 into his skin.
  • the resulting actions of the applicator 150 are perceived to be an automated response to the applicator being “triggered.”
  • the user does not perceive that he is supplying additional force to drive the sharp 4030 to pierce his skin despite that all the driving force is provided by the user and no additional biasing/driving means are used to insert the sharp 4030.
  • the retraction of the sharp 4030 is automated by the coil return spring 1118 of the applicator 150.
  • a system for measurement of an analyte level includes: an analyte sensor configured to detect an in vivo analyte level in a bodily fluid of a user; sensor electronics coupled with the analyte sensor and configured to receive electrical signals generated by the analyte sensor corresponding to the detected analyte level; and a sensor control device comprising a housing configured to be worn on skin of the user, wherein the sensor electronics are disposed within the housing, wherein the sensor control device comprises an ammeter comprising a display configured to indicate the detected analyte level, and wherein the display is operatively coupled to the sensor electronics.
  • the ammeter comprises a display window, a movable needle, and a scale comprising a range of glucose concentrations, wherein a position of the needle along the scale indicates the detected analyte level.
  • the analyte sensor comprises a working electrode, and wherein the ammeter is configured to indicate the detected analyte level based on an electrical current generated by the working electrode.
  • the analyte sensor is a glucose sensor.
  • the analyte sensor includes a proximal portion configured to be positioned above the skin of the user and to be electrically coupled with the sensor electronics disposed in the housing of the sensor control device, and a distal portion configured to be transcutaneously positioned through the skin of the user and in contact with the bodily fluid of the user, wherein the distal portion of the analyte sensor is configured to detect the analyte level in the bodily fluid.
  • the sensor control device further comprises wireless communications circuitry configured to transmit data indicative of the analyte level to a reader device, wherein the wireless communications circuitry is disposed in the housing.
  • the wireless communications circuitry transmits data indicative of the analyte level according to a Near Field Communication (NFC) protocol.
  • NFC Near Field Communication
  • the wireless communications circuitry transmits data indicative of the analyte level according to a Bluetooth or Bluetooth Low Energy protocol.
  • a system for measurement of an analyte level includes: an analyte sensor configured to detect an in vivo analyte level in a bodily fluid of a user; sensor electronics coupled with the analyte sensor and configured to receive electrical signals generated by the analyte sensor corresponding to the detected analyte level; and a sensor control device comprising a housing configured to be worn on skin of the user, wherein the sensor electronics are disposed within the housing, wherein the sensor control device comprises a display configured to indicate the detected analyte level, and wherein the display is operatively coupled to the sensor electronics, and wherein the display comprises at least one light.
  • a brightness of the at least one light is proportional to the detected analyte level.
  • the at least one light is a plurality of LED lights, wherein an illumination pattern of the plurality of LED lights is indicative of the detected analyte level of the user.
  • a color displayed on the at least one light is indicative of the detected analyte level.
  • the at least one light is a plurality of LED lights, wherein a color displayed on the plurality of lights is indicative of the detected analyte level.
  • the color displayed is a first color if the detected analyte level is below a target analyte range.
  • the color displayed is second color if the detected analyte level is within the target analyte range.
  • the color displayed is third color if the detected analyte level is above the target analyte range.
  • the display comprises a digital display configured to display a numerical value of the detected analyte level.
  • the display comprises a seven-segment display configured to display a numerical value of the detected analyte level.
  • the ammeter is configured to indicate an electric current generated at a working electrode of the analyte sensor.
  • Clause 13 The system of any of clauses 4 or 12, wherein the display comprises a seven-segment display configured to display a numerical value of the detected analyte level.
  • Clause 14 The system of any of clauses 1-13, wherein the electrical signals are analog signals, wherein the sensor electronics comprises a processor configured to convert the analog signals to digital signals corresponding to the analyte level.
  • Clause 16 The system of any of clauses 1-15, wherein the analyte sensor is a glucose sensor.
  • Clause 18 The system of any of clauses 1-17, wherein the sensor control device further comprises wireless communications circuitry configured to transmit data indicative of the analyte level to a reader device, wherein the wireless communications circuitry is disposed in the housing.
  • Clause 19 The system of clause 18, wherein the wireless communications circuitry transmits data indicative of the analyte level according to a Near Field Communication (NFC) protocol.
  • NFC Near Field Communication
  • Clause 20 The system of clause 18, wherein the wireless communications circuitry transmits data indicative of the analyte level according to a Bluetooth or Bluetooth Low Energy protocol.
  • a system for measurement of an analyte level comprising: an analyte sensor configured to detect an in vivo analyte level in a bodily fluid of a user, wherein the analyte sensor comprises a working electrode; and a housing comprising an ammeter, wherein the ammeter is electrically coupled to the analyte sensor and is configured to indicate detect the analyte level, wherein the housing is configured to be worn on skin of the user.
  • the ammeter comprises a display window, a movable needle, and a scale indicating a range of analyte concentrations, and wherein a position of the needle along the scale corresponds to the electric current generated at the working electrode.
  • Clause 23 The system of any of clauses 21-22, wherein the detected analyte level corresponds to an electrical current received from the analyte sensor.
  • Clause 24 The system of any of clauses 21-23, wherein the ammeter is configured to indicate an electric current generated at a working electrode of the analyte sensor.
  • Clause 25 The system of any of clauses 21-24, further comprising sensor electronics electrically coupled to the analyte sensor, wherein the sensor electronics is disposed within the housing.
  • Clause 26 The system of clause 25, wherein the ammeter is electrically coupled to the sensor electronics, and wherein the sensor electronics is electrically coupled with the working electrode.
  • Clause 27 The system of any of clauses 21-26, wherein the analyte sensor is a glucose sensor.
  • the analyte sensor comprises: a proximal portion configured to be positioned above the user’s skin and to be electrically coupled with the ammeter, and a distal portion configured to be transcutaneously positioned through the user’s skin and in contact with the bodily fluid of the user, wherein the distal portion of the analyte sensor is configured to detect an analyte in the bodily fluid.
  • Clause 29 The system of any of clauses 21-28, wherein the system further comprises wireless communications circuitry configured to transmit data indicative of an analyte level to a reader device, wherein the wireless communications circuitry is disposed in the housing.
  • Clause 30 The system of clause 29, wherein the wireless communications circuitry transmits data indicative of the analyte level according to a Near Field Communication (NFC) protocol.
  • NFC Near Field Communication
  • Clause 31 The system of clause 29, wherein the wireless communications circuitry transmits data indicative of the analyte level according to a Bluetooth or Bluetooth Low Energy protocol.

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Abstract

L'invention concerne des systèmes, des dispositifs et des procédés de mesure d'un taux d'analytes dans un fluide corporel d'un sujet. En particulier, l'invention concerne divers modes de réalisation de dispositifs de commande de capteur comprenant un affichage. L'affichage peut se trouver sur ou dans le boîtier de l'unité appliquée sur le corps. L'affichage peut être directement couplé électroniquement au capteur d'analyte ou peut être indirectement couplé électroniquement au capteur d'analyte par l'intermédiaire d'un système électronique de capteur.
PCT/US2024/052567 2023-10-24 2024-10-23 Systèmes, dispositifs et procédés de surveillance d'analytes Pending WO2025090609A1 (fr)

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US63/545,430 2023-10-24

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Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4953552A (en) * 1989-04-21 1990-09-04 Demarzo Arthur P Blood glucose monitoring system
US20050177037A1 (en) * 2004-01-09 2005-08-11 Seiki Okada Extracting kit, extracting device, and extracting method
US20080103374A1 (en) * 2005-01-19 2008-05-01 Sysmex Corporation Analyzer and Cartridge for Extracting Analyte
WO2010084917A1 (fr) * 2009-01-23 2010-07-29 オムロンヘルスケア株式会社 Dispositif de collecte de liquide organique permettant une collecte efficace de liquide organique et dispositif d'analyse de liquide organique permettant une analyse précise
RU184634U1 (ru) * 2018-06-22 2018-11-01 Акционерное общество "Приборостроительный завод "ВИБРАТОР" Отсчетное устройство измерительного прибора
US20210177315A1 (en) 2018-06-07 2021-06-17 Abbott Diabetes Care Inc. Focused sterilization and sterilized sub-assemblies for analyte monitoring systems
US20220110560A1 (en) 2009-02-03 2022-04-14 Abbott Diabetes Care Inc. Analyte sensor and apparatus for insertion of the sensor

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4953552A (en) * 1989-04-21 1990-09-04 Demarzo Arthur P Blood glucose monitoring system
US20050177037A1 (en) * 2004-01-09 2005-08-11 Seiki Okada Extracting kit, extracting device, and extracting method
US20080103374A1 (en) * 2005-01-19 2008-05-01 Sysmex Corporation Analyzer and Cartridge for Extracting Analyte
WO2010084917A1 (fr) * 2009-01-23 2010-07-29 オムロンヘルスケア株式会社 Dispositif de collecte de liquide organique permettant une collecte efficace de liquide organique et dispositif d'analyse de liquide organique permettant une analyse précise
US20220110560A1 (en) 2009-02-03 2022-04-14 Abbott Diabetes Care Inc. Analyte sensor and apparatus for insertion of the sensor
US20210177315A1 (en) 2018-06-07 2021-06-17 Abbott Diabetes Care Inc. Focused sterilization and sterilized sub-assemblies for analyte monitoring systems
RU184634U1 (ru) * 2018-06-22 2018-11-01 Акционерное общество "Приборостроительный завод "ВИБРАТОР" Отсчетное устройство измерительного прибора

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