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WO2025240114A1 - Moniteur d'analyte en continu implantable - Google Patents

Moniteur d'analyte en continu implantable

Info

Publication number
WO2025240114A1
WO2025240114A1 PCT/US2025/026828 US2025026828W WO2025240114A1 WO 2025240114 A1 WO2025240114 A1 WO 2025240114A1 US 2025026828 W US2025026828 W US 2025026828W WO 2025240114 A1 WO2025240114 A1 WO 2025240114A1
Authority
WO
WIPO (PCT)
Prior art keywords
induction coil
sensor
implantable
implantable continuous
circuit board
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.)
Pending
Application number
PCT/US2025/026828
Other languages
English (en)
Inventor
Louis B. GIANNI
Erich J. IWEN
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Abbott Diabetes Care Inc
Original Assignee
Abbott Diabetes Care Inc
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Abbott Diabetes Care Inc filed Critical Abbott Diabetes Care Inc
Publication of WO2025240114A1 publication Critical patent/WO2025240114A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

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
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3468—Trocars; Puncturing needles for implanting or removing devices, e.g. prostheses, implants, seeds, wires
    • 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
    • A61B5/14507—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 specially adapted for measuring characteristics of body fluids other than blood
    • A61B5/1451—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 specially adapted for measuring characteristics of body fluids other than blood for interstitial fluid
    • 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
    • A61B5/1473—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 invasive, e.g. introduced into the body by a catheter
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
    • A61B5/1468—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue using chemical or electrochemical methods, e.g. by polarographic means
    • A61B5/1486—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue using chemical or electrochemical methods, e.g. by polarographic means using enzyme electrodes, e.g. with immobilised oxidase
    • A61B5/14865—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue using chemical or electrochemical methods, e.g. by polarographic means using enzyme electrodes, e.g. with immobilised oxidase invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2560/00—Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
    • A61B2560/02—Operational features
    • A61B2560/0204—Operational features of power management
    • A61B2560/0214—Operational features of power management of power generation or supply
    • A61B2560/0219—Operational features of power management of power generation or supply of externally powered implanted units
    • 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
    • A61B5/14546—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 analytes not otherwise provided for, e.g. ions, cytochromes

Definitions

  • 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.
  • a sensor control device may be worn on the body of an individual who requires analyte monitoring.
  • Such sensor control devices can be referred to as on-body units (OBUs), on-body sensors, continuous glucose monitors (CGMs), or CGM units.
  • OBUs on-body units
  • CGMs continuous glucose monitors
  • the sensor control device may have a small form-factor, and can be assembled and/or applied by the individual with a sensor applicator.
  • the application process includes applying a sensor, such as an analyte sensor that senses a user's analyte level in a bodily fluid, using an applicator mechanism, such that the sensor comes into contact with a bodily fluid.
  • a sensor such as an analyte sensor that senses a user's analyte level in a bodily fluid
  • control and powercomponents of the sensor control device typically reside external to the user's body (e.g., within a housing adhered to the user's skin) while a sensor probe protrudes into the user's body system to interact with interstitial fluid to facilitate analyte sensing.
  • the sensor control device may also be configured to transmit analyte data to another device, from which the individual or the individual's health care provider ("HCP") can review the data and make therapy decisions.
  • HCP health care provider
  • the disclosed subject matter includes an implantable continuous glucose monitor that includes a printed circuit board, one or more sensor electronics installed on the printed circuit board, and a glucose sensor communicatively coupled to at least some of the one or more sensor electronics.
  • the glucose sensor can be configured to provide measurement data to the at least some of the one or more sensor electronics.
  • the continuous glucose monitor further includes a rechargeable battery connected to the printed circuit board and configured to supply power to the one or more sensor electronics.
  • the continuous glucose monitor further includes a receiver induction coil configured to produce an induced current for charging the rechargeable battery when the receiver induction coil is arranged within or near an alternating magnetic field generated via a transmitter induction coil of a charging device.
  • the transmitter induction coil and the receiver induction coil can be configured to interact in a transcutaneous manner to facilitate charging of the rechargeable battery.
  • the continuous glucose monitor further includes a polymer encapsulation medium that encapsulates the printed circuit board, the one or more sensor electronics, the rechargeable battery, and the receiver induction coil. At least part of the glucose sensor can remain unencapsulated by the polymer encapsulation medium to expose the glucose sensor to interstitial fluid when the implantable continuous glucose monitor is subcutaneously implanted in a subject.
  • the disclosed subject matter includes an implantable continuous glucose monitor system that includes an implantable continuous glucose monitor.
  • the implantable continuous glucose monitor includes a printed circuit board, one or more sensor electronics installed on the printed circuit board, and a glucose sensor communicatively coupled to at least some of the one or more sensor electronics.
  • the glucose sensor can be configured to provide measurement data to the at least some of the one or more sensor electronics.
  • the continuous glucose monitor further includes a rechargeable battery connected to the printed circuit board and configured to supply power to the one or more sensor electronics.
  • the continuous glucose monitor further includes a receiver induction coil configured to produce an induced current for charging the rechargeable battery when the receiver induction coil is arranged within or near an alternating magnetic field generated via a transmitter induction coil of a charging device.
  • the transmitter induction coil and the receiver induction coil can be configured to interact in a transcutaneous manner to facilitate charging of the rechargeable battery.
  • the continuous glucose monitor further includes a polymer encapsulation medium that encapsulates the printed circuit board, the one or more sensor electronics, the rechargeable battery, and the receiver induction coil. At least part of the glucose sensor can remain unencapsulated by the polymer encapsulation medium to expose the glucose sensor to interstitial fluid when the implantable continuous glucose monitor is subcutaneously implanted in a subject.
  • the continuous glucose monitor system further includes an insertion system configured to implant the implantable continuous glucose monitor in the subject.
  • the continuous glucose monitor system further includes the charging device including the transmitter induction coil configured to generate the alternating magnetic field for facilitating charging of the rechargeable battery in the transcutaneous manner.
  • the transmitter induction coil and the receiver induction coil can be configured to interact in a transcutaneous manner to facilitate charging of the rechargeable battery.
  • the continuous analyte monitor further includes a polymer encapsulation medium that encapsulates the printed circuit board, the one or more sensor electronics, the rechargeable battery, and the receiver induction coil. At least part of the analyte sensor can remain unencapsulated by the polymerencapsulation medium to expose the analyte sensor to interstitial fluid when the implantable continuous analyte monitor is subcutaneously implanted in a subject.
  • an implantable continuous analyte monitor may include a printed circuit board (PCB), one or more sensor electronics, an analyte sensor, a rechargeable battery connected to the PCB and configured to supply power to the sensor electronic(s), a receiver induction coil configured to produce an induced current for charging the rechargeable battery in a wireless and transcutaneous manner, and a polymerencapsulation medium that encapsulates the PCB, the sensor electronic(s), the rechargeable battery, and the receiver induction coil. At least part of the analyte sensor remains unencapsulated by the polymer encapsulation medium to expose the analyte sensor to interstitial fluid when the implantable continuous analyte monitor is subcutaneously implanted in a subject.
  • PCB printed circuit board
  • sensor electronics an analyte sensor
  • a rechargeable battery connected to the PCB and configured to supply power to the sensor electronic(s)
  • a receiver induction coil configured to produce an induced current for charging the rechargeable battery in a wireless and transcutaneous manner
  • Figure 1 illustrates a system overview of a sensor applicator, reader device, monitoring system, network, and remote system, in accordance with implementations of the disclosed subject matter.
  • Figure 2 illustrates a block diagram depicting an example embodiment of a reader device, in accordance with implementations of the disclosed subject matter.
  • FIGS 3A and 3B illustrate block diagrams depicting example embodiments of sensor control devices (or on-body sensors), in accordance with implementations of the disclosed subject matter.
  • Figure 4 illustrates an example implantable continuous glucose monitor, in accordance with implementations of the disclosed subject matter.
  • FIGS 5 and 6 illustrate additional examples of implantable continuous glucose monitors with alternative coil configurations, in accordance with implementations of the disclosed subject matter.
  • FIG. 7 illustrates another example of an implantable continuous glucose monitor with an alternative glucose sensor configuration, in accordance with implementations of the disclosed subject matter.
  • Figure 8 illustrates an example insertion system for inserting an implantable continuous glucose monitor into a subject, in accordance with implementations of the disclosed subject matter.
  • Figures 9 through 13 illustrate conceptual representations of acts associated with inserting an implantable continuous glucose monitor into a subject, in accordance with implementations of the disclosed subject matter.
  • Figure 14 illustrates an example charging device for charging an implantable continuous glucose monitor in a transcutaneous manner, in accordance with implementations of the disclosed subject matter.
  • embodiments of the present disclosure include systems, devices, and methods associated with implantable continuous analyte monitors, such as implantable continuous glucose monitors that can be used to facilitate in vivo continuous glucose monitoring.
  • the control and power components of the sensor control device typically reside outside of the user's body.
  • the control and power components may reside within a housing adhered to the user's skin, while a sensor probe protrudes into the user's body system to interact with interstitial fluid to facilitate glucose monitoring.
  • Conventional CGM units are often provided with an accompanying applicator to allow the user to selfapply the CGM unit to their own body.
  • the CGM unit may be preloaded within the applicator, and the user may position the applicator over a bodily structure on which the CGM unit is to be adhered (e.g., on the user's arm).
  • the user may activate an actuation mechanism or other trigger of the applicator to cause the CGM unit to press against and adhere to the skin of the user and to cause firing of a sharp to bring the sensor probe into contact with interstitial fluid under the user's skin.
  • conventional CGM systems can achieve various benefits for patients experiencing diabetes and for health care providers, conventional CGM systems are associated with various shortcomings and/or challenges.
  • user selfapplication of the CGM units can give rise to various errors, such as improper sensor placement, insufficient pressure during application (which can result in adhesion failure), and/or others.
  • adhesives used to adhere a CGM unit to a user's body e.g., cyanoacrylate
  • cyanoacrylate can cause allergic reactions in some users.
  • external placement of the control and power components of a CGM unit on the user's body can cause interferences with day-to-day activities (e.g., snagging on clothing) and/or can be regarded as unsightly by some users.
  • conventional applicator or insertion mechanisms for CGM systems include numerous components, such as a housing, a sharp, a sharp carrier, a sheath, a firing mechanism, and/or others.
  • the numerous components associated with existing applicator or insertion mechanisms for CGM systems can give rise to high device complexity, high manufacturing costs, increased error rates, and/or other challenges.
  • CGM units typically include single-use batteries that power the sensor electronics of the CGM unit after application to the user's body for a predetermined time period (e.g., 14 days, or another time period).
  • a predetermined time period e.g. 14 days, or another time period.
  • users typically repeatedly engage in CGM unit removal and re-application of a new CGM unit to maintain continuous glucose monitoring functionality for extended time periods. For example, for CGM units with a battery life of 14 days, a user would engage in 26 sessions of CGM unit removal and re-application of a new CGM unit throughout a year. The performance of numerous CGM unit applications over time can present many instances in which user errors may occur.
  • CGM unit applications users are repeatedly subjected to discomforts associated with sensor application (e.g., a sharp firing through the user's skin), which can degrade user experiences and can decrease user motivation to perform sensor application. Still furthermore, some users find difficulty in maintaining a consistent supply of replacement CGM units on-hand for upcoming unit removal and re-application sessions, which can result in gaps in continuous glucose monitoring. Also, the use of numerous CGM units for a single user over time results in significant material waste.
  • an implantable CGM unit can include a printed circuit board (PCB) with one or more sensor electronics installed thereon.
  • the implantable CGM can further include a glucose sensor that is configured to provide measurement data to at least some of the sensor electronics.
  • the implantable CGM can further include a rechargeable battery connected to the PCB and configured to supply power to the sensor electronics.
  • the implantable CGM can further include a receiver induction coil that is configured to produce an induced current for charging the rechargeable battery when arranged within or near an alternating magnetic field generated via a charging device.
  • the transmitter and receiver induction coils can be configured to interact in a transcutaneous manner to facilitate charging of the rechargeable battery.
  • the implantable CGM can further include a polymer encapsulation medium that encapsulates the PCB, the sensor electronics, the rechargeable battery, and the receiver induction coil. At least part of the glucose sensor may remain unencapsulated to expose the glucose sensor to interstitial fluid when the implantable CGM is subcutaneously implanted in a subject (or user).
  • An implantable CGM can be provided as part of an implantable CGM system that includes an insertion system and a charging device for charging the rechargeable battery in a transcutaneous manner.
  • the insertion system can include an incision tool and an inserter tool.
  • the implantable CGM may be preloaded in the inserter tool.
  • An implantable CGM system and/or components associated therewith as described herein can provide various advantages relative to existing CGM systems/units. For instance, an implantable CGM may be inserted by a healthcare provider or other skilled person, which may reduce the incidence of application errors. As another example, because an implantable CGM can be subcutaneously implanted into a user, the use of potentially allergenic adhesives may be avoided, and user concerns regarding unsightliness and interference with daily life may be mitigated. Furthermore, because an implantable continuous glucose or other analyte monitor may have a lower likelihood of impact with objects in patient environments, numerous implant locations become possible (e.g., between ribs, under the arm, sub-clavicle, and/or other locations).
  • an insertion tool for an implantable CGM can comprise a simple construction including a plunger with a dissection tip, an insertion channel, and various physical features for ease of use (e.g., a flared edge, finger recesses, wings).
  • an implantable CGM system can have reduced device complexity, manufacturing cost, error rates, waste, etc. relative to conventional CGM systems that rely on disposable applicator mechanisms.
  • the encapsulated design can require no adhesive, which is a known limitation of life expectancy on externally attached conventional CGMs and is also a known allergen in a subset of the population.
  • an implantable CGM may be inserted once to achieve continuous glucose monitoring over a long period of time (e.g., forthe life of the subject). Users can thus avoid subjection to repeated CGM unit removal and re-application procedures to achieve continuous glucose monitoring over extended periods. Users can also avoid allocating organizational resources to ensuring that an adequate supply of replacement CGM units is on-hand and can avoid discomfort and/or potential errors associated with repeated CGM unit self-applications.
  • implantable CGM Although examples provided herein focus, in at least some respects, on an implantable CGM, the principles disclosed herein can be applicable to other types of implantable analyte monitors, such as implantable lactate, cholesterol, creatinine, alcohol, glutamate, and/or other monitors.
  • Continuous Analyte Monitoring systems
  • Continuous Glucose Monitoring systems
  • flash Analyte Monitoring systems
  • flash Glucose Monitoring systems or simply “Flash” systems
  • 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 (e.g., on-body unit or OBU) 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 in 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,” a “continuous glucose monitor” or “CGM,” a CGM 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 can 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 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, laptops, tablets, smartphones, or wearable devices such as smartwatches, head-mounted displays, or other mobile electronic devices have also been utilized with or incorporated into in vivo and in vitro monitoring systems.
  • Example wireless protocols include Bluetooth, Bluetooth Low Energy (BLE, BTLE, Bluetooth SMART, etc.), Near Field Communication (NFC), and others.
  • the sensor control device 102 can include an antenna to facilitate such communication over the communication path 140, which can be implemented as a chip (e.g., encapsulated along with a PCB), an integrated wire in a PCBA (e.g., PCB 404), or a multiuse function of an induction coil (e.g., coil 176, described hereafter).
  • Charging device 106 can be used to perform charging of a battery of the sensor control device 102 in a transcutaneous manner, as will be described in more detail hereinafter.
  • 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, wearable device, 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 include 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.
  • charging device 106 can communicate with reader device 120, network 190, and/or other devices via communications path 145 by wired or wireless techniques as described herein.
  • FIG. 2 is a block diagram depicting an example embodiment of a reader device 120 (e.g., 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 can be electrically and communicatively coupled in a manner to provide a functional device.
  • FIGs 3A and 3B 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 processing capability for facilitating provision of end result 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 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 analog front end
  • AFE power management
  • processor 166 processor 166
  • communication circuitry 168 which can be implemented as a transmitter, receiver, transceiver, passive circuit, or otherwise according to the communication protocol.
  • 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 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 in some instances. Memory 163 can be volatile and/or non-volatile memory.
  • ASIC 161 is coupled with power source 172 (e.g., a rechargeable battery that is rechargeable via a receiver induction coil 176).
  • AFE 162 interfaces with in vivo analyte sensor 104 and receives measurement data therefrom and outputs the data in digital form.
  • the digital data output by the AFE 162 can be processed (e.g., by processor 166 or another processing entity), to obtain endresult data (e.g., glucose discrete and/or trend values).
  • endresult data e.g., glucose discrete and/or trend values.
  • the digital data and/or end-result data can be provided to communication circuitry 168 for sending, by way of antenna 171, to reader device 120 (not shown in Figure 2), for example, where further processing may be performed, if necessary, by the resident software application to display the data.
  • the measurement data, digital data, and/or end-result data associated with the different analyte sensors 104 may be processed, calculated, and/or composited/combined to determine additional metrics, such as calculated assays.
  • processing of data associated with multiple analytes may be performed on the sensor control device 102 itself (e.g., via processor 166 and/or other control circuitry) and/or via other communicatively connected devices (e.g., one or more reader devices 120, cloud resources, etc.).
  • the communicatively connected device(s) can be configured to present alerts and/or notifications based on the data collected and/or processed in association with any quantity of analytes monitored via the sensor control device 102.
  • the data collected and/or processed in association with the monitored analyte(s) is used in conjunction with other patient-specific data (e.g., biometric information, which may be collected via other wearable devices) to monitor patient wellbeing, diagnose patient conditions/states, and/or generate recommended patient care activities.
  • patient-specific data e.g., biometric information, which may be collected via other wearable devices
  • 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 sensor electronics 160 may comprise semiconductor chips 161 and/or 174 and/or the high-level functional units thereof (e.g., AFE 162, memory 163 and/or 165, power management circuitry 164, processor(s) 166, communication circuitry 168) in any suitable organizational structure (e.g., any suitable chip quantity or combination).
  • the sensor electronics 160 may be installed on or supported by one or more printed circuit boards and/or may be powered by the power source 172 (e.g., a rechargeable battery that is rechargeable via receiver induction coil 176).
  • FIG 4 illustrates an example implantable CGM 402, which can correspond to the sensor control device 102 described hereinabove with reference to Figures 1, 3A, and 3B.
  • the implantable continuous glucose monitor 402 can include one or more sensor electronics 160 described hereinabove with reference to Figures 1, 3A, and 3B.
  • the sensor electronics 160 may be installed on a PCB 404 of the implantable CGM 402.
  • the implantable CGM 402 is illustrated in Figure 4 as including a single PCB 404, an implantable CGM 402 can include any quantity of PCBs, and the sensor electronics 160 of the implantable CGM 402 may be distributed among the PCB(s) in any suitable manner.
  • the implantable CGM 402 includes a rechargeable battery 406 (e.g., corresponding to the power source 172 discussed above), which can be connected to the PCB 404 via one or more conductive retention members 408 or other connection means (e.g., a battery slot).
  • the rechargeable battery 406 is configured to supply power to the sensor electronics 160 installed on the PCB 404 (e.g., which can be managed via the power management circuitry 164).
  • the rechargeable battery 406 can be embodied with various characteristics for powering components of the implantable CGM 402.
  • the rechargeable battery 406 can comprise a 3V lithium ion rechargeable battery (other voltages may be used; other chemistries may be used, such as nickel-metal hydride, nickel-cadmium, or others).
  • the rechargeable battery 406 can have a 50 mAh capacity and a 500 Wh/liter energy density (other capacities and energy densities may be used).
  • the rechargeable battery 406 is disc-shaped, though other shapes are possible.
  • the rechargeable battery 406 can be any size (e.g., 12 mm diameter x 3 mm height, or another size).
  • the rechargeable battery 406 can be configured to be rechargeable even after being completely discharged, which can eliminate the need to re-implant a new implantable CGM 402 if a user fails to maintain a charged state for the rechargeable battery 406.
  • the rechargeable battery 406 can be rechargeable via wireless charging, such as induction-based wireless charging. Such functionality can enable the rechargeable battery 406 to be recharged in a transcutaneous manner, which can enable a single implantable CGM 402 to provide continuous glucose monitoring for a subject for an extended time period without re-implanting a new implantable CGM 402 (e.g., theoretically fora time period well beyond the life of the subject, such as upto 250 years). [0050] In the example shown in Figure 4, recharging of the rechargeable battery 406 can be accomplished via a receiver induction coil 410 (e.g., corresponding to the receiver induction coil 176 discussed above).
  • a receiver induction coil 410 e.g., corresponding to the receiver induction coil 176 discussed above.
  • the receiver induction coil 410 can produce an induced current for charging the rechargeable battery 406 when positioned within or near an alternating magnetic field.
  • an alternating magnetic field may be generated by a transmitter induction coil of a charging device 106 that is external to the user.
  • the user may place the charging device 106 proximate to the subcutaneous position of the implantable CGM 402, enabling the alternating magnetic field generated by the charging device 106 to transcutaneously induce a current in the receiver induction coil 410.
  • the induced current produced by the receiver induction coil 410 can charge the rechargeable battery 406, enabling the implantable CGM 402 to monitor glucose levels of the subject through multiple charge/discharge cycles (e.g., 3000 or another quantity of recharge cycles). Additional details related to a charging device for an implantable continuous glucose monitor system 100 will be provided hereinafter with reference to Figure 14.
  • the turns of the receiver induction coil 410 are embedded on the PCB 404 with the winding plane of the receiver induction coil 410 being parallel to the planar body of the PCB 404.
  • the receiver induction coil 410 may be embedded on the PCB 404 by printing or fabricating traces directly on the PCB 404 to form the receiver induction coil 410.
  • the winding plane of the receiver induction coil 410 can be parallel to the surface 412 of the PCB 404 that provides the largest area of the PCB 404.
  • the implantable CGM 402 shown in Figure 4 furthermore includes a polymer encapsulation medium 414 that encapsulates the PCB 404, the sensor electronics 160, the rechargeable battery 406, and the receiver induction coil 410 of the implantable CGM 402.
  • the polymer encapsulation medium 414 can comprise acrylic (e.g., polymethyl methacrylate) or another biocompatible polymer suitable for in vivo implantation, such as silicone, polyurethane, certain epoxies, polyimide, parylene, and/or others.
  • the polymer encapsulation medium 414 can hermetically seal components of the implantable CGM 402 to adapt the implantable CGM 402 for in vivo implantation.
  • FIG. 4 furthermore illustrates that the implantable CGM 402 can include a glucose sensor 416 (e.g., corresponding to analyte sensor 104 discussed above).
  • the glucose sensor 416 is communicatively coupled to one or more of the sensor electronics 160 of the implantable CGM 402 (e.g., to the AFE 162), enabling the glucose sensor 416 to acquire and provide measurement data indicating glucose levels.
  • the glucose sensor 416 may take on various forms. In the example shown in Figure 4, the glucose sensor 416 is implemented as an areal region 418 (e.g., a plate or a pad) that is coated with glucose oxidase.
  • the glucose oxidase may catalyze the oxidation of glucose present in interstitial fluid to hydrogen peroxide and gluconic acid, with the enzymatic reaction being proportional to the concentration of glucose in the interstitial fluid.
  • the production of hydrogen peroxide may be detected electrochemically by the glucose sensor 416, such as by applying a potential across the areal region 418 to cause the hydrogen peroxide to undergo a reduction reaction to generate a current proportional to the concentration of hydrogen peroxide (and to the glucose concentration).
  • Measurement data capturing the current may be output to other sensor electronics 160 (and/or processed or preprocessed on-sensor) to provide end result data indicating glucose levels, trends, or other information for the subject.
  • the areal region 418 of the glucose sensor 416 may remain unencapsulated by the polymer encapsulation medium 414 to expose the areal region 418 to interstitial fluid when the polymer encapsulation medium 414 is subcutaneously implanted in a subject.
  • Figure 4 depicts a surface 420 of the polymer encapsulation medium 414 with a line pattern to more clearly illustrate the exposure of the areal region 418.
  • utilizing an exposed areal region 418 to facilitate glucose sensing can enable increased contact with interstitial fluid to provide more robust and/or accurate measurement data (e.g., relative to utilizing a probe).
  • the areal region 418 is positioned on a spacer 422 that offsets the areal region 418 from the surface 412 of the PCB 404.
  • a spacer 422 that offsets the areal region 418 from the surface 412 of the PCB 404.
  • Such a configuration can allow the polymer encapsulation medium 414 to occupy space surrounding the PCB 404 to seal the components thereon while allowing the areal region 418 to remain unencapsulated.
  • the height of the spacer 422 is within about 10% (or another proportion) of the thickness of the polymer encapsulation medium 414 over the surface 412 of the PCB 404.
  • a spacer may comprise an angled, curved, or bent profile, or the areal region may be exposed at a lateral surface of the polymerencapsulation medium (e.g., at a sidewall), orthe receiver induction coil may be arranged on the PCB adjacent to the interface region between the spacer and the PCB (rather than surrounding the interface region).
  • Figure 4 focuses on an example in which the receiver induction coil 410 is embedded directly on the PCB 404, other configurations for a receiver induction coil of an implantable CGM 402 are within the scope of the present disclosure.
  • Figure 5 illustrates an example implantable CGM 502, which includes components similar to the implantable CGM 402 described above with reference to Figure 4.
  • the implantable CGM 502 shown in Figure 5 includes a PCB 504, rechargeable battery 506, receiver induction coil 510, polymer encapsulation medium 514, and glucose sensor 516 positioned on a spacer 522.
  • the receiver induction coil 510 includes turns that are suspended within the polymer encapsulation medium 514 and that are not embedded or printed on the PCB 504.
  • the receiver induction coil 510 shown in Figure 5 has a greater diameter than the diameter of the PCB 504, which can, in some instances, contribute to charging ease and/or efficiency (e.g., relative to implementations where the diameter of the receiver induction coil 510 is constrained by the diameter of the PCB 504).
  • a receiver induction coil 510 can include a combination of turns that are printed on the PCB 504 and turns that are suspended within the polymer encapsulation medium 514.
  • Figure 6 provides another example implantable CGM 602 that includes components similar to the implantable CGM 402 described above with reference to Figure 4, such as a PCB 604, rechargeable battery 606, receiver induction coil 610, polymer encapsulation medium 614, and glucose sensor 616 positioned on a spacer 622.
  • the receiver induction coil 610 also includes turns that are suspended within the polymer encapsulation medium 614 and that are not embedded or printed on the PCB 604.
  • Figure 6 illustrates that the central axis of the receiver induction coil 610 can be offset from the PCB 604, which can enable an implantable CGM 602 to take on various overall shapes (e.g., an elongated shape).
  • FIG. 7 illustrates another example implantable CGM 702 that includes components similar to the implantable CGM 402 discussed hereinabove with reference to Figure 4, such as a PCB 704, rechargeable battery 706, receiver induction coil 710, and polymer encapsulation medium 714.
  • the implantable CGM 702 includes a glucose sensor 716 that is communicatively coupled to sensor electronics 160 of the PCB 704.
  • an implantable continuous analyte monitor may include components similar to the implantable CGMs described hereinabove, such as a PCB, rechargeable battery, receiver induction coil, and polymer encapsulation medium.
  • a continuous analyte monitor may further comprise an analyte sensor that is at least partially unencapsulated by the polymerencapsulation medium.
  • the analyte sensor may include an exposed areal region, plate, or pad, a sensor probe, or another type of sensor construction. Aside from glucose oxidase, the analyte sensor can include other types of enzymes for performing analyte detection, such as lactate oxidase, cholesterol oxidase, creatininase oxidase, creatinase oxidase, sarcosine oxidase, alcohol oxidase, glutamate oxidase, and/or others.
  • enzymes for performing analyte detection such as lactate oxidase, cholesterol oxidase, creatininase oxidase, creatinase oxidase, sarcosine oxidase, alcohol oxidase, glutamate oxidase, and/or others.
  • an implantable continuous analyte monitor can include any quantity of analyte sensors, which may be adapted to measure levels of the same or different analytes and can enable multiplexing of analytes.
  • an implantable continuous analyte monitor may comprise at least two analyte sensors, with one being adapted to measure glucose levels and with another being adapted to measure lactate levels.
  • an implantable continuous analyte monitor includes multiple analyte sensors
  • different analyte sensors can have the same or different sensor constructions (e.g., one may comprise an exposed areal region, pad, or plate, whereas another may comprise an exposed sensor probe).
  • implantable CGMs described hereinabove with reference to Figures 4, 5, 6, and 7 include certain overall shapes (e.g., disc-like or elongated disc-like shapes), other overall shapes may be used, such as rodlike shapes, spherical or ellipsoidal shapes, soft prism shapes, and/or others (e.g., any shape without a sharp edge).
  • the components of an implantable continuous glucose or analyte monitor such as a rechargeable battery, PCB, areal region, plate, pad, spacer, receiver induction coil, etc. can have any suitable shape.
  • Figure 8 illustrates an insertion system 800 (e.g., corresponding to insertion system 150 discussed above) for inserting an implantable CGM into a subject.
  • the insertion system 800 shown in Figure 8 includes an incision tool 810 and an insertion tool 820.
  • the insertion tool 820 is adapted for insertion of an implantable CGM that has an elongated disc-like shape.
  • the insertion system 800 shown in Figure 8 is merely one example, and other types of insertion systems (or insertion systems with varied shapes or sizes of components) may be used for different shapes, sizes, and/or types of implantable continuous glucose or other analyte monitors.
  • the incision tool 810 includes a blade 812 and a handle 814 and is usable to form an incision site on a subject through which an implantable CGM may be inserted via the insertion tool 820.
  • Figure 9 illustrates a conceptual example of a health care provider 902 stretching the skin of a subject 904 and using the incision tool 810 to form an incision site 906 on the body of the subject 904.
  • the incision site may be formed on various parts of the body of the subject, depending on convenience to the patient/subject and/or the analyte to be measured.
  • the incision site may be formed on the abdomen, back of the upper arm, upper buttocks (e.g., for young children), or other locations.
  • the incision site 906 is formed on the abdomen of the subject 904.
  • the insertion tool 820 includes a device body 822 that defines a loading slot 824.
  • the loading slot 824 can be configured to retain an implantable CGM in preparation for implanting the implantable CGM in a subject.
  • the device body 822 can further comprise tabs or other retention members for retaining an implantable CGM within the loading slot 824.
  • the loading slot 824 can comprise an elongated disc-like shape to accommodate an elongated disc-like implantable CGM (other loading slot shapes may be implemented to accommodate other shapes and/or sizes of implantable CGMs).
  • the device body 822 also defines an insertion channel through which a plunger 826 extends.
  • the insertion channel may be open to the loading slot 824, which can allow an implantable CGM positioned within the loading slot 824 to drop into the insertion channel when the plunger 826 is withdrawn (described below).
  • the plunger 826 includes a proximal end 828 with a broad face for easy manipulation by a health care provider.
  • the plunger 826 also includes a distal end 830 that has a dissection tip 832.
  • the dissection tip 832 can be advanced through an incision site formed by the incision tool 810 to create a subcutaneous pocket within the subject.
  • a health care provider may grip the insertion tool 820 by placing their first and second fingers on wings 834 defined by the device body 822 and by placing their thumb on the proximal end 828 of the plunger 826. This can prevent the plunger 826 from withdrawing or retracting relative to the device body 822 during advancement of the dissection tip 832 through the incision site.
  • the insertion tool 820 may further comprise a flared edge 836 defined by the device body 822, which may constrain advancement of the dissection tip 832 into the incision site.
  • the health care provider may advance the dissection tip 832 into the incision site until the flared edge 836 reaches the incision site. Fully advancing the dissection tip 832 into the incision site until the flared edge 836 reaches the incision site can enable the dissection tip 832 to form a subcutaneous cavity or pocket within the subject that can receive an implantable CGM.
  • the device body 822 of the insertion tool 820 may further define finger recesses 838, which the health care provider can manipulate to hold the insertion tool 820 in position with the flared edge 836 in contact with the incision site after full advancement of the dissection tip 832 through the incision site.
  • the plunger 826 While holding the insertion tool 820 in such a position after full advancement of the dissection tip 832 (e.g., after the subcutaneous cavity is formed), the plunger 826 may be withdrawn/retracted, which may allow an implantable CGM positioned within the loading slot 824 to drop into the insertion channel defined by the device body 822. After the implantable CGM becomes positioned within the insertion channel, the plunger 826 may be re-advanced to push the implantable CGM through the incision site into the subcutaneous pocket.
  • Figure 10 illustrates a conceptual example of the health care provider 902 gripping the insertion tool 820 as described above and advancing the dissection tip 832 of the plunger 826 into the incision site 906.
  • the insertion tool 820 includes an implantable CGM 1002 positioned within the loading slot 824.
  • the health care provider 902 may initially insert the dissection tip 832 into the incision site 906 at approximately a 45 degree angle (or another angle) relative to the surrounding skin of the subject 904 and, after advancing the dissection tip 832 past the skin of the subject 904, adjust the angle of the insertion tool 820 to be nearly parallel to the surrounding skin of the subject 904.
  • the health care provider 902 may continue to advance the dissection tip 832 (followed by the plunger 826) into the incision site 906 until the flared edge 836 contacts the incision site 906, allowing the dissection tip 832 to form a subcutaneous pocket within the subject 904.
  • Figure 11 illustrates the health care provider 902 holding the finger recesses 838 of the insertion tool 820 to maintain contact between the flared edge 836 and the incision site 906 after advancement of the dissection tip 832 into the incision site 906.
  • Figure 11 also illustrates the health care provider 902 withdrawing the plunger 826 (e.g., by manipulating the proximal end 828), which, as noted above, may allow the insertion channel of the insertion tool 820 to receive an implantable CGM 1002 that was pre- loaded into the loading slot 824.
  • the plunger 826 may be partially re-advanced to push the implantable CGM 1002 through the incision site 906 and into the subcutaneous pocket formed by the dissection tip 832 in the subject 904.
  • the plunger 826 may comprise a stop feature 1102 that may interface with the device body 822 to constrain advancement of the plunger 826 while using the plunger 826 to push the implantable CGM 1002 into the subcutaneous pocket.
  • Figure 12 illustrates the health care provider 902 holding the wings 834 and the proximal end 828 of the plunger 826 to advance the plunger 826 to push the implantable CGM 1002 into the subcutaneous pocket of the subject 904.
  • the health care provider 902 may apply pressure near the incision site 906 to prevent the implantable CGM 1002 from displacing while withdrawing the insertion tool 820 from the subject 904, as illustrated in Figure 13.
  • the central axis of the receiver induction coil of the implantable CGM 1002 may become oriented toward the dermal layer of the subject 904, which can contribute to ease and/or efficiency of transcutaneous charging of the implantable CGM 1002.
  • an implantable CGM that comprises a rod-like shape may be inserted via a rod implantation device (e.g., on the rear of the upper arm).
  • FIG 14 illustrates an example charging device 1402 (e.g., corresponding to the charging device 106 described above) for transcutaneously charging an implantable CGM after insertion of the implantable CGM into a subject.
  • the charging device 1402 may comprise a power source and a transmitter induction coil.
  • the transmitter induction coil can generate an alternating magnetic field when the power source causes an electrical current to travel through the transmitter induction coil.
  • the power source of the charging device 1402 comprises a chargeable battery that can be charged (e.g., via connection to a residential or commercial power outlet) prior to a session of charging an implanted CGM.
  • the charging device 1402 can be disconnected from an external power supply and can be positioned on or near the location of the implanted CGM on the body of the subject to perform transcutaneous charging without encumbrance by a power cable. In other instances, the charging device 1402 maintains a wired connection to an external power supply during transcutaneous charging.
  • the charging device 1402 may omit a rechargeable battery in some implementations.
  • FIG 14 also illustrates a wearable mount 1404, which can be used in conjunction with the charging device 1402 to facilitate transcutaneous charging of an implanted CGM.
  • the wearable mount 1404 can be adapted to retain the charging device 1402.
  • the wearable mount 1404 includes a sleeve 1406 for retaining the charging device 1402, though other retention means may be used.
  • the wearable mount 1404 can be secured to the body of the subject to hold the charging device 1402 in proximity to the subcutaneously implanted CGM, allowing the charging device 1402 to charge the implanted CGM.
  • the wearable mount 1404 includes straps 1408 and a clip 1410 to facilitate securement of the wearable mount 1404 to the body of a subject.
  • a wearable mount 1404 can be embodied in other forms and/or with other securement means for securing the wearable mount 1404 to the body of a user.
  • the wearable mount 1404 may comprise a flexible arm band, sleeve, or waistband, or an adjustable belt or band.
  • the wearable mount 1404 and the charging device 1402 are integrally formed with one another.
  • a fully charged implanted CGM may perform continuous glucose monitoring for a time period (e.g., 30 days, or another time period).
  • a user may utilize a charging device 1402 (and optionally a wearable mount 1404) to charge the implanted CGM in a transcutaneous manner.
  • transcutaneous charging can be performed passively, such as while the user performs other tasks (e.g., sitting at a desk, sleeping, etc.).
  • a user may monitor battery life and/or charging processes of the implanted CGM and/or the charging device 1402 via a reader device 120 or other computing system.
  • wireless power transfer assemblies may be incorporated into an implantable continuous glucose or other analyte monitor to perform transcutaneous charging via other wireless charging modalities, such as resonant inductive charging, radio frequency charging, and/or others.
  • Clause 7 The implantable continuous glucose monitor of any of clauses 3 to 6, wherein a winding plane of the receiver induction coil is substantially perpendicular to a height of the spacer.
  • Clause 11 The implantable continuous glucose monitor of any of clauses 1 to 9, wherein one or more turns of the receiver induction coil are suspended within the polymer encapsulation medium and are not embedded on the printed circuit board.
  • Clause 17 The implantable continuous glucose monitor system of any of clauses 13 to 16, wherein the charging device comprises a wearable mount configured to retain the transmitter induction coil at a desired position relative to the subject.
  • Clause 18 The implantable continuous glucose monitor system of any of clauses 13 to 17, wherein at least the part of the glucose sensor that remains unencapsulated by the polymer encapsulation medium comprises an areal region coated with glucose oxidase.
  • Clause 20 The implantable continuous glucose monitor system of clause 18 or 19, wherein the areal region is substantially parallel to the surface of the printed circuit board.
  • Clause 21 The implantable continuous glucose monitor system of clause 19 or 20, wherein a height of the spacer is within 10% of a thickness of the polymer encapsulation medium over the surface of the printed circuit board.
  • Clause 22 The implantable continuous glucose monitor system of clause 19, 20 or 21, wherein one or more turns of the receiver induction coil surround the spacer.
  • Clause 23 The implantable continuous glucose monitor system of any of clauses 19 to 22, wherein a winding plane of the receiver induction coil is substantially perpendicular to a height of the spacer.
  • Clause 24 The implantable continuous glucose monitor system of any of clauses 13 to 23, wherein at least part of the glucose sensorthat remains unencapsulated by the polymer encapsulation medium comprises a glucose oxidase probe.
  • Clause 25 The implantable continuous glucose monitor system of any of clauses 13 to 24, wherein a winding plane of the receiver induction coil is substantially parallel to a planar body of the printed circuit board.
  • Clause 26 The implantable continuous glucose monitor system of any of clauses 13 to 25, wherein one or more turns of the receiver induction coil are embedded on the printed circuit board.
  • Clause 27 The implantable continuous glucose monitor system of any of clauses 13 to 25, wherein one or more turns of the receiver induction coil are suspended within the polymer encapsulation medium and are not embedded on the printed circuit board.
  • Clause 28 The implantable continuous glucose monitor system of any of clauses 13 to 25, or clause 27, wherein the receiver induction coil comprises a greater diameter than the printed circuit board.
  • An implantable continuous analyte monitor comprising: one or more sensor electronics; an analyte sensor communicatively coupled to at least some of the one or more sensor electronics, the analyte sensor being configured to provide measurement data to the at least some of the one or more sensor electronics; a rechargeable battery electrically connected to and configured to supply power to the one or more sensor electronics; a wireless power transfer assembly configured to charge the rechargeable battery in a transcutaneous manner to facilitate charging of the rechargeable battery; and a polymer encapsulation medium that encapsulates the one or more sensor electronics, the rechargeable battery, and the wireless power transfer assembly, wherein at least part of the analyte sensor remains unencapsulated by the polymer encapsulation medium to expose the analyte sensor to interstitial fluid when the implantable continuous analyte monitor is subcutaneously implanted in a subject.
  • Clause 34 The implantable continuous analyte monitor of clause 31, 32 or 33, wherein the wireless power transfer assembly comprises a receiver induction coil, wherein one or more turns of the receiver induction coil surround the spacer.
  • Clause 35 The implantable continuous analyte monitor of any of clauses 31 to 34, wherein the wireless power transfer assembly comprises a receiver induction coil, wherein a winding plane of the receiver induction coil is substantially perpendicular to a height of the spacer.
  • Clause 36 The implantable continuous analyte monitor of any of clauses 29 to 35, wherein at least part of the analyte sensor that remains unencapsulated by the polymer encapsulation medium comprises a sensor probe.
  • Clause 37 The implantable continuous analyte monitor of any of clauses 29 to 36, wherein the wireless power transfer assembly comprises a receiver induction coil, wherein a winding plane of the receiver induction coil is substantially parallel to a planar body of a printed circuit board on which the one or more sensor electronics are installed.
  • Clause 38 The implantable continuous analyte monitor of any of clauses 29 to 37, wherein the wireless power transfer assembly comprises a receiver induction coil, wherein one or more turns of the receiver induction coil are embedded on a printed circuit board on which the one or more sensor electronics are installed.
  • the wireless power transfer assembly comprises a receiver induction coil, wherein one or more turns of the receiver induction coil are suspended within the polymer encapsulation medium and are not embedded on a printed circuit board on which the one or more sensor electronics are installed.
  • Clause 40 The implantable continuous analyte monitor of any of clauses 29 to 37 or clause 39, wherein the wireless power transfer assembly comprises a receiver induction coil, wherein the receiver induction coil comprises a greater diameter than a printed circuit board on which the one or more sensor electronics are installed.
  • Clause 41 The implantable continuous analyte monitor of any one of clauses 29 through 40, wherein the implantable continuous analyte monitor is configured for subcutaneous implantation anywhere, such as between the ribs, under the arm, subclavicle, or other locations.
  • Clause 42 The implantable continuous analyte monitor of any one of clauses 29 through 41, wherein the implantable continuous analyte monitor comprises a shape without a sharp edge, such as a spherical, cylindrical, disk, elliptical, or other shape.
  • Clause 43 The implantable continuous analyte monitor of any one of clauses 29 through 42, further comprising a plurality of analyte sensors adapted to measure levels of the same or different analytes, such as for facilitating multiplexing of analytes.
  • apparatus comprising means for implementing any of the methods described herein, including any of the preferred features.

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Abstract

Un moniteur d'analyte en continu implantable peut comprendre une carte de circuit imprimé (PCB), un ou plusieurs composants électroniques de capteur, un capteur d'analyte, une batterie rechargeable connectée à la PCB et configurée pour alimenter le(s) composant(s) électronique(s) du capteur, une bobine d'induction de récepteur configurée pour produire un courant induit pour charger la batterie rechargeable de manière sans fil et transcutanée, et un milieu d'encapsulation polymère qui encapsule la PCB, le(s) composant(s) électronique(s) du capteur, la batterie rechargeable et la bobine d'induction de récepteur. Au moins une partie du capteur d'analyte reste non encapsulée par le milieu d'encapsulation polymère pour exposer le capteur d'analyte au fluide interstitiel lorsque le moniteur d'analyte en continu implantable est implanté par voie sous-cutanée chez un sujet.
PCT/US2025/026828 2024-05-17 2025-04-29 Moniteur d'analyte en continu implantable Pending WO2025240114A1 (fr)

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Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20090030294A1 (en) * 2004-05-03 2009-01-29 Dexcom, Inc. Implantable analyte sensor
US20230211076A1 (en) * 2021-12-30 2023-07-06 Paul Weber Compressible, minimally invasive implants and related systems and methods

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20090030294A1 (en) * 2004-05-03 2009-01-29 Dexcom, Inc. Implantable analyte sensor
US20230211076A1 (en) * 2021-12-30 2023-07-06 Paul Weber Compressible, minimally invasive implants and related systems and methods

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
BAJ-ROSSI CAMILLA ET AL: "Full Fabrication and Packaging of an Implantable Multi-Panel Device for Monitoring of Metabolites in Small Animals", IEEE TRANSACTIONS ON BIOMEDICAL CIRCUITS AND SYSTEMS, IEEE, US, vol. 8, no. 5, 1 October 2014 (2014-10-01), pages 636 - 647, XP011563880, ISSN: 1932-4545, [retrieved on 20141106], DOI: 10.1109/TBCAS.2014.2359094 *

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