Techniques for reducing leakage currents in an analyte sensor system
Patent Information
- Application Number
- PCT/US2026/021360
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2025-03-28
- Filing Date
- 2026-03-27
- Publication Date
- 2026-10-01
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Figure US2026021360_01102026_PF_FP_ABST
Abstract
Description
Dexcom Ref. No.: 0997-PCT01TECHNIQUES FOR REDUCING LEAKAGE CURRENTS IN AN ANALYTE SENSOR SYSTEMCROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims the benefit of and priority to U.S. Provisional Patent Application No. 63 / 779,508, filed March 28, 2025, which is assigned to the assignee of the present application and is hereby expressly incorporated by reference in its entirety for all applicable purposes, as if fully set forth herein.BACKGROUND
[0002] The present application relates generally to medical devices such as analyte sensors, and more particularly to techniques for reducing leakage currents in an analyte sensor system.
[0003] Diabetes is a metabolic condition relating to the production or use of insulin by the body. Insulin is a hormone that allows the body to use glucose for energy, or store glucose as fat.
[0004] When a person eats a meal that contains carbohydrates, the food is processed by the digestive system, which produces glucose in the person's blood. Blood glucose can be used for energy, or stored as fat. The body normally maintains blood glucose levels in a range that provides sufficient energy to support bodily functions and avoids problems that can arise when glucose levels are too high, or too low. Regulation of blood glucose levels depends on the production and use of insulin, which regulates the movement of blood glucose into cells.
[0005] When the body does not produce enough insulin, or when the body is unable to effectively use insulin that is present, blood sugar levels can elevate beyond normal ranges. The state of having a higher than normal blood sugar level is called "hyperglycemia." Chronic hyperglycemia can lead to a number of health problems, such as cardiovascular disease, cataract and other eye problems, nerve damage (neuropathy), and kidney damage. Hyperglycemia can also lead to acute problems, such as diabetic ketoacidosis - a state in which the body becomes excessively acidic due to the presence of blood glucose and ketones, which are produced when the body cannot use glucose. The state of having lower than normal blood glucose levels is called "hypoglycemia." Severe hypoglycemia can lead to acute crises that can result in seizures or death.P+S Ref. No.: DEXC / 0997PC 1Dexcom Ref. No.: 0997-PCT01
[0006] A diabetes patient can receive insulin to manage blood glucose levels. Insulin can be received, for example, through a manual injection with a needle. Wearable insulin pumps are also available. Diet and exercise also affect blood glucose levels. A glucose sensor can provide an estimated glucose concentration level, which can be used as guidance by a patient or caregiver.
[0007] Diabetes conditions are sometimes referred to as "Type 1" and "Type 2". A Type 1 diabetes patient is typically able to use insulin when it is present, but the body is unable to produce sufficient amounts of insulin, because of a problem with the insulinproducing beta cells of the pancreas. A Type 2 diabetes patient may produce some insulin, but the patient has become "insulin resistant" due to a reduced sensitivity to insulin. The result is that even though insulin is present in the body, the insulin is not sufficiently used by the patient's body to effectively regulate blood sugar levels.
[0008] Blood sugar concentration levels may be monitored with an analyte sensor, such as a continuous glucose monitor. A wearable continuous glucose monitor may be powered by a battery that powers the sensor and other components, such as wireless communication circuitry. It is important that battery power be consistently available to assure that analyte concentration levels can be sensed and communicated by the analyte sensor.
[0009] This Background is provided to introduce a brief context for the Summary and Detailed Description that follow. This Background is not intended to be an aid in determining the scope of the claimed subject matter nor be viewed as limiting the claimed subject matter to implementations that solve any or all of the disadvantages or problems presented above.SUMMARY
[0010] One aspect provides an analyte sensor system. The analyte sensor system includes printed circuit board (PCB) and an implantable analyte sensor, operatively connected to the PCB, configured to generate one or more electrical signals that are proportional to an analyte concentration level of a user of the analyte sensor system. The PCB has a first thickness, the PCB includes a cut-out over which or through which at least a portion of the implantable analyte sensor extends, the cut-out has sidewalls having a second thickness less than or equal to the first thickness of the PCB, and the sidewalls are at least partially lined with a conductive material that is electrically connected to a groundP+S Ref. No.: DEXC / 0997PC 2Dexcom Ref. No.: 0997-PCT01plane of the PCB and configured to dissipate stray voltage potential associated with the cut-out and to cause one or more leakage currents associated with the implantable analyte sensor to be less than one or more thresholds based on the dissipated stray voltage potential.
[0011] One aspect provides a method for wireless communication by analyte sensor system. The method includes generating, by an implantable analyte sensor of the analyte sensor system, one or more electrical signals that are proportional to an analyte concentration level of a user of the analyte sensor system; generating, by one or more processors of the analyte sensor system based on the one or more electrical signal generated by the implantable analyte sensor, analyte data indicating the analyte concentration level of the user; and transmitting, by a transceiver of the analyte sensor system, the analyte data to a display device for display to the user. In some aspects, the analyte sensor system includes a printed circuit board (PCB) configured to operatively connect the implantable analyte sensor, the one or more processors, and the transceiver. In some aspects, the PCB has a first thickness. In some aspects, the PCB includes a cutout over which or through which at least a portion of the implantable analyte sensor extends. In some aspects, the cut-out has sidewalls having a second thickness less than or equal to the first thickness of the PCB. In some aspects, the sidewalls are at least partially lined with a conductive material that is electrically connected to a ground plane of the PCB and configured to dissipate stray voltage potential associated with the cut-out.
[0012] Other aspects provide: an apparatus operable, configured, or otherwise adapted to perform the aforementioned methods as well as those described elsewhere herein; a non-transitory, computer-readable media comprising instructions that, when executed by one or more processors of an apparatus, cause the apparatus to perform the aforementioned methods as well as those described elsewhere herein; a computer program product embodied on a computer-readable storage medium comprising code for performing the aforementioned methods as well as those described elsewhere herein; and an apparatus comprising means for performing the aforementioned methods as well as those described elsewhere herein. By way of example, an apparatus may comprise a processing system, a device with a processing system, or processing systems cooperating over one or more networks.
[0013] The following description and the appended figures set forth certain features for purposes of illustration.P+S Ref. No.: DEXC / 0997PC 3Dexcom Ref. No.: 0997-PCT01BRIEF DESCRIPTION OF THE DRAWINGS
[0014] FIG. 1 illustrates an example diabetes management system, according to some embodiments disclosed herein.
[0015] FIG. 2 illustrates a more detailed view of a health management system including a display device that is communicatively coupled to an analyte sensor system, according to some embodiments disclosed herein.
[0016] FIG. 3A is an example analyte sensor system, according to some embodiments disclosed herein.
[0017] FIG. 3B is an example analyte sensor system, according to some embodiments disclosed herein.
[0018] FIG. 3C illustrates aspects of an example analyte sensor system, according to some embodiments disclosed herein.
[0019] FIG. 4 illustrates a simplified block diagram of an analyte sensor system, according to certain aspects.
[0020] FIGS.5A and 5B illustrate perspective views of a printed circuit board (PCB) of the analyte sensor system, according to certain aspects.
[0021] FIG. 6 depicts a method for wireless communication by an analyte sensor system, according to certain aspects.
[0022] FIG. 7 depicts aspects of an example a health management device, according to certain aspects.DETAILED DESCRIPTION
[0023] Aspects of the present disclosure provide techniques for reducing leakage currents in an analyte sensor system.Introduction to Health Management Systems
[0024] FIG. 1 depicts a health management system 100 including an example continuous analyte sensor system (SS) 8 having continuous analyte sensor(s) and sensor electronics, in accordance with certain aspects of the present disclosure. For example, SS 8 may be configured to continuously monitor one or more analytes of a user 50, in accordance with certain aspects of the present disclosure.
[0025] As shown, SS 8 includes sensor electronics module 12 and one or more P+S Ref. No.: DEXC / 0997PC 4Dexcom Ref. No.: 0997-PCT01analyte sensor(s) 10 (individually referred to herein as analyte sensor 10 and collectively referred to herein as analyte sensors 10) associated with sensor electronics module 12. In some embodiments, the one or more analyte sensor(s) 10 may comprise one or more continuous analyte sensors configured to provide continuous analyte concentration level measurements. Sensor electronics module 12 may be in wireless communication (e.g.. directly or indirectly) with one or more of display devices 110, 120, 130, and 140, and / or server system 134.
[0026] In certain embodiments, the analyte sensor(s) 10 may comprise one or more sensors for detecting and / or measuring analyte(s). The analyte sensor(s) 10 may be a multi-analyte sensor configured to continuously measure two or more analytes or a single analyte sensor configured to continuously measure a single analyte as a non-invasive device, a subcutaneous device, a transcutaneous device, a transdermal device, and / or an intravascular device. In certain embodiments, the analyte sensor(s) 10 may be configured to continuously measure analyte concentration levels of the user 50 using one or more techniques, such as enzymatic techniques, chemical techniques, physical techniques, electrochemical techniques, potentiostatic techniques, potentiometric techniques, impedimetric techniques, coulometric techniques, spectrophotometric techniques, polarimetric techniques, calorimetric techniques, iontophoretic techniques, radiometric techniques, immunochemical techniques, and the like. The term ‘“continuous.” as used herein, can mean fully continuous, semi-continuous, periodic, etc. In certain aspects, the analyte sensor(s) 10 provides a data stream indicative of the concentration of one or more analytes of the user 50. The data stream may include raw data signals, which are then converted into a calibrated and / or filtered data stream used to provide estimated analyte value(s) to the user 50.
[0027] In certain embodiments, the analyte sensor(s) 10 may be configured to continuously measure one or more analytes in a body of the user 50, such as ions (e.g., sodium, potassium, hydrogen, lithium, magnesium, calcium, chloride, sulfite, sulfate, phosphate, and / or ammonium), uric acid, urea, ketones, glucose, lactate, and / or creatinine.
[0028] In certain embodiments, the analyte sensor(s) 10 may comprise a percutaneous wire that has a proximal portion coupled to the sensor electronics module 12 and a distal portion with several electrodes, such as a measurement electrode and a reference electrode. The measurement (or working) electrode may be coated, covered,P+S Ref. No.: DEXC / 0997PC 5Dexcom Ref. No.: 0997-PCT01treated, embedded, etc., with one or more chemical molecules that react with a particular analyte, and the reference electrode may provide a reference electrical voltage. The measurement electrode may generate the analog electrical signal, which is conveyed along a conductor that extends from the measurement electrode to the proximal portion of the percutaneous wire that is coupled to the sensor electronics module 12. After the SS 8 has been applied to epidermis of the user 50, analyte sensor(s) 10 penetrates the epidermis, and the distal portion extends into the dermis and / or subcutaneous tissue under epidermis. Other configurations of analyte sensor(s) 10 may also be used, such as a multianalyte sensor that includes multiple measurement electrodes, each generating an analog electrical signal that represents the concentration levels of a particular analyte. Accordingly, analyte sensor(s) 10 is configured to generate at least one analog electrical signal that is proportional to the concentration level of a particular analyte, and sensor electronics module 12 is configured to convert the analog electrical signal into an analyte sensor count values, calibrate the analyte sensor count values based on the sensitivity profile of the analyte sensor(s) 10 to generate measured analyte concentration levels, and transmit the measured analyte concentration level data, including the measured analyte concentration levels, to a display device, such as display devices 210, 220, 230, and / or 240. via a wireless connection. For example, sensor electronics module 12 may be configured to sample the analog electrical signal at a particular sampling period (or rate), such as every 1 second (1 Hz), 5 seconds, 10 seconds, 30 seconds, 1 minute, 3 minutes, 5 minutes, etc., and to transmit the measured analyte concentration data to the display¬ device at a particular transmission period (or rate), which may be the same as (or longer than) the sampling period, such as every 1 minute (0.016 Hz), 5 minutes, 10 minutes, 30 minutes, at the conclusion of the wear period, etc. Depending on the sampling and transmission periods, the measured analyte concentration data transmitted to the displaydevice include at least one measured analyte concentration level having an associated time tag, sequence number, etc. Additional details regarding analyte concentration level measurement and the configuration of the analyte sensor(s) 10 and sensor electronics module 12 may be found in U.S. patent application Ser. No. 18 / 241,658 filed on September 1, 2023 and entitled, “DEVICES AND METHODS FOR MEASURING A CONCENTRATION OF A TARGET ANALYTE IN A BIOLOGICAL FLUID IN VIVO,’’ which is incorporated herein by reference in its entirety.
[0029] In certain embodiments, analyte sensor(s) 10 may incorporate aP+S Ref. No.: DEXC / 0997PC 6Dexcom Ref. No.: 0997-PCT01thermocouple within, or alongside, the percutaneous wire to provide an analog temperature signal to the sensor electronics module 12, which may be used to correct the analog electrical signal or the measured analyte data for temperature. In other embodiments, the thermocouple may be incorporated into the sensor electronics module 12 above the adhesive pad. or, alternatively, the thermocouple may contact the epidermis of the patient through openings in the adhesive pad. In some embodiments, the analyte sensor(s) 10 may incorporate a percutaneous flexible planar substrate including a plurality of electrodes, such as 2 electrodes, 3 electrodes, 4 electrodes, 5 electrodes, 6 electrodes, 7 electrodes, or 8 electrodes.
[0030] In certain embodiments, sensor electronics module 12 includes electronic circuitry associated with measuring and processing the continuous analyte sensor data, including prospective algorithms associated with processing and calibration of the sensor data. Sensor electronics module 12 can be physically coupled to analyte sensor(s) 10 and can be integral with (non-releasably attached to) or releasably attachable to analyte sensor(s) 10. Sensor electronics module 12 may include hardware, firmware, and / or software that enable measurement of levels of analyte(s) via analyte sensor(s) 10. For example, sensor electronics module 12 can include an electrochemical analog front end (e.g., a potentiostat, galvanostat, coulostat, etc.), a power source for providing power to the sensor (including power switches and controlling logic), other components useful for signal processing and data storage, and a tel emet ry module for transmitting data from the sensor electronics module to, e.g., one or more display devices. Electronics can be affixed to a printed circuit board (PCB), or the like, and can take a variety of forms. For example, the electronics can take the form of an integrated circuit (IC), such as an Application-Specific Integrated Circuit (ASIC), an electrochemical analog front end (AFE), a microcontroller, and / or a processor.
[0031] Display devices 110. 120, 130, and / or 140 are configured for displaying displayable sensor data, including analyte data, which may be transmitted by sensor electronics module 12. Each of display devices 110, 120, 130, and / or 140 may include a display such as a touchscreen display 112, 122, 132, and / or 142 for displaying sensor data to a patient and / or for receiving inputs from the patient. For example, a graphical user interface (GUI) may be presented to the patient for such purposes. In certain embodiments, the display devices may include other types of user interfaces such as a voice user interface instead of, or in addition to, a touchscreen display for communicatingP+S Ref. No.: DEXC / 0997PC 7Dexcom Ref. No.: 0997-PCT01sensor data to the patient of the display device and / or for receiving patient inputs. In certain embodiments, one, some, or all of display devices 110, 120, 130, 140 may be configured to display or otherwise communicate the sensor information as it is communicated from sensor electronics module 12 (e.g.. in a data package that is transmitted to respective display devices), without any additional prospective processing required for calibration and / or real-time display of the sensor data.
[0032] The plurality of display devices 110, 120, 130, 140 depicted in FIG. 1 may include a custom or proprietary display device, for example, display device 110, especially designed for displaying certain types of displayable sensor information associated with analyte data received from sensor electronics module 12 (e.g., a numerical value and / or an arrow, in certain embodiments). In certain embodiments, one of the plurality of display devices 110, 120, 130, 140 includes a smartphone, such as a mobile phone, based on an Android, iOS, or another operating system configured to display a graphical representation of the continuous sensor data (e.g., including current and / or historic data). In some embodiments, one of the plurality of display devices 110, 120.130, 140 may include a home automation system display or speakers. In certain embodiments, health management system 100 further includes a medical delivery' device (e.g., an insulin pump or pen). Sensor electronics module 12 may be configured to transmit sensor information and / or analyte data to medical delivery device. The medical delivery device (not shown) may' be configured to administer a certain dosage of insulin or another medicament to the user based on the sensor information and / or analyte data (e.g., which may include a recommended insulin dosage) received from the sensor electronics module 12.
[0033] Server system 134 may be used to directly or indirectly collect analyte data from SS 8 and / or the plurality of display devices, for example, to perform analytics thereon, generate universal or individualized models for analyte concentration levels and profiles, provide services or feedback, including from individuals or systems remotely monitoring the analyte data, perform or assist SS 8 and the plurality' of display devices with identification, authentication, etc., according to the embodiments described herein, so on. Note that, in certain embodiments, server system 134 may be representative of multiple systems or computing devices that perform the functions of server system 134 (e.g., in a distributed manner).
[0034] The term “analyte” as used herein is a broad term and is to be given itsP+S Ref. No.: DEXC / 0997PC 8Dexcom Ref. No.: 0997-PCT01ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refers without limitation to a substance or chemical constituent in a biological fluid (e.g., blood, interstitial fluid, cerebral spinal fluid, lymph fluid, urine, sweat, saliva, etc.) that can be analyzed. Analytes can include naturally occurring substances, artificial substances, metabolites, electrolytes, ions, gasses, hormones, proteins, enzymes, neurotransmitters, infectious agents, and / or reaction products. In some examples, the analyte measured by the sensing regions, devices, and methods is glucose. However, other analytes are contemplated as well, including but not limited to acarboxyprothrombin; acylcamitine; adenine phosphoribosyl transferase; adenosine deaminase; albumin; alpha-fetoprotein; amino acid profiles (arginine (Krebs cycle), histidine / urocanic acid, homocysteine, phenylalanine / tyrosine, tryptophan); andrenostenedione; antipyrine; arabinitol enantiomers; arginase; benzoylecgonine (cocaine); bilirubin, biotinidase; biopterin; c-reactive protein; carnitine; camosinase; CD4; ceruloplasmin; chenodeoxycholic acid; chloroquine; cholesterol; cholinesterase; conjugated 1-|3 hydroxy-cholic acid; cortisol; creatine; creatine kinase; creatine kinase MM isoenzyme; creatinine; cyclosporin A; d-penicillamine; deethylchloroquine; dehydroepiandrosterone sulfate; DNA (acetylator polymorphism, alcohol dehydrogenase, alpha 1 -antitrypsin, cystic fibrosis. Duchenne / Becker muscular dystrophy, glucose-6-phosphate dehydrogenase, hemoglobin A, hemoglobin S, hemoglobin C, hemoglobin D, hemoglobin E, hemoglobin F, D-Punjab, beta-thalassemia, hepatitis B virus, HCMV, HIV-1, HTLV-1, Leber hereditary optic neuropathy, MCAD, RNA, PKU. Plasmodium vivax, 21 -deoxy cortisol); desbutylhalofantrine; dihydropteridine reductase; dipthena / tetanus antitoxin; erythrocyte arginase; erythrocyte protoporphyrin; esterase D; fatty acids / acylglycines; free P-human chorionic gonadotropin; free erythrocyte porphyrin; free thyroxine (FT4); free tri-iodothyronine (FT3); fumarylacetoacetase; galactose / gal- 1 -phosphate; galactose- 1 -phosphate uridyltransferase; gentamicin; glucose-6-phosphate dehydrogenase; glutathione; glutathione perioxidase; glycerol; glycocholic acid; glycosylated hemoglobin; halofantrine; hemoglobin variants; hexosaminidase A; human erythrocyte carbonic anhydrase I; 17-alpha-hydroxyprogesterone; hypoxanthine phosphoribosyl transferase; immunoreactive trypsin; beta-hydroxybutyrate; ketones; lactate; lead; lipoproteins ((a). B / A-l, ); lysozyme; mefloquine; netilmicin; oxygen; phenobarbitone; phenytoin; phytanic / pristanic acid; potassium, sodium, and / or other blood electrolytes; progesterone; prolactin; prolidase; purine nucleoside phosphorylase; quinine; reverse tri-iodothyronine P+S Ref. No.: DEXC / 0997PC 9Dexcom Ref. No.: 0997-PCT01(rT3); selenium; serum pancreatic lipase; sissomicin; somatomedin C; specific antibodies (adenovirus, anti-nuclear antibody, anti-zeta antibody, arbovirus, Aujeszky's disease virus, dengue virus, Dracunculus medinensis, Echinococcus granulosus, Entamoeba histolytica, enterovirus, Giardia duodenalisa, Helicobacter pylori, hepatitis B virus, herpes virus, HIV-1, IgE (atopic disease), influenza virus, Leishmania donovani. leptospira, measles / mumps / rubella, Mycobacterium leprae. Mycoplasma pneumoniae, Myoglobin, Onchocerca volvulus, parainfluenza virus, Plasmodium falciparum, poliovirus, Pseudomonas aeruginosa, respiratory syncytial virus, rickettsia (scrub typhus), Schistosoma mansoni, Toxoplasma gondii, Trepenoma pallidium, Trypanosoma cruzi / rangeli, vesicular stomatis virus, Wuchereria bancrofti, yellow fever virus); specific antigens (hepatitis B virus, HIV-1); succinylacetone; sulfadoxine; theophylline; thyrotropin (TSH); thyroxine (T4); thyroxine-binding globulin; trace elements; transferrin; UDP-galactose-4-epimerase; urea; uric acid; uroporphyrinogen I synthase; vitamin A; white blood cells; and zinc protoporphyrin. Salts, sugar, protein, fat, vitamins, and hormones naturally occurring in blood or interstitial fluids can also constitute analytes in certain examples. The analyte can be naturally present in the biological fluid, or endogenous, for example, a metabolic product, a hormone, an antigen, an antibody, and the like. Alternately, the analyte can be introduced into the body, or exogenous, for example, a contrast agent for imaging, a radioisotope, a chemical agent, a fluorocarbon-based synthetic blood, or a drug or pharmaceutical composition, including but not limited to insulin; ethanol; cannabis (marijuana, tetrahydrocannabinol, hashish); inhalants (nitrous oxide, amyl nitrite, butyl nitrite, chlorohydrocarbons, hydrocarbons); cocaine (crack cocaine); stimulants (amphetamines, methamphetamines, Ritalin, Cylert, Preludin, Didrex, PreState, Voranil, Sandrex, Plegine); depressants (barbiturates, methaqualone, tranquilizers such as Valium, Librium, Miltown, Serax, Equanil, Tranxene); hallucinogens (phencyclidine, lysergic acid, mescaline, peyote, psilocybin); narcotics (heroin, codeine, morphine, opium, meperidine, Percocet, Percodan. Tussionex. Fentanyl. Darvon, Talwin, Lomotil); designer drugs (analogs of fentanyl, meperidine, amphetamines, methamphetamines, and phencyclidine, for example, Ecstasy); anabolic steroids; and nicotine. The metabolic products of drugs and pharmaceutical compositions are also contemplated analytes. Analytes such as neurochemicals and other chemicals generated within the body can also be analyzed, such as, for example, ascorbic acid, uric acid, dopamine, noradrenaline, 3-methoxytyramine (3MT), 3,4-dihydroxyphenylacetic acid (DOPAC), homovanillic acid (HVA), 5 -hydroxy tryptamine (5HT), 5- P+S Ref. No.: DEXC / 0997PC 10Dexcom Ref. No.: 0997-PCT01hydroxyindoleacetic acid (FH1AA), and histamine.
[0035] The term "ion” as used herein is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refers without limitation to an atom or molecule with a net electric charge due to the loss or gain of one or more electrons. Ions in a biological fluid is referred to as “electrolytes.” Non-limiting examples of ions in biological fluids include sodium (Na+), potassium (K+), magnesium (Mg2+), calcium (Ca2+), hydrogen (H+), lithium (Li+), chloride (C ), sulfide (S2‘), sulfite (SCL2-), sulfate (SO ’), phosphate (PO ’). and ammonium (NH ). An ion is an example of an analyte.
[0036] FIG. 2 illustrates a more detailed view of health management system 100 including a display device 150 that is communicatively coupled to SS 8. In certain embodiments, display device 150 may be any one of display devices 110, 120. 130, and 140 of FIG. 1. In some embodiments, the display device 150 includes smartphone, such as a mobile phone, based on an Android, iOS, or another operating system configured to display a graphical representation of the continuous sensor data (e.g., including current and / or historic data). In some embodiments, the display device 150 may be a smartwatch or another type of device, such as an insulin pump or other type of pump.
[0037] The communication path between SS 8 and display device 150 is shown as communication path 180. In certain embodiments, SS 8 and display device 150 are configured to wirelessly communicate over communication path 180 using low range and / or distance wireless communication protocols. Examples of low range and / or distance wireless communication protocols include Bluetooth and Bluetooth Low Energy (BLE) protocols. In certain embodiments, other short range wireless communications may include Near Field Communications (NFC), radio frequency identification (RFID) communications, IR (infra-red) communications, optical communications. In certain embodiments, wireless communication protocols other than low range and / or distance wireless communication protocols may be used for communication path 180, such as WiFi Direct. Display device 150 is also configured to connect to network 190 (e.g., local area network (LAN), wide area network (WAN), the Internet, etc.). For example, display device 150 may connect to network 190 via a wired (e.g., Ethernet) or wireless (e.g., WLAN, wireless WAN, cellular, Mesh network, personal area network (PAN) etc.) interface. Display device 150 is able to communicate with server system 134 through network 190. The communication path between display device 150 and server system 134P+S Ref. No.: DEXC / 0997PC 11Dexcom Ref. No.: 0997-PCT01is shown as communication path 181 via network 190.
[0038] Note that, in certain embodiments, SS 8 may be able to independently (e.g.. wirelessly) communicate with server system 134 through network 190. An independent communication path between SS 8 and server system 134 is shown as communication path 182. However, in certain other embodiments, SS 8 may not be configured with the necessary hardware / software to establish, for example, an independent wireless communication path with server system 134 through network 190. In such embodiments, SS 8 may communicate with server system 134 through display device 150. An indirect or pass-through communication path between SS 8 and server system 134 is shown as communication path 183.
[0039] In embodiments where display device 150 is a proprietary display device, such as display device 110 designed specifically for the communication of analyte data, display device 150 may not be configured with the necessary hardware / software for independently connecting to network 190. Instead, in certain such embodiments, display device 150 is configured to establish a wired or wireless communication path 184 (e.g., through a Universal System Bus (USB) connection) with computer device 103, which is configured to communicate with server system 134 through network 190. For example, computer device 103 may connect to network 190 via a wired (e g., Ethernet) or wireless (e.g., WLAN, wireless WAN, cellular, etc.) interface. In some embodiments, the display device 150 may be capable of independently communicating with server system 134 through network 190, independent of computer device 103.
[0040] Health management system 100 additionally includes server system 134, which in turn includes server 135 that is coupled to storage 136 (e.g.. one or more computer storage systems, cloud-based storage systems and / or services, etc ). In certain embodiments, server system 134 may be located or execute in a public or private cloud. In certain embodiments, server system 134 is located or executes on-premises (“on-prem”). As discussed, server system 134 is configured to receive, collect, and / or monitor information, including analyte data and related information, as well as encryption / authentication information from SS 8 and / or display device 150. Such information may include input responsive to the analyte data or input (e.g., the user’s analyte concentration measurements and other physiological / behavioral information) received in connection with an analyte monitoring or sensor application running on SS 8 or display device 150. This information may be stored in storage 136 and may beP+S Ref. No.: DEXC / 0997PC 12Dexcom Ref. No.: 0997-PCT01processed, such as by an analytics engine capable of performing analytics on the information. An example of an analyte sensor application that may be executable on display device 150 is analyte sensor application 121, as further described below.
[0041] In certain embodiments, server system 134 at least partially directs communications between SS 8 and display device 150, for example, for facilitating authentication therebetween. Such communications include messaging (e.g., advertisement, command, or other messaging), message delivery, and analyte data. For example, in certain embodiments, server system 134 may process and exchange messages between SS 8 and display device 150 related to frequency bands, timing of transmissions, security, alarms, and so on. In certain embodiments, server system 134 may also update information stored on SS 8 and / or display device 150. In certain embodiments, server system 134 may send / receive information to / from SS 8 and or display device 150 in realtime or sporadically. Further, in certain embodiments, server system 134 may implement cloud computing capabilities for SS 8 and / or display device 150.
[0042] FIG. 2 also illustrates the components of SS 8 in further detail. As shown, in certain embodiments, SS 8 includes analyte sensor(s) 10 coupled to sensor electronics module 12. As shown, the sensor electronics module 12 includes one or more hardware components, such one or more processors 11, sensor measurement circuitry’ 13, one or more memories 14, connectivity interface 15, and real time clock (RTC) 17. In some embodiments, the one or more hardware components of the sensor electronics module 12 may be implemented as ASIC on a printed circuit board (PCB).
[0043] As shown, sensor electronics module 12 includes the sensor measurement circuitry 13 that is coupled to analyte sensor(s) 10 (such as a potentiostat) for processing and managing sensor data. Sensor measurement circuitry 13 may also be coupled to the one or more processors 11 of the sensor electronics module 12. In some embodiments, the one or more processors 11 may be a general-purpose or application-specific microprocessor, an ASIC, a field programmable gate array (FPGA). etc., that executes instructions to perform control, computation, input / output, etc. functions for the sensor electronics module 12. The one or more processors 11 may include a single integrated circuit, such as a micro processing device, or multiple integrated circuit devices and / or circuit boards working in cooperation to accomplish the appropriate functionality.
[0044] In some embodiments, the one or more processors 11 may be configured toP+S Ref. No.: DEXC / 0997PC 13Dexcom Ref. No.: 0997-PCT01sample an analog electrical signal received from the analyte sensor(s) 10 using the analog-to-digital (A / D) signal processing circuitry, such as the sensor measurement circuitry 13, at regular intervals (such as the sampling period) to generate analyte sensor count values based on the analog electrical signals received from the analyte sensor(s) 10, calibrate the analyte sensor count values based on the sensitivity profile of the analyte sensor(s) 10 to generate measured analyte concentration levels, and generate measured analyte data from the measured analyte concentration levels, generate sensor data packages that include, inter alia, the measured analyte concentration level data. The one or more processors 11 may store the measured analyte concentration level data in the one or more memories 14. and generate the sensor data packages at regular intervals (such as the transmission period) for transmission to the display device 150. The one or more processors 11 may also add additional data to the sensor data packages, such as supplemental sensor information that includes a sensor identifier, a sensor status, temperatures that correspond to the measured analyte data, etc. The sensor data packages are then wirelessly transmitted over a wireless connection to the display device 150. In certain embodiments, the wireless connection is a Bluetooth or Bluetooth Low Energy (BLE) connection. In such embodiments, the sensor data packages are transmitted in the form of Bluetooth or BLE data packets to the display device 150.
[0045] In some embodiments, the one or more processors 11 may perform part or all of the functions of the sensor measurement circuitry 13 for obtaining and processing sensor measurement values from analyte sensor(s) 10. The one or more processors 11 may also be coupled to the one or more memories 14 and the RTC 17 for storing and tracking sensor data. In addition, the one or more processors 11 may be further coupled to the connectivity interface 15, which includes a radio unit or transceiver (TRX) 16 for sending sensor data (e.g., measured analyte concentration levels) and receiving requests and commands from an external device, such as display device 150. As used herein, the term transceiver generally refers to a device or a collection of devices that enable SS 8 to (e.g., wirelessly) transmit and receive data. It is contemplated that, in some embodiments, the sensor measurement circuitry 13 may carry out all the functions of the one or more processors 11 or vice versa.
[0046] Transceiver 16 may be configured with the necessary hardware and wireless communications protocols for enabling wireless communications between SS 8 and other devices, such as display device 150 and / or server system 134. For example, as describedP+S Ref. No.: DEXC / 0997PC 14Dexcom Ref. No.: 0997-PCT01above, transceiver 16 may be configured with the necessary hardware and communication protocols to establish a Bluetooth or BLE connection with display device 150. As one of ordinary skill in the art appreciates, in such an example, the necessary' hardware may include a Bluetooth or BLE security manager and / or other Bluetooth or BLE related hardware / software modules configured for Bluetooth or BLE communications standards. In some embodiments where SS 8 is configured to establish an independent communication path with server system 134, transceiver 16 may be configured with the necessary hardware and communication protocols (e.g., long range wireless cellular communication protocol, such as, GSM, CDMA, LTE, VoLTE, 3G, 4G, 5G communication protocols) for establishing a wireless connection to network 190 to connect with server system 134. As discussed elsewhere, other short range protocols, may also be used for communication between display device 150 and a SS 8 such as NFC, RFID, etc.
[0047] FIG. 2 similarly illustrates the components of display device 150 in further detail. As shown, display device 150 includes connectivity interface 128, one or more processors 126, one or more memories 127, a real time clock (RTC) 163, a display 125 for presenting a graphical user interface (GUI), and a storage 123. Abus (not shown here) may be used to interconnect the various elements of display device 150 and transfer data between these elements. Connectivity interface 128 includes a transceiver (TRX) 129 used for receiving sensor data (e.g., measured analyte concentration levels) from SS 8 and for sending requests, instructions, and / or data to SS 8 as well as server system 134. Transceiver 129 is coupled to other elements of display device 150 via connectivity7interface 128 and / or the bus. Transceiver 129 may include multiple transceiver modules operable on different wireless standards. For example, transceiver 129 may be configured with one or more communication protocols, such as wireless communication protocol(s) for establishing a wireless communication path with network 190 and / or low range wireless communication protocol(s) (e.g., Bluetooth or BLE) for establishing a wireless communication path 180 with SS 8. Additionally, connectivity interface 128 may in some cases include additional components for controlling radio and / or wired connections, such as baseband and / or Ethernet modems, audio / video codecs, and so on.
[0048] In some embodiments, when a standardized communication protocol is used between display device 150 and SS 8, commercially available transceiver circuits may be utilized that incorporate processing circuitry to handle low level dataP+S Ref. No.: DEXC / 0997PC 15Dexcom Ref. No.: 0997-PCT01communication functions such as the management of data encoding, transmission frequencies, handshake protocols, security, and the like. In such embodiments, the one or more processors 126 of display device 150 and / or the one or more processors 11 of SS 8 may not need to manage these activities, but instead provide desired data values for transmission, and manage high level functions such as power up or down, set a rate at which messages are transmitted, and the like. Instructions and data values for performing these high level functions can be provided to the transceiver circuits via a data bus and transfer protocol established by the manufacturer of transceivers 129 and 16. However, in embodiments where a standardized communication protocol is not used between transceivers 129 and 16 (e.g., when non-standardized or modified protocols are used), the one or more processors 126 and 11 may be configured to execute instructions associated with proprietary communications protocols (e.g., one or more of the communications protocols described herein) to control and manage their respective transceivers. In addition, when non-standardized or modified protocols are used, customized circuitries may be used to service such protocols.
[0049] The one or more processors 126 may include processor sub-modules, including, by way of example, an applications processor that interfaces with and / or controls other elements of display device 150 (e.g., connectivity interface 128, analyte sensor application 121 (hereinafter “sensor application 121"), display 125, RTC 163, one or more memories 127, storage 123, etc.). In certain embodiments, the one or more processors 126 is configured to perform functions related to device management, such as, for example, managing lists of available or previously paired devices, information related to network conditions (e.g., link quality and the like), information related to the timing, type, and / or structure of messaging exchanged between SS 8 and display device 150, and so on. The one or more processors 126 may further be configured to receive and process user input, such as, for example, a user's biometric information, such as the user’s finger print (e.g., to authorize the user's access to data or to be used for authorization / encryption of data, including analyte data), as well as analyte data.
[0050] The one or more processors 126 may include and / or be coupled to circuitry such as logic circuits, memory, a battery and power circuitry, and other circuitry drivers for periphery components and audio components. The one or more processors 126 and any sub-processors thereof may include logic circuits for receiving, processing, and / or storing data received and / or input to display device 150, and data to be transmitted orP+S Ref. No.: DEXC / 0997PC 16Dexcom Ref. No.: 0997-PCT01delivered by display device 150. As described above, the one or more processors 126 may be coupled by a bus to display 125, connectivity interface 128, storage 123, etc. Hence, the one or more processors 126 may receive and process electrical signals generated by these respective elements and thus perform various functions. By way of example, the one or more processors 126 may access stored content from storage 123 and one or more memories 127 at the direction of analyte sensor application 121, and process the stored content to be displayed by display 125. Additionally, the one or more processors 126 may process the stored content for transmission via connectivity interface 128 to SS 8 and / or server system 134. Display device 150 may include other peripheral components not shown in detail in FIG. 2.
[0051] In certain embodiments, the one or more memories 127 may include volatile memory, such as random access memory (RAM) for storing data and / or instructions for software programs and applications, such as analyte sensor application 121. Display 125 presents a GUI associated with operating system 162 and / or analyte sensor application 121. In various embodiments, a user may interact with analyte sensor application 121 via a corresponding GUI presented on display 125. By way of example, display 125 may be a touchscreen display that accepts touch input. Analyte sensor application 121 may process and / or present analyte-related data received by display device 150 and present such data via display 125. Additionally, analyte sensor application 121 may be used to obtain, access, display, control, and / or interface with analyte data and related messaging and processes associated with SS 8 (e.g., and / or any other medical device (e.g., insulin pump or pen) that are communicatively coupled with display device 150), as is described in further detail herein.
[0052] Storage 123 may be a non-volatile storage for storing software programs, instructions, data, etc. For example, storage 123 may store analyte sensor application 121 that, when executed using the one or more processors 126, for example, receives input (e.g., by a conventional hard / soft key or a touch screen, voice detection, or other input mechanism), and allows a user to interact with the analyte data and related content via display 125. In various embodiments, storage 123 may also store user input data and / or other data collected by display device 150 (e.g.. input from other users gathered via analyte sensor application 121). Storage 123 may further be used to store volumes of analyte data received from SS 8 (or any other medical data received from other medical devices (e.g., insulin pump, pen, etc.) for later retrieval and use, e.g.,P+S Ref. No.: DEXC / 0997PC 17Dexcom Ref. No.: 0997-PCT01for determining trends and triggering alerts.
[0053] As described above, SS 8, in certain embodiments, gathers analyte data (e.g.. measured analyte concentration levels) from analyte sensor(s) 10 and transmits the same or a modified version of the collected data to display device 150. Data points regarding analyte values may be gathered and transmitted over the life of analyte sensor(s) 10 (e.g., in the range of 1 to 30 days or more). New measurements may be transmitted often enough to adequately monitor analyte concentration levels. In certain embodiments, rather than having the transmission and receiving circuitry of each of SS 8 and display device 150 continuously communicate, SS 8 and display device 150 may regularly and / or periodically establish a communication channel among each other. Thus, in such embodiments, SS 8 may, for example, communicate with display device 150 at predetermined time intervals. The duration of the predetermined time interval can be selected to be long enough so that SS 8 does not consume too much power by transmitting data more frequently than needed, yet frequent enough to provide substantially real-time sensor information (e.g., measured glucose values or analyte data) to display device 150 for output (e.g., via display 125) to the user. While the predetermined time interval is every five minutes in some embodiments, it is appreciated that this time interval can be varied to be any desired length of time. In other embodiments, transceivers 129 and 16 may be continuously communicating. For example, in certain embodiments, transceivers 129 and 16 may establish a session or connection there between and continue to communicate together until the connection is lost.
[0054] Analyte sensor application 121 may be downloaded, installed, and initially configured / setup on display device 150. For example, display device 150 may obtain analyte sensor application 121 from server system 134, or from another source, such as an application store or the like, via a network, e.g., network 190. Following installation and setup, analyte sensor application 121 may be configured to access, process, and / or interface with analyte data (e g., whether stored on server system 134, locally from storage 123, from SS 8, or any other medical device). By way of example, analyte sensor application 121 may present a menu that includes various controls or commands that may be executed in connection with the operation of SS 8, display device 150. one or more other display devices (e.g., display device 110, 130, 140, etc.), and / or one or more other partner devices, such as an insulin pump. For example, analyte sensor application 121 may be used to interface with or control other display and / or partnerP+S Ref. No.: DEXC / 0997PC 18Dexcom Ref. No.: 0997-PCT01devices, for example, to deliver or make available thereto analyte data, including for example by receiving / sending analyte data directly to the other display and / or partner device and / or by sending an instruction for SS 8 and the other display and / or partner device to be connected.
[0055] In certain embodiments, after downloading analyte sensor application 121, as one of the initial steps, the user may be directed by analyte sensor application 121 to establish a secure wireless connection between the display device 150 to the SS 8 of the user, which the user may have already placed on their body. A wireless communication path 180 between display device 150 and SS 8 allows SS 8 to transmit analyte measurements to display device 150 and for the tw o devices to engage in any of the other interactions described above.
[0056] FIG. 3A illustrates a perspective view of the SS 8 described with respect to FIGS. 1 and 2. As shown, the sensor electronics module 12 of the SS 8 may include an outer housing with a first, top portion 392 and a second, bottom portion 394. In embodiments, the outer housing may include a clamshell design.
[0057] As shown in FIG. 3A, the outer housing may feature a generally oblong shape. The outer housing may further include aperture 396 disposed substantially through a center portion of outer housing and adapted for analyte sensor(s) 10 and needle insertion through a bottom of SS 8. In embodiments, aperture 396 may be a channel or elongated slot. SS 8 may further include an adhesive patch 326 configured to secure SS 8 to epidermis of a user (e.g., user 50 described with respect to FIG. 1). In embodiments, adhesive patch 326 may include an adhesive suitable for skin adhesion, for example a pressure sensitive adhesive (e.g., acrylic, rubber-based, or other suitable type) bonded to a carrier substrate (e.g., spun lace polyester, polyurethane film, or other suitable type) for skin attachment, though any suitable type of adhesive is also contemplated. As shown, adhesive patch 326 may feature an aperture 398 aligned with aperture 396 such that analyte sensor(s) 10 may pass through a bottom of SS 8 and through adhesive patch 326.
[0058] FIG. 3B illustrates a bottom perspective view of SS 8 of FIG. 3A. FIG. 3B further illustrates aperture 396 disposed substantially in a center portion of a bottom of SS 8, and aperture 398, both adapted for analyte sensor(s) 10 and needle insertion.
[0059] FIG. 3C illustrates a cross-sectional view of SS 8 of FIGs.3A and 3B. FIG.3C illustrates the first, top portion 392 and the second, bottom portion 394 of the outerP+S Ref. No.: DEXC / 0997PC 19Dexcom Ref. No.: 0997-PCT01housing, adhesive patch 326, aperture 396 in the center portion of SS 8, aperture 398 in the center portion of adhesive patch 326, and analyte sensor(s) 10 passing through aperture 396. As sensor electronics module 12, previously described in connection with FIGS. 1 and 2, may further include a PCB 304 for communicatively coupling one or more hardware components of the sensor electronics module 12 of the SS 8. such as the analyte sensor(s) 10, the one or more processors 11, the sensor measurement circuitry 13, the one or more memories 14, the connectivity interface 15, and the RTC 17. Additionally, as shown, the sensor electronics module 12 may include a battery 302, which may be electrically coupled to the PCB 304 and configured to provide power to the one or more hardware components of the SS.
[0060] Additionally, the analyte sensor(s) 10 may include one or more electrodes 337 configured to sense or measuring analyte concentration levels of a user (e.g., user 50), such as a glucose concentration level. For example, the one or more electrodes 337 may include a working electrode coated with an enzyme, such as glucose oxidase or glucose dehydrogenase, which facilitates a reaction with glucose. This reaction produces an electroactive compound, such as hydrogen peroxide or an electron mediator, which generates an electrical signal at the one or more electrodes 337. The signal is proportional to the glucose concentration and may be received and processed by one or more hardware components of the sensor electronics module 12 (e.g., the one or more processors 11 and / or the sensor measurement circuitry 13) via an input pin on the PCB 304. In some embodiments, the electrode may also include additional layers or coatings, such as membranes to reduce interference from other substances, to improve measurement accuracy.Techniques for Reducing Leakage Currents in an Analyte Sensor System
[0061] Analyte sensor systems are increasingly being used to measure analytes in patients, providing valuable health information for disease management and overall wellness. These systems are designed to continuously or intermittently monitor analyte concentration levels, offering real-time or near-real-time insights into various physiological conditions. A typical analyte sensor system may include a housing formed by low-pressure molding (LPM), which encloses and protects a power source, such as a battery, a microcontroller unit (MCU), an analog front-end (AFE). a transceiver, and at least a portion of an implantable analyte sensor.P+S Ref. No.: DEXC / 0997PC 20Dexcom Ref. No.: 0997-PCT01
[0062] The analyte sensor system may also include a printed circuit board (PCB) that electrically connects the battery, the MCU, the AFE, and the analyte sensor. In some cases, the battery may be secured to the PCB using a battery clip, which may be coated with an insulating material. In some cases, the analyte sensor may include a plurality of electrodes, such as a working electrode (WE) and a reference electrode (RE), with a sensing layer disposed therebetween that facilitates a chemical reaction with a target analyte of a user, causing the analyte sensor to generate one or more electrical signals that are proportional to a concentration level of the target analyte. In some embodiments, the WE and RE of the analyte sensor may each be electrically connected to the PCB by a respective electrical pad disposed on the PCB.
[0063] In some embodiments, the PCB may include a cut-out extending partially or fully through the PCB, with at least a portion of the analyte sensor disposed over the cutout. The cut-out may be configured to provide flexibility for the analyte sensor when deployed into the user's body, helping to prevent detachment from the PCB. Additionally, an encapsulant layer may be deposited over the connections of the WE and RE to their respective electrical pads on the PCB to protect the connections from environmental exposure and mechanical stress.
[0064] In some embodiments, the AFE performs multiple measurements of the analyte concentration level over a period of time based on one or more electrical signals, with each measurement taken at a particular sampling frequency (e.g., every' minute). An analog-to-digital converter (ADC) of the AFE may then convert each measurement from an analog format to a digital format before providing the digital measurements to the MCU. The MCU may then generate analyte data indicating an estimated concentration level of the target analyte based on the digital measurements, which may be derived by¬ averaging the measurements performed over a defined period. The MCU may then use a transceiver to transmit the analyte data to a display device according to a particular transmission frequency (e g., every five minutes) for display to the user.
[0065] A technical challenge associated with current analyte sensor systems is the presence of leakage currents, which may arise due to voltage differentials between various components on the PCB. These leakage currents may impact an accuracy of analyte measurements, reduce a usable lifespan of the analyte sensor, and accelerate depletion of the battery. A significant source of these leakage currents may be the high stray voltage potential that originates from the battery of the analyte sensor system and surrounds theP+S Ref. No.: DEXC / 0997PC 21Dexcom Ref. No.: 0997-PCT01cut-out of the PCB during operation. For example, in some cases, this stray voltage potential may reach approximately 2.46 volts, which is considerably higher than the typical operating voltage of the analyte sensor (e.g., around 0.6 volts). The voltage differential between the area surrounding the cut-out and the analyte sensor may create unintended current pathways, including current flowing through the electrical pads associated with the electrodes of the analyte sensor, the LPM, the encapsulant layer, the battery clip coating, and other circuit elements of the PCB. These unintended leakage currents can introduce noise into one or more electrical signals generated by the analyte sensor based on the target analyte. As a result, the accuracy of the estimated concentration level of the target analyte, as indicated in the analyte data provided to the user, may be significantly affected.
[0066] In addition to measurement inaccuracies, leakage currents may also contribute to accelerated degradation of the sensing layer of the analyte sensor. For example, the unintended current flow may cause electrochemical reactions that degrade the chemistry of the sensing layer of the analyte sensor more rapidly than intended, limiting the sensor’s usable lifespan.
[0067] Furthermore, leakage currents may impact the battery life of the analyte sensor system. For example, the analyte sensor system may be stored for an extended period of time before being shipped to the user. To conserve battery' life, the analyte sensor system may be placed in an off state or a low-power state while in storage and during shipment. However, during this prolonged storage period, leakage currents may significantly drain the battery of the analyte sensor systems. As a result, by the time the analyte sensor system reaches the user, the battery’s capacity' may already be substantially depleted, potentially reducing an operational lifespan of the analyte sensor system.
[0068] Accordingly, aspects of the present disclosure provide techniques for reducing leakage currents within an analyte sensor system. In some cases, these techniques may include forming a grounding ring around the cut-out of the PCB. For example, in some embodiments, the sidewalls of the cut-out of the PCB may be lined with a conductive material that is electrically connected to a ground plane of the PCB. In some embodiments, a strip of the conductive material may also be disposed on a bottom surface of the PCB and / or a top surface of the PCB and may at least partially encircle the cut-out of the PCB. In some embodiments, the grounding ring may be used to dissipate the stray voltage potential surrounding the cut-out of the PCB, thereby reducing the voltageP+S Ref. No.: DEXC / 0997PC 22Dexcom Ref. No.: 0997-PCT01differential and decreasing the leakage currents that would otherwise flow therefrom. Reducing these leakage currents may improve the accuracy of analyte measurements, prolong the usable lifespan of the analyte sensor by mitigating electrochemical degradation, and decrease power consumption to extend battery life.
[0069] FIG. 4 illustrates an example analyte sensor system 400, according to certain aspects. In some cases, the analyte sensor system may be an example of the analyte sensor system 8 depicted and described with respect to FIGS. 1, 2, 3A, 3B, and 3C. As shown, the analyte sensor system 400 includes sensor electronics unit 402 comprising a PCB 404, a battery 406, an implantable analyte sensor 408, an AFE 410, and an MCU 412. In some embodiments, the PCB 404 may operatively and / or electrically connect the battery 406, the implantable analyte sensor 408, the AFE 410. and the MCU 412. In some cases, the PCB 404 may be an example of the PCB 304 depicted and described with respect to FIG.3C
[0070] In some cases, the analyte sensor 408 may be an example of the analyte sensor(s) 10 depicted and described with respect to FIG. 2. In some cases, the analyte sensor 408 may include a plurality of electrodes, such as a working electrode and a reference electrode, with a sensing layer disposed therebetween that facilitates a chemical reaction with a target analyte of a user, causing the analyte sensor 408 to generate one or more electrical signals that are proportional to a concentration level of the target analyte. The AFE 410 may use sensor measurement circuitry 414 to perform measurements of the analyte concentration level based on the one or more electrical signals generated by the analyte sensor 408. In some cases, the sensor measurement circuitry 414 may be an example of the sensor measurement circuitry 13 depicted and described with respect to FIG. 2. In some embodiments, the measurements may be passed through one or more filters 416, such as a low-pass filter, to reduce noise and improve signal accuracy. The measurements may then be converted from an analog format to a digital format by one or more ADCs 418.
[0071] After the measurements have been converted to the digital format, the measurements may be provided to the MCU 412. The MCU 412 may process the digital measurements using one or more processors 420 to generate analyte data indicating the analyte concentration level of the user, which may then be stored in the one or more memories 422. The analyte sensor system 400 may then use a transceiver 424 to periodically transmit the analyte data to a display device (e.g., display device 150) forP+S Ref. No.: DEXC / 0997PC 23Dexcom Ref. No.: 0997-PCT01display to the user.
[0072] In some cases, the one or more processors 420 may be an example of the one or more processors 11 depicted and described with respect to FIG. 2. In some cases, the one or more memories 422 may be an example of the one or more memories 14 depicted and described with respect to FIG. 2. In some cases, the transceiver 424 may be an example of the transceiver 16 depicted and described with respect to FIG. 2.
[0073] FIGS. 5A and 5B illustrate perspective views of the PCB 404 of the analyte sensor system. Specifically, FIG.5A illustrates a bottom surface 502 of the PCB 404 that is configured to face a body of the user when the analyte sensor system 400 is worn by the user while FIG. 5B illustrates a top surface 504 of the PCB 404 that is configured to face in a direction opposite to the bottom surface 502.
[0074] As noted above, the PCB 404 may operatively and / or electrically connect the battery 406, the analyte sensor 408, the AFE 410, and the MCU 412. For example, in some embodiments, FIG. 5A illustrates that the battery 406 may be disposed on the bottom surface 502 of the PCB 404 and securely fastened using a battery clip 503, while FIG. 5B shows the AFE 410 and MCU 412 may be disposed on the top surface 504 of the PCB 404. In some cases, the PCB 404 may also include circuitry 506 for operatively and / or electrically connecting the battery 406, the AFE 410 (e.g., sensor measurement circuitry 414, the one or more filters 416, and the one or more ADCs 418), and the MCU 412 (e.g., the one or more processors 420, the one or more memories 422, and the transceiver 424). In some embodiments, the circuitry 506 may be included on the bottom surface 502 of the PCB 404. In some cases, as illustrated in FIG. 5B, the circuitry 506 may be included on the top surface 504 of the PCB 404. In some embodiments, when the circuitry 506 is included on the top surface 504 of the PCB 404, the PCB 404 may include a plurality of vias 505, which are conductive pathways that electrically connect the components on the bottom surface of the PCB, such as the battery 406, to the circuitry 506 on the top surface of the PCB. In some embodiments, a typical via may have a size of about 0.15 mm to 0.5 mm in diameter, depending on the type of via and PCB design requirements.
[0075] Further, as illustrated in FIGS. 5A and 5B, the PCB may include a cut-out 514 over which or through which at least a portion of the analyte sensor 408 extends. In some embodiments, the cut-out 514 may provide flexibility for the analyte sensor 408P+S Ref. No.: DEXC / 0997PC 24Dexcom Ref. No.: 0997-PCT01when the analyte sensor 408 is deployed into the body of the user, helping to prevent detachment from the PCB 404. In some embodiments, the PCB 404 may have a first thickness (Tl) while the cut-out 514 of the PCB 404 may include sidewalls having a second thickness (T2) that are less than or equal to the first thickness of the PCB. In other words, the cut-out 514 may extend partially through the PCB 404 (e.g., when T2 < Tl) or may extend fully through the PCB 404 (e.g., when T2 = Tl). Further, in some embodiments, the cut-out 514 may have a width (Wl) that is significantly larger than a typical via. For example, in some embodiments, the width (Wl) of the cut-out 514 of the PCB 404 may be approximately 10% to 90% of a width (W2) of the PCB 404. In some embodiments, the width (Wl) of the cut-out 514 may be approximately 7.65 millimeters (mm) while the width (W2) of the PCB 404 may be approximately 20-21 mm.
[0076] FIG. 5A illustrates an embodiment in which the portion of the analyte sensor 408 extends over the cut-out 514 of the PCB 404 but not through the cut-out 514. In this embodiment, as shown in FIG. 5A, the bottom surface 502 of the PCB 404 may include a first electrical pad 508 to which the WE of the analyte sensor 408 may be connected. Additionally, as shown, the bottom surface 502 of the PCB 404 may also include a second electrical pad 510 to which the RE of the analyte sensor 408 may be connected. In some embodiments, as shown at 512 in FIG. 5B, the first electrical pad 508 and the second electrical pad 510 may each, respectively, be connected to an input of the AFE 410, allowing signals generated by the analyte sensor 408 (e.g., that are proportional to an analyte concentration of a target analyte of the user) to be received by the AFE 410.
[0077] In some embodiments, however, the first electrical pad 508 and the second electrical pad 510 may be disposed on the top surface 504 of the PCB 404. In this embodiment, at least a portion of the analyte sensor 408 may extend through the cut-out 514 from the bottom surface 502 to the top surface 504, and may be connected to the first electrical pad 508 and the second electrical pad 510 disposed on the top surface 504 in a similar manner as shown in FIG. 5A.
[0078] As discussed above, without the techniques presented herein, a high stray voltage potential originating from the battery 406 may surround the cut-out 514, leading to unintended leakage currents associated with at least the analyte sensor 408 that introduce noise into signals generated by the analyte sensor 408, accelerate degradation of the sensor’s sensing layer, and drain battery capacity during storage, ultimately affecting measurement accuracy, sensor lifespan, and device longevity.P+S Ref. No.: DEXC / 0997PC 25Dexcom Ref. No.: 0997-PCT01
[0079] However, in some embodiments, to reduce these unintended leakage currents, the sidewalls of the cut-out 514 of the PCB 404 may be at least partially lined with a conductive material, which may be electrically connected to a ground plane 520 of the PCB 404, forming a grounding ring 518 around the cut-out 514 of the PCB 404. In some embodiments, the grounding ring 518 may be used to dissipate the high stray voltage potential that may otherwise surround the cut-out 514 of the PCB 404 and cause the leakage currents to flow, as discussed above. For example, in some cases, while the analyte sensor system 400 is operating, the grounding ring 518 may reduce the voltage potential surrounding the cut-out 514 of the PCB 404 to <1 volt (e.g., approximately 0.6 volts), compared to 2.46 volts without the grounding ring 518.Leakage Leakage Difference in Currents ofCurrents without Currents with Leakage Percent AnalyteGrounding Ring Grounding Ring Currents Difference Sensor(pA) (pA) (pA)IWE 6.47 4.81 1.662 26% IRE 127.14 90.44 36.70 29%Table 1
[0080] For example, as shown in Table 1, without the grounding ring 518, the WE of the analyte sensor 408 may experience a leakage current of approximately 6.47 pico amps (pA) while the RE of the analyte sensor 408 may experience a leakage current of approximately 127.14 pA. As discussed above, these leakage currents may affect the accuracy of the analyte data indicating the analyte concentration level of the user, may reduce the usable lifetime associated with the analyte sensor, and may increase battery depletion. In contrast, however, when using the grounding ring 518, the leakage current associated with the WE may be reduced to approximately 4.81 pA, representing a difference of 1.662 pA or 26%. Similarly , the leakage current associated with the RE may be reduced to approximately 90.44 pA, representing a difference of 36.70 pA or 29%. As a result, the reduced leakage currents may enhance accuracy by minimizing signal interference, extend the analyte sensor’s usable lifetime by reducing degradation, and decrease battery' depletion by lowering unnecessary power consumption.
[0081] In some embodiments, the conductive material may comprise copper, silver, gold, nickel, aluminum, tin, or a combination thereof. In some embodiments, at least a portion of the grounding ring 518 may extend from the sidewalls of the cut-out 514 of the PCB up onto the top surface 504 of the PCB 404 and / or the bottom surface 502 of theP+S Ref. No.: DEXC / 0997PC 26Dexcom Ref. No.: 0997-PCT01PCB 404. For example, as shown in FIGS.5A and 5B, in some embodiments, a strip 522 of the conductive material of the grounding ring 518 may be optionally disposed on the bottom surface 502 of the PCB 404 and / or top surface 504 of the PCB 404 at least partially encircling the cut-out 514. In some cases, the strip 522 may further reduce leakage currents associated with the cut-out 514 of the PCB 404.
[0082] In some cases, to further reduce leakage currents, the cut-out 514 of the PCB 404 may optionally be at least partially filled with an encapsulant layer 516. In some embodiments, the encapsulant layer 516 may also be deposited over the connections of WE and RE to the first electrical pad 508 and the second electrical pad 510, respectively, to protect these connections from environmental exposure and mechanical stress. In some embodiments, the encapsulant layer 516 may be composed of a dielectric material having a resistivity in the range of 4.2x109ohm-meters (Q m) to 1.29xlOnQ m.Example Operations
[0083] FIG. 6 shows an example of a method 600 of wireless communication by an analyte sensor system, such as the analyte sensor system 8 of FIGS. 1 and FIG. 2 and / or the analyte sensor system 400 depicted and described with respect to FIGS. 4, 5A, and 5B
[0084] Method 600 begins at step 605 with generating one or more electrical signals that are proportional to an analyte concentration level of a user of the analyte sensor system. In some cases, the operations of this step refer to, or may be performed by, an implantable analyte sensor of the analyte sensor system, such as the analyte sensor 701 described with reference to FIG. 7.
[0085] Method 600 then proceeds to step 610 with generating, by one or more processors of the analyte sensor system based on the one or more electrical signal generated by the implantable analyte sensor, analyte data indicating the analyte concentration level of the user. In some cases, the operations of this step refer to, or may be performed by, circuitry for generating and / or code for generating as described with reference to FIG. 7.
[0086] Method 600 then proceeds to step 615 with transmitting, by a transceiver of the analyte sensor system, the analyte data to a display device for display to the user. In some aspects, the analyte sensor system includes a printed circuit board (PCB) configured to operatively connect the implantable analyte sensor, the one or more processors, and the P+S Ref. No.: DEXC / 0997PC 27Dexcom Ref. No.: 0997-PCT01transceiver. In some aspects, the PCB has a first thickness. In some aspects, the PCB includes a cut-out over which or through which at least a portion of the implantable analyte sensor extends. In some aspects, the cut-out has sidewalls having a second thickness less than or equal to the first thickness of the PCB. In some aspects, the sidewalls are at least partially lined with a conductive material that is electrically connected to a ground plane of the PCB and configured to dissipate stray voltage potential associated with the cut-out and to cause one or more leakage currents associated with the implantable analyte sensor to be less than one or more thresholds based on the dissipated stray voltage potential. In some cases, the operations of this step refer to, or may be performed by, circuitry for transmitting and / or code for transmitting as described with reference to FIG. 7.
[0087] In some aspects, a width of the cut-out is approximately 10% to 90% a width of the PCB.
[0088] In some aspects, while the analyte sensor system is operating, a voltage potential immediately surrounding the cut-out on the PCB is less than or equal to 1 volt.
[0089] In some aspects, the stray voltage potential originates from a battery of the analyte sensor system.
[0090] In some aspects, the implantable analyte sensor includes a working electrode (WE) and a reference electrode (RE).
[0091] In some aspects, based on the dissipated stray voltage potential, the conductive material is configured to cause a first leakage current, of the one or more leakage currents, associated with the WE of the implantable analyte sensor to be less than a first threshold of the one or more thresholds. In some aspects, based on the dissipated stray voltage potential, the conductive material is configured to cause a second leakage current, of the one or more leakage currents, associated with the RE of the implantable analyte sensor to be less than a second threshold of the one or more thresholds.
[0092] In some aspects, the first threshold is at least 6.47 pico amperes (pA) when there is no conductive material on the sidewalls; and the second threshold is at least 127.14 pA when there is no conductive material on the sidewalls.
[0093] In some aspects, the PCB has a bottom surface that is configured to face a body of the user when the analyte sensor system is worn by the user; and the PCB has a top surface that is configured to face in a direction opposite to the bottom surface.P+S Ref. No.: DEXC / 0997PC 28Dexcom Ref. No.: 0997-PCT01
[0094] In some aspects, at least one of: a strip of the conductive material is also disposed on the bottom surface of the PCB at least partially encircling the cut-out; or a strip of the conductive material is also disposed on the top surface of the PCB at least partially encircling the cut-out.
[0095] In some aspects, the portion of the implantable analyte sensor extends over the cut-out of the PCB; the WE is electrically connected to a first electrical pad disposed on the bottom surface of the PCB; and the RE is electrically connected to a second electrical pad disposed on the bottom surface of the PCB.
[0096] In some aspects, the portion of the implantable analyte sensor extends through the cut-out of the PCB; the working electrode is electrically connected to a first electrical pad disposed on the top surface of the PCB; and the reference electrode is electrically connected to a second electrical pad disposed on the top surface of the PCB.
[0097] In some aspects, the cut-out is at least partially filled with a dielectric material.
[0098] In some aspects, the conductive material comprises copper, silver, gold, nickel, aluminum, tin, or a combination thereof.
[0099] In one aspect, method 600, or any aspect related to it, may be performed by an apparatus, such as health management device 700 of FIG. 7, which includes various components operable, configured, or adapted to perform the method 600. Health management device 700 is described below in further detail.
[0100] Note that FIG. 6 is just one example of a method, and other methods including fewer, additional, or alternative steps are possible consistent with this disclosure.Example Health Management Device
[0101] FIG.7 depicts aspects of an example health management device 700. In some aspects, health management device 700 is an analyte sensor system, such as the SS 8 described with respect to FIGS. 1, 2, 3A, 3B, and 3C and / or the analyte sensor system 400 described with respect to FIGS. 4, 5A, and 5B.
[0102] The health management device 700 includes a processing system 705 coupled to the transceiver 745 (e.g., a transmitter and / or a receiver). The transceiver 745 is configured to transmit and receive signals for the health management device 700 viaP+S Ref. No.: DEXC / 0997PC 29Dexcom Ref. No.: 0997-PCT01the antenna 750, such as the various signals as described herein. The processing system 705 may be configured to perform processing functions for the health management device 700, including processing signals received and / or to be transmitted by the health management device 700.
[0103] The health management device 700 includes an analyte sensor 701 configured to generate one or more electrical signals that are proportional to an analyte concentration level of a user of the health management device 700. In various aspects, the analyte sensor 701 may be representative of the analyte sensor(s) 10 as described with respect to FIG.2 and / or the analyte sensor 408 as described with respect to FIGS. 4, 5A, and 5B. The processing system 705 includes one or more processors 710. In various aspects, the one or more processors 710 may be representative of the one or more processors 11 as described with respect to FIG. 2 and / or the one or more processors 420 as described with respect to FIG. 4. The analyte sensor 701 and the one or more processors 710 are coupled to a computer-readable medium / memory 725 via a bus 740. In some aspects, the computer-readable medium / memory 725 may be representative of the one or more memories 14 as described with respect to FIG. 2 and / or the one or more memories 422 as described with respect to FIG. 4. In certain aspects, the computer-readable medium / memory 725 is configured to store instructions (e.g., computerexecutable code) that when executed by the one or more processors 710, cause the one or more processors 710 to perform the method 600 described with respect to FIG. 6, or any aspect related to this method. Note that reference to a processor performing a function of health management device 700 may include one or more processors 710 performing that function of health management device 700.
[0104] In the depicted example, computer-readable medium / memory 725 stores code (e.g., executable instructions), such as code for generating 730 and code for transmitting 735. Processing of the code for generating 730 and code for transmitting 735 may cause the health management device 700 to perform the method 600 described with respect to FIG. 6, or any aspect related to it.
[0105] The one or more processors 710 include circuitry configured to implement (e.g., execute) the code stored in the computer-readable medium / memory 725, including circuitry such as circuitry for generating 715 and circuitry for transmitting 720. Processing with circuitry for generating 715 and circuitry for transmitting 720 may cause the health management device 700 to perform the method 600 described with respect toP+S Ref. No.: DEXC / 0997PC 30Dexcom Ref. No.: 0997-PCT01FIG. 6, or any aspect related to it.Example Clauses
[0106] Implementation examples are described in the following numbered clauses:
[0107] Clause 1: A method for wireless communication by analyte sensor system, comprising: generating, by an implantable analyte sensor of the analyte sensor system, one or more electrical signals that are proportional to an analyte concentration level of a user of the analyte sensor system; generating, by one or more processors of the analyte sensor system based on the one or more electrical signal generated by the implantable analyte sensor, analyte data indicating the analyte concentration level of the user; and transmitting, by a transceiver of the analyte sensor system, the analyte data to a display¬ device for display to the user, wherein: the analyte sensor system includes a printed circuit board (PCB) configured to operatively connect the implantable analyte sensor, the one or more processors, and the transceiver the PCB has a first thickness the PCB includes a cutout over which or through which at least a portion of the implantable analyte sensor extends the cut-out has sidewalls having a second thickness less than or equal to the first thickness of the PCB the sidewalls are at least partially lined with a conductive material that is electrically connected to a ground plane of the PCB and configured to: dissipate stray voltage potential associated with the cut-out; and cause one or more leakage currents associated with the implantable analyte sensor to be less than one or more thresholds based on the dissipated stray voltage potential.
[0108] Clause 2: The method of Clause 1, wherein a width of the cut-out is approximately 10% to 90% a width of the PCB.
[0109] Clause 3: The method of any one of clauses 1-2, wherein: while the analyte sensor system is operating, a voltage potential immediately surrounding the cut-out on the PCB is less than or equal to 1 volt; and the stray voltage potential originates from a battery of the analyte sensor system.
[0110] Clause 4: The method of any one of Clause 1-3, wherein the implantable analyte sensor includes a working electrode (WE) and a reference electrode (RE).[OHl] Clause 5: The method of Clause 5, wherein based on the dissipated stray voltage potential, the conductive material is configured to cause: a first leakage current, of the one or more leakage currents, associated with the WE of the implantable analyteP+S Ref. No.: DEXC / 0997PC 31Dexcom Ref. No.: 0997-PCT01sensor to be less than a first threshold of the one or more thresholds; and a second leakage current, of the one or more leakage currents, associated with the RE of the implantable analyte sensor to be less than a second threshold of the one or more thresholds.
[0112] Clause 6: The method of Clause 5, wherein: the first threshold is at least 6.47 pico amperes (pA) when there is no conductive material on the sidewalls; and the second threshold is at least 127.14 pA when there is no conductive material on the sidewalls.
[0113] Clause 7: The method of Clause 5, wherein: the PCB has a bottom surface that is configured to face a body of the user when the analyte sensor system is worn by the user; and the PCB has a top surface that is configured to face in a direction opposite to the bottom surface.
[0114] Clause 8: The method of Clause 7, wherein at least one of: a strip of the conductive material is also disposed on the bottom surface of the PCB at least partially encircling the cut-out; or a strip of the conductive material is also disposed on the top surface of the PCB at least partially encircling the cut-out.
[0115] Clause 9: The method of Clause 7, wherein: the portion of the implantable analyte sensor extends over the cut-out of the PCB; the WE is electrically connected to a first electrical pad disposed on the bottom surface of the PCB; and the RE is electrically connected to a second electrical pad disposed on the bottom surface of the PCB.
[0116] Clause 10: The method of Clause 7, wherein: the portion of the implantable analy te sensor extends through the cut-out of the PCB; the WE is electrically connected to a first electrical pad disposed on the top surface of the PCB; and the RE is electrically connected to a second electrical pad disposed on the top surface of the PCB.
[0117] Clause 11 : The method of any one of Clauses 1-10. wherein the cut-out is at least partially filled with a dielectric material.
[0118] Clause 12: The method of any one of Clauses 1-11, wherein the conductive material comprises copper, silver, gold, nickel, aluminum, tin, or a combination thereof.
[0119] Clause 13: An apparatus, comprising: at least one memory comprising executable instructions; and at least one processor configured to execute the executable instructions and cause the apparatus to perform a method in accordance with any combination of Clauses 1-12.
[0120] Clause 14: An apparatus, comprising means for performing a method inP+S Ref. No.: DEXC / 0997PC 32Dexcom Ref. No.: 0997-PCT01accordance with any combination of Clauses 1-12.
[0121] Clause 15: A non-transitory computer-readable medium comprising executable instructions that, when executed by at least one processor of an apparatus, cause the apparatus to perform a method in accordance with any combination of Clauses 1-12.
[0122] Clause 16: A computer program product embodied on a computer-readable storage medium comprising code for performing a method in accordance with any combination of Clauses 1-12.Additional Considerations
[0123] In this document, the terms “computer program medium” and “computer usable medium” and “computer readable medium”, as well as variations thereof, are used to generally refer to transitory or non-transitory media. These and other various forms of computer program media or computer usable / readable media may be involved in carrying one or more sequences of one or more instructions to a processing device for execution. Such instructions embodied on the medium, may generally be referred to as “computer program code” or a “computer program product” or “instructions” (which may be grouped in the form of computer programs or other groupings). When executed, such instructions may enable a computing module, such as the SS 8, the analyte sensor system 400, circuitry' related thereto, and / or a processor thereof or connected thereto to perform features or functions of the present disclosure as discussed herein (for example, in connection with methods described above and / or in the claims), including for example when the same is / are incorporated into a system, apparatus, device and / or the like.
[0124] Various embodiments have been described with reference to specific example features thereof. It will, however, be evident that various modifications and changes may be made thereto without departing from the broader spirit and scope of the various embodiments as set forth in the appended claims. The specification and figures are, accordingly, to be regarded in an illustrative rather than a restrictive sense. It will be appreciated that, for clarity purposes, the above description has described embodiments with reference to different functional units. However, it will be apparent that any suitable distribution of functionality between different functional units may be used without detracting from the invention. For example, functionality illustrated to be performed by separate computing devices may be performed by the same computing device. Likewise,P+S Ref. No.: DEXC / 0997PC 33Dexcom Ref. No.: 0997-PCT01functionality illustrated to be performed by a single computing device may be distributed amongst several computing devices. Hence, references to specific functional units are only to be seen as references to suitable means for providing the described functionality, rather than indicative of a strict logical or physical structure or organization.
[0125] Although described above in terms of various example embodiments and implementations, it should be understood that the various features, aspects and functionality described in one or more of the individual embodiments are not limited in their applicability to the particular embodiment with which they are described, but instead may be applied, alone or in various combinations, to one or more of the other embodiments of the present application, whether or not such embodiments are described and whether or not such features are presented as being a part of a described embodiment. Thus, the breadth and scope of the present application should not be limited by any of the above-described example embodiments.
[0126] Terms and phrases used in the present application, and variations thereof, unless otherwise expressly stated, should be construed as open ended as opposed to limiting. As examples of the foregoing: the term “including” should be read as meaning “including, without limitation” or the like; the term “example” is used to provide illustrative instances of the item in discussion, not an exhaustive or limiting list thereof; the terms “a” or “an” should be read as meaning “at least one,” “one or more” or the like; the term “set” should be read to include one or more objects of the ty pe included in the set; and adjectives such as “conventional,” “traditional,” “normal,” “standard,” “known” and terms of similar meaning should not be construed as limiting the item described to a given time period or to an item available as of a given time, but instead should be read to encompass conventional, traditional, normal, or standard technologies that may be available or known now or at any time in the future. Similarly, the plural may in some cases be recognized as applicable to the singular and vice versa. Likewise, where this document refers to technologies that would be apparent or known to one of ordinary skill in the art, such technologies encompass those apparent or known to the skilled artisan now or at any time in the future.
[0127] The presence of broadening words and phrases such as “one or more,” “at least,” “but not limited to” or other like phrases in some instances shall not be read to mean that the narrower case is intended or required in instances where such broadening phrases may be absent. The use of the term “module” does not imply that the componentsP+S Ref. No.: DEXC / 0997PC 34Dexcom Ref. No.: 0997-PCT01or functionality described or claimed as part of the module are all configured in a common package. Indeed, any or all of the various components of a module, whether control logic, circuitry, or other components, may be combined in a single package or separately maintained and may further be distributed in multiple groupings or packages or across multiple locations.
[0128] Additionally, the various embodiments set forth herein are described in terms of example block diagrams, flow charts, and other illustrations. As will become apparent to one of ordinary skill in the art after reading this document, the illustrated embodiments and their various alternatives may be implemented without confinement to the illustrated examples. For example, block diagrams and their accompanying description should not be construed as mandating a particular architecture or configuration. Moreover, the operations and sub-operations of various methods described herein are not necessarily limited to the order described or shown in the figures, and one of skill in the art will appreciate, upon studying the present disclosure, variations of the order of the operations described herein that are within the spirit and scope of the disclosure.
[0129] It will be understood that each block of the flowchart illustrations, and combinations of blocks in the flowchart illustrations, can be implemented by execution of computer program instructions. These computer program instructions may be loaded onto a computer or other programmable data processing apparatus (such as a controller, microcontroller, microprocessor or the like) in a sensor electronics system to produce a machine, such that the instructions which execute on the computer or other programmable data processing apparatus create instructions for implementing the functions specified in the flowchart block or blocks. These computer program instructions may also be stored in a computer-readable memory that can direct a computer or other programmable data processing apparatus to function in a particular manner, such that the instructions stored in the computer-readable memory produce an article of manufacture including instructions which implement the function specified in the flowchart block or blocks. The computer program instructions may also be loaded onto a computer or other programmable data processing apparatus to cause a series of operational steps to be performed on the computer or other programmable apparatus to produce a computer implemented process such that the instructions which execute on the computer or other programmable apparatus provide steps for implementing the functions specified in the flowchart block or blocks presented herein.P+S Ref. No.: DEXC / 0997PC 35Dexcom Ref. No.: 0997-PCT01
[0130] It should be appreciated that all methods and processes disclosed herein may be used in any glucose or other analyte monitoring system, continuous or intermittent. It should further be appreciated that the implementation and / or execution of all methods and processes may be performed by any suitable devices or systems, whether local or remote. Further, any combination of devices or systems may be used to implement the present methods and processes.
[0131] In addition, the operations and sub-operations of methods described herein may be carried out or implemented, in some cases, by one or more of the components, elements, devices, modules, circuitry, processors, etc. of systems, apparatuses, devices, environments, and / or computing modules described herein and referenced in various of figures of the present disclosure, as well as one or more sub- components, elements, devices, modules, processors, circuitry, and the like depicted therein and / or described with respect thereto. In such instances, the description of the methods or aspects thereof may refer to a corresponding component, element, etc., but regardless of whether an explicit reference is made, one of skill in the art will recognize upon studying the present disclosure when the corresponding component, element, etc. may be used. Further, it will be appreciated that such references do not necessarily limit the described methods to the particular component, element, etc. referred to. Thus, it will be appreciated by one of skill in the art that aspects and features described above in connection with (sub-) components, elements, devices, modules, and circuitry, etc., including variations thereof, may be applied to the various operations described in connection with methods described herein, and vice versa, without departing from the scope of the present disclosure.P+S Ref. No.: DEXC / 0997PC 36
Claims
Dexcom Ref. No.: 0997-PCT01CLAIMS1. An analyte sensor system, comprising:a printed circuit board (PCB); andan implantable analyte sensor, operatively connected to the PCB, configured to generate one or more electrical signals that are proportional to an analyte concentration level of a user of the analyte sensor system, wherein:the PCB has a first thickness;the PCB includes a cut-out over which or through which at least a portion of the implantable analyte sensor extends;the cut-out has sidewalls having a second thickness less than or equal to the first thickness of the PCB; andthe sidewalls are at least partially lined with a conductive material that is electrically connected to a ground plane of the PCB and configured to:dissipate stray voltage potential associated with the cut-out; and cause one or more leakage currents associated with the implantable analyte sensor to be less than one or more thresholds based on the dissipated stray voltage potential.
2. The analyte sensor system of claim 1, wherein a width of the cut-out is approximately 10% to 90% a width of the PCB.
3. The analyte sensor system of claim 1, wherein:while the analyte sensor system is operating, the stray voltage potential immediately surrounding the cut-out on the PCB is less than or equal to 1 volt; and the stray voltage potential originates from a battery of the analyte sensor system.
4. The analyte sensor system of claim 1, wherein the implantable analyte sensor includes a working electrode (WE) and a reference electrode (RE).
5. The analyte sensor system of claim 4, wherein based on the dissipated stray voltage potential, the conductive material is configured to cause:a first leakage current, of the one or more leakage currents, associated with the WE of the implantable analyte sensor to be less than a first threshold of the one or more thresholds; andP+S Ref. No.: DEXC / 0997PC 37Dexcom Ref. No.: 0997-PCT01a second leakage current, of the one or more leakage currents, associated with the RE of the implantable analyte sensor to be less than a second threshold of the one or more thresholds.
6. The analyte sensor system of claim 5, wherein:the first threshold is at least 6.47 pico amperes (pA) when there is no conductive material on the sidewalls; andthe second threshold is at least 127.14 pA when there is no conductive material on the sidewalls.
7. The analyte sensor system of claim 4, wherein:the PCB has a bottom surface that is configured to face a body of the user when the analyte sensor system is worn by the user; andthe PCB has a top surface that is configured to face in a direction opposite to the bottom surface.
8. The analyte sensor system of claim 7, wherein at least one of:a strip of the conductive material is also disposed on the bottom surface of the PCB at least partially encircling the cut-out; ora strip of the conductive material is also disposed on the top surface of the PCB at least partially encircling the cut-out.
9. The analyte sensor system of claim 7. wherein:the portion of the implantable analyte sensor extends over the cut-out of the PCB;the WE is electrically connected to a first electrical pad disposed on the bottom surface of the PCB; andthe RE is electrically connected to a second electrical pad disposed on the bottom surface of the PCB.
10. The analyte sensor system of claim 7, wherein:the portion of the implantable analyte sensor extends through the cut-out of the PCB;P+S Ref. No.: DEXC / 0997PC 38Dexcom Ref. No.: 0997-PCT01the WE is electrically connected to a first electrical pad disposed on the top surface of the PCB; andthe RE is electrically connected to a second electrical pad disposed on the top surface of the PCB.
11. The analyte sensor system of claim 1, wherein the cut-out is at least partially filled with a dielectric material.
12. The analyte sensor system of claim 1, wherein the conductive material comprises copper, silver, gold, nickel, aluminum, tin, or a combination thereof.
13. The analy te sensor sy stem of claim 1, further comprising one or more processors, wherein the PCB operatively connects the implantable analyte sensor to the one or more processors.
14. The analyte sensor system of claim 13, wherein the one or more processors are configured to:receive the one or more electrical signals from the implantable analyte sensor; generate, based on the one or more electrical signals received from the implantable analyte sensor, analyte data indicating the analyte concentration level of the user; andtransmit the analyte data to a display device for display to the user.
15. A method for wireless communication by analyte sensor system, comprising: generating, by an implantable analyte sensor of the analyte sensor system, one or more electrical signals that are proportional to an analyte concentration level of a user of the analyte sensor system;generating, by one or more processors of the analyte sensor system based on the one or more electrical signals generated by the implantable analyte sensor, analyte data indicating the analyte concentration level of the user; andtransmitting, by a transceiver of the analyte sensor system, the analyte data to a display device for display to the user, wherein:P+S Ref. No.: DEXC / 0997PC 39Dexcom Ref. No.: 0997-PCT01the analyte sensor system includes a printed circuit board (PCB) configured to operatively connect the implantable analyte sensor, the one or more processors, and the transceiver;the PCB has a first thickness;the PCB includes a cut-out over which or through which at least a portion of the implantable analyte sensor extends;the cut-out has sidewalls having a second thickness less than or equal to the first thickness of the PCB; andthe sidewalls are at least partially lined with a conductive material that is electrically connected to a ground plane of the PCB and configured to:dissipate stray voltage potential associated with the cut-out; and cause one or more leakage currents associated with the implantable analyte sensor to be less than one or more thresholds based on the dissipated stray voltage potential.P+S Ref. No.: DEXC / 0997PC 40