Systems, devices, and methods for specimen monitoring systems

Abstract

To provide systems and methods for detecting changes or fluctuations in an analyte concentration signal that are abnormal, e.g., exceed a predetermined threshold, a current trend of analyte concentration measurements, etc.SOLUTION: Signals indicative of analyte concentration in a host may be received from an analyte sensor. The signals may be monitored, and a determination can be made as to whether there is a change in the signal. Upon detecting such a change, the change can be compensated such that a representation of the signal indicates the analyte concentration. Optionally, the cause of the detected changes or fluctuations can also be determined, and information regarding the detected changes or fluctuations can be recorded and analyzed for subsequent optimization of the systems and methods as well as for transmitting alerts, notifications, etc. to a user to take corrective action.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] Cross - reference to related applications All priority claims identified in the application data sheet or any amendment thereof shall be incorporated herein by reference under 37 CFR 1.57. This application claims the benefit of U.S. Provisional Application No. 62 / 315,539, filed Mar. 30, 2016. The above application is hereby incorporated by reference in its entirety and made a part of this specification as clearly as if set forth herein.

[0002] Various embodiments generally relate to the continuous monitoring of analyte values received from an analyte sensor system, and particularly to transmitter fault detection and response to such faults.

Background Art

[0003] Diabetes mellitus is a disorder in which the pancreas cannot produce sufficient insulin (type 1 or insulin - dependent) and / or insulin is ineffective (type 2 or non - insulin - dependent). In a diabetic state, the sufferer endures high blood sugar, which in turn gives rise to many physiological disorders associated with the deterioration of small blood vessels (renal failure, skin ulcers or bleeding into the vitreous of the eye). Hypoglycemic reactions (low blood sugar) can be induced by inadvertent over - dosing of insulin or following the normal administration of insulin or glucose - lowering agents associated with excessive exercise or insufficient food intake.

[0004] Traditionally, people with diabetes have carried around self-monitoring blood glucose (SMBG) monitors, which generally require the uncomfortable finger-prick method. Due to the lack of comfort and convenience, people with diabetes typically only measure their glucose levels two to four times a day. Unfortunately, these time intervals are so far apart that people with diabetes often realize too late that they are experiencing hyperglycemia or hypoglycemia, which can sometimes lead to dangerous side effects. In fact, it is unlikely that people with diabetes will take timely SMBG values, nor is it likely that they will know if their blood glucose levels are rising (getting higher) or falling (getting lower) using conventional monitoring systems and methods.

[0005] Therefore, various non-invasive, transdermal (e.g., transcutaneous) and / or implantable electrochemical sensors have been developed to continuously detect and / or quantify blood glucose levels. These devices typically transmit raw or minimally processed data for subsequent analysis at remote devices, which may include displays. [Overview of the project] [Means for solving the problem]

[0006] Details of one or more implementations of the features described in this specification are shown in the attached drawings and the description below. Other features, embodiments, and advantages will become apparent from the description, drawings, and claims. Note that the relative dimensions in the following figures may not be drawn to a constant ratio.

[0007] According to one embodiment, a computer-based execution method includes receiving a signal from a sample sensor representing the host sample concentration and monitoring the signal. The computer-based execution method further includes determining whether there is a change in the signal and compensating for this change in the signal so that the signal display reflects the host sample concentration.

[0008] According to one embodiment, the method includes comparing the current clock time with a previously stored clock time after an interruption in the operation of the sensor measurement circuit of the sample sensor system. The method further includes synchronizing the current clock time with the previously stored clock time and incrementing a timestamp associated with EGV data transfer based on the previously stored clock time.

[0009] According to one embodiment, the system includes a sample sensor adapted for transmitting sample concentration data. The system further includes a sensor measurement circuit adapted for receiving sample concentration data from the sensor and detecting changes in the sample concentration data, the sensor measurement circuit compensating for fluctuations in the sample concentration data that exceed a predetermined threshold.

[0010] According to one embodiment, the sensor electronic device includes a processor and an offset circuit. The offset circuit is configured to apply an offset current to the received sample concentration signal that is affected by noise when the processor determines that noise is present.

[0011] According to one embodiment, the method includes a processor in a system operating under power supplied by a battery receiving one or more operating parameters associated with the battery. The method further includes monitoring the performance characteristics of the battery and determining whether the monitored performance characteristics deviate from a reference performance characteristic based on one or more received operating parameters. The method further includes wirelessly updating one or more operating parameters if it is determined that the monitored performance characteristics deviate from the reference performance characteristic.

[0012] According to one embodiment, the method includes receiving one or more operating parameters representing a battery profile in a processor controlling a sensor measurement circuit. The method further includes receiving boundary inputs based on one or more operating parameters and determining whether one or more received operating parameters fall within the range of the received input boundary. If it is determined that one or more received operating parameters fall outside the range of the received boundary input, the method further includes sending a notification to a user interface associated with the sensor measurement circuit that one or more operating parameters require updating.

[0013] According to one embodiment, the method includes determining the operation schedule information of a sample sensor system and identifying payload information associated with the operation. The method further includes calculating the operating frequency of a charge pump according to the payload and schedule information. The method further includes instructing the charge pump to operate at the calculated operating frequency during the occurrence of the operation.

[0014] Any feature of the embodiments specified herein is applicable to all other embodiments and forms identified herein. Furthermore, any feature of an embodiment can be combined in any way, in part or in whole, with any other embodiment described herein, for example, one, two, or three or more embodiments may be combined in whole or in part. Furthermore, any feature of an embodiment can be arbitrary with respect to any other embodiment. Any embodiment of a method can be performed by a system or apparatus of another embodiment, and any embodiment of a system can be configured to perform a method of another embodiment.

[0015] Detailed descriptions are provided with reference to the accompanying drawings. The drawings are provided solely for illustrative purposes and represent only typical or illustrative embodiments. These drawings are provided to facilitate the understanding of the systems and methods described herein and are not intended to limit the breadth, scope, or applicability of the various embodiments. [Brief explanation of the drawing]

[0016] [Figure 1] Figure 1 is a diagram illustrating a specific embodiment of an exemplary persistent sample sensor system communicating with at least one display device, according to the various technologies described herein. [Figure 2A] Figure 2A is a block diagram of the sensor electronic device module of the example continuous sample sensor system shown in Figure 1. [Figure 2B] Figure 2B shows a perspective view and a side view of the sensor electronic device module illustrated in Figure 2A. [Figure 2C] Figure 2C shows a perspective view and a side view of the sensor electronic device module illustrated in Figure 2A. [Figure 3] Figure 3 is a block diagram showing elements of an exemplary continuous sample monitoring system and display device communicating with each other, according to various embodiments of the present disclosure. [Figure 4A] Figure 4A is a flowchart illustrating exemplary operations performed for compensation for variations in the sample concentration signal according to various embodiments of the present disclosure. [Figure 4B] Figure 4B is a flowchart illustrating exemplary operations performed to detect variations in the sample concentration signal according to various embodiments of this disclosure. [Figure 4C] Figure 4C is a flowchart illustrating exemplary operations performed to determine the cause of fluctuations in the sample concentration signal according to various embodiments of this disclosure. [Figure 5A] Figure 5A illustrates the addition of sample concentration signals, noise, and offset current according to various embodiments of this disclosure. [Figure 5B] Figure 5B illustrates the addition of sample concentration signals, noise, and offset current according to various embodiments of this disclosure. [Figure 5C] Figure 5C illustrates the addition of sample concentration signals, noise, and offset current according to various embodiments of this disclosure. [Figure 5D]FIG. 5D illustrates the sample concentration signal and the addition of noise and offset current according to various embodiments of the present disclosure. [Figure 6] FIG. 6 is a flowchart showing an exemplary calibration operation to be performed according to various embodiments of the present disclosure. [Figure 7] FIG. 7 shows the implementation of a guard band according to various embodiments of the present disclosure. [Figure 8] FIG. 8 is a flowchart showing an exemplary clock resynchronization operation to be performed according to various embodiments of the present disclosure. [Figure 9A] FIG. 9A is a block diagram of battery-related aspects of the exemplary sensor electronic device module of FIG. 2A. [Figure 9B] FIG. 9B is a flowchart showing an exemplary operation to be performed to achieve a battery configuration according to various embodiments of the present disclosure. [Figure 9C] FIG. 9C is a flowchart showing an exemplary operation according to various embodiments of the present disclosure to determine potential battery problems, such as whether operating parameters are incorrectly input, using boundaries. [Figure 9D] FIG. 9D is a circuit diagram showing elements of an exemplary charge pump. [Figure 9E] FIG. 9E shows an exemplary output voltage with ripple associated with a charge pump according to various embodiments of the present disclosure. [Figure 9F] FIG. 9F shows an exemplary output voltage without ripple associated with a charge pump according to various embodiments of the present disclosure. [Figure 10] FIG. 10 is a block diagram of an exemplary computing module that can be used to implement various features of the embodiments described in the present disclosure.

MODE FOR CARRYING OUT THE INVENTION

[0017] The following description illustrates some exemplary embodiments of the technology disclosed in detail. Those skilled in the art will recognize that there are numerous variations and modifications of the disclosed embodiments that are included by their scope. Therefore, the description of specific exemplary embodiments should not be considered limiting to the scope of this disclosure.

[0018] overview The aforementioned continuous detection or quantification of blood glucose levels can be achieved using a continuous glucose monitor (CGM), which is one example of a continuous sample sensor. Specifically, a continuous sample sensor measures the concentration of a given sample (e.g., glucose) in a host, and the raw signal is generated by an electronic device associated with the continuous sample sensor (sometimes called a sensor electronic device module). The sensor electronic device module can be physically connected to the continuous sample sensor and includes an electronic device / sensor measurement circuit configured to process a data stream associated with the sample concentration measured by the continuous sample sensor in order to generate sensor information, including raw signal / raw sensor data, converted sensor data and / or any other sensor data derived therefrom, e.g., predictive or trend data. The sensor electronic device module can be further configured to generate sensor information customized for each display device, thereby allowing different display devices to receive different sensor information for presentation to the host, host caregiver, etc. Furthermore, the sensor electronic device module also includes one or more communication modules, such as a wireless transmitter, for transmitting the sensor information to the display device. The display device may include one or more communication modules for transmitting sensor information or other data, such as fault or error information (described in more detail below), to a remote server or database.

[0019] The above description assumes that a highly reliable and true raw signal is received by the sensor electronic device module. However, in some cases, failures or errors may occur, and the raw signal is no longer reliable or true. These failures or errors may be detectable by analysis of the signal, the clinical situation, or both. This allows for identification to be performed to distinguish it from the actual measured signal behavior, as well as from the corresponding signal processing that may change in accordance with the failure. Therefore, appropriate fault identification and corresponding processing techniques are used.

[0020] Failures or errors can occur in many ways, depending on whether they are related to the host's physiological activity, such as metabolic reactions, and / or because the in vivo portion of the continuous sample sensor settles into the host environment over time during use. They may also be transient events within the patient's control or related to the external environment surrounding the continuous sample sensor. Accordingly, various embodiments aim to detect failures or errors in the continuous sample sensor system and to implement one or more corrective / compensatory measures in response to the detected failures or errors, thereby providing the user of the sample sensor system with accurate sample measurement data. For example, according to various embodiments, it is possible to detect peculiar or abnormal changes or fluctuations in the signal representing the host sample concentration. Once detected, the cause of the signal change can be determined, and the signal change can be accounted for so that the host sample concentration is accurately represented.

[0021] As used herein, the term “specimen” is a broad term and should be given its ordinary and customary meaning to those skilled in the art (and not limited to any special or customized meaning), and further, though not limited, refers to a substance or chemical component in a biological fluid that can be analyzed (e.g., blood, tissue fluid, cerebrospinal fluid, lymph, or urine). A specimen may include naturally occurring substances, artificial substances, metabolites, and / or reaction products. In some embodiments, a specimen for measurement by a sensor head, device, and method is a specimen. However, other specimens are similarly intended, and are not limited to, the following: acarboxyprothrombin, acylcarnitine, adenine phosphoribosyl transferase, adenosine deaminase, albumin, alphafetoprotein, amino acid profiles (arginine (Krebs cycle), histidine / urocanic acid, homocysteine, phenylalanine / tyrosine, tryptophan), andrenostenedione, antipyrine, arabinitol enantiomer enantiomers), arginase, benzoylecgonine (cocaine), biotinidase, biopterin, C-reactive protein, carnitine, carnosinase, CD4, ceruloplasmin, chenodeoxycholic acid, chloroquine, cholesterol, cholinesterase, conjugated 1-β hydroxycholic acid, cortisol, creatine kinase, creatine kinase MM isoenzyme, cyclosporine AA) d-penicillamine, de-ethylchloroquine, dehydroepiandrosterone sulfate, DNA (acetylator polymorphism), alcohol dehydrogenase, alpha 1-antitrypsin, cystic fibrosis, Duchenne / Becker muscular dystrophy, analyte-6-phosphate dehydrogenase, hemoglobin A, hemoglobin S, hemoglobin C, hemoglobin D, hemoglobin E, hemoglobin F F), D-Punjab, beta-thalassemia, hepatitis B virus, HCMV, HIV-1, HTLV-1, Leber hereditary optic neuropathy, MCAD, RNA, PKU, Plasmodium vivax, sexual differentiation, 21-deoxycortisol), desbutylhalofantrine, dihydropteridine reductase, diphtheria / tetanus antitoxin, erythrocyte arginase, erythrocyte protoporphyrin, esterase D, fatty acid / acylglycine acids / acylglycines), free β-human chorionic gonadotropins (freeβ-human chorionic gonadotropin), free erythrocyte porphyrin, free thyroxine (FT4), free tri-iodothyronine (FT3), fumarylacetoacetase, galactose / gal-1-phosphate, galactose-1-phosphate uridyltransferase, gentamicin, analyte-6-phosphate dehydrogenase, glutathione, glutathione perioxidase, glycocholic acid, glycosylated hemoglobin hemoglobin, halofantrine, hemoglobin variants, hexosaminidase A, human erythrocyte carbonic anhydrase I, 17-alpha-hydroxyprogesterone, hypoxanthine phosphoribosyl transferase, immunoreactive trypsin, lactate, lead, lipoproteins ((a), B / A-1, 13), lysozyme, mefloquine, netilmicin, phenobarbital, phenytoin, phytanic / pristanic acidAcid, progesterone, prolactin, prolidase, purine nucleoside phosphorylase inhibitor, quinine, reverse triiodothyronine (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 pneumomae, myoglobin, Onchocerca volvulus, parainfluenza virus (virus), Plasmodium falciparum (Plasmodium falciparum)falciparum), poliovirus, Pseudomonas aeruginosa, respiratory syncytial virus (RSV), rickettsia (scrub typhus), Schistosoma mansoni, Toxoplasma gondii, Treponema pallidium, Trypanosoma cruzi / rangeli, vesicular stomatitis virus, Wuchereria bancrofti, yellow fever virus), specific antigens (hepatitis B virus) HIV-1 virus, succinylacetone, sulfadoxine, theophylline, thyrotropin (TSH), thyroxine (T4), thyroxine-binding globulin, trace elements, transferrin, UDP-galactose-4-epimerase, urea, uroporphyrinogen I synthase, vitamin A, white blood cells, zinc protoporphyrin(protoporphyrin). Salts, sugars, proteins, fats, vitamins, and hormones naturally present in blood or tissue fluid can also constitute a sample in certain embodiments. Samples may be naturally present in biological fluids, such as metabolites, hormones, antigens, antibodies, etc. Alternatively, samples may be introduced into the body and include, but are not limited to, contrast agents for imaging, radioisotopes, chemical agents, fluorocarbon-based synthetic blood, or drug or pharmaceutical compositions: Insulin, ethanol, cannabis (marijuana, tetrahydrocannabinol, hashish), inhalants (nitrous oxide, amyl nitrite, butyl nitrite, chlorohydrocarbons, hydrocarbons), cocaine (crack cocaine) 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) (acid), mescaline, peyote, psilocybin), narcotics (heroin, codeine, morphine, opium, meperidine, Percocet, Percodan, Tussionex, fentanyl, Darvon, Talwin, Lomotil), synthetic narcotics (designer)Drugs (fentanyl, meperidine, amphetamines, methamphetamines, and phencyclidine (e.g., analogues of ecstasy)), muscle-building agents (anabolic steroids), and nicotine. Metabolites of drugs and pharmaceutical compositions are also intended subjects. Samples of neurochemicals and other chemicals generated within the body can also be analyzed, such as ascorbic acid, uric acid, dopamine, norepinephrine, 3-methoxytyramine (3MT), 3,4-dihydroxyphenylacetic acid (DOPAC), homovanillic acid (HVA), 5-hydroxytryptamine (5HT), and 5-hydroxyindoleacetic acid (FHIAA).

[0022] In some embodiments, a system is provided for the continuous measurement of a host sample, comprising a continuous sample sensor configured to continuously measure the concentration of a host sample, and a sensor electronic device module physically connected to the continuous sample sensor to receive the sample concentration measurements and transmit them to a display device. In particular, the sensor electronic device module includes electronics configured to process a data stream associated with the sample concentration, measured by the continuous sample sensor, and generating sensor information, including raw sensor data, converted sensor data, and / or any other sensor data or data derived therefrom, such as predictive or trend data. The sensor electronic device module may be further configured to generate sensor information customized for each display device, thereby allowing different display devices to receive different sensor information for display on the host, host caregiver, etc. Furthermore, the sensor electronic device module also includes one or more communication modules, such as a wireless transmitter, for transmitting the sensor information to the display device.

[0023] As used herein, the terms “raw data,” “raw data stream,” “raw data signal,” “data signal,” and “data stream” can refer to an analog or digital signal from a continuous sample sensor associated with a measured sample, but are not limited to these terms. For example, the raw data stream provided by a continuous sample sensor to a sensor electronic device module may be digital data of “counts” converted by an A / D converter from an analog signal (e.g., voltage or current) representing sample concentration, which may include a number of time-interval data points from a substantially continuous sample sensor, each containing individual measurements acquired at time intervals ranging from fractions of a second to, for example, one minute, two minutes, or five minutes or more. In some embodiments, the raw data / count may represent sensor information accumulated or averaged over a period of time (e.g., five minutes). Furthermore, the term “count” can refer to a unit of measurement of a digital signal. For example, the raw data stream or raw data signal measured in counts may be associated with a voltage (e.g., converted by an A / D converter), which is directly associated with a current from a working electrode (described in more detail later).

[0024] In some embodiments, the sensor electronics module may be configured to search for a display device and / or attempt to communicate with a display device wirelessly. In some embodiments, the search for a display device and / or the attempt to communicate with it wirelessly may occur in a predetermined and / or programmable order (e.g., gradually and / or stepwise). It should be noted that the sensor electronics module is not necessarily tied to a single display device. Rather, the sensor electronics module may be configured to communicate with multiple different display devices, in any way that may be directly, systematically, simultaneously (e.g., via broadcast), regularly, periodically, randomly, on demand, in response to inquiries, based on alerts or alarms, and / or similar forms.

[0025] Depending on the embodiment, the sensor electronic device module receives sensor information from a continuous sample sensor. This sensor information may be raw data received and processed by a display device, for example, by one or more algorithms, in order to generate and / or display estimated sample values. In the context of continuous glucose monitoring, the estimated sample values ​​may be estimated glucose value (EGV) data. For example, some display devices may include display commands (software programming that includes commands configured to display sensor information and optionally query the sensor electronic device module to obtain displayable sensor information) that are configured to enable the display of displayable sensor information on them.

[0026] In other embodiments, processing of raw data can be performed in the sensor electronic device module. That is, the necessary algorithms, software, and / or other processing functionalities for converting raw data into estimated sample value data can be implemented in the sensor electronic device module rather than in the display device. Converting raw data in the sensor electronic device module can avoid the possibility of inconsistent estimated sample value data due to inconsistent calibration between two or more display devices, for example. Furthermore, implementing this functionality in the sensor electronic device module can deter third-party display device / drug delivery device providers from tampering with or modifying the processing algorithms and software.

[0027] In some embodiments, a particular display device may communicate directly wirelessly with the sensor electronic device module, although intermediate network hardware, firmware, and / or software may be included in the direct wireless communication. In some embodiments, a repeater (e.g., a Bluetooth® repeater) can be used to retransmit the transmitted sensor information to a location far beyond the adjacent range of the telemetry module of the sensor electronic device module. In some embodiments, a receiver (e.g., a Bluetooth® receiver) can be used to retransmit the transmitted sensor information to a display device (e.g., a television screen) in possibly a different format, such as a text message.

[0028] In some embodiments, one or more display devices are configured to query a sensor electronic device module for sensor information, where the display devices request sensor information from the sensor electronic device module in an "on-demand" manner, for example, by answering the query. In some embodiments, the sensor electronic device module is configured for periodic, systematic, regular, irregular, or aperiodic transmission of sensor information to one or more display devices (e.g., every minute, two minutes, five minutes, or ten minutes or more). In some embodiments, the sensor electronic device module is configured to transmit data packages associated with triggered alerts (e.g., triggered by one or more alert conditions). However, any combination of the above-described states of data transfer can be performed by any combination of sensor electronic device modules and display devices.

[0029] Exemplary configuration of a continuous sample monitoring system Sample sensors, such as glucose sensors, can be any device capable of measuring the concentration of a sample. One exemplary embodiment, described later, utilizes a portable glucose sensor. However, it should be understood that the devices and methods described herein can be applied to any device capable of detecting a substance representing glucose concentration or the concentration or presence of another sample and outputting an output signal representing glucose concentration.

[0030] In some embodiments, the glucose sensor is a continuous device, e.g., subcutaneous, transdermal, non-invasive, intraocular, and / or intravascular (e.g., intravenous) device. In some embodiments, multiple intermittent blood samples can be analyzed. The glucose sensor can be used with any glucose measurement method, including enzymatic, chemical, physical, electrochemical, optical, photochemical, fluorescence-based, spectrophotometric, spectroscopic (e.g., optical absorption spectroscopy, Raman spectroscopy, etc.), polarization measurement, calorimetry, iontophoresis, radiometric analysis, and the like.

[0031] Glucose sensors can utilize any known detection method, including invasive, minimally invasive, and non-invasive detection techniques, to provide a data stream representing the concentration of the host sample. The data stream, as described above, is generally a raw data signal used to provide useful values ​​of the sample to users, such as patients or healthcare professionals (e.g., physicians), who may be using the sensor.

[0032] In one preferred embodiment, the sample sensor is an implantable glucose sensor, such as that described, for example, in U.S. Patent No. 6,001,067 and U.S. Patent Publication No. 2005 / 0027463. In another preferred embodiment, the sample sensor is a transdermal glucose sensor, such as that described, for example, in U.S. Patent Publication No. 2006 / 0020187. In yet another embodiment, the sensor is configured to be implanted in the host's blood vessels or tissue, such as those described, for example, in U.S. Patent Publication No. 2007 / 0027385, U.S. Patent Publication No. 2008 / 0119703, U.S. Patent Publication No. 2008 / 0108942 and U.S. Patent Publication No. 2007 / 0197890. In one yet another embodiment, the sustained glucose sensor includes a transdermal sensor, such as that described, for example, in U.S. Patent No. 6,565,509. In other alternative embodiments, the sustained glucose sensor includes, for example, a subcutaneous sensor as described in U.S. Patent No. 6,579,690 or U.S. Patent No. 6,484,046. In other alternative embodiments, the sustained glucose sensor includes, for example, a refillable subcutaneous sensor as described in U.S. Patent No. 6,512,939. In other alternative embodiments, the sustained glucose sensor includes, for example, an intravascular sensor as described in U.S. Patent No. 6,477,395. In other alternative embodiments, the sustained glucose sensor includes an intravascular sensor as described in U.S. Patent No. 6,424,847.

[0033] Figure 1 is a diagram illustrating an exemplary continuous sample monitoring system 100, which includes a sample sensor system 124 operationally connected to a host 120 and a plurality of display devices 134a-e according to a particular aspect of this disclosure. It should be noted that the display device 134e may, instead of being a display device, or in addition to being a display device, be a drug delivery device that can work with the sample sensor system 124 to deliver drugs to the host 120. The sample sensor system 124 may include a sensor electronic device module 126 and a continuous sample sensor 122 associated with the sensor electronic device module 126. The sensor electronic device module 126 may communicate directly wirelessly with one or more of the plurality of display devices 134a-e via wireless communication signals. As detailed below, the display devices 134a-e may also communicate with the sample sensor system 124 between themselves and / or through each other. For convenience of reference, the wireless communication signals from the sample sensor system 124 to the display devices 134a-e may be referred to as “uplink” signals 128. For example, wireless communication signals from display devices 134a to e to the sample sensor system 124 may be called "downlink" signals 130. Wireless communication signals between two or more display devices 134a to e may be called "crosslink" signals 132. In addition, wireless communication signals may include data transmitted by one or more display devices 134a to d to one or more remote servers 140 or network entities, such as cloud-based servers or databases, via "long-range" uplink signals 136 (e.g., cellular signals), and can receive long-range downlink signals 138 transmitted by the remote servers 140.

[0034] The sensor electronic device module 126 includes a sensor electronic device configured to process sensor information and generate converted sensor information. In one embodiment, the sensor electronic device module 126 includes electronic circuitry including an expected algorithm related to processing and calibrating continuous sample sensor data, which is associated with measuring and processing data from the continuous sample sensor 122. The sensor electronic device module 126 can be integrated with (non-removably mounted) the continuous sample sensor 122 or removable, to achieve a physical connection between them. The sensor electronic device module 126 may include hardware, firmware, and / or software that enables sample-level measurement. For example, the sensor electronic device module 126 may include a potentiostat, a power supply for supplying power to the continuous sample sensor 122, other components for signal processing and data storage, and a telemetry module for transmitting data from itself to one or more display devices 134a-e. The electronic device can be fixed to a printed circuit board (PCB) or the like and can take on various forms. For example, electronic devices can take the form of integrated circuits (ICs), such as application-specific integrated circuits (ASICs), microcontrollers, and / or processors. Examples of systems and methods for processing sensor sample data are described in more detail herein and in U.S. Patents 7,310,544 and 6,931,327, as well as U.S. Patent Publications 2005 / 0043598, 2007 / 0032706, 2007 / 0016381, 2008 / 0033254, 2005 / 0203360, 2005 / 0154271, 2005 / 0192557, 2006 / 0222566, 2007 / 0203966, and 2007 / 0208245, all of which are incorporated herein by reference for all purposes.

[0035] The display devices 134a-e are configured to display drug delivery, communicate alarms, and / or provide justification for sensor information transmitted by the sensor electronic device module 126 (for example, in customized data packages transmitted to one or more display devices 134a-e based on their respective preferences). Each display device 134a-e may include a display, such as a touchscreen display, for showing sensor information to a user (often a host 120 or a caregiver / healthcare professional) and / or receiving input from the user. In some embodiments, the display devices 134a-e may include other types of user interfaces, such as a voice user interface that replaces or adds to the touchscreen display for communicating sensor information to the user of the display devices 134a-e and / or receiving user input. In some embodiments, one, some, or all of the display devices 134a-e are configured to display or transmit sensor information as it is transmitted from the sensor electronic device module 126 (for example, in data packages transmitted to each of the display devices 134a-e) without any additional foresight processing required for calibration and real-time display of the sensor information.

[0036] In the embodiment shown in Figure 1, one of the plurality of display devices 134a-e may be a custom-made display device 134a specifically designed to show a particular type of displayable sensor information (e.g., numerical values ​​and arrows in some embodiments) associated with sample values ​​received from the sensor electronic device module 126. In some embodiments, one of the plurality of display devices 134a-e may be a portable device 134c such as a mobile phone or palmtop computer based on the Android, iOS operating system or other operating system, where the portable device 134c may have a relatively larger display and may be configured to show a graphic display of continuous sensor data (e.g., including current and historical data). Other display devices may include a tablet 134d, a smartwatch 134b, a drug delivery device 134e, a blood glucose meter and / or other portable devices such as a desktop or laptop computer.

[0037] As described above, since the different display devices 134a to e provide different user interfaces, the content of the data package (e.g., the amount, format, and / or type of data to be displayed, alarms, etc.) can be customized for each specific display device and / or display device type (e.g., programmed differently by the manufacturer and / or by the end user). Accordingly, in the embodiment of Figure 1, one or more of the display devices 134a to e can communicate wirelessly, directly or indirectly, with the sensor electronic device module 126, enabling multiple different types and / or levels of display and / or functionality related to sensor information, which are described in further detail elsewhere herein.

[0038] Continuous sample sensor Typically, the continuous sample sensor 122 may also be an implantable sample (e.g., glucose) sensor that measures glucose concentration using current-measuring electrochemical sensor technology. The electrode comprising the continuous sample sensor 122 may include a working electrode, a counter electrode, and a reference electrode. In embodiments, a counter electrode is provided to balance the current generated by the species being measured at the working electrode. In the case of a glucose oxidase-based glucose sensor, the species being measured at the working electrode is H2O2. Glucose oxidase catalyzes the conversion of oxygen and glucose to hydrogen peroxide and gluconate according to the following reaction: Glucose + O2 Gluconate + H2O2

[0039] Since there is a proportional change in the product H2O2 for each glucose molecule metabolized, the glucose concentration can be determined by monitoring the change in H2O2. The oxidation of H2O2 by the working electrode balances the reduction of ambient oxygen, enzyme-generated H2O2, or other depletable species at the counter electrode. Furthermore, the H2O2 produced from the glucose oxidase reaction reacts at the surface of the working electrode to produce two protons (2H+), two electrons (2e), and one oxygen molecule (O2).

[0040] In some other embodiments, additional electrodes may be included in the assembly, for example, in a three-electrode system (operating, reference, and counter electrodes) and an additional working electrode (for example, configured as a basic subtractive electrode or an electrode that can be used to generate oxygen, configured for measuring an additional sample). U.S. Patent No. 7,081,195, U.S. Patent Publication No. 2005 / 0143635, and U.S. Patent Publication No. 2007 / 0027385, respectively, are cited herein by reference and describe several systems and methods for implementing and using additional working electrodes, counter electrodes, and reference electrodes. In some embodiments where two or more working electrodes are provided, the second working electrode may be configured to be substantially similar to the first working electrode but placed on top of it without enzymes. In this way, the basic signal can be determined and subtracted from the first signal to produce a difference signal, i.e., a signal of glucose only that is substantially unaffected by fluctuations of basic or interfering species in the signal, as described, for example, in U.S. Patent Publication Nos. 2005 / 0143635, U.S. Patent Publication Nos. 2007 / 0027385, U.S. Patent Publication Nos. 2007 / 0213611 and U.S. Patent Publication Nos. 2008 / 0083617, which are incorporated herein by reference in their entirety.

[0041] Sensor electronic device module Figure 2A is a block diagram illustrating an embodiment of the sensor electronic device module 126 (Figure 1). The sensor electronic device module 126 may include an application-specific integrated circuit (ASIC) 205, a user interface 222, a temperature sensor 252, a motion sensor 254, a body sensor 256, and a clock 258. The ASIC 205 may also be coupled with a communication port 238 and a battery 234. Although Figure 2A shows the ASIC 205 including many electronic circuit components, the ASIC 205 can be replaced with any suitable logic device, such as a field-programmable gate array (FPGA), a microprocessor, an analog circuit, or one or more other digital and / or analog circuits. Furthermore, the ASIC 205 may include one or more additional mechanisms of the sensor electronic device module 126 as described elsewhere herein, or one or more features illustrated in Figure 2A as part of the ASIC, such as the telemetry module 208, potentiostat 210, offset / calibration module 232, data storage memory 220, and clock 258, may be separated from the ASIC.

[0042] In this embodiment, a potentiostat 210 (one embodiment of the analog front end (AFE)) is coupled to the persistent sample sensor 122, for example via a data line 212, to receive sensor information acquired / measured by the persistent sample sensor 122. In some embodiments, the potentiostat 210 biases the persistent sample sensor 122 by supplying a voltage to it via the data line 212, enabling the measurement of a current value representing the sample concentration of the host (also called the analog portion). The potentiostat 210 may have one channel or multiple channels (and corresponding one or more data lines 212), for example, depending on the number of working electrodes. In some embodiments, the potentiostat 210 includes a resistor (not shown) that converts current to voltage. In some embodiments, a current-to-frequency converter is provided, for example, configured to continuously accumulate current measured using a charge counter. In some embodiments, an A / D converter digitizes the analog signal into a "count" (as described above) for processing. Therefore, the counts in the resulting raw data stream can be directly correlated to the current measured by the potentiostat 210.

[0043] The processor 214 controls the processing of the sensor electronic device module 126. In some embodiments, the processor 214 is formed as part of a custom chip such as an ASIC; however, a computer system other than an ASIC can be used to process the data as described herein; for example, a microprocessor can be used for some or all of the processing of the sensor electronic device module. The processor 214 typically provides program memory 216, which provides semi-permanent storage of data, such as stored data such as sensor identifiers (IDs), and programming for processing the data stream (e.g., filtering, calibration, fail-safe testing, etc.). The processor 214 can also be used for cache memory of the continuous sample monitoring system 100, for example, to temporarily store recent sensor data. In some embodiments, the processor 214 includes storage components such as ROM, RAM, dynamic RAM, static RAM, non-static RAM, EEPROM, rewritable ROM, and flash memory. In one embodiment, RAM 218 can be used for cache memory of the continuous sample monitoring system 100, for example, to temporarily store recent sensor information.

[0044] In some embodiments, the processor 214 includes a digital filter, such as an infinite or finite impulse response (IIR or FIR) filter, configured to smooth the raw data stream from the AID converter. Typically, the digital filter is programmed to filter data sampled at predetermined time intervals (also called the sample rate). In some embodiments, these time intervals determine the sample rate of the digital filter, for example, when the potentiostat 210 is configured to measure a sample at separate time intervals. In some other embodiments, when the potentiostat 210 is configured to measure a sample continuously, for example using a current-versus-frequency converter, the processor 214 can be programmed to request a digital value from an integrator at predetermined time intervals, also called the acquisition time. In these other embodiments, the value acquired by the processor 214 can be averaged over the acquisition time, which should be given to the persistence of the current measurement. Thus, the acquisition time determines the sample rate of the digital filter.

[0045] In one embodiment, the processor 214 can be further configured to generate data packages for transmission to one or more display devices. Furthermore, the processor 214 can also generate data packets for transmission to these external sources, for example, via telemetry. As described above, the data packages can be customized for each display device 134a-e and may include any available data such as sensor information with customized and / or converted sensor data, sensor / sensor electronic device module ID codes, raw data, filtered data, calibrated data, rate of change information, trend information, error detection or correction, and / or the like.

[0046] The data storage memory 220 is operably connected to the processor 214 and configured to store various sensor information. In some embodiments, the data storage memory stores, for example, continuous sample sensor data for 1 day, 5 days, 9 days, 14 days, 15 days, 20 days, 30 days or more. In some embodiments, the data storage memory 220 stores sensor information such as raw sensor data (one or more raw sample concentration values), calibrated data, filtered data, converted sensor data and / or any other displayable sensor information. Although separate data storage memory 220 and program memory 216 are shown in Figure 2A, those skilled in the art will recognize various configurations including one or more memories that provide the necessary storage space to support data processing and required memory for the sensor electronic device module 126.

[0047] The telemetry module 208 is operably connected to the processor module 214 and provides hardware, firmware, and / or software that enables wireless communication between the sensor electronic device module 126 and one or more display devices 134a-e. Various wireless communication technologies that can be implemented with the telemetry module 208 include radio frequency (RF), infrared (IR), Bluetooth®, Bluetooth® Low Energy (BLE), spread spectrum communication schemes, frequency hopping communication, Zigbee, IEEE 802.11 / 802.16, wireless (e.g., cellular) telecommunications, paging network communication, near-field communication (NFC), radio frequency identification (RFID) magnetic induction, satellite data communication, GPRS, ANT, and / or similar. In one preferred embodiment, the telemetry module 208 includes a Bluetooth® chip. In some embodiments, Bluetooth® technology is implemented in combination with the telemetry module 208 and the processor 214.

[0048] Battery 234 is operationally connected to the processor 214 (and possibly other components of the sensor electronics module 126) and provides the necessary power to the sensor electronics module 126. In some embodiments, the battery is a manganese-lithium battery, but any battery of appropriate size and power can be used (e.g., AAA, nickel-cadmium, zinc-carbon, alkali group, lithium, nickel metal hydride, lithium-ion, zinc-air, zinc-mercury oxide, silver-zinc, or sealed). In some embodiments, battery 234 is rechargeable. In some embodiments, multiple batteries can be used to power the system. In some embodiments, battery 234 may be a custom-made battery having one or more customized sizes, shapes and / or capacities optimized for the sensor electronics module 126, and including reduced-capacity batteries if the sensor electronics module 126 has low energy requirements.

[0049] It should be noted that the battery 234 can be connected to or incorporated into a printed circuit board assembly (PCBA) (on which one or more components of the sensor electronic device module 126 are placed) using flexible electronic devices or flexible circuit technology. The use of flexible circuit technology eliminates the need for rigid soldering of the battery 234 onto the PCBA, which was previously required, allowing the battery 234 to be positioned more freely, which in turn allows for greater flexibility in terms of the shape and size reduction of the sensor electronic device module 126. Furthermore, during conventional installation of the battery onto the PCBA, the battery is usually rigidly soldered onto the PCBA and then epoxy-coated. Because the battery may have different thermal properties than the surrounding circuitry, heating of the battery during the epoxy process can cause deflection of the PCBA and / or other components installed on it. In contrast, the use of flexible circuit technology allows the battery 234 to move during the epoxy curing process without affecting the surrounding circuitry.

[0050] The charger and / or regulator 236 may be configured to receive energy from an internal and / or external charger. In some embodiments, the battery regulator (or balancer) 236 adjusts the charging process by bleeding off excess charge current, allowing all cells of the sensor electronics module 126 or the battery 234 to be fully charged without overcharging other cells or batteries. In some embodiments, the battery (or multiple battery) 234 is configured to be charged via an inductive and / or wireless charging pad. Those skilled in the art are aware of various known methods for charging batteries, which may be implemented in the systems described herein, including wired connections (cables / plugs) and wireless methods.

[0051] One or more communication ports 238 (also called external connectors) are provided to enable communication with other devices, for example, a PC communication (com) port, which enables communication with a system that is separate from or integrated with the sensor electronic device module 126. The communication ports may include, for example, a serial (e.g., general-purpose serial bus, i.e., "USB") communication port, which enables communication with another computer system (e.g., a PC, smartphone, personal portable information device, i.e., "PDA", server, or similar). In one embodiment, the sensor electronic device module 126 can transmit data to a separate computing device for retrospective analysis of historical data by the patient and / or physician.

[0052] Environmental sensors can also be utilized in various embodiments. For example, a temperature sensor, such as temperature sensor 252, can be used to measure the temperature of the host 120 and / or the sensor electronic device module 126. A motion sensor 254 can sense or determine changes in the host 120 to which the persistent sample sensor 122 is implanted or operationally connected. A pressure sensor 256 can be used to detect pressure on the persistent sample sensor 122 and / or pressure on adjacent tissue. It should be noted that more, for example, other types of sensors or fewer sensors can be implemented in various embodiments to sense or detect changes associated with the host and / or persistent sample system, which may cause one or more fluctuations or changes in the signal.

[0053] The clock 258 can control the speed at which the processor 214 executes instructions. As will be described later, the speed of the clock 258 can be set as needed. Furthermore, the offset / calibration module 232 can be a circuit / logic component used to provide an offset current when measuring current / count to shift the received signal in the potentiostat 210, and to calibrate the potentiostat 210 for that additional offset current. In one embodiment, the offset current can also be adjusted by the offset / calibration module 232.

[0054] In conventional continuous sample sensor systems, the skin contact portion of the sensor electronics is generally simplified to minimize the complexity and / or size of the electronics on the skin, providing, for example, only raw, calibrated, and / or filtered data to display devices 134a-e configured to perform calibration and other algorithms required to display sensor information. In contrast, the sensor electronics module 126 performs prospective algorithms used to generate converted sensor data and / or displayable sensor information, which include, for example, evaluating the clinical acceptability of criteria and / or sensor data, evaluating calibration data for best calibration based on inclusion criteria, evaluating the quality of calibration, comparing estimated sample values ​​over time to corresponding measured sample values, analyzing variability of estimated sample values, evaluating the stability of the sensor and / or sensor data, detecting signal artifacts (noise), replacing signal artifacts, determining the rate of change and / or trend of sensor data, performing dynamic and intelligent sample value estimation, performing diagnoses on the sensor and / or sensor information, and setting the operating mode. This involves evaluating data for deviations and / or doing the same, which are described in more detail in U.S. Patent Nos. 7,310,544, 6,931,327, U.S. Patent Publication Nos. 2005 / 0043598, 2007 / 0032706, 2007 / 0016381, 2008 / 0033254, 2005 / 0203360, 2005 / 0154271, 2005 / 0192557, 2006 / 0222566, 2007 / 0203966 and 2007 / 0208245, each of which is fully incorporated herein by reference. Furthermore, the sensor electronic device module 126 is configured to store the converted sensor data (e.g., estimated sample values, trend information) and transmit the sensor information to multiple different display devices 134a to e.In some embodiments, the display device is configured to show the sensor information as received from the sensor electronic device module 126 without any additional sensor data processing.

[0055] The user interface 222 may include various interfaces such as one or more buttons 224, a liquid crystal display (LCD) 226, a vibrator 228, an audio transducer (e.g., a speaker) 230, a backlight (not shown), and / or similar. The component including the user interface 222 can provide control for interacting with a user (e.g., a host). One or more buttons 224 may enable, for example, toggle operations, menu selection, option selection, state selection, yes / no responses to on-screen questions, a "stop" function (e.g., for alarms), a "recognize" function (e.g., for alarms), reset, and / or similar. The LCD 226 may provide the user with, for example, visual data output. The audio transducer 230 (e.g., a speaker) may provide an audible signal in response to the activation of specific alerts, such as current and / or predicted hyperglycemia and hypoglycemia conditions.

[0056] Figures 2B and 2C are perspective and side views of a specimen sensor system 124 including a mount unit 240 and an attached sensor electronic device module 126 in several embodiments, showing their functional position and including the mount unit and sensor electronic device module that mate and engage inside. In some embodiments, the mount unit 240, also called a housing or sensor pod, includes a base 242 that is adapted to be fixed to the epidermis of a host. The base 242 can be formed from a variety of rigid or flexible materials and preferably includes a thin base to minimize the protrusion of the specimen sensor system 124 from the host 120 during use. In some embodiments, the base 242 is formed from at least a flexible material, which is considered to offer numerous advantages over conventional transcutaneous sensors, which can unfortunately have the drawback of motion-related artifacts associated with the movement of the host 120 when the host 120 is using the specimen sensor system 124. The mounting unit 240 and / or the sensor electronic device module 126 can be placed on the sensor insertion site to protect the site and / or achieve a minimum footprint (utilizing the surface area of ​​the host's epidermis).

[0057] In some embodiments, a detachable connection is provided between the mount unit 240 and the sensor electronic device module 126, thereby improving manufacturability, i.e., when the persistent sample sensor 122 is replaced after its service life, the relatively inexpensive mount unit 240 can be discarded while the relatively more expensive sensor electronic device module 126 can be reused. In some preferred embodiments, the sensor electronic device module 126 is configured by signal processing (programming) and consists of, for example, filtering, calibration and / or other algorithms that are useful for calibrating and / or displaying sensor information, as mentioned above. However, an integrated (non-detachable) sensor electronic device module 126 can be configured according to other embodiments.

[0058] In some embodiments, the contact 244 is mounted on or within a subassembly hereinafter referred to as the contact subassembly 246, which is configured to fit within the base 242 of the mounting unit 240 and a hinge 248, the hinge 248 enabling the contact subassembly 246 to rotate axially between a first position (for insertion) and a second position (for use) relative to the mounting unit 240. The term “hinge” as used herein is a broad term and is used in its usual sense to refer to any various axial rotation, articulation and / or hinge mechanism (e.g., adhesive hinge, sliding joint, etc.), but is not limited thereto, and the term hinge does not necessarily mean a fulcrum or fixed point from which articulation occurs. In some embodiments, the contact 244 is formed from a conductive elastomer material such as carbon black elastomer, thereby extending the persistent sample sensor 122.

[0059] In certain embodiments, the mount unit 240 includes an adhesive pad 250, which includes a removable support layer, located on the back of the mount unit 240. Thus, the mount unit 240 is attached to the epidermis of the host 120 by removing the support layer and pressing the base portion 242 of the mount unit 240 onto the epidermis of the host 120. In addition, or alternatively, the adhesive pad 240 can be positioned over part or all of the specimen sensor system 124 after the insertion of the persistent specimen sensor 122 is complete to ensure adhesion and optionally ensure an airtight or watertight seal around the wound exit site (or insertion site) (not shown). A suitable adhesive pad can be selected or designed to widen, stretch, adapt, and / or allow ventilation of the site (e.g., the epidermis of the host 120). Embodiments described with respect to Figures 2B and 2C are described in further detail with reference to U.S. Patent No. 7,310,544, which is incorporated herein by reference.

[0060] Wireless communication Figure 3 is a block diagram showing exemplary components of a sample sensor system 124, at least one of a plurality of display elements 134a, and communication between them. The sample sensor system 124 may include a portable persistent sample sensor 312 (one embodiment of the persistent sample sensor 122 in Figure 1) coupled to a sensor measurement circuit 310 for processing and managing sensor data. The sensor measurement circuit 310 may be coupled to a processor 314 (part of the sensor electronics module 126 in Figure 1). In some embodiments, the processor 314 may perform some or all of the functions of the sensor measurement circuit 310 for acquiring and processing sensor measurements from the portable persistent sensor 312. The processor may further be coupled to a wireless unit or transceiver 316 (part of the sensor electronics module 126 in Figure 1, which may be a telemetry module 232 in one embodiment) for transmitting sensor information to an external device, such as a display device 134a used to show or provide sensor information to a user, and for receiving requests and commands from that external device. As used herein, the terms “wireless unit” and “transceiver” are interchangeable and generally refer to a device capable of wirelessly transmitting and receiving data. Such data transmission and reception further include the use of antenna 324. It should be noted that multiple antennas may be available in the specimen sensor system 124. The specimen sensor system 124 may further include a memory 318 (which is also part of the sensor electronic device module 126 in Figure 1) and a real-time clock (RTC) 320 (an illustrative embodiment of clock 205 in Figure 2A) for storing and tracking sensor information. In some embodiments, the specimen sensor system 124 further includes near-field communication (NFC) functionality. In some embodiments, an NFC tag 322 is mounted / integrated into the electronic device of the specimen sensor system 124 or incorporated, for example, into a housing or mounting unit 240. Although not explicitly shown, the NFC tag 322 may be included as part of a transceiver 316, making the transceiver 316 a “high-performance transceiver”.

[0061] A wireless communication protocol can be used to transmit and receive data between the sample sensor system 124 and the display device 134a. The wireless communication protocol used can be designed for use in wireless sensor networks, optimized for periodic and small-volume data transmission (which can be transmitted at a low rate if necessary) between multiple devices over short distances (e.g., a personal area network (PAN)). For example, a wireless communication protocol can be optimized for periodic data transfer where a transceiver can transmit data over short intervals and then enter a low-power mode for longer intervals. The wireless communication protocol can have low overhead requirements and reduce power consumption, both for normal data transfer and for initially setting up the communication channel (e.g., by reducing header overhead). In some embodiments, a burst broadcast scheme (e.g., one-way communication) can be used. This eliminates the overhead required for acknowledgment signals and enables periodic transmission with almost no power consumption.

[0062] The wireless communication protocol can be further configured to establish communication channels with multiple display devices, for example, two or more display devices 134a-e, while simultaneously implementing interference avoidance schemes. In some embodiments, the wireless communication protocol can utilize an adaptive isochronous network topology that defines various time slots and frequency bands for communication with some of the display devices 134a-e. The wireless communication protocol can thus modify the transmission window and frequency in response to interference and to support communication with multiple display devices 134a-e. Accordingly, the wireless protocol can use a time and frequency division multiplexing (TDMA) based scheme. The wireless communication protocol can also use direct spread spectrum (DSSS) and frequency hopping spread spectrum schemes. Various network topologies can be used to support short-range and / or low-power wireless communications such as peer-to-peer, start, tree, or mesh network topologies (e.g., WiFi, Bluetooth®, and Bluetooth® Low Energy (BLE)). The wireless communication protocol can operate in various frequency bands, for example, open ISM bands such as 2.4 GHz. Furthermore, to reduce power consumption, the wireless communication protocol can be configured to optimally configure the data rate according to power consumption. A corresponding antenna 340, like the antenna 324 of the sample sensor system 124, is used in the display device 134a for transmitting / receiving data to and from the sample sensor system 124. Additionally, one or more antennas can be used in addition to antenna 340 to enable the various aforementioned communication protocols to operate at their required frequencies / frequency ranges.

[0063] The display device 134a can be used to alert a user, such as a host 120, and provide sensor information, and may include a processor 330 for processing and managing the sensor information. The display device 134a may include a display 332, a memory 334, and a real-time clock 336 for displaying, storing, and tracking the sensor information, respectively. The display device 134a may further include a wireless unit or transceiver 338 for receiving sensor information and for transmitting requests, commands, and data to the sample sensor system 124. The transceiver 338 may further use a wireless communication protocol. The memory 334 may also be used to store an operating system and / or custom (e.g., proprietary) application designed for wireless data communication between a transceiver, such as a transceiver 316, and the display device 134a. The memory 334 may be a single memory device or multiple memory devices, and may be volatile or non-volatile memory for storing data and / or instructions for software programs and applications. Instructions can be executed by the processor 330 to control the transceiver 338.

[0064] In the case of the display device 134e, which may be a drug delivery device in addition to or instead of a display device, it should be understood that alerts and / or sensor information provided by the persistent sample sensor 122 facing the sensor electronic device module 126 can be used to initiate and / or adjust drug delivery to the host 120.

[0065] In some embodiments, when a standardized communication protocol is used, commercially available transceiver circuits incorporating processing circuits for handling low-level data communication functions such as data encoding, transmission frequency, and handshake protocol management can be utilized. In these embodiments, processors 314 and 330 do not need to manage these tasks, but rather provide desired data values ​​for transmission and manage high-level functions such as power increases and decreases and message transmission rates. Instructions and data values ​​for performing these high-level functions can be provided to transceiver circuits 316 and 338, respectively, via data buses and transfer protocols established by the manufacturers of transceiver circuits 316 and 338.

[0066] Components of the sample sensor system 124 may require periodic replacement. For example, the portable continuous sample sensor 312, which can be mounted on the sensor electronic device module 126 containing the sensor measurement circuit 310, processor 314, memory 318, and transceiver 316, and the battery (not shown) may require periodic replacement (e.g., every 7 to 30 days). The sensor electronic device module 126 can be configured to remain powered and operational for considerably longer periods than the portable continuous sample sensor 312 (e.g., 3 months, 6 months, or beyond) until the battery requires replacement. Replacing these components can be difficult and may require the assistance of a trained worker. Reducing the need for replacement of such components, including the battery where replaceable, would greatly improve the convenience of the sample sensor system 124 for the host 120.

[0067] When the sensor electronic device module 126 is used for the first time (or, in some cases, after the battery is replaced and it is restarted), it can connect to the portable persistent sample sensor 312. Furthermore, as will be described later, there may be a way to initially establish communication between the display device 134a and the sensor electronic device module 126 when it is used for the first time or restarted (e.g., when the battery is replaced). Once the display device 134a and the sensor electronic device module 126 have established communication, they can communicate periodically and / or continuously over the service life of several portable persistent sample sensors 312, for example, until the battery or all of the sensor electronic device module 126 needs to be replaced. Each time a persistent sample sensor 312 is replaced, notification of the new persistent sample sensor 312 can be sent / exchanged via the previously established communication between the sensor electronic device module 126 and the display device 134a.

[0068] According to one embodiment, the sample sensor system 124 collects and processes sample measurements from the continuous sample sensor 312 and periodically transmits sensor information representing the sample measurement values ​​to the display device 134a. The measurement values ​​are collected and transmitted throughout the usable period of the continuous sample sensor 312 (e.g., in the range of 1 to 30 days or more). New measurement values ​​may need to be transmitted frequently enough to adequately monitor sample levels. Rather than having transmit and receive circuits for each sample sensor system 124 and display device 134a that communicate continuously, the sample sensor system 124 and display device 134a may establish a communication channel between them periodically and periodically. In this way, the sample sensor system 124 can communicate wirelessly with the display device 134a at predetermined time intervals. The length of the predetermined time interval can be selected to be sufficiently long so that the sample sensor system 124 does not consume too much power by transmitting data more frequently than necessary, yet is still sufficient to provide the user with substantially real-time sensor information (e.g., measured sample values) to one or more display devices 134a-e for output (e.g., display). While the predetermined time interval is every 5 minutes in some embodiments, it is understood that this time interval can be varied to any desired length. It should be noted that other embodiments considered include, for example, the transmission of irregular or aperiodic sensor information from the sample sensor system 124 to one or more display devices 134a-e.

[0069] Fault detection, identification, and compensation As previously mentioned, various embodiments detect errors associated with measured host sample concentrations and take corrective actions to ensure that the host sample concentration is accurately represented. Inaccurate representations of sample concentration values, such as those shown to the user, can lead to users taking inappropriate actions that degrade the performance of predictive or closed-loop algorithms and worsen user confidence in the persistent sample system.

[0070] Figure 4A is a flowchart illustrating the operations performed according to the embodiments and methods disclosed herein. In operation 400, a signal representing the host sample concentration is received from the sample sensor. In operation 402, the signal is monitored, and in operation 403, it is determined whether there is a change in the signal. In other words, a fluctuation in the signal representing the host sample concentration is detected. In operation 410, the cause of the change or fluctuation in the signal is determined. In operation 420, the change in the signal is compensated so that the host sample concentration is accurately represented (i.e., in the display of a signal representing a noise-free host sample concentration (e.g., a compensated signal)). In another example, compensation for fluctuation may include compensation for one or more types of fluctuation or noise, and the compensated signal may represent one or more types of noise-free sample concentrations. It should be noted that the order of these steps can be changed. For example, one or more of the sensors described above may detect an abnormal condition in the continuous sample monitoring system 100 (e.g., a fluctuation exceeding a predetermined threshold), which may be associated with a subsequently detected fluctuation in the signal. Specific embodiments addressing fault detection and response are described in further detail below. It should be noted that operation 410 is represented by a dotted line, indicating that it is an arbitrary operation. That is, and as will be detailed below, fluctuations or noise can be compensated without necessarily requiring prior determination of the cause of the fluctuations or noise. In other words, certain embodiments can detect fluctuations in the signal and compensate accordingly by adjusting the signal in some way that produces more accurate sample concentration readings.

[0071] Fault detection and identification The measured sample, for example, the glucose signal or data received by the potentiostat 210, may be affected by various factors. The influence of these various factors manifests as abnormal fluctuations or changes in the measured sample signal or data, such as large spikes and / or increases in noise. Accordingly, various embodiments are responsible for detecting and addressing these abnormal fluctuations or changes. In some embodiments, the causes of the abnormal fluctuations or changes can also be identified and utilized as a basis for compensating for the abnormal fluctuations or changes and / or for collecting information such as statistical information to optimize the operation of the sample sensor system 124, for example.

[0072] For example, during electrostatic discharge (ESD) events or due to normal physical activity / movement performed by the user, the measured glucose signal may be subject to significant fluctuations or even lost. In addition, the measured sample signal may be affected by problems in one or more elements of the sensor electronic device module 126 (e.g., transceiver 316). For example, the transceiver 316 may introduce noise into the measured sample signal, thereby affecting the measured sample signal captured by the working electrode during the measurement procedure. As another example, the sensor electronic device module 126 may suffer a power outage due to unexpected battery depletion, which may result in an interruption of continuous sample monitoring.

[0073] Regarding noise issues, the "internal" aspects of the sample sensor system 124, such as the offset / calibration module 232, can inherently introduce noise into the measured sample signal. That is, noise is a characteristic of all electronic circuits, and the introduction of additional circuits, such as the offset / calibration module 232, will result in noise. For example, thermal noise can be caused by the thermal motion of electrons, while shot noise can result from random fluctuations in the current flowing through the circuit. Further noises may arise from manufacturing defects or differences in quality (e.g., conductivity variations). Problems can also arise from noises such as triboelectric noise and parasitic leakage, as described below. In addition, "external" factors (where "external" refers to factors occurring / originating outside the sample sensor system 124, such as the host 120), such as the motion or operation of the continuous sample sensor 122 and / or the sensor electronic device module 126, can also produce noise and / or otherwise inaccurate readings. In particular, if the sensor electronics module 126 is accidentally pressed or moved due to the normal operation of the host 120, this may result in phase fluctuations (considered noise) in the measured sample signal / observed level.

[0074] Figure 4B shows exemplary operations (operations 400, 402, and 403 in Figure 4A) performed to detect fluctuations or changes in a signal representing the host sample concentration. As previously mentioned, in operation 402, the host signal (e.g., a measured glucose signal) is monitored. In operation 404, the presence of fluctuation is based on a comparison (i.e., identification) of the host signal with reference information. As mentioned above, the reference information may be some relevant predetermined threshold, clinical situation data, known glucose levels, etc. In operation 406, data regarding the fluctuation is acquired. In some embodiments, the acquisition of fluctuation data may include reducing the sampling rate and / or overclocking the ASIC205 (described in more detail later) to obtain more accurate fluctuation data.

[0075] The detection of abnormal fluctuations or changes can be achieved by distinguishing between abnormal or unusual sample concentration levels and “normal” or expected sample concentration levels. Discrimination may include determining whether the received signal or data matches or meets predetermined criteria, or performing a comparison between clinical context information corresponding to user data excluding sample concentration levels / measurements. Discrimination may include analyzing the signal using time-series, frequency-based, or wavelet-based techniques. Discrimination may include raw signal analysis, residual signal analysis, pattern analysis, and / or slow-speed vs. fast sampling. Discrimination may include projecting the received signal onto multiple templates, each corresponding to a failure mode. Discrimination may include fluctuation analysis or ambiguous logic analysis. The received clinical status data can be selected from a group consisting of age, anthropometric data, medications currently acting on the patient, temperature compared to a reference, patient disability history, patient activity level, patient exercise level, level of patient interaction with a glucose monitor, glucose signal value pattern, clinical glucose values ​​and their derivatives, range of patient glucose levels over an entire period, duration of patient glucose levels being maintained within a certain range, patient glucose status, blood glucose-urinary urgency index, time, or blood pressure. Clinical status data may include time since transplantation, and clinical status criteria may include a time range since transplantation during which setbacks and recovery impairments are likely. Clinical status data may also include clinical glucose values ​​and data selected from a group consisting of age, anthropometric data, activity, exercise, clinical use of data, or patient interaction with a sample monitor. Exemplary identification systems and methods available according to various embodiments herein are described in U.S. Patent Application No. 14 / 717,643.

[0076] Figure 4C shows an example of an operation performed when determining the cause of the signal fluctuation (operation 410 in Figure 4A). Generally, an attempt is made to associate the detection fluctuation with a detection state or expression that may have caused the fluctuation. Thus, in operation 412, one or more detectors, such as the temperature sensor 252 and motion sensor 254 described above, are queried to obtain information about at least one detection state that is affecting at least one of the host and persistent sample sensor systems that detected the signal fluctuation.

[0077] For example, the pressure sensor 256 can detect pressure or compression using capacitive sensing. The pressure sensor 256 may include a metal foil embedded in the sensor electronic device module 126 and having opposing metal plates at the bottom of the sensor electronic device module 126 that are separated by a compressible membrane. In this way, pressure on the sensor electronic device module 126 compresses the membrane, thereby changing the capacitance detected by the opposing metal plates and foil.

[0078] The motion sensor 254 may also be an accelerometer, such as a three-axis accelerometer, for detecting user activity / movement. The motion sensor 254 may also be used for compression detection, for example, to sense that the sensor electronic module 126 is in an inverted position. As a result of analysis of this sensor data (distinct from sensor information measured or determined by the continuous sample sensor 122, which relates to sample concentration) by the processor 214, the processor 214 may determine that the user is lying on the sensor electronic module 126. The processor 214 may then take the step of identifying (described in more detail later) that the sensor electronic module 126 may give an incorrect reading of the measured sample concentration due to oxygen deficiency, for example, because a user tissue area near the sensor electronic module 126 is being pressed or pinched. The motion sensor 254 may further include a three-axis compass, which can be used in conjunction with the three-axis accelerometer to better determine the user's activity level.

[0079] Furthermore, signal fluctuations may occur due to other external factors, such as sensor drift. For example, sensor drift can occur in the continuous sample sensor 122. Sensor drift can refer to a phenomenon in which sensitivity information (e.g., the relationship between the measured current per unit time and the glucose level) can be affected by changes in temperature. Since temperature can affect glucose metabolism, any change in temperature (whether occurring in the user or the sample sensor system 124) can change the sensitivity of the continuous sample sensor 122, which may result in inaccurate glucose measurements or levels being presented to the user.

[0080] Temperature fluctuations may be due to external factors (e.g., changes in the user's body temperature) and / or internal factors (e.g., changes in the temperature of the circuit including the sensor electronic device module 126 or the continuous sample sensor 122 itself). Therefore, the temperature sensor 252 can be used to detect whether a malfunction or fluctuation may be occurring due to sensor drift. In particular, predetermined knowledge of a specific amount of drift associated with a particular temperature or temperature range can be used as a basis for compensating for any fluctuations or noise (to be described in more detail later) when the presence or occurrence of that particular temperature or temperature range is detected.

[0081] It should be noted that the temperature sensor 252 can measure the skin temperature of the host, tissue adjacent to the implantation site of the persistent sample sensor 122, etc. Therefore, the temperature sensor 252 can be implemented in a variety of ways and / or, but is not limited to, an array of sensors including, but is not limited to, an infrared temperature sensor positioned beneath the sensor electronics module 126 (very close to the host's epidermis) so as to be visible through the mount unit 240, a thermocouple temperature sensor protruding from the bottom of the sensor electronics module 126 to allow contact with the host's epidermis through the mount unit 240, and a semiconductor temperature sensor embedded in the mount unit 240 to allow direct epidermal contact. It should be further noted that any sensor itself or the data storage memory 220 can store sensor manufacturing and calibration information (whether it is the temperature sensor 252 or another sensor such as, for example, the motion sensor 254, the pressure sensor 256, etc.). Such stored sensor manufacturing and calibration information includes, but is not limited to, factory calibration settings or information, sensor identification information, etc. Such information can be stored and used for comparative purposes, or, for example, as a baseline or threshold that the sensor electronic device module 126 can use as a basis for determining sensor and / or temperature drift, noise, faults, fluctuations, etc. Furthermore, the temperature sensor 252 can also be implemented as a subcutaneous temperature sensor to sense the temperature near or at the tip of the continuous sample sensor 122. Various temperature sensors described above can also be used to measure the temperature of other sensors and can be used for efforts to correlate and compensate for fluctuations and their causes.

[0082] Problems such as spikes and / or noise in measured glucose values ​​may arise from liquid ingress. That is, liquids such as water may accidentally seep into the sensor electronic device module 126, causing fluctuations and / or noise in the glucose signal. In particular, water leakage into / through the sensor electronic device module 126 or the mounting unit 240 may temporarily cause the measured glucose signal to spike above "normal" levels to the extent that it leads to noise. For example, as a result of water infiltration, severe noise may occur after a large spike in the measured glucose value. After drying, severe noise may reappear before the measured glucose value gradually normalizes. It should be noted that a humidity sensor (not shown) capable of detecting moisture can be implemented in the sensor electronic device module 126 and / or as part of the mounting unit 240 to detect the presence of liquid. It should be noted that the various sensors described herein with reference to the figures, such as the pressure sensor 256 and the motion sensor 254, can be implemented as separate sensors or as sensors with combined functionality.

[0083] In operation 414, the variation is associated with at least one detected state based on at least one characteristic of the variation. For example, the time over which the variation occurs can be used to associate the occurrence of several states captured by the sensor with the variation. In addition, the type and / or amount of the variation (e.g., internal or external noise) or the frequency of the variation (e.g., a sudden push or a large spike due to ESD) can provide a basis for the association. In operation 416, data representing the variation is recorded. For example, data on when and how the variation occurred can be captured and recorded and used to provide a further understanding of the variation in glucose values ​​(or to be used later to compensate for or better adjust for future variations). Recording may occur locally and / or may need to be wirelessly transmitted to a remote server for use / analysis of the data by technicians, doctors, nurses, etc. Once a fluctuation or change is detected, the fault can be categorized based on the received signal, clinical situation information, or both, and categorizing the fault here includes categorizing the fault as a sensor environment fault or a system error / artifact fault, and / or subcategorizing the fault as, for example, a compression fault or an early wound reaction. In other words, the cause of the fluctuation or change can be determined. For example, the fluctuation occurs by determining the presence of several signal criteria measured by the processor 214, followed by several patterns that are not usually related to physiological changes, e.g., a rate of change (sudden drop) of the raw sensor signal. The processor 214 can have knowledge with respect to time and sensor information indicating that the user may be asleep (e.g., from the motion sensor 254 sensing an overall absence of activity over a period of time), and that the user may have rolled over the persistent sample sensor 122 (e.g., from the pressure sensor 256).Upon receiving such sensor data and comparing it with the information known to the processor 214 (i.e., time), the processor 214 can determine that the user was asleep and lying on the persistent sample sensor 122, and that this caused the sharp drop in glucose readings (i.e., due to oxygen deprivation at the implantation site of the persistent sample sensor 122).

[0084] As soon as the cause of the malfunction is determined, the processor 214 may take one or more actions to notify the user of the cause and, for example, to suggest a corrective response. For example, if a sharp drop in glucose reading occurs and it is determined that this is due to the user rolling over on the persistent sample sensor 122 (as described above), the processor 214 may instruct the user interface 222 and / or one or more of the display devices 134a-e to activate an alert or notification. For example, the user interface 222 may activate the vibrator motor 228 to alert the user and / or simultaneously display a notification on the LCD 226 instructing the user to change position. In this way, the user can take corrective action. The processor 214 may further instruct the user interface and / or one or more of the display devices 134a-e to notify the user that they should wait for more accurate results before taking any corrective action. Furthermore, information can be collected about the occurrence of a fault and / or the cause of such a fault, so that the processor 214 can better predict or estimate a better or more optimal time to transmit the EGV data to one or more display devices 134a~e. For example, if the processor 214 determines that the user has rolled on the persistent sample sensor 122, it may introduce a delay before transmitting the current EGV data.

[0085] When a disturbance, such as an abnormal or anomalous fluctuation or change in the signal, is detected and the cause of the disturbance is determined, the fluctuation or change in the signal is accounted for so that the host sample concentration is accurately represented.

[0086] compensation Noise compensation As mentioned above, noise, whether originating from the circuitry within the sample sensor system 124 or from external sources, can affect the sample concentration signal acquired by the working electrode. Therefore, various embodiments can use offsets to compensate for such noise.

[0087] The continuous sample sensor 122 is typically configured to operate at very low currents (e.g., in the picoampere (pA) range). Figure 5A is an illustrative graph showing the glucose signal 500 (current I in pA units) over time t. Figure 5A shows an illustrative sample measurement at approximately 100 pA. Noise levels introduced by internal noise sources (e.g., the circuit and / or the triboelectric effect described above) can far exceed those of the glucose signal level and may even cause the glucose signal level to drop below zero. An example of this is illustrated in Figure 5B, where the noise signal 502 oscillates between 200 pA and -200 pA. If the sensor electronics module 126 is configured to measure only positive signal values, no noise that causes the glucose signal level to drop below zero will be observed and compensated for.

[0088] In the embodiment illustrated in Figure 5C, a measurement signal is shown that includes the actual glucose signal (i.e., glucose signal 500 and noise signal 502) (i.e., measurement signal = glucose signal + noise). Recalling the exemplary glucose signal illustrated in Figure 5A (glucose signal = 100 pA) and the exemplary noise signal illustrated in Figure 5B (noise oscillating between 200 pA and -200 pA), the resulting signal 504 in Figure 5C oscillates between 300 pA and -100 pA without any offset. The portion of the measurement signal between 0 pA and -100 pA is not observed or accounted for. Thus, the value obtained by averaging (e.g., filtering) the measurement signal (e.g., signal 504) may contain errors. For example, the average value obtained by averaging the measurement signal 504 (e.g., not accounting for negative portions) may be incorrectly higher (i.e., positively biased).

[0089] Therefore, in some embodiments, an offset current is introduced so that the measured signal also includes the offset, in addition to the actual glucose signal and any noise (i.e., measured signal = glucose signal + noise + offset). Figure 5D illustrates an example of such a measured signal 506, where, for example, the addition of an offset of 100 pA increases the measured signal, and as a result all noise can be captured (the measured signal does not drop below zero) and compensated for. In such embodiments, the accurate value is obtained by averaging the measured signal. In some embodiments, the offset value can be subtracted after averaging the measured signal.

[0090] It should be noted that some embodiments utilize a filtering mechanism that averages the measurement signal. In some cases, as noise increases, the average value of the measurement signal may be positively biased. Recalling the example illustrated in Figure 5C, any negative portion of the measurement signal is not accounted for. As shown above, this causes an averaging error. Therefore, various embodiments may also compensate for the averaging error by using an offset circuit.

[0091] Triboelectric noise has been mentioned previously. Triboelectric effects are phenomena that occur due to friction between materials with different charges. In the case of triboelectric noise, the averaged sum can be zero. For example, triboelectric noise can be effectively canceled out by capturing all noise present in the measurement signal. However, in some embodiments, the continuous sample sensor 122 cannot capture the negative portion of the measurement signal, thus leading to an averaging error. Since the measurement signal (current) is proportional to the glucose concentration, an incorrectly high reading presents a problem (especially if the user is hypoglycemic).

[0092] Implementing an offset current can be achieved by using a programmable offset current (e.g., 0nA, 10nA, 20nA, 40nA). It should be noted that the offset current can range from picoamperes to nanoamperes, and the offset currents described above are merely examples. Such programmable offset currents can be implemented during the manufacturing stage by the offset / calibration module 232. Alternatively, based on noise measurements, for example, each time a new continuous sample sensor 122 is used, or during real-time use of the sample sensor system 126, an appropriate offset current can be selected / utilized by the offset / calibration module 232. It should be noted that in scenarios where the measurement signal, including the true glucose signal and noise signal, oscillates between positive values ​​only, the offset current does not need to be utilized. Therefore, the option described above has an offset current of 0nA. In one embodiment, the processor 214 can monitor glucose and noise signal values ​​and predetermined thresholds for such signals, resulting in the selection / utilization of the offset current as described herein. In some embodiments, if the zero-peak value or a percentage of the zero-peak value of the noise signal (e.g., half of the zero-peak value) exceeds that of the glucose signal or glucose value, the processor 214 can monitor the measurement signal, including the glucose and noise signal. The processor 214 can monitor the measurement signal by continuously, periodically, aperiodicly, or by sampling the signal received by the potentiostat 210 from the sample sensor 122 according to a predetermined schedule. As soon as the processor 214 analyzes the measurement signal and determines that the zero-peak value or a percentage of the zero-peak value of the noise signal exceeds that of the glucose signal or glucose value, the processor 214 instructs the offset / calibration module 232 to inject an appropriate offset current.

[0093] Furthermore, the offset current shifts the glucose and noise signals (measured signals) upwards so that they are greater than zero, and can capture any portion of the measured signal that would have been truncated without the offset. Then, the processor 214 or the offset / calibration module 232 can subtract the known offset from the measured signal and, in some cases, the averaged measured signal, depending on the appropriate software / algorithm, in order to read out the true glucose signal level. In some embodiments, the processor 214 and / or the offset / calibration module 232 can operate simply to add an offset current, while in other embodiments, the processor 214 and / or the offset / calibration module 232 can be configured to add an offset current and then subtract any added offset current.

[0094] As mentioned earlier, electrical circuits inherently generate noise. Therefore, the same applies to the offset / calibration module 232. That is, the use of the offset circuit in the offset / calibration module 232 adds another variable (offset current) to the measured signal, which, if not compensated for, can result in the addition of further errors / noise, both in itself and in its own way. In other words, the true offset value cannot be obtained from the offset circuit. Therefore, some embodiments also compensate for the noise generated by the offset circuit.

[0095] In particular, the processor 214, depending on the appropriate software / algorithm, “blocks” or prohibits the operation of the working electrode. Then, the potentiostat 210 (and / or processor 214) can be adjusted for “true zero” (e.g., offset current). In some cases, the processor 214 and / or calibration module 232 may provide a calibration procedure for determining the offset current. That is, the software / algorithm can disable the external connection (data line 212) to the working electrode, and as a result, it can calculate the offset current from the offset / calibration module 232 instead of the normally calculated current flow between the working electrode and the counter electrode. It should be noted that calibration can be initiated based on a predetermined schedule after the installation of a new persistent sample sensor 122, etc. Another trigger for initiating calibration can be a tendency, determined by the processor 214, indicating that an increasingly larger offset current is occurring over a certain threshold time. This can be determined by monitoring the number of times the offset / calibration module 232 is activated and / or recording the amount of offset current used in the data storage memory 220.

[0096] Figure 6 shows exemplary operations performed to achieve offset current compensation calibration according to various embodiments. In operation 600, the operation of the working electrode is disabled. As described above, the working electrode is substantially blocked or disabled, and as a result, a true zero current can be calculated from the offset / calibration module 232 instead of the normally calculated current flow between the working electrode and the counter electrode. For example, ignoring noise, I(total, i.e., measured value) = I(working electrode, WE) + I(offset)

[0097] As soon as the working electrode is turned off, sample measurements are no longer acquired, and the offset value can be determined in operation 602. I(measured value) = I(offset)

[0098] Once calibrated, the working electrode can be enabled in operation 604. As soon as the average sample concentration level is calculated, the offset value can be subtracted from the averaged result in operation 606 to read the glucose signal level. That is, the processor 214 or offset / calibration module 232 can then subtract the known offset from the averaged measurement signal to read the actual glucose signal level, depending on the appropriate software / algorithm.

[0099] It should be noted that calibration can be performed in various ways. For example, calibration can be performed based on a predetermined schedule. For instance, if the applied current offset changes, but it is known that the variation in the current offset is related to a specific amount over a certain period of time, the calibration may be scheduled accordingly. Alternatively, a one-time calibration can be performed (e.g., during manufacturing). Or, real-time calibration can be performed. For example, if the offset current changes frequently, the processor 214 or the offset / calibration module 232 can perform additional calibration steps.

[0100] In particular, in response to noise and / or spikes associated with liquid ingress issues, user-initiated calibration can be performed as a compensatory measure. When there is a large increase in estimated glucose value (EGV) data after severe noise (which may occur as a result of water ingress, as described above), user confidence in EGV should be considered low. Therefore, the sample sensor system 124 can prompt and / or alert the user to perform calibration of the continuous sample sensor 122, or, for example, ask the user about current activity or confirm that an accidental water leak has occurred. Furthermore, the processor 214 can prompt the user and instruct the user interface 222 to input the blood glucose values ​​acquired, respectively. If the blood glucose values ​​differ significantly from the EGV, the processor 214 can alert or warn the user of a potential malfunction and instruct the user interface 222 to wait a predetermined amount of time during which a time calibration can be performed to ensure that the continuous sample sensor 122 is in proper operating conditions. It should be noted that in some embodiments, the alerts and / or questions described above can be sent to and / or provided by one or more of the display devices 134a to e. Thus, one or more of the display devices 134a to 3 may have their own user interface, including one or more input mechanisms, displays, notification mechanisms, etc.

[0101] Another problem that may arise from the introduction of offset current is sensor (temperature) drift. As mentioned above, sensor drift can be experienced in the continuous sample sensor 122 due to temperature changes. Since temperature can affect glucose metabolism, any temperature change (whether occurring in the user or the sample sensor system 124) can alter the sensitivity of the continuous sample sensor 122, which may result in inaccurate glucose measurements or levels being presented to the user. Therefore, temperature calibration can be performed to compensate for temperature drift.

[0102] In this example, the introduction of an additional (offset) current may cause temperature drift within the sensor electronics module 126, and the resulting temperature difference may unfavorably affect the offset value. Alternatively, the offset current may have the drawback of temperature drift, which can occur due to temperature fluctuations within the circuitry of the sensor electronics module 126 itself. To compensate, an offset / calibration module 232 can be used during manufacturing (e.g., factory calibration) to address the fluctuations in the offset value caused by the temperature of the sensor electronics module. That is, temperature fluctuations can be captured using the temperature sensor 252, and as soon as a predetermined temperature fluctuation threshold (e.g., shown in a lookup table or pre-programmed into an appropriate algorithm, etc.) is detected, the processor 214 can instruct the offset / calibration module 232 to perform a calibration procedure. In some embodiments, it may be the processor 214 that performs the calibration procedure, regardless of whether those calibration procedures are initiated due to offset current problems, temperature drift, etc. It should be noted that the calibration disclosed herein may refer to various types or methods of calibration. In some embodiments, calibration can refer to a one-point calibration process, a three-point calibration process, and so on. For example, a three-point calibration can be performed for offsets that include different value ranges, while a one-point calibration can be performed for addressable temperature drift, for example, if the sensor electronic device module 126 has a single operating temperature / range.

[0103] According to another type of compensation, the processor 214 can continuously detect temperature (such as the host, one or more components of the continuous sample sensor system 124) and compensate for changes in glucose information that may occur due to temperature fluctuations by referring to a lookup table or based on a real-time algorithm that links glucose levels and / or current values ​​to temperature. Alternatively, the processor 214 can refer to the temperature sensor 252 whenever there is a fluctuation in the measured glucose reading and compensate for that change according to a given fluctuation in temperature. That is, the processor 214 can compensate for the measured sample level "directly" based on the temperature measurement rather than (or in addition to) compensating for noise as a result of sensor drift. For example, as soon as the processor 214 receives information from the temperature sensor 252 that a particular temperature has been detected, the processor 214 can adjust the received glucose value in a manner corresponding to the sensed temperature until the temperature sensor 252 senses that the temperature has returned to a default value or range. In one embodiment, the processor 214 accesses a lookup table, for example, to determine how much the received glucose value should be adjusted based on temperature or a temperature range.

[0104] According to some embodiments, the temperature of the sensor electronic module 126 is associated with the temperature of the continuous sample sensor 122, and the temperature of the sensor electronic module 126 is used to correct / compensate for offset current-temperature drift faults in the sample concentration readings. For example, the processor 214 can receive temperature information from the temperature sensor 252 regarding the current temperature of the sensor electronic module 126. The processor 214 or the offset / calibration module 232 can then update the calibration value of the continuous sample sensor 122 and adjust the calibration value of the continuous sample sensor 122 (which may be set for various temperature values). In other words, any change or fluctuation in the glucose reading can be sensed and associated with temperature changes affecting the sensor electronic module 126.

[0105] Another method of compensation can rely on impedance measurement. Impedance can be used as one way to change the characteristics of the sensor. In other words, a change in impedance can be associated with some change in the sensor. Therefore, compensation measures can be taken based on impedance. Impedance can be determined based on additional electrodes or the operating and reference electrodes themselves. For example, when the continuous sample sensor is first implanted in the host 120, tissue damage occurs, so the physiological response to the tissue damage can affect the sensor operation. Therefore, the processor 214 can determine the impedance of the reference electrode. The processor 214 can further measure the wound response, for example, by measuring the temperature of the host 120, and thus the wound response and the measured impedance can be associated. In this way, the processor 214 can continue to measure the impedance of the reference electrode, for example, until the impedance returns to normal or the default impedance, at which point the processor 214 can continue to acquire sample measurements from the continuous sample sensor 122.

[0106] As an alternative to, or in combination with, some embodiments that utilize offset current to shift the measured signal (including noise), the sensitivity of the persistent sample sensor 122 can be effectively increased by enabling a high current output. That is, by increasing the current range (i.e., measuring a higher output current), any noise that may be introduced into the measured (current) signal will be a small percentage of the total current range. It should be noted that multiple ranges can be covered within a single sensor design or by multiple generations of sensors. For example, multiple programmable current ranges, e.g., 50nA, 80nA, 170nA, 240nA, can be used instead of just one, for example, the default current range, typically 16nA, in which case the current range is the sum of the measured glucose signal and any added offset current values. Because the proportion of noise to the increased current range is small, the increased current range can preemptively compensate for the noise. The implementation of these current ranges can be done in a software-controlled programming register. In one embodiment, the processor 214 can detect the presence of a new sample sensor 122 in the sample sensor system 124. Based on the detection, an appropriate current range can be implemented. For example, the processor 214 can refer to a data memory containing information related to current ranges for various types of sensors and corresponding types of sensors. Based on the reference, the processor 214 can implement an appropriate current range for the selected sample sensor 122.

[0107] As described above, operation 406 in Figure 4B includes acquiring data on fluctuations, which may include, in the case of noise, using a faster clock 258 or operating clock 258 at a faster speed to make a more accurate measurement of the noise causing the fluctuations. A more accurate measurement of noise is not limited to detecting fluctuations, but can be used to better compensate for that noise.

[0108] In some embodiments, the potentiostat 210 is not always able to capture noise details, or even adequately. Furthermore, larger noise signals generally have higher frequencies. In the case of non-triboelectric (non-transient) noise, for example, if the host is lying on the persistent sample sensor 122 and there is not enough oxygen available for the enzymes in the persistent sample sensor 122 to metabolize glucose, the measured glucose signal will be abnormal.

[0109] To address these issues, higher sampling rates can be used to capture noise details, such as triboelectric noise details and non-triboelectric / non-transient noise details that do not tend to cancel each other out (despite the use of current offsets mentioned above), and higher sampling (by reducing the sampling interval and / or overclocking) can determine noise trends / characteristics that would normally go unnoticed at slower sampling rates. These identified noise trends / characteristics can then be used to better determine the noise source and implement appropriate correction / compensation measures.

[0110] As described above, in operation 404, the determination of the presence of variation is made by the processor 214 by comparing the current sample measurement with reference information such as the trend of previous sample measurement values. If the processor 214 determines the presence of abnormal data or data variation, the processor 214 can adjust the measurement / sampling interval. That is, the measurement / sampling interval used by the potentiostat 210 can be reduced, for example, from 30 seconds to 2 seconds. In addition, the ASIC 205 can be overclocked, for example, by operating the clock 258 at a faster speed. For example, at a signal frequency of 0.5 Hz, only one sample is received every 2 seconds. Overclocking can be used to increase the number of samples received, where the fundamental frequency of the clock 258 (32 kHz) is increased, for example, by 2 times, 4 times, 8 times, etc.

[0111] Another source of internal noise may originate from some artifacts or particles (i.e., a certain type of resistance) trapped between electrodes during the manufacturing process. Due to these artifacts, a small current may flow across the potential difference (voltage) due to the resulting resistance. This current then introduces errors in the measured glucose signal. Therefore, in some embodiments, noise due to parasitic leakage is reduced.

[0112] As described above, the continuous sample sensor 122 may have various electrodes, for example, reference and working / current electrodes. Similarly, sensors such as the temperature sensor 252, motion sensor 254, and pressure sensor 256 may also have electrodes connected to a PCB on which an ASIC 205 can be mounted, for example. To reduce parasitic leakage current, the working electrode signal may be surrounded by a signal of the same voltage potential. That is, the sensor circuit may be surrounded by the same voltage potential (guard band) to eliminate leakage current (e.g., current flow from the working electrode to the ground). In other words, potential-voltage differences that may cause unnecessary measurement current flow are eliminated. Figure 7 shows an example implementation of such a guard band. Figure 7 shows electrode 700 with a guard band 702 mounted around it. In one embodiment, the processor 214 may monitor various voltage signal values, for example, voltage signal values ​​on the sensor electronic device module 126 and voltage signal values ​​on the electrodes, and may further compare the various monitored voltage signal values. The comparison may be performed periodically and / or when a fluctuation in the signal is detected. In one embodiment, a suitable entity of the processor 214 or ASIC 205 can then appropriately cause the connection, disconnection, and / or change of the voltage potential of the guard band 702. In some embodiments, the guard band can be mounted on a multilayer of the PCB, surrounding the working electrodes, where vias can be used to connect the multilayer.

[0113] Timing and battery failure compensation In addition to compensating for noise and / or variability in the measured sample / glucose signal, some embodiments also address the detection and response to timing errors, battery-related interruptions and failures, and the like.

[0114] Timing errors can occur when the sensor electronic device module 126 loses its timing due to a destructive event. In response to such an event, measures can be taken to resynchronize the clock 258. For example, the sensor electronic device module 126 may be affected by an ESD event. As a result, EGV data may be transmitted at the wrong time and / or associated with the wrong timestamp. That is, since an ESD event may result in a reset of the clock 258, EGV data transmitted after the occurrence of an ESD event may be incorrectly timestamped based on the "reset" timestamp instead of the "actual" timestamp.

[0115] To address this type of timing error, and referring to Figures 3 and 8, in operation 800, the processor 314 can compare the current clock time (i.e., time from the real-time clock 320) with a previously stored clock time (i.e., time stored in memory 318) after an interruption in the operation of the sensor electronics module 126. If the sensor electronics module 126 loses time, for example, due to an ESD event, in operation 802, the current clock time is synchronized to the previously stored clock time, and in operation 804, the timestamp associated with the EGV data transfer is incremented based on the previously stored clock time. That is, the processor 314 can read the time stored in memory 318 and increment it based on the stored time rather than the time from the real-time clock 320. Thus, for time stamping purposes, this value is used for the next EGV value. In addition, the processor 314 can reset the real-time clock 320 so that it can be used again for time stamping of EGV data. It should be noted that data storage memory 220 or some memory of processor 314 can buffer timestamps, and as a result, any clock reset can be detected by processor 314, at which point processor 314 can perform the comparison described above to obtain the "actual" clock / timestamp. Processor 314 can also recognize ESD events caused by other component sample sensor system 124 that have been reset or are in an "offline" state for a period of time. Furthermore, a type of monitoring circuit can be implemented to inform processor 314 that sample sensor system 124 is functioning correctly. If the monitoring circuit is not functioning properly (e.g., by clock 320), processor 314 can consider that an event such as an ESD event has occurred.

[0116] Regarding battery-related errors, ESD events can cause errors in the sensor electronics module 126, resulting in abnormally high glucose values ​​due to high current drain. Therefore, some embodiments can detect such high current modes, and the sensor electronics module 126 can take action to exit the high current drain mode. In particular, some embodiments monitor general-purpose input / output (GPIO) ports / pins to detect high current drain modes. In some embodiments, for example, a "suitable" battery life profile can be stored in data storage memory 220, which can then be compared with sample battery life measurements using a comparison algorithm. Sample battery life measurements can be acquired and compared with a suitable battery life profile based on the expected battery life at a given time (assuming normal or appropriate use). In some embodiments, battery 234 can be disconnected from sensor electronics module 406 and connected to a dummy load with known impedance or current draw characteristics to determine its current power level. In other embodiments, a Coulomb counter can be used to provide a value representing the cumulative amount of charge drawn from battery 234 to determine the current power level. It should be noted that the battery 234, like the sensor electronic device module 126 or its components, may be a victim of temperature-distorted battery life predictions. Therefore, in a manner very similar to the embodiments described above, where the temperature sensor 252 is used to determine the temperature of the sensor electronic device module 126, the continuous sample sensor 122, etc., the temperature sensor 252 may also be used to determine the operating temperature of the battery 234, and the calculated battery life can be compensated for or adjusted based on this operating temperature.

[0117] This comparison allows the processor 214 to determine, for example, that the current battery life profile indicates faster corrosion than expected from a proper battery life profile, which can indicate that the sensor electronics module 126 is experiencing a high-current drain mode. Once a high-current drain mode is detected, the processor 214 can reset the sensor electronics module 126. As mentioned above, it should be noted that this can also prompt a reset or resynchronization of the clock 258 based on previously stored time. For ultra-low-current devices such as the sensor electronics module 126, it should be further noted that conventional battery monitoring equipment reduces battery life, and the comparison algorithm described above relies on logic for detection that does not significantly impact battery life. As mentioned above, adding such circuitry can add noise that requires additional compensation, so such embodiments are also an improvement over using fuses / circuit breakers.

[0118] During manufacturing, for example, for testing / quality control purposes, power can be drawn from the battery 234. Therefore, before the sensor electronic device module 126 is used by the host, it will have suffered a loss of battery power. Thus, some embodiments can switch between a wireless charging mode and a normal, drop-in power supply mode. In particular, and as illustrated in Figure 9A, the sensor electronic device module 126 may have an energy harvesting chip 280 and a charging chip 282, which are implemented as part of the ASIC 205, for example. In this way, during the first mode (for example, during manufacturing), the sensor electronic device module 126 can be powered wirelessly using the wireless charger 286, thereby avoiding the depletion of the battery 234. The energy harvesting chip 280 can collect power from the wireless charger 286 and the charging chip 282, via the ASIC 205. In the second mode (for example, during normal use), the ASIC 205 can draw power from the battery 234. A mode selector 284 can be used to alternate between a first mode and a second mode. The mode selector 284 may be a non-persistent circuit such as a switch, logical component, or trace that bypasses battery 234 in the first mode and allows battery 234 to connect to the ASIC 205 in the second mode. In some embodiments, battery 234 may be a rechargeable battery, or another rechargeable battery 234' may be used as an additional power source. During the first mode, the mode selector 284 can enable wireless charging of the ASIC 205 and / or the rechargeable battery 234' that powers the ASIC 205. During this mode, the rechargeable battery 234' can also be recharged by wireless charging. In the second mode, battery 234 and / or the rechargeable battery 234 can be used to power the ASIC 205.

[0119] Furthermore, there may be a lack of information or data logging during manufacturing, making it difficult to trace back battery malfunction issues during normal use (by the host). Therefore, some embodiments use enhanced data logging to capture details about the sensor electronics module 126 and / or battery 234 during the manufacturing phase, thereby allowing these details to be investigated and / or potentially correlated with issues related to the sensor electronics module 126 and / or battery 234 that occurred during normal use. In particular, the processor 214 can log data about the contract manufacturing steps and the state of the sensor electronics module 126 and / or battery 234 (e.g., battery level, reset count, mode switching, etc.) both before and after being placed into storage mode before use by the host (in the data storage memory 220 or a special partition therein that persists for the entire lifespan of the sensor electronics module 126). Alternatively, such data can be sent to an external storage device, for example, a cloud-based server, via the communication port 238, along with information identifying the specific sensor electronics module and / or battery, so as not to affect the storage space on the data storage memory 220. Later inspections of the sensor electronic device module 126 and / or battery 234 can be associated with this previously stored data. For this purpose, battery 234 may have a battery integrated circuit (IC) that can provide identification information about battery 234. This additional data logging does not adversely affect the lifespan of battery 234 due to the first mode of wireless charging described above. In addition to logging the contract manufacturing steps, data can be collected, for example, from a temperature sensor 252 to obtain ambient temperature data indicating the temperature generated in the sensor electronic device module 126 and / or battery 234 during the manufacturing process. Furthermore, according to the received sensor information during manufacturing, test specimen measurement signals, etc., the processor 214 can perform pre-use offset, calibration, and other compensation measures as described above.

[0120] Furthermore, batteries can have different battery chemistry properties, and batteries can be manufactured or obtained from different manufacturers. Additionally, different models or versions of sensor electronics modules may be used with these different types of batteries. As a result of this variability in battery characteristics, as well as the characteristics of the sensor electronics module, the overall performance characteristics often lack commonality. Therefore, some embodiments take into account the reconfiguration of variable parameters in the sensor electronics module 126.

[0121] In particular, each type, model, or set of batteries may have its own unique battery performance characteristics or battery profile. These may include, but are not limited to, operating characteristics such as voltage range, sustained rated current, pulsed rated current, and voltage threshold. Such battery parameters are used in calculations performed by the firmware / processor of the sensor electronics module 126 over the course of the sensor electronics module 126's lifespan, in order to enable the sensor electronics module 126 to predict when a given battery will run out of charge / how long the battery will last. As will be described later, in some embodiments, one or more battery operating parameters (for example, for different types of batteries) may be transmitted from the server 138 to the sensor electronics module 126 (for example, via one of the display devices).

[0122] To ensure optimal performance of the sensor electronic device module 126, for example, to avoid unexpected battery drain and potential interruptions in the transmission of sensor information, in some embodiments, the sensor electronic device module 126 can be updated after battery installation to one or more display devices 134a-e. Figure 9B shows exemplary operation performed by the sensor electronic device module 126 to achieve battery configuration. As previously mentioned, one or more operating parameters are received in operation 900. In operation 902, the performance characteristics of the battery (e.g., battery 234) are monitored over time. In operation 904, the sensor electronic device module 126 determines, based on one or more received operating parameters, whether the monitored performance characteristics of battery 234 deviate from reference performance (e.g., a known battery profile stored in data storage memory 220). If it deviates, in operation 906, one or more operating parameters can be updated wirelessly, for example, through communication port 238. In this way, the operation of the sensor electronic device module 126, such as the EGV transmission characteristics and connection preferences for one or more of the display devices 134a to e, can be configured to match the appropriate performance characteristics of the battery 234.

[0123] In some embodiments, if operating parameters are entered incorrectly, boundaries can be used to determine potential battery problems. That is, as shown in operation 910 in Figure 9C, one or more operating parameters representing the battery profile are received by the sensor electronics module 126. These operating parameters can be used by the firmware of the sensor electronics module 126 to characterize the battery profile, the examples of which are described above. In addition, boundaries are entered in operation 912 based on one or more operating parameters. These boundaries can refer to the minimum / maximum expected performance characteristics for one or more operating parameters associated with a particular battery. In operation 914, the sensor electronics module 126 determines whether one or more operating parameters exceed the entered boundaries. If they do not, no action is required in 916. That is, if the determination is performed during manufacturing, the sensor electronics module 126 can enter sleep or low-power memory mode until powered on by the user. If the determination is performed while the sensor electronics module 126 is already operating, it can continue operating. However, if the sensor electronic device module 126 determines that one or more received operating parameters exceed an input boundary, the processor 214 may, in operation 918, instruct the user interface 222 or display devices 134a-e to display a notification, issue a warning, or alert the user or manufacturing personnel that the operating parameters require updating. In some embodiments, the sensor electronic device module may determine when to provide an alert notification (e.g., for low voltage) based on one of the reconfigurable battery operating parameters (e.g., voltage thresholds) for different types of batteries.

[0124] In some embodiments, as shown in Figure 9A, the charge pump 288 can be implemented in a sample sensor system 124 that may increase (e.g., double) the battery voltage of a single battery (e.g., battery 234) to perform power-intensive operation. Thus, in those embodiments, an additional battery may not be required, thus conveniently saving physical space in the sample sensor system 124 (i.e., by not installing an extra battery). The charge pump 288 may be internally coupled to the ASIC 205. Furthermore, Figure 9D shows an embodiment of an equivalent model of the charge pump (voltage multiplier) 920. For example, in model 920, the equivalent resistor 926 has a resistance value of Requiv = 1 / Cext * Fclock, where Cext is the value of the capacitor 928 and Fclock (Hz) is the clock frequency. In one embodiment, the fixed capacitor value of Cext determines the value of Fclock, which determines the equivalent resistance Requiv of the charge pump 288 or 920, which determines the output current capacity of the charge pump (i.e., how much load it can drive). In other words, Fclock and Requiv essentially determine the output voltage Vp.

[0125] In some implementations, the charge pump can be operated via a feedback control network that can respond to load surges by increasing the Fclock frequency. However, due to the reactive nature of the control mechanism, the output voltage 930 may experience undesirable ripples or glitches, as shown in Figure 9E. In some implementations, undesirable ripples in the output voltage can be eliminated. In such implementations, the processor 214 can identify and determine the schedule or timing of power-intensive operations (e.g., wireless transmission of sensor data and / or internal database access of sensor data). In addition, the processor 214 can determine the payload of those operations (e.g., power or current consumption associated with wireless transmission of sensor data and / or internal database access of sensor data). Based on the operation schedule and payload information, the processor 214 can calculate and set the operating frequency of the charge pump 920, i.e., the corresponding value of Fclock, for each operation at those scheduled times, according to the payload information. In one embodiment, the processor 214 can access a database for schedule and payload information for multiple operations and further store the corresponding calculated operating frequency Fclock for each operation. For example, the processor 214 can instruct the charge pump 288 to operate at one of the calculated frequencies corresponding to one of the operations (on a predetermined schedule based on payload information). Implementing such a method minimizes or, in some cases eliminates, voltage ripple or glitches in the output voltage 932 (as shown in Figure 9F) to ensure steady-state operation of the sensor sample system 124.

[0126] It should also be noted that the various combinations of the embodiments / operational scenarios described above can be combined in different ways to achieve one or more desired operating characteristics in a continuous sample measurement system. Although the various embodiments have been described in the context of continuous sample measurement, for example, continuous glucose monitoring, the various embodiments can also be adapted for other situations, such as monitoring of vital signals.

[0127] As used herein, the term “module” may describe a given unit of functionality that can be performed by one or more embodiments of this application. As used herein, a module may be implemented using any form of hardware, software, or combination thereof. For example, one or more processors, controllers, ASICs, PLAs, PALs, CPLDs, FPGAs, logic components, software routines, or other mechanisms may be implemented to form a module. Modules, circuits, processors, etc., can be fixed to a printed circuit board (PCB) or the like and can take on various forms. In implementation, the various modules described herein may be implemented as separate modules or functions, and the described features may be shared in part or as a whole among one or more modules. In other words, as will be apparent to those skilled in the art after reading this description, the various features and functionalities described herein can be performed in any given application and in one or more separate or shared modules in various combinations and substitutions. A person skilled in the art will understand that even if various features or elements of functionality are described or requested individually as separate modules, these features and functionalities can be shared among one or more common software and hardware elements, and that such descriptions do not require or imply that separate hardware or software components must be used to implement such features or functionalities.

[0128] Where components or modules of an application are made entirely or partially using software, in one embodiment, these software elements can be implemented to operate on a computing or processing circuit capable of performing the functionality described relating thereto. One such exemplary computing module that can be used to implement various functions of the systems and methods disclosed herein is shown in Figure 10. Various embodiments are described with respect to this embodiment computing module 1000. After reading this description, it will be clear to those skilled in the art how to implement applications using other computing modules or architectures.

[0129] Referring here to Figure 10, the computing module 1000 can represent, for example, computing or processing power found within the range of auto-adjustable displays, desktops, laptops, notebooks and tablet computers, portable computing devices (tablets, PDAs, smartphones, mobile phones, palmtops, etc.), workstations or other devices with displays, servers, or any other type of special-purpose or general-purpose computing device that may be desirable or appropriate for a given application or environment. For example, the computing module 1000 may be one embodiment of the display devices 134a-e or the sensor electronic device module 126. The computing module 1000 may also represent computing power embedded in or available within a given device. For example, the computing module may be found in other electronic devices, such as other electronic devices, which may include, as an example, some form of portable computing device and processing power.

[0130] The computing module 1000 may include one or more processors, controllers, control modules, or other processing devices, such as a processor 1004. The processor 1004 may be implemented using a general-purpose or special-purpose processing engine, such as a microprocessor, controller, or other control logic. In the example shown in the figure, the processor 1004 is connected to the bus 1002, but any communication medium can be used to facilitate interaction with other components of the computing module 1000 or to communicate externally.

[0131] The computing module 1000 may also include one or more memory modules, which are referred to herein simply as main memory 1008. For example, preferably, random access memory (RAM) or other dynamic memory may be used to store information and instructions executed by the processor 1004. The main memory 1008 may also be used to store temporary variables or other intermediate information during the execution of instructions executed by the processor 1004. The computing module 1000 may also include read-only memory ("ROM") or other static storage devices coupled to the bus 1002 for storing static information and instructions for the processor 1004.

[0132] The computing module 1000 may also include one or more different forms of information storage mechanisms 1010, which may include, for example, a media drive 1012 and a storage device interface 1020. The media drive 1012 may include a drive or other mechanism for supporting a fixed or removable storage medium 1014. For example, a hard disk drive, a solid-state drive, a magnetic tape drive, an optical disc drive, a compact disc (CD) or digital video disc (DVD) drive (R or RW), or other removable or fixed media drive may be provided. Thus, the storage medium 1014 may include, for example, a hard disk, an integrated circuit assembly, a magnetic tape, a cartridge, an optical disc, a CD or DVD, or other fixed or removable media that is read by, written to, or accessed by the media drive 1012. As these embodiments show, the storage medium 1014 may include a computer-usable storage medium in which computer software or data is stored.

[0133] In another embodiment, the information storage mechanism 1010 may include other similar means that enable computer programs or other instructions or data to be loaded into the computing module 1000. Such means may include, for example, a fixed or removable storage device 1022 and interface 1020. Embodiments of such storage device 1022 and interface 1020 may include a program cartridge and cartridge interface, removable memory (e.g., flash memory or other removable memory modules) and memory slots, PCMCIA slots and cards, and other fixed or removable storage units 1022 and interface 1020 that can transfer software and data from the storage device 1022 to the computing module 1000.

[0134] The computing module 1000 may also include a communication interface 1024. The communication interface 1024 may be used to enable the transfer of software and data between the computing module 1000 and external devices, such as cloud-based servers or other remotely located entities. Embodiments of the communication interface 1024 may include a modem or soft modem, a network interface (e.g., Ethernet®, network interface card, WiMedia, IEEE 802.XXX or other interface), a communication port (e.g., a USB port, IR port, RS232 port, Bluetooth® interface or other port), or other communication interfaces. The software and data transferred via the communication interface 1024 may typically be carried by signals, which can be electronic, electromagnetic (including optical), or other signals that can be exchanged by a given communication interface 1024. These signals may be provided to the communication interface 1024 via a channel 1028. This channel 1028 may carry signals and may be implemented using a wired connection or a wireless communication medium. Some embodiments of the channel may include telephone lines, cellular links, RF links, optical links, network interfaces, local or wide area networks, and other wired or wireless communication channels.

[0135] In this document, the terms “computer program medium” and “computer-usable medium” are used generally to refer to temporary or non-temporary media (e.g., memory 1008, storage device 1020, medium 1014, and channel 1028). These, and other, forms of computer program mediums or computer-usable media may relate to transmitting one or more sequences of one or more instructions to a processing device for execution. Such instructions embodied in a medium are generally referred to as “computer program code” or “computer program product” (which may be classified in the form of a computer program or other grouping). When executed, such instructions may enable computing module 1000 to perform features or functions of this application as described herein.

[0136] Methods and Systems The following methods, sensor electronic devices, and systems are provided.

[0137] Method 1: A computer-based method comprising receiving a signal from a sample sensor representing the host sample concentration, monitoring the signal, determining whether there is a change in the signal, and compensating for the change in the signal such that the display of the signal at least represents the host sample concentration.

[0138] Method 2: An embodiment of Method 1, further comprising determining the cause of the change in the signal.

[0139] Method 3: An embodiment of Method 2, wherein determining the cause of the change in the signal involves associating the change in the signal with an event identified by one or more sensors in the sample sensor system.

[0140] Method 4: An embodiment of Method 2 or 3, further comprising recording and transmitting information relating to the cause of the change in the signal and at least one of the changes in the signal to at least one of a remote server, a local data storage memory, and a display device.

[0141] Method 5: An embodiment of Method 1, wherein the change in the signal includes a noise signal component added to the signal representing the sample concentration of the host.

[0142] Method 6: An embodiment of Method 5, wherein the source of the noise signal component is located within the sample sensor system in which the sample concentration of the host is determined.

[0143] Method 7: An embodiment of Method 6, wherein the source of the noise signal component includes circuitry inside the sample sensor system.

[0144] Method 8: An embodiment of Method 5, wherein accounting for the change in the signal includes adding an offset current to the signal and noise signal components representing the sample concentration of the host, such that the signal and noise signal components representing the sample concentration of the host are shifted by an amount corresponding to the offset current.

[0145] Method 9: An embodiment of Method 5, further comprising relatively reducing the noise signal component by increasing the sensitivity of a sample sensor for measuring the sample concentration in the host.

[0146] Method 10: An embodiment of Method 9, wherein increasing the sensitivity of the sample sensor includes increasing the current range over which the sample sensor operates.

[0147] Method 11: An embodiment of Method 8, wherein the source of the noise signal component includes the added offset current.

[0148] Method 12: An embodiment of Method 11, further comprising determining the offset current by performing a calibration procedure to at least compensate for the noise signal component resulting from the addition of the offset current.

[0149] Method 13: An embodiment of Method 12, wherein the execution of the calibration procedure includes prohibiting the operation of the working electrode of the sample sensor for measuring the sample concentration in the host in order to enable the measurement of only the offset current.

[0150] Method 14: An embodiment of Method 13, wherein the execution of the calibration procedure further includes enabling the operation of the working electrode, measuring the sample concentration of the host including the offset current, and subtracting the measured offset current from the measured sample concentration of the host.

[0151] Method 15: An embodiment of Method 14 in which the calibration procedure is performed according to one of a predetermined schedule, on a one-time basis, or in real time.

[0152] Method 16: An embodiment of Method 1, wherein the change in the signal includes fluctuations caused by temperature drift of a sample sensor for measuring the sample concentration in the host.

[0153] Method 17: An embodiment of Method 16, further comprising performing a temperature calibration to compensate for variations in the offset current added to the signal representing the sample concentration of the host due to temperature.

[0154] Method 18: An embodiment of Method 16, wherein the temperature drift of the sample sensor is determined based on an impedance measurement of the reference electrode of the sample sensor.

[0155] Method 19: An embodiment of Method 5, further comprising capturing details of the noise signal component by overclocking the circuitry of the sample sensor for measuring the sample concentration of the host by reducing at least one of the sampling intervals in which the sample concentration of the host is measured.

[0156] Method 20: An embodiment of Method 5, wherein the source of the noise signal component includes a current flow induced by an artifact of the overall voltage difference between at least two electrodes of a sample sensor for measuring the sample concentration in the host.

[0157] Method 21: An embodiment of Method 5, further comprising implementing a guard band having the same voltage difference to compensate for the current flow induced by the artifact.

[0158] Method 22: An embodiment of Method 5, wherein the source of the noise signal component is outside the sample sensor system in which the host sample concentration is determined.

[0159] Method 23: Compensating for the noise signal component by at least one of the following: detecting the noise signal component outside the sample sensor system via one or more sensors; adding an offset current to the signal representing the sample concentration of the host and the noise signal component; and determining the offset current by performing a calibration procedure to compensate for the noise signal component resulting from the addition of the offset current. An embodiment of method 22 further includes the following:

[0160] Method 24: An embodiment of Method 1, wherein the change in the signal includes a spike in the host's sample concentration.

[0161] Method 25: An embodiment of Method 24, further comprising directly adjusting the sample concentration value by a predetermined adjustment amount based on one or more factors causing the spike.

[0162] Method 26: A method comprising comparing the current clock time with a previously stored clock time after an interruption in the operation of the sensor measurement circuit of a sample sensor system, synchronizing the current clock time with the previously stored clock time, and incrementing a timestamp associated with EGV data transfer based on the previously stored clock time.

[0163] Method 27: An embodiment of Method 26, wherein the real-time clock, whose current clock time is thereby determined, is reset by the interruption of the operation of the sensor measurement circuit, and the interruption of the operation of the sensor measurement circuit includes an electrostatic discharge event.

[0164] System 28: A system comprising a sample sensor suitable for transmitting sample concentration data, and a sensor measurement circuit suitable for receiving sample concentration data from the sensor and detecting changes in the sample concentration data, the sensor measurement circuit for compensating for fluctuations in the sample concentration data that exceed a predetermined threshold.

[0165] System 29: An embodiment of System 28, further comprising a memory adapted for storing information relating to the fluctuations in the sample concentration data, and a transmitter adapted for transmitting information relating to the fluctuations to at least one of a remote server and a display device adapted for showing abnormal fluctuations or information derived therefrom.

[0166] System 30: An embodiment of System 28 or 29, comprising one or more environmental sensors for determining environmental conditions that may be causing the fluctuations in the sample concentration data.

[0167] System 31: An embodiment of System 28 or 29, further comprising an offset current circuit adapted to add an offset current to a signal representing sample concentration data and a noise signal component associated with the fluctuation, such that the sample concentration data and the noise signal component are shifted to a level above zero.

[0168] System 32: An embodiment of System 31, wherein the offset current circuit is activated to add the offset current in response to a determination that the zero peak value associated with the noise signal component is greater than the signal representing the sample concentration data.

[0169] System 33: An embodiment of System 31, wherein the offset current circuit adds the offset current according to one or more programmed offset currents.

[0170] System 34: An embodiment of System 33, further comprising a processor adapted to compensate for the noise signal component and subtract the added offset current from the received sample concentration data to obtain sample concentration data representing the actual sample concentration without the noise signal component.

[0171] System 35: An embodiment of System 34, wherein the processor is further adapted to capture details of the noise signal component by overclocking the circuitry of the sample sensor, thereby reducing at least one of the sampling intervals in which the sample concentration data is measured.

[0172] System 36: An embodiment of System 28, further comprising a guard band having the same voltage difference as present between at least two electrodes of the sample sensor and compensating for current flow induced by artifacts across the entire voltage difference.

[0173] System 37: An embodiment of System 28, further comprising a processor adapted to directly adjust sample concentration data by predetermined adjustment amounts based on one or more factors causing the abnormal fluctuation.

[0174] Sensor electronic device 38: A sensor electronic device including a processor and an offset circuit configured to apply an offset current to a received sample concentration signal affected by noise in accordance with the processor's determination of the presence of the noise.

[0175] Sensor electronic device 39: An embodiment of the sensor electronic device 38, further comprising a calibration circuit that determines the offset current by compensating for noise generated by the offset circuit.

[0176] Sensor electronic device 40: The embodiment of the sensor electronic device 39, wherein the processor or one of the calibration circuits inhibits the operation of the working electrode of the sample sensor to measure the sample concentration of the host, enabling the measurement of only the offset current resulting in the sample concentration signal.

[0177] Sensor electronic device 41: An embodiment of the sensor electronic device 39, wherein the processor or one of the calibration circuits enables the operation of the working electrode to measure the sample concentration of the host including the offset current, and subtracts the measured offset current from the measured sample concentration of the host.

[0178] Sensor electronic device 42: An embodiment of the sensor electronic device 39, wherein the processor or one of the calibration circuits performs a temperature calibration to compensate for temperature-dependent fluctuations in the offset current.

[0179] An embodiment of the sensor electronic device 43 according to the sensor electronic device 39, further comprising an energy harvesting chip, a charging chip, and a mode selector for switching between wireless charging mode and battery power supply mode.

[0180] An embodiment of the sensor electronic device 43, wherein a wireless charger wirelessly drives the sensor electronic device via an energy harvesting chip adapted to collect power from the charging chip during a first mode.

[0181] Sensor electronic device 45: An embodiment of the sensor electronic device 44, wherein a battery supplies power to the sensor electronic device in a second mode, and the battery is bypassed in the first mode.

[0182] Method 46: A method comprising: receiving one or more operating parameters associated with a battery in a processor of a system operating under power provided by the battery; monitoring the performance characteristics of the battery; determining, based on the one or more received operating parameters, whether the monitored performance characteristics deviate from a reference performance characteristic; and wirelessly updating the one or more operating parameters in response to the determination that the monitored performance characteristics deviate from the reference performance characteristic.

[0183] Method 47: An embodiment of Method 46, wherein the reference performance characteristics include a known profile associated with the battery.

[0184] Method 48: An embodiment of Method 46, further comprising adapting the operation of a sensor electronic device powered by the battery in accordance with the updated performance characteristics of the battery.

[0185] Method 49: A method comprising: receiving one or more operating parameters representing a battery profile in a processor controlling a sensor measurement circuit; receiving boundary inputs based on the one or more operating parameters; determining whether the one or more received operating parameters are within the range of the received boundary inputs; and, if it is determined that the one or more received operating parameters are outside the range of the received boundary inputs, sending a notification to a user interface associated with the sensor measurement circuit that the one or more operating parameters require updating.

[0186] Method 50: An embodiment of Method 49, wherein the boundary input includes minimum and maximum expected performance characteristics associated with one or more operating parameters.

[0187] Method 51: A method comprising determining schedule information for the operation of a sample sensor system, identifying payload information associated with the operation, calculating the operating frequency of a charge pump according to the payload and schedule information, and instructing the charge pump to operate at the calculated operating frequency during the occurrence of the operation.

[0188] Method 52: An embodiment of Method 51, wherein the operation includes transmitting sensor data from the sample sensor system.

[0189] Although this disclosure is illustrated and described in detail in the drawings and above, such illustrations and descriptions should be considered illustrative or exemplary and not limiting. This disclosure is not limited to the embodiments disclosed. Variations of the disclosed embodiments can be understood and performed by those skilled in the art in practicing the requested disclosure from a study of the drawings, disclosure and the attached claims.

[0190] All references cited herein are incorporated herein by reference in their entirety. To the extent that any publications and patents or patent applications cited by reference conflict with any disclosures contained herein, this Specification is intended to supersede and / or take precedence over any such conflicting material.

[0191] Unless otherwise specified, all terms (including technical and scientific terms) should be given their ordinary and customary meanings to those skilled in the art, and should not be limited to special or customized meanings unless expressly so herein. It should be noted that the use of certain terms when describing specific features or aspects of the Disclosure should not be interpreted as meaning that the term is redefined herein to be limited to any specific feature of the function or aspect of the Disclosure to which the term relates. Terms and expressions used in this application and its variations should be interpreted as expandable, rather than restrictive, unless expressly stated, particularly in the appended claims. As such, the term “including” should be read as “including, without limitation,” “including but not limited to,” and so on. As used herein, the term “comprising” is synonymous with “including,” “containing,” or “characterized by,” and is inclusive or expandable, and does not exclude additional, undescribed elements or method steps. The term “having” should be interpreted as “having at lest.” The term “includes” should be interpreted as “includes but is not limited to.” The term “example” is used to provide typical examples of the items under consideration, and is not an exhaustive or restrictive list.Adjectives (such as “known,” “normal,” “standard,” etc., and similar terms) should not be interpreted as limiting the items described to items available during a given period or at a given point in time, but rather as encompassing known, normal, or standard technologies that may be available now or at any point in the future. And terms such as “preferably,” “preferred,” “desired,” or “desirable,” and similar terms should not be interpreted as meaning that a particular feature is decisive, essential, or even important to the structure or function of this disclosure. It should not be understood as meaning that, but rather as simply intended to highlight alternative or additional features that may or may not be used in a particular embodiment. Similarly, group items linked with the conjunction "and" should not be read as requiring any one of those items to be present in the group, but rather as "and / or" unless explicitly stated otherwise. Likewise, group items linked with the conjunction "or" should not be read as requiring mutual exclusivity among the group, but rather as "and / or" unless explicitly stated otherwise.

[0192] If a range of values ​​is given, it is understood that the upper and lower limits, as well as each value that falls between the upper and lower limits of the range, are included in the embodiment.

[0193] In substantially any use of plural and / or singular terms herein, a person skilled in the art can convert from plural to singular and / or singular to plural as appropriate to the context and / or use. Various singular / plural substitutions may be explicitly stated herein for clarity. The indefinite articles “a” or “an” do not exclude the plural. A single processor or other unit can perform the functions of several items detailed in the claims. The mere fact that certain means are detailed in different dependent claims does not imply that combinations of these means cannot be effectively used. No reference symbol in a claim should be construed as limiting scope.

[0194] It will be further understood by those skilled in the art that if a specific number is intended in the introduced claim, such intention is explicitly stated in the claim, and if such statement is not made, such intention does not exist. For example, to aid understanding, the following appended claims may introduce a claim by including the use of the introductory phrases “at least one” and “one or more.” However, even when the same claim includes the introductory phrases “one or more” or “at least one” and an indefinite article such as “a” or “an,” the use of such phrases should not be interpreted as meaning that the introduction of the claim by the indefinite article “a” or “an” is limited to any particular claim containing such introduced claim in relation to embodiments containing only such description (for example, “a” or “an” should normally be interpreted as meaning “at least one” or “one or more”). The same applies to the use of definite articles used to introduce a claim. In addition, even when a specific number is explicitly stated in an introduced claim, a person skilled in the art will recognize that such a statement should generally be interpreted as meaning at least the number stated (for example, if there is a statement that is merely “two descriptions” without other modifiers, it usually means at least two descriptions or two or more descriptions). Furthermore, in examples where notation similar to “at least one of A, B, and C, etc.” is used, such a structure is generally intended in a sense that a person skilled in the art will understand (for example, “a system having at least one of A, B, and C” includes, but is not limited to, a system having only A, only B, only C, both A and B, both A and C, both B and C, and / or all of A, B and C, etc.).In examples where notation similar to "at least one of A, B, or C" is used, such constructions are generally intended in a sense that a person skilled in the art would understand (for example, "a system having at least one of A, B, or C" includes, but is not limited to, systems having only A, only B, only C, both A and B, both A and C, both B and C, and / or all of A, B, and C). A person skilled in the art will further understand that substantially any disjunction and / or disjunction phrase representing two or more selectable terms should be understood as intended to include the possibility of including one of those terms, either of the terms, or both of the terms, whether in the description, in the claims, or in the drawings. For example, the phrase "A or B" will be understood to include the possibility of "A or B" or "A and B".

[0195] All numbers used in the specifications, such as the quantities of components and reaction conditions, should be understood to be modified in all examples by the term “approximately.” Therefore, unless otherwise indicated, the numerical parameters described herein are approximations that may vary depending on the desired properties to be obtained. At the very least, and not in any attempt to limit the scope of an application under the doctrine of equivalents to any claim of any application claiming priority to this application, each numerical parameter should be interpreted with regard to the number of significant figures and ordinary rounding methods.

[0196] Furthermore, although the foregoing has been described in some detail with figures and examples for clarity and understanding, it will be apparent to those skilled in the art that certain changes and modifications can be implemented. Accordingly, the descriptions and examples should not be construed as limiting the scope of this disclosure to specific embodiments and examples described herein, but rather are intended to cover all modifications and variations that accompany the true scope and spirit of this disclosure. [Explanation of symbols]

[0197] 100 Continuous Sample Monitoring Systems 122 Continuous Sample Sensor 124 Sample Sensor System 126 Sensor Electronic Device Module 128 "Uplink" signal 138 Long-distance downlink signal 140 Remote Servers

Claims

1. A first sensor configured to generate a first signal related to the host glucose concentration, A second sensor configured to generate a second signal related to the host's posture, A sensor electronic device operably connected to the first sensor and the second sensor, configured to generate first data from the first signal and second data from the second signal, A sensor system comprising a processor configured to detect that the host has rolled over the first sensor by (a) comparing the second data with a time, such that the host rolling over the first sensor is related to a sharp drop in the glucose reading of the first data due to oxygen deficiency at the implantation site of the first sensor, and (b) detecting a correlation between the first data and the second data.

2. The sensor system according to claim 1, wherein the processor is configured to detect a posture that causes compression of host tissue.

3. The sensor system according to claim 1, wherein the processor is configured to associate the attitude with fluctuations in the first signal.

4. The sensor system according to claim 1, wherein the processor is configured to detect a decrease in the first signal caused by oxygen deficiency in the first sensor.

5. The sensor system according to claim 2, wherein the processor is configured to detect the first signal fluctuation caused by compression of the host tissue.

6. The sensor system according to claim 1, wherein the second data indicates that the host is lying on at least a portion of the sensor system.

7. The sensor system according to claim 1, wherein the first sensor includes a transdermal glucose sensor.

8. The sensor system according to claim 1, wherein the second sensor includes an accelerometer.

9. The sensor system according to claim 8, wherein the accelerometer includes a three-axis accelerometer.

10. The sensor system according to claim 1, wherein the processor is configured to detect the reversed position of the sensor electronic device due to the host lying on the sensor electronic device.

11. The sensor system according to claim 8, further comprising a three-axis compass that works in conjunction with the accelerometer to determine the host's activity level.

12. The sensor system according to claim 1, further comprising a real-time clock.

13. The sensor system according to claim 1, wherein the processor is configured to detect the fluctuation of the first signal as a sharp drop in the raw sensor signal that is not caused by normal physiological changes.

14. The sensor system according to claim 1, wherein the sensor electronic device includes the processor.

15. A method for measuring the glucose concentration in a host, A transdermal sample sensor generates a first signal related to the glucose concentration of the host, Another sensor generates a second signal related to the orientation of the host, The sensor electronic device of the sample sensor system receives the first signal and the second signal, A method comprising: (a) comparing the second signal with a time, such that the host rolling over the transdermal sample sensor is related to a sharp drop in the glucose reading of the first signal due to oxygen deficiency at the implantation site of the transdermal sample sensor; and (b) detecting a correlation between the characteristics of the first signal and the characteristics of the second signal, thereby detecting that the host has rolled over the transdermal sample sensor.

16. The method according to claim 15, further comprising generating the second signal using the accelerometer, which is another sensor.

17. The method according to claim 16, wherein the processor detects the reversed position of the accelerometer due to the host lying on the transdermal sample sensor.

18. The method according to claim 15, wherein the processor detects that the host is lying on at least a portion of the sample sensor system.

19. The method according to claim 18, further comprising the processor supplying the host with a notification instructing the host to change its location.

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