This technical disclosure relates to a smartwatch that includes a non-invasive analyte sensor in addition to other smartwatch functionality.
A sensor that uses radio or microwave frequency bands of the electromagnetic spectrum for in vivo medical diagnostics is disclosed in U.S. Pat. No. 10,548,503. Additional examples of sensors that purport to be able to use radio or microwave frequency bands of the electromagnetic spectrum to detect a substance in a person are disclosed in U.S. Patent Application Publication 2019/0008422 and U.S. Patent Application Publication 2020/0187791.
A smartwatch and a system that uses the smartwatch are described. The smartwatch includes a non-invasive analyte sensor that is configured to non-invasively detect an analyte in a person wearing the smartwatch via spectroscopic techniques using non-optical frequencies such as in the radio or microwave frequency bands of the electromagnetic spectrum. The smartwatch also includes other functionality such as time keeping, date keeping, one or more additional sensors configured to sense one or more physiological properties of the wearer.
In some embodiments, data from the analyte sensor and data from the other functionality of the smartwatch can be collected and analyzed. In additional embodiments, the other/additional data can be collected using a second sensor, which may be a wearable sensor or a non-wearable sensor. Using the collected data, one or more correlations between the analyte data and the other data can be determined. The correlation(s) can aid a caregiver, such as a doctor or other caregiver, in a diagnoses of a medical condition of the wearer and/or determine a treatment plan for the wearer, and/or the correlations can provide information to the wearer in regulating their physiological condition, and/or the correlation(s) can be used for long term tracking of a physiological condition of the wearer.
The analyte sensor of the smartwatch can be used to detect the presence of the analyte of interest, as well an amount of the analyte or a concentration of the analyte within the wearer of the smartwatch. The analyte can include, but is not limited to, one or more of blood glucose, blood alcohol, white blood cells, or luteinizing hormone.
In addition to the non-invasive analyte sensor, the smartwatch can also include one or more additional sensors configured to sense one or more physiological properties of the wearer. Example of a physiological property that can be sensed include, but are not limited to, user temperature; user heart rate; user blood pressure; user oxygen saturation; or a bioelectric impedance. The smartwatch can also include one or more additional functionalities including, but not limited to, a camera; an accelerometer; a pedometer; a fitness/activity tracker; an altimeter; a barometer; a compass; a global positioning system; a sleep monitor; a fall sensor; a microphone; and a speaker.
In another embodiment, the one or more additional sensors that are configured to sense the one or more physiological properties of the wearer can be in a second wearable or non-wearable sensor separate from the smartwatch.
In one embodiment described herein, a smartwatch can include a housing portion having a touchscreen display on an upper face thereof, at least one rechargeable battery within the housing portion providing electrical power, and a non-invasive analyte sensor at least partially in the housing portion. The non-invasive analyte sensor can include at least one transmit antenna and at least one receive antenna, where the at least one transmit antenna is positioned and arranged to transmit a signal into a person wearing the smartwatch, and the signal is in a radio or microwave frequency range of the electromagnetic spectrum. The at least one receive antenna is positioned and arranged to detect a response resulting from transmission of the signal by the at least one transmit antenna into the person. The smartwatch further includes a first stored mobile application that interfaces with and controls operation of the non-invasive analyte sensor and whereby an analyte measurement obtained by the non-invasive analyte sensor can be displayed on the touchscreen display, a time-keeping circuit whereby a current time can be displayed on the touchscreen display, a date-keeping circuit whereby a current date can be displayed on the touchscreen display, and a wristband attached to the housing portion.
In another embodiment, a system can include the smartwatch described herein, and a data analysis system in electronic communication with and receiving data collected by the smartwatch. The data includes first data on an analyte detected by the non-invasive analyte sensor and second data collected by the smartwatch. In another embodiment, the second data can be collected by a second wearable or non-wearable sensor separate from the smartwatch. The data analysis system is programmed to determine one or more correlations between the first data and the second data. The data analysis system can be included in the smartwatch or it can be separate from the smartwatch.
The following is a detailed description of a smartwatch, a system that employs the smartwatch, and methods involving use of data collected by the smartwatch. A smartwatch as used herein refers to a digital watch that is worn around a user's wrist/arm, has a touchscreen display that allows the user to navigate watch functionality and perform actions by touching or hovering over the touchscreen. Examples of conventional smartwatches include, but are not limited to, the Apple Watch™, the Samsung Galaxy™ Watch, and the Fitbit™, and many others. The non-invasive analyte sensor described herein can be incorporated into any type of smartwatch.
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The smartwatch 10 displays various icons 24 on the touchscreen display 16. Each icon 24 represents an App (i.e. a mobile application) that can be launched (i.e. initiated) by selecting the icon 24, for example using either the user's finger or using the button 22. Each App controls a functionality of the smartwatch 10. For example, as described in further detail below, the smartwatch 10 can include a non-invasive analyte sensor 26 along with an App 28 (best seen in
The display 16 can also display information relating to the sensor 26, such as information on the sensor readings and/or information relating to the analysis of the data collected by the sensor 26. For example, the display 16 can display charts, number-based readings, data analysis outcomes, and other information.
The smartwatch 10 can also include at least one second or additional sensor 30 along with an associated App 32 (best seen in
Instead of the second sensor 30 being on the smartwatch 10, the second sensor 30 can be part of a sensing device that is separate from the smartwatch 10 as depicted in
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The transmit signal can be generated by a transmit circuit (not shown) that is controlled by a controller (not shown). Transmit circuits for generating transmit signals in the RF or microwave frequency range are well known in the art. In one embodiment, the transmit circuit can include, for example, a connection to the battery 46, a frequency generator, and optionally filters, amplifiers or any other suitable elements for a circuit generating an RF or microwave frequency electromagnetic signal. In an embodiment, the signal generated by the transmit circuit can have at least two discrete frequencies (i.e. a plurality of discrete frequencies), each of which is in the range from about 10 kHz to about 100 GHz. In another embodiment, each of the at least two discrete frequencies can be in a range from about 300 MHz to about 6000 MHz. In an embodiment, the transmit circuit can be configured to sweep through a range of frequencies that are within the range of about 10 kHz to about 100 GHz, or in another embodiment a range of about 300 MHz to about 6000 MHz. In an embodiment, the transmit circuit can be configured to produce a complex transmit signal, the complex signal including a plurality of signal components, each of the signal components having a different frequency. The complex signal can be generated by blending or multiplexing multiple signals together followed by transmitting the complex signal whereby the plurality of frequencies are transmitted at the same time. Further information on transmit antennas, transmit circuits and controllers can be found in U.S. Pat. No. 10,548,503, U.S. Patent Application Publication 2019/0008422, and U.S. Patent Application Publication 2020/0187791, the entire contents of each are incorporated herein by reference in their entirety.
The receive antenna(s) 52 is positioned, arranged, and configured to detect one or more electromagnetic response signals 56 that result from the transmission of the transmit signal 54 by the transmit antenna 50 into the user and impinging on an analyte. The receive antenna 52 can be an electrode or any other suitable receiver of electromagnetic signals in the radio frequency (RF) or microwave range. In an embodiment, the receive antenna 52 is configured to detect electromagnetic signals having at least two frequencies, each of which is in the range from about 10 kHz to about 100 GHz, or in another embodiment a range from about 300 MHz to about 6000 MHz. The receive antenna 52 can have any arrangement and orientation relative to the arm 20 that is sufficient to allow detection of the response signal(s) 56 to allow the analyte sensing to take place. In one non-limiting embodiment, the receive antenna 52 can be arranged to face in a direction that is substantially toward the arm 20.
A receive circuit (not shown) is electrically connectable to the receive antenna 52 and conveys the received response from the receive antenna 52 to the controller. The receive circuit can have any configuration that is suitable for interfacing with the receive antenna 52 to convert the electromagnetic energy detected by the receive antenna 52 into one or more signals reflective of the response signal(s) 56. The construction of receive circuits are well known in the art. The receive circuit can be configured to condition the signal(s) prior to providing the signal(s) to the controller, for example through amplifying the signal(s), filtering the signal(s), or the like. Accordingly, the receive circuit may include filters, amplifiers, or any other suitable components for conditioning the signal(s) provided to the controller. In an embodiment, at least one of the receive circuit or the controller can be configured to decompose or demultiplex a complex signal, detected by the receive antenna 52, including a plurality of signal components each at different frequencies into each of the constituent signal components. In an embodiment, decomposing the complex signal can include applying a Fourier transform to the detected complex signal. However, decomposing or demultiplexing a received complex signal is optional. Instead, in an embodiment, the complex signal detected by the receive antenna can be analyzed as a whole (i.e. without demultiplexing the complex signal) to detect the analyte as long as the detected signal provides enough information to make the analyte detection. Further information on receive antennas, and receive circuits can be found in U.S. Pat. No. 10,548,503, U.S. Patent Application Publication 2019/0008422, and U.S. Patent Application Publication 2020/0187791, the entire contents of each are incorporated herein by reference in their entirety.
With continued reference to
The analyte(s) detected by the sensor 26 can be any analyte that one may wish to detect that may be present in blood or interstitial fluid in the user's arm. The analyte(s) that is detected can include, for example, naturally occurring substances, artificial substances, metabolites, and/or reaction products. For example, the analyte(s) can include, but is not limited to, one or more of blood glucose; blood alcohol; white blood cells; luteinizing hormone; insulin; acarboxyprothrombin; acylcarnitine; adenine phosphoribosyl transferase; adenosine deaminase; albumin; alpha-fetoprotein; amino acid profiles (arginine (Krebs cycle), histidine/urocanic acid, homocysteine, phenylalanine/tyrosine, tryptophan); andrenostenedione; antipyrine; arabinitol enantiomers; arginase; benzoylecgonine (cocaine); biotinidase; biopterin; c-reactive protein; carnitine; pro-BNP; BNP; troponin; carnosinase; CD4; ceruloplasmin; chenodeoxycholic acid; chloroquine; cholesterol; cholinesterase; conjugated 1-β hydroxy-cholic acid; cortisol; creatine kinase; creatine kinase MM isoenzyme; cyclosporin A; 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, D-Punjab, beta-thalassemia, hepatitis B virus, HCMV, HTLV-1, Leber hereditary optic neuropathy, MCAD, RNA, PKU, Plasmodium vivax, sexual differentiation, 21-deoxycortisol); desbutylhalofantrine; dihydropteridine reductase; diptheria/tetanus antitoxin; erythrocyte arginase; erythrocyte protoporphyrin; esterase D; fatty acids/acylglycines; free β-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; 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, β); lysozyme; mefloquine; netilmicin; phenobarbitone; phenytoin; phytanic/pristanic acid; progesterone; prolactin; prolidase; purine nucleoside phosphorylase; quinine; reverse tri-iodothyronine (rT3); selenium; serum pancreatic lipase; sissomicin; somatomedin C; specific antibodies (adenovirus, anti-nuclear antibody, anti-zeta antibody, arbovirus, Aujeszky's disease virus, dengue virus, Dracunculus medinensis, Echinococcus granulosus, Entamoeba histolytica, enterovirus, Giardia duodenalisa, Helicobacter pylori, hepatitis B virus, herpes virus, HIV-1, IgE (atopic disease), influenza virus, Leishmania donovani, leptospira, measles/mumps/rubella, Mycobacterium leprae, Mycoplasma pneumoniae, Myoglobin, Onchocerca volvulus, parainfluenza virus, Plasmodium falciparum, polio virus, Pseudomonas aeruginosa, respiratory syncytial virus, rickettsia (scrub typhus), Schistosoma mansoni, Toxoplasma gondii, Trepenoma pallidium, Trypanosoma cruzi/rangeli, vesicular stomatis virus, Wuchereria bancrofti, yellow fever virus); specific antigens (hepatitis B virus, HIV-1); succinylacetone; sulfadoxine; theophylline; thyrotropin (TSH); thyroxine (T4); thyroxine-binding globulin; trace elements; transferrin; UDP-galactose-4-epimerase; urea; uroporphyrinogen I synthase; vitamin A; and zinc protoporphyrin.
The analyte(s) can also include one or more chemicals introduced into the user. The analyte(s) can include a marker such as a contrast agent, a radioisotope, or other chemical agent. The analyte(s) can include a fluorocarbon-based synthetic blood. The analyte(s) can include a drug or pharmaceutical composition, with non-limiting examples including ethanol; cannabis (marijuana, tetrahydrocannabinol, hashish); inhalants (nitrous oxide, amyl nitrite, butyl nitrite, chlorohydrocarbons, hydrocarbons); cocaine (crack cocaine); stimulants (amphetamines, methamphetamines, Ritalin, Cylert, Preludin, Didrex, PreState, Voranil, Sandrex, Plegine); depressants (barbiturates, methaqualone, tranquilizers such as Valium, Librium, Miltown, Serax, Equanil, Tranxene); hallucinogens (phencyclidine, lysergic acid, mescaline, peyote, psilocybin); narcotics (heroin, codeine, morphine, opium, meperidine, Percocet, Percodan, Tussionex, Fentanyl, Darvon, Talwin, Lomotil); designer drugs (analogs of fentanyl, meperidine, amphetamines, methamphetamines, and phencyclidine, for example, Ecstasy); anabolic steroids; and nicotine. The analyte(s) can include other drugs or pharmaceutical compositions. The analyte(s) can include neurochemicals or other chemicals generated within the body, such as, for example, ascorbic acid, uric acid, dopamine, noradrenaline, 3-methoxytyramine (3MT), 3,4-Dihydroxyphenylacetic acid (DOPAC), Homovanillic acid (HVA), 5-Hydroxytryptamine (5HT), and 5-Hydroxyindoleacetic acid (FHIAA).
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With continued reference to
The data analysis system 48, whether it is in the smartwatch 10, the mobile device 62 or the server 64, receives data relating to an analyte detected by the non-invasive analyte sensor of the smartwatch 10 and receives additional data collected by the smartwatch or by a separate sensor. The additional data can be data collected by the second sensor 30 (
In some embodiments, the analyte-related data and the additional data can be one-time readings taken at a particular time. In other embodiments, the analyte-related data and the additional data can be gathered over a sensing period. The sensing period can be any time period over which one may be able to determine a correlation between the analyte-related data collected by the smartwatch 10 and the additional data collected by the smartwatch 10. For example, the sensing period may be about equal to or greater than 1 hour, equal to or greater than 8 hours, equal to or greater than 24 hours, equal to or greater than 1 week, equal to or greater than 1 month, equal to or greater than 1 year, or shorter or longer sensing periods.
Correlations between the analyte-related data collected by the smartwatch 10 and the additional data can include, but are not limited to, determining changes in the analyte level (i.e. amount of analyte) relative to the additional data so that the wearer of the smartwatch may alter (increase or decrease) their analyte level, or determining lack of changes in the analyte level relative to the additional data so that the wearer of the smartwatch may maintain their analyte level. For example, if one assumes the analyte being detected by the analyte sensor of the smartwatch is blood glucose and the additional data is the heart rate of the user, the data analysis system 48 may determine that there is a correlation, based on the data provided to the data analysis system 48, between the blood glucose level and the heart rate including, but not limited to, the blood glucose level going down as the user's heart rate goes up. Based on this determined correlation, a signal can be sent to the smartwatch 10 (and/or to the user's mobile device 62) advising the user of this correlation and/or indicating to the user that the user should exercise more in order to reduce his or her blood glucose level. Alternatively, the data analysis system 48 could determine that the user's blood glucose level remains at a particular value over a range of heart rates in which case a signal can be sent to the smartwatch 10 (and/or to the user's mobile device 62) advising the user of this correlation and/or indicating to the user that the user should keep his or her heart rate in this range in order to maintain his or her blood glucose level.
Another example of a possible correlation between the analyte-related data and the additional data includes, but is not limited to, a correlation between blood glucose levels detected by the analyte sensor of the smartwatch and blood pressure levels. In this example, the data could indicate that the user's blood glucose increases as their blood pressure increases. Based on this determined correlation, a signal can be sent to the smartwatch 10 (and/or to the user's mobile device 62) advising the user of this correlation and/or indicating to the user that the user should take steps to reduce his or her blood pressure reduce his or her blood glucose level. Many other correlations between an analyte and other data collected by the smartwatch and optionally the separate second sensor 30 are possible.
In some embodiments, the analyte sensor of the smartwatch can be used to detect two or more analytes in the user, and the data can be analyzed to look for a correlation between the two analytes. For example, assuming the analyte sensor detects both blood glucose levels and blood alcohol levels, the data collected by the smartwatch may reveal a decrease or an increase in blood glucose levels with rising blood alcohol levels.
Referring to
A signal(s) can be generated based on the results of the analysis, and in step 78, the signal(s) can be sent to the smartwatch, either directly or via the user's mobile device. The signal(s) can cause the smartwatch and/or the mobile device to generate at least one signal that provides an indication to the user regarding the results of the data analysis. The signal generated by the smartwatch and/or the mobile device can be a visual signal (for example, a message, a numerical value, or a graphical display on the touchscreen display) and/or audible alarm or message. The signal(s) sent to the smartwatch can also include instructions to the user on steps to take to regulate the analyte, such as blood glucose.
The examples disclosed in this application are to be considered in all respects as illustrative and not limitative. The scope of the invention is indicated by the appended claims rather than by the foregoing description; and all changes which come within the meaning and range of equivalency of the claims are intended to be embraced therein.
Number | Date | Country | |
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63115178 | Nov 2020 | US |