Replaceable sensor system and method

Abstract

To provide a suitable replaceable sensor system and method.SOLUTION: Disclosed herein is a sensing system that may comprise a replaceable sensor element, a reader system, and optionally a mount for adhering the device to a patient or a connection device. Also disclosed herein are methods and designs for conveniently, e.g., magnetically, mounting a sensor board on a wearable system. Also disclosed herein are methods and designs for reading and writing signals from and to the sensor elements while attached to the wearable system for subsequent transmission and processing. Also disclosed herein are designs and methods for creating a FPC sensor board that is magnetically attachable using a magnetic core.SELECTED DRAWING: Figure 1A

Description

[Background technology]

[0001] (CROSS-REFERENCE TO RELATED APPLICATIONS) This application claims the benefit of U.S. Provisional Application No. 62 / 645,565, filed March 20, 2018, which application is incorporated herein by reference.

[0002] Noninvasive, rapid, and convenient methods of sensing signals (e.g., physiological signals) are increasingly becoming an area of ​​focus for healthcare, in clinical settings, or for the general consumer market. However, conventional monitoring systems may lack the capabilities (e.g., sensitivity, specificity, etc.) for detecting disease and / or body physiology, or the convenience required in today's world. For example, invasive methods may be necessary, or blood or urine may be required for monitoring. Thus, there may be a need for a noninvasive and effective method for monitoring body physiology or detecting disease, for example, via sweat. Summary of the Invention [Means for solving the problem]

[0003] Embodiments disclosed herein provide devices, systems, and methods for monitoring physiological signals. Disposable or replaceable sensors may be utilized in monitoring physiological signals with high sensitivity and / or specificity. Various physiological signals, including glucose or lactate, may be monitored conveniently and in real time without inconvenience to the user. For example, a user may wear a device (e.g., a patch or small attachment such as a wrist strap) anywhere on their body (e.g., as a wristband), and the device may monitor and detect sweat and screen physiological signals. Small, disposable or replaceable sensors may be beneficially provided that can be coupled to and detached from the device so that signals can be accurately and conveniently monitored.

[0004] According to some aspects of the present disclosure, a modular sensor is disclosed that may include a substrate, a plurality of contact electrodes provided on a surface of the substrate, and a plurality of sensing lines disposed between the plurality of contact electrodes and collectively forming a plurality of sensor elements, each sensor element comprising at least one sensing line extending longitudinally between a pair of contact electrodes, the modular sensor being configured to be operably and releasably coupled to a device for use as a sensing device.

[0005] In some embodiments, the modular sensor is configured to function as an active sensing unit when electronically coupled to the device. In some embodiments, the modular sensor is configured to fit within a recessed housing on the device. In some embodiments, the modular sensor is protected by the recessed housing. In some embodiments, the substrate includes a ferrous metal or alloy and the device includes a magnetic material. In some embodiments, the modular sensor is configured to be coupled and held in place on the device via attractive forces between the magnetic material and the ferrous metal or alloy.

[0006] In some embodiments, at least one of the plurality of sensing lines comprises a nanoscale material. In some embodiments, at least one of the plurality of sensing lines comprises graphene. In some embodiments, each of the plurality of sensing lines comprises graphene. In some embodiments, the plurality of sensor elements are configured to detect one or more markers in a fluid. In some embodiments, the plurality of sensor elements are configured to detect one or more biomarkers in a biological fluid of a subject. In some embodiments, the plurality of sensor elements are configured to detect the same biomarker.

[0007] In some embodiments, the biological fluid includes sweat or interstitial fluid acquired through the surface of the skin. In some embodiments, the biological fluid includes breath or lung-derived water vapor acquired from exhalation onto the device. In some embodiments, each of the multiple sensor elements is configured to detect a different biomarker. In some embodiments, the multiple sensor elements are configured to operate in a multi-channel multiplexed configuration. In some embodiments, the one or more biomarkers include electrolytes, glucose, lactate, IL6, cytokines, HER2, cortisol, ZAG, cholesterol, vitamins, proteins, drug molecules, metabolites, peptides, amino acids, DNA, RNA, aptamers, enzymes, biomolecules, chemical molecules, synthetic molecules, or combinations thereof. In some embodiments, the one or more biomarkers include electrolytes, glucose, and lactate.

[0008] In some embodiments, the biological fluid sample comprises sweat, breath, saliva, earwax, urine, semen, plasma, biological fluids, chemical fluids, air samples, gas samples, or combinations thereof. In some embodiments, the biological fluid sample comprises sweat or breath. In some embodiments, the plurality of sensor elements are configured to detect one or more biomarkers upon contact with the biological fluid sample. In some embodiments, the plurality of sensor elements are capable of detecting one or more biomarkers in a non-invasive manner without requiring puncturing the subject's skin to extract the biological fluid sample.

[0009] In some embodiments, the plurality of sensor elements are configured to detect the presence and concentration of one or more biomarkers in substantially real time when the device is worn on or in proximity to the subject. In some embodiments, data indicative of the presence and concentration of the one or more biomarkers is collected and stored by the device. In some embodiments, the data is collected and stored on the device over a period of time while the device is worn on or in proximity to the subject. In some embodiments, the modular sensor is configured to be operably and releasably coupled to the device without the use of tools. In some embodiments, the modular sensor is configured to be operably and releasably coupled to the device within less than 10 seconds.

[0010] Also disclosed is a sensing apparatus that may include a plurality of modular sensors configured to detect one or more biomarkers in a biological fluid sample from a subject when the device is worn by or in proximity to the subject, and a device configured to interchangeably and releasably couple to a selected modular sensor from the plurality of modular sensors, the device configured to receive, store, and transmit sensing signals from the modular sensors.

[0011] In some embodiments, the device comprises a transmitter configured to transmit the sensed signal over a network. In some embodiments, the transmitter is configured to transmit the sensed signal to a mobile device associated with and in proximity to the subject. In some embodiments, the device comprises a recessed housing configured to receive and support the modular sensor. In some embodiments, the device is releasably coupled to the modular sensor via a magnetic attachment mechanism. In some embodiments, the magnetic attachment mechanism includes a magnetic material provided on at least one of the modular sensor and the device, and an ferrous metal or alloy provided on at least one of the modular sensor and the device. In some embodiments, the device is configured to be releasably coupled to a strap or patch, the strap or patch configured to be worn on a portion of the subject's body. In some embodiments, the plurality of modular sensors comprises at least one graphene-based sensor.

[0012] Also disclosed is a device, which may include a processing module configured to operably couple to at least one sensor selected from the group consisting of a plurality of discrete biological or chemical sensors, the two or more different sensors for detecting two or more different target analytes being interchangeably and releasably attachable to the device depending on the type of target analyte to be detected from a subject's sample collected on the device while the subject is wearing or in proximity to the device.

[0013] In some embodiments, the sample comprises sweat, saliva, breath, blood, or other biological fluid of the subject. In some embodiments, the different target analytes comprise different biomarkers and / or chemical agents. In some embodiments, the biomarkers are selected from the group consisting of electrolytes, glucose, and lactate. In some embodiments, at least one of the sensors is configured to measure pH or ion concentration of the sample. In some embodiments, at least one of the sensors comprises a graphene-based sensor. In some embodiments, the plurality of discrete sensors are heterogeneous sensors comprising (i) at least one graphene-based sensor and (ii) at least one non-graphene-based sensor. In some embodiments, the processing module is configured to detect and monitor the level of a first target analyte when a first sensor specific to the first target analyte is attached to the device. In some embodiments, the processing module is configured to switch to detecting and monitoring a second target analyte when the first sensor is removed from the device and replaced with a second sensor specific to the second target analyte. In some embodiments, the processing module is located onboard the device and is configured to process sensor data substantially in real time as the data is collected by the at least one sensor to detect and monitor levels of one or more target analytes. In some embodiments, the device comprises a graphical display for displaying the detected levels of the one or more target analytes. In some embodiments, the processing module is configured to transmit the processed sensor data to a remote device, server, or third-party entity. In some embodiments, the processing module comprises a recommendation engine configured to prescribe corrective or mitigating measures based on the detected levels of the one or more target analytes.

[0014] In some embodiments, a modular sensing kit is disclosed. The modular sensing kit may include (1) a device and (2) a plurality of discrete biological or chemical sensors as claimed in any aspect or embodiment. In some embodiments, a quick-release mechanism provided on the device allows different discrete sensors to be manually attached to and detached from the device without the use of tools. In some embodiments, the multiple discrete sensors are provided separately from the device. In some embodiments, one or more of the discrete sensors are configured for single use with the device and are disposed of after each use by a subject. In some embodiments, one or more of the discrete sensors are configured for multiple use with the device and can be reused and re-used for multiple use by a subject. In some embodiments, the multiple discrete sensors have different sensitivities to the same or different target analytes. In some embodiments, the multiple discrete sensors include a first sensor and a second sensor both configured to detect a target analyte, the first sensor having a higher sensitivity than the second sensor. In some embodiments, the first sensor is capable of detecting a substantially lower level or concentration of the target analyte compared to the second sensor.

[0015] Also disclosed is a device that may include a processing module operably coupled to three or more different discrete biological or chemical sensors, the processing module configured to selectively activate the three or more different discrete biological or chemical sensors in different multiplexed configurations depending on a desired type of sensing application of interest.

[0016] In some embodiments, the different multiplexing configurations allow multiple different target analytes to be detected from a subject's sample collected on the device when the subject is wearing or in proximity to the device. In some embodiments, the different multiplexing configurations enable increased sensitivity in detecting and monitoring the different target analytes. In some embodiments, the processing module is configured to selectively activate a fewer number of biological or chemical sensors to reduce power consumption of the device. In some embodiments, the processing module is configured to selectively activate a greater number of biological or chemical sensors to improve sensitivity in detecting and monitoring the different target analytes. In some embodiments, the three or more discrete sensors comprise a first sensor for detecting a first target analyte, a second sensor for detecting a second target analyte, and a third sensor for detecting a third target analyte. In some embodiments, the processing module is configured to selectively activate at least two of the first, second, and third sensors. In some embodiments, the processing module is configured to selectively activate (1) the first and second sensors in a first multiplexed configuration, (2) the second and third sensors in a second multiplexed configuration, or (3) the first and third sensors in a third multiplexed configuration. In some embodiments, the processing module is capable of detecting (1) the presence and (2) concentrations of two or more different target analytes at and above 1 fg / L in a sample having a volume of less than 1 μL collected from a subject on the device when the subject is wearing or in proximity to the device. In some embodiments, the device is capable of detecting the presence and concentrations of two or more different target analytes in less than 1 second.

[0017] Also disclosed is a method of fabricating a modular sensor that may include providing a sensor substrate comprising at least two electrodes disposed on a surface of the substrate, depositing a layer of graphene on the surface of the sensor substrate between the at least two electrodes, metallizing at least a portion of the layer of graphene at or near the at least two electrodes, passivating at least a portion of the layer of graphene with a passivating polymer, and optionally functionalizing at least a portion of the layer of graphene, wherein functionalizing the layer of graphene is performed with a receptor layer, the receptor layer being sensitive to a target analyte.

[0018] In some embodiments, the receptor layer comprises a receptor selected from the group consisting of pyrene boronic acid (PBA), pyrene N-hydroxysuccinimide ester (pyrene-NHS), organic chemicals, aromatic molecules, cyclic molecules, enzymes, proteins, antibodies, viruses, single-stranded DNA (ssDNA), aptamers, inorganic materials, synthetic molecules, and biological molecules. In some embodiments, the target analyte comprises an electrolyte, glucose, lactate, IL6, cytokine, HER2, cortisol, ZAG, cholesterol, vitamin, protein, drug molecule, metabolite, peptide, amino acid, DNA, RNA, aptamer, enzyme, biomolecule, chemical molecule, synthetic molecule, or combination thereof. In some embodiments, the substrate comprises polyamide, polyethylene terephthalate (PET), dimethylpolysiloxane (PDMS), poly(methyl methacrylate) (PMMA), other plastics, silicon dioxide, silicon, glass, aluminum oxide, sapphire, germanium, gallium arsenide, indium phosphide, silicon-germanium alloys, fabric, textile, silk, paper, cellulose-based materials, insulators, metals, semiconductors, or combinations thereof. In some embodiments, the substrate is flexible. In some embodiments, the passivating polymer comprises acrylic, PMMA, silicone, polysilicone, PDMS, rubber, hot melt copolymer, EVA copolymer, ethylene acrylate, PET, polyamide, PTFE, fluoropolymer, thermoplastic, gel, hydrogel, polypropylene, polyethylene, polyolefin, polyvinyl chloride, polyester, polyurethane, styrene block copolymer, polycaprolactone, polycarbonate, fluoropolymer, silicone rubber, thermoplastic elastomer, polypyrrole, or combinations thereof. In some embodiments, the passivating polymer is polyurethane. In some embodiments, depositing the graphene layer includes heating the substrate above a fusion temperature of a functionalized inverse polymer disposed between the graphene layer and the substrate. In some embodiments, the method further includes functionalizing a first portion of the substrate near the graphene layer with a hydrophilic material. In some embodiments, a second portion of the substrate near the graphene layer is not functionalized with a hydrophilic material.In some embodiments, the second portion of the substrate is functionalized with a hydrophobic material.

[0019] According to some aspects of the present disclosure, a modular sensor is provided that may include a substrate, a plurality of contact electrodes provided on a surface of the substrate, and a plurality of sensing lines disposed between the plurality of contact electrodes and collectively forming a plurality of sensor elements, each sensor element comprising at least one sensing line extending longitudinally between a pair of contact electrodes, the modular sensor being configured to be operably and releasably coupled to a device for use as a wearable sensing device.

[0020] In some embodiments, the modular sensor is configured to function as an active sensing unit when electronically coupled to the device. In some embodiments, the modular sensor is configured to fit within a recessed housing on the device. In some embodiments, the modular sensor is protected by the recessed housing when the device is worn by a subject. In some embodiments, the substrate includes a ferrous metal or alloy, and the device includes a magnetic material. In some embodiments, the modular sensor is configured to be coupled to and held in place on the device via an attractive force between the magnetic material and the ferrous metal or alloy. In some embodiments, at least one of the plurality of sensing lines includes graphene. In some embodiments, each of the plurality of sensing lines includes graphene.

[0021] In some embodiments, the multiple sensor elements are configured to detect one or more biomarkers in a biological fluid sample from a subject when the device is worn by the subject. In some embodiments, the multiple sensor elements are configured to detect the same biomarker. In some embodiments, each of the multiple sensor elements is configured to detect a different biomarker. In some embodiments, the multiple sensor elements are configured to operate in a multi-channel multiplexed configuration. In some embodiments, the one or more biomarkers include electrolytes, glucose, lactate, IL6, cytokines, HER2, cortisol, ZAG, cholesterol, vitamins, proteins, drug molecules, metabolites, peptides, amino acids, DNA, RNA, aptamers, enzymes, biomolecules, chemical molecules, synthetic molecules, or combinations thereof. In some embodiments, the one or more biomarkers include electrolytes, glucose, and lactate. In some embodiments, the biological fluid sample includes sweat, breath, saliva, earwax, urine, semen, plasma, biofluids, chemical fluids, air samples, gas samples, or combinations thereof. In some embodiments, the biological fluid sample includes sweat or breath. In some embodiments, the plurality of sensor elements are configured to detect one or more biomarkers when in contact with a biological fluid sample.

[0022] In some embodiments, the multiple sensor elements are capable of detecting one or more biomarkers in a non-invasive manner without requiring puncturing the subject's skin to extract a biological fluid sample. In some embodiments, the multiple sensor elements are configured to detect the presence and concentration of one or more biomarkers in substantially real time when the device is worn on the subject. In some embodiments, data indicative of the presence and concentration of the one or more biomarkers is collected and stored by the device. In some embodiments, the data is collected and stored on the device over a period of time that the device is worn on the subject. In some embodiments, the modular sensor is configured to be operably and releasably coupled to the device without the use of tools. In some embodiments, the modular sensor is configured to be operably and releasably coupled to the device within less than 10 seconds.

[0023] Also disclosed is a wearable sensing device that may include a plurality of modular sensors configured to detect one or more biomarkers in a biological fluid sample of a subject when the device is worn by the subject, and a device configured to interchangeably and releasably couple to a modular sensor selected from the plurality of modular sensors, the device configured to receive and store sensing signals from the modular sensors.

[0024] In some embodiments, the device comprises a transmitter configured to transmit the sensed signal over a network. In some embodiments, the transmitter is configured to transmit the sensed signal to a mobile device associated with and in proximity to the subject. In some embodiments, the device comprises a recessed housing configured to receive and support the modular sensor. In some embodiments, the device is releasably coupled to the modular sensor via a magnetic attachment mechanism. In some embodiments, the magnetic attachment mechanism includes a magnetic material provided on at least one of the modular sensor and the device, and an ferrous metal or alloy provided on at least one of the modular sensor and the device. In some embodiments, the device is configured to be releasably coupled to a strap, the strap configured to be worn on a portion of the subject's body. In some embodiments, the plurality of modular sensors comprises at least one graphene-based sensor.

[0025] Also disclosed is a wearable device, which may include a processing module configured to operably couple to at least one sensor selected from the group consisting of a plurality of discrete biological or chemical sensors, the two or more different sensors for detecting two or more different target analytes being interchangeably and releasably attachable to the wearable device when the subject is wearing the device depending on the type of target analyte to be detected from the subject's sample collected on the wearable device.

[0026] In some embodiments, the sample comprises sweat, saliva, breath, blood, or other biological fluid of the subject. In some embodiments, the different target analytes comprise different biomarkers and / or chemical agents. In some embodiments, the biomarkers are selected from the group consisting of electrolytes, glucose, and lactate. In some embodiments, at least one of the sensors is configured to measure pH or ion concentration of the sample. In some embodiments, at least one of the sensors comprises a graphene-based sensor. In some embodiments, the plurality of discrete sensors is a heterogeneous sensor comprising (i) at least one graphene-based sensor and (ii) at least one non-graphene-based sensor.

[0027] In some embodiments, the processing module is configured to detect and monitor levels of a first target analyte when a first sensor specific to the first target analyte is attached to the wearable device. In some embodiments, the processing module is configured to switch to detecting and monitoring a second target analyte when the first sensor is removed from the wearable device and replaced with a second sensor specific to the second target analyte. In some embodiments, the processing module is located onboard the wearable device and configured to process sensor data substantially in real time as data is collected by the at least one sensor to detect and monitor levels of one or more target analytes. In some embodiments, the wearable device comprises a graphical display for displaying the detected levels of one or more target analytes. In some embodiments, the processing module is configured to transmit the processed sensor data to a remote device, a server, or a third-party entity. In some embodiments, the processing module comprises a recommendation engine configured to prescribe corrective or mitigating measures based on the detected levels of one or more target analytes.

[0028] Also disclosed is a modular sensing kit. The modular sensing kit may include (1) a wearable device and (2) a plurality of discrete biological or chemical sensors of any embodiment disclosed herein. In some embodiments, a quick-release mechanism provided on the wearable device allows different discrete sensors to be manually attached to and detached from the wearable device without the use of tools. In some embodiments, the multiple discrete sensors are provided separately from the wearable device. In some embodiments, one or more of the discrete sensors are configured for single use with the wearable device and are disposed of after each use by a subject. In some embodiments, one or more of the discrete sensors are configured for multiple use with the wearable device and can be reused and re-used for multiple uses by a subject. In some embodiments, the multiple discrete sensors have different sensitivities to the same or different target analytes. In some embodiments, the multiple discrete sensors include a first sensor and a second sensor both configured to detect a target analyte, the first sensor having a higher sensitivity than the second sensor. In some embodiments, the first sensor is capable of detecting a substantially lower level or concentration of the target analyte compared to the second sensor.

[0029] Also disclosed is a wearable device. The wearable device may include a processing module operably coupled to three or more different discrete biological or chemical sensors, the processing module configured to selectively activate the three or more different discrete biological or chemical sensors in different multiplexed configurations depending on the subject's desired type of sensing application. In some embodiments, the different multiplexed configurations allow multiple different target analytes to be detected from a subject's sample collected on the wearable device when the subject is wearing the device. In some embodiments, the different multiplexed configurations enable increased sensitivity in detecting and monitoring the different target analytes. In some embodiments, the processing module is configured to selectively activate a fewer number of biological or chemical sensors to reduce power consumption of the wearable device. In some embodiments, the processing module is configured to selectively activate a greater number of biological or chemical sensors to improve sensitivity in detecting and monitoring the different target analytes. In some embodiments, the three or more discrete sensors include a first sensor for detecting a first target analyte, a second sensor for detecting a second target analyte, and a third sensor for detecting a third target analyte.

[0030] In some embodiments, the processing module is configured to selectively activate at least two of the first, second, and third sensors. In some embodiments, the processing module is configured to selectively activate (1) the first and second sensors in a first multiplexed configuration, (2) the second and third sensors in a second multiplexed configuration, or (3) the first and third sensors in a third multiplexed configuration. In some embodiments, the processing module is capable of detecting (1) the presence and (2) concentrations of two or more different target analytes at 1 femtogram / liter (fg / L) or greater in a sample having a volume of less than 1 microliter (μL) collected from a subject on the wearable device when the subject is wearing the device. In some embodiments, the wearable device is capable of detecting the presence and concentrations of two or more different target analytes within less than 1 second.

[0031] Also disclosed is a method of fabricating a modular sensor that may include providing a sensor substrate comprising at least two electrodes disposed on a surface of the substrate, depositing a layer of graphene on the surface of the sensor substrate between the at least two electrodes, metallizing at least a portion of the layer of graphene at or near the at least two electrodes, passivating at least a portion of the layer of graphene with a passivating polymer, and optionally functionalizing at least a portion of the layer of graphene, wherein functionalizing the layer of graphene is performed with a receptor layer, the receptor layer being sensitive to a target analyte.

[0032] In some embodiments, the receptor layer comprises a receptor selected from the group consisting of pyrene boronic acid (PBA), pyrene N-hydroxysuccinimide ester (pyrene-NHS), organic chemicals, aromatic molecules, cyclic molecules, enzymes, proteins, antibodies, viruses, single-stranded DNA (ssDNA), aptamers, inorganic materials, synthetic molecules, and biological molecules. In some embodiments, the target analyte comprises an electrolyte, glucose, lactate, IL6, cytokine, HER2, cortisol, ZAG, cholesterol, vitamin, protein, drug molecule, metabolite, peptide, amino acid, DNA, RNA, aptamer, enzyme, biomolecule, chemical molecule, synthetic molecule, or combination thereof. In some embodiments, the substrate comprises polyamide, polyethylene terephthalate (PET), dimethylpolysiloxane (PDMS), poly(methyl methacrylate) (PMMA), other plastics, silicon dioxide, silicon, glass, aluminum oxide, sapphire, germanium, gallium arsenide, indium phosphide, silicon-germanium alloys, fabric, textile, silk, paper, cellulose-based materials, insulators, metals, semiconductors, or combinations thereof. In some embodiments, the substrate is flexible. In some embodiments, the passivating polymer comprises acrylic, PMMA, silicone, polysilicone, PDMS, rubber, hot melt copolymer, EVA copolymer, ethylene acrylate, PET, polyamide, PTFE, fluoropolymer, thermoplastic, gel, hydrogel, polypropylene, polyethylene, polyolefin, polyvinyl chloride, polyester, polyurethane, styrene block copolymer, polycaprolactone, polycarbonate, fluoropolymer, silicone rubber, thermoplastic elastomer, polypyrrole, or combinations thereof. In some embodiments, the passivating polymer is polyurethane.

[0033] In some embodiments, depositing the graphene layer includes heating the substrate above a fusion temperature of a functionalized inverse polymer disposed between the graphene layer and the substrate. In some embodiments, the method further includes functionalizing a first portion of the substrate near the graphene layer with a hydrophilic material. In some embodiments, a second portion of the substrate near the graphene layer is not functionalized with a hydrophilic material. In some embodiments, the second portion of the substrate is functionalized with a hydrophobic material.

[0034] Thus, in one aspect, a disposable sensor may be provided. The disposable sensor may include a substrate, two or more contact electrodes disposed on a surface of the substrate, and a sensor element disposed between the two or more contact electrodes, the substrate being approximately 5 cm 3 Contains a volume equal to or less than

[0035] In some embodiments, the volume is about 0.5 cm 3 In some embodiments, the sensor element comprises graphene. In some embodiments, the sensor is configured to detect glucose, lactate, or other biomarkers. In some embodiments, the sensor is configured to contact sweat, saliva, or breath and screen for disease or micronutrient information. In some embodiments, the sensor comprises a contact area configured to contact a user's finger. In some embodiments, the sensor comprises a magnet.

[0036] In another aspect, a transmitter may be provided that includes a receiving port for receiving a disposable sensor, the receiving port including a mechanism for coupling to the disposable sensor, a processor operably coupled to the receiving port, and an outer housing.

[0037] In some embodiments, the mechanism comprises a magnet. In some embodiments, the transmitter is about 100 cm 3 In some embodiments, the transmitter has a volume equal to or less than about 50 cm 3In some embodiments, the transmitter comprises a volume equal to or less than 100 μm. In some embodiments, the transmitter comprises a coupling mechanism for coupling with a strap. In some embodiments, the strap is a wrist strap. In some embodiments, the processor is configured to receive the signal from the disposable sensor and screen for disease or micronutrient information. In some embodiments, the processor is configured to screen for disease or micronutrient information in real time.

[0038] In another aspect, a system for sensing a signal is provided, and may include a disposable sensor, a transmitter having a sensor-receiving portion for receiving the disposable sensor, and an attachment having a transmitter-receiving portion for receiving the transmitter.

[0039] It should be understood that different aspects of the invention can be understood individually, collectively, or in combination with one another. The various aspects of the invention described herein may be applied to any of the specific applications described below, or for any other type of sensor or device.

[0040] Other objects and features of the present invention will become apparent upon review of the specification, claims, and accompanying drawings. The present invention provides, for example, the following. (Item 1) 1. A modular sensor comprising: A substrate; a plurality of contact electrodes provided on a surface of the substrate; a plurality of sensing lines disposed between the plurality of contact electrodes and collectively forming a plurality of sensor elements, each sensor element comprising at least one sensing line extending longitudinally between a pair of contact electrodes; Equipped with The modular sensor is configured to be operably and releasably coupled to a device for use as a sensing device. (Item 2) Item 1, wherein the modular sensor is configured to function as an active sensing unit when electronically coupled to the device. (Item 3) Item 10. The modular sensor of item 1, wherein the modular sensor is configured to fit within a recessed housing on the device. (Item 4) Item 4. The modular sensor of item 3, wherein the modular sensor is protected by the recessed housing. (Item 5) Item 10. The modular sensor of item 1, wherein the substrate comprises a ferrous metal or alloy and the device comprises a magnetic material. (Item 6) Item 6. The modular sensor of item 5, wherein the modular sensor is configured to be coupled and held in place on the device via an attractive force between the magnetic material and the ferrous metal or alloy. (Item 7) Item 10. The modular sensor of item 1, wherein at least one of the plurality of sensing lines comprises a nanoscale material. (Item 8) Item 8. The modular sensor of item 7, wherein at least one of the plurality of sensing lines comprises graphene. (Item 9) Item 9. The modular sensor of item 8, wherein each of the plurality of sensing lines comprises graphene. (Item 10) Item 10. The modular sensor of item 1, wherein the plurality of sensor elements are configured to detect one or more markers in a fluid. (Item 11) Item 10. The modular sensor of item 1, wherein the plurality of sensor elements are configured to detect one or more biomarkers in a biological fluid of a subject. (Item 12) Item 12. The modular sensor of item 11, wherein the multiple sensor elements are configured to detect the same biomarker. (Item 13) Item 12. The modular sensor of item 11, wherein the biological fluid comprises sweat or interstitial fluid obtained through the surface of the skin. (Item 14) Item 12. The modular sensor of item 11, wherein the biological fluid comprises breath or lung-derived water vapor obtained from exhalation onto the device. (Item 15) Item 12. The modular sensor of item 11, wherein each of the plurality of sensor elements is configured to detect a different biomarker. (Item 16) Item 12. The modular sensor of item 11, wherein the plurality of sensor elements are configured to operate in a multi-channel multiplexed configuration. (Item 17) Item 12. The modular sensor of item 11, wherein the one or more biomarkers include an electrolyte, glucose, lactate, IL6, cytokine, HER2, cortisol, ZAG, cholesterol, vitamin, protein, drug molecule, metabolite, peptide, amino acid, DNA, RNA, aptamer, enzyme, biomolecule, chemical molecule, synthetic molecule, or combination thereof. (Item 18) Item 18. The modular sensor of item 17, wherein the one or more biomarkers include electrolytes, glucose, and lactate. (Item 19) Item 12. The modular sensor of item 11, wherein the biological fluid sample comprises sweat, breath, saliva, earwax, urine, semen, plasma, biofluids, chemical fluids, air samples, gas samples, or combinations thereof. (Item 20) 20. The modular sensor of claim 19, wherein the biological fluid sample comprises sweat or breath. (Item 21) Item 12. The modular sensor of item 11, wherein the plurality of sensor elements are configured to detect the one or more biomarkers when in contact with the biological fluid sample. (Item 22) Item 12. The modular sensor of item 11, wherein the plurality of sensor elements are capable of detecting the one or more biomarkers in a non-invasive manner without requiring puncturing the subject's skin to extract the biological fluid sample. (Item 23) Item 12. The modular sensor of item 11, wherein the plurality of sensor elements are configured to detect the presence and concentration of the one or more biomarkers in substantially real time when the device is worn on or in proximity to the subject. (Item 24) Item 24. The modular sensor of item 23, wherein data indicative of the presence and concentration of the one or more biomarkers is collected and stored by the device. (Item 25) Item 25. The modular sensor of item 24, wherein the data is collected and stored on the device over a period of time while the device is worn on or in proximity to the subject. (Item 26) Item 10. The modular sensor of item 1, wherein the modular sensor is configured to be operably and releasably coupled to the device without the use of tools. (Item 27) Item 10. The modular sensor of item 1, wherein the modular sensor is configured to be operably and releasably coupled to the device within less than 10 seconds. (Item 28) A sensing device, comprising: a plurality of modular sensors configured to detect one or more biomarkers in a biological fluid sample of the subject when the device is worn by or in proximity to the subject; a device configured to interchangeably and releasably couple to a selected modular sensor from the plurality of modular sensors, the device configured to receive, store, and transmit sensed signals from the modular sensor; A sensing device comprising: (Item 29) Item 29. The sensing apparatus of item 28, wherein the device comprises a transmitter configured to transmit the sensing signal over a network. (Item 30) Item 29. The sensing apparatus of item 28, wherein the transmitter is configured to transmit the sensing signal to a mobile device associated with and in proximity to the object. (Item 31) Item 29. The sensing apparatus of item 28, wherein the device comprises a recessed housing configured to receive and support the modular sensor. (Item 32) Item 29. The sensing apparatus of item 28, wherein the device is releasably coupled to the modular sensor via a magnetic attachment mechanism. (Item 33) Item 33. The sensing apparatus of item 32, wherein the magnetic attachment mechanism includes a magnetic material provided on at least one of the modular sensor and the device, and a ferrous metal or alloy provided on at least one of the modular sensor and the device. (Item 34) Item 33. The sensing apparatus of item 32, wherein the device is configured to be releasably coupled to a strap or patch, the strap or patch being configured to be worn on a portion of the subject's body. (Item 35) Item 33. The sensing device of item 32, wherein the plurality of modular sensors comprises at least one graphene-based sensor. (Item 36) A device, a processing module configured to operably couple to at least one sensor selected from the group consisting of a plurality of discrete biological or chemical sensors; Equipped with A device in which two or more different sensors for detecting two or more different target analytes are interchangeably and releasably attachable to the device depending on the type of target analyte to be detected from a subject's sample collected on the device when the subject is wearing or in proximity to the device. (Item 37) 37. The device of claim 36, wherein the sample comprises sweat, saliva, breath, blood, or other biological fluid of the subject. (Item 38) 37. The device of claim 36, wherein the different target analytes comprise different biomarkers and / or chemical agents. (Item 39) Item 39. The device of item 38, wherein the biomarker is selected from the group consisting of electrolytes, glucose, and lactate. (Item 40) Item 37. The device of item 36, wherein at least one of the sensors is configured to measure pH or ion concentration of the sample. (Item 41) Item 37. The device of item 36, wherein at least one of the sensors comprises a graphene-based sensor. (Item 42) Item 37. The device of item 36, wherein the plurality of discrete sensors are heterogeneous sensors comprising: (i) at least one graphene-based sensor; and (ii) at least one non-graphene-based sensor. (Item 43) 37. The device of claim 36, wherein the processing module is configured to detect and monitor the level of a first target analyte when a first sensor specific to the first target analyte is attached to the device. (Item 44) Item 44. The device of item 43, wherein the processing module is configured to switch to detecting and monitoring the second target analyte when the first sensor is removed from the device and replaced by a second sensor specific to the second target analyte. (Item 45) Item 45. The device of item 44, wherein the processing module is located onboard the device and is configured to process sensor data substantially in real time as the data is collected by the at least one sensor to detect and monitor levels of one or more target analytes. (Item 46) 46. ​​The device of claim 45, wherein the device comprises a graphical display for displaying the detected levels of the one or more target analytes. (Item 47) Item 46. The device of item 45, wherein the processing module is configured to transmit the processed sensor data to a remote device, server, or third party entity. (Item 48) 46. ​​The device of claim 45, wherein the processing module comprises a recommendation engine configured to prescribe a corrective or mitigating action to the subject based on the detected levels of the one or more target analytes. (Item 49) A modular sensing kit comprising: (1) a device; and (2) a plurality of discrete biological or chemical sensors according to item 36. (Item 50) 50. The sensing kit of item 49, wherein a quick release mechanism provided on the device allows different discrete sensors to be manually attached to and detached from the device without the use of tools. (Item 51) Item 50. The sensing kit of item 49, wherein the plurality of discrete sensors are provided separately from the device. (Item 52) 50. The sensing kit of claim 49, wherein one or more of the discrete sensors are configured for single use with the device and are disposed of after each use by the subject. (Item 53) 50. The modular sensing kit of claim 49, wherein one or more of the discrete sensors are configured for multiple use with the device and are capable of being reused and re-used in multiple use contacts by the subject. (Item 54) 50. The sensing kit of item 49, wherein the plurality of discrete sensors have different sensitivities to the same or different target analytes. (Item 55) Item 50. The sensing kit of item 49, wherein the plurality of discrete sensors comprises a first sensor and a second sensor both configured to detect a target analyte, the first sensor having a higher sensitivity than the second sensor. (Item 56) 56. The sensing kit of item 55, wherein the first sensor is capable of detecting a substantially lower level or concentration of the target analyte compared to the second sensor. (Item 57) A device, A processing module operably coupled to three or more different discrete biological or chemical sensors. Equipped with The device, wherein the processing module is configured to selectively activate the three or more different discrete biological or chemical sensors in different multiplexed configurations depending on a desired type of sensing application of interest. (Item 58) 58. The device of claim 57, wherein the different multiplexed configurations allow multiple different target analytes to be detected from the subject's sample collected on the device when the subject is wearing or in proximity to the device. (Item 59) 58. The device of claim 57, wherein the different multiplexed configurations enable increased sensitivity in the detection and monitoring of the different target analytes. (Item 60) Item 58. The device of item 57, wherein the processing module is configured to selectively activate fewer of the biological or chemical sensors to reduce power consumption of the device. (Item 61) Item 58. The device of item 57, wherein the processing module is configured to selectively activate a greater number of the biological or chemical sensors to improve sensitivity in detecting and monitoring the different target analytes. (Item 62) Item 58. The device of item 57, wherein the three or more discrete sensors comprise a first sensor for detecting a first target analyte, a second sensor for detecting a second target analyte, and a third sensor for detecting a third target analyte. (Item 63) Item 63. The device of item 62, wherein the processing module is configured to selectively activate at least two of the first, second, and third sensors. (Item 64) Item 64. The device of item 63, wherein the processing module is configured to selectively activate (1) the first and second sensors in a first multiplexed configuration, (2) the second and third sensors in a second multiplexed configuration, or (3) the first and third sensors in a third multiplexed configuration. (Item 65) 58. The device of claim 57, wherein the processing module is capable of detecting (1) the presence and (2) concentrations of two or more different target analytes at 1 fg / L or greater in a sample having a volume of less than 1 μL collected from the subject on the device when the subject is wearing or in proximity to the device. (Item 66) 66. The device of claim 65, wherein the device is capable of detecting the presence and concentration of the two or more different target analytes within less than one second. (Item 67) 1. A method of fabricating a modular sensor, comprising: (a) providing a sensor substrate, the sensor substrate comprising at least two electrodes disposed on a surface of the substrate; (b) depositing a layer of graphene on a surface of the sensor substrate between the at least two electrodes; (c) metallizing at least a portion of the graphene layer at or near the at least two electrodes; (d) passivating at least a portion of the graphene layer with a passivating polymer; (e) optionally functionalizing at least a portion of the graphene layer, wherein functionalizing the graphene layer is performed with a receptor layer, the receptor layer being sensitive to a target analyte; A method comprising: (Item 68) 68. The method of claim 67, wherein the receptor layer comprises a receptor selected from the group consisting of pyrene boronic acid (PBA), pyrene N-hydroxysuccinimide ester (pyrene-NHS), organic chemicals, aromatic molecules, cyclic molecules, enzymes, proteins, antibodies, viruses, single-stranded DNA (ssDNA), aptamers, inorganic materials, synthetic molecules, and biological molecules. (Item 69) 68. The method of claim 67, wherein the target analyte comprises an electrolyte, glucose, lactate, IL6, a cytokine, HER2, cortisol, ZAG, cholesterol, a vitamin, a protein, a drug molecule, a metabolite, a peptide, an amino acid, DNA, RNA, an aptamer, an enzyme, a biomolecule, a chemical molecule, a synthetic molecule, or a combination thereof. (Item 70) 68. The method of claim 67, wherein the substrate comprises polyamide, polyethylene terephthalate (PET), dimethylpolysiloxane (PDMS), poly(methyl methacrylate) (PMMA), other plastics, silicon dioxide, silicon, glass, aluminum oxide, sapphire, germanium, gallium arsenide, indium phosphide, an alloy of silicon and germanium, fabric, textile, silk, paper, a cellulose-based material, an insulator, a metal, a semiconductor, or a combination thereof. (Item 71) Item 71. The method of item 70, wherein the substrate is flexible. (Item 72) 68. The method of claim 67, wherein the passivating polymer comprises acrylic, PMMA, silicone, polysilicone, PDMS, rubber, hot melt copolymer, EVA copolymer, ethylene acrylate, PET, polyamide, PTFE, fluoropolymer, thermoplastic, gel, hydrogel, polypropylene, polyethylene, polyolefin, polyvinyl chloride, polyester, polyurethane, styrene block copolymer, polycaprolactone, polycarbonate, fluoropolymer, silicone rubber, thermoplastic elastomer, polypyrrole, or a combination thereof. (Item 73) 73. The method of claim 72, wherein the passivating polymer is a polyurethane. (Item 74) 71. The method of claim 70, wherein depositing the graphene layer comprises heating the substrate above a fusion temperature of a functional inverse polymer disposed between the graphene layer and the substrate. (Item 75) Item 71. The method of item 70, further comprising functionalizing a first portion of the substrate adjacent the graphene layer with a hydrophilic material. (Item 76) Item 76. The method of item 75, wherein a second portion of the substrate adjacent the graphene layer is not functionalized with the hydrophilic material. (Item 77) Item 77. The method of item 76, wherein the second portion of the substrate is functionalized with a hydrophobic material.

[0041] (Incorporated by reference) All publications, patents, and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference. [Brief explanation of the drawings]

[0042] The novel features of the invention are set forth with particularity in the appended claims. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are utilized, and the accompanying drawings of which:

[0043] [Figure 1A] FIG. 1A illustrates a transmitter module comprising a sensor of the present disclosure that may be integrated into a wearable attachment in the form of an armband, according to some embodiments.

[0044] [Figure 1B] FIG. 1B illustrates a transmitter module comprising a sensor of the present disclosure that may be integrated into a wearable attachment in the form of a patch, according to some embodiments.

[0045] [Figure 1C] FIG. 1C illustrates a transmitter module comprising a sensor of the present disclosure that may be integrated with a patch placed on the back of a connection device, according to some embodiments.

[0046] [Figure 2] FIG. 2 shows an isometric view of a sensor, according to some embodiments.

[0047] [Figure 3A] FIG. 3A illustrates a top view of a sensor, according to some embodiments.

[0048] [Figure 3B] FIG. 3B illustrates a side view of a sensor, according to some embodiments.

[0049] [Figure 3C] FIG. 3C illustrates a bottom view of the sensor, according to some embodiments.

[0050] [Figure 4]4A, 4B, and 4C illustrate additional examples of sensors, according to some embodiments.

[0051] [Figure 5] 5A and 5B illustrate examples of a sensor substrate with a single sensor element and an example of a sensor substrate with multiplexed sensor elements, according to some embodiments.

[0052] [Figure 6A] FIG. 6A illustrates a first example of a transmitter module, according to an embodiment.

[0053] [Figure 6B] FIG. 6B illustrates a top view of a transmitter module, according to some embodiments.

[0054] [Figure 6C] FIG. 6C illustrates a side view of a transmitter module, according to some embodiments.

[0055] [Figure 6D] FIG. 6D illustrates a bottom view of a transmitter module without a sensor mounted thereon, according to some embodiments.

[0056] [Figure 6E] FIG. 6E illustrates a bottom view of a transmitter with a sensor module mounted thereon, according to some embodiments.

[0057] [Figure 7A] FIG. 7A illustrates an exploded view of the interior of a transmitter module, according to some embodiments.

[0058] [Figure 7B] FIG. 7B illustrates a side view of the interior of the transmitter along a slice through the transmitter, according to some embodiments.

[0059] [Figure 7C] FIG. 7C illustrates an isometric view of the transmitter with the top housing removed, according to some embodiments.

[0060] [Figure 7D] FIG. 7D illustrates a top view of the transmitter with the top housing removed, according to some embodiments.

[0061] [Figure 7E] FIG. 7E illustrates a side view of the transmitter with the top housing removed, according to some embodiments.

[0062] [Figure 8] 8A, 8B, and 8C illustrate a second exemplary transmitter module, according to some embodiments.

[0063] [Figure 9A] FIG. 9A illustrates an exploded view of the interior of a second example transmitter module, according to some embodiments.

[0064] [Figure 9B] FIG. 9B illustrates a side view of the interior of a second example transmitter module along a slice through the transmitter, according to some embodiments.

[0065] [Figure 10A] FIG. 10A illustrates a transmitter module comprising a sensor of the present disclosure integrated into a wearable armband, according to some embodiments.

[0066] [Figure 10B] FIG. 10B illustrates a bottom view of a biosensing system, according to some embodiments.

[0067] [Figure 10C] FIG. 10C illustrates a transmitter module of the present disclosure that is removable from a wearable armband, according to some embodiments.

[0068] [Figure 10D] FIG. 10D illustrates a wearable armband with a strap mechanism engaged, according to some embodiments.

[0069] [Figure 11] 11A, 11B, and 11C illustrate a second example of a wearable armband, according to some embodiments.

[0070] [Figure 12A] FIG. 12A illustrates an example of a top view of a patch mount with a transmitter module mounted thereon, according to some embodiments.

[0071] [Figure 12B] FIG. 12B illustrates an example of a patch mount with the transmitter module decoupled from the patch mount, according to some embodiments.

[0072] [Figure 12C] FIG. 12C illustrates a diagram of an integrated sensor patch system, according to some embodiments.

[0073] [Figure 13] 13A, 13B, 13C, and 13D illustrate examples of patch systems that can be coupled to a transmitter module, which can also be coupled to an armband, according to some embodiments.

[0074] [Figure 14] FIG. 14 illustrates a wearable device of the present disclosure connecting with two connection devices, according to some embodiments.

[0075] [Figure 15] FIG. 15 illustrates an example connection device that is programmed or otherwise configured to interface with a transmitter module, according to some embodiments.

[0076] [Figure 16A] FIG. 16A shows a transmitter module being decoupled from a docking station, according to some embodiments.

[0077] [Figure 16B] FIG. 16B shows a transmitter module coupled to a docking station, according to some embodiments.

[0078] [Figure 17A] FIG. 17A shows a transmitter module being decoupled from a docking station, according to some embodiments.

[0079] [Figure 17B] FIG. 17B shows a transmitter module coupled to a docking station, according to some embodiments. DETAILED DESCRIPTION OF THE INVENTION

[0080] A non-invasive, rapid, and convenient method of sensing a signal (e.g., a physiological signal) may be desirable. For example, there is a need for screening for disease and / or generally monitoring body physiology without using blood or urine in the general population, patients (e.g., diabetics), and athletes. The present disclosure provides devices, systems, and methods for non-invasively, rapidly, and conveniently monitoring physiological signals with high sensitivity and / or specificity. In one example, a system or device provided herein may sense a biomarker such as glucose level or osmolality. For example, the system or device may non-invasively measure glucose and / or electrolytes in real time from other bodily fluids such as sweat or saliva.

[0081] The systems and methods of the present disclosure may detect biological fluids. In some examples, the biological fluids include solutions with polar molecules, gases with polar molecules, target sensing analytes, or combinations thereof. In some examples, the biological fluids include sweat, breath, saliva, earwax, urine, semen, plasma, interstitial fluid, lung-derived water vapor, biofluids, chemical fluids, air samples, gas samples, or combinations thereof. In some embodiments, the target analytes include electrolytes, glucose, lactate, IL6, cytokines, HER2, cortisol, ZAG, cholesterol, vitamins, proteins, drug molecules, metabolites, peptides, amino acids, DNA, RNA, aptamers, enzymes, biomolecules, chemical molecules, synthetic molecules, or combinations thereof.

[0082] The system or device may also be worn unobtrusively (e.g., daily) in a convenient patch or strap form factor. The device may be worn, synchronized (e.g., with a server), and used to track the user's health or general physical condition in real time. The user may take further action, if desired, using the information provided by the device.

[0083] The system may transmit data using Bluetooth® and may interact with a user, for example, using a screen or one or more light-emitting diodes (LEDs). The transmitter module of the system may include a processing module and, optionally, an outer housing. The housing may house the sensor writer / reader assembly, associated electronics, a communication device, and / or a magnet to facilitate attachment of the sensor to the transmitter.

[0084] The sensor may be removably coupled to the transmitter. The sensor may include a sensor substrate, electrodes, and a sensor element such as graphene. The weight of the biosensing system may be negligible, for example, equal to or less than approximately 500 g, 400 g, 300 g, 200 g, 150 g, 120 g, 100 g, 80 g, 60 g, 40 g, 30 g, 20 g, 10 g, 5 g, 4 g, 3 g, 2 g, or 1 g. Optionally, the sensor may be a disposable sensor. Alternatively, or in addition, the sensor may be a replaceable sensor. For example, the sensor may be used, cleaned or treated, and used again. While disposable sensors are primarily discussed herein, it should be understood that details and / or descriptions discussed with respect to disposable sensors may also be applicable to replaceable sensors.

[0085] As described throughout, the present systems, devices, and methods provide a non-invasive, rapid, and convenient way of sensing signals, which can be provided by one or more of the following: 1) a replaceable magnetic sensor substrate; 2) a flexible printed circuit material with built-in sensor electrodes and metal vias folded around a magnetic iron sheet; 3) a sensor substrate with alternating hydrophobic and hydrophilic regions to promote sweat specificity / absorbency; 4) metal contact and passivation layer thickness and application method; 5) a dual conductive layer strategy: graphene, conductive layer 1, curing, conductive layer 2, then passivation; 6) a constant current of 5-200 microamps across the sensor and an 8-bit or higher voltage readout; or 7) a wearable mounting unit: a band and a patch.

[0086] Biosensors

[0087] The biosensor of the present disclosure may detect biological fluids. In some examples, the biological fluids include solutions with polar molecules, gases with polar molecules, target sensing analytes, or combinations thereof. In some examples, the biological fluids include sweat, breath, saliva, earwax, urine, semen, plasma, interstitial fluid, lung-derived water vapor, biofluids, chemical fluids, air samples, gas samples, or combinations thereof. In some embodiments, the target analytes include electrolytes, glucose, lactate, IL6, cytokines, HER2, cortisol, ZAG, cholesterol, vitamins, proteins, drug molecules, metabolites, peptides, amino acids, DNA, RNA, aptamers, enzymes, biomolecules, chemical molecules, synthetic molecules, or combinations thereof.

[0088] In some cases, the biosensors of the present disclosure may be portable. In some cases, the biosensors may be in proximity to the subject. In some cases, the biosensors may be carried by the user. In some cases, the biosensors may be attached to a connection device, such as those disclosed elsewhere herein, which may be carried by the user. In some cases, the biosensors may be a wearable device, which may be coupled to the user.

[0089] 1A, 1B, and 1C illustrate the coupling of systems and devices of the present disclosure to a user and a connected device, according to some embodiments. The systems and devices of the present disclosure may be biosensing systems. The biosensing systems may be configured to monitor various physiological signals, such as glucose or lactate levels. The biosensing systems may monitor a user's electrolyte levels. The biosensing systems may monitor these signals by receiving bodily fluids, such as sweat, breath, or saliva. The systems or devices referenced herein may be referred to as SweatSmart® systems. SweatSmart® systems may also be collectively referred to as SweatSmart® devices. In some instances, the sensors may be disposable, while the transmitter and forearm attachment may not.

[0090] In one aspect, a wearable sensing device is provided that may include a plurality of modular sensors configured to detect one or more biomarkers in a biological fluid sample of a subject when the device is worn by the subject, and a device configured to interchangeably and releasably couple to a plurality of modular sensors selected from the modular sensors, the device configured to receive and store sensing signals from the modular sensors.

[0091] As illustrated in FIG. 1A , the transmitter module 200 comprising the sensor 100 of the present disclosure may be integrated into a wearable attachment in the form of an armband 300. The band can be designed to be worn around the forearm, side arm, lower back, leg, etc. using mechanisms such as Velcro® or a strap mechanism. The bottom layer of the band can be built with a wavy silicone pattern to prevent slippage while on the skin. Pores can be built into the band for breathability. A cavity, e.g., a hole, can be provided in the band for inserting the transmitter module 200 from the bottom side of the band. Once the transmitter module 200 (with the sensor 100) is inserted into the band and tightly fitted, the band can be strapped around the forearm or other desired area on the skin for continuous monitoring of metabolites, including glucose and other markers from sweat.

[0092] As shown in FIG. 1B , the transmitter module 200 comprising the sensor 100 of the present disclosure may be integrated into a wearable attachment in the form of a patch 400. The patch 400 may comprise an adhesive layer coupled to a mounting portion. The mounting portion may comprise a cavity with an opening toward the skin. The transmitter module 200 (with the sensor 100) can be inserted onto the patch from the top side and mated using a mechanism such as a magnetic or mechanical mechanism. For example, the transmitter module can be snapped onto the sensor substrate (e.g., of the patch) using a combination of magnetic and mechanical force. The adhesive protective film can be peeled off and then placed on the skin for continuous disease monitoring from sweat. While a patch configured to receive a transmitter is described, it should be understood that the patch may also comprise an integrated transmitter, as described elsewhere herein. For example, the patch may comprise a fully integrated transmitter that is not removable from the patch.

[0093] Although biosensing systems utilizing wrist strap and patch configurations are described herein, it should be understood that the biosensing system may have any configuration. For example, the biosensing system may be integrated into an armband, headband, leg strap, chest strap, ankle band, etc. The biosensing system may also be integrated into a piece of clothing, such as a compression garment, such as a sock, shirt, underwear, or undershirt. The biosensing system may also be utilized to monitor skin adjacent to the ankle, calf muscles, knee, quadriceps, hamstrings, lower back, obliques, ribs, intercostal muscles, sternum, clavicle, pectoral muscles, deltoids, shoulders, latissimus dorsi, biceps, triceps, elbow, forearm, or wrist.

[0094] In some cases, the biosensor of the present disclosure may not be physically connected to a user. For example, in some cases, the biosensor may be a stand-alone device. For example, the biosensor may be attached to a connectivity device, as disclosed elsewhere herein. For example, a biosensor that may not be physically connected to a user may be a breath sensor. For example, a biosensor that may not be physically connected to a user may be used to analyze biological fluids collected from a user (e.g., blood, amniotic fluid, etc.) and placed on a sensor, such as a modular sensor. The biosensor may be proximate to the user. For example, a biosensor that may not be physically connected to a user may be an environmental sensor. In some cases, the transmitter module 200 with the sensor 100 may be a stand-alone device. In some cases, a patch system of the present disclosure may be used to attach the transmitter module 200 or an integrated transmitter module 200 to a connectivity device. In some cases, a strap as disclosed herein may be utilized to attach the transmitter and sensor to a connectivity device. In some cases, the attachment devices of the present disclosure may be used sensor side up to expose the sensor to airborne biological fluids such as breath.

[0095] 1C, a transmitter module 200 including a sensor of the present disclosure can be integrated with a patch 400 placed on the back of a connectivity device 500, such as a cell phone, for breath sensing applications. It is contemplated that the breath sensing system of the present disclosure may be integrated into a watch, may be freestanding and have a clip for attachment to clothing, may be worn on a neck cord or chain, etc.

[0096] According to some aspects of the present disclosure, a modular sensor (e.g., sensor 100) is provided. The modular sensor may include a substrate, a plurality of contact electrodes provided on a surface of the substrate, and a plurality of sensing lines disposed between the plurality of contact electrodes and collectively forming a plurality of sensor elements, each sensor element comprising at least one sensing line extending longitudinally between a pair of contact electrodes, the modular sensor being configured to be operably and releasably coupled to a device for use as a wearable sensing device.

[0097] Disclosed herein is a modular sensing kit. The kit may include one or more of the wearable attachments, sensors, and transmitter modules of the present disclosure. The modular sensing kit may include (1) a wearable device (e.g., an attachment mechanism) and (2) multiple discrete biological or chemical sensors (e.g., sensors 100) of any embodiment disclosed herein. In some embodiments, a quick-release mechanism provided on the wearable device allows different discrete sensors to be manually attached to and detached from the wearable device without the use of tools.

[0098] In some embodiments, a plurality of discrete sensors (e.g., sensor 100) are provided separately from the wearable device. In some embodiments, one or more of the discrete sensors are configured for single use with the wearable device and are disposed of after each use in contact with the subject. In some embodiments, one or more of the discrete sensors are configured for multiple use with the wearable device and can be reused and re-used in multiple uses in contact with the subject. In some embodiments, the plurality of discrete sensors have different sensitivities to the same or different target analytes. In some embodiments, the plurality of discrete sensors comprises a first sensor and a second sensor both configured to detect the target analyte, the first sensor having a higher sensitivity than the second sensor. In some embodiments, the first sensor is capable of detecting a substantially lower level or concentration of the target analyte compared to the second sensor.

[0099] Sensor

[0100] 2, 3A, 3B, 3C, 4A, 4B, 4C, 5A, and 5B illustrate a sensor 100 according to some embodiments. In some embodiments, the sensor 100 is a modular sensor. The modular sensor may be configured to function as an active sensing unit when electronically coupled to a device. In some embodiments, the modular sensor is configured to fit within a recessed housing on the device. In some embodiments, the modular sensor is protected by the recessed housing when the device is worn by a subject. In some embodiments, the substrate includes a ferrous metal or alloy, and the device includes a magnetic material. In some embodiments, the modular sensor is configured to be coupled to and held in place on the device via attractive forces between the magnetic material and the ferrous metal or alloy.

[0101] In some embodiments, at least one of the plurality of sensing lines comprises a nanoscale material (e.g., graphene). In some embodiments, each of the plurality of sensing lines comprises a nanoscale material (e.g., graphene). In some embodiments, the plurality of sensing lines may comprise graphene, carbon nanotubes, molybdenum sulfide, boron nitride, metal dichalcogenides, phosphorene, nanoparticles, quantum dots, fullerenes, 2D nanoscale materials, 3D nanoscale materials, 0D nanoscale materials, 1D nanoscale materials, or any combination thereof.

[0102] In some embodiments, the plurality of sensor elements are configured to detect one or more biomarkers in a biological fluid sample from a subject when the device is worn by the subject. In some embodiments, the plurality of sensor elements are configured to detect the same biomarker. In some embodiments, each of the plurality of sensor elements is configured to detect a different biomarker. In some embodiments, the biological fluid sample comprises sweat or breath. In some embodiments, the plurality of sensor elements are configured to detect one or more biomarkers when in contact with the biological fluid sample.

[0103] In some embodiments, the plurality of sensor elements are capable of detecting one or more biomarkers in a non-invasive manner without requiring puncturing the subject's skin to extract a biological fluid sample. In some embodiments, the plurality of sensor elements are configured to detect the presence and concentration of one or more biomarkers in substantially real time when the device is worn on the subject. In some embodiments, data indicative of the presence and concentration of the one or more biomarkers is collected and stored by the device. In some embodiments, the data is collected over a period of time that the device is worn on the subject and stored on the device. In some embodiments, the modular sensor is configured to be operably and releasably coupled to the device without the use of tools. In some embodiments, the modular sensor is configured to be operably and releasably coupled to the device within less than 10 seconds.

[0104] The sensor may be removably coupled to the transmitter. The sensor may include a sensor substrate, electrodes, and a sensor element, such as graphene. The weight of the biosensing system may be negligible, e.g., equal to or less than approximately 500 g, 400 g, 300 g, 200 g, 150 g, 120 g, 100 g, 80 g, 60 g, 40 g, 30 g, 20 g, 10 g, 5 g, 4 g, 3 g, 2 g, or 1 g. Optionally, the sensor may be a disposable sensor. Alternatively, or in addition, the sensor may be a replaceable sensor. For example, the sensor may be used, cleaned or treated, and used again. While disposable sensors are primarily discussed herein, it should be understood that details and / or descriptions discussed with respect to disposable sensors may also be applicable to replaceable sensors.

[0105] FIG. 2 shows an isometric view of a sensor 100, according to some embodiments. As described herein, the sensor 100 may be configured to be removably coupled to a transmitter module 200. The sensor may include a sensor substrate 101, electrode contacts 103, a sensor element 105, and a cutout 107. Optionally, the sensor element may include graphene. The sensor may be a non-invasive sensor and may be utilized to screen bodily fluids for disease and micronutrient information. The sensor may include a biochemical sensor element that functions to detect glucose, lactate, electrolytes, and / or other biomarkers from sweat, breath, saliva, etc. The sensor may have a minimal footprint and a small form factor. For example, the sensor may be approximately 50 cm 3 , 40cm 3 , 30cm 3 , 20cm 3 , 18cm 3 , 16cm 3 , 14cm 3 , 12cm 3 , 10cm 3 , 9cm 3 , 8cm 3 , 7cm 3 , 6cm 3 , 5cm 3 , 4cm 3 , 3cm 3 , 2cm 3 , 1cm 3 The sensor 100 may have a volume equal to or less than 100 mm, or any volume therebetween. The sensor 100 may be replaceable. The sensor 100 may be disposable. In some cases, the sensor may be disposable, while the transmitter module 200 and the wearable attachment 300 may not.

[0106] As shown, the sensor 100 may include a sensor substrate 101. As disclosed herein, the substrate 101 can be polyamide, polyethylene terephthalate (PET), dimethylpolysiloxane (PDMS), poly(methyl methacrylate) (PMMA), other plastics, silicon dioxide, silicon, glass, aluminum oxide, sapphire, germanium, gallium arsenide, indium phosphide, an alloy of silicon and germanium, fabric, textile, silk, paper, a cellulose-based material, an insulator, a metal, a semiconductor, or any combination thereof. The substrate can be rigid, flexible, or any combination thereof. In some embodiments, the substrate can be a flexible substrate and the graphene layer can be epitaxially deposited, such as by exfoliation and deposition.

[0107] As shown, the sensor 100 may include a notch 107. The notch 107 may aid in alignment of the sensor 100 with the transmitter module 200. The notch on the sensor substrate may aid in alignment of the sensor as it is installed into the transmitter module. The notch may define the orientation in which the sensor may be attached to the transmitter module, for example, with the biosensor element facing outward. Such a design may prevent any damage to the sensor element.

[0108] FIG. 3A illustrates a top view of a sensor 100, according to some embodiments. As shown, the sensor may include electrodes 109 that enable coupling with a transmitter module 200 described herein. The electrodes may be integrated into the substrate. The electrodes may include metal contacts. For example, the sensor's electrodes may be configured to couple to the transmitter's electrode contacts, allowing electrical signals to be transmitted and / or received between the two. Metal contact areas may be integrated into the backside of the substrate to enable electrical connection of the transmitter module to a sensor reading system. The surface area of ​​the backside metal contacts can be fabricated to be larger than the pogo pin tip area on the transmitter module to ensure a robust electrical connection between the sensor substrate and the transmitter.

[0109] The sensor may include one or more magnetic components. For example, the sensor substrate itself may be magnetic. In some embodiments, the sensor substrate may include an integrated magnetic element, such as an integrated ferrous material. The substrate may include an integrated sensor electrode with a metal via. For example, the electrode 109 may be a metal via. The via may be formed around an iron or another ferrous material 110. The ferrous material may be an iron core. The via may be formed around an iron sheet. A magnetic sensor substrate with integrated metal contacts can be formed by folding a flexible printed circuit (FPC) substrate and adhesively bonding it around a thin iron sheet.

[0110] In some examples, the sensor may be coupled to the transmitter using one or more of the following attachment mechanisms: clips, latches, snaps, straps, tethers, tape, Velcro®, hook and loop, tack features, screw fasteners, tabs, magnetic fasteners, or any other suitable connection mechanism such as elastic bands and adhesives.

[0111] The thickness, surface area, and overall design of the substrate can be adapted for user ease of handling. In some embodiments, there may be an additional contact surface area for picking up with a finger, so that it may be possible to pick up the sensor without touching the biochemical sensor element area. The sensor may have a first dimension 111 and a second dimension 113. The first dimension may be between 25 millimeters (mm) and 35 mm, and the second dimension may be between 15 mm and 20 mm. The first dimension may be between 10 millimeters (mm) and 50 mm, and the second dimension may be between 5 mm and 40 mm. The first dimension may be between 3 millimeters (mm) and 60 mm, and the second dimension may be between 1 mm and 30 mm.

[0112] 3B illustrates a side view of sensor 100, according to some embodiments. Sensor 100 may have a first dimension 111 and a third dimension 115. The first dimension may be between 30 mm and 35 mm, and the third dimension may be less than 1 mm. The first dimension may be between 10 mm and 50 mm, and the third dimension may be less than 5 mm.

[0113] 3C illustrates a bottom view of sensor 100, according to some embodiments. The bottom of sensor 100 may be configured to contact a biological fluid of the present disclosure. As shown, sensor 100 comprises substrate 101, electrode contacts 103, and sensor element deposition area 115. Sensor element 105 may be deposited on sensor deposition area 115. Sensor element 105 may comprise embodiments, variations, and examples of biosensor elements as disclosed herein. Sensor element 105 may be comprised of graphene.

[0114] The electrode contacts 103 may enable electrical coupling between the sensor elements 105 and the electrodes 109, which may then enable electrical contact with the transmitter 200. The electrode contacts 103 may be integrated into the substrate. The electrode contacts 103 may be metal contacts. For example, the sensor's electrode contacts 103 may be sufficiently conductive to couple to the electrodes 109, allowing signals to be transmitted and / or received between the two. Metal contact areas may be integrated onto the substrate to enable electrical connection to the transmitter module's sensor reading system. As shown, on one side of the electrode contacts, each sensor element may be connected to a common ground. The common ground may be a virtual ground. As shown, each sensor element may be connected in parallel with an individual electrode 109 on the other side of the sensor. This arrangement may allow each sensor element to be read in parallel. For example, each sensor element may be multiplexed. For example, the three electrode contacts on sensor 100 may comprise electrical leads 117, 119, and 121, which may respectively connect to the three electrodes 109 on opposing surfaces of the sensor. Ground may be connected to a ground electrode on the opposing surface of the sensor. Each sensor element may be connected to an analog-to-digital converter in transmitter module 200 via a pogo pin in this manner.

[0115] 4A, 4B, and 4C illustrate additional examples of sensors, according to some embodiments. As shown in FIG. 4A, the electrodes 109 on the side of the sensor facing the transmitter module may be aligned perpendicular to the long axis of the device. The electrode contacts and electrodes may be arranged in variable patterns and angles. As shown in FIG. 4A, the sensor 100 may be made smaller or larger, may be any shape, and may have any aspect ratio. The sensor may be sized sufficiently to be handled by a user without touching the sensor element 105.

[0116] Biosensor Metal Contacts

[0117] 5A and 5B illustrate examples of a sensor substrate 101 with a single sensor element 105 and an example of a sensor substrate 101 with multiplexed sensor elements 105-1, 105-2, and 105-3, according to some embodiments. In some cases, the sensor elements may be multiplexed. In some embodiments, there may be two or more sensor elements. In some embodiments, there may be fewer than 100 sensor elements. For example, there may be 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 15, 20, 25, 30, 50, 100, 1,000, or more sensor elements. In some embodiments, different multiplexing configurations allow multiple different target analytes to be detected from a subject's sample collected on a wearable device when the subject is wearing the device. For example, the three or more discrete sensors include a first sensor for detecting a first target analyte, a second sensor for detecting a second target analyte, and a third sensor for detecting a third target analyte. Each sensor element may be configured to detect a specific target analyte. The sensor may detect two or more of an electrolyte, glucose, lactate, IL6, cytokine, HER2, cortisol, ZAG, cholesterol, vitamin, ion, protein, drug molecule, metabolite, peptide, amino acid, DNA, RNA, aptamer, enzyme, biomolecule, chemical molecule, or synthetic molecule. The sensor may detect electrolyte, glucose, and lactate.

[0118] In some embodiments, different multiplexed configurations enable increased sensitivity in detecting and monitoring different target analytes. For example, a wearable device may include a processing module operably coupled to three or more different discrete biological or chemical sensors. The processing module may be configured to selectively activate the three or more different discrete biological or chemical sensors in different multiplexed configurations depending on the desired type of sensing application of interest. For example, the processing module may be configured to selectively activate a fewer number of biological or chemical sensors to reduce power consumption of the wearable device. Additionally or alternatively, the processing module may be configured to selectively activate a larger number of biological or chemical sensors to improve sensitivity in detecting and monitoring different target analytes.

[0119] In some embodiments, the processing module is configured to selectively activate at least two of the first, second, and third sensors. In some embodiments, the processing module is configured to selectively activate (1) the first and second sensors in a first multiplexed configuration, (2) the second and third sensors in a second multiplexed configuration, or (3) the first and third sensors in a third multiplexed configuration. In some embodiments, the processing module is capable of detecting (1) the presence and (2) concentrations of two or more different target analytes between 1 femtogram / liter (fg / L) and 1,000 ng / L in a sample having a volume of less than 100 μL collected from a subject on a wearable device when the subject is wearing the device. The processing module may be capable of detecting concentrations greater than 1 femtogram / liter (fg / L). The processing module may be capable of detecting concentrations greater than 250 femtograms / liter (fg / L). The processing module may be capable of detecting concentrations greater than 0.250 ng / L in a sample. The processing module may be capable of detecting concentrations greater than 0.100 ng / L in a sample. The processing module may be capable of detecting concentrations greater than 0.250 ng / L in a sample having a volume of less than 10 μL. The processing module may be capable of detecting concentrations greater than 1 fg / L in a sample having a volume of less than 1 μL. The processing module may be capable of detecting concentrations greater than 250 fg / L in a sample having a volume of less than 1 μL. The processing module may be capable of detecting concentrations greater than 0.250 ng / L in a sample having a volume of less than 1 μL. The processing module may be capable of detecting concentrations greater than 250 fg / L in a sample having a volume of less than 0.1 μL.

[0120] In some embodiments, the wearable device is capable of detecting the presence and concentration of two or more different target analytes in less than 1 second. In some embodiments, the wearable device is capable of detecting the presence and concentration of two or more different target analytes in less than 100 milliseconds. In some embodiments, the wearable device is capable of detecting the presence and concentration of two or more different target analytes in less than 1 millisecond.

[0121] As shown, a sensor element (e.g., graphene or any nanoscale material layer) may be deposited on a sensor substrate. The sensor element of the present disclosure may comprise a field-effect transistor including a drain electrode, a source electrode, an electrically insulating substrate, a nanoscale material layer disposed on the substrate, and a polar-fluid-induced gate terminal created by a polar fluid exposed to the nanoscale material layer. In some cases, the nanoscale material layer may partially define a conductive and chemically sensitive channel. The nanoscale material layer and the channel may extend between and be electrically connected to the drain and source electrodes. In some embodiments, the polar fluid includes a target analyte. In some embodiments, the polar fluid has a charge concentration sufficient to induce a polar-fluid gate voltage in response to the target analyte that optimizes the gate voltage versus channel current characteristics of the field-effect transistor.

[0122] The field-effect transistor of the present disclosure may comprise a nanoscale material layer. The nanoscale material layer may include graphene, carbon nanotubes, molybdenum sulfide, boron nitride, metal dichalcogenides, phosphorene, nanoparticles, quantum dots, fullerenes, 2D nanoscale materials, 3D nanoscale materials, 0D nanoscale materials, 1D nanoscale materials, or any combination thereof. The field-effect transistor of the present disclosure may be a graphene field-effect transistor. For example, any applicable method can be applied to fabricate a graphene field-effect transistor, including the information disclosed in International Patent Publication No. WO 2015 / 164,552 (incorporated herein by reference in its entirety). The sensor of the present disclosure may comprise a gateless graphene field-effect transistor, such as that described in Published International Patent Application No. WO 2017 / 216641 (incorporated herein by reference in its entirety).

[0123] In an exemplary method of depositing a sensor element, a graphene sensor electrode with a functionalized inverse polymer can be created. The inverse polymer material can be selected to bond, fuse, or adhere a target substrate, such as the substrates of the present disclosure, and / or a flexible printed circuit. The graphene / polymer composite can then be bonded to the substrate 101 at the deposition area 115 between the built-in metal contacts 103 by heating the substrate above the fusion temperature of the inverse polymer. Graphene sensors may additionally be deposited by adhesives, by mechanical fasteners, by post-deposition encapsulation, by thermal curing, by gluing, etc.

[0124] In some cases, the sensor substrate with the bonded graphene biosensor (e.g., sensor element 105) can then be later functionalized with selective biochemical molecules. For example, a graphene layer may be functionalized with a receptor layer deposited on the nanoscale material (e.g., graphene) layer. The receptor layer may comprise a receptor that targets a target analyte. In some embodiments, the receptor may include pyrene boronic acid (PBA), pyrene N-hydroxysuccinimide ester (pyrene-NHS), an organic chemical, an aromatic molecule, a cyclic molecule, an enzyme, a protein, an antibody, a virus, a single-stranded DNA (ssDNA), an aptamer, an inorganic material, a synthetic molecule, or a biological molecule. In some embodiments, the target analyte includes an electrolyte, glucose, lactate, IL6, a cytokine, HER2, cortisol, ZAG, cholesterol, a vitamin, a protein, a drug molecule, a metabolite, a peptide, an amino acid, DNA, RNA, an aptamer, an enzyme, a biomolecule, a chemical molecule, a synthetic molecule, or a combination thereof.

[0125] For example, a biosensor functionalized with PBA can exhibit high sensitivity for D-glucose with a limit of detection (LOD) of 250 femtograms per liter. Pyreneboronic acid is attached to the graphene surface using pi-pi bonds. PBA forms a reversible boron-anion complex with D-glucose.

[0126] For example, a biosensor may be functionalized with lactate oxidase (LOx) on the graphene surface using mediated pyrene-NHS binding chemistry. Lactate oxidase can specifically bind to lactate molecules in a fluid. The LOx-functionalized biosensor may have a highly selective response (>94%) to lactate concentrations in different control fluids. In another example, a pyrene-NHS-functionalized biosensor exhibits high sensitivity for lactate, i.e., 2.78 e with a limit of detection (LOD) of approximately 250 femtograms / liter. -12 millimolar (mmol / L).

[0127] Without being limited by theory, the hydrophobicity of the graphene layer may lead to the induced movement of polar fluids across the surface of the biosensor. Increased hydrophobicity between the graphene surface and the polar fluid may repel the polar fluid from the graphene surface (such as NaCl in deionized water). The higher the concentration of polar molecules (e.g., NaCl) in the fluid, the greater the repellency effect. This effect may be used to functionalize the surface of the sensor substrate. For example, a portion of the sensor substrate surrounding the sensor deposition area may be functionalized with a hydrophilic material. The hydrophilic material may attract biological fluids, such as sweat, toward the sensor element. A second portion of the sensor substrate near the sensor element may be unfunctionalized or functionalized with a hydrophobic material. The combination of these two functionalized portions may facilitate sweat flow over the sensor element and away from the sensor element.

[0128] Interfacing a graphene sensor to a sensor reading system can be difficult. One challenge in commercial graphene sensors can be connecting the graphene sensor element to the outside world. In some embodiments, metal contacts may need to be created on the graphene surface to connect the graphene sensor 105 to other elements. Metallization techniques may include using lithography techniques, including photolithography, electron beam lithography, etc., to create metal contacts on the graphene surface. However, some metallization techniques may introduce defects, dopants, and irreversible contamination onto the graphene sensor, which can damage the material.

[0129] In some embodiments, the present disclosure provides methods for metallizing graphene films using printing techniques or by smearing / printing a liquid conductive paint to create electrical, optical, or microelectromechanical (MEMS) devices. In one exemplary method, a skin-safe conductive paint can first be smeared on both edges of a graphene sensor to form source-drain structures. The conductive paint can be smeared, printed, painted, or applied. The conductive paint may be in limited or no contact with the electrodes to prevent contact damage. The conductive ink can be printed, smeared, painted, or applied such that a portion of the ink is disposed on the graphene surface of the sensor element 105 and a portion is disposed on the metal contact layer 103 beneath the graphene surface, which may optionally be pre-integrated into the sensor substrate 101. The surface tension of the ink can allow it to spread across the underlying metal contact surface without leaking into the surrounding insulating flexible printed circuit area, thus ensuring specificity and limiting cross-contamination.

[0130] In some embodiments, the ink thickness can be in the range of 40 microns to 500 microns. The thickness can be adjusted depending on the required robustness of the sensor element, for example, to prevent damage to the sensor during contact with the skin. In some cases, the conductive ink thickness can be greater than 200 microns. In some cases, the conductive ink thickness can be less than 200 microns. In some cases, a passivation layer can be disposed on the ink. In some cases, the ink can then be cured by baking at high temperatures.

[0131] In some cases, the conductive ink may comprise a conductive material and a binder. In some embodiments, the binder may be a resin or adhesive compounded with a conductive material such as gold, silver, copper, nickel, or other metals or alloys. In some embodiments, the conductive material may include conductive particles, such as metal particles. The conductive material may include conductive metal nanoparticles (NPs), conductive metal alloys, core / shell systems, etc. The metal particles may have an average size of about 0.5 to about 10 microns and an aspect ratio of at least about 3:1.

[0132] The resin or adhesive may be composited with the conductive material. In some embodiments, a polymer thick film may be formed. The resin or adhesive may be a thermoset, such as epoxy, acrylic, polyester, etc. The polymer may be a thermoplastic, such as polyimide siloxane, nylon, neoprene, rubber, polyvinyl butyral terpolymer, etc. The binder and conductive material may be dissolved in a solvent, such as a glycol ether or similar high vapor pressure solvent, configured to evaporate over time.

[0133] Once the ink is cured, the passivation polymer can be smeared / printed over the metal contact layer so that the area of ​​the passivation polymer is greater than the area of ​​the metal contact layer to avoid any exposure of the metal edges. The thickness of the passivation polymer layer can be selected to ensure that the final thickness of the metal passivation layer is at least 200 microns. Such a thickness can limit abrasion or damage to the graphene sensor element while the sensor is in contact with the skin.

[0134] Optionally, specific non-bleeding materials can be selected as the passivation polymer, such as acrylic, PMMA, silicone, polysilicone, PDMS, rubber, hot melt copolymer, EVA copolymer, ethylene acrylate, PET, polyamide, PTFE, fluoropolymer, thermoplastic, gel, hydrogel, polypropylene, polyethylene, polyolefin, polyvinyl chloride, polyester, polyurethane, styrene block copolymer, polycaprolactone, polycarbonate, fluoropolymer, silicone rubber, thermoplastic elastomer, polypyrrole, etc. The passivation layer can be polyurethane.

[0135] In some embodiments, more than one passivation layer may be applied. In some embodiments, a different passivation layer may be applied to the nanoscale material than that applied to the metallized or contact areas. In some cases, the passivation layer may be polyurethane and PMMA. The passivation layer may additionally aid in the attachment of the graphene layer.

[0136] Also disclosed is a method for fabricating a modular sensor. The method may include: (a) providing a sensor substrate including at least two electrodes disposed on a surface of the substrate; (b) depositing a layer of graphene on the surface of the sensor substrate between the at least two electrodes; (c) metallizing at least a portion of the layer of graphene at or near the at least two electrodes; passivating at least a portion of the layer of graphene with a passivating polymer; and (d) optionally functionalizing at least a portion of the layer of graphene, wherein functionalizing the layer of graphene is performed with a receptor layer, the receptor layer being sensitive to a target analyte. The order in which some or all of operations (a)-(d) may be performed should not be considered limiting. Rather, one of ordinary skill in the art, having the benefit of this disclosure, will understand that some of (a)-(d) may be performed in various orders not disclosed, or even in parallel. Some operations may be omitted.

[0137] In some embodiments, depositing the graphene layer includes heating the substrate above a fusion temperature of a functionalized inverse polymer disposed between the graphene layer and the substrate. In some embodiments, the method further includes functionalizing a first portion of the substrate near the graphene layer with a hydrophilic material. In some embodiments, a second portion of the substrate near the graphene layer is not functionalized with a hydrophilic material. In some embodiments, the second portion of the substrate is functionalized with a hydrophobic material.

[0138] In some embodiments, a current is applied and a voltage is measured for each sensor element. In some embodiments, a voltage is applied and a current is measured for each sensor element. In some embodiments, an oscillating current or voltage is applied and the shift in response frequency is measured. In some embodiments, a constant current of 5 to 200 microamps may be applied across the sensor 105. The time-varying voltage from the sensor may be measured at the transmitter 200, which may be in electrical communication with the sensor elements 105. The voltage across the sensor 105 may be read at 8 bits or higher by a DAC onboard the transmitter module 200.

[0139] In some embodiments, the transmitter module 200 may recognize the sensor 100. The transmitter may recognize the sensor as reused. The transmitter may recognize the sensor as not manufactured by an approved source. The transmitter may recognize the sensor electronically, such as with a "handshake." The transmitter may recognize the sensor by a radio frequency identification tag. The transmitter may recognize the sensor by physical indicia, such as a pattern on the surface of the sensor.

[0140] Transmitter / Processing Module

[0141] In some embodiments, the wearable device may comprise a processing module configured to operably couple to at least one sensor selected from the group consisting of a plurality of discrete biological or chemical sensors, wherein the two or more different sensors for detecting two or more different target analytes are interchangeably and releasably attachable to the wearable device when the subject is wearing the device depending on the type of target analyte to be detected from the subject's sample collected on the wearable device. The processing module may comprise an embodiment, variation, or implementation of a transmitter module disclosed herein.

[0142] In some embodiments, the processing module is configured to detect and monitor levels of a first target analyte when a first sensor specific to the first target analyte is attached to the wearable device. In some embodiments, the processing module is configured to switch to detecting and monitoring a second target analyte when the first sensor is removed from the wearable device and replaced with a second sensor specific to the second target analyte. In some embodiments, the processing module is located onboard the wearable device and configured to process sensor data substantially in real time as data is collected by the at least one sensor to detect and monitor levels of one or more target analytes. In some embodiments, the wearable device comprises a graphical display for displaying the detected levels of one or more target analytes. In some embodiments, the processing module is configured to transmit the processed sensor data to a remote device, a server, or a third-party entity. In some embodiments, the processing module comprises a recommendation engine configured to prescribe corrective or mitigating measures based on the detected levels of one or more target analytes.

[0143] In some embodiments, the device comprises a transmitter configured to transmit the sensed signal over a network. In some embodiments, the transmitter is configured to transmit the sensed signal to a mobile device associated with and in proximity to the subject. In some embodiments, the device comprises a recessed housing configured to receive and support the modular sensor. In some embodiments, the device is releasably coupled to the modular sensor via a magnetic attachment mechanism. In some embodiments, the magnetic attachment mechanism includes a magnetic material provided on at least one of the modular sensor and the device, and an ferrous metal or alloy provided on at least one of the modular sensor and the device. In some embodiments, the device is configured to be releasably coupled to a strap, the strap configured to be worn on a portion of the subject's body. In some embodiments, the plurality of modular sensors comprises at least one graphene-based sensor.

[0144] FIG. 6A illustrates a first example of a transmitter module 200, according to an embodiment. The transmitter may include a processor or processing module. The transmitter module 200, also referred to herein as a transmitter module or processor module, may include an integrated sensor reading system. The transmitter module may have a top cover 210. The top cover 210 may have an indentation 212, which may aid in attachment of the transmitter module 200 to a wearable attachment of the present disclosure. The transmitter module 200 may have a decorative element on the top cover. In some cases, the top cover serves as a button 214. In some cases, the button is a capacitive button. In some cases, the top cover is compressible to provide user input to the device.

[0145] 6B illustrates a top view of the transmitter module 200, according to some embodiments. As shown, the overall dimensions of the transmitter can be small. For example, the transmitter can be approximately 500 cm 3 , 400cm 3, 300cm 3 , 200cm 3 , 150cm 3 , 120cm 3 , 100cm 3 , 90cm 3 , 80cm 3 , 70cm 3 , 60cm 3 , 50cm 3 , 40cm 3 , 30cm 3 , 20cm 3 , 15cm 3 , 10cm 3 , 5cm 3 The transmitter may have an overall volume equal to or less than 100 mm, 120 mm, 180 mm, 220 mm, 240 mm, 320 mm, 360 mm, 400 mm, 420 mm, 480 mm, 500 mm, 520 mm, 560 mm, 580 mm, 600 mm, 620 mm, 640 mm, 660 mm, 700 mm, 720 mm, 760 mm, 780 mm, 780 mm, 790 mm, 800 mm, 810 mm, 820 mm, 830 mm, 840 mm, 850 mm, 860 mm, 870 mm, 880 mm, 890 mm, 900 mm, 910 mm, 920 mm, 930 mm, 940 mm, 950 mm, 96

[0146] As shown in FIG. 6B, the transmitter module 200 may have a first external dimension and a second external dimension. The first external dimension may be 32 mm and the second external dimension may be 42 mm. The first external dimension may be in a range of 1 mm to 200 mm and the second external dimension may be in a range of 1 mm to 200 mm. The first external dimension may be in a range of 5 mm to 50 mm and the second external dimension may be in a range of 10 mm to 100 mm. The transmitter may have a first external dimension 230, a second external dimension 232, and a third external dimension 234, as shown elsewhere herein.

[0147] 6C illustrates a side view of transmitter module 200, according to some embodiments. Transmitter 200 may have a third outer dimension. The third outer dimension may be 13.5 mm. The third outer dimension may be less than 100 mm. The third outer dimension may be less than 30 mm. The third outer dimension may be in a range of 1 to 100 mm.

[0148] FIG. 6D illustrates a bottom view of the transmitter module 200 without the sensor 100 mounted thereon, according to some embodiments. FIG. 6E illustrates a bottom view of the transmitter 200 with the sensor module 100 mounted thereon, according to some embodiments. The transmitter module may house multiple magnets that, when brought within sufficient proximity, produce sufficient force to attract the replaceable sensor substrate. In some cases, the transmitter may include a recess 221 on the bottom surface of the transmitter module's bottom cover 220. The recess may allow the sensor to be mounted so that the user-facing surface of the sensor 100 is flush with the bottom surface of the bottom cover 220. As shown, the transmitter may include various components, such as magnets, which allow for easy coupling and uncoupling with the sensor. As shown, the transmitter module may include an electrical feedthrough area 204, which may facilitate electrical contact between the sensor element and the processing unit.

[0149] 8A, 8B, and 8C illustrate a second exemplary transmitter module 200, according to some embodiments. FIG. 8A illustrates an exemplary transmitter module in the form of a watch face, according to some embodiments. The transmitter module 200 may be configured to couple to a strap via a strap mount 218. Examples, embodiments, or variations of the sensor 100 of the present disclosure may be removably coupled to the transmitter module 200. The sensor 100 may be flush with the bottom surface 220 of the transmitter module 200. In some cases, the sensor may not be flush with the bottom surface 220 or may be slightly above it, for example, which may aid in contact between the sensor element and the skin.

[0150] 8B illustrates a bottom view of a second example of a transmitter module, according to some embodiments. The transmitter module 200 may include an electrical feedthrough portion 204 on the bottom surface 200 of the transmitter module. The electrical feedthrough portion may include an opening for a pogo pin to pass through. As shown, the transmitter module may include an electrical feedthrough area 204, which may facilitate electrical contact between the sensor element and the processing unit. In some cases, the transmitter may include a recess on the bottom surface of the transmitter module's bottom cover 220.

[0151] FIG. 8C illustrates a top view of a second example transmitter module, according to some embodiments. The size and scale of the second example transmitter module may be substantially similar to other examples and embodiments described herein. The transmitter may have a first external dimension, a second external dimension, and a third external dimension as shown anywhere herein. The first external dimension may be 34 mm, and the second external dimension may be 37 mm. The first external dimension may be in a range of 1 mm to 200 mm, and the second external dimension may be in a range of 1 mm to 200 mm. The first external dimension may be in a range of 5 mm to 50 mm, and the second external dimension may be in a range of 10 mm to 100 mm. The transmitter may have a third external dimension. The third external dimension may be 13.5 mm. The third external dimension may be less than 100 mm. The third external dimension may be less than 30 mm. The third outer dimension may be in the range of 1 to 100 mm.

[0152] FIG. 7A illustrates an exploded view of the interior of transmitter module 200, according to some embodiments. The transmitter may include a top cover 210 and a bottom cover 220, which together may house circuitry and other components that may be used to power, control, or interface with sensor 100 of the present disclosure. The top and bottom covers may be polycarbonate. The top and bottom covers may be plastic. The top and bottom covers may be colored or finished so that they are aesthetically appealing. Transmitter 200 may include a dual battery scheme with a power sharing mechanism, signal processing electronics, sensor interface electronics, an ADC converter, a microprocessor unit (MCU) integrated with an integrated Bluetooth® low energy (BLE) chip, an antenna, and associated RF electronics.

[0153] The bottom cover 220 may include a seal ring 222 on its exterior surface, which may isolate the electronics associated with the interior of the transmitter from the biological fluid of the present disclosure. The seal ring may interface between the interior of the transmitter module and the exterior of the transmitter module via the feedthrough area 204. The seal ring may be made of thermoplastic polyurethane. The transmitter may include one or more magnetic elements 205 inside the transmitter. The one or more magnetic elements may be disposed on the interior surface of the transmitter 200. The magnetic elements may be arranged to interface with magnetic material on the sensor 100 of the present disclosure. The magnetic elements may include a ferrous material, such as iron. The magnetic elements may include a permanent magnet. The magnetic material may include one or more of neodymium, samarium cobalt, alnico, ceramic, ferrite, iron, nickel, cobalt, or any other magnetic material. The magnetic material may be a permanent magnet. The magnetic material may be a rare earth magnet. The magnetic elements may be separated from the one or more batteries by a spacer 211. The spacer may be a shock absorber.The spacer may comprise ethylene vinyl acetate.

[0154] The transmitter may further include one or more batteries 203. The batteries may have a charging voltage between 2 and 4.5 volts. The batteries may carry a charge between 10 and 1000 milliamp hours. The batteries may carry a charge greater than 10 milliamp hours. The batteries may be lithium ion batteries. The batteries may be lithium ion polymer batteries.

[0155] As shown, transmitter 200 may include a printed circuit board (PCB) 201. PCB 201 may include a microcontroller unit with an on-board CPU, memory, data storage unit, 3-axis accelerometer, analog-to-digital converter (DAC), Bluetooth® radio, etc. PCB 201 may be attached to bottom cover 220 by screws 213. In some embodiments, transmitter 200 may be disassembled and reassembled. In other embodiments, transmitter 200 cannot be disassembled without damage to one or more components, which may be tamper-resistant. While screws are provided in the illustrated embodiment, the device may also be assembled using glue, solder, snaps, etc.

[0156] FIG. 7B illustrates a side view of the interior of the transmitter 200 along a slice through the transmitter, according to some embodiments. As shown, various components are arranged within the housing via a compact design. As shown, the bottom cover 220 may include openings within the feedthrough area 204 that are sized and shaped to receive the pogo pins 209. The pogo pins may be made of brass or another conductive material, such as gold or copper. The pogo pins may be axially compressible. The pogo pins may include internal springs to provide a restoring force that can return the pogo pins to their original length after axial compression. The pogo pins may facilitate absorption of excess kinetic energy by the sensor board because they snap into place. The pogo pins may facilitate a consistent electrical connection between the sensor 100 and the printed circuit board 201. The pogo pins may have a long duty cycle, facilitating a robust electrical connection between the sensor board and the transmitter module. The pogo pin system may reduce any damage to the sensor reading assembly of the transmitter module. As shown, pogo pins may be placed between the batteries 203 to facilitate a compact transmitter design.

[0157] FIG. 7C illustrates an isometric view of transmitter 200 with the top housing removed, according to some embodiments. PCB 201 has been removed for illustrative purposes. In some embodiments, the transmitter includes a display to transmit visual information to a user. The display may include one or more light-emitting diodes (LEDs) 207. The one or more LEDs may display light, which may provide a visual cue to the user through top cover 210. Top cover 210 may include a transparent portion. In some examples, the transparent portion is rectangular. In some examples, the transparent portion is shaped like a logo. One or more LEDs may have one or more colors. For example, the LEDs may be blue, green, and red. The duration and intensity of the LEDs may be varied to provide information to the user regarding the function or operation of the device. Multiple LEDs may be turned on at a single time to create a variety of colors (e.g., a gamut of colors). The LEDs may be electrically connected to PCB 201 via a Serial AT attachment 215.

[0158] FIG. 7D illustrates a top view of transmitter 200 with the top housing removed, according to some embodiments. FIG. 7E illustrates a side view of transmitter 200 with the top housing removed, according to some embodiments. As shown, transmitter 200 may have compact dimensions. The transmitter may have a first external dimension 230, a second external dimension 232, and a third external dimension 234, as described elsewhere herein. The transmitter may have a first internal dimension 231 and a second internal dimension 233. The first internal dimension may be the length of PCB 201. The second internal dimension may be the width of LED 207. The first internal dimension may be between 30 mm and 35 mm, and the second internal dimension may be between 15 mm and 20 mm. The first internal dimension may be between 130 mm and 5 mm, and the second internal dimension may be between 115 mm and 2 mm. The first and second internal dimensions may be less than the first and second external dimensions.

[0159] In some embodiments, the PCB 201 includes a central processing unit (CPU, also referred to herein as "processor" and "computer processor"), which can be a single-core or multi-core processor or multiple processors for parallel processing. The PCB 201 also includes memory or memory locations (e.g., random access memory, read-only memory, flash memory). The PCB 201 may include an electronic storage unit (e.g., a hard disk or other non-volatile memory). The PCB 201 may further include a communication interface (e.g., a network adapter, a Bluetooth adapter, etc.) and peripheral devices disposed thereon for communication with one or more other systems. The memory, storage unit, communication interface, and any other peripheral devices may communicate with the CPU through a communication bus. The storage unit can be a data storage unit (or data repository) for storing data.

[0160] The transmitter 200 can be operatively coupled to a computer network ("network") with the aid of a communication interface. The communication interface may include or communicate with an onboard Bluetooth® radio. The MCU may include an RF antenna. The network can be the Internet, an Internet and / or an extranet, or an intranet and / or an extranet in communication with the Internet. The network, in some cases, is a telecommunications and / or data network. The network can include one or more computer servers, which can enable distributed computing such as cloud computing. The network, in some cases, can implement a peer-to-peer network with the aid of the transmitter, which can allow devices coupled to the device to behave as clients or servers.

[0161] In some embodiments, the PCB 201 includes a digital-to-analog converter (DAC) disposed thereon. The DAC may convert analog data from one or more sensor elements 105 into a digital signal. The DAC may receive voltages from one or more sensor elements. The DAC may digitize the voltage data with at least 8-bit resolution. The DAC may comprise one or more channels. In some cases, each sensor element may be connected to a single channel on the DAC. In some cases, each channel is read in sequence and digitized using a DAC with a single channel. In some cases, the digitized data may be compressed, downsampled, or otherwise reduced in size to facilitate ease of transfer. Control and / or operation of the DAC may be operated using instructions from a CPU.

[0162] Data may be recorded continuously. In some cases, data may be recorded every 500 milliseconds (ms). In some cases, data may be recorded every 10 ms, 20 ms, 50 ms, 100 ms, 200 ms, 500 ms, every second, 10 seconds, 1 minute, or more. Data may be recorded at intervals within a range defined by any two of the preceding values. Data may be recorded for a period of time, and then data collection may stop for a period of time. For example, data may be collected for 1 minute, 1 hour, 2 hours, 5 hours, 1 day, 5 days, 1 year, or more. Data may be collected for a period of time within a range defined by any two of the preceding values. Data may be collected for a period of time defined by a single workout.

[0163] In some embodiments, PCB 201 includes a storage and / or memory device disposed thereon. The storage and / or memory device is one or more physical devices used to store data or programs on a temporary or permanent basis. In some embodiments, the device is a volatile memory that requires power to maintain the stored information. In some embodiments, the device is a non-volatile memory that retains the stored information when the transmitter module is not powered. In further embodiments, the non-volatile memory comprises flash memory. In some embodiments, the non-volatile memory comprises dynamic random access memory (DRAM). In some embodiments, the non-volatile memory comprises ferroelectric random access memory (FRAM). In some embodiments, the non-volatile memory comprises phase change random access memory (PRAM). In further embodiments, the storage and / or memory device is a combination of devices such as those disclosed herein.

[0164] The CPU can execute sequences of machine-readable instructions, which may be embodied in a program or software. The instructions may be stored in a memory location, such as a memory. The instructions can be directed to the CPU, which can then be programmed or otherwise configured to implement the methods of the present disclosure. Examples of operations performed by the CPU include fetch, decode, execute, and write back. The CPU can be part of a circuit, such as an integrated circuit. One or more other components located on PCB 201 can be included in the circuit. In some cases, the circuit is an application-specific integrated circuit (ASIC) or a field-programmable gate array (FPGA).

[0165] The PCB 201 may include a storage unit. The storage unit may store files such as drivers, libraries, and saved programs. The storage unit may store user data, such as user preferences and user programs. The transmitter module 200 may include one or more additional data storage units, in some cases external, such as located on a remote server communicating through an intranet or the Internet.

[0166] The transmitter module 200 can communicate with one or more remote computer systems over a network, for example, via a Bluetooth® connection. For example, the transmitter 200 can communicate with a user's remote computer system. Examples of remote computer systems include a personal computer (e.g., a portable PC), a slate or tablet PC (e.g., an Apple (R) iPad(R), Samsung (R) Galaxy Tab), phone, smartphone (e.g., Apple (R) iPhone(R), Android-compatible devices, Blackberry (R) ), or a personal digital assistant.

[0167] The PCB 201 may include a three-axis accelerometer disposed thereon. For example, the accelerometer may be used to monitor the movement of a user of the wearable device. A movement event detected by the accelerometer may turn on the device or begin collecting data about the device. A lack of movement events over a period of time may cause the device to enter a low-power mode or turn off. Movement data may be logged over time to detect correlations between the amount, type, or other quality of the biological fluid of the present disclosure and the amount or intensity of movement. Sensor data may be correlated with accelerometer data.

[0168] The PCB 201 may include a battery charging integrated circuit disposed thereon. For example, the battery charging IC may monitor the battery charging voltage. The battery charging IC may control the battery charging voltage and / or current. For example, the battery charging IC may prevent overcharging. The battery charging IC may increase battery life. Input power control may further be controlled through the use of one or more voltage regulators, such as a low-dropout regulator.

[0169] The PCB 201 may be configured to connect to and receive data from an input device. In some embodiments, the transmitter module 200 may include an input device to receive information from a user. The input device may be a button on the exterior of the transmitter 200. The button may turn on the device. The button may start or stop measurements. The button may reset the device. The button may be configured to start or stop data synchronization with an external device. The MCU may be configured to receive information from the user in the form of one or more of whether a button was pressed, the length of the press, and the number of consecutive presses.

[0170] PCB 201 may be configured to connect to and control a display disposed within transmitter 200. In some embodiments, the transmitter includes a display to transmit visual information to a user. The display may include one or more LEDs 207. The one or more LEDs may display light, which may be visible to a user through top cover 210. Top cover 210 may include a transparent portion. In some examples, the transparent portion is rectangular. In some examples, the transparent portion is shaped like a logo. One or more LEDs may have one or more colors. For example, the LEDs may be blue, green, and red. The duration and intensity of the LEDs may be varied to provide information to a user regarding the function or operation of the device.

[0171] See Table 1 for example specifications for the MCU of this disclosure. The following values ​​are provided as examples only and are not intended to be limiting. [Table 1]

[0172] FIG. 9A illustrates an exploded view of the interior of a second example of a transmitter module 200, according to some embodiments. The transmitter may include a top cover 210 and a bottom cover 220, which together may house circuitry and other components that may be used to power, control, or interface with the sensor 100 of the present disclosure. The top and bottom covers may be polycarbonate. The top and bottom covers may be plastic. The top and bottom covers may be colored or finished so that they are aesthetically appealing. The transmitter 200 may include a dual battery scheme with a power sharing mechanism, signal processing electronics, sensor interface electronics, an ADC converter, a microprocessor unit (MCU) integrated with an integrated Bluetooth® low energy (BLE) chip, an antenna, and associated RF electronics, as described elsewhere herein.

[0173] The bottom cover 220 may include a seal ring on its exterior surface, which may isolate the electronics associated with the transmitter interior from the biological fluid of the present disclosure. The seal ring may interface between the interior of the transmitter module and the exterior of the transmitter module via the feedthrough area 204. The seal ring may be made of thermoplastic polyurethane. The transmitter may include one or more magnetic elements 205 inside the transmitter. The one or more magnetic elements may be disposed on the interior surface of the transmitter 200. The magnetic elements may be arranged to interface with magnetic material on the sensor 100 of the present disclosure. The magnetic elements may include a ferrous material, such as iron. The magnetic elements may include a permanent magnet. The magnetic material may include one or more of neodymium, samarium cobalt, alnico, ceramic, ferrite, iron, nickel, cobalt, or any other magnetic material. The magnetic material may be a permanent magnet. The magnetic material may be a rare earth magnet. The magnetic elements may be separated from the one or more batteries by a spacer. The spacer may be a shock absorber. The spacer may comprise ethylene vinyl acetate.

[0174] The transmitter may further include one or more batteries 203. The batteries may have a charging voltage between 2 and 4.5 volts. The batteries may carry a charge between 10 and 1000 milliamp hours. The batteries may carry a charge greater than 10 milliamp hours. The batteries may be lithium ion batteries. The batteries may be lithium ion polymer batteries.

[0175] As shown, transmitter 200 may include a printed circuit board (PCB) 201. PCB 201 may include a microcontroller unit with an on-board CPU, memory, data storage unit, 3-axis accelerometer, analog-to-digital converter (DAC), Bluetooth® radio, etc. PCB 201 may be attached to bottom cover 220 by screws 213. PCB 201 may be operably coupled to screen 219 to provide visual cues to the user. The screen may be an LCD. The screen may be an LED array. In some embodiments, the display is a cathode ray tube (CRT). In some embodiments, the display is a liquid crystal display (LCD). In further embodiments, the display is a thin film transistor liquid crystal display (TFT-LCD). In some embodiments, the display is an organic light emitting diode (OLED) display. In various further embodiments, the OLED display is a passive matrix OLED (PMOLED) or an active matrix OLED (AMOLED) display. In some embodiments, the display is a plasma display. In other embodiments, the display is a video projector. In still further embodiments, the display is a combination of devices such as those disclosed herein.

[0176] In some embodiments, transmitter 200 may be disassembled and reassembled. In other embodiments, transmitter 200 cannot be disassembled without damage to one or more components, which may be tamper-resistant. Although screws are provided in the illustrated embodiment, the device may also be assembled using glue, solder, snaps, etc.

[0177] FIG. 9B illustrates a side view of the interior of a second example of a transmitter module 200 along a slice through the transmitter, according to some embodiments. As shown, various components are arranged within the housing via a compact design. As shown, the bottom cover 220 may include openings within the feedthrough area 204 that are sized and shaped to receive the pogo pins 209. The pogo pins may be made of brass or another conductive material, such as gold or copper. The pogo pins may be axially compressible. The pogo pins may include internal springs to provide a restoring force that can return the pogo pins to their original length after axial compression. The pogo pins may facilitate absorption of excess kinetic energy of the sensor board because they snap into place. The pogo pins may facilitate a consistent electrical connection between the sensor 100 and the printed circuit board 201. The pogo pins may have a long duty cycle to facilitate a robust electrical connection between the sensor board and the transmitter module. The pogo pin system can reduce any damage to the sensor reading assembly of the transmitter module. As shown, the pogo pins can be located between the batteries 203, facilitating a compact transmitter design.

[0178] In some embodiments, transmitter 200 may include a user input mechanism. The one or more user input mechanisms may include one or more buttons. For example, bottom cover 220 may include a button, which is capacitive sensor 217. For example, top cover 220 may include a second button, which is second capacitive sensor 219. The one or more buttons may be conventional switches or mechanical buttons. The one or more buttons may be a keyboard. In some cases, the wearable device does not have a user input mechanism. In some cases, the wearable device may be controlled by a connected device, such as a mobile device or a remote processor as described herein.

[0179] User Interaction

[0180] Methods as described herein can be implemented using machine (e.g., computer processor) executable code stored on an electronic storage location of the transmitter module 200, such as on a memory or electronic storage unit. The machine-executable or machine-readable code can be provided in the form of software. During use, the code can be executed by the processor. In some cases, the code can be read from a storage unit and stored on a memory for easy access by the processor. In some situations, the electronic storage unit can be omitted and the machine-executable instructions can be stored on a memory.

[0181] The following are examples of user interactions with the devices of the present disclosure and are not intended to be limiting. Other lighting schemes, including colors and durations, are also contemplated. Other user-initiated events are also contemplated.

[0182] Switch and LED light scheme a. Turn on the device: Press the button for 3 seconds, confirmed by a non-blinking blue LED b. Device connected: Blue LED starts flashing every 5 seconds c. Battery less than 10% charged: Magenta LED starts flashing every 5 seconds d. Charging: Fully charged - Magenta LED, Fully charged - Green LED e. Firmware update: Press and hold for 8 seconds, the three colors will flash in sequence f. When the device enters firmware update state, after 1 minute, if no update action is taken, the device will be turned off

[0183] Sensor Light Scheme: a. Red for electrolytes, yellow for glucose, and white for lactate b. If electrolytes, glucose, or lactate are below threshold, the blue light will flash every 5 seconds, and the individual electrolyte, glucose, and lactate colors will flash rapidly in sequence every minute. c. If only one is below the threshold, only that individual color may flash. d. If two are below, both will flash in the following order: first red, second yellow, and finally white.

[0184] Sensor On / Off Light Scheme a. Sensor inserted: Device turns on b. If no device is connected: Automatically turns off after 5 minutes c. Automatically turns off when the sensor is removed

[0185] In some embodiments, the biosensor system has a screen. The screen may be on-board the transmitter module 200. The screen may be associated with a connected device. In some cases, the on-board screen 216 may include providing a user with values ​​for the amount of one or more of electrolytes, glucose, or lactate, for example, in milligrams per deciliter. The values ​​may be provided substantially in real time. The values ​​may be time averages, moving averages, maximum values ​​within a measurement period, minimum values ​​within a measurement period, etc.

[0186] The transmitter may include a tactile feedback system. For example, the transmitter may vibrate and / or flash to prompt the user that a value has dropped below a threshold or risen above a threshold. For example, the transmitter may prompt the user to adjust the value of one or more of electrolytes, glucose, or lactate. The transmitter may prompt the user to drink water. The transmitter may prompt the user to ingest dietary substances such as sugars. The transmitter may prompt the user to temporarily suspend physical activity, e.g., to take a break. The transmitter may prompt the user to view data related to the connected device.

[0187] Armband System

[0188] 10A, 10B, 10C, 10D, 11A, 11B, and 11C illustrate examples, embodiments, and variations of a biosensor system of the present disclosure. Such systems may include any of the examples, embodiments, and variations of the transmitter module 200 and sensor 100 described herein. The biosensor system of the present disclosure may be integrated into a wearable attachment. The wearable attachment may include an armband. The wearable attachment may include a patch.

[0189] While biosensing systems utilizing wrist strap and patch configurations are described herein, it should be understood that the biosensing system may have any configuration. For example, the biosensing system may be integrated into an armband, headband, leg strap, chest strap, ankle band, etc. The biosensing system may be integrated into a piece of clothing, such as a compression garment, such as a sock, shirt, underwear, or undershirt. The biosensing system may be utilized to monitor the skin adjacent to the ankle, calf muscles, knee, quadriceps, hamstrings, lower back, obliques, ribs, intercostal muscles, sternum, clavicle, pectoral muscles, deltoids, shoulders, latissimus dorsi, biceps, triceps, elbow, forearm, or wrist.

[0190] FIG. 10A illustrates a transmitter module 200 including a sensor of the present disclosure integrated into a wearable armband 300, according to some embodiments. The system may include the transmitter 200, a strap 303, and a sensor (not shown). As shown, the biosensing system may have a compact size so that it can be worn discretely. For example, the biosensing system may be worn discretely on a user's forearm, wrist, or upper arm. The strap 303 may include a buckle side 302 and a connection side 301. The strap 303 may include natural or synthetic materials. The strap material may be comfortable to the user. The strap material may be fabric, cloth, canvas, leather, cotton, nylon, polypropylene, polyester, linen, Lycra, Dyneema, Kevlar, Nomex, etc.

[0191] The bottom layer of the band can be built with a wavy silicone pattern to prevent slippage while on the skin. Pores can be built into the band for breathability. A cavity, e.g., a hole, can be provided in the band for inserting the transmitter module 200 from the bottom side of the band. Once the transmitter module 200 (with the sensor 100) is inserted into the band and tightly fitted, the band can be strapped around the forearm or other desired area on the skin for continuous monitoring of metabolites, including glucose and other markers from sweat. In some cases, the transmitter module may be inserted into the band after tightening to provide the proper tight fit for monitoring. For example, the transmitter can be removed, the sensor can be changed, and the transmitter can be reinserted to continue monitoring without loosening the band.

[0192] The dimensions of the armband system may be varied to fit the body part of the user being monitored. For example, the length of the band may be long enough to be attached circumferentially around the arm, leg, ankle, chest, etc. The band may be provided in variable lengths to fit various patient sizes. The band may include sufficient band material to be securely attached via a buckle mechanism, as described elsewhere herein. In some embodiments, the total length of the band may be approximately 250 mm. In some embodiments, the total length of the band may be in the range of 100 mm to 1000 mm. In some embodiments, the total length of the band may be 200 mm to 400 mm. The maximum width of the armband may be 20 mm to 100 mm. The maximum width of the band may be 1 mm to 200 mm.

[0193] 10B illustrates a bottom view of a biosensing system, according to some embodiments. As shown, the transmitter module 200 may house the sensor 100, which may be exposed on the bottom surface so that the sensor or its sensor element may come into contact with a user. The sensor element may come into contact with a user's biological fluids, as described elsewhere herein.

[0194] FIG. 10C illustrates a transmitter module 200 of the present disclosure that is removable from a wearable armband 100, according to some embodiments. As shown, the transmitter may be freely coupled and uncoupled from the attachment. Optionally, the attachment may include a mating surface that may allow for easy coupling and uncoupling with the transmitter. Optionally, the mating surface may include magnets, hooks, notches, snap-on mechanisms, etc. that allow for easy coupling and uncoupling with the transmitter. Optionally, the transmitter and forearm attachment may be configured to be used over weeks, months, or years, while the sensor may be configured to be used for a shorter period of time, e.g., hours, days, weeks, months, or years. The sensor 100 may be disposable. The sensor 100 may be replaceable.

[0195] FIG. 10D illustrates a wearable armband with a strap mechanism engaged, according to some embodiments. A fabric hook and loop system with a buckle is shown, but many possible fastening systems may also be used. For example, the wearable armband may have a watch buckle and a free side with a hole for receiving the watch buckle. The wearable armband may have a hook and loop fastener such as Velcro®. The fabric hook may be on the buckle side and the fabric loop may be on the connecting side. As shown, the fabric of the strap may be partially hook and partially loop on the connecting side so that the connecting side can be threaded through the buckle on the buckle side and the hook and loop portions may meet. The strap 303 may be adjustable. The strap 303 may include any system that holds the sensor of the present disclosure in contact with the user's skin. The buckles may comprise end fittings (e.g., S-hooks, snap hooks, bolt / anchor plates, J-hooks, flat hooks, etc.), fasteners (e.g., over-center, cam, ratchet, etc.), or buckles (e.g., slide buckles, snap buckles, etc.). Users can mix and match these individual components and place them in any desired location on the device and platform. The individual components can have various connection mechanisms such as hook and loop (Velcro®), snaps, tack features, screw fasteners, tabs, or any other suitable connection mechanism such as elastic bands and adhesives.

[0196] 11A, 11B, and 11C illustrate a second example of a wearable armband, according to some embodiments. FIG. 11A illustrates a transmitter module 200, including a sensor of the present disclosure, integrated into a wearable armband 300, according to some embodiments. The system may include the transmitter 200, two-piece straps 304 and 305, and a sensor (not shown). As shown, the biosensing system may have a compact size so that it can be worn discretely. For example, the biosensing system may be worn discretely on the user's forearm, wrist, or upper arm. The strap may include a first portion 304 and a second portion 305. The first and second portions of the strap may include natural or synthetic materials. The strap material may be comfortable to the user. The strap material may be fabric, cloth, canvas, leather, cotton, nylon, polypropylene, polyester, linen, Lycra, Dyneema, Kevlar, Nomex, or the like.

[0197] The bottom layer of the band can be built with a wavy silicone pattern to prevent slippage while on the skin. Pores can be built into the band for breathability. A cavity, e.g., a hole, can be provided in the band for inserting the transmitter module 200 from the bottom side of the band. Once the transmitter module 200 (with the sensor 100) is inserted into the band and tightly fitted, the band can be strapped around the forearm or other desired area on the skin for continuous monitoring of metabolites, including glucose and other markers from sweat. In some cases, the transmitter module may be inserted into the band after tightening to provide the proper tight fit for monitoring. For example, the transmitter can be removed, the sensor can be changed, and the transmitter can be reinserted to continue monitoring without loosening the band.

[0198] The first and second portions may be removably coupled to the transmitter module 200 from the strap mount 318. The transmitter module 200 may be configured to couple to a strap via the strap mount 218. Any example, embodiment, or variation of the sensor 100 of the present disclosure may be removably coupled to the transmitter module 200. As shown, the first and second portions of the strap each have a release portion for uncoupling the strap from the transmitter module 200.

[0199] FIG. 11B illustrates a bottom view of a biosensing system, according to some embodiments. As shown, the transmitter module 200 may house the sensor 100, which may be exposed on the bottom surface so that the sensor or its sensor element may contact the user. The sensor element may contact the user's biological fluids, as described elsewhere herein. As shown, the strap portion may be freely coupled and uncoupled with the transmitter module. Optionally, the transmitter module may include a mating surface that may allow for easy coupling and uncoupling with the strap portion. Optionally, the mating surface may include magnets, hooks, notches, snap-on mechanisms, etc. that allow for easy coupling and uncoupling with the transmitter module. Optionally, the transmitter and forearm attachment may be configured to be used over weeks, months, or years, while the sensor may be configured to be used for a shorter period of time, e.g., hours, days, weeks, months, or years. The sensor 100 may be disposable. The sensor 100 may be replaceable.

[0200] FIG. 11C illustrates a top view of an armband system with example dimensions, according to some embodiments. The dimensions of the armband system may be varied to fit the body part of the user being monitored. For example, the length of the band may be long enough to attach circumferentially around the arm, leg, ankle, chest, etc. The band may be provided in variable lengths to fit various patient sizes. The band may include sufficient band material to be securely attached via a buckle mechanism, as described elsewhere herein. In some examples, the total length of the band may be approximately 250 mm. In some examples, the total length of the band may be in the range of 100 mm to 1000 mm. In some examples, the total length of the band may be 200 mm to 400 mm. The maximum width of the armband may be 20 mm to 100 mm. The maximum width of the band may be 1 mm to 200 mm.

[0201] While a fabric hook and loop system with a buckle is shown, many possible fastening systems may also be used. For example, a wearable armband may have a watch buckle and a free side with a hole for receiving the watch buckle. The wearable armband may have a hook and loop fastener such as Velcro®. The fabric hook may be on the buckle side and the fabric loop may be on the connecting side. As shown, the fabric of the strap may be partially hook and partially loop on the connecting side so that the connecting side is threaded through the buckle on the buckle side and the hook and loop portions may meet. Both strap portions may be adjustable. The strap portions may include any system that holds the sensor of the present disclosure in contact with the user's skin. The buckle may include an end fitting (e.g., S-hook, snap hook, bolt / anchor plate, J-hook, flat hook, etc.), a fastener (e.g., over-center, cam, ratchet, etc.), or a buckle (e.g., slide buckle, snap buckle, etc.). A user can mix and match these individual components and place them in any desired location on the device and platform. The individual components can have a variety of attachment mechanisms, such as hook and loop (Velcro®), snaps, tack features, screw fasteners, tabs, or any other suitable attachment mechanism, such as elastic bands and adhesives.

[0202] Patch System

[0203] 12A, 12B, 12C, 13A, and 13B show a patch mounting portion 400, which can receive a transmitter module 200 of the present disclosure. The patch system of the present disclosure may include a receiving area and flat portion 405 and a receiving portion 410. Optionally, in any of the embodiments disclosed herein, the flat portion can include an annular ring-like shape. An adhesive (not shown) can be disposed on the flat portion of the housing base to facilitate adhesion of the device to the subject's skin and create a seal after the device is placed on the skin.

[0204] FIG. 12A illustrates an example of a top view of a patch mount with a transmitter module mounted thereon, according to some embodiments. FIG. 12B illustrates an example of a patch mount with the transmitter module decoupled from the patch mount, according to some embodiments. Referring to FIG. 12B, the flat portion 405 of the housing base can be configured to be placed on a subject's skin (e.g., on the upper arm). The flat portion can be provided to surround the receiving portion 410. An adhesive (not shown) can be placed on the flat portion of the housing base. The adhesive can create a seal on the skin that prevents the device from being removed from the skin without intentional removal from the user. A suitable biocompatible adhesive or gasket material can be placed on the flat portion of the housing base for improved contact and to facilitate adhesion of the device to the subject's skin. Any suitable adhesive can be used. The adhesive can be a hydrogel, acrylic, polyurethane gel, hydrocolloid, or silicone gel.

[0205] The planar portion 405 may comprise a flexible base that can conform to the shape of the user's skin on which the patch mount is mounted. The flexible base may be plastic, silicone, natural or synthetic rubber, thermoplastic polyurethane, nylon, and neoprene.

[0206] The receiving portion 410 may comprise a material sufficiently rigid to hold the transmitter module disposed therein. The transmitter portion may be attached to the receiving portion by clips, latches, snaps, straps, tethers, Velcro®, tape, hook and loop, tack features, screw fasteners, tabs, magnetic fasteners, or any other suitable connection mechanism, such as elastic bands and adhesives. The receiving portion may be sized and shaped to receive the transmitter module 200 of the present disclosure. The receiving portion may have an opening, which may facilitate contact between the sensor disposed on the patient-facing surface of the transmitter module and the skin. In some cases, the receiving portion and the planar portion are disposable. In some cases, the receiving portion and the planar portion may be reused.

[0207] The planar portion may include an adhesive on the bottom (patient-facing) surface. The adhesive can be a hydrogel. Optionally, in any of the embodiments disclosed herein, the hydrogel can include a synthetic polymer, a natural polymer, a derivative thereof, or a combination thereof. Examples of synthetic polymers include, but are not limited to, poly(acrylic acid), poly(vinyl alcohol) (PVA), poly(vinylpyrrolidone) (PVP), poly(ethylene glycol) (PEG), and polyacrylamide. Examples of natural polymers include, but are not limited to, alginate, cellulose, chitin, chitosan, dextran, hyaluronic acid, pectin, starch, xanthan gum, collagen, silk, keratin, elastin, resilin, gelatin, and agar.

[0208] In some embodiments, the adhesive can be pre-attached to the planar portion 405 on the skin-facing side. The device can include a protective film or backing that covers the adhesive on the planar portion. The protective film can be removed prior to using the device and placing the device on the subject's skin. In another embodiment, the adhesive in the form of a gel, hydrogel, paste, or cream can be applied to the subject's skin or to the planar portion on the housing base of the device prior to placing the device on the subject's skin. The adhesive can then be placed in contact with the subject's skin for a predetermined amount of time (e.g., about a few seconds to a few minutes) to form an adhesive layer between the skin and the device. The adhesive can be a pressure-sensitive adhesive or a heat-sensitive adhesive. In some embodiments, the adhesive can be hypoallergenic.

[0209] In some embodiments, the adhesive can be a releasable adhesive and can have a shape and size corresponding to the flat portion on the housing base of the device. In the example shown in FIG. 12B, the flat portion on the housing base can be in the shape of an annular ring, but any shape is contemplated. Thus, the releasable adhesive can be provided as an annular ring corresponding to the flat portion on the housing base. The skin-facing side of the transmitter module can be exposed to the patient's skin through an annular opening in the flat portion. In some embodiments, additional support can be provided between the flat portion and the adhesive. In some embodiments, the flat portion can include a foam layer between the flat portion and the adhesive.

[0210] FIG. 12C illustrates a diagram of an integrated sensor patch system according to some embodiments. In the illustrated embodiment, a transmitter module 200 may be integrated into the patch system of the present disclosure along with a sensor 100. The integrated sensor patch system may include an integrated sensor and transmitter module 290. The integrated sensor and transmitter module may be mounted on a planar portion 405, which may also include an adhesive disposed thereon, as disclosed herein. FIG. 12C also illustrates a plurality of discrete sensor elements 105, which may be disposed on the top surface of the integrated sensor patch system. The illustrated embodiment may be attached to a connection device of the present disclosure, for example, as a breath sensing system.

[0211] 13A, 13B, 13C, and 13D illustrate an example of a patch system, according to some embodiments, which may be coupled to a transmitter module, which in turn may be coupled to an armband. FIG. 13A illustrates an example of a top view of a patch system, according to some embodiments, which may be coupled to a transmitter module, which in turn may be coupled to an armband. The flat portion 405 of the housing base can be configured to be placed on the subject's skin (e.g., on the upper arm). The flat portion can be provided to surround the receiving portion 410.

[0212] As shown, the patch system 400 may be smaller than the body part to be measured. The flat portion 405 may be circular, ellipsoidal, rectangular, square, irregular, or any other shape. The flat portion may be cut to fit a shape, which may allow for movement of the underlying tissue. The flat portion may be cut to fit a shape, which may provide support to the underlying tissue. The illustrated embodiment shows a circular flat portion with a diameter of 90 millimeters. The diameter of the flat portion may be less than 500 mm. The diameter of the flat portion may be less than 100 mm. The diameter of the flat portion may be less than 10 millimeters. The size of the flat portion may be sufficient to allow for coupling of a transmitter module of the present disclosure.

[0213] 13B illustrates an example of a side view of a patch system, according to some embodiments, which may be coupled to a transmitter module, which in turn may be coupled to an armband. As shown, the patch system may have an overall height (e.g., the distance from the patient's skin to the top of the device) of less than 10 mm. In some examples, the overall height is less than 30 mm. In some examples, the overall height is less than 5 mm. In some cases, the patch system includes side walls that are sufficiently tall to clip a transmitter module into the patch system, as disclosed herein.

[0214] 13C and 13D illustrate an example of a patch system coupled to a transmitter module, which in turn can be coupled to an armband, according to some embodiments. The receiving portion 410 may comprise a material sufficiently rigid to hold the transmitter module disposed therein. The transmitter portion may be attached to the receiving portion by clips, latches, snaps, straps, tethers, Velcro®, tape, hook and loop, tack features, screw fasteners, tabs, magnetic fasteners, or any other suitable connection mechanism, such as elastic bands and adhesives. The receiving portion may be sized and shaped to receive the transmitter module 200 of the present disclosure. The receiving portion may have an opening 415, which can facilitate contact between the skin and a sensor disposed on the patient-facing surface of the transmitter module. In some cases, the receiving portion and planar portion are disposable. In some cases, the receiving portion and planar portion may be reused.

[0215] Connected Devices

[0216] 14 shows a wearable device of the present disclosure connecting with two connected devices, according to some embodiments. In the illustrated embodiment, transmitter module 200 may receive and / or transmit data to a first connected device, which is a smartphone or tablet 500. In the illustrated embodiment, smartphone or tablet 500 may receive and / or transmit data to a second connected device, which is a remote server 550. In some cases, a remote server may not be needed. In some cases, a smartphone or tablet may not be needed.

[0217] In some embodiments, the systems, devices, and methods described herein include or use one or more connection devices. The connection device may be a digital processing device, which may be connected wirelessly or by a wired connection to the devices and systems of the present disclosure. In some embodiments, the connection device may optionally be connected to a computer network. In further embodiments, the connection device is optionally connected to the Internet to access the World Wide Web. In still further embodiments, the connection device is optionally connected to a cloud computing infrastructure. In other embodiments, the connection device is optionally connected to an intranet. In other embodiments, the connection device is optionally connected to a data storage device. In other embodiments, the connection device is connected to a cellular data network. In still other embodiments, the connection device is connected via Bluetooth®.

[0218] In accordance with the description herein, suitable connection devices include, by way of non-limiting example, server computers, desktop computers, laptop computers, notebook computers, sub-notebook computers, netbook computers, netpad computers, set-top computers, media streaming devices, handheld computers, Internet appliances, mobile smartphones (e.g., Apple (R) iPhone(R), Android-compatible devices, Blackberry (R) ), tablet computers (e.g., Apple (R) iPad(R), Samsung (R)Galaxy Tab), personal digital assistants, video game consoles, and vehicles. Those skilled in the art will recognize that many smartphones are suitable for use in the systems described herein. Those skilled in the art will recognize that many smartphones are suitable for use in the systems described herein. Those skilled in the art will also recognize that optional televisions, video players, and digital music players with optional computer network connectivity are suitable for use in the systems described herein. Suitable tablet computers include booklet, slate, and convertible configurations, as known to those skilled in the art.

[0219] According to the description herein, the connected device may be a mobile device 500 such as a laptop, tablet, or smartphone. In some cases, the mobile device may be local to the user. A connected device that is a mobile device may be a mobile smartphone (e.g., an Apple (R) iPhone(R), Android-compatible devices, Blackberry (R) ), tablet computers (e.g., Apple (R) iPad(R), Samsung (R) The mobile device may be a Galaxy Tab, a desktop computer, a laptop computer, etc. The mobile device may allow for user control of the device.

[0220] In some cases, the mobile device may allow a user to access all or a portion of the sensor data. The mobile device may include a user interface. The mobile device may include software stored thereon that may allow a user to control the functionality of the device. The software may include a mobile app. The software may include a browser plug-in. The software may include a standalone application. The software may allow a user to control functionality such as turning the device on or off, calibration, firmware updates, alerts, sensitivity, number of analyte types, sensor type settings, etc. In some examples, the mobile device may display to the user the values ​​of one or more analytes of the present disclosure (e.g., analyte concentrations). The mobile device may display the analyte values ​​substantially in real time. The mobile device may display upper and / or lower thresholds for one or more analytes. For example, the patient may be able to see if the analyte level is too high or too low. In some cases, the user interface may prompt the user to change behavior based on the collected data.

[0221] According to the description herein, the connection device may be a remote server 550. The remote server may be a cloud server. The remote server may store data. For example, the remote server may store data that does not need to be immediately available to the user. The remote server may store data when there is insufficient space to store data on the mobile device and / or transmitter module itself. The remote server may analyze the data. The remote server may store data that can be analyzed by a third party, such as a doctor, personal trainer, coach, etc.

[0222] computer program

[0223] In some embodiments, the platforms, systems, media, and methods disclosed herein include at least one computer program or the use of the same. A computer program includes a sequence of instructions executable within a CPU of a connected device, written to perform specified tasks. The computer-readable instructions may be implemented as program modules, such as functions, objects, application programming interfaces (APIs), data structures, and the like, that perform particular tasks or implement particular abstract data types. Given the disclosure provided herein, those skilled in the art will recognize that computer programs can be written in various languages ​​and in various versions.

[0224] The functionality of the computer-readable instructions may be combined or distributed as desired in various environments. In some embodiments, a computer program comprises one sequence of instructions. In some embodiments, a computer program comprises multiple sequences of instructions. In some embodiments, a computer program is provided from one location. In other embodiments, a computer program is provided from multiple locations. In various embodiments, a computer program includes one or more software modules. In various embodiments, a computer program includes, in part or in whole, one or more web applications, one or more mobile applications, one or more stand-alone applications, one or more web browser plug-ins, extensions, add-ins, or add-ons, or a combination thereof.

[0225] Mobile Applications

[0226] In some embodiments, the computer program comprises a mobile application that is provided to the connected device. In some embodiments, the mobile application is provided to the mobile connected device when the device is manufactured. In other embodiments, the mobile application is provided to the connected device via a computer network as described herein.

[0227] In light of the disclosure provided herein, mobile applications are created using hardware, languages, and development environments known in the art and by techniques known to those skilled in the art. Those skilled in the art will recognize that mobile applications are written in a number of languages. Suitable programming languages ​​include, by way of non-limiting example, C, C++, C#, Objective-C, Java, Javascript, Pascal, Object Pascal, and Python. TM , Ruby, VB.NET, WML, and XHTML / HTML with or without CSS, or a combination thereof.

[0228] Suitable mobile application development environments are available from several sources. Commercially available development environments include, by way of non-limiting example, AirplaySDK, AlcheMo, and Appcelerator. (R) , Celsius, Bedrock, Flash Lite, .NET Compact Framework, Rhomobile, and WorkLight Mobile Platform. Other development environments are available at no cost, including, by way of non-limiting example, Lazarus, MobiFlex, MoSync, and Phonegap. Mobile device manufacturers also provide SDKs for the iPhone® and iPad® (iOS), Android, and iOS devices, by way of non-limiting example. TM SDK, Blackberry (R) SDK, BREW SDK, Palm (R)The Company distributes software developer kits, including the OS SDK, Symbian SDK, webOS SDK, and Windows Mobile SDK.

[0229] Those skilled in the art will recognize, by way of non-limiting example, Apple (R) App Store, Google (R) Play, Chrome WebStore, Blackberry (R) App World, App Store for Palm devices, App Catalog for webOS, Windows Marketplace for Mobile, Nokia (R) Ovi Store for devices, Samsumg (R) Apps, and Nintendo (R) It will be appreciated that several commercial forums are available for the distribution of mobile applications, including the DSi Shop.

[0230] Web Applications

[0231] In some embodiments, the computer program comprises a web application. Given the disclosure provided herein, those skilled in the art will recognize that web applications, in various embodiments, utilize one or more software frameworks and one or more database systems. In some embodiments, the web application comprises a Microsoft (R) The web application is built on a software framework such as .NET or Ruby on Rails (RoR). In some embodiments, the web application utilizes one or more database systems, including, by way of non-limiting example, relational, non-relational, object-oriented, associative, and XML database systems. In further embodiments, a suitable relational database system is, by way of non-limiting example, Microsoft (R) SQL Server, mySQL TM , and Oracle (R)Those skilled in the art will also recognize that web applications, in various embodiments, are written in one or more versions of one or more languages. Web applications may be written in one or more markup languages, presentation definition languages, client-side scripting languages, server-side scripting languages, database query languages, or combinations thereof. In some embodiments, web applications are written to some extent in a markup language such as HyperText Markup Language (HTML), Extensible HyperText Markup Language (XHTML), or Extensible Markup Language (XML). In some embodiments, web applications are written to some extent in a presentation definition language such as Cascading Style Sheets (CSS). In some embodiments, web applications are written to some extent in asynchronous Javascript and XML (AJAX), Flash, or other languages. (R) Actionscript, Javascript, or Silverlight (R) In some embodiments, the web application is written in a client-side scripting language such as Active Server Pages (ASP), ColdFusion, etc. (R) , Perl, Java (registered trademark), JavaServer Pages (JSP), Hypertext Preprocessor (PHP), Python TM , Ruby, Tcl, Smalltalk, WebDNA (R) In some embodiments, the web application is written in part in a database query language such as Structured Query Language (SQL). In some embodiments, the web application is written in part in a server-side scripting language such as IBM (R) Lotus Domino (R) In some embodiments, the web application includes a media player component. In various further embodiments, the media player component may be a media player component, such as, by way of non-limiting example, Adobe (R) Flash (R), HTML5, Apple (R) QuickTime (R) , Microsoft (R) Silverlight (R) , Java®, and Unity (R) The present invention utilizes one or more of many suitable multimedia technologies, including:

[0232] Web browser plugin

[0233] In some embodiments, the computer program includes a web browser plug-in (e.g., extension). In computing, a plug-in is one or more software components that add specific functionality to a larger software application. Software application manufacturers support plug-ins to allow third-party developers to create the ability to extend the application, help easily add new features, and reduce the size of the application. When supported, plug-ins allow for customization of the functionality of the software application. For example, plug-ins are commonly used in web browsers to play video, generate interactivity, scan for viruses, and display specific file types. Those skilled in the art will recognize that plug-ins, such as Adobe (R) Flash (R) Player, Microsoft (R) Silverlight (R) , and Apple (R) QuickTime (R) In some embodiments, the toolbar comprises one or more web browser extensions, add-ins, or add-ons. In some embodiments, the toolbar comprises one or more explorer bars, tool bands, or desk bands.

[0234] In light of the disclosure provided herein, one of ordinary skill in the art would be able to implement a number of programming languages, including, by way of non-limiting examples, C++, Delphi, Java, PHP, Python, etc. TM , and VB.NET, or a combination thereof.

[0235] A web browser (also called an Internet browser) is a software application designed for use with a network-connected device to retrieve, present, and traverse information resources on the World Wide Web. Suitable web browsers include, by way of non-limiting example, the Microsoft (R) Internet Explorer (R) , Mozilla (R) Firefox (R) , Google (R) Chrome, Apple (R) Safari (R) , Opera Software (R) Opera (R) , and KDE Konqueror. In some embodiments, the web browser is a mobile web browser. Mobile web browsers (also called microbrowsers, minibrowsers, and wireless browsers) are designed for use on mobile connected devices, including, by way of non-limiting examples, handheld computers, tablet computers, netbook computers, subnotebook computers, smartphones, music players, personal digital assistants (PDAs), and handheld video game systems. Suitable mobile web browsers include, by way of non-limiting examples, Google (R) Android (R) Browser, RIM Blackberry (R) Browser, Apple (R) Safari (R) , Palm (R) BLzer, Palm (R) webOS (R)Browser, Mozilla for Mobile (R) Firefox (R) , Microsoft (R) Internet Explorer (R) Mobile, Amazon (R) Kindle (R) Basic Web, Nokia (R) Browser, Opera Software (R) Opera (R) Mobile, Sony (R) PSP TM Including the browser.

[0236] Standalone Applications

[0237] In some embodiments, the computer program includes a standalone application, which is a program that is launched as an independent computer process rather than an add-on to an existing process, e.g., a plug-in. Those skilled in the art will recognize that standalone applications are often compiled. A compiler is a computer program that converts source code written in a programming language into binary object code, such as assembly language or machine code. Suitable compiled programming languages ​​include, by way of non-limiting example, C, C++, Objective-C, COBOL, Delphi, Eiffel, Java, Lisp, and Python. TM , Visual Basic, and VB.NET, or a combination thereof. Compilation is often performed, at least in part, to create an executable program. In some embodiments, a computer program includes one or more executable compiled applications.

[0238] Software Module

[0239] In some embodiments, the platforms, systems, media, and methods disclosed herein involve the use of software, server, and / or database modules, or portions thereof. In light of the disclosure provided herein, software modules are created by techniques known to those skilled in the art using machines, software, and languages ​​known in the art. The software modules disclosed herein are implemented in numerous ways. In various embodiments, a software module comprises a file, a section of code, a programming object, a programming structure, or a combination thereof. In further various embodiments, a software module comprises multiple files, multiple sections of code, multiple programming objects, multiple programming structures, or a combination thereof. In various embodiments, one or more software modules comprise, by way of non-limiting examples, a web application, a mobile application, and a standalone application. In some embodiments, a software module is within one computer program or application. In other embodiments, a software module is within more than one computer program or application. In some embodiments, a software module is hosted on one machine. In other embodiments, a software module is hosted on more than one machine. In further embodiments, a software module is hosted on a cloud computing platform. In some embodiments, the software modules are hosted on one or more machines at one location. In other embodiments, the software modules are hosted on one or more machines at more than one location.

[0240] Processing Device

[0241] 15 illustrates an exemplary connectivity device 1501 programmed or otherwise configured to interface with transmitter module 200, according to some embodiments. In further embodiments, the connectivity device includes one or more hardware central processing units (CPUs), general-purpose graphics processing units (GPGPUs), or field-programmable gate arrays (FPGAs) that perform the functionality of the device. In still further embodiments, the connectivity device further comprises an operating system configured to execute executable instructions.

[0242] In some embodiments, the connected device includes an operating system configured to execute executable instructions. An operating system includes software, including programs and data, that manages the device's hardware and provides services for the execution of applications. Those skilled in the art will recognize that suitable server operating systems include, by way of non-limiting examples, FreeBSD, OpenBSD, NetBSD, (R) , Linux (registered trademark), Apple (R) Mac OS X Server (R) , Oracle (R) Solaris (R) , Windows(R) Server (R) , and Novell (R) NetWare (R) Those skilled in the art will recognize that suitable personal computer operating systems include, by way of non-limiting example, Microsoft (R) Windows (registered trademark), Apple (R) Mac OS X (R) , UNIX, and UNIX-like operating systems such as GNU / Linux. In some embodiments, the operating system is provided by cloud computing. Those skilled in the art will also recognize that suitable mobile smartphone operating systems include, by way of non-limiting example, Nokia (R)Symbian (R) OS, Apple (R) iOS (R) , Research In Motion (R) Blackberry OS (R) , Google (R) Android (R) , Microsoft (R) Windows Phone (R) OS, Microsoft (R) Windows(R) Mobile (R) OS, Linux (registered trademark), and Palm (R) webOS (R) Those skilled in the art will also recognize that suitable media streaming device operating systems include, by way of non-limiting example, Apple TV. (R) , Roku (R) , Boxee (R) , Google TV (R) , Google Chromecast (R) , Amazon Fire (R) , and Samsung (R) HomeSync (R) Those skilled in the art will also recognize that suitable video game console operating systems include, by way of non-limiting example, Sony (R) PS3 (R) , Sony (R) PS4 (R) , Microsoft (R) Xbox 360 (R) , Microsoft Xbox One, Nintendo (R) Wii (R) , Nintendo (R) Wii U (R) , and Ouya (R) You will also recognize that this includes:

[0243] In some embodiments, the device includes a storage and / or memory device. A storage and / or memory device is one or more physical devices used to temporarily or permanently store data or programs. In some embodiments, the device is volatile memory and requires power to maintain stored information. In some embodiments, the device is nonvolatile memory and retains stored information when the connected device is not powered. In further embodiments, the nonvolatile memory comprises flash memory. In some embodiments, the nonvolatile memory comprises dynamic random access memory (DRAM). In some embodiments, the nonvolatile memory comprises ferroelectric random access memory (FRAM®). In some embodiments, the nonvolatile memory comprises phase change random access memory (PRAM). In other embodiments, the device is a storage device, including, by way of non-limiting examples, a CD-ROM, a DVD, a flash memory device, a magnetic disk drive, a magnetic tape disk, an optical disk drive, and a cloud computing-based storage device. In further embodiments, the storage and / or memory device is a combination of devices such as those disclosed herein.

[0244] In some embodiments, the connection device includes a display for transmitting visual information to a user. In some embodiments, the display is a cathode ray tube (CRT). In some embodiments, the display is a liquid crystal display (LCD). In further embodiments, the display is a thin film transistor liquid crystal display (TFT-LCD). In some embodiments, the display is an organic light emitting diode (OLED) display. In various further embodiments, the OLED display is a passive matrix OLED (PMOLED) or an active matrix OLED (AMOLED) display. In some embodiments, the display is a plasma display. In other embodiments, the display is a video projector. In still further embodiments, the display is a combination of devices such as those disclosed herein.

[0245] In some embodiments, the connection device includes an input device for receiving information from a user. In some embodiments, the input device is a keyboard. In some embodiments, the input device is a pointing device, including, by way of non-limiting examples, a mouse, trackball, trackpad, joystick, game controller, or stylus. In some embodiments, the input device is a touchscreen or multi-touchscreen. In other embodiments, the input device is a microphone for capturing voice or other audio input. In other embodiments, the input device is a video camera or other sensor for capturing motion or visual input. In further embodiments, the input device is a Kinect, Leap Motion, or equivalent. In still further embodiments, the input device is a combination of devices such as those disclosed herein.

[0246] Referring again to FIG. 15 , an exemplary connectivity device 1501 is programmed or otherwise configured to connect to a transmitter module as described herein. The device 1501 can coordinate various aspects of the transmitter module 200 of the present disclosure, such as performing data processing, storing data, turning the device on and off, synchronizing data to an external server, etc. In this embodiment, the connectivity device 1501 includes a central processing unit (CPU, also referred to herein as a “processor” and “computer processor”) 1505, which can be a single-core or multi-core processor or multiple processors for parallel processing. The connectivity device 1501 also includes memory or memory locations 1510 (e.g., random access memory, read-only memory, flash memory), an electronic storage unit 1515 (e.g., a hard disk), a communication interface 1520 (e.g., a network adapter, Bluetooth® radio, etc.) for communicating with one or more other systems, and peripheral devices 1525, such as cache, other memory, data storage, and / or electronic display adapters. The memory 1510, the storage unit 1515, the interface 1520, and the peripheral devices 1525 communicate with the CPU 1505 through a communication bus (a physical line) such as a motherboard. The storage unit 1515 can be a data storage unit (or data repository) for storing data.

[0247] Connectivity device 1501 can be operatively coupled to a computer network (“network”) 1530 with the aid of communication interface 1520. Network 1530 can be the Internet, an Internet and / or extranet, or an intranet and / or extranet in communication with the Internet. Network 1530, in some cases, is a telecommunications and / or data network. Network 1530 can include one or more computer servers, which can enable distributed computing such as cloud computing. Network 1530, in some cases, can implement a peer-to-peer network with the aid of device 1501, which can allow devices coupled to device 1501 to behave as clients or servers.

[0248] Continuing with reference to FIG. 15, CPU 1505 can execute sequences of machine-readable instructions, which may be embodied in a program or software. The instructions may be stored in a memory location, such as memory 1510. The instructions can be directed to CPU 1505, which can then program or otherwise configure CPU 1505 to implement the methods of the present disclosure. Examples of operations performed by CPU 1505 can include fetch, decode, execute, and write back. CPU 1505 can be part of a circuit, such as an integrated circuit. One or more other components of device 1501 can be included in the circuit. In some cases, the circuit is an application-specific integrated circuit (ASIC) or a field-programmable gate array (FPGA).

[0249] 15, storage unit 1515 can store files such as drivers, libraries, and saved programs. Storage unit 1515 can store user data, e.g., user preferences and user programs. Connectivity device 1501 can include one or more additional data storage units that, in some cases, are external, such as located on a remote server communicating through an intranet or the Internet.

[0250] Continuing with reference to FIG. 15, the connected device 1501 can communicate with one or more remote computer systems through a network 1530. For example, the device 1501 can communicate with a user's remote computer system. Examples of remote computer systems include a personal computer (e.g., a portable PC), a slate or tablet PC (e.g., an Apple (R) iPad(R), Samsung (R) Galaxy Tab), phone, smartphone (e.g., Apple (R) iPhone(R), Android-compatible devices, Blackberry (R) ), or a personal digital assistant.

[0251] Methods as described herein can be implemented using machine (e.g., computer processor) executable code stored on an electronic storage location of the connectivity device 1501, such as on the memory 1510 or electronic storage unit 1515. The machine-executable or machine-readable code can be provided in the form of software. During use, the code can be executed by the processor 1505. In some cases, the code can be read from the storage unit 1515 and stored on the memory 1510 for easy access by the processor 1505. In some situations, the electronic storage unit 1515 can be omitted and the machine-executable instructions are stored on the memory 1510.

[0252] Non-transitory computer-readable storage medium In some embodiments, the platforms, systems, media, and methods disclosed herein include one or more non-transitory computer-readable storage media encoded with a program including instructions executable by an operating system of an optionally networked digital processing device. In further embodiments, the computer-readable storage medium is a tangible component of the digital processing device. In still further embodiments, the computer-readable storage medium is optionally removable from the digital processing device. In some embodiments, computer-readable storage media include, by way of non-limiting examples, CD-ROMs, DVDs, flash memory devices, solid-state memory, magnetic disk drives, magnetic tape drives, optical disk drives, cloud computing systems and services, and the like. In some cases, the programs and instructions are encoded on the medium permanently, substantially permanently, semi-permanently, or non-transitoryly.

[0253] The processes described above are described in terms of computer software and hardware. The techniques described may constitute machine-executable instructions embodied in a tangible or non-transitory machine (e.g., computer) readable storage medium that, when executed by a machine, will cause the machine to perform the operations described. In addition, the processes may be embodied in hardware, such as an application-specific integrated circuit ("ASIC") or the like.

[0254] A tangible non-transitory machine-readable storage medium includes any mechanism that provides (i.e., stores) information in a form accessible by a machine (e.g., a computer, a network device, a personal digital assistant, a manufacturing tool, any device with a set of one or more processors, etc.). For example, machine-readable storage media include recordable / non-recordable media (e.g., read-only memory (ROM), random access memory (RAM), magnetic disk storage media, optical storage media, flash memory devices, etc.).

[0255] Docking Station

[0256] 16A, 16B, 17A, and 17B illustrate a docking station 600, according to some embodiments, which may be coupled to a transmitter module 200. The transmitter module may comprise an embodiment, variation, or implementation of the transmitter module 200 described anywhere herein.

[0257] FIG. 16A shows a transmitter module decoupled from a docking station, according to some embodiments. FIG. 16B shows a transmitter module coupled to a docking station, according to some embodiments. As shown, the transmitter may be freely decoupled and coupled to the docking station, which may provide a convenient method of charging the transmitter. Optionally, the transmitter may be charged via a wire or wirelessly. Optionally, the docking station may also be utilized to provide an interface for coupling the transmitter to an external computer or to upload transmitter data to a database. The docking station may include one or more sockets for connecting the docking station to a wall socket. The docking station may include one or more ports for connecting the docking station to a computer. The docking station may be charged and / or connected to external devices via USB.

[0258] FIG. 17A shows a transmitter module decoupled from a docking station, according to some embodiments. FIG. 17B shows a transmitter module coupled to a docking station, according to some embodiments. As shown, the transmitter may be freely decoupled and coupled to the docking station, which may provide a convenient method of charging the transmitter. Optionally, the transmitter may be charged via a wire or wirelessly. Optionally, the docking station may also be utilized to provide an interface for coupling the transmitter to an external computer or to upload transmitter data to a database. The docking station may include one or more ports for connecting the docking station to a wall socket. The docking station may include one or more ports for connecting the docking station to a computer. The docking station may be charged and / or connected to external devices via USB.

[0259] While preferred embodiments of the present invention have been shown and described herein, it will be apparent to those skilled in the art that such embodiments are provided by way of example only. Numerous modifications, changes, and substitutions will now occur to those skilled in the art without departing from the invention. It is understood that various alternatives to the embodiments of the invention described herein may be employed in practicing the invention. The following claims define the scope of the invention, and it is intended that methods and structures within the scope of these claims and their equivalents be covered thereby.

Claims

[Claim 1] An interchangeable sensor system, method, etc. as described in the drawings.

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