Systems, devices, and methods for analyte monitoring

Abstract

Systems, devices and methods are provided for measurement of an analyte level in a bodily fluid of a subject. In particular, disclosed herein are various embodiments of sensor control devices include a display. The display may be on or in the housing of the on-body unit. The display may be directly electronically coupled to the analyte sensor or may be indirectly electronically coupled to the analyte sensor through the sensor electronics.

Description

SYSTEMS, DEVICES, AND METHODS FOR ANALYTE MONITORINGCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to, and the benefit of, U.S. Provisional Application No. 63 / 545,430, filed October 24, 2023, which is hereby expressly incorporated by reference in its entirety for all purposes.FIELD

[0002] The subject matter described herein relates generally to systems, devices, and methods for in vivo analyte monitoring.BACKGROUND

[0003] The detection and / or monitoring of analyte levels, such as glucose, ketones, lactate, oxygen, hemoglobin AIC, or the like, can be vitally important to the overall health of a person, particularly for an individual having diabetes. Patients suffering from diabetes mellitus can experience complications including loss of consciousness, cardiovascular disease, retinopathy, neuropathy, and nephropathy. Persons with diabetes are generally required to monitor their glucose levels to ensure that they are being maintained within a clinically safe range, and may also use this information to determine if and / or when insulin is needed to reduce glucose levels in their bodies, or when additional glucose is needed to raise the level of glucose in their bodies.

[0004] Growing clinical data demonstrates a strong correlation between the frequency of glucose monitoring and glycemic control. Despite such correlation, however, many individuals diagnosed with a diabetic condition do not monitor their glucose levels as frequently as they should due to a combination of factors including convenience, testing discretion, pain associated with glucose testing, and cost.

[0005] To increase patient adherence to a plan of frequent glucose monitoring, in vivo analyte monitoring systems can be utilized, in which a sensor control device may be worn on the body of an individual who requires analyte monitoring. To increase comfort and convenience for the individual, the sensor control device may have a small form-factor, and can be assembled and applied by the individual with a sensor applicator. The application process includes inserting a sensor, such as an analyte sensor that senses a user’s analyte level in a bodily fluid, using anapplicator or insertion mechanism, such that the sensor comes into contact with a bodily fluid. The sensor control device may also be configured to transmit analyte data to another device, from which the individual or her health care provider (“HCP”) can review the data and make therapy decisions.

[0006] Continuous glucose monitoring relies on the use of a mobile device (cell phone or designated reader) to retrieve and display glucose signals to the user. This requirement may preclude those with limited access to power, smartphone technology, or technological literacy.

[0007] Thus, a need exists for a continuous analyte monitoring system that provides a display or output of analyte levels on the sensor control device, and is economical to manufacture.SUMMARY

[0008] Provided herein are example embodiments of systems, devices and methods for the assembly and use of an applicator and a sensor control device of an in vivo analyte monitoring system. A sensor control device can be provided that includes a sensor control device or on- body unit that includes a display configured to qualitatively or quantitively display a measured analyte level.

[0009] A simple, low-powered system is described that includes a sensor control device with an on-board display. In some embodiments, a sensor control device may include a semi- quantitative analogue display that employs an ammeter actuated by the current generated by the glucose response. In other embodiments, alternative qualitative and quantitative designs using microchip-powered LED displays are described.

[0010] Systems, devices and methods are provided for measurement of an analyte level in a bodily fluid of a subject. In particular, disclosed herein are various embodiments of sensor control devices include a display. The display may be on or in the housing of the on-body unit. The display may be directly electronically coupled to the analyte sensor or may be indirectly electronically coupled to the analyte sensor through the sensor electronics.

[0011] Other systems, devices, methods, features and advantages of the subject matter described herein will be or will become apparent to one with skill in the art upon examination of the following figures and detailed description. It is intended that all such additional systems, devices, methods, features, and advantages be included within this description, be within the scope of the subject matter described herein, and be protected by the accompanying claims. In noway should the features of the example embodiments be construed as limiting the appended claims, absent express recitation of those features in the claims.BRIEF DESCRIPTION OF THE FIGURES

[0012] The details of the subject matter set forth herein, both as to its structure and operation, may be apparent by study of the accompanying figures, in which like reference numerals refer to like parts. The components in the figures are not necessarily to scale, emphasis instead being placed upon illustrating the principles of the subject matter. Moreover, all illustrations are intended to convey concepts, where relative sizes, shapes and other detailed attributes may be illustrated schematically rather than literally or precisely.

[0013] FIG. 1 is a system overview of a sensor applicator, reader device, monitoring system, network, and remote system.

[0014] FIG. 2A is a block diagram depicting an example embodiment of a reader device.

[0015] FIGS. 2B and 2C are block diagrams depicting example embodiments of sensor control devices.

[0016] FIGS. 2D-2H are block diagrams depicting example embodiments of sensor control devices with displays.

[0017] FIG. 3 A is a side view depicting an example embodiment of an applicator device coupled with a cap.

[0018] FIG. 3B is a side perspective view depicting an example embodiment of an applicator device and cap decoupled.

[0019] FIG. 3C is a perspective view depicting an example embodiment of a distal end of an applicator device and electronics housing.

[0020] FIG. 4A is side view depicting an example embodiment of a housing.

[0021] FIG. 4B is a perspective view depicting an example embodiment of a distal end of a housing.

[0022] FIG. 4C is a side cross-sectional view depicting an example embodiment of a housing.

[0023] FIG. 5A is a side view depicting an example embodiment of a sheath.

[0024] FIG. 5B is a perspective view depicting an example embodiment of a proximal end of a sheath.

[0025] FIG. 5C is a close-up perspective view depicting an example embodiment of a distal side of a detent snap of a sheath.

[0026] FIG. 5D is a side view depicting an example embodiment of features of a sheath.

[0027] FIG. 5E is an end view of an example embodiment of a proximal end of a sheath.

[0028] FIG. 6A is a proximal perspective view depicting an example embodiment of a device carrier.

[0029] FIG. 6B is a distal perspective view depicting an example embodiment of a device carrier.

[0030] FIG. 7 is a proximal perspective view of an example embodiment of a sharp carrier.

[0031] FIG. 8 is a side cross-section depicting an example embodiment of a sharp carrier.

[0032] FIG. 9 is a top view of an exemplary sensor control device with a display.

[0033] FIGS. 10A-10C are exemplary embodiments of sensor control devices with an ammeter.

[0034] FIGS. 10D-10E are exemplary embodiments of housings of sensor control devices with portions of an ammeter.

[0035] FIGS. 11 A-l IB are exemplary displays with at least one light.

[0036] FIG. 12 is an exemplary digital display.

[0037] FIGS. 13A-13E illustrate cross-sectional views depicting an example embodiment of an applicator during various stages of deployment.DETAILED DESCRIPTION

[0038] Before the present subject matter is described in detail, it is to be understood that this disclosure is not limited to the particular embodiments described, as such may, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting, since the scope of the present disclosure will be limited only by the appended claims.

[0039] As used herein and in the appended claims, the singular forms “a,” “an,” and “the” include plural referents unless the context clearly dictates otherwise.

[0040] The publications discussed herein are provided solely for their disclosure prior to the filing date of the present application. Nothing herein is to be construed as an admission that the present disclosure is not entitled to antedate such publication by virtue of prior disclosure.Further, the dates of publication provided may be different from the actual publication dates, which may need to be independently confirmed.

[0041] Generally, embodiments of the present disclosure include systems, devices, and methods for the use of analyte sensor insertion applicators for use with in vivo analyte monitoring systems. An applicator can be used to position the sensor control device on a human body with an analyte sensor in contact with the wearer’s bodily fluid. The embodiments provided herein are improvements to reduce the likelihood that a sensor is improperly inserted or damaged, or elicits an adverse physiological response. Other improvements and advantages are provided as well. The various configurations of these devices are described in detail by way of the embodiments which are only examples.

[0042] Furthermore, many embodiments include in vivo analyte sensors structurally configured so that at least a portion of the sensor is, or can be, positioned in the body of a user to obtain information about at least one analyte of the body. It should be noted, however, that the embodiments disclosed herein can be used with in vivo analyte monitoring systems that incorporate in vitro capability, as well as purely in vitro or ex vivo analyte monitoring systems, including systems that are entirely non-invasive.

[0043] Furthermore, for each and every embodiment of a method disclosed herein, systems and devices capable of performing each of those embodiments are covered within the scope of the present disclosure. For example, embodiments of sensor control devices are disclosed and these devices can have one or more sensors, analyte monitoring circuits (e.g., an analog circuit), memories (e.g., for storing instructions), power sources, communication circuits, transmitters, receivers, processors and / or controllers (e.g., for executing instructions) that can perform any and all method steps or facilitate the execution of any and all method steps. These sensor control device embodiments can be used and can be capable of use to implement those steps performed by a sensor control device from any and all of the methods described herein.

[0044] Before describing these aspects of the embodiments in detail, however, it is first desirable to describe examples of devices that can be present within, for example, an in vivo analyte monitoring system, as well as examples of their operation, all of which can be used with the embodiments described herein.

[0045] There are various types of in vivo analyte monitoring systems. “Continuous Analyte Monitoring” systems (or “Continuous Glucose Monitoring” systems), for example, can transmitdata from a sensor control device to a reader device continuously without prompting, e.g., automatically according to a schedule. “Flash Analyte Monitoring” systems (or “Flash Glucose Monitoring” systems or simply “Flash” systems), as another example, can transfer data from a sensor control device in response to a scan or request for data by a reader device, such as with a Near Field Communication (NFC) or Radio Frequency Identification (RFID) protocol. In vivo analyte monitoring systems can also operate without the need for finger stick calibration.

[0046] In vivo analyte monitoring systems can be differentiated from “in vitro” systems that contact a biological sample outside of the body (or “ex vivo”) and that typically include a meter device that has a port for receiving an analyte test strip carrying bodily fluid of the user, which can be analyzed to determine the user’s blood sugar level.

[0047] In vivo monitoring systems can include a sensor that, while positioned in vivo, makes contact with the bodily fluid of the user and senses the analyte levels contained therein. The sensor can be part of the sensor control device that resides on the body of the user and contains the electronics and power supply that enable and control the analyte sensing. The sensor control device, and variations thereof, can also be referred to as a “sensor control unit,” an “on-body electronics” device or unit, an “on-body” device or unit, or a “sensor data communication” device or unit, to name a few.

[0048] In vivo monitoring systems may also include a device that receives sensed analyte data from the sensor control device and processes and / or displays that sensed analyte data, in any number of forms, to the user. This device, and variations thereof, can be referred to as a “handheld reader device,” “reader device” (or simply a “reader”), “handheld electronics” (or simply a “handheld”), a “portable data processing” device or unit, a “data receiver,” a “receiver” device or unit (or simply a “receiver”), or a “remote” device or unit, to name a few. Other devices such as personal computers have also been utilized with or incorporated into in vivo and in vitro monitoring systems.Exemplary In Vivo Analyte Monitoring System

[0049] FIG. l is a conceptual diagram depicting an example embodiment of an analyte monitoring system 100 that includes a sensor applicator 150, a sensor control device 102, and a reader device 120. Sensor applicator 150 can be used to deliver sensor control device 102 to a monitoring location on a user’s skin where a sensor 104 is maintained in position for a period oftime by an adhesive patch 105. Sensor control device 102 is further described in FIGS. 2B and 2C, and can communicate with reader device 120 via a communication path 140 using a wired or wireless technique. Example wireless protocols include Bluetooth, Bluetooth Low Energy (BLE, BTLE, Bluetooth SMART, etc.), Near Field Communication (NFC) and others. Users can monitor applications installed in memory on reader device 120 using screen 122 and input 121 and the device battery can be recharged using power port 123. More detail about reader device 120 is set forth with respect to FIG. 2A below. Reader device 120 can communicate with local computer system 170 via a communication path 141 using a wired or wireless technique. Local computer system 170 can include one or more of a laptop, desktop, tablet, phablet, smartphone, set-top box, video game console, or other computing device and wireless communication can include any of a number of applicable wireless networking protocols including Bluetooth, Bluetooth Low Energy, Wi-Fi or others. Local computer system 170 can communicate via communications path 143 with a network 190 similar to how reader device 120 can communicate via a communications path 142 with network 190, by wired or wireless technique as described previously. Network 190 can be any of a number of networks, such as private networks and public networks, local area or wide area networks, and so forth. A trusted computer system 180 can include a server and can provide authentication services and secured data storage and can communicate via communications path 144 with network 190 by wired or wireless technique.Exemplary Reader Device

[0050] FIG. 2A is a block diagram depicting an example embodiment of a reader device configured as a smartphone. Here, reader device 120 can include a display 122, input component 121, and a processing core 206 including a communications processor 222 coupled with memory 223 and an applications processor 224 coupled with memory 225. Also included can be separate memory 230, RF transceiver 228 with antenna 229, and power supply 226 with power management module 238. Further included can be a multi-functional transceiver 232 which can communicate over Wi-Fi, NFC, Bluetooth, BTLE, and GPS with an antenna 234. As understood by one of skill in the art, these components are electrically and communicatively coupled in a manner to make a functional device.Exemplary Sensor Control Devices

[0051] FIGS. 2B and 2C are block diagrams depicting example embodiments of sensor control device 102 having analyte sensor 104 and sensor electronics 160 (including analyte monitoring circuitry) that can have the majority of the processing capability for rendering endresult data suitable for display to the user. In FIG. 2B, a single semiconductor chip 161 is depicted that can be a custom application specific integrated circuit (ASIC). Shown within ASIC161 are certain high-level functional units, including an analog front end (AFE) 162, power management (or control) circuitry 164, processor 166, and communication circuitry 168 (which can be implemented as a transmitter, receiver, transceiver, passive circuit, or otherwise according to the communication protocol). In this embodiment, both AFE 162 and processor 166 are used as analyte monitoring circuitry, but in other embodiments either circuit can perform the analyte monitoring function. Processor 166 can include one or more processors, microprocessors, controllers, and / or microcontrollers, each of which can be a discrete chip or distributed amongst (and a portion of) a number of different chips.

[0052] A memory 163 is also included within ASIC 161 and can be shared by the various functional units present within ASIC 161, or can be distributed amongst two or more of them. Memory 163 can also be a separate chip. Memory 163 can be volatile and / or non-volatile memory. In this embodiment, ASIC 161 is coupled with power source 172, which can be a coin cell battery, or the like. AFE 162 interfaces with in vivo analyte sensor 104 and receives measurement data therefrom and outputs the data to processor 166 in digital form, which in turn processes the data to arrive at the end-result glucose discrete and trend values, etc. This data can then be provided to communication circuitry 168 for sending, by way of antenna 171, to reader device 120 (not shown), for example, where minimal further processing is needed by the resident software application to display the data.

[0053] FIG. 2C is similar to FIG. 2B but instead includes two discrete semiconductor chips162 and 174, which can be packaged together or separately. Here, AFE 162 is resident on ASIC 161. Processor 166 is integrated with power management circuitry 164 and communication circuitry 168 on chip 174. AFE 162 includes memory 163 and chip 174 includes memory 165, which can be isolated or distributed within. In one example embodiment, AFE 162 is combined with power management circuitry 164 and processor 166 on one chip, while communication circuitry 168 is on a separate chip. In another example embodiment, both AFE 162 andcommunication circuitry 168 are on one chip, and processor 166 and power management circuitry 164 are on another chip. It should be noted that other chip combinations are possible, including three or more chips, each bearing responsibility for the separate functions described, or sharing one or more functions for fail-safe redundancy.

[0054] As described in US 2021 / 0177315 and US 2022 / 0110560, which are hereby expressly incorporated by reference in their entireties for all purposes, analyte sensor 104, e.g., a glucose sensor, includes a proximal portion configured to be positioned above a user’s skin and to be electrically coupled with electronics disposed in the electronics housing of the sensor control device. A distal portion of the sensor 104 is configured to be transcutaneously positioned through the user’s skin and in contact with a bodily fluid of the user. The distal portion of the sensor 104 is configured to detect an analyte in the bodily fluid. In some embodiments, the bodily fluid is interstitial fluid.Exemplary Sensor Control Device with a Display

[0055] As seen in FIG. 9, the sensor control device 102 or on-body unit may include a housing 107. Sensor electronics may be disposed within the housing 107 when present. The housing 107 may be coupled to an adhesive patch 105 that is adapted to adhere the housing 107 to skin of the user. The housing 107 may include an opening 109 configured to receive the sensor 104 and sharp. The housing 107 may include a display 200 that indicates a measured analyte level (e.g., glucose level) of the user. The display 200 may be a qualitative or quantitative display. In some embodiments, as seen in FIGS. 10A-10E, the display 200 may be an ammeter 210. In other embodiments, the display 200 may be a digital or a qualitative display. For example, the display 200 may be a qualitative low-high series of LED lights. Alternatively, the display 200 may be fully qualitative LCD or, alternatively, a 7-segment display that displays the glucose levels determined by the sensor electronics.

[0056] As seen in FIGS. 10A-10E, the ammeter 210 may be in an opening of the housing 107 and include a printed scale 212 beneath a needle 214, and encased under a clear window that allows the user to read an analyte level according to the position of the needle 214 on the scale 212. In some embodiments, the needle 214 may be actuated directly by current produced on a working electrode of the sensor.

[0057] In some embodiments, the display 200 (e.g., ammeter 210) may be directly coupled to the electrodes from the sensor 104. As seen in FIG. 2D, the display 200 may be in series with or replace the sensor electronics 160.

[0058] In some embodiments, the sensor control devices 102 may also include sensor electronics. In some embodiments, the sensor electronics may additionally enable the communication of measured and / or determined analyte levels to a reader device. FIGS. 2E and 2F are block diagrams depicting example embodiments of sensor control device 102 having analyte sensor 104 and sensor electronics 160 (including analyte monitoring circuitry) where the display 200 is directly coupled to the analyte sensor 104. As mentioned above, in some embodiments, the display 200 may be an ammeter 210 that includes a needle 214 that is actuated directly by current produced on a working electrode of the sensor. In some embodiments, as seen in FIG. 2E, a single semiconductor chip 161 is depicted that can be a custom application specific integrated circuit (ASIC). Shown within ASIC 161 are certain high-level functional units, including an analog front end (AFE) 162, power management (or control) circuitry 164, processor 166, and communication circuitry 168 (which can be implemented as a transmitter, receiver, transceiver, passive circuit, or otherwise according to the communication protocol). In this embodiment, both AFE 162 and processor 166 are used as analyte monitoring circuitry, but in other embodiments either circuit can perform the analyte monitoring function. Processor 166 can include one or more processors, microprocessors, controllers, and / or microcontrollers, each of which can be a discrete chip or distributed amongst (and a portion of) a number of different chips.

[0059] A memory 163 is also included within ASIC 161 and can be shared by the various functional units present within ASIC 161, or can be distributed amongst two or more of them. Memory 163 can also be a separate chip. Memory 163 can be volatile and / or non-volatile memory. In this embodiment, ASIC 161 is coupled with power source 172, which can be a coin cell battery, or the like. AFE 162 interfaces with in vivo analyte sensor 104 and receives measurement data therefrom and outputs the data to processor 166 in digital form, which in turn processes the data to arrive at the end-result glucose discrete and trend values, etc. This data can then be provided to communication circuitry 168 for sending, by way of antenna 171, to reader device 120 (not shown), for example, where minimal further processing is needed by the resident software application to display the data.

[0060] FIG. 2F is similar to FIG. 2E in that the display 200 is directly coupled to the analyte sensor 104. In contrast to FIG. 2E, the embodiment of FIG. 2F instead includes two discrete semiconductor chips 162 and 174, which can be packaged together or separately. Here, AFE 162 is resident on ASIC 161. Processor 166 is integrated with power management circuitry 164 and communication circuitry 168 on chip 174. AFE 162 includes memory 163 and chip 174 includes memory 165, which can be isolated or distributed within. In one example embodiment, AFE 162 is combined with power management circuitry 164 and processor 166 on one chip, while communication circuitry 168 is on a separate chip. In another example embodiment, both AFE 162 and communication circuitry 168 are on one chip, and processor 166 and power management circuitry 164 are on another chip. It should be noted that other chip combinations are possible, including three or more chips, each bearing responsibility for the separate functions described, or sharing one or more functions for fail-safe redundancy.

[0061] In some embodiments, the display 200 may be coupled or electrically coupled to the sensor electronics 160. As seen in FIGS. 2G and 2H, the display may be coupled to the sensor electronics and the one or more processors of the sensor electronics may display a determined analyte level on the display 200. The analyte sensor 104, the sensor electronics 160, and the AFE 162 and memory 163, may interact as described with respect to FIGS. 2B-2C. In some embodiments, the sensor electronics 160 may convert electrical signals, e.g., analog signals, from the electrodes to digital signal in the ASIC and the one or more processors may determine an analyte level, which can then be displayed on the display 200 and may also optionally be communicated to a reader device 120, server, network 190, or cloud. The display may include one or more lights, e.g., one or more LED lights. In some embodiments, as seen in FIG. 11 A, a pattern of lights displayed can convey a relative analyte level of the user. For example, an illumination pattern of the lights may indicate whether or not the user is in a target analyte range. In some embodiments, a color displayed of lights may convey a relative analyte level of the user, e.g., whether the user’s analyte level is below a target range (e.g., red), within a target range (e.g., green), or above a target range (e.g., yellow or orange). In some embodiments, the display may include a plurality of lights, and each light of the plurality of lights may be associated with an analyte range, and the one or more processors may illuminate the light associated with a measured analyte level. For example, as seen in FIG. 1 IB, display 240 may illuminate light 242 when the user’s measured analyte level is below a target range, light 244 when the user’smeasured analyte level is within a target range, and light 246 when the user’s measured analyte level is above a target range. In some embodiments, lights 242, 244, 246 may also be different colors, as mentioned with respect to other embodiments. Alternatively, in some embodiments, a brightness of the one or more lights may convey a relative analyte level of the user, e.g., whether the user’s analyte level is below a target range, within a target range, or above a target range.

[0062] In some embodiments, as seen in FIG. 12, the display 200 may be a 7-segment display or other digital display that can display a numerical value of a measured analyte level.Example Embodiment of Sensor Applicator Device

[0063] FIG. 3 A is a side view depicting an example embodiment of an applicator device 150 coupled with screw cap 708. This is one example of how applicator 150 is shipped to and received by a user, prior to assembly by the user with a sensor. In other embodiments, applicator 150 can be shipped to the user with the sensor and sharp contained therein. FIG. 3B is a side perspective view depicting applicator 150 and cap 708 after being decoupled. FIG. 3C is a perspective view depicting an example embodiment of a distal end of an applicator device 150 with electronics housing 706 and adhesive patch 105 removed from the position they would have retained within device carrier 710 of sheath 704, when cap 708 is in place.Example Embodiment of Applicator Housins

[0064] FIG. 4A is a side view depicting an example embodiment of the applicator housing 702 that can include an internal cavity with support structures for applicator function. A user can push housing 702 in a distal direction to activate the applicator assembly process and then also to cause delivery of sensor control device 102, after which the cavity of housing 702 can act as a receptacle for a sharp. In the example embodiment, various features are shown including housing orienting feature 1302 for orienting the device during assembly and use. Tamper ring groove 1304 can be a recess located around an outer circumference of housing 702, distal to a tamper ring protector 1314 and proximal to a tamper ring retainer 1306. Tamper ring groove 1304 can retain a tamper ring so users can identify whether the device has been tampered with or otherwise used. Housing threads 1310 can secure housing 702 to complimentary threads on cap 708 (FIGS. 3A and 3B) by aligning with complimentary cap threads and rotating in a clockwise or counterclockwise direction. A side grip zone 1316 of housing 702 can provide an exteriorsurface location where a user can grip housing 702 in order to use it. Grip overhang 1318 is a slightly raised ridge with respect to side grip zone 1316 which can aid in ease of removal of housing 702 from cap 708. A shark tooth 1320 can be a raised section with a flat side located on a clockwise edge to shear off a tamper ring (not shown), and can hold the tamper ring in place after a user has unscrewed cap 708 and housing 702. In the example embodiment four shark teeth 1320 are used, although more or less can be used as desired.

[0065] FIG. 4B is a perspective view depicting a distal end of housing 702. Here, three housing guide structures (or “guide ribs”) 1321 are located at a 120 degree angles with respect to each other, and at 60 degree angles with respect to locking structures (or “locking ribs”) 1340, of which there are also three at 120 degree angles with respect to each other. Other angular orientations, either symmetric or asymmetric, can be used, as well as any number of one or more structures 1321 and 1340. Here, each structure 1321 and 1340 is configured as a planar rib, although other shapes can be used. Each guide rib 1321 includes a guide edge (also called a “sheath guide rail”) 1326 that can pass along a surface of sheath 704 (e.g., guide rail 1418 described with respect to FIG. 5 A). An insertion hard stop 1322 can be a flat, distally facing surface of housing guide rib 1321 located near a proximal end of housing guide rib 1321. Insertion hard stop 1322 provides a surface for a sensor electronics carrier travel limiter face 1420 of a sheath 704 (FIG. 5B) to abut during use, preventing sensor electronics carrier travel limiter face 1420 from moving any further in a proximal direction. A carrier interface post 1327 passes through an aperture 1510 (FIG. 6A) of device carrier 710 during an assembly. A device carrier interface 1328 can be a rounded, distally facing surface of housing guide ribs 1321 which interfaces with device carrier 710.

[0066] FIG. 4C is a side cross-section depicting an example embodiment of a housing. In the example embodiment, side cross-sectional profiles of housing guide rib 1321 and locking rib 1340 are shown. Locking rib 1340 includes sheath snap lead-in feature 1330 near a distal end of locking rib 1340 which flares outward from central axis 1346 of housing 702 distally. Each sheath snap lead-in feature 1330 causes detent snap round 1404 of detent snap 1402 of sheath 704 as shown in FIG. 5C to bend inward toward central axis 1346 as sheath 704 moves towards the proximal end of housing 702. Once past a distal point of sheath snap lead-in feature 1330, detent snap 1402 of sheath 704 is locked into place in locked groove 1332. As such, detent snap1402 cannot be easily moved in a distal direction due to a surface with a near perpendicular plane to central axis 1346, shown as detent snap flat 1406 in FIG. 5C.

[0067] As housing 702 moves further in a proximal direction toward the skin surface, and as sheath 704 advances toward the distal end of housing 702, detent snaps 1402 shift into the unlocked grooves 1334, and applicator 150 is in an “armed” position, ready for use. When the user further applies force to the proximal end of housing 702, while sheath 704 is pressed against the skin, detent snap 1402 passes over firing detent 1344. This begins a firing sequence due to release of stored energy in the deflected detent snaps 1402, which travel in a proximal direction relative to the skin surface, toward sheath stopping ramp 1338 which is slightly flared outward with respect to central axis 1346 and slows sheath 704 movement during the firing sequence. The next groove encountered by detent snap 1402 after unlocked groove 1334 is final lockout groove 1336 which detent snap 1402 enters at the end of the stroke or pushing sequence performed by the user. Final lockout recess 1336 can be a proximally-facing surface that is perpendicular to central axis 1346 which, after detent snap 1402 passes, engages a detent snap flat 1406 and prevents reuse of the device by securely holding sheath 704 in place with respect to housing 702. Insertion hard stop 1322 of housing guide rib 1321 prevents sheath 704 from advancing proximally with respect to housing 702 by engaging sensor electronics carrier travel limiter face 1420.Example Embodiment of Applicator Sheath

[0068] FIGS. 5A and 5B are a side view and perspective view, respectively, depicting an example embodiment of sheath 704. In this example embodiment, sheath 704 can stage sensor control device 102 above a user’s skin surface prior to application. Sheath 704 can also contain features that help retain a sharp in a position for proper application of a sensor, determine the force required for sensor application, and guide sheath 704 relative to housing 702 during application. Detent snaps 1402 are near a proximal end of sheath 704, described further with respect to FIG. 5C below. Sheath 704 can have a generally cylindrical cross section with a first radius in a proximal section (closer to top of figure) that is shorter than a second radius in a distal section (closer to bottom of figure). Also shown are a plurality of detent clearances 1410, three in the example embodiment. Sheath 704 can include one or more detent clearances 1410, eachof which can be a cutout with room for sheath snap lead-in feature 1330 to pass distally into until a distal surface of locking rib 1340 contacts a proximal surface of detent clearance 1410.

[0069] Guide rails 1418 are disposed between sensor electronics carrier traveler limiter face 1420 at a proximal end of sheath 704 and a cutout around lock arms 1412. Each guide rail 1418 can be a channel between two ridges where the guide edge 1326 of housing guide rib 1321 can slide distally with respect to sheath 704.

[0070] Lock arms 1412 are disposed near a distal end of sheath 704 and can include an attached distal end and a free proximal end, which can include lock arm interface 1416. Lock arms 1412 can lock device carrier 710 to sheath 704 when lock arm interface 1416 of lock arms 1412 engage lock interface 1502 of device carrier 710. Lock arm strengthening ribs 1414 can be disposed near a central location of each lock arm 1412 and can act as a strengthening point for an otherwise weak point of each lock arm 1412 to prevent lock arm 1412 from bending excessively or breaking.

[0071] Detent snap stiffening features 1422 can be located along the distal section of detent snaps 1402 and can provide reinforcement to detent snaps 1402. Alignment notch 1424 can be a cutout near the distal end of sheath 704, which provides an opening for user alignment with sheath orientation feature of platform 808. Stiffening ribs 1426 can include buttresses, that are triangularly shaped here, which provide support for detent base 1436. Housing guide rail clearance 1428 can be a cutout for a distal surface of housing guide rib 1321 to slide during use.

[0072] FIG. 5C is a close-up perspective view depicting an example embodiment of detent snap 1402 of sheath 704. Detent snap 1402 can include a detent snap bridge 1408 located near or at its proximal end. Detent snap 1402 can also include a detent snap flat 1406 on a distal side of detent snap bridge 1408. An outer surface of detent snap bridge 1408 can include detent snap rounds 1404 which are rounded surfaces that allow for easier movement of detent snap bridge 1408 across interior surfaces of housing 702 such as, for example, locking rib 1340.

[0073] FIG. 5D is a side view depicting an example embodiment of sheath 704. Here, alignment notch 1424 can be relatively close to detent clearance 1410. Detent clearance 1410 is in a relatively proximal location on distal portion of sheath 704.

[0074] FIG. 5E is an end view depicting an example embodiment of a proximal end of sheath 704. Here, a back wall for guide rails 1446 can provide a channel to slidably couple with housing guide rib 1321 of housing 702. Sheath rotation limiter 1448 can be notches whichreduce or prevent rotation of the sheath 704. In a general sense, the embodiments described herein operate by flattening and stretching a skin surface at a predetermined site for sensor insertion. Moreover, the embodiments described herein may also be utilized for other medical applications, such as, e.g., transdermal drug delivery, needle injection, wound closure stitches, device implantation, the application of an adhesive surface to the skin, and other like applications.

[0075] By way of background, those of skill the art will appreciate that skin is a highly anisotropic tissue from a biomechanical standpoint and varies largely between individuals. This can affect the degree to which communication between the underlying tissue and the surrounding environment can be performed, e.g., with respect to drug diffusion rates, the ability to penetrate skin with a sharp, or sensor insertion into the body at a sharp-guided insertion site.Example Embodiments of Device Carriers

[0076] FIG. 6A is a proximal perspective view depicting an example embodiment of device carrier 710 that can retain sensor electronics within applicator 150. It can also retain sharp carrier 1102 with sharp module 2500. In this example embodiment, carrier 710 generally has a hollow round flat cylindrical shape, and can include one or more deflectable sharp carrier lock arms 1524 (e.g., three) extending proximally from a proximal surface surrounding a centrally located spring alignment ridge 1516 for maintaining alignment of spring 1104. Each lock arm 1524 has a detent or retention feature 1526 located at or near its proximal end. Shock lock 1534 can be a tab located on an outer circumference of device carrier 710 extending outward and can lock device carrier 710 for added safety prior to firing. Rotation limiter 1506 can be a proximally extending relatively short protrusion on a proximal surface of device carrier 710 which limits rotation of carrier 710. Sharp carrier lock arms 1524 can interface with sharp carrier 1102 as described with reference to FIGS. 7 and 8 below.

[0077] FIG. 6B is a distal perspective view of device carrier 710. Here, one or more sensor electronics retention spring arms 1518 (e.g., three) are normally biased towards the position shown and include a detent 1519 that can pass over the distal surface of electronics housing 706 of device 102 when housed within recess or cavity 1521. In certain embodiments, after sensor control device 102 has been adhered to the skin with applicator 150, the user pulls applicator 150 in a proximal direction, i.e., away from the skin. The adhesive force retains sensor controldevice 102 on the skin and overcomes the lateral force applied by spring arms 1518. As a result, spring arms 1518 deflect radially outwardly and disengage detents 1519 from sensor control device 102 thereby releasing sensor control device 102 from applicator 150.Example Embodiments of Sharp Carriers

[0078] FIGS. 7 and 8 are a proximal perspective view and a side cross-sectional view, respectively, depicting an example embodiment of sharp carrier 1102. Sharp carrier 1102 can grasp and retain sharp module 2500 within applicator 150. Near a distal end of sharp carrier 1102 can be anti-rotation slots 1608 which prevent sharp carrier 1102 from rotating when located within a central area of sharp carrier lock arms 1524 (as shown in FIG. 6 A). Anti -rotation slots 1608 can be located between sections of sharp carrier base chamfer 1610, which can ensure full retraction of sharp carrier 1102 through sheath 704 upon retraction of sharp carrier 1102 at the end of the deployment procedure.

[0079] As shown in FIG. 8, sharp retention arms 1618 can be located in an interior of sharp carrier 1102 about a central axis and can include a sharp retention clip 1620 at a distal end of each arm 1618.Exemplary Firms Mechanism of Applicators

[0080] FIGS. 17A-17E illustrate example details of embodiments of the internal device mechanics of “firing” the applicator 150 to apply sensor control device 102 to a user and including retracting sharp 4030 safely back into used applicator 150. All together, these drawings represent an example sequence of driving sharp 4030 (supporting an analyte sensor 4104 coupled to sensor control device 102) into the skin of a user, withdrawing the sharp 4030 while leaving the analyte sensor 4104 behind in operative contact with interstitial fluid of the user, and adhering the sensor control device 102 to the skin of the user with an adhesive patch 4124. Modification of such activity for use with the alternative applicator assembly embodiments and components can be appreciated in reference to the same by those with skill in the art. Moreover, applicator 150 may be a sensor applicator having one-piece architecture or a two- piece architecture as disclosed herein.

[0081] Turning now to FIG. 13A, a sensor 4104 is supported within sharp 4030, just above the skin 1104 of the user. The sheath 704 is held by detents 1344 within the applicator 150 suchthat appropriate downward force along the longitudinal axis of the applicator 150 will cause the resistance provided by the detents 1344 to be overcome so that sharp 4030 and sensor control device 102 can translate along the longitudinal axis into (and onto) skin 1104 of the user. In addition, deflectable sharp carrier lock arms 1524 of device carrier 710 engage the sharp retraction assembly 1024 to maintain the sharp 4030 in a position relative to the sensor control device 102.

[0082] In FIG. 13B, user force is applied to overcome or override detents 1344 and sheath 704 collapses into housing 702 driving the sensor control device 102 (with associated parts) to translate down as indicated by the arrow L along the longitudinal axis. An inner diameter of the sheath 704 constrains the position of deflectable sharp carrier lock arms 1524 through the full stroke of the sensor / sharp insertion process. The retention of the retention features 1526 of deflectable sharp carrier lock arms 1524 against complimentary faces 1116 of the sharp carrier 1102 (in some embodiments, an exterior surface of the sharp carrier 4102) maintains the position of the members with return spring 1118 fully energized.

[0083] In FIG. 13C, sensor 4104 and sharp 4030 have reached full insertion depth. In so doing, the deflectable sharp carrier lock arms 1524 clear the inner diameter of sheath 704. Then, the compressed force of the coil return spring 1118 drives retention features 1526 radially outward, releasing force to drive the sharp carrier 1102 or 4102 of the sharp retraction assembly 1024 to pull the (slotted or otherwise configured) sharp 4030 out of the user and off of the sensor 4104 as indicated by the arrow R in FIG. 13D.

[0084] With the sharp 4030 fully retracted as shown in FIG. 13E, the sheath 704 comprises a final locking feature 1120. Subsequently, the spent applicator assembly 150 is removed from the insertion site, leaving behind the sensor control device 102, and with the sharp 4030 secured safely inside the applicator assembly 150. The spent applicator assembly 150 is now ready for disposal.

[0085] Operation of the applicator 150 when applying the sensor control device 102 is designed to provide the user with a sensation that both the insertion and retraction of the sharp 4030 is performed automatically by the internal mechanisms of the applicator 150. In other words, the present invention avoids the user experiencing the sensation that he is manually driving the sharp 4030 into his skin. Thus, once the user applies sufficient force to overcome the resistance from the detent features of the applicator 150, the resulting actions of the applicator150 are perceived to be an automated response to the applicator being “triggered.” The user does not perceive that he is supplying additional force to drive the sharp 4030 to pierce his skin despite that all the driving force is provided by the user and no additional biasing / driving means are used to insert the sharp 4030. As detailed above in FIG. 13C, the retraction of the sharp 4030 is automated by the coil return spring 1118 of the applicator 150.

[0086] It should be noted that all features, elements, components, functions, and steps described with respect to any embodiment provided herein are intended to be freely combinable and substitutable with those from any other embodiment. If a certain feature, element, component, function, or step is described with respect to only one embodiment, then it should be understood that that feature, element, component, function, or step can be used with every other embodiment described herein unless explicitly stated otherwise. This paragraph therefore serves as antecedent basis and written support for the introduction of claims, at any time, that combine features, elements, components, functions, and steps from different embodiments, or that substitute features, elements, components, functions, and steps from one embodiment with those of another, even if the following description does not explicitly state, in a particular instance, that such combinations or substitutions are possible. Thus, the foregoing description of specific embodiments of the disclosed subject matter has been presented for purposes of illustration and description. It is explicitly acknowledged that express recitation of every possible combination and substitution is overly burdensome, especially given that the permissibility of each and every such combination and substitution will be readily recognized by those of ordinary skill in the art.

[0087] While the embodiments are susceptible to various modifications and alternative forms, specific examples thereof have been shown in the drawings and are herein described in detail. It will be apparent to those skilled in the art that various modifications and variations can be made in the method and system of the disclosed subject matter without departing from the spirit or scope of the disclosed subject matter. Thus, it is intended that the disclosed subject matter include modifications and variations that are within the scope of the appended claims and their equivalents. Furthermore, any features, functions, steps, or elements of the embodiments may be recited in or added to the claims, as well as negative limitations that define the inventive scope of the claims by features, functions, steps, or elements that are not within that scope.

[0088] Various aspects of the present subject matter are set forth below, in review of, and / or in supplementation to, the embodiments described thus far, with the emphasis here being on theinterrelation and interchangeability of the following embodiments. In other words, an emphasis is on the fact that each feature of the embodiments can be combined with each and every other feature unless explicitly stated otherwise or logically implausible. The embodiments described herein are restated and expanded upon in the following paragraphs without explicit reference to the figures.

[0089] In many embodiments, a system for measurement of an analyte level includes: an analyte sensor configured to detect an in vivo analyte level in a bodily fluid of a user; sensor electronics coupled with the analyte sensor and configured to receive electrical signals generated by the analyte sensor corresponding to the detected analyte level; and a sensor control device comprising a housing configured to be worn on skin of the user, wherein the sensor electronics are disposed within the housing, wherein the sensor control device comprises an ammeter comprising a display configured to indicate the detected analyte level, and wherein the display is operatively coupled to the sensor electronics.

[0090] In some embodiments, the ammeter comprises a display window, a movable needle, and a scale comprising a range of glucose concentrations, wherein a position of the needle along the scale indicates the detected analyte level.

[0091] In some embodiments, the analyte sensor comprises a working electrode, and wherein the ammeter is configured to indicate the detected analyte level based on an electrical current generated by the working electrode.

[0092] In some embodiments, the analyte sensor is a glucose sensor.

[0093] In some embodiments, the analyte sensor includes a proximal portion configured to be positioned above the skin of the user and to be electrically coupled with the sensor electronics disposed in the housing of the sensor control device, and a distal portion configured to be transcutaneously positioned through the skin of the user and in contact with the bodily fluid of the user, wherein the distal portion of the analyte sensor is configured to detect the analyte level in the bodily fluid.

[0094] In some embodiments, the sensor control device further comprises wireless communications circuitry configured to transmit data indicative of the analyte level to a reader device, wherein the wireless communications circuitry is disposed in the housing.

[0095] In some embodiments, the wireless communications circuitry transmits data indicative of the analyte level according to a Near Field Communication (NFC) protocol.

[0096] In some embodiments, the wireless communications circuitry transmits data indicative of the analyte level according to a Bluetooth or Bluetooth Low Energy protocol.

[0097] In many embodiments, a system for measurement of an analyte level includes: an analyte sensor configured to detect an in vivo analyte level in a bodily fluid of a user; sensor electronics coupled with the analyte sensor and configured to receive electrical signals generated by the analyte sensor corresponding to the detected analyte level; and a sensor control device comprising a housing configured to be worn on skin of the user, wherein the sensor electronics are disposed within the housing, wherein the sensor control device comprises a display configured to indicate the detected analyte level, and wherein the display is operatively coupled to the sensor electronics, and wherein the display comprises at least one light.

[0098] In some embodiments, a brightness of the at least one light is proportional to the detected analyte level.

[0099] In some embodiments, the at least one light is a plurality of LED lights, wherein an illumination pattern of the plurality of LED lights is indicative of the detected analyte level of the user.

[0100] In some embodiments, a color displayed on the at least one light is indicative of the detected analyte level.

[0101] In some embodiments, the at least one light is a plurality of LED lights, wherein a color displayed on the plurality of lights is indicative of the detected analyte level. In some embodiments, the color displayed is a first color if the detected analyte level is below a target analyte range. In some embodiments, the color displayed is second color if the detected analyte level is within the target analyte range. In some embodiments, the color displayed is third color if the detected analyte level is above the target analyte range.

[0102] In some embodiments, the display comprises a digital display configured to display a numerical value of the detected analyte level.

[0103] In some embodiments, the display comprises a seven-segment display configured to display a numerical value of the detected analyte level.

[0104] In some embodiments, the electrical signals are analog signals, wherein the sensor electronics comprises a processor configured to convert the analog signals to digital signals corresponding to the analyte level.

[0105] In some embodiments, the display is on the housing.

[0106] In some embodiments, the analyte sensor is a glucose sensor.

[0107] In some embodiments, the analyte sensor includes a proximal portion configured to be positioned above the skin of the user and to be electrically coupled with the sensor electronics disposed in the housing of the sensor control device, and a distal portion configured to be transcutaneously positioned through the skin of the user and in contact with the bodily fluid of the user, wherein the distal portion of the analyte sensor is configured to detect the analyte level in the bodily fluid.

[0108] In some embodiments, the sensor control device further comprises wireless communications circuitry configured to transmit data indicative of the analyte level to a reader device, wherein the wireless communications circuitry is disposed in the housing.

[0109] In some embodiments, the wireless communications circuitry transmits data indicative of the analyte level according to a Near Field Communication (NFC) protocol.

[0110] In some embodiments, the wireless communications circuitry transmits data indicative of the analyte level according to a Bluetooth or Bluetooth Low Energy protocol.

[0111] In many embodiments, a system for measurement of an analyte level includes: an analyte sensor configured to detect an in vivo analyte level in a bodily fluid of a user, wherein the analyte sensor comprises a working electrode; and a housing comprising an ammeter, wherein the ammeter is electrically coupled to the analyte sensor and is configured to indicate detect the analyte level, wherein the housing is configured to be worn on skin of the user.

[0112] In some embodiments, the ammeter comprises a display window, a movable needle, and a scale indicating a range of analyte concentrations, and wherein a position of the needle along the scale corresponds to the electric current generated at the working electrode.

[0113] In some embodiments, the detected analyte level corresponds to an electrical current received from the analyte sensor.

[0114] In some embodiments, the ammeter is configured to indicate an electric current generated at a working electrode of the analyte sensor.

[0115] In some embodiments, the system further includes sensor electronics electrically coupled to the analyte sensor, wherein the sensor electronics is disposed within the housing. In some embodiments, the ammeter is electrically coupled to the sensor electronics, and wherein the sensor electronics is electrically coupled with the working electrode.

[0116] In some embodiments, the analyte sensor is a glucose sensor.

[0117] In some embodiments, the analyte sensor includes a proximal portion configured to be positioned above the user’s skin and to be electrically coupled with the ammeter, and a distal portion configured to be transcutaneously positioned through the user’s skin and in contact with the bodily fluid of the user, wherein the distal portion of the analyte sensor is configured to detect an analyte in the bodily fluid.

[0118] In some embodiments, the system further includes wireless communications circuitry configured to transmit data indicative of an analyte level to a reader device, wherein the wireless communications circuitry is disposed in the housing. In some embodiments, the wireless communications circuitry transmits data indicative of the analyte level according to a Near Field Communication (NFC) protocol. In some embodiments, the wireless communications circuitry transmits data indicative of the analyte level according to a Bluetooth or Bluetooth Low Energy protocol.ClausesExemplary embodiments are set out in the following numbered clauses.Clause 1. A system for measurement of an analyte level, comprising: an analyte sensor configured to detect an in vivo analyte level in a bodily fluid of a user; sensor electronics coupled with the analyte sensor and configured to receive electrical signals generated by the analyte sensor corresponding to the detected analyte level; and a sensor control device comprising a housing configured to be worn on skin of the user, wherein the sensor electronics are disposed within the housing, wherein the sensor control device comprises an ammeter comprising a display configured to indicate the detected analyte level, and wherein the display is operatively coupled to the sensor electronics.Clause 2. The system of clause 1, wherein the ammeter comprises a display window, a movable needle, and a scale comprising a range of glucose concentrations, wherein a position of the needle along the scale indicates the detected analyte level.Clause 3. The system of clause 2, wherein the analyte sensor comprises a working electrode, and wherein the ammeter is configured to indicate the detected analyte level based on an electrical current generated by the working electrode.Clause 4. A system for measurement of an analyte level, comprising: an analyte sensor configured to detect an in vivo analyte level in a bodily fluid of a user; sensor electronics coupled with the analyte sensor and configured to receive electrical signals generated by the analyte sensor corresponding to the detected analyte level; and a sensor control device comprising a housing configured to be worn on skin of the user, wherein the sensor electronics are disposed within the housing, wherein the sensor control device comprises a display configured to indicate the detected analyte level, and wherein the display is operatively coupled to the sensor electronics, and wherein the display comprises at least one light.Clause 5. The system of clause 4, wherein a brightness of the at least one light is proportional to the detected analyte level.Clause 6. The system of any of clauses 4-5, wherein the at least one light is a plurality of LED lights, wherein an illumination pattern of the plurality of LED lights is indicative of the detected analyte level of the user.Clause 7. The system of clause 4, wherein a color displayed on the at least one light is indicative of the detected analyte level.Clause 8. The system of clause 4, wherein the at least one light is a plurality of LED lights, wherein a color displayed on the plurality of lights is indicative of the detected analyte level.Clause 9. The system of clause 8, wherein the color displayed is a first color if the detected analyte level is below a target analyte range.Clause 10. The system of any of clauses 8-9, wherein the color displayed is second color if the detected analyte level is within the target analyte range.Clause 11. The system of any of clauses 8-10, wherein the color displayed is third color if the detected analyte level is above the target analyte range.Clause 12. The system of clause 4, wherein the display comprises a digital display configured to display a numerical value of the detected analyte level.Clause 13. The system of any of clauses 4 or 12, wherein the display comprises a seven-segment display configured to display a numerical value of the detected analyte level.Clause 14. The system of any of clauses 1-13, wherein the electrical signals are analog signals, wherein the sensor electronics comprises a processor configured to convert the analog signals to digital signals corresponding to the analyte level.Clause 15. The system of any of clauses 1-14, wherein the display is on the housing.Clause 16. The system of any of clauses 1-15, wherein the analyte sensor is a glucose sensor.Clause 17. The system of any of clauses 1-16, wherein the analyte sensor comprises: a proximal portion configured to be positioned above the skin of the user and to be electrically coupled with the sensor electronics disposed in the housing of the sensor control device, and a distal portion configured to be transcutaneously positioned through the skin of the user and in contact with the bodily fluid of the user, wherein the distal portion of the analyte sensor is configured to detect the analyte level in the bodily fluid.Clause 18. The system of any of clauses 1-17, wherein the sensor control device further comprises wireless communications circuitry configured to transmit data indicative of the analyte level to a reader device, wherein the wireless communications circuitry is disposed in the housing.Clause 19. The system of clause 18, wherein the wireless communications circuitry transmits data indicative of the analyte level according to a Near Field Communication (NFC) protocol.Clause 20. The system of clause 18, wherein the wireless communications circuitry transmits data indicative of the analyte level according to a Bluetooth or Bluetooth Low Energy protocol.Clause 21. A system for measurement of an analyte level, comprising: an analyte sensor configured to detect an in vivo analyte level in a bodily fluid of a user, wherein the analyte sensor comprises a working electrode; and a housing comprising an ammeter, wherein the ammeter is electrically coupled to the analyte sensor and is configured to indicate detect the analyte level, wherein the housing is configured to be worn on skin of the user.Clause 22. The system of clause 21, wherein the ammeter comprises a display window, a movable needle, and a scale indicating a range of analyte concentrations, and wherein a position of the needle along the scale corresponds to the electric current generated at the working electrode.Clause 23. The system of any of clauses 21-22, wherein the detected analyte level corresponds to an electrical current received from the analyte sensor.Clause 24. The system of any of clauses 21-23, wherein the ammeter is configured to indicate an electric current generated at a working electrode of the analyte sensor.Clause 25. The system of any of clauses 21-24, further comprising sensor electronics electrically coupled to the analyte sensor, wherein the sensor electronics is disposed within the housing.Clause 26. The system of clause 25, wherein the ammeter is electrically coupled to the sensor electronics, and wherein the sensor electronics is electrically coupled with the working electrode.Clause 27. The system of any of clauses 21-26, wherein the analyte sensor is a glucose sensor.Clause 28. The system of any of clauses 21-27, wherein the analyte sensor comprises: a proximal portion configured to be positioned above the user’s skin and to be electrically coupled with the ammeter, and a distal portion configured to be transcutaneously positioned through the user’s skin and in contact with the bodily fluid of the user, wherein the distal portion of the analyte sensor is configured to detect an analyte in the bodily fluid.Clause 29. The system of any of clauses 21-28, wherein the system further comprises wireless communications circuitry configured to transmit data indicative of an analyte level to a reader device, wherein the wireless communications circuitry is disposed in the housing.Clause 30. The system of clause 29, wherein the wireless communications circuitry transmits data indicative of the analyte level according to a Near Field Communication (NFC) protocol.Clause 31. The system of clause 29, wherein the wireless communications circuitry transmits data indicative of the analyte level according to a Bluetooth or Bluetooth Low Energy protocol.

Claims

CLAIMSWhat is claimed is:

1. A system for measurement of an analyte level, comprising: an analyte sensor configured to detect an in vivo analyte level in a bodily fluid of a user; sensor electronics coupled with the analyte sensor and configured to receive electrical signals generated by the analyte sensor corresponding to the detected analyte level; and a sensor control device comprising a housing configured to be worn on skin of the user, wherein the sensor electronics are disposed within the housing, wherein the sensor control device comprises an ammeter comprising a display configured to indicate the detected analyte level, and wherein the display is operatively coupled to the sensor electronics.

2. The system of claim 1, wherein the ammeter comprises a display window, a movable needle, and a scale comprising a range of glucose concentrations, wherein a position of the needle along the scale indicates the detected analyte level.

3. The system of claim 2, wherein the analyte sensor comprises a working electrode, and wherein the ammeter is configured to indicate the detected analyte level based on an electrical current generated by the working electrode.

4. A system for measurement of an analyte level, comprising: an analyte sensor configured to detect an in vivo analyte level in a bodily fluid of a user; sensor electronics coupled with the analyte sensor and configured to receive electrical signals generated by the analyte sensor corresponding to the detected analyte level; and a sensor control device comprising a housing configured to be worn on skin of the user, wherein the sensor electronics are disposed within the housing, wherein the sensor control device comprises a display configured to indicate the detected analyte level, and wherein the display is operatively coupled to the sensor electronics, and wherein the display comprises at least one light.

5. The system of claim 4, wherein a brightness of the at least one light is proportional to the detected analyte level.

6. The system of claim 4, wherein the at least one light is a plurality of LED lights, wherein an illumination pattern of the plurality of LED lights is indicative of the detected analyte level of the user.

7. The system of claim 4, wherein a color displayed on the at least one light is indicative of the detected analyte level.

8. The system of claim 4, wherein the at least one light is a plurality of LED lights, wherein a color displayed on the plurality of lights is indicative of the detected analyte level.

9. The system of claim 8, wherein the color displayed is a first color if the detected analyte level is below a target analyte range.

10. The system of claim 9, wherein the color displayed is second color if the detected analyte level is within the target analyte range.

11. The system of claim 10, wherein the color displayed is third color if the detected analyte level is above the target analyte range.

12. The system of claim 4, wherein the display comprises a digital display configured to display a numerical value of the detected analyte level.

13. The system of claim 4, wherein the display comprises a seven-segment display configured to display a numerical value of the detected analyte level.

14. The system of any of claims 1 and 4, wherein the electrical signals are analog signals, wherein the sensor electronics comprises a processor configured to convert the analog signals to digital signals corresponding to the analyte level.

15. The system of any of claims 1 and 4, wherein the display is on the housing.

16. The system of any of claims 1 and 4, wherein the analyte sensor is a glucose sensor.

17. The system of any of claims 1 and 4, wherein the analyte sensor comprises: a proximal portion configured to be positioned above the skin of the user and to beelectrically coupled with the sensor electronics disposed in the housing of the sensor control device, and a distal portion configured to be transcutaneously positioned through the skin of the user and in contact with the bodily fluid of the user, wherein the distal portion of the analyte sensor is configured to detect the analyte level in the bodily fluid.

18. The system of any of claims 1 and 4, wherein the sensor control device further comprises wireless communications circuitry configured to transmit data indicative of the analyte level to a reader device, wherein the wireless communications circuitry is disposed in the housing.

19. The system of claim 18, wherein the wireless communications circuitry transmits data indicative of the analyte level according to a Near Field Communication (NFC) protocol.

20. The system of claim 18, wherein the wireless communications circuitry transmits data indicative of the analyte level according to a Bluetooth or Bluetooth Low Energy protocol.

21. A system for measurement of an analyte level, comprising: an analyte sensor configured to detect an in vivo analyte level in a bodily fluid of a user, wherein the analyte sensor comprises a working electrode; and a housing comprising an ammeter, wherein the ammeter is electrically coupled to the analyte sensor and is configured to indicate detect the analyte level, wherein the housing is configured to be worn on skin of the user.

22. The system of claim 21, wherein the ammeter comprises a display window, a movable needle, and a scale indicating a range of analyte concentrations, and wherein a position of the needle along the scale corresponds to the electric current generated at the working electrode.

23. The system of claim 21, wherein the detected analyte level corresponds to an electrical current received from the analyte sensor.

24. The system of claim 21, wherein the ammeter is configured to indicate an electric current generated at a working electrode of the analyte sensor.

25. The system of claim 21, further comprising sensor electronics electrically coupled to the analyte sensor, wherein the sensor electronics is disposed within the housing.

26. The system of claim 25, wherein the ammeter is electrically coupled to the sensor electronics, and wherein the sensor electronics is electrically coupled with the working electrode.

27. The system of claim 21, wherein the analyte sensor is a glucose sensor.

28. The system of claim 21, wherein the analyte sensor comprises: a proximal portion configured to be positioned above the user’s skin and to be electrically coupled with the ammeter, and a distal portion configured to be transcutaneously positioned through the user’s skin and in contact with the bodily fluid of the user, wherein the distal portion of the analyte sensor is configured to detect an analyte in the bodily fluid.

29. The system of claim 21, wherein the system further comprises wireless communications circuitry configured to transmit data indicative of an analyte level to a reader device, wherein the wireless communications circuitry is disposed in the housing.

30. The system of claim 29, wherein the wireless communications circuitry transmits data indicative of the analyte level according to a Near Field Communication (NFC) protocol.

31. The system of claim 29, wherein the wireless communications circuitry transmits data indicative of the analyte level according to a Bluetooth or Bluetooth Low Energy protocol.

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