WO2024254033A1

WO2024254033A1 - Systems, devices, and methods for analyte monitoring

Info

Publication number: WO2024254033A1
Application number: PCT/US2024/032350
Authority: WO
Inventors: Shridhara A. Karinka; Vivek S. RAO; Chung-Che C. WANG; Peter G. ROBINSON; Sebastien Doan Ky Nam NGUYEN; Dharmendra S. PATEL; Jennifer Olson
Original assignee: Abbott Diabetes Care Inc
Current assignee: Abbott Diabetes Care Inc
Priority date: 2023-06-09
Filing date: 2024-06-04
Publication date: 2024-12-12
Anticipated expiration: 2025-12-09

Abstract

Systems, devices and methods are provided for inserting and reinserting at least a portion of one in vivo analyte sensor for sensing an analyte level in a bodily fluid of a subject. In some emboidments, a sensor control device is disclosed which includes a first analyte sensor and a second analyte sensor, wherein the first analyte sensor and second analyte sensor can be configured to be inserted at different depths and can be configured to sense different physiological parameters. In particular, disclosed herein are various embodiments of applicators, sensor control devices, and components thereof, designed to reduce trauma to tissue of a sensor insertion site and to increase the likelihood of accurately monitoring the user's analyte level.

Description

SYSTEMS, DEVICES, AND METHODS FOR ANALYTE MONITORING

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] The application claims priority to U.S. Application Serial No. 63/472,198 filed June 9, 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 A1C, 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] With the continued development of analyte monitoring devices and systems, there is a need for such analyte monitoring devices, systems, and methods, as well as for processes for manufacturing analyte monitoring devices and systems that are cost effective, convenient, and provide discreet monitoring to encourage frequent analyte monitoring to improve glycemic control. Additionally, there is a need for such analyte monitoring devices, systems, and methods that reduce pain and trauma associated with analyte monitoring and testing.

[0006] While current sensors can be convenient for users, they are also susceptible to malfunctions. These malfunctions can be caused by user error, lack of proper training, poor user coordination, overly complicated procedures, physiological responses to the inserted sensor, and other issues. This can be particularly true for analyte monitoring systems having sensors used to measure an analyte level in interstital fluid (“ISF”), and which are inserted using sharps (also known as “introducers” or “needles”). Some prior art stsems, for example, may utilize certain mechanisms and features that are susceptible to failure or reduced efficacy due to adverse conditions. In addition, some prior art systems may utilize sharps that can create trauma to surrounding tissue at the sensor insertion site, which can lead to inaccurate analyte level measurements. These challenges and others described herein can lead to a failure to properly monitor the patient’s analyte level.

[0007] Thus, a need exists for more reliable sensor insertion devices, systems and methods, that are easy to use by the patient, less prone to error, less susceptible to malfunctions and mechanical failures, and which reduce trauma to an insertion site.

SUMMARY

[0008] Systems, devices and methods are provided for inserting and reinserting at least a portion of one in vivo analyte sensor for sensing an analyte level in a bodily fluid of a subject. In some emboidments, a sensor control device is disclosed which includes a first analyte sensor and a second analyte sensor, wherein the first analyte sensor and second analyte sensor can be configured to be inserted at different depths and can be configured to sense different physiological parameters. In particular, disclosed herein are various embodiments of applicators, sensor control devices, and components thereof, designed to reduce trauma to tissue of a sensor insertion site and to increase the likelihood of accurately monitoring the user’s analyte level.

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 which comprises a first sensor (e.g., a first analyte sensor) and a second sensor (e.g., a second analyte sensor). According to some embodiments, the first analyte sensor comprises a distal portion configured to be positioned in contact with an interstitial fluid of a user and to generate signals associated with a measured analyte level. As embodied herein, the analyte sensor can be configured to sense at least one of lactate, glucose, or ketone. [0009] According to an aspect of the embodiments, the second analyte sensor can comprise an array of small, short, rigid, and sharp dermal sensors or micro analyte-sensors (also herein referred to as “micro-sensors”). In some embodiments, the distal portion of the first analyte sensor forms a tip sufficiently sharpened so as to effectively penetrate and puncture the skin surface. Further, in some embodiments, the distal portion of each micro-sensor comprises a micro-needle sufficiently sharpened so as to effectively be positioned in the skin of the user. [0010] According to an aspect of the embodiments, the first analyte sensor is inserted into the skin of the user at a first insertion depth, and the second analyte sensor is inserted into the skin of the user at second insertion depth. In some embodiments, the second insertion depth is less than the first insertion depth.

[0011] According to another aspect of the embodiments, the first analyte sensor can be withdrawn from the skin of the user, and reinserted into the skin of the user at a later time. In some embodiments, the first analyte sensor is withdrawn into a chamber disposed within the sensor control device. The chamber can be a sterilizing chamber filled with an anti-septic gel, gluid, gas, or the like, that is configured to sterilize the first analyte sensor or a portion thereof prior to reinsertion.

[0012] According to another aspect of the embodiments, the first analyte sensor can be automatically or manually withdrawn. In some embodiments, the first analyte sensor can be automatically or manually reinserted. In some embodiments, the first analyte sensor is linked to a piezo-driven system or motor, wherein the piezo-driven system or motor is configured to control initial insertion, withdrawal and/or reinsertion of the first analyte sensor.

[0013] According to another aspect of the embodiments, the first analyte sensor can transition between an active state and an inactive state, wherein in the active state, the first analyte sensor is configured to sense in-vivo analyte levels of the user, and wherein in the inactive state, the first analyte sensor has ceased or paused sensing in-vivo analyte levels of the user and is withdrawn from the skin of the user.

[0014] According to another aspect of the embodiments, the sensor control device can comprise a first sensor control device subassembly comprising the first analyte sensor (and in some embodiments, sensor electronics) and a second sensor control device subassembly comprising the second analyte sensor. In some embodiments, the first sensor control device subassembly and a second sensor control device subassembly of the sensor control device can be applied separately or in two stages. In some embodiments, in a first stage, the second sensor control device subassembly is applied to the skin either manually by the user, or by an applicator comprising a handle and a sensor control device dispenser. In the first stage, the second sensor control device subassembly can be applied to the user’s skin by a roll-out application process. In a second stage of the application process, the first sensor control device subassembly is coupled with the second sensor control device subassembly by using an applicator assembly.

[0015] According to another aspect of the embodiments, the entire sensor control device comprising the first analyte sensor and second analyte sensor can be applied in one stage as a unitary piece onto the user’s skin. In some embodiments, the first analyte sensor includes a sharpened tip and does not require use of a sharp. In other embodiments, the first analyte sensor requires a sharp for insertion into the skin. In the one-stage application process, an applicator assembly is used to apply the sensor control device onto the user’s skin.

[0016] The embodiments provided herein may be improvements to prevent or reduce the likelihood that a sensor elicits an adverse physiological response. Other improvements and advantages may be provided as well. The various configurations of these devices are described in detail by way of embodiments which are only examples.

[0017] 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 no way 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

[0018] 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. [0019] FIG. 1 is a system overview of a sensor applicator, reader device, monitoring system, network, and remote system.

[0020] FIG. 2A is a block diagram depicting an example embodiment of a reader device.

[0021] FIGS. 2B and 2C are block diagrams depicting example embodiments of sensor control devices.

[0022] FIG. 3A is a side view depicting an example embodiment of an applicator device coupled with a cap.

[0023] FIG. 3B is a side perspective view depicting an example embodiment of an applicator device and cap decoupled.

[0024] FIG. 3C is a perspective view depicting an example embodiment of a distal end of an applicator device and electronics housing.

[0025] FIG. 4A is side view depicting an example embodiment of a housing.

[0026] FIG. 4B is a perspective view depicting an example embodiment of a distal end of a housing.

[0027] FIG. 4C is a side cross-sectional view depicting an example embodiment of a housing.

[0028] FIG. 5A is a side view depicting an example embodiment of a sheath.

[0029] FIG. 5B is a perspective view depicting an example embodiment of a proximal end of a sheath.

[0030] FIG. 5C is a close-up perspective view depicting an example embodiment of a distal side of a detent snap of a sheath.

[0031] FIG. 5D is a side view depicting an example embodiment of features of a sheath.

[0032] FIG. 5E is an end view of an example embodiment of a proximal end of a sheath.

[0033] FIG. 6A is a proximal perspective view depicting an example embodiment of a device carrier.

[0034] FIG. 6B is a distal perspective view depicting an example embodiment of a device carrier.

[0035] FIG. 7 is a proximal perspective view of an example embodiment of a sharp carrier.

[0036] FIG. 8 is a side cross-section depicting an example embodiment of a sharp carrier.

[0037] FIGS. 9A to 9B are top and bottom perspective views, respectively, depicting an example embodiment of a sensor module. [0038] FIGS. 10A and 10B are perspective views depicting an example embodiment of a sensor connector.

[0039] FIG. 11 A is a perspective view depicting an example embodiment of a sensor.

[0040] FIG. 1 IB is a side view of an exemplary sensor, in accordance with one embodiment of the disclosed subject matter.

[0041] FIGS. 12 is a perspective view depicting an example embodiment of a sharp module [0042] FIG. 13 is a side perspective view of an example embodiment of a sensor control device.

[0043] FIGS. 14A-14C illustrate cross-sectional views depicting an example embodiment of a sensor control device during various stages of retraction of the first analyte sensor.

[0044] FIG. 15 is a perspective view of an example embodiment of an applicator with a dispenser.

[0045] FIGS. 16A, 16B, and 16C are side perspective, back side, and bottom side views, respectively, of an example embodiment of an applicator.

[0046] FIGS. 17A and 17B are top side perspective and side views, respectively, of an example embodiment of a dispenser.

[0047] FIG. 18 depicts a first stage of a roll-out application process to deploy a sensor control device.

[0048] FIGS. 19A-19E illustrate cross-sectional views depicting an example embodiment of an applicator during various stages of deployment.

[0049] FIGS. 20A a side view depicting an example embodiment of an applicator device coupled with a cap.

[0050] FIG. 20B is a perspective view depicting an example embodiment of a distal end of an applicator device and sensor control device.

[0051] FIG. 20C is a side perspective view depicting an example embodiment of an applicator device applying the sensor control device onto a skin surface of the user.

[0052] FIG. 20D is a side perspective view of an example embodiment of a sensor control device applied to the skin surface of theh user.

DETAILED DESCRIPTION

[0053] 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.

[0054] As used herein and in the appended claims, the singular forms “a,” “an,” and “the” include plural referents unless the context clearly dictates otherwise.

[0055] The publications discussed herein are provided solely for their disclosure prior to the fding 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.

[0056] 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.

[0057] 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.

[0058] 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.

[0059] 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.

[0060] There are various types of in vivo analyte monitoring systems. “Continuous Analyte Monitoring” systems (or “Continuous Glucose Monitoring” systems), for example, can transmit data 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.

[0061] 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.

[0062] 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.

[0063] In vivo monitoring systems can 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

[0064] 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 of time 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

[0065] 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

[0066] 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 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.

[0067] 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.

[0068] FIG. 2C is similar to FIG. 2B but 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.

Example Embodiment of Sensor Applicator Device

[0069] 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 Housing

[0070] FIG. 4A is 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 exterior surface 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 hold 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.

[0071] 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 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.

[0072] 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 snap 1402 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.

[0073] 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

[0074] 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, each of 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. [0075] 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.

[0076] 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.

[0077] 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. [0078] 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.

[0079] 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.

[0080] 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 which reduce 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.

[0081] 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

[0082] 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.

[0083] 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 control device 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

[0084] 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.

[0085] 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 Sensor Modules

[0086] FIGS. 9A and 9B are a top perspective view and a bottom perspective view, respectively, depicting an example embodiment of sensor module 504. Module 504 can hold a connector 2300 (FIGS. 10A and 10B) and a sensor 104 (FIG. HA). Module 504 is capable of being securely coupled with electronics housing 706. One or more deflectable arms or module snaps 2202 can snap into the corresponding features 2010 of housing 706. A sharp slot 2208 can provide a location for sharp tip 2502 to pass through and sharp shaft 2504 to temporarily reside. A sensor ledge 2212 can define a sensor position in a horizontal plane, prevent a sensor from lifting connector 2300 off of posts and maintain sensor 104 parallel to a plane of connector seals. It can also define sensor bend geometry and minimum bend radius. It can limit sensor travel in a vertical direction and prevent a tower from protruding above an electronics housing surface and define a sensor tail length below a patch surface. A sensor wall 2216 can constrain a sensor and define a sensor bend geometry and minimum bend radius.

[0087] FIGS. 10A and 10B are perspective views depicting an example embodiment of connector 2300 in an open state and a closed state, respectively. Connector 2300 can be made of silicone rubber that encapsulates compliant carbon impregnated polymer modules that serve as electrical conductive contacts 2302 between sensor 104 and electrical circuitry contacts for the electronics within housing 706. The connector can also serve as a moisture barrier for sensor 104 when assembled in a compressed state after transfer from a container to an applicator and after application to a user’s skin. A plurality of seal surfaces 2304 can provide a watertight seal for electrical contacts and sensor contacts. One or more hinges 2308 can connect two distal and proximal portions of connector 2300.

[0088] FIG. 11A is a perspective view depicting an example embodiment of sensor 104. A neck 2406 can be a zone which allows folding of the sensor, for example ninety degrees. A membrane on tail 2408 can cover an active analyte sensing element of the sensor 104. Tail 2408 can be the portion of sensor 104 that resides under a user’s skin after insertion. A flag 2404 can contain contacts and a sealing surface. A biasing tower 2412 can be a tab that biases the tail 2408 into sharp slot 2208. A bias fulcrum 2414 can be an offshoot of biasing tower 2412 that contacts an inner surface of a needle to bias a tail into a slot. A bias adjuster 2416 can reduce a localized bending of a tail connection and prevent sensor trace damage. Contacts 2418 can electrically couple the active portion of the sensor to connector 2300. A service loop 2420 can translate an electrical path from a vertical direction ninety degrees and engage with sensor ledge 2212 (FIG. 9B).

[0089] FIG. 1 IB is a side view of an example sensor 11900, according to one or more embodiments of the disclosure. The sensor 11900 may be similar in some respects to any of the sensors described herein and, therefore, may be used in an analyte monitoring system to detect specific analyte concentrations. As illustrated, the sensor 11900 includes a tail 11902, a flag 11904, and a neck 11906 that interconnects the tail 11902 and the flag 11904. The tail 11902 includes an enzyme or other chemistry or biologic and, in some embodiments, a membrane may cover the chemistry. In use, the tail 11902 is transcutaneously received beneath a user’s skin, and the chemistry included thereon helps facilitate analyte monitoring in the presence of bodily fluids.

[0090] The tail 11902 may be received within a hollow or recessed portion of a sharp (not shown) to at least partially circumscribe the tail 11902 of the sensor 11900. As illustrated, the tail 11902 may extend at an angle Q offset from horizontal. In some embodiments, the angle Q may be about 85°. Accordingly, in contrast to other sensor tails, the tail 11902 may not extend perpendicularly from the flag 11904, but instead at an angle offset from perpendicular. This may prove advantageous in helping maintain the tail 11902 within the recessed portion of the sharp. [0091 ] The tail 11902 includes a first or bottom end 11908a and a second or top end 11908b opposite the bottom end 11908a. A tower 11910 may be provided at or near the top end 11908b and may extend vertically upward from the location where the neck 11906 interconnects the tail 11902 to the flag 11904. During operation, if the sharp moves laterally, the tower 11910 will help pivot the tail 11902 toward the sharp and otherwise stay within the recessed portion of the sharp. Moreover, in some embodiments, the tower 11910 may provide or otherwise define a protrusion 11912 that extends laterally therefrom. When the sensor 11900 is mated with the sharp and the tail 11902 extends within the recessed portion of the sharp, the protrusion 11912 may engage the inner surface of the recessed portion. In operation, the protrusion 11912 may help keep the tail 11902 within the recessed portion.

[0092] The flag 11904 may comprise a generally planar surface having one or more sensor contacts 11914 arranged thereon. The sensor contact(s) 11914 may be configured to align with a corresponding number of compliant carbon impregnated polymer modules encapsulated within a connector.

[0093] In some embodiments, as illustrated, the neck 11906 may provide or otherwise define a dip or bend 11916 extending between the flag 11904 and the tail 11902. The bend 11916 may prove advantageous in adding flexibility to the sensor 11900 and helping prevent bending of the neck 11906.

[0094] In some embodiments, a notch 11918 (shown in dashed lines) may optionally be defined in the flag near the neck 11906. The notch 11918 may add flexibility and tolerance to the sensor 11900 as the sensor 11900 is mounted to the mount. More specifically, the notch 11918 may help take up interference forces that may occur as the sensor 11900 is mounted within the mount.

[0095] In the above embodiments, a distal portion of the sensor 104 or 11900 is referred to as a “sensor tail.” However, those of skill in the art will appreciate that other sensor geometries are in the scope of the present disclosure, including sensor wires having a distal portion.

Example Embodiments of Sharp Modules

[0096] FIG. 12 is a perspective view depicting an example embodiment of sharp module 2500 prior to assembly within sensor module 504 (FIGS. 9A and 9B). Sharp 2502 can include a distal tip 2506 which can penetrate the skin while carrying sensor tail in a hollow or recess of sharp shaft 2504 to put the active surface of the sensor tail into contact with bodily fluid. A hub push cylinder 2508 can provide a surface for a sharp carrier to push during insertion. A hub small cylinder 2512 can provide a space for the extension of sharp hub contact faces 1622 (FIG. 8). A hub snap pawl locating cylinder 2514 can provide a distal-facing surface of hub snap pawl 2516 for sharp hub contact faces 1622 to abut. A hub snap pawl 2516 can include a conical surface that opens clip 1620 during installation of sharp module 2500. Further details regarding embodiments of sharp modules, sharps, their components, and variants thereof, are described in U.S. Patent Publication No. 2014/0171771, which is incorporated by reference herein in its entirety and for all purposes.

Exemplary Embodiment of Sensor Structures and Features Related Thereto

[0097] FIG. 13 is a side perspective view depicting an example embodiment of sensor control device 102 configured to provide minimally invasive analyte sensing and/or invasive analyte sensing. According to an aspect of the embodiments, sensor control device 102 comprises a first sensor 2104 and a second sensor 3104. In some embodiments, the first sensor 2104 is a first sensor 2104. In some embodiments, the second sensor 3104 is a second sensor 3104. Further, the second sensor 3104 can comprise an array of dermal sensors (e.g., dermaly analyte sensors) or micro analyte-sensors 3105 (also herein referred to as “micro-sensor(s) 3105”). In some embodiments, the micro-sensor(s) 3105 are configured to be small, short, rigid, and sharp micro-sensors 3105. The micro-sensors 3105 are sensors configured to be shorter in length than the first sensor 2104. The micro-sensors 3105 can be between one millimeter and two millimeters in length. In some embodiments, the micro-sensors 3105 can be any length less than five millimeters in length. In some embodiments, first sensor 2104 can be similar to sensor 104 or sensor 11900 and, therefore, may be used in conjunction with the sensor applicator 150, which may deliver the sensor control device 102 comprising the first sensor 2104 to a target monitoring location on a user’s skin. In other embodiments, the first sensor 2104 can be similar to sensor 104 or 11900, except that first sensor 2104 comprises a distal portion 2108 which forms a tip sufficiently sharpened so as to effectively penetrate and puncture the skin surface. This sensor design can be advantageous in that it would remove the need for a sharp.

[0098] According to an aspect of the embodiments, and with reference to FIG. 13, the distal portion 2108 of the first sensor 2104 is configured to be reinserted into a user’s skin one or more times. For example, after the initial insertion of the distal portion 2108 under the skin surface of the user, the distal portion 2108 can be withdrawn and reinserted at a later time. According to an aspect of the embodiments, the distal portion 2108 is configured to be initially inserted and reinserted into the skin surface of the user at a first insertion depth.

[0099] In some embodiments, initial insertion, retraction and/or reinsertion can be automated or manually done by the user. As shown in FIGS. 14A-114C, in some embodiments, the sensor control device comprises a piezo-driven system or motor 2150. In some embodiments, the piezo-driven system or motor 2150 is disposed within a chamber 2700 in the sensor control device 102. In some exemplar embodiments, a piezo-driven system or motor 2150 is linked to the first sensor 2104 and is utilized to drive the distal portion 2108 of the first sensor 2104 into and out of the skin (as shown in FIGS. 14A-14C). In some embodiments, an analyte monitoring application (“application” or “app”) can be utilized to control insertion, reinsertion and/or withdrawal of the distal portion 2108. In this manner, insertion, reinsertion and/or withdrawal of the distal portion 2108 can be app-controlled. Those of skill in the art will also appreciate that the analyte monitoring application can reside on a device such as, e.g., a smart phone or a dedicated receiver.

[00100] FIG. 14A illustrates the first analyte sensor’s distal portion 2108 inserted under the skin surface of the user prior to the piezo-driven system or motor 2150 retracting it. FIG. 14B depicts retraction of the distal portion 2108 utilizing the piezo-driven system or motor 2150. Specifically, the distal portion 2108 is guided through one or more side walls 2712 and pulled in radially into the chamber 2700.

[00101] As shown in FIGS. 14A-14C, the sensor control device 102 can comprise the chamber 2700. In some exemplar embodiments, the chamber 2700 is a sterile chamber 2700. In some embodiments, and as shown in FIGS. 14A-14C, the chamber 2700 is configured to receive the first sensor 2104 or at least a portion of the first sensor 2104 (e.g., the distal portion 2108). Specifically, the chamber 2700 can comprise antiseptic gel, gas, fluid, or the like for sterilization of the first sensor 2104 or a portion of the first sensor 2104. In some embodiments, the portion of the first sensor 2104 that is configured to be inserted underneath the skin surface of the user (e.g., the distal portion 2108) is the portion which is configured to be sterilized in the chamber 2700. Specifically, the first sensor 2104 or a portion thereof can be sterilized after withdrawal of the distal portion 2108 from the user’s skin and prior to reinsertion of the distal portion 2108 underneath the user’s skin. Further, after initial insertion of the distal portion 2108, a puncture hole is created on the user’s skin. As such, reinsertion can be done with less force than required for initial insertion, and can thus be done by utilizing the motor and/or piezo-driven system 2150. Though not illustrated, the motor and/or piezo-driven system 2150 can be activated so as to pull the first sensor 2104 or a portion thereof from the chamber so as to reinsert the distal portion 2108 underneath the skin surface of the user through the puncture hole.

[00102] According to an aspect of the embodiments, the user can manually select when to withdraw and reinsert the first sensor 2104 or a portion thereof (e.g., the distal portion 2108). In some embodiments, withdrawal and reinsertion of the distal portion 2108 is automated. In some embodiments, the first sensor 2104 or a portion thereof is configured to be withdrawn from the user’s skin after a predetermined number of days (e.g., three days, seven days, eight days, nine days, etc.). In this manner, the first sensor 2104 or a portion thereof can be withdrawn prior to an immune response being triggered or possible microphage attack of the distal portion 2108 of the first sensor 2104, or the portion of the first sensor 2104 that is inserted underneath the user’s skin surface.

[00103] Further, in some embodiments, the distal portion 2108 of first sensor 2104 is configured to be reinserted underneath the user’s skin surface after a predetermined number of days (e.g., three days, seven days, eight days, nine days, etc.). In this manner, the distal portion 2108 of the first sensor 2104 can be reinserted after an immune response has dissipated or ceased.

[00104] According to another aspect of the embodiments, the first sensor 2104 is configured to sense in-vivo analyte levels of the user when a portion thereof has been inserted underneath the skin surface of the user, or is in an “active” state. Further, the first sensor 2104 is configured to cease or pause sensing in-vivo analyte levels of the user when the first sensor 2104 is fully withdrawn into the chamber 2700, or when the distal portion 2108 is retracted from the skin of the user. In this regard, the first sensor 2104 is in an “inactive” state. As such, and because the first sensor 2104 is only intermittently in the active state, the lifespan of the first sensor 2104 can be prolonged (e.g., the lifespan of the first sensor 2104 can exceed 14 days, and can be 30 days or more).

[00105] Referring to FIGS. 13, and 14A-14C, and according to another aspect of the embodiments, each micro-sensor 3105 includes a distal portion 3108 extending distally from an 1200 underside of the sensor control device 102. The array of micro-sensors 3105 can be disposed so as to protrude from the underside 1200 of the sensor control device 102. In some embodiments, the micro-sensors 3105 can comprise a shortened distal portion 3108 which comprises a micro-needle 3109 sufficiently sharpened so as to effectively be positioned in the skin of the user at a second insertion depth. The micro-needle 3109 can be any length needed to reach an interstitial fluid of the user. In some embodiments, the micro-needle 3109 can be between 0.8 millimeters (mm) to 3 mm in length. In this regard, the micro-sensors 3105 can be positioned in the skin of the user without the need for a sharp. Further, shorter analyte sensors, such as the micro-sensors 3105, will cause less trauma and could improve or eliminate the risk of early signal attenuation (“ESA”) created by wound trauma.

[00106] In some embodiments, and as best shown in FIG. 13, the shortened distal portion 3108 of each micro-sensor 3105 is shorter in length than the distal portion 2108 of second sensor 2104. In this regard, the micro-sensors 3105 and the first sensor 2104 are configured to sense analyte levels at different depths. Specifically, the second insertion depth is less than the first insertion depth. As such, the second sensor 3104 can allow for better fault checks and accuracy through averaging sensed analyte data.

[00107] In some embodiments, the distal portion 3108 of each micro-sensor 3105 in the array can include an enzyme or other chemistry or biological and, in some embodiments, a membrane can cover the chemistry. In use, the distal portion 3108 of each micro-sensor 3105 is positioned in the user’s skin. In some embodiments, the distal portion 3108 of each micro-sensor 3105 can include the same or different enzyme, chemistry, or biological composition as the other distal portions 3108 of each micro-sensor 3105 in the array. Further, in some embodiments, the distal portion 3108 of each micro-sensor 3105 can include the same or different enzyme, chemistry, or biological composition as the distal portion 2108 of the first sensor 2104. In some exemplar embodiments, the distal portion 3108 of each micro-sensor 3105 can include a body temperature sensor, glucose level sensor, analyte sensor, a skin measurement sensor, or the like. In this manner, the micro-sensors 3105 can provide a different values and/or data than the first sensor 2104. Further, the micro-sensors 3105 can be configured to provide values and/or data for control and beyond expiration of the first sensor 2104. Those of skill in the art will recognize that different sensors can be utilized without departing from the scope of the disclosure. [00108] According to an aspect of the embodiments, the micro-sensors 3104 are configured to collectively sense a physiological parameter at the same as the first sensor 2104 is sensing in vivo analyte levels. In other words, the micro-sensors 3104 can sense physiological parameters when the first sensor 2104 is in the active state. Further, the micro-sensors 3104 can sense physiological parameters when the first sensor 2104 is in the inactive state, or when the distal portion 2108 of the first sensor 2104 is withdrawn into the chamber 2700. In some embodiments, the physiological parameter(s) sensed by the micro-sensor(s) 3104 can be an analyte level of the user. Moreover, in some embodiments, the physiological parameter sensed by the micro-sensors 3104 can be an analyte level of the user that is also being sensed by the first sensor 2104. In some embodiments, when the first sensor 2104 is in the active state, it can sense in vivo analyte levels that can be used to calibrate the micro-sensors 3104. In this manner, the micro-sensors 3104 can continue providing accurate sensor readings while the first sensor 2104 is in the inactive state.

[00109] According to another aspect of the embodiments, the sensor control device 102 can comprise sensor electronics 160 (not illustrated) which can include, but is not limited to, a printed circuit board, one or more processors, one or more batteries (e.g., one or more printed batteries), an antenna, a semiconductor chip, to name a few.

[00110] As best shown in FIG. 13, the sensor control device 102 includes electronics housing 706, which can be generally disc-shaped and have a circular cross-section. In other embodiments, however, the electronics housing 706 can exhibit other cross-sectional shapes, such as ovoid, oval, or polygonal, without departing from the scope of the disclosure. With particular reference to FIG. 13, and according to an aspect of the embodiments, sensor control device 102 can be partially or entirely flexible. In some embodiments, the sensor control device 102 comprises one or more flexible portions 1810 and a structurally rigid portion 1811. In some exemplar embodiments, the structurally rigid portion 1811 can be disposed between the one or more flexible portions 1810. In some embodiments, the flexible portion 1810 is thinner in width than the structurally rigid portion 1811. The structurally rigid portion 6111 can protrude in a proximal direction from a top exterior surface of the sensor control device 102 so as to have a height greater than a height of the flexible portion(s) 1810. In some embodiments, the structurally rigid portion 1811 forms the electronics housing 706 and houses the sensor electronics 160 (not illustrated) therein. In this regard, the stiffness of the structurally rigid portion 1811 maintains rigidity over the sensor electronics 160 (not illustrated) so as to stabilize and hold the sensor electronics 160 in place. In some embodiments, the array of micro-sensors 3105 are arranged along an underside 1200 of the one or more flexible portions 1810 of the sensor control device 102. The structurally right portion 1811 and one or more flexible portions are described in U.S. Application No. 63/467,573, which is incorporated by reference herein in its entirety for all purposes.

[00111] Specifically, and with reference to FIG. 13, the array of micro-sensors 3105 can be arranged along an outer periphery sensor control device 102. More specifically, the first sensor 2104 can be arranged in a central region relative to the array of micro-sensors 3105 on the sensor control device 102.

Exemplary Two-Stage Application Process for the Sensor Control De vice

[00112] According to an aspect of some embodiments, and with reference to FIGS. 15-19E, the sensor control device 102 can be applied in two stages. Specifically, in some embodiments, the sensor control device 102 comprises a first sensor control device subassembly 102a and a second sensor control device subassembly 102b. More specifically, the first sensor control device subassembly 102a comprises the first sensor 2104, and the second sensor control device subassembly 102b comprises the second sensor 3104 comprising the micro-sensors 3105. In this regard, the first sensor control device subassembly 102a is applied separately from the second sensor control device subassembly 102b. In some embodiments, the first sensor control device subassembly 102a also includes the sensor electronics 160. As such, application of the first sensor control device subassembly 102 will include sensor electronics 160 and the first sensor 2104.

[00113] According to another aspect of the embodiments, the second sensor control device subassembly 102b comprises the array of micro sensors 3104 which can be arranged along the outer periphery of the sensor control device 102. In some embodiments, in the first stage of application, the second sensor control device subassembly 102b is applied to the skin either manually by the user, or by an applicator 1950 comprising a handle 1951 and a sensor control device dispenser 1952 (also herein referred to as a “dispenser” 1952), as depicted in FIG. 15 and as will be described in detail below. Further, in the second stage of application (depicted through FIGS. 19A-19E), the first sensor control device subassembly 102a is coupled with the second sensor control device subassembly 102b (not shown in FIGS. 19A-19E) by using applicator 150a. Specifically, and as will be described in further detail below, the first sensor control device subassembly 102a can be applied to the skin of the user by positioning the first sensor control device subassembly 102a in a central region of the second sensor subassembly 102b.

[00114] In some embodiments, in the first stage of application, the second sensor control device subassembly 102b is initially rolled into a cylindrical shape and is configured to flatten and adhere to the skin surface as the user rolls out the second sensor control device subassembly 102b. In some embodiments, the applicator 1950 comprising the dispenser 1952 is utilized to roll out the second sensor control device subassembly 102b. In this manner, the array of microsensors 3105 are positioned in the user’s skin as they make contact with the skin surface during the roll-out application process. As such, though not illustrated, once the second sensor control device subassembly 102b has been rolled out onto the user’s skin surface, the first sensor control device subassembly 102a comprising the first sensor 2104 can be applied to the user’s skin surface.

[00115] FIGS. 16A-16C depict an exemplar embodiment of the applicator 1950 without the dispenser 1952 disposed thereon. FIGS. 16A, 16B, and 16C, are side perspective, back side, and bottom side views, respectively, of the applicator 1950 comprising the handle 1951 and a cylindrical or substantially cylindrical shaped dispenser receiving portion 1953 with a hollow interior 1954. Specifically, the handle 1951 is configured to be held by the user and extends from a proximal portion of the applicator 1950. The handle 1951 can be an elongate handle 1951 with a generally cylindrical or barrel-like shape. Further, in some embodiments, a metal bar 1955 can extend from a distal end of the handle 1951, wherein the bottom end of the metal bar 1955 comprises the dispenser receiving portion 1953. In some embodiments, and as best shown in FIG. 16A, the metal bar 1955 is configured to comprise a first portion 1961, a second portion 1962, a third potion 1963, and a fourth portion 1964. Specifically, the first portion 1961 forms the top end of the metal bar 1955. More specifically, the fourth portion 1964 forms the bottom end, wherein the dispenser receiving portion 1953 extends longitudinally therefrom. Further, in some embodiments, the first portion 1961 lies along a different longitudinal axis than the fourth portion 1964. In some embodiments, the first portion 1961 is perpendicular or substantially perpendicular to the fourth portion 1964. In this regard, an exterior surface 1956 of the dispenser receiving portion 1953 is configured to be parallel to the user’s skin surface when the user is holding the handle 1951 of the applicator 1950.

[00116] According to an aspect of the embodiments, and as best depicted in FIGS. 16B and 16C, the exterior surface 1956 of the dispenser receiving portion 1953 can include one or more locking features 1957 which are configured to interface with one or more corresponding slots 1987 on the dispenser 1952 so as to securely hold the dispenser 1952 (not shown in FIGS. 16A- 16C) on the applicator 1950. In some embodiments, and as best shown in FIG. 16C, the dispenser receiving portion 1953 can include three locking features 1957.

[00117] FIGS. 17A and 17B are top side perspective and side views, respectively, of the dispenser 1952. As shown in FIGS. 17A and 17B, the dispenser 1952 can comprise a shell 1981 and an inner ring 1982. Specifically, the shell 1981 is sized and configured to be received by the dispenser receiving portion 1953 (not depicted in FIGS. 17A-17B). More specifically, the shell 1981 is configured so as to be complementary in shape to the dispenser receiving portion 1953. In some embodiments, the shell 1981 can comprise a C-shape or substantially cylindrical shape. The shell 1981 is configured to partially enclose the inner ring 1982. Further, and as best shown in FIG. 17A, the shell 1981 comprises an interior surface 1983 which defines an inner space 1984. According to an aspect of the embodiments, the interior surface 1983 of the shell 1981 has a diameter greater than a diameter of the exterior surface 1956 of the dispenser receiving portion

1953 (not shown in FIGS. 17A-17B) and is configured to interface therewith. Further, the one or more slots 1987 are arranged along the interior surface 1983 of the shell 1981. Thus, the one or more slots 1987 of the interior surface 1983 can engage with the one or more locking features 1957 of the dispenser receiving portion 1953 (not shown) as the interior surface 1983 of the shell 1981 interfaces with the exterior surface 1956 of the dispenser receiving portion 1953. Further, in some embodiments, the inner space 1984 is configured so as to align with the hollow interior

1954 of the dispenser receiving portion 1953 when the one or more slots 1987 are engaged with the one or more locking features 1957. In some embodiments, when the dispenser 1952 is received by the dispenser receiving portion 1953, it is configured to pivot, rotate, or roll so as to dispense the second sensor control device subassembly 102b during the application process. In some embodiments, a rotary mechanism is utilized to allow the dispenser 1952 to rotate about the dispenser receiving portion’s 1953 axis. All moving components can be housed in the dispenser 1952.

[00118] According to an aspect of the embodiments, and as best shown in FIG. 18, the second sensor control device subassembly 102b can be arranged along an outer circumference 1988 of the inner ring 1982. In this regard, the inner ring 1982 defines a roller for second sensor control device subassembly 102b as it is configured to be released from the inner ring 1982 and adhere to the skin surface through the roll-out process utilizing the applicator 1950.

[00119] FIG. 18 illustrates a first stage of the roll-out application process with the applicator 1950. With reference to FIG. 18, to apply second sensor control device subassembly 102b onto the user’s skin surface, the dispenser 1952 must be assembled onto the handle’s dispenser receiving portion 1953 and, subsequently, rolled across an insertion site. The second sensor control device subassembly 102b is not initially visible and is rather enclosed by the shell 1981 prior to application. Specifically, to expose the second sensor control device subassembly 102b, the inner ring 1982 must be rotated via rolling. According to some embodiments, the user must first exert a downward pressure on the handle 1951 to initiate the roll-out application process. Specifically, a minimum insertion pressure can be achieved by ensuring that rolling does not activate until a predetermined amount of pressure is manually applied by the user. In this regard, the application process requires a “push and roll” mechanism. Though not illustrated, once the application process has been initiated by the minimum insertion pressure being achieved, the user can then roll the dispenser 1952 so as to apply the second sensor control device subassembly 102b. The roll-out application with applicator 1950 is described in U.S. Application No. 63/467,573, which is incorporated by reference herein in its entirety for all purposes.

[00120] In the second stage of the application process, the applicator 150a, which is similar to applicator 150, is utilized to apply first sensor control device subassembly 102a onto the skin surface of the user. Specifically, FIGS. 19A-19E illustrate example details of embodiments of the internal device mechanics of “firing” the applicator 150a to apply the first sensor control device subassembly 102a to the user and including retracting sharp 2502 safely back into used applicator 150a. All together, these drawings represent an example sequence of driving sharp 2502 (supporting the analyte sensor 2104 coupled to the first sensor control device subassembly 102a) into the skin of a user, withdrawing the sharp 2502 while leaving the analyte sensor 2104 behind in operative contact with interstitial fluid of the user, and adhering the first sensor control device subassembly 102a to the skin of the user with an adhesive patch 105 (not shown). 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 150a may be a sensor applicator having one-piece architecture or a two-piece architecture as disclosed herein.

[00121] Turning now to FIG. 19A, a sensor 2104 is supported within sharp 2502, just above the skin 1106 of the user. The sheath 704 is held by detents 1344 within the applicator 150 such that 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 2502 and sensor control device 102 can translate along the longitudinal axis into (and onto) skin 1106 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 2502 in a position relative to the first sensor control device subassembly 102a.

[00122] In FIG. 19B, user force is applied to overcome or override detents 1344 and sheath 704 collapses into housing 702 driving the first sensor control device subassembly 102a (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 maintains the position of the members with return spring 1118 fully energized.

[00123] In FIG. 19C, sensor 2104 and sharp 2502 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 of the sharp retraction assembly 1024 to pull the (slotted or otherwise configured) sharp 2502 out of the user and off of the first sensor 2104 as indicated by the arrow R in FIG. 19D.

[00124] With the sharp 2502 fully retracted as shown in FIG. 19E, the sheath 704 comprises a final locking feature 1120. Subsequently, the spent applicator assembly 150a is removed from the insertion site, leaving behind the first sensor control device subassembly 102a onto the skin surface of the user and within the central region of the second sensor control device subassembly 102b, and with the sharp 2502 secured safely inside the applicator assembly 150a. The spent applicator assembly 150a is now ready for disposal.

[00125] Operation of the applicator 150a when applying the first sensor control device subassembly 102a is designed to provide the user with a sensation that both the insertion and retraction of the sharp 2501 is performed automatically by the internal mechanisms of the applicator 150a. In other words, the present invention avoids the user experiencing the sensation that he is manually driving the sharp 2502 into his skin. Thus, once the user applies sufficient force to overcome the resistance from the detent features of the applicator 150a, the resulting actions of the applicator 150a 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 2502 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 2502. As detailed above in FIG. 19C, the retraction of the sharp 2502 is automated by the coil return spring 1118 of the applicator 150a.

[00126] In some embodiments, the applicator 150a further comprises a button (not illustrated). The button is configured to be pressed by the user so as to activate the motor or piezo-drive system 2150 of the sensor control device 102. As such, and according to an aspect of the embodiments, when the user wants to retract the first sensor 2104 or a portion thereof, the user can press the button to activate the motor or piezo driven system 2150, which thereby withdraws the first sensor 2104 or a portion thereof, and pulls it into the chamber 2700.

[00127] Further, in some embodiments, though not illustrated, an applicator can be utilized to apply first sensor control device subassembly 102a when the first sensor 2104 includes a sharpened tip and does not require use of a sharp.

Exemplary One-Stage Application Process for the Sensor Control Device

[00128] According to an aspect of some embodiments, and with reference to FIGS. 20A-20D, the sensor control device 102 can be applied in one stage. Specifically, in some embodiments, the entire sensor control device 102 comprising the first sensor 2104 and second sensor 3104 can be applied as a unitary piece or all at once. More specifically, an applicator 150b can be utilized to apply the sensor control device 102 to a user’s skin surface. Applicator 150b can be utilized in a similar manner as applicator 150a, as described with reference to FIGS. _. Further, in some exemplar embodiments applicator 150b can be utilized to apply the sensor control device 102 when the first sensor 2104 includes a sharpened tip and does not require use of a sharp.

[00129] FIGS. 20A-20D represent an example sequence of driving the first sensor 2104 and micro-sensors 3105 (coupled to the sensor control device 102) into the skin of the user. FIG. 20A is a side view depicting an example embodiment of an applicator device 150b coupled with screw cap 208. Screw cap 208 is similar to screw cap 708 depicted in FIG. 3A. FIG. 20B is a perspective view depicting an example embodiment of a distal end of an applicator device 150b with sensor control device 102 comprising the first sensor 2104 and the second sensor 3104 comprising the micro-sensors 3105. FIG. 20C is a side perspective view illustrating downward force being exerted along the longitudinal axis (illustrated by red arrows) of the applicator 150b, thereby causing the sensor control device 102 (not shown in FIG. 20C) to translate along the longitudinal axis into (and onto) skin 1106 of the user. FIG. 20D is a side perspective view of the sensor control device 102 adhered to the skin 1106 of the user, wherein the first sensor 2104 and second sensor 3104 have been inserted into the skin 1160 of the user.

[00130] According to an aspect of the embodiments, though not illustrated, the first sensor 2104 can be guided by a rigid structure with the device carrier 710 which provide stiffness for sensor insertion and retraction. In some embodiments, because the first sensor 2104 comprises a distal tip 2108 with a sharpened tip, it can provide the necessary force for reinsertion.

[00131] In some embodiments, during application, pressure is evenly distributed across the sensor control device 102 so as to apply an equal amount of pressure to both the first sensor 2104 and second sensor 3104. In other embodiments, during application, differential pressure is exerted across the sensor control device 102. For example, the pressure exerted on a first portion of the sensor control device 102 comprising the micro-sensors 3105 (e.g., the outer periphery of the sensor control device 102) can be less than the pressure exerted on the portion of the sensor control device 102 comprising the first sensor 2104.

[00132] In some embodiments, the applicator 150b further comprises a button (not illustrated). The button is configured to be pressed by the user so as to activate the motor or piezo-drive system 2150 of the sensor control device 102. As such, and according to an aspect of the embodiments, when the user wants to retract the first sensor 2104, the user can press the button to activate the motor or piezo driven system 2150, which thereby withdraws the first sensor 2104 and pulls it into the chamber. [00133] Furthermore, it will be understood by those of skill in the art that the sensor control device embodiments described herein can similarly be used with any of the sensors and applicators described herein, including embodiments of features related thereto, such as sensor electronics.

[00134] 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. [00135] 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.

[00136] Exemplary embodiments are set forth in the following numbered clauses:

1. A system for measurement of an analyte level, comprising: a first analyte sensor, a portion of which is configured to penetrate a skin surface of a user and be positioned at a first insertion depth under the skin surface of the user, wherein the portion of the first analyte sensor is further configured to be withdrawn from and reinserted under the skin surface of the user; a sensor control device configured to house one or more sensor electronics and the first analyte sensor; a second analyte sensor comprising an array of micro-sensors disposed along an underside of the sensor control device, wherein each micro-sensor of the array of micro-sensors comprises a corresponding distal portion configured to be inserted under the skin surface of the user at a second insertion depth less than the first insertion depth; and a chamber disposed within the sensor control device, wherein the chamber is configured to receive the first analyte sensor upon withdrawal of the portion of the first analyte sensor.

2. The system of clause 1, wherein the chamber comprises an antiseptic gel, gas, or fluid configured to sterilize the portion of the first analyte sensor.

3. The system of clause 1 or 2, wherein the chamber comprises a motor or a piezodriven system, wherein the motor or piezo-driven system is configured to withdraw and reinsert the portion of the first analyte sensor.

4. The system of clause 1, 2 or 3, wherein the portion of the first analyte sensor comprises a sharpened tip configured to puncture the skin surface of the user.

5. The system of any preceding clause, wherein the corresponding distal portion of each micro-sensor of the array of micro-sensors comprises a micro-needle.

6. The system of any preceding clause, wherein the first analyte sensor is configured to transition between an active state and an inactive state, wherein the first analyte sensor is further configured to sense an in vivo analyte level of the user when in the active state. 7. The system of any preceding clause, wherein the array of micro-sensors are configured to collectively sense a physiological parameter at a same time as the first analyte sensor is configured to sense an in vivo analyte level.

8. The system of any preceding clause, wherein the sensor control device comprises a first sensor control device subassembly and a second sensor control device subassembly, wherein the first sensor control device subassembly comprises the first analyte sensor and the one or more electronics, and wherein the second sensor control device subassembly comprises the second analyte sensor.

9. The system of clause 8, wherein the first sensor control device subassembly is configured to be applied to the skin surface of the user separately from the second sensor control device subassembly.

10. The system of clause 8 or 9, wherein the second sensor control device subassembly is configured to be applied to the skin surface of the user either manually by the user or with a dispenser.

11. The system of clause 8, 9 or 10, wherein the second sensor control device subassembly is configured to be rolled onto the skin surface of the user.

12. The system of any of clauses 8 to 11, wherein the first sensor control device subassembly is configured to be coupled with the second sensor control device subassembly by using an applicator, wherein the first sensor control device subassembly is applied to the skin surface of the user by positioning the first sensor control device subassembly in a central region of the second sensor control device subassembly on the skin surface of the user.

13. The system of any preceding clause, wherein the sensor control device is applied to the skin surface of the user as a unitary piece, wherein the sensor control device is applied to the skin surface of the user by an applicator. 14. The system of any preceding clause, wherein the portion of the first analyte sensor is configured to be guided through one or more side walls in the chamber and pulled in radially into the chamber upon withdrawal.

15. The system of any preceding clause, wherein the portion of the first analyte sensor which is configured to penetrate the skin surface of the user is further configured to puncture a hole in the skin surface of the user, wherein the portion of the first analyte sensor is further configured to be withdrawn into the chamber comprising a motor or a piezo-driven system, wherein the motor or piezo-driven system is configured to pull the portion of the first analyte sensor from the chamber to reinsert the portion of the first analyte sensor into the skin surface of the user through the hole.

16. The system of any preceding clause, wherein the chamber comprises a motor or a piezo-driven system, wherein the motor or piezo-driven system is configured to withdraw and reinsert the portion of the first analyte sensor, and wherein the motor or piezo-driven system is further configured to withdraw the portion of the first analyte sensor from the skin surface of the user after a first predetermined number of days.

17. The system of clause 16, wherein the first predetermined number of days is eight days.

18. The system of any preceding clause, wherein the chamber comprises a motor or a piezo-driven system, wherein the motor or piezo-driven system is configured to withdraw and reinsert the portion of the first analyte sensor, and wherein the motor or piezo-driven system is further configured to reinsert the portion of the first analyte sensor into the skin surface of the user after a second predetermined number of days following withdrawal of the portion of the first analyte sensor.

19. The system of clause 18, wherein the second predetermined number of days is three days. 20. The system of any preceding clause, wherein the chamber comprises a motor or a piezo-driven system, wherein the motor or piezo-driven system is configured to withdraw and reinsert the portion of the first analyte sensor, and wherein the motor or piezo-driven system is further configured to withdraw the portion of the first analyte sensor from the skin surface of the user prior to an immune response or a microphage attack being triggered.

21. The system of any preceding clause, wherein the chamber comprises a motor or a piezo-driven system, wherein the motor or piezo-driven system is configured to withdraw and reinsert the portion of the first analyte sensor, and wherein the motor or piezo-driven system is further configured to reinsert the portion of the first analyte sensor into the skin surface of the user after an immune response has dissipated.

22. The system of any preceding clause, wherein the array of micro-sensors are disposed along an outer periphery of the sensor control device.

23. The system of any preceding clause, wherein the first analyte sensor is a first glucose sensor, and wherein the second analyte sensor is a second glucose sensor.

24. The system of any preceding clause, wherein the first analyte sensor is a glucose sensor, and wherein the array of micro-sensors can comprise a body temperature sensor.

25. The system of any preceding clause, wherein the first analyte sensor has a lifespan of 30 days or more.

26. The system of any preceding clause, wherein the first analyte sensor is configured to calibrate the second analyte sensor.

27. The system of any preceding clause, wherein the sensor control device comprises one or more flexible portions and a structurally rigid portion. 28. The system of clause 27, wherein the one or more flexible portions are configured to be thinner in width than the structurally rigid portion.

29. The system of clause 27 or 28, wherein the structurally rigid portion forms an electronics housing configured to house the one or more sensor electronics.

30. The system of clause 27, 28 or 29, wherein the array of micro-sensors are arranged along the one or more flexible portions of the sensor control device.

Claims

CLAIMS What is claimed is:

2. The system of claim 1, wherein the chamber comprises an antiseptic gel, gas, or fluid configured to sterilize the portion of the first analyte sensor.

3. The system of claim 1, wherein the chamber comprises a motor or a piezo-driven system, wherein the motor or piezo-driven system is configured to withdraw and reinsert the portion of the first analyte sensor.

4. The system of claim 1, wherein the portion of the first analyte sensor comprises a sharpened tip configured to puncture the skin surface of the user.

5. The system of claim 1, wherein the corresponding distal portion of each microsensor of the array of micro-sensors comprises a micro-needle.

6. The system of claim 1, wherein the first analyte sensor is configured to transition between an active state and an inactive state, wherein the first analyte sensor is further configured to sense an in vivo analyte level of the user when in the active state.

7. The system of claim 1, wherein the array of micro-sensors are configured to collectively sense a physiological parameter at a same time as the first analyte sensor is configured to sense an in vivo analyte level.

8. The system of claim 1, wherein the sensor control device comprises a first sensor control device subassembly and a second sensor control device subassembly, wherein the first sensor control device subassembly comprises the first analyte sensor and the one or more electronics, and wherein the second sensor control device subassembly comprises the second analyte sensor.

9. The system of claim 8, wherein the first sensor control device subassembly is configured to be applied to the skin surface of the user separately from the second sensor control device subassembly.

10. The system of claim 8, wherein the second sensor control device subassembly is configured to be applied to the skin surface of the user either manually by the user or with a dispenser.

11. The system of claim 8, wherein the second sensor control device subassembly is configured to be rolled onto the skin surface of the user.

12. The system of claim 8, wherein the first sensor control device subassembly is configured to be coupled with the second sensor control device subassembly by using an applicator, wherein the first sensor control device subassembly is applied to the skin surface of the user by positioning the first sensor control device subassembly in a central region of the second sensor control device subassembly on the skin surface of the user.

13. The system of claim 1, wherein the sensor control device is applied to the skin surface of the user as a unitary piece, wherein the sensor control device is applied to the skin surface of the user by an applicator.

14. The system of claim 1, wherein the portion of the first analyte sensor is configured to be guided through one or more side walls in the chamber and pulled in radially into the chamber upon withdrawal.

15. The system of claim 1, wherein the portion of the first analyte sensor which is configured to penetrate the skin surface of the user is further configured to puncture a hole in the skin surface of the user, wherein the portion of the first analyte sensor is further configured to be withdrawn into the chamber comprising a motor or a piezo-driven system, wherein the motor or piezo-driven system is configured to pull the portion of the first analyte sensor from the chamber to reinsert the portion of the first analyte sensor into the skin surface of the user through the hole.

16. The system of claim 1, wherein the chamber comprises a motor or a piezo-driven system, wherein the motor or piezo-driven system is configured to withdraw and reinsert the portion of the first analyte sensor, and wherein the motor or piezo-driven system is further configured to withdraw the portion of the first analyte sensor from the skin surface of the user after a first predetermined number of days.

17. The system of claim 16, wherein the first predetermined number of days is eight days.

18. The system of claim 1, wherein the chamber comprises a motor or a piezo-driven system, wherein the motor or piezo-driven system is configured to withdraw and reinsert the portion of the first analyte sensor, and wherein the motor or piezo-driven system is further configured to reinsert the portion of the first analyte sensor into the skin surface of the user after a second predetermined number of days following withdrawal of the portion of the first analyte sensor.

19. The system of claim 18, wherein the second predetermined number of days is three days.

20. The system of claim 1, wherein the chamber comprises a motor or a piezo-driven system, wherein the motor or piezo-driven system is configured to withdraw and reinsert the portion of the first analyte sensor, and wherein the motor or piezo-driven system is further configured to withdraw the portion of the first analyte sensor from the skin surface of the user prior to an immune response or a microphage attack being triggered.

21. The system of claim 1, wherein the chamber comprises a motor or a piezo-driven system, wherein the motor or piezo-driven system is configured to withdraw and reinsert the portion of the first analyte sensor, and wherein the motor or piezo-driven system is further configured to reinsert the portion of the first analyte sensor into the skin surface of the user after an immune response has dissipated.

22. The system of claim 1, wherein the array of micro-sensors are disposed along an outer periphery of the sensor control device.

23. The system of claim 1, wherein the first analyte sensor is a first glucose sensor, and wherein the second analyte sensor is a second glucose sensor.

24. The system of claim 1, wherein the first analyte sensor is a glucose sensor, and wherein the array of micro-sensors can comprise a body temperature sensor.

25. The system of claim 1, wherein the first analyte sensor has a lifespan of 30 days or more.

26. The system of claim 1, wherein the first analyte sensor is configured to calibrate the second analyte sensor.

27. The system of claim 1, wherein the sensor control device comprises one or more flexible portions and a structurally rigid portion.

28. The system of claim 27, wherein the one or more flexible portions are configured to be thinner in width than the structurally rigid portion.

29. The system of claim 27, wherein the structurally rigid portion forms an electronics housing configured to house the one or more sensor electronics.

30. The system of claim 27, wherein the array of micro-sensors are arranged along the one or more flexible portions of the sensor control device.