SYSTEMS, DEVICES AND METHODS FOR ANALYTE SENSORS - Patent application

Abstract

11. A method comprising: receiving a plurality of analyte data corresponding to an analyte level over a first time period as monitored by an analyte sensor in fluid contact with a bodily fluid below a skin surface; receiving a plurality of temperature data over the first time period from a temperature sensor; determining a rate of change of the plurality of temperature data over the first time period; receiving a user input to confirm exposure to a radiological test during the first time period if the determined rate of change of the plurality of temperature data is above a predetermined threshold; and adjusting the plurality of analyte data over the first time period based on the confirmed exposure to the radiological test.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit under 35 U.S.C. § 119(e) of U.S. Provisional Patent Application No. 63 / 312,742, filed February 22, 2022, which is incorporated by reference in its entirety for all purposes.

[0002] The subject matter described herein relates generally to systems, devices, and methods for analyte sensors, such as body worn sensor pack assemblies and systems, devices, and methods for mitigating the effects of radiation testing on measured analyte levels. [Background technology]

[0003] Detecting and / or monitoring the levels of analytes such as glucose, ketones, lactate, oxygen, or hemoglobin A1C can be of great importance to the health of individuals with diabetes. Patients with diabetes mellitus can suffer from complications including loss of consciousness, cardiovascular disease, retinopathy, neuropathy, and nephropathy. Generally, diabetic patients are required to monitor their glucose levels to ensure that their glucose levels are maintained within a clinically safe range, and can use that information to determine whether and / or when insulin is required to reduce glucose levels in the body or when additional glucose is required to increase glucose levels in the body.

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

[0005] To increase patient adherence to a frequent glucose monitoring regimen, an in vivo analyte monitoring system can be utilized on the body of an individual requiring analyte monitoring, in which a sensor control device can be worn. To increase comfort and convenience for the individual, the sensor control device can have a small form factor and can be assembled and applied by the individual using a sensor applicator. The application process includes inserting a sensor, such as a dermal sensor that senses the user's analyte level in bodily fluids located in the dermal layer of the human body, using the applicator or insertion feature such that the sensor is in contact with the bodily fluid. The sensor control device can also be configured to transmit analyte data to another device from which the individual or her health care provider ("HCP") can review the data to make treatment decisions.

[0006] While current continuous glucose monitors and sensor control devices may be convenient for the user, they can be made more useful by being adapted for use during magnetic resonance imaging (MRI) or other radiological diagnostic examinations.

[0007] Magnetic resonance imaging (MRI) is an effective, non-invasive imaging technique for generating clear images of anatomical structures within the human body, providing an efficient means for diagnosing disorders such as neurological and cardiac abnormalities, identifying tumors, and the like. In brief, a patient is placed in the center of a large superconducting magnet that generates a strong static magnetic field. The static field causes protons in the tissues of the body to align with the axis of the static field. A pulsed radio frequency (RF) magnetic field is then applied, causing the protons to precess about the axis of the static field. In addition, a pulsed gradient magnetic field is applied to cause the protons in selected locations of the body to emit RF signals, and these signals are detected by sensors in the MRI system. Based on the RF signals emitted by the protons, the MRI system then generates detailed images of selected locations of the body, typically slice images of the organ of interest.

[0008] A significant problem with MRI is that its strong magnetic field can interfere with the operation of continuous glucose monitors (CGMs). Typically, a CGM includes a sensor control device positioned on the human body with a sensor in contact with the wearer's bodily fluids to measure analyte levels. The magnetic field from an MRI can cause changes in the function of the CGM. Thus, wearers are generally advised to avoid exposure to MRI. [Prior art documents] [Patent documents]

[0009] [Patent Document 1] US Patent Publication No. 2019 / 0069823 [Patent Document 2] International Publication No. 2018 / 136898 [Patent Document 3] International Publication No. 2019 / 236850 [Patent Document 4] International Publication No. 2019 / 236859 [Patent Document 5] International Publication No. 2019 / 236876 [Patent Document 6] US Patent Publication No. 2020 / 0196919 [Patent Document 7] US Patent Publication No. 2013 / 0150691 [Patent Document 8] US Patent Publication No. 2016 / 0331283 [Patent Document 9] US Patent Publication No. 2018 / 0235520 [Patent Document 10] US Patent Publication No. 2014 / 0171771 [Patent Document 11] US Patent Publication No. 2020 / 0188678A1 [Patent Document 12] U.S. Pat. No. 10,668,292 Summary of the Invention [Problem to be solved by the invention]

[0010] However, it would be preferable to allow a user to continue wearing a CGM device even during an MRI examination, so long as any inaccurate CGM readings are addressed before they are reported to the user. Thus, a need exists for systems, devices, and methods for mitigating the effects of radiation examinations on sensor control devices, sensors, and measured analyte levels. [Means for solving the problem]

[0011] The objects and advantages of the presently disclosed subject matter will be set forth in and apparent from the description which follows, as well as being learned by practice of the presently disclosed subject matter. Additional advantages of the presently disclosed subject matter will be realized and attained by the methods and systems particularly pointed out in the specification and claims hereof, as well as the appended drawings.

[0012] To achieve the above and other advantages and in accordance with the objectives of the presently disclosed subject matter, as embodied and broadly described, the presently disclosed subject matter relates to a method including receiving a plurality of analyte data over a first time period monitored by an analyte sensor in fluid contact with a bodily fluid below a skin surface, the plurality of analyte data corresponding to an analyte level; receiving a plurality of temperature data over the first time period from a temperature sensor; determining a rate of change of the plurality of temperature data over the first time period; receiving a user input to confirm exposure to a radiological test during the first time period if the determined rate of change of the plurality of temperature data is above a predetermined threshold; and adjusting the plurality of analyte data over the first time period based on the confirmed exposure to the radiological test.

[0013] According to an embodiment, the time period may include one hour. The predetermined threshold may be 4 degrees Celsius over 15 minutes. The user input may be received through a reader device.

[0014] According to an embodiment, adjusting the plurality of analyte data can include deleting the plurality of analyte data spanning the first time period. Adjusting the plurality of analyte data can include ignoring the plurality of analyte data spanning the first time period.

[0015] According to an embodiment, the temperature data may include epidermal temperature data. According to an embodiment, confirming exposure to the radiological test may include at least one of prompting and generating an alarm.

[0016] According to an embodiment, the method may include receiving a user input indicating a first time period corresponding to expected exposure to a radiological test; receiving a plurality of analyte data over the first time period monitored by an analyte sensor in fluid contact with bodily fluid below the skin surface, the plurality of analyte data corresponding to an analyte level; receiving a plurality of temperature data related to the skin surface over the first time period from a temperature sensor; determining a rate of change of the plurality of temperature data over the first time period; confirming exposure to the radiological test during the first time period if the determined rate of change of the plurality of temperature data is above a predetermined threshold; and adjusting the plurality of analyte data over the first time period based on the confirmed exposure to the radiological test. [Brief description of the drawings]

[0017] Details of the subject matter presented herein, both as to structure and operation, will be apparent from consideration of the accompanying drawings, in which like reference numerals indicate like parts. The components in these figures are not necessarily to scale, with emphasis instead being placed upon illustrating the principles of the inventive subject matter. Moreover, all illustrative examples are intended to convey design concepts, and relative sizes, shapes, and other detailed attributes may be illustrated generally, rather than precisely or precisely.

[0018] [Figure 1] 1 is a system schematic diagram of a sensor applicator, a reader device, a monitor system, a network, and a remote system. [Figure 2A] FIG. 2 is a block diagram illustrating an exemplary embodiment of a reader device. [Figure 2B] FIG. 2 is a block diagram illustrating an exemplary embodiment of a sensor control device. [Figure 2C] FIG. 2 is a block diagram illustrating an exemplary embodiment of a sensor control device. [Figure 3A] FIG. 1 is a close-up perspective view depicting an exemplary embodiment in which a user prepares a tray for assembly. [Figure 3B] 11A-11C are side views depicting an exemplary embodiment of a user preparing the applicator device for assembly. [Figure 3C] FIG. 13 is a close-up perspective view depicting an exemplary embodiment in which a user inserts an applicator device into a tray during assembly. [Figure 3D] 13 is a close-up perspective view depicting an exemplary embodiment in which a user removes the applicator device from a tray during assembly. [Figure 3E] FIG. 1 is a close-up perspective view illustrating an exemplary embodiment in which a patient applies a sensor with an applicator device. [Figure 3F] FIG. 1 is a close-up perspective view depicting an exemplary embodiment of a patient with an applied sensor and a used applicator device. [Figure 4A] 1 is a side view depicting an exemplary embodiment of an applicator device coupled to a cap. [Figure 4B] 1 is a side perspective view depicting an exemplary embodiment of an applicator device and cap separated. [Figure 4C] 1 is a perspective view depicting an exemplary embodiment of a distal end of an applicator device and an electronics housing. [Figure 5A] FIG. 2 is an isometric view of another exemplary sensor control device. [Figure 5B] FIG. 2 is a side view of another exemplary sensor control device. [Figure 6A] FIG. 5C is an exploded isometric top view of the sensor control device of FIGS. 5A-5B. [Figure 6B] FIG. 5C is an exploded isometric bottom view of the sensor control device of FIGS. 5A-5B. [Figure 7] FIG. 2 is a cross-sectional side view of an assembled and sealed subassembly according to one or more embodiments. [Figure 8A] 5A-5B , in cross-sectional side views illustrating the assembly of a sensor applicator with the sensor control device of FIG. 5A. [Figure 8B] 5A-5B , in cross-sectional side views illustrating the assembly of a sensor applicator with the sensor control device of FIG. 5A. [Figure 8C] 5A-5B , in cross-sectional side views illustrating the assembly of a sensor applicator with the sensor control device of FIG. 5A. [Figure 9A] FIG. 21D is a perspective view of the cap post of FIG. 21C in accordance with one or more additional embodiments. [Figure 9B] FIG. 21D is a top view of the cap post of FIG. 21C in accordance with one or more additional embodiments. [Figure 10] FIG. 18C is a cross-sectional side view of the sensor control device of FIGS. 18A-18B. [Figure 11A] FIG. 13 is a cross-sectional side view of a sensor applicator waiting to deploy a sensor control device at a target monitor location. [Figure 11B] FIG. 13 is a cross-sectional side view of a sensor applicator waiting to deploy a sensor control device at a target monitor location. [Figure 12A] 5A-5B are cross-sectional side views illustrating the assembly and disassembly of an exemplary embodiment of the sensor applicator and sensor control device of FIGS. [Figure 12B] 5A-5B are cross-sectional side views illustrating the assembly and disassembly of an exemplary embodiment of the sensor applicator and sensor control device of FIGS. [Figure 12C] 5A-5B are cross-sectional side views illustrating the assembly and disassembly of an exemplary embodiment of the sensor applicator and sensor control device of FIGS. [Figure 13A] FIG. 1 is a side view of an exemplary sensor control device in accordance with one or more embodiments of the present disclosure. [Figure 13B]FIG. 1 is an isometric view of an exemplary sensor control device in accordance with one or more embodiments of the present disclosure. [Figure 14A] FIG. 3 is an exploded isometric top view of the sensor control device of FIG. 2 according to one or more embodiments. [Figure 14B] FIG. 3 is an exploded isometric bottom view of the sensor control device of FIG. 2 according to one or more embodiments. [Figure 15] FIG. 31A is a cross-sectional side view of the sensor control device of FIGS. 31A-31B and 14A-14B according to one or more embodiments. [Figure 16] FIG. 14C is an exploded isometric view of a portion of another embodiment of the sensor control device of FIGS. 13A-13B and 14A-14B. [Figure 17A] FIG. 32A is an isometric bottom view of the mount of FIGS. 13A-13B and 32A-32B. [Figure 17B] FIG. 32C is an isometric top view of the sensor cap of FIGS. 13A-13B and 32A-32B. [Figure 18A] FIG. 2 is a side view of an exemplary sensor applicator according to one or more embodiments. [Figure 18B] FIG. 1 is a cross-sectional side view of an exemplary sensor applicator according to one or more embodiments. [Figure 19] FIG. 1 illustrates exemplary changes in glucose readings before, during, and after exposure to a nuclear magnetic resonance imaging protocol. [Figure 20] FIG. 1 shows an overview of RF induced heating results for MRI in accordance with one or more embodiments. [Figure 21] FIG. 1 shows a summary of MRI gradient induced heating results in one or more embodiments. [Figure 22] FIG. 13 illustrates the measured maximum artifacts of an exemplary embodiment at 3T for gradient echo and spin echo sequences. [Figure 23] 1 is a flow diagram illustrating an example routine associated with determining exposure to a radiological examination in accordance with one or more embodiments. [Figure 24]1 is a flow diagram illustrating an example routine associated with determining exposure to a radiological examination in accordance with one or more embodiments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0019] Before describing the subject matter of the present invention in detail, it is to be understood that the disclosure is not limited to particular embodiments described, which can, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, since the scope of the disclosure is not to be limited except by the claims.

[0020] As used in this specification and claims, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise.

[0021] The documents discussed herein are provided solely for their disclosure prior to the filing date of the present application. Nothing herein should be construed as an admission that the present disclosure is not entitled to antedate such documents by virtue of prior disclosure. Further, the dates of documents provided may be different from the actual publication dates, which may need to be independently confirmed.

[0022] In general, embodiments of the present disclosure include systems, devices, and methods suitable for use with an analyte sensor insertion applicator suitable for use with an in vivo analyte monitor system. The applicator can be provided to a user in a sterile package with an electronics housing of a sensor control device included therein. According to some embodiments, a structure such as a container separate from the applicator can also be provided to a user as a sterile package with a sensor module and a sharps module included therein. A user can couple the sensor module to the electronics housing and further couple the sharps to the applicator through an assembly process that includes inserting the applicator into the container in a specified manner. In other embodiments, the applicator, sensor control device, sensor module, and sharps module can be provided in a single package. The applicator can be used to place the sensor control device on the human body with the sensor in contact with the wearer's bodily fluids. The embodiments provided herein are improvements that reduce the likelihood of the sensor being improperly inserted or damaged or inducing an adverse physiological response. Other improvements and advantages are also provided. Various configurations of these devices are described in detail with examples of embodiments only.

[0023] Additionally, many embodiments include an in vivo analyte sensor that is structurally configured such that at least a portion of the sensor is disposed or can be disposed on the body of a user to obtain information regarding at least one analyte in the body. However, it should be noted that the embodiments disclosed herein can be used with in vivo analyte monitoring systems that incorporate extracorporeal functionality, as well as purely ex vivo or ex vivo analyte monitoring systems, including completely non-invasive systems.

[0024] Additionally, systems and devices capable of performing each of the embodiments of the methods disclosed herein are encompassed within the present disclosure. For example, sensor control device embodiments are disclosed, which may have one or more sensors, analyte monitor circuitry (e.g., analog circuitry), memory (e.g., for storing instructions), power sources, communication circuitry, transmitters, receivers, processors, and / or controllers (e.g., for executing instructions) that may perform or facilitate the performance of any and all method steps. These sensor control device embodiments may be used and may have the functionality to perform steps performed by the sensor control device from any and all of the methods described herein.

[0025] As mentioned above, described herein are several embodiments of systems, devices, and methods that provide improved assembly and use of dermal sensor insertion devices for use with in vivo analyte monitor systems. In particular, several embodiments of the present disclosure improve sensor insertion methods associated with in vivo analyte monitor systems, and are specifically designed to prevent premature retraction of the insertion sharps during the sensor insertion process. For example, some embodiments include a dermal sensor insertion mechanism with a high firing rate and delayed sharps retraction. In other embodiments, the sharps retraction mechanism can be motion-activated such that the sharps do not retract until the user pulls the applicator away from the skin. As a result, these embodiments can reduce the likelihood of prematurely extracting the insertion sharps during the sensor insertion process, reduce the likelihood of incorrect sensor insertion, and reduce the likelihood of damaging the sensor during the sensor insertion process, to name a few advantages. Several embodiments of the present disclosure also provide an improved insertion sharps module that accounts for the small scale of dermal sensors and the relatively shallow insertion path present in the dermal layer of a subject. In addition to this, several embodiments of the present disclosure are designed to prevent undesired axial and / or rotational movement of applicator components during sensor insertion. These embodiments can thus reduce the likelihood of capillary disruption resulting in instability of the positioned dermal sensor, inflammation at the insertion site, damage to surrounding tissue, and contamination of the dermal layer fluid with blood, to name a few advantages. In addition, to mitigate inaccurate sensor readings that may be caused by trauma at the insertion site, some embodiments of the present disclosure can reduce distal depth penetration of the needle relative to the sensor tip during insertion.

[0026] However, before describing the above-mentioned aspects of the embodiments in detail, it is desirable to first describe examples of devices and their operation that may be present, for example, in an in vivo analyte monitor system, all of which may be used in conjunction with the embodiments described herein.

[0027] There are various types of in vivo analyte monitor systems. A "continuous analyte monitor" system (or "continuous glucose monitor" system), for example, may transmit data continuously, e.g., automatically according to a schedule, from the sensor control device to the reader device without requiring acknowledgment. As another example, an "intermittent analyte monitor system" (or "intermittent glucose monitor" system or simply "intermittent" system) may relay data from the sensor control device using a near field communication (NFC) protocol or a radio frequency identification (RFID) protocol, etc., upon scanning by the reader device or data as appropriate. An in vivo analyte monitor system may operate without the need for finger stick calibration.

[0028] In vivo analyte monitor systems can be distinguished from "ex vivo" systems, which generally include a measurement device that contacts a biological sample outside the body (or "ex vivo") and has a port for accepting an analyte test strip that can carry a user's bodily fluid and be analyzed to determine the user's blood glucose level.

[0029] An in-vivo monitoring system may include a sensor that contacts a user's bodily fluid while disposed in the living body and senses the analyte level contained therein. The sensor may be part of a sensor control device that resides on the user's body, the sensor control device including the electronics and power source that enable and control the analyte sensing. Sensor control devices and variations thereof may be referred to as "sensor control units," "on-body electronics" devices or units, "on-body" devices or units, or "sensor data communication" devices or units, to name a few.

[0030] An in-vivo monitoring system may include a device that accepts sensed analyte data from the sensor control device and processes and / or displays it to a user in any form. This device and variations thereof may be referred to as a "handheld reader device", "reader device", (or simply "reader"), "handheld electronic device" (or simply "handheld"), "portable data processing" device or unit, "data receiver", "receiver" device or unit (or simply "receiver"), or "remote" device or unit, to name a few. Other devices, such as personal computers, have also been used with or incorporated into in-vivo or in-vivo monitoring systems.

[0031] Exemplary Embodiments of an In-Vivo Analyte Monitor System FIG. 1 is a conceptual diagram illustrating an exemplary embodiment of an analyte monitor system 100 including a sensor applicator 150, a sensor control device 102, and a reader device 120. In this case, the sensor applicator 150 can be used to deliver the sensor control device 102 to a monitoring location on a user's skin where the sensor 104 is held stationary for a period of time by an adhesive patch 105. The sensor control device 102 will be described in more detail in FIG. 2B and FIG. 2C, and can communicate with the reader device 120 through a communication path 140 using wired or wireless technology. Exemplary wireless protocols include Bluetooth, Bluetooth low energy (such as BLE, BTLE, Bluetooth Smart), Near Field Communication (NFC), and others. A user can monitor applications installed in memory on the reader device 120 using a screen 122 and input 121, and the device's battery can be recharged using a power port 123. More details regarding the reader device 120 are set forth below in FIG. 2A. The reader device 120 can communicate with a local computer system 170 through a communication path 141 using wired or wireless technology. The 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 the wireless communication can include any of several applicable wireless network connection protocols, including Bluetooth, Bluetooth Low Energy (BTLE), Wi-Fi, or others. The local computer system 170 can communicate with the network 190 through a communication path 143 using wired or wireless technology as described above in a manner similar to the manner in which the reader device 120 can communicate with the network 190 through the communication path 142. The network 190 can be any of several networks, such as private and public networks, local area networks, or wide area networks, etc.The trusted computer system 180 may include a server, may provide authentication services and secure data storage, and may communicate with the network 190 through a communications path 144 using wired or wireless technologies.

[0032] Exemplary embodiments of a reader device 2A is a block diagram illustrating an exemplary embodiment of a reader device configured as a smartphone. In this case, the reader device 120 may include a display 122, an input component 121, a processing core 206 including a communication processor 222 coupled to a memory 223, and an application processor 224 coupled to a memory 225. Similarly, a separate memory 230, an RF transceiver 228 having an antenna 229, and a power source 226 having a power management module 238 may be included. Additionally, a multi-function transceiver 232 capable of communicating through Wi-Fi, NFC, Bluetooth, BTLE, and GPS using an antenna 234 may be included. As will be appreciated by those skilled in the art, these components are electrically and communicatively coupled to create a functional device.

[0033] Exemplary embodiments of a sensor control device 2B and 2C are block diagrams illustrating an exemplary embodiment of a sensor control device 102 having an analyte sensor 104 and sensor electronics 160 that may have most of the processing functionality for rendering final result data suitable for display to a user. FIG. 2B shows a single semiconductor chip 161 that may be a custom application specific integrated circuit (ASIC). Within the ASIC 161 are shown certain high level functional units including an analog front end (AFE) 162, a power management (or control) circuit 164, a processor 166, and a communication circuit 168 (which may be implemented as a transmitter, receiver, transceiver, passive circuitry, or other communication protocol). In this embodiment, both the AFE 162 and the processor 166 are used as analyte monitor circuitry, although in other embodiments, either circuitry may perform the analyte monitor function. The processor 166 may include one or more processors, microprocessors, controllers, and / or microcontrollers, each of which may be a separate chip or distributed among (and be part of) several different chips.

[0034] Also included within the ASIC 161 is a memory 163, which may be shared by the various functional units present within the ASIC 161 or may be distributed among two or more of these functional units. The memory 163 may be a separate chip. The memory 163 may be a volatile and / or non-volatile memory. In this embodiment, the ASIC 161 is coupled to a power source 170, which may be a coin cell battery or the like. The AFE 162 interconnects with the in-vivo analyte sensor 104 and accepts measurement data therefrom and outputs these data in digital form to a processor 166, which further processes these data to provide final result glucose individual values ​​and glucose trend values, etc. These data may then be provided to a communication circuit 168 for transmission through an antenna 171, for example, to a reader device 120 (not shown), where little further processing is required by a resident software application to display the data.

[0035] FIG. 2C is similar to FIG. 2B, but includes two separate semiconductor chips 162 and 174, which may be packaged together or separately. In this case, AFE 162 resides 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 may be isolated or distributed within it. In one exemplary 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 exemplary embodiment, both AFE 162 and communication circuitry 168 are on one chip, while 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 performing separate functions as described, or sharing one or more functions to achieve fail-safe redundancy.

[0036] According to an embodiment, the sensor control device 102 may include a temperature sensor for measurement of the skin near the insertion site. The temperature readings may be used to adjust the measurement data generated from the analyte sensor 104, as discussed in more detail below. Additional details of suitable devices, systems, methods, components, and their operation and related features are provided in U.S. Patent Publication No. 2019 / 0069823, filed November 5, 2018, which is incorporated herein by reference in its entirety.

[0037] Exemplary embodiments of an assembly process for a sensor control device The components of the sensor control device 102 may be acquired by the user in multiple packages that require final assembly by the user prior to delivery to the appropriate user location. Figures 3A-3D depict an exemplary embodiment of a user assembly process for the sensor control device 102 including preparation of the individual components prior to combining the components to provide a sensor for delivery. Figures 3E-3F depict an exemplary embodiment of delivery of the device 102 to the appropriate user location by selecting an appropriate delivery location and applying the sensor control device 102 to the location.

[0038] 3A is a close-up perspective view depicting an exemplary embodiment in which a user provides a container 810, in this case configured as a tray for the assembly process (although other packaging can be used). The user can accomplish this preparation by removing the lid 812 from the tray 810 to expose the platform 808, for example, by peeling the non-adhered portion of the lid 812 from the tray 810 such that the adhered portion of the lid 812 is removed. Removal of the lid 812 can be as appropriate in various embodiments as long as the platform 808 is sufficiently exposed within the tray 810. The lid 812 can then be set aside.

[0039] 3B is a side view depicting an exemplary embodiment of a user preparing applicator device 150 for assembly. Applicator device 150 may be provided in a sterile package sealed by cap 708. Preparing applicator device 150 may include disconnecting housing 702 from cap 708 to expose sheath 704 (FIG. 3C). This disconnection may be accomplished by twisting (or otherwise detaching) cap 708 off of housing 702. Cap 708 may be set aside.

[0040] 3C is a close-up perspective view depicting an exemplary embodiment in which a user inserts applicator device 150 into tray 810 during assembly. Initially, a user may insert sheath 704 into platform 808 inside tray 810 after housing orientation feature 1302 (or slot or recess) and tray orientation feature 924 (abutment or detent) are aligned. Inserting sheath 704 into platform 808 temporarily unlocks sheath 704 from housing 702, and also temporarily unlocks platform 808 from tray 810. At this stage, removal of applicator device 150 from tray 810 will result in the same condition as before the initial insertion of applicator device 150 into tray 810 (i.e., the process can be reversed or interrupted at this point and repeated without further ramifications).

[0041] During distal advancement of the housing 702, the sheath 704 maintains its position relative to the housing 702 within the platform 808 and can couple with the platform 808 to advance the platform 808 distally relative to the tray 810. This step unlocks and collapses the platform 808 within the tray 810. The sheath 704 disengages from a locking mechanism (not shown) within the tray 810, thereby unlocking the sheath 704 from the housing 702 and preventing it from moving (relatively) while the housing 702 advances the platform 808 distally. At the end of advancement of the housing 702 and platform 808, the sheath 704 is permanently unlocked from the housing 702. At the end of distal advancement of the housing 702, the sharps and sensor (not shown) within the tray 810 can couple with the electronics housing (not shown) within the housing 702. The operation and interaction of the applicator device 150 with the tray 810 is described in more detail below.

[0042] 3D is a close-up perspective view depicting an exemplary embodiment in which a user removes applicator device 150 from tray 810 during assembly. A user can remove applicator 150 from tray 810 by advancing housing 702 proximally relative to tray 810 or other movement that has the same end effect as decoupling applicator 150 and tray 810. Applicator device 150 is removed with sensor control device 102 (sharp, sensor, electronics) (not shown) fully assembled therein and positioned for delivery.

[0043] 3E is a close-up perspective view depicting an exemplary embodiment in which a patient applies the sensor control device 102 to a target area of ​​the skin, for example on the abdomen or other suitable location, with the applicator device 150. Advancing the housing 702 causes the sheath 704 therein to collapse distally, applying the sensor to the target location such that the adhesive layer on the bottom surface of the sensor control device 102 adheres to the skin. The sharps automatically retract when the housing 702 is fully advanced, while the sensor (not shown) is left in place to measure the analyte level.

[0044] 3F is a close-up perspective view depicting an exemplary embodiment of a patient with the sensor control device 102 in application position. The user can then remove the applicator 150 from the application site.

[0045] 3A-3F and elsewhere herein, may result in a reduction or elimination of the possibility of accidental damage, permanent deformation, or incorrect assembly of applicator components compared to prior art systems. Because the applicator housing 702 directly engages the platform 808 while the sheath 704 is unlocked, rather than indirect engagement through the sheath 704, the relative angle between the sheath 704 and the housing 702 will not result in damage or permanent deformation of the arms or other components. The potential for relatively high forces during assembly (as with conventional devices) is reduced, thereby reducing the possibility of user assembly failure.

[0046] Exemplary embodiments of a sensor applicator device FIG 4A is a side view depicting an exemplary embodiment of applicator device 150 coupled to a screw cap 708. This view is an example of how applicator 150 is shipped and received by a user prior to assembly with a sensor by the user. FIG 4B is a side perspective view depicting applicator 150 and cap 708 after they have been separated. FIG 4C is a perspective view depicting an exemplary embodiment of the distal end of applicator device 150 with electronics housing 706 and adhesive patch 105 removed from the position they would have been maintained in sensor electronics carrier 710 of sheath 704 when cap 708 was in place.

[0047] Exemplary embodiments of applicator and sensor control device for one-piece architecture Briefly referring back to FIGS. 1 and 3A-3G, in a two-piece architecture system, the sensor tray 202 and the sensor applicator 102 are provided to the user as separate packages, thus requiring the user to unpack each package and ultimately assemble the system. In some applications, these separate sealed packages allow the sensor tray 202 and the sensor applicator 102 to be sterilized in separate sterilization processes that are unique to the contents of each package and are otherwise incompatible with the contents of the other. More specifically, the sensor tray 202, including the plug assembly 207, including the sensor 110 and the sharps 220, can be sterilized using radiation sterilization, such as electron beam (or "e-beam") irradiation. However, radiation sterilization may damage electrical components located within the electronics housing of the sensor control device 102. As a result, if the sensor applicator 102 enclosing the electronics housing of the sensor control device 102 needs to be sterilized, it may be sterilized by another method, such as gas chemical sterilization, for example, using ethylene oxide. However, gas chemical sterilization can destroy enzymes or other chemical and biological agents contained on the sensors 110. Due to this sterilization incompatibility, the sensor tray 202 and the sensor applicator 102 are typically sterilized in separate sterilization processes and then packaged separately, thereby requiring the user to ultimately assemble the components for use.

[0048] According to the disclosed embodiments of the present invention, the sensor control device 102 can be modified to provide a one-piece architecture that allows for the application of sterilization techniques specifically designed for the one-piece architecture sensor control device. The one-piece architecture allows the sensor applicator 150 and the sensor control device 102 to be shipped to the user in a single sealed package that does not require any final user assembly steps. In other words, the user only needs to unpack one package and then deliver the sensor control device 102 to the target monitoring location. The one-piece system architecture described herein can prove advantageous because it eliminates component parts, various fabrication process steps, and user assembly steps. This results in less packaging and waste, and less user error or contamination of the system.

[0049] 5A and 5B are isometric and side views, respectively, of another exemplary sensor control device 5002 in accordance with one or more embodiments of the present disclosure. The sensor control device 5002 may be similar in some respects to the sensor control device 102 of FIG 1 and therefore may be best understood with reference thereto. Moreover, the sensor control device 5002 may replace the sensor control device 102 of FIG 1 and therefore may be used in conjunction with the sensor applicator 102 of FIG 1 that may deliver the sensor control device 5002 to a target monitor location on a user's skin.

[0050] However, unlike the sensor control device 102 of FIG. 1, the sensor control device 5002 may include a one-piece system architecture that does not require a user to unpack multiple packages and final assemble the sensor control device 5002 prior to application. In other words, upon receipt by the user, the sensor control device 5002 is already fully assembled and properly positioned within the sensor applicator 150 (FIG. 1). To use the sensor control device 5002, the user only needs to open one barrier (e.g., cap 708 of FIG. 3B) for use, and then immediately deliver the sensor control device 5002 to the target monitoring location.

[0051] As shown, the sensor control device 5002 includes an electronics housing 5004 that is generally disc-shaped and may have a circular cross-section. However, in other embodiments, the electronics housing 2004 may exhibit other cross-sectional shapes, such as oval or polygonal, without departing from the scope of the present disclosure. The electronics housing 5004 may be configured to house or otherwise contain various electrical components used to operate the sensor control device 5002. In at least one embodiment, an adhesive patch (not shown) may be disposed on the bottom of the electronics housing 5004. The adhesive patch may be similar to the adhesive patch 105 of FIG. 1 and may thus aid in adhering the sensor control device 5002 to the user's skin for use.

[0052] As shown, the sensor control device 5002 includes an electronics housing 5004 including a shell 5006 and a mateable mount 5008. The shell 5006 can be secured to the mount 5008 by a variety of methods, such as a snap engagement, an interference fit, sonic welding, one or more mechanical fasteners (e.g., screws), a gasket, an adhesive, or any combination thereof. In some cases, the shell 5006 can be secured to the mount 5008 such that a sealed interface is created between the shell 5006 and the mount 5008.

[0053] The sensor control device 5002 may further include a sensor 5010 (partially visible) and a sharp 5012 (partially visible) that is used to aid in transdermal delivery of the sensor 5010 beneath the skin of a user during application of the sensor control device 5002. As shown, corresponding portions of the sensor 5010 and sharp 5012 extend distally from a bottom of the electronics housing 5004 (e.g., mount 5008). The sharp 5012 may include a sharp hub 5014 configured to securely carry it. As can be seen most clearly in FIG. 5B, the sharp hub 5014 may include or otherwise define a mating member 5016. To couple the sharp 5012 to the sensor control device 5002, the sharp 5012 may be advanced axially through the electronics housing 5004 until the sharp hub 5014 engages a top surface of the shell 5006 and the mating member 5016 extends distally from the bottom of the mount 5008. When the sharp 5012 penetrates the electronics housing 5004, the exposed portion of the sensor 5010 can be received within the hollow or recessed (arcuate) portion of the sharp 5012. The remainder of the sensor 5010 is disposed within the electronics housing 5004.

[0054] The sensor control device 5002 may further include a sensor cap 5018, which is shown in FIGS. 5A-5B disassembled or detached from the electronics housing 5004. The sensor cap 5016 may be removably coupled to the sensor control device 5002 (e.g., the electronics housing 5004) at or near the bottom of the mount 5008. The sensor cap 5018 may help provide a sealing barrier surrounding exposed portions of the sensor 5010 and the sharps 5012 to protect against gas chemical sterilization. As shown, the sensor cap 5018 may include a generally cylindrical body having a first end 5020a and an opposing second end 5020b. The first end 5020a may be open to provide access into an interior chamber 5022 defined within the body. In contrast, the second end 5020b may be closed and may provide or otherwise define an engagement feature 5024. As described herein, the engagement feature 5024 can assist in mating the sensor cap 5018 with a cap (e.g., cap 708 of FIG. 3B) of a sensor applicator (e.g., sensor applicator 150 of FIGS. 1 and 3A-3G) and can assist in removing the sensor cap 5018 from the sensor control device 5002 when the cap is removed from the sensor applicator.

[0055] The sensor cap 5018 can be removably coupled to the electronics housing 5004 at or near the bottom of the mount 5008. More specifically, the sensor cap 5018 can be removably coupled to a mating member 5016 that extends distally from the bottom of the mount 5008. In at least one embodiment, for example, the mating member 5016 can define a set of male threads 5026a (FIG. 5B) that can mate with a set of female threads 5026b (FIG. 5A) defined by the sensor cap 5018. In some embodiments, the male and female threads 5026a, 5026b can include a flat thread design (e.g., lacking a helical curvature), which can prove advantageous for molding these parts. Alternatively, the male and female threads 5026a, 5026b can include a helical threaded engagement. Thus, the sensor cap 5018 can be threadably coupled to the sensor control device 5002 at the mating member 5016 of the Sharp hub 5014. In other embodiments, the sensor cap 5018 can be removably coupled to the mating member 5016 by other types of engagement including, but not limited to, an interference or friction fit or a frangible member or material that can be broken with a small separation force (e.g., axial or rotational force).

[0056] In some embodiments, the sensor cap 5018 may include a monolithic (single) structure extending between the first end 5020a and the second end 5020b. However, in other embodiments, the sensor cap 5018 may include two or more component parts. In the illustrated embodiment, for example, the sensor cap 5018 may include a seal ring 5028 disposed at the first end 5020a and a desiccant cap 5030 disposed at the second end 5020b. The seal ring 5028 may help seal the inner chamber 5022 as described in more detail below. In at least one embodiment, the seal ring 5028 may include an elastomeric O-ring. The desiccant cap 5030 may store or include a desiccant that helps maintain a preferred humidity level within the inner chamber 5022. Additionally, the desiccant cap 5030 may define or otherwise provide an engagement feature 5024 for the sensor cap 5018.

[0057] 6A and 6B are exploded isometric top and bottom views, respectively, of a sensor control device 5002 according to one or more embodiments. The shell 5006 and the mount 5008 act as opposing clamshell halves that encase or otherwise substantially enclose various electronic components of the sensor control device 5002. More specifically, the electronic components may include, but are not limited to, a printed circuit board (PCB), one or more resistors, transistors, capacitors, inductors, diodes, and switches. A data processing unit and a battery may be mounted on or otherwise interact with the PCB. The data processing unit may include, for example, an application specific integrated circuit (ASIC) configured to perform one or more functions or routines related to the operation of the sensor control device 5002. More specifically, the data processing unit may be configured to perform data processing functions, where such functions may include, but are not limited to, filtering and encoding a plurality of data signals, each of which corresponds to a collected analyte level of a user. The data processing unit may further include or otherwise communicate with an antenna for communicating with the reader device 120 (FIG. 1). A battery may power the sensor control device 5002, and more specifically, the electronic components of the PCB. Although not shown, the sensor control device 5002 may further include an adhesive patch that may be attached to the bottom 5102 (FIG. 6B) of the mount 5008 to help adhere the sensor control device 5002 to the user's skin for use.

[0058] The sensor control device 5002 may provide or otherwise include a sealed subassembly that includes, among other component parts, a shell 5006, a sensor 5010, sharps 5012, and a sensor cap 5018. The sealed subassembly of the sensor control device 5002 may help isolate the sensor 5010 and sharps 5012 within an inner chamber 5022 (FIG. 6A) of the sensor cap 5018 during a gas chemical sterilization process that could otherwise adversely affect the chemical agents provided on the sensor 5010.

[0059] The sensor 5010 may include a tail 5104 that extends from an opening 5106 (FIG. 6B) defined in the mount 5008 to be transdermally received under the skin of the user. The tail 5104 may have an enzyme or other chemical agent included thereon to help facilitate analyte monitoring. The sharp 5012 may include a sharp tip 5108 extendable through an opening 5110 (FIG. 51A) defined by the shell 5006, which may be coaxially aligned with the opening 5106 of the mount 5008. When the sharp tip 5108 penetrates the electronics housing 5004, the tail 5104 of the sensor 5010 may be received within a hollow or recessed portion of the sharp tip 5108. The sharp tip 5108 may be configured to penetrate the skin while carrying the tail 5104, bringing the active chemical agent of the tail 5104 into contact with bodily fluids.

[0060] The sharp tip 5108 can be advanced through the electronics housing 5004 until the sharp hub 5014 engages the top surface of the shell 5006 and the mating member 5016 extends from the opening 5106 in the bottom 5102 of the mount 5008. In some embodiments, a sealing member (not shown), such as an O-ring or seal ring, can be sandwiched between the sharp hub 5014 and the top surface of the shell 5006 to help seal the interface between these two components. In some embodiments, the sealing member can include a separate component part, or alternatively, can form an integral part of the shell 5006, such as a co-molded or overmolded component part.

[0061] The sealing subassembly may further include a collar 5112 positioned within the electronics housing 5004 and extending at least partially into the opening 5106. The collar 5112 may be a generally annular structure defining or otherwise providing an annular ridge 5114 on an upper surface thereof. In some embodiments, as shown, a groove 5116 may be defined within the annular ridge 5114, which may be configured to house or otherwise receive a portion of the sensor 5010 that extends laterally within the electronics housing 5004.

[0062] When assembling the sealing subassembly, a bottom 5118 of the collar 5112 can be exposed at the opening 5106 and can sealingly engage the first end 5020a of the sensor cap 5018, and more specifically, the seal ring 5028. In contrast, an annular ridge 5114 on the top of the collar 5112 can sealingly engage an inner surface (not shown) of the shell 5006. In at least one embodiment, a seal member (not shown) can be sandwiched between the annular ridge 5114 and the inner surface of the shell 5006 to form a sealing interface. In such an embodiment, the seal member can extend (flow) into a groove 5116 defined in the annular ridge 5114, thereby sealing around the sensor 5010 extending laterally within the electronics housing 5004. The seal member can include, for example, an adhesive, a gasket, or an ultrasonic weld, and can help isolate enzymes and other chemical agents contained on the tail 5104.

[0063] 20 is a cross-sectional side view of an assembled seal subassembly 5200 according to one or more embodiments. The seal subassembly 5200 may form a portion of the sensor control device 5002 of FIGS. 5A-5B and 6A-6B and may include portions of the shell 5006, the sensor 5010, the sharp 5012, the sensor cap 5018, and the collar 5112. The seal subassembly 5200 may be assembled in a variety of ways. In one assembly process, the sharp 5012 may be coupled to the sensor control device 5002 by extending the sharp tip 5108 through an opening 5110 defined in an upper portion of the shell 5006 and advancing the sharp 5012 through the shell 5006 until the sharp hub 5014 engages the upper portion of the shell 5006 and the mating member 196 extends distally from the shell 5006. In some embodiments, as described above, a sealing member 5202 (e.g., an O-ring or sealing ring) can be sandwiched between the sharp hub 5014 and the top surface of the shell 5006 to help seal the interface between these two components.

[0064] The collar 5112 may then be received over the mating member 5016 and advanced toward the inner surface 5204 of the shell 5006 to allow the annular ridge 5114 to engage the inner surface 5204. The seal member 5206 may be sandwiched between the annular ridge 5114 and the inner surface 5204, thereby forming a sealed interface. The seal member 5206 may extend (flow) into a groove 5116 (FIGS. 6A-6B) defined in the annular ridge 5114, thereby sealing around the sensor 5010 extending laterally within the electronics housing 5004 (FIGS. 6A-6B). However, in other embodiments, the collar 5112 may first be sealed to the inner surface 5204 of the shell 5006, followed by the extension of the sharps 5012 and sharps hub 5014 through the opening 5110 as described above.

[0065] The female threads 5026b of the sensor cap 5018 may be threadably engaged with the male threads 5026a of the fitting 5016, thereby removably coupling the sensor cap 5018 to the sensor control device 5002. Tightening (rotating) the mating engagement between the sensor cap 5018 and the fitting 5016 may force the first end 5020a of the sensor cap 5018 into a sealing engagement with the bottom 5118 of the collar 5112. Additionally, tightening the mating engagement between the sensor cap 5018 and the fitting 5016 may improve the sealing interface between the sharp hub 5014 and the top of the shell 5006, and between the annular ridge 5114 and the inner surface 5204 of the shell 5006.

[0066] The inner chamber 5022 may be sized and otherwise configured to receive the tail 5104 and the sharp tip 5108. Additionally, the inner chamber 5022 may be sealed to isolate the tail 5104 and the sharp tip 5108 from substances that may adversely interact with the chemical agents of the tail 5104. In some embodiments, a desiccant 5208 (shown in dashed lines) may be present in the inner chamber 5022 to maintain the proper humidity level.

[0067] 8A-8C are step-by-step cross-sectional side views illustrating the assembly of a sensor applicator 102 with a sensor control device 5002 according to one or more embodiments. Once the sensor control device 5002 is fully assembled, it can be loaded into the sensor applicator 102. With reference to FIG. 8A, the sharps hub 5014 can include or otherwise define hub snap tabs 5302 configured to assist in coupling the sensor control device 5002 to the sensor applicator 102. More specifically, the sensor control device 5002 can be advanced into the sensor applicator 102 and the hub snap tabs 5302 can be received by corresponding arms 5304 of a sharps carrier 5306 positioned within the sensor applicator 102.

[0068] 8B shows the sensor control device 5002 received by the sharps carrier 5306 and thus secured within the sensor applicator 102. Once the sensor control device 5002 is loaded into the sensor applicator 102, the cap 210 can be coupled to the sensor applicator 102. In some embodiments, the cap 210 and housing 208 can have a set of counter-mateable threads 5308 that allow the cap 210 to be twisted onto the housing 208 in a clockwise (or counter-clockwise) direction, thereby securing the cap 210 to the sensor applicator 102.

[0069] As shown, the sheath 212 is further positioned within the sensor applicator 102, which may include a sheath locking mechanism 5310 configured to ensure that the sheath 212 does not prematurely collapse during an impact event. In the illustrated embodiment, the sheath locking mechanism 5310 may provide a threaded engagement between the cap 210 and the sheath 212. More specifically, one or more female threads 5312a may be defined or otherwise provided on an inner surface of the cap 210, and one or more male threads 5312b may be defined or otherwise provided on the sheath 212. The female threads 5312a and male threads 5312b may be configured to threadably mate when the cap 210 is threadedly engaged with the sensor applicator 102 via the threads 5308. The female and male threads 5312a, 5312b may have the same thread pitch as the threads 5308 that allow the cap 210 to be screwed onto the housing 208.

[0070] 8C shows the cap 210 fully threadedly coupled to the housing 208. As shown, the cap 210 may further provide or otherwise define a cap post 5314 centrally located therein and extending proximally from a bottom of the cap 210. The cap post 5314 may be configured to receive at least a portion of the sensor cap 5018 when the cap 210 is screwed onto the housing 208.

[0071] With the sensor control device 5002 loaded into the sensor applicator 102 and the cap 210 properly secured, the sensor control device 5002 can then be subjected to a gas chemical sterilization configured to sterilize its electronics housing 5004 and any other exposed portions. Because the sensor 5010 and distal portion of the sharps 5012 are sealed within the sensor cap 5018, the chemicals used during the gas chemical sterilization process cannot interact with the enzymes, chemical and biological agents provided on the tail 5104, as well as other sensor components, such as the membrane coating that regulates analyte inflow.

[0072] 9A and 9B are perspective and top views, respectively, of a cap post 5314 in accordance with one or more additional embodiments. In the illustrated view, a portion of a sensor cap 5018 is received within the cap post 5314, and more specifically, a desiccant cap 5030 of the sensor cap 5018 is disposed within the cap post 5314.

[0073] As shown, the cap post 5314 can define a receiver feature 5402 configured to receive the engagement feature 5024 of the sensor cap 5018 when the cap 210 (FIG. 8C) is coupled (e.g., threaded) to the sensor applicator 102 (FIGS. 8A-8C). However, when the cap 210 is removed from the sensor applicator 102, the receiver feature 5402 prevents the engagement feature 914 from reversing direction and thus preventing the sensor cap 5018 from separating from the cap post 5314. Instead, removing the cap 210 from the sensor applicator 102 simultaneously causes the sensor cap 5018 to decouple from the sensor control device 5002 (FIGS. 5A-5B and 8A-8C), thereby exposing a distal portion of the sensor 5010 (FIGS. 8A-8C) and the sharps 5012 (FIGS. 8A-8C).

[0074] Many design variations of the receiver feature 5402 can be used without departing from the scope of this disclosure. In the illustrated embodiment, the receiver feature 5402 includes one or more flexible members 5404 (two shown) that are expandable or flexible to receive an engagement feature 5024 (FIGS. 5A-5B). The engagement feature 5024 can include, for example, an enlarged head, and the flexible members 5404 can include a collet-type device that includes a plurality of flexible fingers configured to bend radially outward to receive the enlarged head.

[0075] The compliant member 5404 may further provide or otherwise define a corresponding ramp surface 5406 configured to interact with one or more opposing cam surfaces 5408 provided on an outer wall of the engagement feature 5024. The configuration and alignment of the ramp surface 5406 and the opposing cam surface 5408 are such that the cap 210 can rotate in a first direction A (e.g., clockwise) relative to the sensor cap 5018, but the cap post 5314 binds against the sensor cap 5018 when the cap 210 is rotated in a second direction B (e.g., counterclockwise). More specifically, when the cap 210 (and thus the cap post 5314) rotates in the first direction A, the cam surface 5408 engages the ramp surface 5406, which engagement urges the compliant member 5404 to bend radially outward or otherwise deflect, creating a ratchet effect. However, rotating the cap 210 (and thus the cap post 5314) in the second direction B drives the inclined surface 5410 of the cam surface 5408 into the opposing inclined surface 5412 of the ramp surface 5406, resulting in the sensor cap 5018 engaging with the flexible member 5404.

[0076] 10 is a cross-sectional side view of a sensor control device 5002 positioned within a cap 210 according to one or more embodiments. As shown, the opening to the receiver feature 5402 exhibits a first diameter D3, whereas the engagement feature 5024 of the sensor cap 5018 exhibits a second diameter D4 that is larger than the first diameter D3 and larger than the outer diameter of the remainder of the sensor cap 5018. When the sensor cap 5018 extends into the cap post 5314, the flexible member 5404 of the receiver feature 5402 can bend (expand) radially outward to accommodate the engagement feature 5024. In some embodiments, as shown, the engagement feature 5024 can provide or otherwise define a sloped or frusto-conical outer surface that aids in forcing the flexible member 5404 radially outward. Once the engagement feature 5024 advances beyond the receiver feature 5402 , the flexible member 5404 can bend back to (or towards) its natural state, thereby locking the sensor cap 5018 into the cap post 5314 .

[0077] As the cap 210 is threaded (twisted onto) the housing 208 (FIGS. 8A-8C) in a first direction A, the cap post 5314 rotates correspondingly in the same direction, gradually introducing the sensor cap 5018 into the cap post 5314. As the cap post 5314 rotates, the ramp surface 5406 of the flexible member 5404 ratchets against the opposing cam surface 5408 of the sensor cap 5018. This continues until the cap 210 is fully threaded (twisted onto) the housing 208. In some embodiments, the ratcheting action can occur over two full revolutions of the cap 210 before the cap 210 reaches its final position.

[0078] To remove the cap 210, the cap 210 is rotated in the second direction B, which correspondingly rotates the cap post 5314 in the same direction, such that the cam surface 5408 (i.e., the ramp surface 5410 in FIGS. 9A-9B ) engages against the ramp surface 5406 (i.e., the ramp surface 5412 in FIGS. 9A-9B ). As a result, continued rotation of the cap 210 in the second direction B correspondingly rotates the sensor cap 5018 in the same direction, thereby unscrewing the mating member 5016 and allowing the sensor cap 5018 to detach from the sensor control device 5002. Decoupling the sensor cap 5018 from the sensor control device 5002 exposes the distal portions of the sensor 5010 and the sharps 5012, thus positioning the sensor control device 5002 for firing (use).

[0079] 11A and 11B are cross-sectional side views of the sensor applicator 102 waiting to deploy the sensor control device 5002 at a target monitor location according to one or more embodiments. More specifically, FIG. 11A shows the sensor applicator 102 waiting to deploy (fire) the sensor control device 5002, and FIG. 11B depicts the sensor applicator 102 in the process of deploying (fire) the sensor control device 5002. As shown, the cap 210 (FIGS. 8A-8C and 55) is removed and correspondingly the sensor cap 5018 (FIGS. 8A-8C and 55) is disconnected (removed), thereby exposing the tail 5104 of the sensor 5010 and the sharp tip 5108 of the sharp 5012, as described above. With respect to the sheath 212 and the sharps carrier 5306 , the sensor applicator 102 further includes a sensor carrier 5602 (alternatively referred to as a “puck” carrier) that helps position and secure the sensor control device 5002 within the sensor applicator 102 .

[0080] 11A, as shown, the sheath 212 includes one or more sheath arms 5604 (one shown) configured to interact with one or more corresponding detents 5606 (one shown) defined within the housing 208. Alternatively, the detents 5606 are referred to as "firing" detents. When the sensor control device 5002 is initially installed within the sensor applicator 102, the sheath arms 5604 may be received within the detents 5606, thereby placing the sensor applicator 102 in a fired position. In the fired position, the engagement member 5016 extends distally beyond the bottom of the sensor control device 5002. As discussed below, the process of firing the sensor applicator 102 retracts the engagement member 5016 so that it does not contact the user's skin.

[0081] The sensor carrier 5602 may further include one or more carrier arms 5608 (one shown) configured to interact with a corresponding one or more grooves 5610 (one shown) defined on the sharps carrier 5306. A spring 5612 may be disposed within a cavity defined by the sharps carrier 5306, and the spring 5612 may passively bias the sharps carrier 5306 upwardly within the housing 208. However, when the carrier arm 5608 is properly received within the groove 5610, the sharps carrier 5306 is maintained in place and prevented from moving upwardly. The carrier arm 5608 is sandwiched between the sheath 212 and the sharps carrier 5306, and a radial shoulder 5614 defined on the sheath 212 may be sized to maintain the carrier arm 5608 engaged within the groove 5610, thereby maintaining the sharps carrier 5306 in place.

[0082] In FIG. 11B, the sensor applicator 102 is in the process of being fired. As discussed herein with reference to FIGS. 3F-3G, this firing can be accomplished by advancing the sensor applicator 102 towards a target monitoring location until the sheath 212 engages the user's skin. Continuation of pressure on the sensor applicator 102 against the skin can disengage the sheath arms 5604 from the corresponding detents 5606, thereby allowing the sheath 212 to collapse into the housing 208. As the sheath 212 begins to collapse, the radial shoulder 5614 eventually disengages from radial engagement with the carrier arm 5608, thereby allowing the carrier arm 5608 to disengage from the groove 5610. The passive spring force of the spring 5612 then pushes the sharps carrier 5306 freely upward, thereby forcing the carrier arm 5608 out of engagement with the groove 5610, thereby allowing the sharps carrier 5306 to move slightly upward within the housing 208. In some embodiments, fewer coils can be incorporated into the design of the spring 5612 to increase the spring force required to overcome the engagement between the carrier arm 5608 and the groove 5610. In at least one embodiment, one or both of the carrier arm 5608 and the groove 5610 can be angled to help facilitate disengagement.

[0083] As the sharps carrier 5306 moves upward within the housing 208, the sharps hub 5014 can move correspondingly in the same direction, causing a partial retraction of the engaging member 5016 so that the engaging member 5016 is flush, substantially flush, or near-flush with the bottom of the sensor control device 5002. As will be appreciated, this ensures that the engaging member 5016 does not come into contact with the user's skin, which could otherwise adversely affect sensor insertion, or cause undue pain, or prevent an adhesive patch (not shown) disposed on the bottom of the sensor control device 5002 from properly adhering to the skin.

[0084] 12A-12C are step-by-step cross-sectional side views illustrating assembly and disassembly of an alternative embodiment of a sensor applicator 102 and a sensor control device 5002 in accordance with one or more additional embodiments. As generally described above, the fully assembled sensor control device 5002 can be loaded into the sensor applicator 102 by coupling the hub snap prongs 5302 into the arms 5304 of a sharps carrier 5306 positioned within the sensor applicator 102.

[0085] In the illustrated embodiment, the sheath arm 5604 of the sheath 212 can be configured to interact with a first detent 5702a and a second detent 5702b defined within the housing 208. The first detent 5702a may alternatively be referred to as a "locking" detent and the second detent 5702b may alternatively be referred to as a "firing" detent. When the sensor control device 5002 is initially installed within the sensor applicator 102, the sheath arm 5604 may be received within the first detent 5702a. As described below, the sheath 212 may be actuated to move the sheath arm 5604 to the second detent 5702b, thereby placing the sensor applicator 102 in a fired position.

[0086] 12B, the cap 210 is aligned with and advanced towards the housing 208 such that the sheath 212 is received within the cap 210. Instead of rotating the cap 210 relative to the housing 208 to couple the cap 210 to the housing 208, the threads of the cap 210 can be snapped onto corresponding threads of the housing 208. Axial cuts or slots 5703 (one shown) defined in the cap 210 can allow a portion of the cap 210 proximate the threads to flex outwardly and snap into engagement with the threads of the housing 208. When the cap 210 is snapped onto the housing 208, the sensor cap 5018 can be snapped into the cap post 5314 accordingly.

[0087] 8A-8C, the sensor applicator 102 can include a sheath locking mechanism configured to ensure that the sheath 212 does not prematurely collapse during an impact event. In the illustrated embodiment, the sheath locking mechanism includes one or more ribs 5704 (one shown) defined near a base of the sheath 212, the rib 5704 configured to interact with one or more ribs 5706 (two shown) defined near a base of the cap 210 and a shoulder 5708. The rib 5704 can be configured to engage between the rib 5706 and the shoulder 5708 while attaching the cap 210 to the housing 208. More specifically, once the cap 210 is snapped onto the housing 208, the cap 210 can be rotated (e.g., clockwise) such that the rib 5704 of the sheath 212 is positioned between the rib 5706 and shoulder 5708 of the cap 210, which "locks" the cap 210 in place until a user counter-rotates the cap 210 to remove it for use. The engagement of the rib 5704 between the rib 5706 and shoulder 5708 of the cap 210 can prevent the sheath 212 from prematurely collapsing.

[0088] In Figure 12C, the cap 210 has been removed from the housing 208. As with the embodiment of Figures 8A-8C, the cap 210 can be removed by counter-rotating it, which correspondingly rotates the cap post 5314 in the same direction, unscrewing the sensor cap 5018 from the mating member 5016, as generally described above. Additionally, disconnecting the sensor cap 5018 from the sensor control device 5002 exposes a distal portion of the sensor 5010 and the sharps 5012.

[0089] When the cap 210 is twisted off the housing 208, a rib 5704 defined on the sheath 212 can slidingly engage an upper portion of a rib 5706 defined on the cap 210. The upper portion of the rib 5706 can provide a corresponding ramp surface that causes an upward displacement of the sheath 212 when the cap 210 is rotated, and as a result of moving the sheath 212 upward, the sheath arm 5604 flexes out of engagement with the first detent 5702a and is received within the second detent 5702b. When the sheath 212 moves to the second detent 5702b, the radial shoulder 5614 disengages from radial engagement with the carrier arm 5608, thereby causing the passive spring force of the spring 5612 to urge the sharp carrier 5306 upward, forcing the carrier arm 5608 out of engagement with the groove 5610. As the sharps carrier 5306 moves upward within the housing 208, the engaging member 5016 can correspondingly retract until it is flush, substantially flush, or near-flush with the bottom of the sensor control device 5002. At this point, the sensor applicator 102 is in the fired position. Thus, in this embodiment, removing the cap 210 correspondingly retracts the engaging member 5016.

[0090] Exemplary Embodiments of Seal Arrangements for Analyte Monitoring Systems 13A and 13B are side and isometric views, respectively, of an exemplary sensor control device 9102 in accordance with one or more embodiments of the present disclosure. The sensor control device 9102 may be similar in some respects to the sensor control device 102 of FIG. 1 and therefore may be best understood with reference thereto. Moreover, the sensor control device 9102 may replace the sensor control device 102 of FIG. 1 and therefore may be used in conjunction with the sensor applicator 102 of FIG. 1, which may deliver the sensor control device 9102 to a target monitor location on the user's skin.

[0091] As shown, the sensor control device 9102 includes an electronics housing 9104 that may be generally disc-shaped and have a circular cross-section. However, in other embodiments, the electronics housing 9104 may exhibit other cross-sectional shapes, such as oval, elliptical, or polygonal, without departing from the scope of the present disclosure. The electronics housing 9104 includes a shell 9106 and a mount 9108 matable therewith. The shell 9106 may be secured to the mount 9108 by a variety of methods, such as a snap engagement, an interference fit, sonic welding, laser welding, one or more mechanical fasteners (e.g., screws), a gasket, an adhesive, or any combination thereof. In some cases, the shell 9106 may be secured to the mount 9108 such that a sealed interface occurs between the shell 9106 and the mount 9108. An adhesive patch 9110 may be disposed or otherwise attached to the underside of the mount 9108. Similar to the adhesive patch 105 of FIG. 1, the adhesive patch 9110 can be configured to maintain the sensor control device 9102 fixed in place on the user's skin during operation.

[0092] The sensor control device 9102 may further include a sensor 9112 and a sharp 9114 that is used to aid in transdermal delivery of the sensor 9112 beneath the skin of a user during application of the sensor control device 9102. Corresponding portions of the sensor 9112 and sharp 9114 extend distally from a bottom of the electronics housing 9104 (e.g., mount 9108). A sharp hub 9116 may be overmolded onto the sharp 9114 and configured to securely carry the sharp 9114. As can be seen most clearly in FIG. 13A , the sharp hub 9116 may include or otherwise define a mating member 9118. In assembling the sharp 9114 into the sensor control device 9102, the sharp 9114 can be advanced axially through the electronics housing 9104 until the sharp hub 9116 engages the top surface of the electronics housing 9104 or an internal component of the electronics housing 9104 and the mating member 9118 extends distally from the bottom of the mount 9108. As described below, in at least one embodiment, the sharp hub 9116 can sealingly engage an upper portion of a seal overmolded onto the mount 9108. As the sharp 9114 penetrates the electronics housing 9104, the exposed portion of the sensor 9112 can be received within the hollow or recessed (arcuate) portion of the sharp 9114. The remainder of the sensor 9112 is disposed within the electronics housing 9104.

[0093] The sensor control device 9102 may further include a sensor cap 9120, shown in FIGS. 13A-13B separated from the electronics housing 9104. The sensor cap 9120 may help provide a sealing barrier that surrounds and protects exposed portions of the sensor 9112 and the sharps 9114. As shown, the sensor cap 9120 may include a generally cylindrical body having a first end 9122a and an opposing second end 9122b. The first end 9122a may be open to provide access into an interior chamber 9124 defined within the body. In contrast, the second end 9122b may be closed and may provide or otherwise define an engagement feature 9126. As described in more detail below, the engagement features 9126 can assist in fitting the sensor cap 9120 to a cap of a sensor applicator (e.g., the sensor applicator 102 of FIG. 1) and can assist in removing the sensor cap 9120 from the sensor control device 9102 when the sensor cap is removed from the sensor applicator.

[0094] The sensor cap 9120 can be removably coupled to the electronics housing 9104 at or near the bottom of the mount 9108. More specifically, the sensor cap 9120 can be removably coupled to a mating member 9118 extending distally from the bottom of the mount 9108. In at least one embodiment, for example, the mating member 9118 can define a set of matable male threads 9128a (FIG. 13A) with a set of female threads 9128b (FIG. 13B) defined within the inner chamber 9124 of the sensor cap 9120. In some embodiments, the male and female threads 9128a, 9128b can include a flat thread design (e.g., lacking a helical curvature) or can alternatively comprise a helical threaded engagement. Thus, in at least one embodiment, the sensor cap 9120 can be threadably coupled to the sensor control device 9102 at the mating member 9118 of the sharp hub 9116. In other embodiments, the sensor cap 9120 can be removably coupled to the mating member 9118 by other types of engagement, including but not limited to an interference or friction fit, or a frangible member or substance (e.g., wax, adhesive, etc.) that can be broken by a slight separation force (e.g., axial or rotational force).

[0095] In some embodiments, the sensor cap 9120 may include a monolithic (single) structure extending between the first end 9122a and the second end 9122b. However, in other embodiments, the sensor cap 9120 may include two or more component parts. In the illustrated embodiment, for example, the body of the sensor cap 9120 may include a desiccant cap 9130 disposed at the second end 9122b. The desiccant cap 9130 may contain or include a desiccant that helps maintain a preferred humidity level within the inner chamber 9124. Additionally, the desiccant cap 9130 may define or otherwise provide an engagement feature 9126 for the sensor cap 9120. In at least one embodiment, the desiccant cap 9130 may include an elastomeric plug that is inserted into a bottom end of the sensor cap 9120.

[0096] 14A and 14B are exploded isometric top and bottom views, respectively, of a sensor control device 9102 according to one or more embodiments. The shell 9106 and mount 9108 act as opposing clamshell halves that encase or otherwise substantially enclose various electronic components (not shown) of the sensor control device 9102. Exemplary electronic components that may be disposed between the shell 9106 and the mount 9108 include, but are not limited to, batteries, resistors, transistors, capacitors, inductors, diodes, and switches.

[0097] The shell 9106 can define a first opening 9202a and the mount 9108 can define a second opening 9202b, where the openings 9202a, 9202b can align when the shell 9106 is properly mounted to the mount 9108. As can be seen most clearly in FIG. 14A , the mount 9108 can provide or otherwise define a pedestal 9204 that protrudes from an inner surface of the mount 9108 at the second opening 9202b. The pedestal 9204 can define at least a portion of the second opening 9202b. Additionally, a channel 9206 can be defined on an inner surface of the mount 9108, where the channel 9206 can surround the pedestal 9202. In the illustrated embodiment, the channel 9206 is circular in shape, but it is contemplated that the channel 9206 could alternatively be another shape, such as elliptical, oval, or polygonal.

[0098] The mount 9108 may include a molded part made of a rigid material such as plastic or metal. In some embodiments, the seal 9208 may be overmolded onto the mount 9108, and the seal 9208 may be made of an elastomer, rubber, polymer, or another flexible material suitable for facilitating a sealing interface. In embodiments in which the mount 9108 is made of plastic, the mount 9108 may be molded in a first "shot" of injection molding, and the seal 9208 may be overmolded onto the mount 9108 in a second "shot" of injection molding. Thus, the mount 9108 may be referred to or otherwise characterized as a "two-shot mount."

[0099] In the illustrated embodiment, the seal 9208 is overmolded onto the mount 9108 at the pedestal 9204 and may also be overmolded onto the bottom of the mount 9108. More specifically, the seal 9208 may define or otherwise be provided with a first seal element 9210a overmolded onto the pedestal 9204 and a second seal element 9210b (FIG. 14B) interconnected therewith and overmolded onto the mount 9108 at the bottom of the mount 9108. In some embodiments, one or both of the seal elements 9210a, 9210b may help form a corresponding section of the second opening 9202b. Although the seal 9208 is described herein as being overmolded onto the mount 9108, it is also contemplated that one or both of the seal elements 9210a, 9210b may include an elastomeric component part separate from the mount 9208, such as an O-ring or gasket.

[0100] The sensor control device 9102 may further include a collar 9212, which may be a generally annular structure that defines a central opening 9214. The central opening 9214 may be sized to receive the first seal element 9210a and may align with both the first opening 9202a and the second opening 9202b when the sensor control device 9102 is properly assembled. The shape of the central opening 9214 may generally match the shape of the second opening 9202b and the first seal element 9210a.

[0101] In some embodiments, the collar 9212 can define or otherwise be provided with an annular lip 9216 on its bottom surface. The annular lip 9216 can be sized or otherwise configured to fit or be received within a channel 9206 defined on an inner surface of the mount 9108. In some embodiments, a groove 9218 can be defined on the annular lip 9216 and can be configured to accommodate or otherwise receive a portion of the sensor 9112 that extends laterally within the mount 9108. In some embodiments, the collar 9212 can further define or otherwise be provided with a collar channel 9220 ( FIG. 14A ) on its top surface that is sized to receive or otherwise fit within an annular ridge 9222 ( FIG. 14B ) defined on an inner surface of the shell 9106 when the sensor control device 9102 is properly assembled.

[0102] The sensor 9112 may include a tail 9224 that extends through a second opening 9202b defined in the mount 9108 to be transdermally received under the skin of the user. The tail 9224 may have an enzyme or other chemical agent included thereon to help facilitate analyte monitoring. The sharp 9114 may include a sharp tip 9226 extendable through a first opening 9202a defined by the shell 9106. The tail 9224 of the sensor 9112 may be received within a hollow or recessed portion of the sharp tip 9226 as the sharp tip 9226 penetrates the electronics housing 9104. The sharp tip 9226 may be configured to pierce the skin while carrying the tail 9224 to place the active chemical agent of the tail 9224 in contact with bodily fluids.

[0103] The sensor control device 9102 can provide a sealed subassembly that includes portions of the shell 9106, the sensor 9112, the sharp 9114, the seal 9208, the collar 9212, and the sensor cap 9120, among other component parts. The sealed subassembly can help isolate the sensor 9112 and the sharp 9114 in the inner chamber 9124 (FIG. 14A) of the sensor cap 9120. In assembling the sealed subassembly, the sharp tip 9226 is advanced through the electronics housing 9104 until the sharp hub 9116 engages the seal 9208, more specifically the first seal element 9210a. The mating member 9118 on the bottom of the sharp hub 9116 can extend out of the second opening 9202b in the bottom of the mount 9108, and the sensor cap 9120 can be coupled to the sharp hub 9116 at the mating member 9118. Coupling the sensor cap 9120 to the Sharp hub 9116 at the mating member 9118 can force a first end 9122a of the sensor cap 9120 into sealing engagement with the seal 9208, and more specifically, with a second seal element 9210b on the bottom of the mount 9108. In some embodiments, when the sensor cap 9120 is coupled to the Sharp hub 9116, a portion of the first end 9122a of the sensor cap 9120 can abut (engage) with the bottom of the mount 9108, and the sealing engagement between the Sharp hub 9116 and the first seal element 9210a can accommodate any tolerance variations between features.

[0104] 15 illustrates a cross-sectional side view of a sensor control device 9102 according to one or more embodiments. As noted above, the sensor control device 9102 can include or otherwise incorporate a sealing subassembly 9302 that can be useful for isolating the sensor 9112 and the sharps 9114 within the inner chamber 9124 of the sensor cap 9120. To assemble the sealing subassembly 9302, the sensor 9112 can be positioned within the mount 9108 such that the tail 9224 extends through a second opening 9202b at the bottom of the mount 9108. In at least one embodiment, a positioning feature 9304 can be defined on an inner surface of the mount 9108, and the sensor 9112 can define a groove 9306 that can mate with the positioning feature 9304 to properly position it within the mount 9108.

[0105] With the sensor 9112 properly positioned, the collar 9212 can be installed on the mount 9108. More specifically, the collar 9212 can be positioned such that a first seal element 9210a of the seal 9208 is received within a central opening 9214 defined by the collar 9212, and the first seal element 9210a generates a radial seal against the collar 9212 at the central opening 9214. Additionally, an annular lip 9216 defined on the collar 9212 can be received within a channel 9206 defined on the mount 9108, and a groove 9218 defined through the annular lip 9216 can be aligned to receive a portion of the sensor 9112 that traverses the channel 9206 in the mount 9108. In some embodiments, an adhesive can be injected into the channel 9206 to secure the collar 9212 to the mount 9108. The adhesive can facilitate a sealed interface between these two components and create a seal around the sensor 9112 at the location of the groove 9218, thereby isolating the tail 9224 from the interior of the electronics housing 9104.

[0106] The shell 9106 may then be mated or otherwise coupled to the mount 9108. In some embodiments, as shown, the shell 9106 may be mated to the mount 9108 through a tongue and groove engagement 9308 at the outer periphery of the electronics housing 9104. An adhesive may be injected (applied) into the groove portion of the engagement 9308 to secure the shell 9106 to the mount 9108 and generate a sealed engagement interface. By mating the shell 9106 to the mount 9108, an annular ridge 9222 defined on an inner surface of the shell 9106 may be received within a collar channel 9220 defined on an upper surface of the collar 9212. In some embodiments, an adhesive may be injected into the collar channel 9220 to secure the shell 9106 to the collar 9212 and facilitate a sealed interface between the two components at this location. When the shell 9106 is mated with the mount 9108, the first seal element 9210a can extend at least partially through (into) a first opening 9202a defined in the shell 9106.

[0107] The sharp 9114 can then be coupled to the sensor control device 9102 by extending the sharp tip 9226 through first and second openings 9202a, 9202b defined and aligned in the shell 9106 and the mount 9108, respectively. The sharp 9114 can be advanced until the sharp hub 9116 engages the seal 9208, and more specifically, the first seal element 9210a. The mating member 9118 can extend (protrude) out of the second opening 9202b at the bottom of the mount 9108 when the sharp hub 9116 engages the first seal element 9210a.

[0108] The sensor cap 9120 can then be removably coupled to the sensor control device 9102 by threadably mating the female threads 9128b of the sensor cap 9120 with the male threads 9128a of the fitting 9118. The inner chamber 9124 can be sized or otherwise configured to receive the tail 9224 and sharp tip 9226 extending from the bottom of the mount 9108. Additionally, the inner chamber 9124 can be sealed to isolate the tail 9224 and sharp tip 9226 from substances that may adversely interact with the chemical agent of the tail 9224. In some embodiments, a desiccant (not shown) can be present in the inner chamber 9124 to maintain the proper humidity level.

[0109] Tightening (rotating) the mating engagement between the sensor cap 9120 and the mating member 9118 can force the first end 9122a of the sensor cap 9120 into axial (e.g., along the centerline of the openings 9202a, 9202b) sealing engagement with the second seal element 9210b and can strengthen the axial sealing interface between the sharp hub 9116 and the first seal element 9210a. Additionally, tightening the mating engagement between the sensor cap 9120 and the mating member 9118 can compress the first seal element 9210a, thereby providing a strong radial sealing engagement between the first seal element 9210a and the collar 9212 at the central opening 9214. Thus, in at least one embodiment, the first seal element 9210a can help facilitate axial and radial sealing engagement.

[0110] As mentioned above, the first and second seal elements 9210a, 9210b can be overmolded onto the mount 9108 and physically connected or otherwise interconnected. Thus, a single injection molding shot can flow through the second opening 9202b of the mount 9108 to generate both ends of the seal 9208. This can prove advantageous in that multiple sealing interfaces can be generated with only a single injection molding shot. Yet another advantage of the two-shot molding design is that the interface between the first and second shots is a more reliable bond than a mechanical seal, as opposed to using separate elastomeric components (e.g., O-rings, gaskets, etc.). Thus, the effective number of mechanical sealing barriers is essentially halved. Additionally, the two-shot components with a single elastomeric shot also have the implication of minimizing the number of two-shot components required to achieve all the necessary sterility barriers. Once properly assembled, the sealing subassembly 9302 can be subjected to a radiation sterilization process to sterilize the sensor 9112 and the sharps 9114. The sealing subassembly 9302 may be subjected to radiation sterilization before or after coupling the sensor cap 9120 to the Sharp hub 9116. The sensor cap 9120 may be made of a material that allows the transmission of radiation therethrough if it is sterilized after coupling the sensor cap 9120 to the Sharp hub 9116. In some embodiments, the sensor cap 9120 may be transparent or translucent, but may otherwise be opaque without departing from the scope of this disclosure.

[0111] FIG. 16 shows an exploded isometric view of a portion of another embodiment of the sensor control device 9102 of FIGS. 13A-13B and 14A-14B. In the embodiments included above, the mount 9108 and the seal 9208 are described as being manufactured by a two-shot injection molding process. However, in other embodiments, as briefly indicated above, one or both of the seal elements 9210a, 9210b of the seal 9208 may include elastomeric component parts that are separate from the mount 9208. In the illustrated embodiment, for example, the first seal element 9210a may be overmolded onto the collar 9212 and the second seal element 9210b may be overmolded onto the sensor cap 9120. Alternatively, the first and second seal elements 9210a, 9210b may include separate component parts, such as gaskets or O-rings, disposed on the collar 9212 and the sensor cap 9120, respectively. By tightening (rotating) the mating engagement between the sensor cap 9120 and the mating member 9118, the second seal element 9210b can be forced into axial sealing engagement with the bottom of the mount 9108, strengthening the axial sealing interface between the sharp hub 9116 and the first seal element 9210a.

[0112] FIG. 17A illustrates an isometric bottom view of a mount 9108 according to one or more embodiments, and FIG. 17B illustrates an isometric top view of a sensor cap 9120 according to one or more embodiments. As shown in FIG. 17A, the mount 9108 can provide or otherwise define one or more recesses or pockets 9402 at or near the opening to the second aperture 9202b. As shown in FIG. 17B, the sensor cap 9120 can provide or otherwise define one or more protrusions 9404 at or near its first end 9122a. The protrusions 9404 can be received within the pockets 9402 when the sensor cap 9120 is coupled to the Sharp hub 9116 (FIGS. 14A-14B and 93). More specifically, as described above, when the sensor cap 9120 is coupled to the mating member 9118 (FIGS. 14A-14B and 93) of the Sharp hub 9116, the first end 9122a of the sensor cap 9120 is brought into sealing engagement with the second seal element 9210b. In this process, the protrusion 9404 can be received within the pocket 9402, which can help prevent premature unscrewing of the sensor cap 9120 from the Sharp hub 9116.

[0113] 18A and 18B are side and cross-sectional side views, respectively, of an exemplary sensor applicator 9502 according to one or more embodiments. The sensor applicator 9502 may be similar in some respects to the sensor applicator 102 of FIG. 1 and, therefore, may be designed to deliver (fire) a sensor control device, such as the sensor control device 9102. FIG. 18A illustrates how the sensor applicator 9502 may be shipped to and received by a user, and FIG. 18B depicts the sensor control device 9102 disposed within the sensor applicator 9502.

[0114] 18A , the sensor applicator 9502 includes a housing 9504 and a cap 9506 removably coupled thereto. In some embodiments, the cap 9506 can be threaded onto the housing 9504 and can include a tamper-evident ring 9508. When the cap 9506 is rotated (e.g., twisted off) relative to the housing 9504, the tamper-evident ring 9508 can be unscrewed, thereby freeing the cap 9506 from the sensor applicator 9502.

[0115] 18B, the sensor control device 9102 is positioned within the sensor applicator 9502. Once the sensor control device 9102 is fully assembled, it can then be loaded into the sensor applicator 9502, and the cap 9506 can be coupled to the sensor applicator 9502. In some embodiments, the cap 9506 and housing 9504 can have opposing matable thread sets that allow the cap 9506 to be twisted onto the housing 9504 in a clockwise (or counterclockwise) direction, thereby securing the cap 9506 to the sensor applicator 9502.

[0116] By securing the cap 9506 to the housing 9504, the second end 9122b of the sensor cap 9120 can be received within a cap post 9510 positioned within the cap 9506 and extending proximally from a bottom of the cap 9506. The cap post 9510 can be configured to receive at least a portion of the sensor cap 9120 when the cap 9506 is coupled to the housing 9504.

[0117] Additional details of suitable devices, systems, methods, components, and their operation, along with associated features, are described in WO 2018 / 136898 to Rao et al., WO 2019 / 236850 to Thomas et al., WO 2019 / 236859 to Thomas et al., WO 2019 / 236876 to Thomas et al., and U.S. Patent Publication No. 2020 / 0196919, filed June 6, 2019, the entire contents of each of which are incorporated herein by reference. Additional details regarding embodiments of the applicator, its components, and variations thereof are described in U.S. Patent Publication Nos. 2013 / 0150691, 2016 / 0331283, and 2018 / 0235520, the entire contents of all of which are incorporated herein by reference for all purposes. Additional details regarding embodiments of the SHARP module, SHARP, its components, and variations thereof are described in U.S. Patent Publication No. 2014 / 0171771, the entire contents of which are incorporated herein by reference for all purposes.

[0118] Exemplary Methods for Detection of Radiological Examinations More and more patients are incorporating the use of continuous glucose monitors into their diabetes management plans. Continuous glucose monitors (CGMs) have been shown to be reliable and accurate, but some concerns remain regarding the stability of CGMs during radiological examinations. In fact, patients wearing CGMs are advised to avoid exposure to whole-body millimeter wave scanners at airport security checkpoints, to avoid passing the sensor through baggage X-ray machines, and to remove the sensor before MRI, CT, or X-ray diagnostic examinations. As used herein, "CGM" refers to the sensor-control device 102, and "radiological examination" can include exposure to whole-body millimeter wave scanners at airport security checkpoints, exposure to baggage X-ray machines, or user exposure to MRI, CT, or X-ray diagnostic examinations.

[0119] Exemplary studies have included a comprehensive evaluation of the effect of common radiological examinations of computed tomography (CT), x-ray scanning, and MRI on sensors and sensor-controlled devices, particularly CGMs having a sensor-controlled device with an analyte sensor for insertion into a subject's bodily fluid, the sensor having a thickness of about 5 mm and a diameter of 21 mm (exemplary embodiments A1 and A2) and a thickness of about 3 mm and a diameter of 35 mm (embodiment B).

[0120] For CT and X-ray, the CGM device was examined under three different radiation exposure conditions: direct, indirect, and scattered radiation. More specifically, for CT, data was collected every 15 minutes using system maximum settings of 140 kV and 360 mA for a total of 10 imaging sessions. The analyte sensor was evaluated after each exposure over the first three sessions and every 15 minutes for the following exposures until 10 sessions were completed. Similarly, for X-ray, system maximum settings of 150 kV and 500 mA were used for the first 11 X-ray exposures, followed by a 20% drop in settings to 120 kV and 400 mA for the remaining 9 exposures to account for overheating of the X-ray system. For the first three sessions, the analyte sensor was evaluated after each exposure session (forward and sideways) and then every 15 minutes for the following exposures until 10 sessions (20 exposures) were completed.

[0121] The acceptance criteria was a glucose error of ≦10 mg / dL for a reference glucose reading of 100 mg / dL. All devices met the functional test acceptance criteria at all exposure conditions and exposure orientations after each repeated exposure session at the maximum exposure scan setting acceptable by each scanner. Since a sensor was only present on the patient's arm for about 14 days and maximum exposure conditions were used for each scan, this radiation exposure for X-ray and CT is far more than a device would be clinically exposed to. Thus, this exemplary study revealed that the functionality of the CGM sensor was not affected by X-ray or CT exposure. Furthermore, the sensor components were clearly visible using both X-ray and CT imaging modalities, thus allowing for clinical interpretation when interpreting the images. In addition, there were minimal artifacts generated by the CGM.

[0122] Nuclear magnetic resonance imaging Similarly, CGM functionality testing was performed by comparing the sensor current before and immediately after MRI exposure under MRI systems using static magnetic fields of 1.5 Tesla (1.5T) and 3 Tesla (3T). Sensors were also tested for functionality 1 hour and 6 hours after MRI exposure. The acceptance criteria was a glucose error of ≦10 mg / dL relative to a reference glucose reading of 100 mg / dL. The sensors warned of glucose readings outside the acceptance criteria during MRI exposure, but glucose readings from all sensors returned to within the acceptance criteria after 1 hour of exposure and remained within the acceptance range after 6 hours of MRI exposure. Referring to FIG. 19, the minimum and maximum changes in glucose readings from three replicate devices of each device type at three exposure stages (pre-exposure, during exposure, and 1 hour after exposure) are shown. Additionally, to include a plot of "during exposure," six different MRI exposure conditions on a 3T scanner were utilized together. Within each group, the maximum and minimum data points are shown overlaid on the mean and standard deviation bars. Similar results were observed when the device was subjected to MRI exposure in a 1.5T scanner.

[0123] In addition, a displacement force test was performed near the bore entrance and on the bore axis of a 3T scanner bore, where the spatial gradient of the static magnetic field is known to be the largest. Based on the results of the displacement force test, the maximum allowable spatial gradient at magnetic field strengths of 1.5T and 3T was determined. The displacement force for exemplary embodiment A1 is 0.132N, and for exemplary embodiment A2, it is 0.109N, which is more than 100x smaller than the force of 15.97N required to detach the sensor control device 102 from the skin of the wearer. Similarly, the displacement force for exemplary embodiment B is 0.063N, which is more than 100x smaller than the force of 7.95N required to detach the sensor control device from the skin of the wearer. Using these detachment forces, the spatial gradient required to detach the sensor was calculated and compared to the expected maximum spatial gradient of 19T / m. The calculated spatial gradient required to detach the sensor was found to be 334.9 T / m and 328.2 T / m for exemplary embodiments A and B, respectively, far exceeding values ​​expected during a clinical MRI imaging study.

[0124] A magnetic induction torque test was performed near the isocenter of a 3T scanner to evaluate the interaction of the maximum uniform static magnetic field with the magnetization in the test sample. The test was performed in three orientations based on qualitative torque results. An acceptance criterion was established such that if the test sample did not show any discernible torque effect, it could be concluded that the device does not pose a risk to the MRI environment in terms of torque-induced device delamination. The maximum allowable magnetic induction torque of the sensor was set to be less than the calculated delamination torque of the device, calculated by assuming rotation about the central plane of the device and simplifying the adhesion force to a single point force at the center of mass of the semicircle of the sensor. The resulting delamination torque was determined to be 0.05 Nm for exemplary embodiments A1 and A2, and 0.018 Nm for exemplary embodiment B.

[0125] RF-induced heating evaluation was performed with temperature probes placed above and below the sensor and at the sensor tip. Calorimetry tests were performed with saline-filled phantoms in the 64 MHz and 128 MHz RF coils and the sensor aligned to the scanner axis, and measured and scanner-warned whole-body average Specific Absorption Rate (SAR) values ​​were recorded for each scan. An acceptance criterion was established such that the RF-induced temperature increase was less than 6°C over a 15-minute scan in normal operating mode with a whole-body console Specific Absorption Rate (SAR) of 2.0 W / kg, determined by whole-body modeling as described below. The tests used individual specification pulse waveforms with a frequency of 10 Hz. RF signals were delivered at frequencies of 63.66 MHz for the 1.5T test and 128.23 MHz for the 3T test. The input power was set such that the whole-body SAR was 2.0 w / kg. Temperature was monitored during the 15-minute RF signal application and for 2 minutes before and after the signal. The temperature increase was determined as the difference between the maximum measured temperature and the initial temperature. The high electric fields resulted in a temperature increase of 2.1° C. at 1.5T and 2.5° C. at 3T at a SAR of 2.0 W / kg, well below the acceptance criteria of <6.0° C. As can be seen in FIG. 20, further evaluation including experimental uncertainty factors of 9% and 4.3% for 1.5T and 3T, respectively, determined the temperature increase to be 2.2° C. at 1.5T and 2.6° C. at 3T.

[0126] For a scanner with a slew rate of 200 T / m / s, gradient-induced heating testing was performed by exposing the sensor-controlled device to a gradient field |dB / dt|rms of 54.1 T / s based on the maximum normal operating mode |dB / dt|RMS exposure for the device at a radial location 25 cm from the isocenter close to the distance of the sensor-controlled device placed on the wearer's outer upper arm. The acceptance criteria for this evaluation was a temperature change of <6.0°C when the gradient coil dB / dt=54 T / s. A sinusoidal waveform with a frequency of 1750 Hz and an amplitude of 1.25 V was used for the test. Temperature probes were placed at the highest heating locations predicted based on the initial hot spot evaluation. A fourth probe was used to monitor the bulk temperature within the uniform region of the gradient coil at least 2 cm from the device. Temperature was monitored during application of the gradient signal for 15 minutes, as well as for 2 minutes before and after the signal. The temperature increase was defined as the difference between the maximum measured temperature and the initial temperature. The measured temperature change was scaled for a dB / dt of 54.1 T / s. As can be seen in Figure 21, a 15 minute gradient exposure of 54.1 T / s resulted in a maximum temperature increase of 0.8°C. Including an experimental uncertainty factor of 7.6%, the temperature increase was 0.9°C.

[0127] Human body modeling was performed to confirm expected safety by scaling the experimental temperature change (ΔT) values ​​to clinically relevant expected ΔT values. The ANSYS® male human body model was used to characterize the whole body and local SAR values. The human body model includes skin, fat, muscle, bone, and organs. Since the glucose sensor is intended for use on the wearer's upper arm, the maximum local SAR values ​​were quantified for a region encompassing a maximum depth of 1 cm on the side of the upper arm. For the local predefined quantitative analysis, the region of interest was defined to encompass a subdermal depth of up to 1 cm on the anterior, lateral, and posterior upper arm skin according to an exemplary medical indication for use. To obtain accurate results, eliminate numerical artifacts, and maintain reasonable computer time, the local SAR values ​​were determined by volume averaging 10 g of tissue. The local SAR values ​​were used to calculate the expected ΔT values. The expected ΔT values ​​obtained from the human body modeling were then scaled to a whole body SAR of 2.0 W / kg (representing the normal operating mode in a clinical scanner). These scaling values ​​represent the maximum expected heating over at least a 15 minute scan under a 2.0W / kg SAR limit. An acceptance criterion was established such that RF-induced temperatures were less than 6°C over a 15 minute scan in normal operating mode with a whole body console specific absorption rate (SAR) of 2.0W / kg. As expected, the highest field and SAR levels occurred in the arms, shoulders, and sides of the body when the scanner landmark locations were around the upper arms. The highest temperature changes were seen when the arms were positioned immediately adjacent to the isocenter of the magnet bore. At 1.5T, all expected temperature value changes were less than 4°C. At 3T, the maximum scan time limit, including a calculated minimum cooling time between scans of 6 minutes, kept all delta T values ​​below 4°C. The highest expected heating after a series of scan and cooling times was determined to be a total of 6°C relative to body temperature. When evaluating isolation of the region of interest at the same landmark locations, the highest levels of volume-averaged SAR occurred in the center of the arms at both 1.5T and 3T.

[0128] During artifact testing, as can be seen in FIG. 22, the maximum radial artifact at 3T standard was determined to be 6.8 cm for exemplary embodiment A1, 6.9 cm for exemplary embodiment A2, and 5.8 cm for exemplary embodiment B.

[0129] Accordingly, FIG. 23 is a flow diagram illustrating a routine associated with determining exposure of a sensor control device to a radiological test according to the present disclosure. As shown, in one embodiment, a plurality of time-separated analyte sensor data during a first time period is received (2310). Thereafter, a plurality of time-separated temperature data during the first time period is received (2320). The temperature data may include epidermal temperature, ambient temperature, subcutaneous temperature, sensor tip temperature, internal body temperature, internal temperature of the sensor control device, etc. Upon detection of an increase in the plurality of time-separated temperature data during the first time period (2330), it is confirmed that the sensor control device was exposed to a radiological test (e.g., but not limited to, nuclear magnetic resonance imaging) during the first time period (2340). In one aspect, the increase in the plurality of time-separated temperature data may include a temperature data rate of change at or greater than 4° C. / 15 minutes. The increase in the plurality of time-separated temperature data may include other variations in rate of change greater or less than 4° C. / 15 minutes within the present disclosure. Additionally, although monitoring and detecting epidermal temperature levels is described above, any suitable body temperature may be measured and used in accordance with aspects of the present disclosure. For example, temperature data may include epidermal temperature, ambient temperature, subcutaneous temperature, sensor tip temperature, core temperature, internal temperature of the sensor control device, etc.

[0130] According to an embodiment, verifying that the sensor control device has been exposed to a radiological examination may include generating an alarm or alert verifying whether the sensor control device has been exposed to a radiological examination such as an MRI. For example, according to an embodiment, in response to the alarm, the user may be requested to verify that the sensor control device has been exposed to a radiological examination. The alarm may be an audio, visual, tactile, or any other type of alarm. The alarm may be generated on the body worn unit or on the user's computer system (i.e., laptop, desktop, tablet, phablet, smartphone, set-top box, video game console, or other computer device) as described above.

[0131] In some embodiments, a prompt may be provided to the user regarding the estimated duration for which the body worn unit underwent a radiological examination. In some embodiments, the user may confirm or adjust the estimated duration for which the body worn unit underwent a radiological examination. For example, upon receiving the prompt for the estimated duration, the user may confirm whether the estimated duration is accurate. Alternatively, the user may adjust the estimated duration of the radiological examination (e.g., upward or downward).

[0132] According to an embodiment, the confirmation that the sensor control device has been exposed to a radiation test may include a user-based input. By way of example and not limitation, upon detection of an increase in the plurality of time-separated temperature data during a first period of time, a user input may be requested (by the reader device 120, by way of example and not limitation) to confirm whether the user has been exposed to a radiation test. According to an embodiment, the user-based input may be retrieved retroactively from the memory 223 of the reader device 120 based on the user input prior to the exposure to the radiation test, such as, by way of example and not limitation, when the user inputs a subsequent anticipated period prior to the exposure to the radiation test when the user anticipates that the sensor control device will be exposed to the radiation test.

[0133] 24 is a flow diagram illustrating a routine associated with determining exposure of a sensor control device to a radiological test according to the present disclosure. As shown, in one embodiment, a user input is retrieved or received indicating a first time period corresponding to expected exposure to a radiological test (2410). A plurality of time-separated analyte sensor data during the first time period is then received (2420). A plurality of time-separated temperature data during the first time period is received (2430) after the start of the first time period corresponding to expected exposure to the radiological test, where the expected start of the radiological test corresponds to the start of the first time period. In step 2440, it is confirmed that the sensor control device was exposed to a radiological test (e.g., but not limited to, nuclear magnetic resonance imaging) during the first time period based on an increase in the plurality of time-separated temperature data during the first time period. In one aspect, an increase in the plurality of time-separated temperature data deemed to support exposure to a radiological test may include a temperature data rate of change at or greater than 4 degrees C / 15 minutes. The increase in the multiple time separated temperature data may include other variations in rate of change greater or less than 4 degrees C / 15 minutes within the present disclosure. Additionally, although monitoring and detection of epidermal temperature levels is described above, any suitable body temperature may be measured and used in accordance with aspects of the present disclosure. For example, temperature data may include epidermal temperature, ambient temperature, subcutaneous temperature, sensor tip temperature, core temperature, internal temperature of the sensor control device, and the like.

[0134] 23 and 24, after determining that the sensor control device was exposed to a radiological test during a first time period, the plurality of time-separated analyte sensor data received during the first time period may be adjusted. By way of example and not limitation, as can be seen in FIGS. 23 and 24, the adjustment may include deleting or ignoring (2350 or 2450) the plurality of time-separated analyte sensor data received during the first time period. Additionally, adjusting the plurality of time-separated analyte sensor data received during the first time period may include adjusting the plurality of time-separated analyte sensor data received during the first time period upward or downward. Depending on the embodiment, the adjustment may be based on a percentage, amount, or may be based on a function of time (e.g., but not limited to, a linear function, a cubic function, an exponential function, etc.) or a function of exposure to the radiological test (e.g., but not limited to, a linear function, a cubic function, an exponential function, etc.). Additionally or alternatively, a notification (visual, audible, vibration, or any combination thereof) may be sent to the user via the remote device 120 informing the user of potential inaccuracies in the plurality of time-separated analyte sensor data received during the first time period. According to an embodiment, the analyte sensor data up to a predetermined period of time after exposure to the radiological test may be deleted or ignored. In one aspect, the predetermined period of time after exposure to the radiological test may include 1 hour, 2 hours, 3 hours, etc.

[0135] Depending on the embodiment, routines associated with determining the exposure of the sensor control device to a radiation test may be executed by the processor 166 of the sensor control device 102 , the processing core 206 of the reader device 120 , or a network device on the network 190 .

[0136] In addition to monitoring and determining temperature as described with respect to various aspects of the present disclosure, while monitoring glucose levels, a routine can be initiated to monitor and use other parameters to determine exposure to radiological testing. For example, an increase in analyte level measured by analyte sensor data during a first period of time can be used to determine exposure to radiological testing. For example, a gradient sensor and / or an accelerometer can be used to determine exposure to radiological testing. Additional description of gradient sensors and / or accelerometers for determining exposure to radiological testing is provided in U.S. Patent Publication No. 2020 / 0188678A1, filed February 24, 2020, and U.S. Patent No. 10,668,292, filed June 2, 2020, the disclosures of each of which are incorporated herein by reference.

[0137] 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 interchangeable with any other embodiment. When a certain feature, element, component, function, or step is described with respect to only one embodiment, it is to be understood that such feature, element, component, function, or step can be used with all other embodiments described herein, unless otherwise expressly stated. Accordingly, this paragraph serves as a pre-existing description and written support for the introduction of claims combining features, elements, components, functions, and steps from various embodiments or substituting features, elements, components, functions, and steps from one embodiment with another, even if the following description does not expressly state that such combinations or substitutions are possible in a particular case. Accordingly, the above description of specific embodiments of the subject matter of the present disclosure has been presented for purposes of illustration and description. It is expressly recognized that an explicit description of all possible combinations and substitutions would be unduly burdensome, especially considering that the permissibility of each and every such combination and substitution would be readily recognized by one of ordinary skill in the art.

[0138] While the embodiments are susceptible to various modifications and variations, specific examples of these embodiments have been shown in the drawings and described in detail herein. It will be apparent to those skilled in the art that various modifications and variations can be made in the methods and systems of the presently disclosed subject matter without departing from the spirit or scope of the presently disclosed subject matter. Accordingly, the presently disclosed subject matter is intended to include modifications and variations that are within the scope of the claims and their equivalents. Moreover, any feature, function, step, or element of the embodiments may be described or added to the claims, and further, negative limitations may be described or added that define the scope of the invention by any feature, function, step, or element not within the scope of the invention. [Explanation of symbols]

[0139] 100 Sample Monitor System 104 In vivo analyte sensors 105 Adhesive Patch 120 Reader Device 150 Sensor Applicator

Claims

1. receiving a plurality of analyte data over a first time period monitored by an analyte sensor below the skin surface in fluid contact with the bodily fluid, the plurality of analyte data corresponding to an analyte level; receiving a plurality of temperature data from a temperature sensor over the first time period; determining a rate of change of the plurality of temperature data over the first period of time; receiving a user input confirming exposure to a radiological examination during the first time period if the determined rate of change of the plurality of temperature data is above a predetermined threshold; adjusting the plurality of analyte data over the first time period based on the confirmed exposure to the radiological examination; A method comprising:

2. The method of claim 1 , wherein the period of time comprises one hour.

3. 10. The method of claim 1, wherein the predetermined threshold is 4 degrees Celsius over 15 minutes.

4. The method of claim 1 , wherein the user input is received through a reader device.

5. 2. The method of claim 1, wherein adjusting the plurality of analyte data comprises deleting the plurality of analyte data spanning the first time period.

6. 2. The method of claim 1, wherein adjusting the plurality of analyte data comprises ignoring the plurality of analyte data over the first time period.

7. The method of claim 1 , wherein the temperature data includes epidermal temperature data.

8. The method of claim 1 , wherein verifying exposure to the radiological examination comprises generating an alarm.

9. receiving a user input indicating a first time period corresponding to an expected exposure to a radiological examination; receiving a plurality of analyte data over the first time period monitored by an analyte sensor below the skin surface in fluid contact with the bodily fluid, the plurality of analyte data corresponding to an analyte level; receiving a plurality of temperature data from a temperature sensor relating to the skin surface over the first time period; determining a rate of change of the plurality of temperature data over the first period of time; confirming exposure to a radiological examination during the first time period if the determined rate of change of the plurality of temperature data is above a predetermined threshold; adjusting the plurality of analyte data over the first time period based on the confirmed exposure to the radiological examination; A method comprising:

10. 10. The method of claim 9, wherein the first period of time comprises one hour.

11. 10. The method of claim 9, wherein the predetermined threshold is 4 degrees Celsius over 15 minutes.

12. The method of claim 9 , wherein the user input is received through a reader device.

13. 10. The method of claim 9, wherein adjusting the plurality of analyte data comprises deleting the plurality of analyte data spanning the first time period.

14. 10. The method of claim 9, wherein adjusting the plurality of analyte data comprises ignoring the plurality of analyte data over the first time period.

15. The method of claim 9 , wherein the temperature data includes epidermal temperature data.

16. 10. The method of claim 9, wherein verifying exposure to the radiological examination comprises generating an alarm.

17. 10. The method of claim 9, wherein the temperature data received from the temperature sensor is at least one of epidermal temperature, ambient temperature, subcutaneous temperature, sensor tip temperature, core temperature, and a temperature inside a sensor control device of the analyte sensor.

18. The method of claim 8 , wherein the alarm is at least one of an audible alarm, a visual alarm, and a tactile alarm.

19. The method of claim 1 , wherein the temperature data received from the temperature sensor is at least one of a skin temperature, an ambient temperature, a subcutaneous temperature, a sensor tip temperature, and a body temperature.

20. 1. A specimen monitor system comprising: an analyte sensor configured to generate data indicative of an analyte level; a temperature sensor configured to generate temperature data; one or more processors operably coupled to the analyte sensor and the temperature sensor, the one or more processors operably coupled to a memory storing instructions that, when executed, perform: receiving a plurality of analyte data over a first time period from the analyte sensor, the plurality of analyte data corresponding to an analyte level; receiving a plurality of temperature data from the temperature sensor over the first time period; determining a rate of change of the plurality of temperature data over the first period of time; receiving a user input confirming exposure to a radiological examination during the first time period if the determined rate of change of the plurality of temperature data is above a predetermined threshold; adjusting the plurality of analyte data over the first time period based on the confirmed exposure to the radiological examination; The analyte monitor system causes the processor to execute a method including:

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