Systems, devices, and methods for analyte monitoring

Abstract

Various embodiments of sensor attacher assemblies for delivering a sensor control unit are disclosed herein, and the embodiments include features for extending the life of the sensor attacher or sensor control unit and reducing susceptibility to mechanical failure of certain components. Some embodiments include, for example, pull tabs coupled to the sensor or battery, an adhesive backing for the sensor control unit, one or more magnets for holding the sensor control unit within the sensor carrier, and a leaf spring retraction mechanism.

Description

Related Applications

[0001] This application claims priority to U.S. Provisional Patent Application No. 63 / 222,851, filed July 16, 2021, which is incorporated herein by reference in its entirety. [Technical field]

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

[0003] Detection and / or monitoring of analyte levels, such as glucose, ketones, lactate, oxygen, hemoglobin AIC, etc., can be critical to the health of individuals with diabetes. Patients with diabetes can experience complications including loss of consciousness, cardiovascular disease, retinopathy, neuropathy, and nephropathy. Diabetic patients are generally required to monitor their glucose levels to ensure they are maintained within a clinically safe range, and this information may be used to determine if and / or when insulin is needed to lower glucose levels in the body, or when additional glucose is needed to raise glucose levels in the body.

[0004] A growing body of clinical data shows a strong correlation between frequency of glucose monitoring and glycemic control. However, despite this correlation, many individuals diagnosed with the 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 compliance with frequent glucose monitoring regimens, in vivo analyte monitoring systems are available. In these systems, a sensor control device may be worn on the body of an individual needing analyte monitoring. To increase the comfort and convenience of the individual, the sensor control device has a small form factor and may be assembled and applied by the individual using a sensor attachment device. The attachment process includes inserting the sensor using an attachment device or insertion mechanism so that the sensor contacts the bodily fluid. The sensor control device may also be configured to transmit analyte data to another device where the individual or a healthcare provider (HCP) can view the data and make treatment decisions.

[0006] Current sensors may be convenient for users, but they are also prone to malfunctions and / or mechanical failures due to improper handling and / or storage of the sensor and / or attachment, user error, lack of proper training, poor user adjustments, overly complicated procedures, and other issues. This may be particularly true for analyte monitoring systems that have in-vivo analyte sensors that are used to measure analyte levels in interstitial fluid (ISF) and are inserted using a sharp object (also known as an introducer or needle). Some conventional systems may use mechanisms and features that are prone to failure or reduced effectiveness due to adverse conditions, for example. These issues and others described herein may result in improperly inserted or damaged sensors that may fail to properly monitor a patient's analyte levels. Summary of the Invention [Problem to be solved by the invention]

[0007] Thus, there is a need for more reliable sensor insertion devices and related systems and methods that are easier for patient use, less prone to error, and less prone to malfunction or mechanical failure. [Means for solving the problem]

[0008] The objectives and advantages of the disclosed subject matter will be set forth in and will be obvious from the following description, and will be learned by practice of the disclosed subject matter. Additional advantages of the disclosed subject matter will be realized and attained by the methods and systems particularly pointed out in the written description and claims thereof and illustrated in the accompanying drawings.

[0009] To achieve these and other advantages, and in accordance with the objects of the presently disclosed subject matter as embodied and broadly described, the presently disclosed subject matter is directed to an attachment for delivering a sensor control device, which may include a housing configured to transition between a first position and a second position, a barrel slidably coupled to the housing, a sharps carrier coupled to a sharps, a sensor control device including an analyte sensor coupled to sensor electronics, and a sensor carrier.

[0010] In some embodiments, the fitment may include an fitment cap threadably coupled to the housing, the fitment cap and the housing defining an interior space, the interior space containing a lightly pressurized inert gas.

[0011] According to some embodiments, the sharps carrier of the attachment may comprise one or more magnets, and the sensor control unit further comprises one or more ferromagnetic components configured to exert a magnetic force on the ferromagnetic components in a proximal direction such that the sensor control unit is retained on the sensor carrier when the housing is in the first position.

[0012] In some embodiments, the sensor control unit may include a connector assembly having a pull tab, the pull tab being comprised of an electrically insulating material and adapted to releasably engage a plurality of sensor contacts of the analyte sensor. In other embodiments, the pull tab may be coupled to a power source of the sensor control unit. According to some embodiments, the sensor control unit may further include an adhesive backing coupled to a bottom surface of the adhesive patch on the bottom surface of the sensor control unit.

[0013] In some embodiments, the attachment may further comprise a leaf spring coupled to a sharp, the sharp configured to position at least a portion of the analyte sensor below the skin surface when the housing is moved to the second position, and the leaf spring configured to retract the sharp into the attachment after the housing is moved to the second position.

[0014] Other systems, devices, methods, features, and advantages of the subject matter described herein will become apparent to one of ordinary skill in the art upon examination of the following figures and detailed description. All such additional systems, devices, methods, features, and advantages are intended to be included within the description, be within the scope of the subject matter described herein, and be protected by the appended claims. These features of the embodiments should not be construed as limiting the appended claims in any way, unless there is an express recitation of the features in the claims. [Brief description of the drawings]

[0015] Details regarding both the structure and operation of the subject matter set forth herein may be apparent from a consideration of the accompanying drawings, in which like numerals refer to like parts. The parts in the drawings are not necessarily to scale, with emphasis instead being placed on illustrating the principles of the subject matter. Additionally, all figures are intended to convey concepts, and relative sizes, shapes, and other detailed attributes may be illustrated diagrammatically, but not precisely or precisely. [Figure 1] FIG. 1 is a system schematic diagram of a sensor mount, a reader, a monitoring system, a network, and a remote system. [Figure 2A] FIG. 2 is a block diagram illustrating an embodiment of a reading device. [Figure 2B] FIG. 2 is a block diagram illustrating an embodiment of a sensor control device. [Figure 2C] FIG. 2 is a block diagram illustrating an embodiment of a sensor control device. [Figure 3A] 1A-1D are step-by-step views of an embodiment of an assembly and installation of an in-vivo analyte monitoring system having a two-piece configuration. [Figure 3B]1A-1D are step-by-step views of an embodiment of an assembly and installation of an in-vivo analyte monitoring system having a two-piece configuration. [Figure 3C] 1A-1D are step-by-step views of an embodiment of an assembly and installation of an in-vivo analyte monitoring system having a two-piece configuration. [Figure 3D] 1A-1D are step-by-step views of an embodiment of an assembly and installation of an in-vivo analyte monitoring system having a two-piece configuration. [Figure 3E] 1A-1D are step-by-step views of an embodiment of an assembly and installation of an in-vivo analyte monitoring system having a two-piece configuration. [Figure 3F] 1A-1D are step-by-step views of an embodiment of an assembly and installation of an in-vivo analyte monitoring system having a two-piece configuration. [Figure 3G] 1A-1D are step-by-step views of an embodiment of an assembly and installation of an in-vivo analyte monitoring system having a two-piece configuration. [Figure 4A] 1 is a side view depicting an embodiment of a mounting device coupled with a cap. [Figure 4B] FIG. 13 is a side perspective view depicting an embodiment of an attachment device and a cap removed. [Figure 4C] 1 is a perspective view illustrating an embodiment of a distal end of a mounting device and an electronic circuit housing. [Figure 4D] FIG. 1 is a top perspective view of an exemplary mounting device in accordance with the subject matter of the present disclosure. [Figure 4E] FIG. 4E is a bottom perspective view of the mounting device of FIG. 4D. [Figure 4F] FIG. 4E is an exploded view of the mounting device of FIG. 4D. [Figure 4G] FIG. 4E is a side cross-sectional view of the mounting device of FIG. 4D. [Figure 5A] FIG. 2 is a base perspective view illustrating an embodiment of a sensor carrier. [Figure 5B] FIG. 2 is an end perspective view illustrating an embodiment of a sensor carrier. [Figure 5C] FIG. 2 is a top perspective view of a sensor carrier according to the subject matter of the present disclosure. [Figure 5D] FIG. 5D is a bottom view of the sensor carrier of FIG. 5C. [Figure 6A] FIG. 1 is a perspective view of a sharps carrier in accordance with the subject matter of the present disclosure. [Figure 6B] FIG. 6B is a side cross-sectional view of the sharps carrier of FIG. 6A. [Figure 6C] FIG. 1 is a perspective view of a sharps carrier in accordance with the subject matter of the present disclosure. [Figure 6D] FIG. 6D is a side cross-sectional view of the sharps carrier of FIG. 6C. [Figure 7] FIG. 1 is a side view of an exemplary sensor in accordance with one or more embodiments of the present disclosure. [Figure 8A] FIG. 1 illustrates a perspective view of an example connector assembly according to one or more embodiments. [Figure 8B] FIG. 1 is a partial exploded perspective view of an example connector assembly according to one or more embodiments. [Figure 8C] FIG. 8C is a bottom perspective view of the connector of FIGS. 8A and 8B. [Figure 8D] FIG. 1 is a perspective view of another example connector assembly according to one or more embodiments. [Figure 8E] FIG. 13 is a partial exploded perspective view of another example connector assembly according to one or more embodiments. [Figure 8F] FIG. 8D and 8E are bottom perspective views of the connector. [Figure 9A] FIG. 2 is a side view of an example sensor control device in accordance with one or more embodiments of the present disclosure. [Figure 9B] FIG. 1 is a perspective view of an example sensor control device in accordance with one or more embodiments of the present disclosure. [Figure 10A] 1 shows a cross-sectional view depicting an embodiment of an attachment in stage 1 of delivery. [Figure 10B] 1 shows a cross-sectional view depicting an embodiment of an attachment at stage 2 of delivery. [Figure 10C] 13 shows a cross-sectional view depicting an embodiment of an attachment at stage 3 of delivery. [Figure 10D] 13 shows a cross-sectional view depicting an embodiment of an attachment at stage 4 of delivery. [Figure 10E] 13 shows a cross-sectional view depicting an embodiment of an attachment at stage 5 of delivery. [Figure 11A] FIG. 1 is a side view of a leaf spring and sharp assembly in accordance with one or more embodiments of the present disclosure. [Figure 11B]FIG. 1 is a side view of a leaf spring and sharp assembly in accordance with one or more embodiments of the present disclosure. [Figure 11C] FIG. 1 is a side view of a leaf spring and sharp assembly in accordance with one or more embodiments of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0016] Before describing the present subject matter in detail, it is to be understood that the present disclosure is not limited to particular embodiments described, as such may, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting. The scope of the present disclosure is limited only by the appended claims.

[0017] As used herein and in the appended claims, the English singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise.

[0018] The disclosures discussed herein are provided solely for their disclosure prior to the filing date of the present application. The disclosure should not be construed as an admission that the invention is not entitled to antedate such publication by prior disclosure. Additionally, the publication dates provided may be different from the actual publication dates, which need to be independently confirmed.

[0019] Generally, embodiments of the present disclosure include systems, devices, and methods for the use of an analyte sensor insertion attachment for use with an in vivo analyte monitoring system. The attachment may be provided to a user in a sterile package that contains the electronics housing of the sensor control unit. According to some embodiments, a structure separate from the attachment, such as a container, may also be provided to a user in a sterile package that contains the sensor module and the sharps module. The user may couple the sharps to the attachment through an assembly process that includes coupling the sensor module to the electronics housing and inserting the attachment into the container in a specified manner. In other embodiments, the attachment, sensor control unit, sensor module, and sharps module may be provided in a single package. The attachment may be used to attach the sensor control unit to a human body and contact the sensor with the wearer's bodily fluids. Some embodiments provided herein are improvements that maintain the sterility of the attachment, sensor control unit, and / or analyte sensor during storage. Some embodiments provided herein reduce the susceptibility of the attachment, sensor control unit, and / or analyte sensor to malfunction and mechanical failure. Other improvements and advantages are also provided. Various configurations of these devices are described in detail as exemplary embodiments only.

[0020] Many embodiments also include in vivo analyte sensors that are structurally configured such that at least a portion of the sensor is or can be placed within a user's body to obtain information about at least one analyte in the body. However, it should be noted that the embodiments disclosed herein may be used with in vivo analyte monitoring systems that have in vitro capabilities as well as purely in vitro or ex vivo analyte monitoring systems (including completely non-invasive systems).

[0021] Also, for each and every embodiment of the methods disclosed herein, systems and devices capable of carrying out each of these embodiments are within the scope of the present disclosure. For example, sensor control device embodiments are disclosed, which may include one or more sensors, analyte monitoring circuitry (e.g., analog circuitry), memory (e.g., for storing instructions), power source, communication circuitry, transmitter, receiver, processor and / or controller (e.g., for executing instructions) that may perform or enable any and all method steps. These sensor control device embodiments may be used and be operable to perform steps carried out by the sensor control device in any and all of the methods described herein. As mentioned above, multiple embodiments of systems, devices, and methods are described herein that allow for improved sensor insertion devices and sensor control devices for use with in vivo analyte monitoring systems. In particular, some embodiments of the present disclosure are configured to extend the life and reduce susceptibility to mechanical failure of certain components of the sensor attachment device. Some embodiments include, for example, a pull tab made of an electrically insulating material coupled to one or more of the sensor contacts, the power source, or another component of the sensor electronics. In some embodiments, the pull tab may be configured to prevent electrical coupling between the sensor control device's power supply and the sensor electronics, thereby protecting the sensor control device's power supply during storage or shipping. In another embodiment, a leaf spring retraction mechanism is provided in the sensor mount to reduce the number of sensor mounting device parts susceptible to mechanical failure. In yet another embodiment, multiple magnetic elements are used to retain the sensor control device within the sensor carrier of the mount to reduce the number of sensor mounting device parts susceptible to mechanical failure. Thus, these embodiments may improve the life and functionality of the sensor mounting device and the sensor control device.

[0022] However, before describing these aspects of the embodiments in detail, it is desirable to first describe examples of devices that may be present in an in-vivo analyte monitoring system and their operation, all of which may be used in conjunction with the embodiments described herein.

[0023] There are various types of in vivo analyte monitoring systems. For example, a continuous analyte monitoring system (or continuous glucose monitoring system) may transmit data from a sensor controller to a reader device automatically and unprompted continuously, such as according to a schedule. As another example, a flash analyte monitoring system (or flash glucose monitoring system or simply flash system) may transfer data from the sensor controller in response to a scan or data request by the reader device, such as using near field communication (NFC) or radio frequency identification (RFID) protocols. In vivo analyte monitoring systems may also operate without the need for finger stick calibration.

[0024] In vivo analyte monitoring systems can be distinguished from ex vivo systems, which contact a biological sample outside the body and typically include a meter having a port for receiving an analyte test strip that contains a user's bodily fluid that can be analyzed to determine the user's blood glucose level.

[0025] In vivo monitoring systems can be distinguished from ex vivo systems, which contact a biological sample outside the body and typically include a meter having a port for receiving a specimen test strip carrying a user's bodily fluid that can be analyzed to determine the user's blood glucose level.

[0026] An in-vivo monitoring system may include a sensor located within the body that contacts the bodily fluid of the user and detects the analyte level therein. The sensor may be part of a sensor control device attached to the user's body that contains electronic circuitry and a power source to enable and control analyte detection. The sensor control device and variations thereof may also be referred to as a "sensor control unit," "body-attached electronics" device or unit, "body-attached" device or unit, or "sensor data communication" device or unit, etc.

[0027] In-vivo monitoring systems may also include devices that receive, process, and / or display the sensed analyte data from the sensor control device to a user in any number of formats. This device and variations thereof may be referred to as a "handheld reader," "reader" (or simply "reader," "handheld electronic device" (or simply "handheld"), "portable data processing" device or unit, "data receiver," "receiving" device or unit (or simply "receiver"), or "remote" device or unit, etc. Other devices, such as personal computers, have also been utilized with or incorporated into in-vivo and in-vitro monitoring systems.

[0028] Representative in vivo specimen monitoring systems FIG. 1 is a conceptual diagram illustrating an embodiment of an analyte monitoring system 100, which includes a sensor attachment device 150, a sensor control device 102, and a reader device 120. The sensor attachment device 150 may be used to deliver the sensor control device 102 to a monitoring location on the skin of a user. The sensor 104 is maintained in place for a period of time by an adhesive patch 105. The sensor control device 102 is further illustrated in FIGS. 2B and 2C and may communicate with the reader device 120 via a communication path 140 using wired or wireless technology. Exemplary wireless protocols include Bluetooth, Bluetooth low energy (BLE, BTLE, Bluetooth SMART, etc.), Near Field Communication (NFC), etc. A user may monitor applications installed in the memory of the reader device 120 using a screen 122 and an input 121, and the device battery may be recharged using a power port 123. The reader device 120 may communicate with a local computer system 170 via a communication path 141 using wired or wireless technology. The local computer system 170 may 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 may include any applicable wireless network protocol including Bluetooth, Bluetooth Low Energy (BTLE), Wi-Fi, etc. As previously described, the local computer system 170 may communicate with the network 190 via communication path 143 in the same manner that the reader device 120 may communicate with the network 190 via communication path 142 using wired or wireless technology. The network 190 may be any network, such as a private network, a public network, a local area network, or a wide area network. The trusted computer system 180 may include a server, providing authentication services and secure data storage, and may communicate with the network 190 via communication path 144 using wired or wireless technology.

[0029] Representative reading device 2A is a block diagram illustrating an embodiment of a reading device configured as a smartphone, where the reading device 120 may include a display 122, an input component 121, and a processing core 206 including a communication processor 222 coupled to a memory 223 and an application processor 224 coupled to a memory 225. It may also include another memory 230, an RF transceiver 228 having an antenna 229, and a power source 226 having a power management module 238. It may further include a multi-function transceiver 232 capable of communicating via Wi-Fi, NFC, Bluetooth, BTLE, and GPS using an antenna 234. As one skilled in the art will appreciate, these components are electrically and communicatively coupled to form a functional device.

[0030] Representative sensor control devices 2B and 2C are block diagrams illustrating an embodiment of a sensor controller 102 having an analyte sensor 104 and sensor electronics 160 (including analyte monitoring circuitry). The sensor controller may have most of the processing power to make the final result data suitable for display to a user. FIG. 2B illustrates a single semiconductor chip 161, which may be a custom application specific integrated circuit (ASIC). Certain high level functional units are shown within the ASIC 161, 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 a transmitter, receiver, transceiver, passive circuitry, etc., depending on the communication protocol). In this embodiment, both the AFE 162 and the processor 166 are used as analyte monitoring circuitry, although in other embodiments, either circuitry may perform the analyte monitoring function. The processor 166 may include one or more processors, microprocessors, controllers, and / or microcontrollers (each of which may be distributed across (and be part of) separate chips or multiple different chips).

[0031] The memory 163 may also be included in the ASIC 161, shared by the various functional units present in the ASIC 161, or distributed among two or more of them. The memory 163 may also 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 173, which may be a coin cell or the like. The AFE 162 interfaces with and receives measurement data from the in vivo analyte sensor 104 and outputs the data in digital form to the processor 166, which processes the data to obtain final result glucose individual values ​​and trend values, etc. This data may be provided to the communication circuitry 168 for transmission via the antenna 171 to the reader 120 (not shown), where resident software applications require minimal additional processing to display the data.

[0032] FIG. 2C is similar to FIG. 2B, but instead includes two separate semiconductor chips 162 and 174, which may be packaged together or separately. AFE 162 resides in 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 separate or distributed. In one embodiment, AFE 162 is combined with power management circuitry 164 and processor 166 on one chip, and communication circuitry 168 is on another chip. In another embodiment, both AFE 162 and communication circuitry 168 are on one chip, and processor 166 and power management circuitry 164 are on another chip. Note that other chip combinations are possible, including three or more chips, each performing a different function or sharing one or more functions for fail-safe redundancy.

[0033] Typical Assembly Process for Sensor Control Units The components of the sensor control unit 102 may be acquired by the user in multiple packages, requiring final assembly by the user prior to delivery to the appropriate user location. Figures 3A-3D depict an embodiment of a process for a user to assemble the sensor control unit 102, including preparing the components prior to joining the separate components together so that the sensor can be delivered. Figures 3E and 3F depict an embodiment of delivery of the sensor control unit 102 to an appropriate user location by selecting an appropriate delivery location and mounting the sensor control unit 102 to that location.

[0034] 3A is a bottom perspective view depicting an embodiment in which a user prepares a container 810, here configured as a tray (although other packaging can be used), for an assembly process. A user may accomplish this preparation by, for example, removing the lid 812 from the tray 810 by peeling an unattached portion of the lid 812 from the tray 810 and removing an attached portion of the lid 812 to expose the platform 808. In various embodiments, removal of the lid 812 may be adequate as long as the platform 808 is properly exposed within the tray 810. The lid 812 may then be set aside.

[0035] 3B is a side view depicting an embodiment in which a user prepares the attachment 150 for assembly. The attachment 150 may be provided in a sterile package sealed with a cap 708. Preparing the attachment 150 may include removing the housing 702 from the cap 708 to expose the barrel 704 (FIG. 3C). This preparation may be accomplished by unscrewing the cap 708 from the housing 702. The cap 708 may then be set aside.

[0036] 3C is a base perspective view depicting an embodiment in which a user inserts the attachment 150 into the tray 810 during assembly. First, a user can insert the tube 704 into the platform 808 in the tray 810 after aligning the housing orientation feature 1302 (slot or recess) with the tray orientation feature 924 (platform or detent). Inserting the tube 704 into the platform 808 temporarily unlocks the tube 704 relative to the housing 702 and also temporarily unlocks the platform 808 relative to the tray 810. At this stage, removal of the attachment 150 from the tray 810 results in the same condition as before the initial insertion of the attachment 150 into the tray 810 (i.e., the process can be reversed or stopped at this point and then repeated).

[0037] The housing 702 is advanced distally to engage the platform 808, allowing the barrel 704 to maintain its position relative to the housing 702 within the platform 808 while the platform 808 is advanced distally relative to the tray 810. This step unlocks the platform 808 and collapses the platform 808 within the tray 810. The barrel 704 contacts and disengages a locking feature (not shown) within the tray 810, unlocking the barrel 704 relative to the housing 702 and preventing it from moving (relatively) while the housing 702 advances the platform 808 distally. At the end of the travel of the housing 702 and platform 808, the barrel 704 is permanently unlocked relative to the housing 702. At the end of the distal travel of the housing 702, the sharps and sensors (not shown) within the tray 810 may be coupled to an electronics housing (not shown) within the housing 702. The operation and interaction of the attachment 150 and tray 810 are described further below.

[0038] 3D is a proximal perspective view depicting an embodiment in which a user removes the attachment 150 from the tray 810 during assembly. The user can remove the attachment 150 from the tray 810 by advancing the housing 702 proximally relative to the tray 810, or by other movements that have the same effect of disengaging the attachment 150 and tray 810 from one another. The attachment 150 is removed with the sensor control unit 102 (sharps, sensors, electronics) (not shown) fully assembled and ready for delivery therein.

[0039] 3E is a proximal perspective view depicting an embodiment in which a patient attaches the sensor control unit 102 to a target area of ​​skin, such as the abdomen, or other suitable location, using the attachment device 150. Distal advancement of the housing 702 collapses the barrel 704 within the housing 702, allowing the adhesive layer on the bottom of the sensor control unit 102 to adhere to the skin and attach the sensor to the target location. When the housing 702 is fully advanced, the sharp is automatically retracted, leaving the sensor (not shown) in place to measure the analyte level.

[0040] 3F is a proximal perspective view depicting an embodiment of a patient with the sensor control unit 102 attached to the mounting location. The user can then remove the mount 150 from the mounting location.

[0041] 3A-3F and elsewhere herein may reduce or eliminate the possibility of accidental damage, permanent deformation, or improper assembly of attachment components compared to conventional systems. Because attachment housing 702 directly engages platform 808 when barrel 704 is unlocked, rather than indirect engagement via barrel 704, the relative angle between barrel 704 and housing 702 does not cause damage or permanent deformation of arms or other components. The possibility of relatively high forces during assembly (as in conventional devices) is reduced, reducing the possibility of failed user assembly.

[0042] Representative sensor mounting device Figure 4A is a side view depicting an embodiment of the attachment 150 coupled with a screw cap 708. This is an example of how the attachment 150 is shipped and received by a user prior to assembly with a sensor by the user. Figure 4B is a side perspective view depicting the attachment 150 and cap 708 after they have been separated. Figure 4C is a perspective view depicting an embodiment of the distal end of the attachment 150 with the electronics housing 706 and adhesive patch 105 removed from their positions within the sensor carrier 710 of the barrel 704 with the cap 708 attached.

[0043] 4D-4G, by way of example and not limitation, the attachment 20150 may be provided to a user as a single integrated assembly. Figures 4D and 4E provide top and bottom perspective views of the attachment 20150, Figure 4F provides an exploded view of the attachment 20150, and Figure 4G provides a cross-sectional side view. The perspective views illustrate the attachment 20150 as it is shipped and received by a user. The exploded and cross-sectional views illustrate the components of the attachment 20150. The attachment 20150 can include a housing 20702, a gasket 20701, a barrel 20704, a sharps carrier 201102, a spring 205612, a sensor carrier 20710 (also called a puck carrier), a sharps hub 205014, a sensor control unit (also called a puck) 20102, an adhesive patch 20105, a desiccant 20502, a cap 20708, a serial label 20709, and a tamper evident feature 20712. When received by a user, only the housing 20702, the cap 20708, the tamper evident feature 20712, and the label 20709 are visible. The tamper evident feature 20712 can be, for example, a sticker coupled to each of the housing 20702 and cap 20708, and can be, for example, irreparably damaged by removing the housing 20702 and cap 20708 from one another, thereby indicating to a user that the housing 20702 and cap 20708 have previously been removed. These features are described in more detail below.

[0044] 4G, in some embodiments, the interior of the housing 20702 and cap 20708 may be lightly pressurized with an inert gas during assembly. According to one aspect of some embodiments, flooding the interior of the housing 20702 and cap 20708 with an inert, dry gas (e.g., nitrogen or argon) during assembly may be used instead of or in addition to a desiccant. According to another aspect of some embodiments, lightly pressurizing the interior of the housing 20702 and cap 20708 with an inert gas may also direct the flow of material outward across the seal formed by the housing 20702 and cap 20708, reducing the possibility of ingress of undesirable contaminants. Also, as an added benefit of some embodiments, a slight release of gas pressure from the fitting may be audible when the user removes the cap 20708, indicating to the user that the seal has not been compromised during shipping and / or storage.

[0045] According to another aspect of some embodiments, the inert gas may be introduced into the housing 20702 using a temperature controlled closed system (not shown). First, one or more fittings 20150 may be placed into the closed system when the closed system is at a first predetermined temperature. In some embodiments, the closed system may already be filled with the inert gas before the fittings 20150 are placed therein. In other embodiments, the closed system may be filled with the inert gas after the fittings 20150 are placed therein. The closed system is sealed to prevent the inert gas from escaping and to prevent outside gas from entering. According to one aspect of some embodiments, when the closed system is maintained at the first predetermined temperature, the fitting housing 20702 and the cap 20708 form a seal as described above. The closed system is then heated to a second predetermined temperature that is higher than the first predetermined temperature. According to one aspect of some embodiments, at the second predetermined temperature, the thermal expansion of the cap 20708 for each of the one or more fittings 20150 can be different (e.g., greater or less) than the thermal expansion of the housing 20702, and the seal of each fitting 20150 can be broken. As a result, when the fittings 20150 are in a broken seal state, the inert gas can diffuse into the interior of each housing 20702. After a predetermined amount of time sufficient to allow the inert gas to diffuse into each housing 20702 has elapsed, the temperature of the closed system can be reduced to a lower temperature. In some embodiments, this lower temperature can be the first predetermined temperature. In other embodiments, this lower temperature can be a third predetermined temperature different from the first predetermined temperature and lower than the second predetermined temperature. At this lower temperature, the cap 20708 can shrink and the seal with the housing 20702 can be reformed. Finally, the one or more fittings can be removed from the closed system.

[0046] Representative sensor carriers FIG. 5A is a proximal perspective view illustrating an embodiment of a sensor carrier 710 capable of holding a sensor control device within the mount 150. The sensor carrier can also hold a sharps carrier 2102 having a sharps module 2500. In this embodiment, the sensor carrier 710 has a generally hollow round flattened cylindrical shape and can include one or more (e.g., three) bendable sharps carrier locking arms 1524 extending proximally from a proximal surface surrounding a centrally located spring alignment ridge 1516 for maintaining alignment of the spring 1104. Each locking arm 1524 has a detent or retention feature 1526 located at or near a proximal end. The impact lock 1534 is an outwardly extending tab located on the periphery of the sensor carrier 710 that can lock the sensor carrier 710 for added safety prior to firing. The rotation limiter 1506 can be a relatively short protruding proximally extending protrusion on the proximal surface of the sensor carrier 710 to limit rotation of the carrier 710. The sharps carrier locking arm 1524 may connect to a sharps carrier 2102, described below with reference to Figures 6A-6E.

[0047] 5B is an end perspective view of the sensor carrier 710, where one or more (e.g., three) sensor electronics retaining spring arms 1518 are generally biased toward the position shown and include detents 1519 that may cross a distal surface of the electronics housing 706 of the device 102 when seated within the recess or cavity 1521. In one embodiment, after the sensor control unit 102 is attached to the skin with the attacher 150, the user pulls the attacher 150 proximally, i.e., away from the skin. The adhesive forces hold the sensor control unit 102 on the skin and overcome the lateral force applied by the spring arms 1518. As a result, the spring arms 1518 bend radially outward, disengaging the detents 1519 from the sensor control unit 102, thereby releasing the sensor control unit 102 from the attacher 150.

[0048] 5C and 5D, for purposes of illustration and not limitation, an exemplary sensor carrier 20710 is provided. The sensor carrier 20710 may include one or more of the features described herein with respect to the sensor carrier, and similar features may operate as described herein. For example, the sensor carrier 20710 may include a base 20710A and first and second retaining arms 20710B. Each retaining arm 20710B may include a first end 20710C coupled to the base 20710A and a free end 20710D. For example, each retaining arm 20710B may be coupled to the base 20710A at a first half of the base 20710A, and the free end 20710D may extend toward a second half of the base 20710A. Each retaining arm 20710B may include a sensor retaining feature 20710E disposed on an inner surface of the sensor retaining arm 20710B. The sensor retaining feature 20710E may be disposed on the free end 20710D. The sensor retaining feature 20710E may be configured to retain the sensor control unit 20102 within the housing 20702. The retaining feature 20710E may include a conical surface and a beveled parting line, which may allow for release of the sensor control unit 20102 after delivery. Each retaining arm 20710B may include a locking portion 20710F disposed on an outer surface of the retaining arm 20710B. The locking portion 20710F may engage with a rib 20704U of the barrel 20704. As described above, the rib 20704U may prevent the sensor retaining arm 20710B from bending outward, for example, upon impact, and may keep the retaining feature 20710E engaged with the sensor control unit 20102, preventing movement of the sensor control unit 20102 upon impact.

[0049] In some embodiments, the sensor control device (e.g., 102 or 20102) may be held to the sensor carrier (e.g., 710 or 20710) by one or more magnets (not shown) disposed on the sharps carrier. According to one aspect of some embodiments, as further described below with respect to Figures 6A-6D, the one or more magnets disposed on the sharps carrier may be configured to attract one or more ferromagnetic components disposed on the sensor control device (e.g., 102 or 20102), thus holding the sensor control device (e.g., 102 or 20102) to the sensor carrier (e.g., 710 or 20710). In some embodiments, the one or more ferromagnetic components may be disposed within a housing of the sensor control device (e.g., 102 or 20102). In some embodiments, one or more magnets may be used in addition to or instead of one or more sensor electronics retaining spring arms 1518 and corresponding detents 1519 (FIGS. 5A, 5B) of sensor carrier 710 or retaining arms 20710B and corresponding sensor retaining features 20710E (FIGS. 5C, 5D) of sensor carrier 20710. In certain embodiments, it may be desirable to use one or more magnets without the spring arms 1518, detents 1519, retaining arms 20710B, and sensor retaining features 20710E (because such structural features may be susceptible to adverse conditions over time during storage or use that may cause, for example, material creep).

[0050] In other embodiments, the sensor control device (e.g., 102 or 20102) may be held to the sensor carrier (e.g., 710 or 20710) by one or more magnets disposed on the sensor carrier itself. According to one aspect of some embodiments, one advantage of disposing one or more magnets on the sensor carrier (e.g., 710 or 20710) is the proximity of the one or more magnets to the sensor control device (e.g., 102 or 20102). As a result, in some embodiments, the one or more magnets on the sensor carrier may be configured to directly engage at least a portion (e.g., a top portion) of the sensor control device, so that less magnetic force may be required. Also, according to another aspect of some embodiments, the adhesive patch may be configured such that the adhesive force is greater than the magnetic force between the one or more magnets and the sensor control device. Thus, after the sensor control device reaches an end position and the adhesive patch is coupled to the skin, the sensor control device may be released from the sensor carrier when the user pulls the attachment away from the skin.

[0051] 5C and 5D, the sensor carrier 20710 may include multiple housing mounting features 20710F1. In some embodiments, for example, the sensor carrier 20710 may include three housing mounting features 20710F1. In other embodiments, the sensor carrier 20710 may include two, four, five, six, or more housing mounting features 20710F1. The housing mounting features 20710F1 may be equally spaced on the sensor carrier 20710 and extend upward from a top surface of the sensor carrier 20710. Each sensor housing mounting feature 20710F1 may include a housing snap 20710G, a housing positioning feature 20710H, a biasing feature 20710I, and a housing stop 20710J. The housing positioning feature 20710H may axially position the sensor carrier 20710 relative to the housing 20702 when the sensor carrier 20710 and the housing 20702 are coupled. The housing snaps 20710G may engage with sensor carrier attachment slots 20702K of the housing 20702 to couple the sensor carrier 20710 to the housing 20702. The biasing features 20710I may engage with sensor carrier biasing features 20702M of the housing 20702 configured to remove slop between the sensor carrier 20710 and the housing 20702.

[0052] The sensor carrier 20710 may further comprise a plurality of, for example, three, sharps carrier locking arms 20710K. The sharps carrier locking arms 20710K may be equally spaced on the sensor carrier 20710 and may extend upwardly from a top surface of the sensor carrier 20710. Each sharps carrier locking arm 20710K may comprise a sharps carrier retaining feature 20710L and a rib 20710M. The rib 20710M may engage with an inner surface of the barrel 20704 biasing the sharps carrier locking arms 20710K inwardly causing the sharps carrier retaining features 20710L to retain the sharps carrier 201102 (described in more detail below). The carrier retaining features 20710L are triangular in side view and U-shaped in top view.

[0053] According to the disclosed subject matter, the sensor carrier 20710 may include a plurality of locking ledges 20710N configured to engage the locking arm interface 20704M of the barrel 20704 described above. For example, the sensor carrier 20710 may include two locking ledges 20710N. The sensor carrier 20710 may include a recess 20710O adjacent each locking ledge 20710N and configured to receive the locking arm interface 20704M upon firing and prevent the locking arm 20704J from engaging the housing 20702. The sensor carrier 20710 may include a hole 20710P through the center of the base 20710A. The hole 20710P may guide and limit the movement of the sharps hub 205014 upon insertion. Additionally or alternatively, the sensor carrier 20710 may include a spring positioning 20710Q.

[0054] The bottom surface of the sensor carrier 20710 may include stiffening ribs 20710R and sensor positioning ribs 20710S that may limit planar movement of the sensor control unit 20102 relative to the sensor carrier 20710. The bottom surface of the sensor carrier 20710 may include a sensor support surface 20710T configured to support the sensor control unit 20102.

[0055] Representative sharps carriers 6A and 6B are base perspective and side cross-sectional views, respectively, depicting an embodiment of the sharps carrier 2102. The sharps carrier 2102 can grip and hold the sharps module 2500 within the attachment 150. The sharps carrier 2102 can also automatically retract upon insertion by one or more springs being loaded and changing from a compressed state to an extended state (described with respect to FIGS. 10A-10E). There can be an anti-rotation slot 1608 near the distal end of the sharps carrier 2102 that prevents the sharps carrier 2102 from rotating when positioned within the central region of the sharps carrier locking arm 1524 (shown in FIG. 9A). The anti-rotation slot 1608 can be located between portions of the sharps carrier base chamfer 1610 and can ensure full retraction of the sharps carrier 2102 through the barrel 704 after retraction of the sharps carrier 2102 at the end of the deployment procedure.

[0056] 6B, the sharps retaining arms 1618 are positioned within the sharps carrier 2102 about a central axis and may include a sharps retaining clip 1620 at the end of each arm 1618. The sharps retaining clips 1620 may have a base surface approximately perpendicular to the central axis that may abut a distally facing surface of the sharps hub 2516.

[0057] 6C and 6D, for purposes of illustration and not limitation, an exemplary sharps carrier 201102 is provided. The sharps carrier 201102 may include one or more features described herein with respect to the sharps carrier, and similar features may operate as described herein. For example, the sharps carrier 201102 may include a series of features for engaging with the three sharps carrier locking arms 20710K of the sensor carrier 20710. These features may include a front partially retracting retaining surface 201102A and a rear partially retracting retaining surface 201102B. The front partially retracting retaining surface 201102A may engage the sharps carrier retaining feature 20710L prior to partial retraction, for example, during shipping and storage. The rear partially retracting retaining surface 201102B may engage the sharps carrier retaining feature 20710L after partial retraction. For example, when the barrel 20704 initially moves proximally relative to the sensor carrier 20710, the rib 20710M of the retention arm 20710L may engage the slot 20704Q of the barrel 20704, which may allow the retention arm 20710L to move radially outwardly and allow the sharp carrier retention feature 20710L to move past the front portion retracting retention surface 201102A and engage the rear portion retracting retention surface 201102B. The height between the end of the front portion retracting retention surface 201102A and the beginning of the rear portion retracting retention surface 201102B may be the distance of the partial retraction. The running surface 201102C may be positioned below the rear portion retracting retention surface 201102B and may slide relative to the retracting retention arm 20710L as the sharp carrier 201102 retracts. The alignment wall 201102D may help keep the sharps carrier 201102 aligned with the sensor carrier 20704 during partial retraction. The sharps carrier 201102 may have a chamfer 201102F which may have an anti-rotation slot 201102E that engages with the retention arm 20710L of the sensor carrier 20710.

[0058] The sharp carrier 201102 may include a sharp retention arm 201102G having an internal lead-in surface 201102I and a sharp hub contact surface 201102H. The retention arm 201102G may receive and retain the sharp hub 205014. The spring stop 201102J may engage the retraction spring 205612.

[0059] 6D, according to some embodiments, the sharps carrier 201102 may also include one or more magnets 201102K for holding the sensor control device to the sensor carrier (e.g., 710 or 20710 in FIGS. 5A-5D). By way of example, the sharps carrier 201102 may include one or more magnets 201102K disposed on a distal-facing surface of the sharps carrier 201102. According to one aspect of some embodiments, the one or more magnets 201102K may be configured to attract one or more ferromagnetic components disposed on the sensor control device, which may hold the sensor control device to the sensor carrier when the sharps carrier 201102 and the sensor carrier are in close proximity to one another. More specifically, when the sharp body carrier 201102K and the sensor carrier are coupled as depicted in Figures 10A-10C, the one or more magnets 201102K are configured to generate a magnetic field of sufficient strength to exert an attractive force in a proximal direction on ferromagnetic components disposed on the sensor control device, thereby holding the sensor control device to the sensor carrier.

[0060] According to another aspect of some embodiments, as shown in FIGURE 10E, the expansion of the return spring upon retraction of the sharps displaces the sharps carrier 201102 proximally away from the sensor carrier. As the sharps carrier 201102 moves further away from the sensor carrier, the one or more magnets 201102K no longer exert sufficient magnetic force to hold the sensor control unit to the sensor carrier. The sensor control unit may then move away from the sensor carrier.

[0061] According to some embodiments, one or more magnets 201102K may be embedded in the end of the sharp carrier 201102 such that the end-facing surface is flush against the sensor carrier. In some embodiments, the one or more magnets 201102K may consist of a single magnetic element or multiple discrete magnetic elements. For example, in some embodiments, the one or more magnets 201102K may consist of a single magnetic element in the shape of a ring. In other embodiments, the one or more magnets 201102K may consist of two, three, four, five, or more discrete magnetic elements disposed on the end-facing surface of the sharp carrier 201102. In still other embodiments, at least a portion of the end of the sharp carrier 201102 may itself be made of a magnetic material. One skilled in the art will appreciate that other configurations and shapes for using one or more magnets to hold the sensor control device to the sensor carrier are possible and fully within the scope of the present disclosure.

[0062] Representative Sensor and Connector Assembly 7 is a side view of an example sensor 11900 in accordance with one or more embodiments of the present disclosure. The sensor 11900 is similar in some respects to any of the sensors described herein and may therefore be used to detect a particular analyte concentration in an analyte monitoring system. As illustrated, the sensor 11900 has a tail 11902, a flag 11904, and a neck 11906 interconnecting the tail 11902 and the flag 11904. The tail 11902 includes an enzyme or other chemical or biological substance, and in some embodiments, a thin film may cover the chemical. In use, the tail 11902 is received transdermally under the skin of a user, and the contained chemical helps enable analyte monitoring in bodily fluids.

[0063] The tail 11902 may be received within a hollow or recess in the sharp (not shown) such that the tail 11902 of the sensor 11900 is at least partially enclosed. As illustrated, the tail 11902 may extend at an angle Q from the horizontal. In some embodiments, the angle Q may be about 85°. Thus, unlike other sensor tails, the tail 11902 may extend from the flag 11904 not perpendicularly, but at an angle that is offset from the vertical. This may be advantageous in helping to maintain the tail 11902 within the recess in the sharp.

[0064] The tail 11902 has a first or bottom end 11908a and a second or top end 11908b opposite the bottom end 11908a. A tower 11910 may be provided at or near the top end 11908b and extend vertically upward from where the neck 11906 interconnects the tail 11902 to the flag 11904. In operation, as the sharp moves laterally, the tower 11910 helps pivot the tail 11902 towards the sharp and otherwise remains within the recess in the sharp. Additionally, in some embodiments, the tower 11910 may provide or have a protrusion 11912 extending laterally therefrom. When the sensor 11900 is mated with the sharp and the tail 11902 extends into the recess in the sharp, the protrusion 11912 may engage an inner surface of the recess. In operation, the protrusion 11912 may help keep the tail 11902 within the recess.

[0065] The flag 11904 can have a generally planar surface on which one or more sensor contacts 11914 are disposed. The sensor contacts 11914 can be configured to mate with a corresponding number of flexible carbon impregnated polymer modules contained within the connector.

[0066] In some embodiments, as illustrated, the neck 11906 may provide or have a recess or bend 11916 extending between the flag 11904 and the tail 11902. The bend 11916 may be advantageous in providing flexibility to the sensor 11900 and helping to prevent the neck 11906 from bending.

[0067] In some embodiments, a notch 11918 (shown in dashed lines) may be provided in the flag near the neck 11906. The notch 11918 may provide flexibility and tolerance to the sensor 11900 when the sensor 11900 is mounted in a platform. More specifically, the notch 11918 may help absorb interference forces that may occur when the sensor 11900 is mounted in a platform.

[0068] 8A and 8B are perspective and partially exploded perspective views of a connector assembly 12000 according to one or more embodiments. As illustrated, the connector assembly 12000 may include a connector 12002, and FIG. 8C is a bottom perspective view of the connector 12002. The connector 12002 may include an injection molded portion that may be used to help secure one or more (four in FIG. 8B) flexible carbon impregnated polymer modules 12004 to the base 12006. More specifically, the connector 12002 may help secure the module 12004 in contact with a sensor contact 11914 (FIG. 7) located on the flag 11904 adjacent the sensor 11900. The module 12004 is made of a conductive material and provides conductive communication between the sensor 11900 and corresponding circuit contacts (not shown) located within the base 12006.

[0069] As best seen in FIG. 8C, the connector 12002 may have a pocket 12008 sized to receive the module 12004. In some embodiments, the connector 12002 may also have one or more recesses 12010 configured to mate with one or more corresponding flanges 12012 ( FIG. 8B ) on the base 12006. Mating the recesses 12010 with the flanges 12012 may secure the connector 12002 to the base 12006, such as by an interference fit. In other embodiments, the connector 12002 may be secured to the base 12006 using an adhesive or by sonic welding.

[0070] 8D and 8E are perspective and partially exploded perspective views of another connector assembly 12100 according to one or more embodiments. As illustrated, the connector assembly 12100 may include a connector 12102, and FIG. 8F is a bottom perspective view of the connector 12102. The connector 12102 may include an injection molded portion that is used to help secure one or more (four in FIG. 8E) flexible metal contacts 12104 to the sensor 11900 on the base 12106. More specifically, the connector 12102 may help secure the contacts 12104 in contact with sensor contacts 11914 (FIG. 7) located on the flag 11904 adjacent the sensor 11900. The contacts 12104 may be made of a stamped conductive material that provides conductive communication between the sensor 11900 and corresponding circuit contacts (not shown) located within the base 12106. In some embodiments, for example, contacts 12104 may be soldered to a PCB (not shown) disposed within pedestal 12106 .

[0071] 8F, the connector 12102 may have a pocket 12108 sized to receive the contact 12104. In some embodiments, the connector 12102 may also have one or more recesses 12110 configured to mate with one or more corresponding flanges 12112 on the base 12106. Mating the recesses 12110 with the flanges 12112 may help secure the connector 12102 to the base 12106, such as by an interference fit. In other embodiments, the connector 12102 may be secured to the base 12106 with an adhesive or by sonic welding.

[0072] In some embodiments, the connector assembly (e.g., 12000 or 12100) may include a pull tab (not shown) made of one or more electrically insulating materials configured to extend battery life and / or prevent current leakage during storage. According to some embodiments, for example, a first portion of the pull tab may releasably engage the sensor 11900 to prevent electrical coupling between the sensor contacts 11914 on the one hand and either the module 12004 of FIG. 8B or the contacts 12104 of FIG. 8E on the other hand. Also, in some embodiments, a second portion of the pull tab may be coupled to the sharp or sharps carrier, such that the pull tab disengages from the sensor 11900 when the attachment is actuated. In other embodiments, the second portion of the pull tab may be coupled to the sharp or sharps carrier, such that the pull tab disengages from the sensor 11900 during or after retraction of the sharp.

[0073] According to other embodiments, a first portion of the pull tab (not shown) may removably engage with a power source (e.g., a battery) to prevent electrical coupling between the power source and the remainder of the sensor electronics (e.g., PCB). In such embodiments, a second portion of the pull tab may be coupled with the sharp or sharps carrier, and the pull tab disengages from the power source when the attacher is actuated or during (or after) retraction of the sharp. In yet other embodiments, a first portion of the pull tab (not shown) may removably engage with any component of the sensor electronics of the sensor control unit (that would otherwise form a closed circuit with the power source). Those skilled in the art will recognize that other configurations for extending battery life and preventing current leakage during storage are possible and are fully within the scope of this disclosure.

[0074] An embodiment of a sensor control device 9A and 9B are side and perspective views, respectively, of an example sensor control device 9102 in accordance with one or more embodiments of the present disclosure. The sensor control device 9102 is similar in some respects to the sensor control device 102 of FIG 1 and therefore may be best understood with reference thereto. Additionally, the sensor control device 9102 replaces the sensor control device 102 of FIG 1 and therefore may be used in conjunction with the sensor attachment device 102 of FIG 1, which may deliver the sensor control device 9102 to a target monitoring location on a user's skin.

[0075] As illustrated, the sensor control device 9102 includes an electronics housing 9104 that is generally disk-shaped and has a circular cross-section. However, in other embodiments, the electronics housing 9104 may have other cross-sectional shapes, such as oval or polygonal, without departing from the scope of the present disclosure. The electronics housing 9104 includes a shell 9106 and a mount 9108 that is matable with the shell 9106. The shell 9106 may be secured to the mount 9108 in a variety of ways, such as by a snap-fit ​​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 connection is created therebetween. An adhesive patch 9110 may be disposed and attached to the underside of the mount 9108. According to one aspect of the embodiment, an adhesive patch 9110 (shown in non-hatched shading in FIG. 9A) can be configured to secure and maintain the sensor control unit 9102 in place against the user's skin during operation.

[0076] The sensor control unit 9102 may further include a sensor 9112 and a sharp 9114 that is used to aid in transcutaneous delivery of the sensor 9112 under the skin of a user when attached to the sensor control unit 9102. The sensor 9112 and corresponding portions of the sharp 9114 extend distally from a bottom (e.g., base 9108) of the electronics housing 9104. The sharp hub 9116 may be overmolded onto the sharp 9114 and configured to secure and support the sharp 9114. As best seen in FIG. 9A , the sharp hub 9116 may include or have a mating member 9118. When the sharp 9114 is assembled to the sensor control device 9102, the sharp 9114 may 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 thereof and the mating member 9118 extends distally from the bottom of the base 9108. As described below, in at least one embodiment, the sharp hub 9116 may sealingly engage a top of an encapsulant overmolded to the base 9108. When the sharp 9114 penetrates the electronics housing 9104, the exposed portion of the sensor 9112 may be received within a cavity or recessed (arcuate) portion of the sharp 9114. The remainder of the sensor 9112 is disposed within the interior of the electronics housing 9104.

[0077] The sensor control device 9102 may further include a sensor cap 9120, shown in FIGS. 9A and 9B removed from the electronics housing 9104. The sensor cap 9120 may help provide a sealing barrier to enclose and protect the exposed portions of the sensor 9112 and sharps 9114. As illustrated, the sensor cap 9120 may comprise a generally cylindrical body having a first end 9122a and a second end 9122b opposite the first end 9122a. The first end 9122a may be open to provide access into an interior chamber 9124 within the body, while the second end 9122b may be closed and may provide or include an engagement feature 9126. As described in more detail below, the engagement features 9126 can aid in mating the sensor cap 9120 with an attachment cap of a sensor attachment (e.g., the sensor attachment 102 of FIG. 1) and can aid in removing the sensor cap 9120 from the sensor control device 9102 after removing the sensor cap from the sensor attachment.

[0078] The sensor cap 9120 may be removably coupled to the electronics housing 9104 at or near the bottom of the base 9108. More specifically, the sensor cap 9120 may be removably coupled to a mating member 9118 extending distally from the bottom of the base 9108. In at least one embodiment, for example, the mating member 9118 may have a set of external threads 9128a (FIG. 9A) that can mate with a set of internal threads 9128b (FIG. 9B) formed within the interior chamber 9124 of the sensor cap 9120. In some embodiments, the external and internal threads 9128a, 9128b may comprise a flat thread configuration (e.g., no helical curvature), but may alternatively comprise a helical thread engagement. Thus, in at least one embodiment, the sensor cap 9120 may 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 may 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 with minimal separation force (e.g., axial or rotational force).

[0079] In some embodiments, the sensor cap 9120 may be a unitary (single) structure extending between the first and second ends 9122a, 9122b. However, in other embodiments, the sensor cap 9120 may be comprised of two or more pieces. 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 and help maintain a desired humidity level within the interior chamber 9124. The desiccant cap 9130 may also include or provide an engagement feature 9126 of the sensor cap 9120. In at least one embodiment, the desiccant cap 9130 may include an elastomeric plug inserted into a bottom end of the sensor cap 9120.

[0080] In some embodiments, the sensor control device 9102 may also include an adhesive backing 9110B (shown in FIG. 9A with cross-hatching) coupled to the bottom surface of the adhesive patch 9110. Under certain conditions, chemical interactions between the adhesive patch 9110, trapped air, desiccants, and outgassing of materials within the housing and cap of the attachment may degrade the adhesive during storage or shipping of the attachment. Applying the adhesive backing 9110B may mitigate degradation of the adhesive of the adhesive patch 9110. According to another aspect of the embodiment, the backing 9110B may be coupled to the sensor cap 9120 such that removal of the sensor cap 9120 causes removal of the adhesive backing 9110B.

[0081] Representative launch mechanisms for one-piece and two-piece attachments 10A-10E illustrate details of an embodiment of the internal device mechanism that actuates the attachment device 216 to attach the sensor control device 222 to a user and safely retracts the sharp 1030 into the attachment device 216. Together, these figures depict an example sequence for driving the sharp 1030 (which supports a sensor coupled to the sensor control device 222) into the user's skin, retracting the sharp leaving the sensor in contact with the user's interstitial fluid, and adhesively adhering the sensor control device to the user's skin. Modifications of the above operations for use with alternative attachment device assembly embodiments and components will be understood by those skilled in the art with reference to the above operations. Additionally, the attachment device 216 may be a one-piece or two-piece sensor attachment device as disclosed herein.

[0082] 10A, the sensor 1102 is supported within the sharp 1030 slightly above the user's skin 1104. Rails 1106 (optionally three) of upper guides 1108 may be provided to control the movement of the mount 216 relative to the barrel 318. The barrel 318 is held within the mount 216 by detent features 1110 such that an appropriate downward force along the longitudinal axis of the mount 216 overcomes the resistive force of the detent features 1110 to allow the sharp 1030 and sensor control unit 222 to translate along the longitudinal axis into the user's skin 1104. Additionally, the capture arm 1112 of the sensor carrier 1022 engages the sharp retraction assembly 1024 to maintain the sharp 1030 in place relative to the sensor control unit 222.

[0083] 10B, a user force is applied that overcomes or overrides the detent feature 1110, causing the barrel 318 to collapse into the housing 314, driving the sensor control unit 222 (and associated components) to translate downward along the longitudinal axis as shown by arrow L. The inner diameter of the upper guide 1108 of the barrel 318 limits the position of the carrier arm 1112 throughout the entire sensor / sharps insertion process. The retention of the detent surface 1114 of the carrier arm 1112 against the complementary surface 1116 of the sharps retraction assembly 1024 maintains the position of these components with the return spring 1118 fully energized.

[0084] In Figure 10C, the sensor 1102 and sharp 1030 have reached their full insertion depth. In doing so, the carrier arm 1112 clears the inner diameter of the upper guide 1108. The compressed force of the coil return spring 1118 then drives the angled stop surface 1114 radially outward, releasing the force and driving the sharp carrier 2102 of the sharp retraction assembly 1024, withdrawing the (grooved) sharp 1030 from the user and away from the sensor 1102 (as shown by arrow R in Figure 10D).

[0085] With the sharp 1030 fully retracted, as shown in Figure 10E, the upper guide 1108 of the barrel 318 is secured by the final locking feature 1120. The used attacher 216 is then removed from the insertion site, leaving behind the sensor control unit 222 and the sharp 1030 securely secured within the attacher 216. The used attacher 216 can then be discarded.

[0086] The movement of the attacher 216 when attaching the sensor control unit 222 is designed to provide the user with the sensation that the insertion and retraction of the sharp 1030 is done automatically by the internal mechanism of the attacher 216. In other words, the present invention prevents the user from experiencing the sensation of manually driving the sharp 1030 into his / her skin. Thus, when the user applies enough force to overcome the resistance from the detent feature of the attacher 216, the resulting movement of the attacher 216 is perceived as an automatic response to the attacher being actuated. Even though all of the driving force is provided by the user and no additional bias / drive means are used to insert the sharp 1030, the user is not aware that he / she is providing additional force to drive the sharp 1030 and pierce the skin. As detailed in FIG. 10C, retraction of the sharp 1030 is automated by the coil return spring 1118 of the attacher 216.

[0087] 11A-11C depict another embodiment of a spring-biased retraction mechanism implemented in a sensor mount. According to one aspect of some embodiments, to reduce the number of parts in the sensor mount (and reduce the number of potential mechanical failures), a leaf spring 1118B can be used in place of the coil return spring 1118 in a sensor mount, such as mount 216 of FIGS. 10A-10E.

[0088] Referring first to FIG. 11A, a partial cross-sectional side view of one sensor mount component according to some embodiments is shown in a pre-launch stage (similar to FIG. 10A). In particular, FIG. 11A depicts a leaf spring 1118B coupled with a sharp 1030B, where the sharp 1030B is spaced from the skin surface 1104. As further shown in FIG. 11A, the leaf spring 1118B is in a first state, where a distal-facing surface of the leaf spring 1118B is convex relative to the skin surface 1104.

[0089] According to some embodiments, the sharp 1030B may be coupled to a central portion of the leaf spring 1118B by an interference fit, sonic welding, laser welding, one or more mechanical fasteners (e.g., screws), a gasket, adhesive, or any combination thereof. In some embodiments, the leaf spring 1118B may be made of the same material as the sharp 1030B (e.g., stainless steel). In other embodiments, the leaf spring 1118B may be made of a first material (e.g., stainless steel) having a first stiffness, and the sharp 1030B may be made of a second material (e.g., plastic) having a second stiffness different from the first stiffness. According to another aspect of some embodiments, similar to the embodiment depicted in FIG. 10A, the sharp 1030B may extend through the sensor control unit 222B, and a portion of the glucose sensor 1102B may be coupled to or partially disposed within a distal portion of the sharp 1030B.

[0090] According to another aspect of some embodiments, a plurality of engagement features 1023A, 1023B are configured to attach the leaf spring 1118B to a sensor carrier (not shown) or a sharps retraction assembly (not shown), such that lowering of the housing, sensor carrier, and sharps retraction assembly moves at least an edge of the leaf spring 1118B in a distal direction.

[0091] FIG 11B is another partial cross-sectional side view of the sensor attacher components according to some embodiments, with the attacher depicted in an insertion stage (similar to FIG 10C). In particular, FIG 11B shows the sharp 1030B after it has penetrated the skin surface 1104, with the sensor 1102B reaching a predetermined insertion depth. According to one aspect of some embodiments, during the insertion stage, an adhesive pad (not shown) on the bottom of the sensor control unit 222B is adhered to the skin surface 1104.

[0092] 11B, the leaf spring 1118B is in a second state, where the surface of the leaf spring 1118B changes from convex (with respect to the skin surface 1104) to generally planar as the attachment housing, sensor carrier, and sharps retraction assembly (not shown) continue to advance in a distal direction. In some embodiments, the generally planar surface of the leaf spring 1118B can also be configured to apply a force to the sensor control unit 222B or the sensor carrier (not shown) in a distal direction.

[0093] 11C is another partial cross-sectional side view of the attachment components according to some embodiments, with the attachment depicted in a retracted stage (similar to FIGS. 10D and 10E). In particular, as the attachment housing (not shown) is displaced further distally, the leaf spring 1118B is in a third state, where the surface of the leaf spring 1118B has reached or exceeded a deformation threshold, causing the leaf spring 1118B to suddenly become concave relative to the skin surface 1104. As a result of the concavity, according to one aspect of some embodiments, the sharp 1030B is retracted proximally and away from the skin surface 1104, while leaving the sensor 1102B below the skin surface 1104. In some embodiments, the concavity may also cause the leaf spring 1118B to become disengaged from the sensor control unit 222B.

[0094] Then, according to some embodiments, the attachment can be removed from the insertion site, leaving behind the sensor control unit 222B and the sharp 1030B safely secured within the attachment assembly. The attachment assembly can now be discarded.

[0095] For any of the attachment embodiments and components thereof described herein (including but not limited to sharps, sharps module, and sensor module embodiments), one of ordinary skill in the art will appreciate that these embodiments may be sized and configured for use with a sensor configured to detect an analyte level of bodily fluid within the epidermis, dermis, or subcutaneous tissue of a subject. In some embodiments, for example, the sharps and distal ends of the analyte sensors disclosed herein may both be sized and configured to be located at a particular distal depth (i.e., the deepest point of penetration into a tissue or layer of the subject's body, e.g., into the epidermis, dermis, or subcutaneous tissue). For some attachment embodiments, one of ordinary skill in the art will appreciate that certain embodiments of the sharps may be sized and configured to be located at a different distal depth within the subject's body relative to a final distal depth of the analyte sensor. In some embodiments, for example, the sharps may be located at a first distal depth within the epidermis of the subject prior to retraction, and the distal end of the analyte sensor may be located at a second distal depth within the dermis of the subject. In other embodiments, the sharp can be located at a first distal depth within the dermis of the subject prior to retraction and the distal end of the analyte sensor can be located at a second distal depth within the subcutaneous tissue of the subject. In yet other embodiments, the sharp can be located at a first distal depth within the subject prior to retraction and the analyte sensor can be located at a second distal depth within the subject, both of which are within the same layer or tissue of the subject's body.

[0096] Additionally, for any of the attachment embodiments described herein, one of ordinary skill in the art will appreciate that the analyte sensor and one or more structural components associated therewith (including, but not limited to, one or more spring mechanisms) may be positioned within the attachment at an offset location relative to one or more axes of the attachment. In some attachment embodiments, for example, the analyte sensor and spring mechanism may be positioned on a first side of the attachment at a first offset location relative to the axis of the attachment, and the sensor electronics may be positioned on a second side of the attachment at a second offset location relative to the axis of the attachment. In other attachment embodiments, the analyte sensor, spring mechanism, and sensor electronics may be positioned on the same side at an offset location relative to the axis of the attachment. One of ordinary skill in the art will appreciate that other permutations and configurations in which any or all of the analyte sensor, spring mechanism, sensor electronics, and other components of the attachment are positioned centrally or offset relative to one or more axes of the attachment are possible and fully within the scope of the present disclosure.

[0097] A number of bending structures are described herein, including, but not limited to, bending detent snaps, bending locking arms, sharp carrier locking arms 1, sharp retaining arms, and module snaps. These bending structures are made of resilient materials such as plastic or metal and operate in a manner well known to those skilled in the art. Each bending structure has a rest state or position toward which the resilient material is biased. If a force is applied to bend or move the structure out of its rest state or position, when the force is removed or relaxed, the bias of the resilient material causes the structure to return to its rest state or position. In many instances, these structures are configured as arms with detents or snaps, although other structures or configurations having the same bending characteristics and ability to return to their rest positions (including, but not limited to, legs, clips, catches, abutment features on the bending member, etc.) can be used.

[0098] Additional details of suitable devices, systems, methods, components, and their operation and related features are set forth in International Publication Nos. WO 2018 / 136898, WO 2019 / 236850, WO 2019 / 236859, WO 2019 / 236876, and U.S. Patent Application Publication No. 2020 / 0196919, filed June 6, 2019, each of which is incorporated herein by reference in its entirety. Additional details regarding embodiments of the attachments, their components, and variations thereof are described in U.S. Patent Application Publication Nos. 2012 / 0197222, 2013 / 0150691, 2016 / 0128615, 2016 / 0331283, 2018 / 0235520, 2019 / 0298240, and 2020 / 0397356. Additional details regarding embodiments of the sharps modules, sharps, components thereof, and variations thereof are described in U.S. Patent Application Publication No. 2014 / 0171771, all of which are incorporated herein by reference in their entirety.

[0099] Exemplary embodiments and features are set forth in the numbered paragraphs below. 1. A sensor mount assembly comprising: a housing configured to transition between a first position and a second position; a cylinder slidably coupled to the housing; a sensor carrier coupled to the housing; a fitting cap screwed to the housing; Equipped with The sensor mount assembly, wherein the mount cap and the housing define an interior space, the interior space containing a lightly pressurized inert gas. 2. The sensor mount assembly of claim 1, wherein the housing includes an mount cap sealing lip configured to contact the mount cap. 3. The sensor mount assembly of claim 2, wherein the mount cap has a sealing interface configured to receive the mount cap sealing lip of the housing. 4. The sensor mount assembly of claim 3, wherein the sealing interface and the mount cap sealing lip are configured to form a seal between the housing and the mount cap. 5. The sensor mount assembly of claim 4, wherein the sealing material further comprises a gasket. 6. The sensor mount assembly of claim 4 or 5, wherein the lightly pressurized inert gas creates an outwardly biased flow across the seal. 7. The sensor mount assembly of any one of claims 1 to 6, wherein the lightly pressurized inert gas comprises nitrogen. 8. The sensor attachment assembly of any one of paragraphs 1 to 7, wherein the attachment cap is configured to hold a desiccant. 9. The sensor attachment assembly according to any one of items 1 to 8, wherein the attachment cap does not have a desiccant. 10. The sensor mounting assembly described in any one of items 1 to 9, wherein the internal space has a first pressure, and the external space of the sensor mounting assembly has a second pressure that is lower than the first pressure. 11. A sensor mount assembly comprising: a housing configured to transition between a first position and a second position; a cylinder slidably coupled to the housing; a sharps carrier comprising one or more magnets; a sensor control unit comprising an analyte sensor, sensor electronics, and one or more ferromagnetic components; a sensor carrier configured to hold the sensor control device; Equipped with the one or more magnets are configured to exert a magnetic force on the ferromagnetic component in a proximal direction such that the sensor control unit is retained on the sensor carrier when the housing is in the first position. 12. The sensor mount assembly of claim 11, wherein the one or more ferromagnetic components are disposed within the sensor control device. 13. The sensor mount assembly of claim 11 or 12, wherein the one or more ferromagnetic components are embedded within a housing of the sensor control device. 14. The sensor mount assembly of any one of items 11 to 13, wherein the sensor carrier is configured to hold the sensor control device using only magnetic force. 15. The sensor mount assembly of any one of items 11 to 14, wherein the one or more magnets are disposed on a distal end-facing surface of the sharps carrier. 16. The sensor mount assembly of any one of items 11 to 15, wherein the one or more magnets are embedded in an end of the sharps carrier. 17. The sensor mounting assembly of any one of items 11 to 16, wherein the one or more magnets consist of a single magnetic element. 18. The sensor mount assembly of claim 17, wherein the single magnetic element has an annular shape. 19. The sensor mount assembly of any one of items 11 to 18, wherein at least a portion of the end of the sharps carrier is made of a magnetic material. 20. The sensor mount assembly of any of paragraphs 11 to 16, wherein the one or more magnets consist of two magnetic elements disposed on a distal-facing surface of the sharps carrier. 21. The sensor mount assembly of any of paragraphs 11 to 16, wherein the one or more magnets consist of three magnetic elements disposed on a distal-facing surface of the sharps carrier. 22. The sensor mount assembly according to any one of items 11 to 21, further comprising a return spring. 23. The sensor mount assembly of claim 22, wherein the return spring is configured to expand and move the sharps carrier in a proximal direction after the housing reaches the second position. 24. The sensor mount assembly of claim 23, wherein the one or more magnets are configured such that after the sharps carrier moves toward the base, magnetic forces acting on the ferromagnetic component are not sufficient to hold the sensor control device to the sensor carrier. 25. The sensor mount assembly of claim 24, wherein the sensor control device is configured to disengage from the sensor carrier after the sharps carrier moves in the proximal direction. 26. A sensor mount assembly comprising: a housing configured to transition between a first position and a second position; a cylinder slidably coupled to the housing; a sharps carrier coupled to the sharps; A sensor control device, an analyte sensor having a plurality of sensor contacts; a connector assembly having one or more of a plurality of sensor modules or a plurality of connector contacts configured to mate with the analyte sensor; Power supply and A sensor control device comprising: a sensor carrier configured to hold the sensor control device; Equipped with The sensor mount assembly, wherein the connector assembly further includes a pull tab made of an electrically insulating material. 27. The sensor mount assembly of claim 26, wherein the pull tab has a first portion that releasably engages the plurality of sensor contacts. 28. The sensor mount assembly of claim 27, wherein the first portion of the pull tab is configured to prevent electrical coupling between the sensor contacts and the plurality of sensor modules. 29. The sensor mount assembly of claim 27, wherein the first portion of the pull tab is configured to prevent electrical coupling between the sensor contact and the plurality of connector contacts. 30. The sensor mount assembly of any one of paragraphs 27 to 29, wherein the pull tab has a second portion that couples with the sharp or the sharp carrier. 31. The sensor mount assembly of claim 30, wherein the pull tab is configured to disengage from the plurality of sensor contacts upon actuation of the sensor mount assembly by movement of the sharps or the sharps carrier. 32. The sensor mount assembly of clause 30, wherein the pull tab is configured to disengage from the plurality of sensor contacts when the sharps or sharps carrier is retracted into the sensor mount assembly. 33. A sensor mount assembly comprising: a housing configured to transition between a first position and a second position; a cylinder slidably coupled to the housing; a sharps carrier coupled to the sharps; A sensor control device, an analyte sensor having a plurality of sensor contacts; a connector assembly configured to mate with the analyte sensor; Power supply and A sensor control device comprising: a sensor carrier configured to hold the sensor control device; Equipped with The sensor mount assembly, wherein the sensor control unit further comprises a pull tab coupled to the power source, the pull tab being made of an electrically insulating material. 34. The sensor mount assembly of paragraph 33, wherein the power source is a coin cell battery. 35. The sensor mount assembly of claim 33 or 34, wherein the pull tab has a first portion that releasably engages the power source. 36. The sensor mount assembly of claim 35, wherein the first portion of the pull tab is configured to prevent electrical coupling between the power source and sensor electronics of the sensor control unit. 37. The sensor mount assembly of claim 35 or 36, wherein the pull tab has a second portion that couples with the sharp or the sharp carrier. 38. The sensor mount assembly of paragraph 37, wherein the pull tab is configured to detach from the power source upon movement of the sharp or the sharp carrier upon actuation of the sensor mount assembly. 39. The sensor mount assembly of paragraph 37, wherein the pull tab is configured to detach from the power source when the sharp or the sharps carrier is retracted into the sensor mount assembly. 40. A sensor mount assembly comprising: a housing configured to transition between a first position and a second position; a cylinder slidably coupled to the housing; a sharps carrier coupled to the sharps; A sensor control device, An electronic circuit housing; sensor electronics disposed within the electronics housing; an analyte sensor coupled to the sensor electronics; an adhesive patch disposed on a bottom surface of the electronic circuit housing; an adhesive backing bonded to a bottom surface of the adhesive patch; A sensor control device comprising: a sensor carrier configured to hold the sensor control device; a sensor cap removably coupled to the sensor control device; A sensor mount assembly comprising: 41. The sensor mount assembly of claim 40, wherein the adhesive backing is coupled to the sensor cap such that removal of the sensor cap causes removal of the adhesive backing. 42. The sensor mount assembly of claim 41, further comprising an mount cap threadedly coupled to the housing, the mount cap configured to remove the sensor cap from the sensor mount assembly when the mount cap is removed from the housing. 43. The sensor control device has a first hole on a top surface of the electronics housing and a second hole on the bottom surface of the electronics housing; the adhesive patch having a third hole; the adhesive backing has a fourth hole; 43. The sensor mount assembly of claim 41 or 42, wherein the sharp extends through the first, second, third, and fourth holes when the housing is in the first position. 44. A sensor mount assembly comprising: a housing configured to transition between a first position and a second position; a barrel slidably coupled to the housing, the barrel having a distal end adapted to abut a skin surface; a leaf spring coupled to the sharp body; a sensor control unit including an analyte sensor coupled to sensor electronics; a sensor carrier configured to hold the sensor control device when the housing is in the first position; Equipped with the sharp is configured to position at least a portion of the analyte sensor below the skin surface when the housing is moved to the second position; The sensor mount assembly, wherein the leaf spring is configured to retract the sharp into the sensor mount assembly after the housing moves to the second position. 45. The sensor mount assembly of claim 44, wherein when the housing is in the first position, the leaf spring is convex relative to the skin surface. 46. ​​The sensor mount assembly of claim 44 or 45, wherein the leaf spring is configured to deform when the housing transitions between the first position and the second position. 47. A sensor attachment assembly according to any one of paragraphs 44 to 46, wherein the leaf spring is generally planar with respect to the skin surface before the sharp is retracted into the sensor attachment assembly. 48. A sensor attachment assembly described in any of items 44 to 47, wherein the sensor control device is configured to adhere to the skin surface when the housing moves to the second position, and the leaf spring becomes approximately planar with respect to the skin surface when the sensor control device is adhered to the skin surface. 49. A sensor mounting assembly according to any one of items 44 to 48, wherein the leaf spring is concave relative to the skin surface after the sharp body is retracted into the sensor mounting assembly. 50. The sensor mount assembly of any one of paragraphs 44 to 49, wherein the leaf spring is coupled to the sharp by an interference fit. 51. The sensor mount assembly of any one of claims 44 to 49, wherein the leaf spring is coupled to the sharp by sonic welding. 52. The sensor mount assembly of any one of claims 44 to 49, wherein the leaf spring is coupled to the sharp by laser welding. 53. The sensor mount assembly of any one of paragraphs 44 to 49, wherein the leaf spring is coupled to the sharp by one or more mechanical fasteners. 54. A sensor mount assembly according to any one of paragraphs 44 to 53, wherein the leaf spring is made of a first material and the sharp body is made of a second material different from the first material. 55. The sensor mount assembly described in any one of paragraphs 44 to 53, wherein the leaf spring and the sharp are made of stainless steel material. 56. The sensor mount assembly described in any one of items 44 to 55, wherein the leaf spring has a first stiffness, and the sharp body has a second stiffness different from the first stiffness. 57. The sensor mount assembly of any one of clauses 44-56, further comprising a plurality of engagement features configured to attach the sensor carrier to the leaf spring. 58. The sensor mount assembly of any one of clauses 44-56, further comprising a plurality of engagement features configured to attach the sharps carrier to the leaf spring. 59. The sensor mount assembly of any one of paragraphs 44 to 58, wherein the leaf spring is further configured to apply a force to the sensor control device in a distal direction. 60. The sensor mount assembly of any one of paragraphs 44 to 59, wherein the leaf spring is further configured to apply a force to the sensor carrier in a distal direction. 61. A method for introducing an inert gas into a sensor mount assembly including a housing and a cap, comprising: placing the sensor mount assembly in a closed system at a first predetermined temperature, where the housing and cap form a seal; heating the closed system from the first predetermined temperature to a second predetermined temperature, where thermal expansion of the cap at the second predetermined temperature causes the cap to unseal from the housing; diffusing the inert gas into the interior of the sensor mount assembly; cooling the closed system from the second predetermined temperature to a third predetermined temperature, where at the third predetermined temperature, contraction of the cap causes the cap to form a seal with the housing; The method includes: 62. The method according to item 61, wherein the inert gas is argon. 63. The method of claim 61 or 62, wherein the first predetermined temperature is equal to the third predetermined temperature. 64. A method according to any of paragraphs 61 to 63, wherein the step of diffusing the inert gas into the interior of the sensor mounting assembly includes maintaining the closed system at the second predetermined temperature for a predetermined period of time. 65. The method of any of paragraphs 61 to 64, further comprising the step of introducing the inert gas into the closed system before placing the sensor mount assembly within the closed system. 66. The method of any of paragraphs 61 to 64, further comprising the step of introducing the inert gas into the closed system after placing the sensor mount assembly within the closed system. 67. A sensor mount assembly comprising: a housing configured to transition between a first position and a second position; a cylinder slidably coupled to the housing; a sensor control unit comprising an analyte sensor, sensor electronics, and one or more ferromagnetic components; a sensor carrier comprising one or more magnets and configured to hold the sensor control device; Equipped with the one or more magnets are configured to exert a magnetic force on the ferromagnetic component in a proximal direction such that the sensor control device is retained on the sensor carrier when the housing is in the first position. 68. The sensor mount assembly of paragraph 67, wherein the one or more ferromagnetic components are disposed within the sensor control device. 69. The sensor attachment assembly of paragraph 67 or 68, wherein the sensor control device further comprises an adhesive patch. 70. The sensor attacher assembly of paragraph 69, wherein the adhesive patch, when coupled with a skin surface, generates an adhesive force greater than the magnetic force. 71. The sensor attacher assembly of paragraph 70, wherein the adhesive patch is configured such that when the sensor control unit adheres to the skin, the adhesive forces detach the sensor control unit from the sensor carrier. 72. A sensor mount assembly comprising: a housing having an interior; a sensor carrier configured to hold a sensor control device and move between a first position and a second position within the interior of the housing, the sensor carrier including a magnet; Equipped with A sensor mount assembly, wherein the sensor control unit includes a glucose sensor coupled to sensor electronics, and when the sensor carrier is in the first position, the sensor control unit is within the interior of the housing. 73. The sensor mount assembly of clause 72, further comprising a sharps carrier, a sharps, and a return spring. 74. The sensor mount assembly of claim 73, wherein the return spring is configured to expand and move the sharps carrier in a proximal direction. 75. The sensor mount assembly of claim 72, wherein the magnet engages at least a portion of the sensor control device. 76. The sensor mount assembly of paragraph 72, wherein the sensor control device is made of a material that responds to a magnetic field generated by the magnet in the sensor carrier. 77. The sensor mount assembly of claim 72, wherein the sensor control device further comprises an adhesive patch disposed on a bottom surface of the sensor control device.

[0100] The above description expressly includes and contemplates methods that are non-surgical, non-invasive methods performed outside the body. These methods are typically performed by a user, who need not be a medical professional.

[0101] It is intended that all features, elements, parts, functions, and steps described with respect to any embodiment provided herein can be freely combined and substituted with those of any other embodiment. If a feature, element, part, function, or step is described with respect to only one embodiment, it should be understood that the feature, element, part, function, or step can be used with all other embodiments described herein, unless otherwise specified. Thus, this paragraph serves as a prelude and support for the introduction of claims combining features, elements, parts, functions, and steps of different embodiments, or substituting features, elements, parts, functions, and steps of one embodiment with those of another embodiment, even if such combinations or substitutions are not specified in a specific example of this description. Thus, the above description of specific embodiments of the disclosed subject matter has been presented for purposes of illustration and description. It is clearly recognized that it would be an undue burden to specify all possible combinations and substitutions, given that one of ordinary skill in the art would readily recognize that all such combinations and substitutions are permissible.

[0102] Although the embodiments are susceptible to various modifications and alternative forms, specific examples thereof have been shown and described in detail herein. It will be apparent to those skilled in the art that various modifications and variations can be made to the methods and systems of the disclosed subject matter without departing from the spirit or scope of the disclosed subject matter. Accordingly, the disclosed subject matter is intended to include modifications and variations within the scope of the appended claims and their equivalents. Also, any feature, function, step, or element of the embodiments may be recited or added to the claims, and negative limitations may be recited to define the scope of the claims by features, functions, steps, or elements not within the scope of the claims. [Explanation of symbols]

[0103] 102 Sensor control device 104 Analyte Sensor 105 Adhesive Patch 120 Reading device 121 Input Parts 122 Display 123 Power Port 140, 141, 142, 143, 144 Communication Channels 150 Sensor Mounting Device 160 Sensor Electronic Circuit 162 Analog Front End 170 Local Computer System 180 Trusted Computer Systems 222 Communications Processor 223, 225, 230 Memory 224 Application Processor 226 Power supply 228 RF Transmitter / Receiver 232 Multi-function Transmitter / Receiver 238 Power Management Module 702 Housing 704 tube 706 Electronic Circuit Housing 708 Cap 710 Sensor carrier 808 units 810 Container 812 Lid 2102 Sharp object carrier 2500 Sharps Module 9102 Sensor control device 9104 Electronic circuit housing 9112 Sensor 9114 Sharp object 11900 Sensor 12000 Connector Assembly 12002 Connector 20102 Sensor control device 20105 Adhesive Patch 20150 Mounting device 20502 Desiccant 20701 Gasket 20702 Housing 20704 Tube 20708 Cap 20709 Label 20710 Sensor carrier 20712 Tamper evident features 201102 Sharps carrier 205014 Sharp hub 205612 Spring

Claims

1. In an assembly for inserting a glucose sensor into a subject's body, (1) An applicator, An applicator housing that defines an interior, A cylinder coupled to the applicator housing and having a tip configured to be disposed on the skin, A sharp body carrier assembly coupled to a sharp body, A sensor carrier having a cavity formed by a base wall and a side wall made of magnetic components, the sensor carrier having a sensor cavity configured to hold a sensor control device therein, A spring having a tip that contacts the sensor carrier, and A cap configured to couple to a distal portion of the applicator housing, An applicator comprising: (2) The sensor control device configured to be worn on the subject's body, An adhesive patch disposed on the bottom surface of the sensor control device and configured to attach the sensor control device to the subject's skin, The glucose sensor, A base side portion configured to be electrically coupled to an electronic circuit, and A tip portion having an enzyme, the tip portion configured to be transcutaneously received under the user's skin for monitoring glucose in the presence of the subject's body fluid, A glucose sensor comprising: and The electronic circuit including one or more processors, a memory, and a communication circuit configured to wirelessly communicate data according to the Bluetooth Low Energy protocol, A sensor control device comprising: Comprising: The sharp body carrier assembly, the sharp body, the spring, the sensor carrier, the magnetic components, and the sensor control device are configured to advance a distance inside the applicator housing with respect to the cylinder in a linear direction from a base position to a distal position, At the base position, the tip of the glucose sensor is received in a portion of the sharp body, The magnetic components of the sensor carrier are configured to exert a magnetic force on one or more ferromagnetic components of the sensor control device, and the sensor carrier is configured to hold the sensor control device within the sensor carrier when the sensor control device is at the base position, At the distal position, the sensor control device is attached to the subject's body by the adhesive patch and is configured to move away from the sensor carrier when the user pulls the applicator away from the skin. An assembly.

2. The sensor control device further includes a housing of the sensor control device that defines the interior of the sensor control device, and the one or more ferromagnetic components are disposed inside the sensor control device. The assembly according to claim 1.

3. The adhesive force generated by the adhesiveness of the adhesive patch is greater than the magnetic force acting on the one or more ferromagnetic components by the magnetic component. The assembly according to claim 2.

4. The spring is configured to retract the sharp body carrier assembly and the sharp body in the base direction into the fixture after the sharp body carrier assembly, the sharp body, the spring, the sensor carrier, the magnetic component, and the sensor control device reach the end position. The assembly according to claim 3.

5. The glucose sensor further includes a base-side portion having one or more electrical contacts. The assembly according to claim 4.

6. The glucose sensor further includes a bent portion between the base-side portion of the glucose sensor and the end portion of the glucose sensor. The assembly according to claim 5.

7. The base-side portion of the glucose sensor is perpendicular to the end portion of the glucose sensor. The assembly according to claim 6.

8. The end of the glucose sensor and the end portion of the sharp body extend in the end direction from the bottom surface of the sensor control device when the sharp body carrier assembly, the sharp body, the spring, the sensor carrier, the magnetic component, and the sensor control device are in the base-side portion. The assembly according to claim 7.

9. The sensor control device further has a first hole in the upper surface of the housing of the sensor control device, The sensor control device further has a second hole in the bottom surface of the sensor control device, When the sharp body carrier assembly, the sharp body, the spring, the sensor carrier, the magnetic component, and the sensor control device are in the base position, the sharp body is configured to extend through the first hole and the second hole. The assembly according to claim 8.

10. The adhesive patch has a third hole, and when the sharp body carrier assembly, the sharp body, the spring, the sensor carrier, the magnetic component, and the sensor control device are in the base position, the sharp body is configured to extend through the third hole. The assembly according to claim 9.

11. The assembly according to claim 10, wherein the sensor carrier does not have one or more spring arms configured to hold the sensor control device.

12. The assembly according to claim 11, wherein the fixture further includes a gasket configured to form a sealing material between the fixture housing and the cap.

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