Systems and devices for analyte monitoring

Abstract

An arrangement for introducing a glucose sensor into a person's body, comprising: (1) an applicator consisting of: an applicator housing defining an interior space; a sheath connected to the applicator housing and having a distal end configured for placement on the skin; a needle carrier assembly connected to a needle; a sensor carrier having a cavity formed by a proximal wall and a side wall, with a magnetic component, the cavity configured to receive a sensor control device therein; a spring having a distal end in contact with the sensor carrier; and a cap configured to be connectable to a distal portion of the applicator housing; (2) the sensor control device configured to be worn on the body of the person, the sensor control device comprising: an adhesive element arranged on the underside of the sensor control device and configured to adhere the sensor control device to the skin of the person; The glucose sensor includes: a proximal portion configured to be electrically coupled to electronics; a distal part with an enzyme, wherein the distal part Part is configured to be absorbed transcutaneously under the skin of the user to monitor glucose in a body fluid of the person; and the electronics one or more processors, a memory and Communication circuitry configured to transmit data wirelessly according to a Bluetooth Low Energy protocol, wherein the needle carrier assembly, the needle, the spring, the sensor carrier, the magnet, and the sensor control device are configured to move within the applicator housing by a predetermined distance relative to the sheath and in a linear direction from a proximal position to a distal position, wherein in the proximal position the distal end of the glucose sensor is received in a portion of the needle, wherein the magnetic component of the sensor carrier is configured to exert a magnetic force on one or more ferromagnetic components of the sensor control device, and wherein the sensor carrier is configured to retain the sensor control device in the sensor carrier when the sensor control device is in the proximal position, and wherein the sensor control device in the distal position is configured to adhere to the skin of the person via the adhesive element and to detach from the sensor carrier when the user pulls the applicator away from the skin.

Description

REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to U.S. Provisional Application No. 63 / 222,851, filed July 16, 2021. AREA

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

[0003] The detection and / or monitoring of analyte concentrations, such as glucose, ketones, lactate, oxygen, hemoglobin AIC, or the like, can be critical to the health of a person with diabetes. Patients suffering from diabetes mellitus can develop complications such as loss of consciousness, cardiovascular disease, retinopathy, neuropathy, and nephropathy. Diabetics generally need to monitor their glucose levels to ensure they remain within a clinically safe range and can also use this information to determine if and / or when insulin is needed to lower their glucose levels or when additional glucose is needed to raise their glucose levels.

[0004] A growing body of clinical data demonstrates a strong association between blood glucose monitoring frequency and blood glucose control. Despite this association, many people diagnosed with diabetes do not monitor their blood glucose levels as frequently as they should, due to a combination of factors, including convenience, discreetness of testing, pain associated with blood glucose monitoring, and cost.

[0005] To improve patient adherence to a frequent blood glucose monitoring schedule, in vivo analyte monitoring systems can be used, in which a sensor control device is worn on the body of an individual requiring analyte monitoring. To increase comfort and ease of use for the individual, the sensor control device can be small in size and can be assembled and applied by the individual using a sensor applicator. The application process involves inserting a sensor using an applicator or insertion mechanism so that the sensor comes into contact with a body fluid. The sensor control device can also be configured to transmit analyte data to another device from which the individual or their healthcare provider ("HCP") can review the data and make treatment decisions.

[0006] While convenient for users, current sensors are also prone to malfunctions and / or mechanical failures due to improper handling and / or storage of the sensor and / or applicator, user error, lack of training, poor user coordination, overly complicated procedures, and other issues. This may be particularly true for analyte monitoring systems that use in vivo analyte sensors to measure an analyte level in an interstitial fluid ("ISF") and that are inserted using sharp instruments (also referred to as "introducers" or "needles"). For example, some prior art systems may have certain mechanisms and features that are prone to failure or reduced effectiveness due to adverse conditions.These and other challenges described herein can lead to improperly inserted or damaged sensors and, consequently, inaccurate monitoring of patient analyte levels.

[0007] Therefore, there is a need for more reliable sensor delivery devices, as well as associated systems and procedures, that are easy for the patient to use, less prone to error, and less susceptible to malfunctions or mechanical failures. SUMMARY

[0008] The purpose and advantages of the disclosed subject matter are set forth in the following description and will become apparent through practical application of the disclosed subject matter. Further 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, as well as from the accompanying drawings.

[0009] To achieve these and other advantages, and in accordance with the purpose of the disclosed subject matter as embodied and broadly described, the disclosed subject matter is directed to an applicator for delivering a sensor control device. The applicator may include a housing configured to move between a first position and a second position; a sheath slidably connected to the housing; a needle carrier connected to a needle; a sensor control device including an analyte sensor connected to sensor electronics; and a sensor carrier.

[0010] In some embodiments, the applicator may comprise an applicator cap that is screwable to the housing, wherein the applicator cap and the housing define an interior space, and wherein the interior space comprises a slightly pressurized inert gas.

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

[0012] In some embodiments, the sensor control device may include a connector assembly having a pull tab, wherein the pull tab is made of an electrically insulating material and wherein the pull tab releasably engages a plurality of sensor contacts of the analyte sensor. In other embodiments, the pull tab may be coupled to a power supply in the sensor control device. According to some embodiments, the sensor control device may further include an adhesive film bonded to an underside of an adhesive plaster on the underside of the sensor control device.

[0013] In some embodiments, the applicator may further comprise a leaf spring connected to a needle, wherein the needle is configured to position at least a portion of the analyte sensor beneath a skin surface when the housing is moved to the second position, and wherein the leaf spring is configured to retract the needle into the applicator after the housing is moved to the second position.

[0014] Other systems, devices, methods, features, and advantages of the subject matter described herein will be or become apparent to one skilled in the art upon examination of the following figures and the detailed description. All such additional systems, devices, methods, features, and advantages are intended to be included in this description, within the scope of the subject matter described herein, and protected by the appended claims. The features of the embodiments are not to be construed as limiting the appended claims in any way unless such features are expressly recited in the claims. SHORT DESCRIPTION OF THE CHARACTERS

[0015] The details of the subject matter described herein, both as to its structure and operation, can be appreciated by examining the accompanying figures, in which like reference numerals designate like parts. The components in the figures are not necessarily to scale; rather, emphasis is placed upon illustrating the principles of the subject matter. Furthermore, all illustrations are intended to convey concepts; relative sizes, shapes, and other detailed features may be depicted schematically rather than literally or precisely. Fig. Figure 1 is a system overview of a sensor applicator, a reader, a monitoring system, a network, and a remote system. Fig. 2A is a block diagram illustrating one embodiment of a reader device. Fig. 2B and Fig. 2C are block diagrams illustrating embodiments of sensor control devices. Fig. 3A-3G are sequential views of one embodiment of the assembly and application of an in vivo analyte monitoring system having a two-part architecture. Fig. 4A is a side view showing one embodiment of an application device connected to a cap. Fig. 4B is a side perspective view showing one embodiment of an applicator and a cap separated from each other. Fig. Figure 4C is a perspective view showing one embodiment of a distal end of an application device and an electronics housing. Fig. 4D is a plan view of an exemplary applicator device according to the disclosed subject matter. Fig. 4E is a bottom view of the applicator device of Fig. 4D. Fig. Figure 4F is an exploded view of the applicator device of Fig. 4D. Fig. 4G is a side sectional view of the applicator device of Fig. 4D. Fig. 5A is a proximal perspective view illustrating one embodiment of a sensor carrier. Fig. Figure 5B is a distal perspective view illustrating one embodiment of a sensor carrier. Fig. 5C is a plan view of a sensor carrier according to the disclosed subject matter. Fig. 5D is a bottom view of the sensor carrier from Fig. 5C. Fig. 6A is a perspective view of a needle carrier according to the disclosed subject matter. Fig. 6B is a side sectional view of the needle carrier of Fig. 6A. Fig. 6C is a perspective view of a needle carrier according to the disclosed subject matter. Fig. 6D is a side sectional view of the needle carrier from Fig. 6C. Fig. 7 is a side view of an exemplary sensor according to one or more embodiments of the disclosure. Fig. 8A and Fig. 8B are isometric and partially exploded isometric views of an exemplary connector assembly according to one or more embodiments. Fig. Figure 8C is an isometric bottom view of the connector from Fig. 8A-8B. Fig. 8D and Fig. 8E are isometric and partially exploded isometric views of another example connector assembly according to one or more embodiments. Fig. 8F is an isometric view from below of the connector from Fig. 8D-8E. Fig. 9A and Fig. 9B are side views and isometric views, respectively, of an exemplary sensor control device according to one or more embodiments of the present disclosure. The Fig. 10A-10E show cross-sectional views illustrating one embodiment of an applicator in various stages of deployment. The Fig. 11A-11C are side views of a leaf spring and needle assembly according to one or more embodiments of the present disclosure. DETAILED DESCRIPTION

[0016] Before describing the present subject matter in detail, it is to be understood that this disclosure is not limited to the specific embodiments described, as these 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 limiting, since the scope of the present disclosure is limited only by the appended claims.

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

[0018] The publications discussed herein represent disclosures prior to the filing date of this application only. Nothing herein is to be construed as an admission that this disclosure cannot be dated back to this publication because of a prior disclosure. Furthermore, the stated publication dates may differ from the actual publication dates, which may require independent confirmation.

[0019] In general, embodiments of the present disclosure include systems, devices, and methods for using applicators to introduce analyte sensors for use with in vivo analyte monitoring systems. An applicator may be provided to the user in a sterile package with an electronics housing of the sensor control device contained therein. According to some embodiments, a structure separate from the applicator, such as a container, may also be provided to the user as a sterile package with a sensor module and a needle module contained therein. The user may connect the sensor module to the electronics housing and connect the needle to the applicator, with the applicator being inserted into the container in a particular procedure. In other embodiments, the applicator, the sensor control device, the sensor module, and the needle module may be provided in a single package.The applicator can be used to position the sensor control device on a human body, with a sensor in contact with the wearer's body fluid. Some embodiments described herein are improvements for maintaining the sterility of the applicator, sensor control device, and / or analyte sensor during storage. Some embodiments described herein reduce the susceptibility of the applicator, sensor control device, and / or analyte sensor to malfunctions and mechanical failures. Other improvements and advantages are also provided. The various configurations of these devices are described in detail with reference to the embodiments, which are only examples.

[0020] Furthermore, many embodiments include in vivo analyte sensors structured such that at least a portion of the sensor is positioned or can be positioned within a user's body to obtain information about at least one analyte of the body. However, it should be noted that the embodiments disclosed herein can be used with in vivo analyte monitoring systems that include in vitro capabilities, as well as purely in vitro or ex vivo analyte monitoring systems, including systems that are entirely non-invasive.

[0021] Furthermore, for each individual embodiment of a method disclosed herein, systems and devices capable of performing each of these embodiments are within the scope of the present disclosure. For example, embodiments of sensor control devices are disclosed, and these devices may include one or more sensors, analyte monitoring circuitry (e.g., an analog circuit), memory (e.g., for storing instructions), power sources, communication circuitry, transmitters, receivers, processors, and / or controllers (e.g., for executing instructions) that can perform all of the method steps or facilitate the performance of all of the method steps. These embodiments of sensor control devices can be used and are capable of implementing the steps performed by a sensor control device from any of the methods described herein.

[0022] As mentioned, several embodiments of systems, devices, and methods are described herein that provide improvements to sensor delivery devices and sensor control devices for use with in vivo analyte monitoring systems. In particular, several embodiments of the present disclosure are designed to improve the longevity of certain components of a sensor delivery device and reduce their susceptibility to mechanical failure. For example, some embodiments include a pull tab comprising an electrically insulating material coupled to one or more of the following: the sensor contacts, the power supply, or another component of the sensor electronics.In certain embodiments, the pull tab can be configured to prevent electrical coupling between the power supply and the sensor electronics of the sensor control device, thereby maintaining power to the sensor control device during storage or transport. In another embodiment, a leaf spring retraction mechanism is implemented in a sensor applicator to reduce the number of potential sensor applicator device components susceptible to mechanical failure. In another embodiment, multiple magnetic elements are used to retain a sensor control device in a sensor carrier of the applicator, also reducing the number of sensor applicator device components susceptible to mechanical failure.Consequently, these embodiments can, among other things, improve the durability and functionality of sensor applicator devices and sensor controllers.

[0023] However, before describing these aspects of the embodiments in detail, it is first desirable to describe examples of devices that may be present in, for example, an in vivo analyte monitoring system and examples of their operation, all of which may be used with the embodiments described herein.

[0024] There are different types of in vivo analyte monitoring systems. Continuous analyte monitoring systems (or continuous glucose monitoring systems), for example, can transmit data from a sensor controller to a reader continuously without prompting, e.g., automatically according to a schedule. Flash analyte monitoring systems (or flash glucose monitoring systems, or simply flash systems), for example, can transmit data from a sensor controller in response to a scan or data request from a reader, such as using a near-field communication (NFC) or radio-frequency identification (RFID) protocol. In vivo analyte monitoring systems can also operate without calibration through a finger prick.

[0025] In vivo analyte monitoring systems differ from "in vitro" systems, which contact a biological sample outside the body (or "ex vivo") and typically include a meter with a port for accepting an analyte test strip containing the user's body fluid, which can be analyzed to determine the user's blood glucose level.

[0026] In vivo monitoring systems may include a sensor that, while in vivo, contacts the user's body fluid and detects analyte concentrations therein. The sensor may be part of the sensor control device, which is located on the user's body and contains the electronics and power supply that enable and control analyte measurement. The sensor control device and variants thereof may also be referred to as a "sensor control unit," "body-worn electronics device or unit," "body-worn device or unit," or "sensor data communication device or unit," to name a few.

[0027] In vivo monitoring systems may also include a device that receives measured analyte data from the sensor control device and processes that measured analyte data in any form and / or displays it to the user. This device, and variants thereof, may be referred to as a "handheld reader," "reader" (or simply "reader"), "handheld electronics" (or simply "handheld"), "portable data processing device" or unit, "data receiver," "receiver device" or unit (or simply "receiver"), or "remote control device" or unit, to name a few. Other devices, such as personal computers, have also been used with or integrated into in vivo and in vitro monitoring systems. Example in vivo analyte monitoring system

[0028] Fig. Figure 1 is a conceptual diagram illustrating an example embodiment of an analyte monitoring system 100 that includes a sensor applicator 150, a sensor controller 102, and a reader 120. Here, the sensor applicator 150 can be used to deliver the sensor controller 102 to a monitoring site on a user's skin, where a sensor 104 is held in place by an adhesive patch 105 for a specific period of time. The sensor controller 102 is shown in Figures Fig. 2B and Fig. 2C and can communicate with the reader device 120 via a communication path 140 using a wired or wireless technology. Examples of wireless protocols include Bluetooth, Bluetooth Low Energy (BLE, BTLE, Bluetooth SMART, etc.), Near Field Communication (NFC), and others. Users can monitor the applications installed on the reader 120 via the display 122 and input device 121, and the device's battery can be charged via the power port 123. The reader 120 can communicate with the local computer system 170 via a communication path 141 using a wired or wireless technology.The local computing system 170 may include one or more of the following components: a laptop, desktop, tablet, phablet, smartphone, set-top box, video game console, or other computing device, and the wireless communication may include any number of suitable wireless networking protocols, including Bluetooth, Bluetooth Low Energy (BTLE), Wi-Fi, or others. The local computing system 170 may communicate with a network 190 via communication path 143, similarly to how the reader 120 may communicate with the network 190 via communication path 142, using a wired or wireless technology as previously described. The network 190 may be one of several networks, such as private networks and public networks, local area networks or wide area networks, and so on.A trusted computer system 180 may include a server and provide authentication services and secure data storage and communicate with the network 190 via a communication path 144 using a wired or wireless technology. Example reader device

[0029] Fig. 2A is a block diagram illustrating one embodiment of a reading device configured as a smartphone. Here, the reading device 120 may include a display 122, an input component 121, and a processor core 206, which may include a communications processor 222 coupled to a memory 223 and an applications processor 224 coupled to a memory 225. Also included may be a separate memory 230, an RF transceiver 228 with antenna 229, and a power supply 226 with a power supply module 238. Further included may be a multifunctional transceiver 232 capable of communicating via Wi-Fi, NFC, Bluetooth, BTLE, and GPS with an antenna 234. As known to those skilled in the art, these components are electrically and communicatively coupled to form a functional device. Example sensor control devices

[0030] The Fig. are block diagrams showing example embodiments of the sensor control device 102 with an analyte sensor 104 and sensor electronics 160 (including analyte monitoring circuitry) that may provide the majority of the processing power for providing final result data suitable for display to the user. Fig. Figure 2B illustrates a single semiconductor chip 161, which may be an application-specific integrated circuit (ASIC). Certain high-level functional units are illustrated within ASIC 161, including an analog front-end (AFE) circuit 162, a power management (or control) circuit 164, a processor 166, and a communications circuit 168 (which may be implemented as a transmitter, receiver, transceiver, passive circuit, or otherwise according to the communications protocol). In this embodiment, both APE 162 and processor 166 are used as the analyte monitoring circuit, but in other embodiments, either circuit 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 a discrete chip or may be distributed across (and form part of) several different chips.

[0031] A memory 163 is also included in ASIC 161 and may be shared by the various functional units present in ASIC 161 or distributed across two or more of them. The memory 163 may also be a separate chip. The memory 163 may be 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 battery or the like. The AFE 162 is connected to the in vivo analyte sensor 104, receives measurement data therefrom, and outputs the data in digital form to the processor 166, which in turn processes the data to obtain the discrete final results for glucose, trend values, etc.This data may then be forwarded to a communication circuit 168 to be sent via an antenna 171, for example, to a reader 120 (not shown), where it requires minimal further processing by the resident software application to display the data.

[0032] Fig. 2C resembles Fig. 2B, but includes two discrete semiconductor chips 162 and 174, which can be packaged together or separately. Here, the AFE 162 is located on ASIC 161. The processor 166 is integrated with power management circuitry 164 and communication circuitry 168 on chip 174. AFE 162 includes memory 163, and chip 174 includes memory 165, which can be isolated or distributed. In one embodiment, AFE 162 is combined with power management circuitry 164 and processor 166 on one chip, while communication circuitry 168 is located on a separate chip. In another embodiment, both the AFE 162 and communication circuitry 168 are located on one chip, and the processor 166 and power management circuitry 164 are located on another chip.It should be noted that other chip combinations are possible, including three or more chips, each responsible for the separate functions described or sharing one or more functions for fail-safe redundancy. Example assembly processes for sensor control devices

[0033] The components of the sensor control device 102 can be purchased by a user in multiple packages, which must be finally assembled by the user before delivery to a suitable user location. Fig. 3A-3D illustrate one embodiment of a user assembly process for the sensor controller 102, including preparation of separate components prior to assembling the components to prepare the sensor for delivery. Fig. 3E-3F illustrate one embodiment of delivering the sensor control device 102 to a suitable user location by selecting the appropriate delivery location and attaching the device 102 to that location.

[0034] Fig. 3A is a proximal perspective view illustrating one embodiment of a user preparing a container 810, configured here as a tray (although other packages may be used), for an assembly process. The user may perform this preparation by removing the lid 812 from the tray 810 to expose the platform 808, for example, by peeling a non-adhesive portion of the lid 812 away from the tray 810, thereby removing the adhesive portions of the lid 812. Removing the lid 812 may be appropriate in various embodiments, as long as the platform 808 within the tray 810 is sufficiently exposed. The lid 812 may then be set aside.

[0035] Fig. 3B is a side view showing one embodiment of a user preparing an applicator device 150 for assembly. The applicator device 150 may be provided in a sterile package sealed by a cap 708. Preparation of the applicator device 150 may include separating the housing 702 from the cap 708 to expose the sheath 704 ( Fig. 3C). This can be achieved by unscrewing (or otherwise separating) the cap 708 from the housing 702. The cap 708 can then be set aside.

[0036] Fig. 3C is a proximal perspective view illustrating one embodiment of a user inserting an applicator device 150 into a tray 810 during assembly. Initially, the user may insert the sheath 704 into the platform 808 within the tray 810 after aligning the housing alignment feature 1302 (or slot or recess) and the tray alignment feature 924 (a stop or detent). Inserting the sheath 704 into the platform 808 temporarily unlocks the sheath 704 relative to the housing 702 and also temporarily unlocks the platform 808 relative to the tray 810. At this stage, removing the application device 150 from the tray 810 results in the same condition as before the application device 150 was first inserted into the tray 810 (i.e., the process can be reversed or aborted at this point and then repeated without consequences).

[0037] The sheath 704 may maintain its position within the platform 808 relative to the housing 702 while the housing 702 is advanced distally, being coupled to the platform 808 to advance the platform 808 distally relative to the tray 810. This step unlocks and collapses the platform 808 within the tray 810. The sheath 704 may contact and disengage locking features (not shown) within the tray 810, thereby unlocking the sheath 704 relative to the housing 702 and preventing the sheath 704 from moving (relatively) while the housing 702 continues to advance the platform 808 distally. At the end of the forward movement of the housing 702 and the platform 808, the sheath 704 is permanently unlocked relative to the housing 702.A needle and sensor (not shown) within the shell 810 can be coupled to an electronics housing (not shown) within the housing 702 at the end of the distal advancement of the housing 702. The operation and interaction of the application device 150 and the shell 810 are described in more detail below.

[0038] Fig. 3D is a proximal perspective view illustrating an embodiment in which a user removes an applicator device 150 from a tray 810 during assembly. A user may remove the applicator 150 from the tray 810 by advancing the housing 702 proximally with respect to the tray 810 or by performing other movements that have the same end effect of decoupling the applicator 150 and the tray 810. The applicator device 150 is removed with the fully assembled sensor control device 102 (not shown) (needle, sensor, electronics) therein and in position for dispensing.

[0039] Fig. 3E is a proximal perspective view illustrating one embodiment of a patient applying the sensor control device 102 to a target area of the skin, such as the abdomen or other suitable location, using the applicator device 150. Distal advancement of the housing 702 collapses the sleeve 704 within the housing 702, and the sensor is applied to the target site such that an adhesive layer on the underside of the sensor control device 102 adheres to the skin. The needle is automatically retracted when the housing 702 is fully advanced, while the sensor (not shown) remains in position to measure analyte concentrations.

[0040] Fig. Figure 3F is a proximal perspective view showing one embodiment of a patient with a sensor control device 102 in an applied position. The user can then remove the applicator 150 from the application site.

[0041] The Fig. 3A-3F and elsewhere herein, can reduce or eliminate the likelihood of accidental breakage, permanent deformation, or improper assembly of applicator components compared to prior art systems. Because the applicator housing 702 engages the platform 808 directly while unlocking the sleeve 704, rather than indirectly via the sleeve 704, the relative angularity between the sleeve 704 and the housing 702 does not result in breakage or permanent deformation of the arms or other components. The potential for relatively high forces (as in conventional devices) during assembly is reduced, which in turn reduces the likelihood of incorrect assembly by the user. Example sensor applicator devices

[0042] Fig. 4A is a side view showing one embodiment of an applicator device 150 connected to a screw cap 708. This is an example of how the applicator 150 is shipped to and received by a user before being assembled with a sensor by the user. Fig. Figure 4B is a side perspective view showing the applicator 150 and cap 708 after separation. Fig. 4C is a perspective view showing an example embodiment of a distal end of an applicator device 150 with electronics housing 706 and adhesive patch 105 removed from the position they would have occupied within the sensor carrier 710 of the sheath 704 if the cap 708 were in place.

[0043] For illustrative purposes and without limitation Fig. Referring to Figures 4D-G, the applicator device 20150 may be provided to a user as a single integrated assembly. Fig. 4D and Fig. 4E show a perspective top view and a perspective bottom view of the applicator device 20150, Fig. 4F shows an exploded view of the applicator device 20150 and Fig. 4G shows a side cutaway view. The perspective views illustrate how the applicator 20150 is shipped to and received by a user. The exploded and cutaway views illustrate the components of the applicator device 20150. The applicator device 20150 may include a housing 20702, a seal 20701, a sleeve 20704, a needle carrier 201102, a spring 205612, a sensor carrier 20710 (also referred to as a "puck carrier"), a needle hub 205014, a sensor control device (also referred to as a "puck") 20102, an adhesive patch 20105, a desiccant 20502, a cap 20708, a serial label 20709, and a tamper evident device 20712. When received by the user, only the body 20702, the cap 20708, the tamper evident 20712 and the label 20709 are visible.The tamper-evident feature 20712 may, for example, be a sticker affixed to the housing 20702 and the cap 20708, and the tamper-evident feature 20712 may, for example, be irreparably damaged by separating the housing 20702 and the cap 20708, thereby indicating to a user that the housing 20702 and the cap 20708 were previously separated. These features are described in more detail below.

[0044] With reference to Fig. 4G, in some embodiments, the interior of the housing 20702 and the cap 20708 may be slightly pressurized with an inert gas during assembly. According to an aspect of some embodiments, filling the interior of the housing 20702 and the cap 20708 with an inert, dry gas (e.g., nitrogen or argon) during assembly may be used either instead of a desiccant or in addition to a desiccant. According to another aspect of some embodiments, slightly pressurizing the interior of the housing 20702 and the cap 20708 with an inert gas may also bias the flow of material outward across the seal formed by the housing 20702 and the cap 20708 and reduce the likelihood of ingress of unwanted contaminants.Furthermore, as a further advantage of some embodiments, a slight release of gas pressure from the applicator may be audible when the user removes the cap 20708 to indicate to the user that the seal has not been compromised during transport and / or storage.

[0045] According to another aspect of some embodiments, an inert gas may be introduced into the interior of the housing 20702 using a closed, temperature-controlled system (not shown). First, one or more applicator devices 20150 may be introduced into the closed system while 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 applicator devices 20150 are placed therein. In other embodiments, the closed system may be filled with the inert gas after the applicator devices 20150 are placed therein. The closed system is sealed so that the inert gas cannot escape and other external gases cannot enter.According to an aspect of some embodiments, when the closed system is maintained at the first predetermined temperature, the applicator housing 20702 and the cap 20708 form a seal, as described in the previous sections. Subsequently, the closed system is heated to a second predetermined temperature that is higher than the first predetermined temperature. According to an aspect of some embodiments, at the second predetermined temperature, for each of the one or more applicator devices 20150, the thermal expansion of the cap 20708 may be different (e.g., greater or lesser) than the thermal expansion of the corresponding housing 20702, thereby unsealing each applicator device 20150. Consequently, the inert gas may diffuse into the interior of each housing 20702 while the applicator device 20150 is in an unsealed state.After a predetermined time sufficient for the inert gas to diffuse into each enclosure 20702, the temperature of the closed system may then be reduced to a lower temperature. In some embodiments, the lower temperature may be the first predetermined temperature. In other embodiments, the lower temperature may be a third predetermined temperature that is different from the first predetermined temperature but lower than the second predetermined temperature. At the lower temperature, the cap 20708 may contract such that the seal with the enclosure 20702 may be re-established. Finally, the one or more applicators may be removed from the closed system. Example sensor carriers

[0046] Fig. 5A is a proximal perspective view showing one embodiment of the sensor carrier 710, which can hold the sensor control device within the applicator 150. It can also hold the needle carrier 2102 with the needle module 2500. In this embodiment, the sensor carrier 710 has a generally hollow, round, flat, cylindrical shape and can include one or more deflectable needle carrier locking arms 1524 (e.g., three) extending proximally from a proximal surface surrounding a centrally located spring alignment rib 1516 to maintain the alignment of the spring 1104. Each locking arm 1524 has a detent or retention feature 1526 at or near its proximal end. The shock absorber 1534 may be a tab that projects outwardly on an outer periphery of the sensor carrier 710 and may lock the sensor carrier 710 prior to deployment for additional security.The rotation limiter 1506 may be a proximally extending, relatively short protrusion on a proximal surface of the sensor carrier 710 that limits the rotation of the carrier 710. The needle carrier locking arms 1524 may engage the needle carrier 2102 as illustrated in the following. Fig. 6A-6E.

[0047] Fig. 5B is a distal perspective view of the sensor carrier 710. Here, one or more retaining spring arms 1518 (e.g., three) for the sensor electronics are normally biased to the position shown and include a detent 1519 that can extend beyond the distal surface of the electronics housing 706 of the device 102 when housed in the recess or cavity 1521. In certain embodiments, after the sensor control device 102 with the applicator 150 has been adhered to the skin, the user pulls the applicator 150 in a proximal direction, i.e., away from the skin. The adhesive force holds the sensor control device 102 to the skin and overcomes the lateral force exerted by the spring arms 1518. As a result, the spring arms 1518 bend radially outward and release the detents 1519 from the sensor control device 102, thereby releasing the sensor control device 102 from the applicator 150.

[0048] For illustrative purposes and without limitation, the Fig. 5C and Fig. 5D, an exemplary sensor carrier 20710 is illustrated. The sensor carrier 20710 may include one or more of the features described herein with respect to sensor carriers, wherein similar features may function as described herein. For example, the sensor carrier 20710 may include a base 20710A and first and second support arms 20710B. Each support arm 20710B may include a first end portion 20710C connected to the base 20710A and a free end portion 20710D. For example, each support arm 20710B may be connected to the base 20710A at a first half of the base 20710A, and the free end portion 20710D may extend toward a second half of the base 20710A. Each support arm 20710B may include a sensor holder 20710E disposed on an inner surface of the support arm 20710B. The sensor holder 20710E may be disposed on the free end portion 20710D.The sensor retainer 20710E may be configured to retain the sensor control device 20102 within the housing 20702. The retainer 20710E may include a conical surface and an angled parting line that facilitates release of the sensor control device 20102 during delivery. Each retainer arm 20710B may include a locking interface 20710F disposed on an outer surface of the retainer arm 20710B. The locking interface 20710F may engage the rib 20704U on the shell 20704. As described above, the rib 20704U can prevent the sensor support arm 20710B from bending outward, for example, in the event of an impact, and thus keep the support device 20710E engaged with the sensor control device 20102 and thereby prevent movement of the sensor control device 20102 in the event of an impact.

[0049] In some embodiments, the sensor control device (e.g., 102 or 20102) may be held in the sensor carrier (e.g., 710 or 20710) by one or more magnets (not shown) disposed on a needle carrier. According to an aspect of some embodiments, and as further described below with respect to the Fig. 6A-6D, one or more magnets disposed in the needle carrier may be configured to attract one or more ferromagnetic components disposed in the sensor control device (e.g., 102 or 20102) and thereby retain the sensor control device (e.g., 102 or 20102) in the sensor carrier (e.g., 710 or 20710). In some embodiments, the one or more ferromagnetic components may be disposed in a housing of the sensor control device (e.g., 102 or 20102). In some embodiments, the one or more magnets may be provided either in addition to or instead of the one or more retaining springs 1518 for the sensor electronics and the corresponding detents 1519 of the sensor carrier 710 ( Fig. 5A - 5B) or the holding arms 20710B with the corresponding sensor holding devices 20710E of the sensor carrier 20710 ( Fig. 5C-5D). In certain embodiments, it may be advantageous to implement the one or more magnets without spring arms 1518, detents 1519, retaining arms 201710B, and sensor retainers 20710E, since such structural features may be exposed to adverse conditions during storage or use, which may, for example, lead to material creep over time.

[0050] In other embodiments, the sensor control device (e.g., 102 or 20102) may be held in the sensor carrier (e.g., 710 or 20710) by one or more magnets disposed in the sensor carrier itself. According to an aspect of some embodiments, there is an advantage to disposing the one or more magnets in the sensor carrier (e.g., 710 or 20710) in proximity between the one or more magnets and the sensor control device (e.g., 102 or 20102). This may require less magnetic force because, in some embodiments, the one or more magnets in the sensor carrier may be configured to directly engage at least a portion of the sensor control device (e.g., a top portion).Furthermore, according to another aspect of some embodiments, the adhesive patch can be configured such that the adhesive property is greater than the magnetic force between the one or more magnets and the sensor control device. Accordingly, after reaching the distal position and the adhesive patch being bonded to the skin, the sensor control unit can detach from the sensor carrier when the user pulls the application device away from the skin.

[0051] With reference to the Fig. 5C and Fig. 5D, the sensor carrier 20710 may include multiple housing attachment features 20710F1. For example, in some embodiments, the sensor carrier 20710 may include three housing attachment features 20710F1. In other embodiments, the sensor carrier 20710 may include two, four, five, six, or more housing attachment features 20710F. The housing attachment features 20710F1 may be equally spaced on the sensor carrier 20710 and extend upwardly from a top surface of the sensor carrier 20710. Each housing attachment element 20710F1 may include a housing snap lock 20710G, a housing positioning element 20710H, a biasing element 20710I, and a housing stop 20710J. The housing positioning device 20710H can position the sensor carrier 20710 axially relative to the housing 20702 when the two are to be connected together.The housing clip 20710G can engage the sensor carrier mounting slots 20702K on the housing 20702 to connect the sensor carrier 20710 to the housing 20702. The biasing device 207101 can engage the sensor carrier biasing device 20702M on the housing 20702, which is configured to eliminate the play between the sensor carrier 20710 and the housing 20702.

[0052] The sensor carrier 20710 may further include a plurality of needle carrier locking arms 20710K, for example, three needle carrier locking arms 20710K. The needle carrier locking arms 20710K may be equally spaced on the sensor carrier 20710 and extend upwardly from a top surface of the sensor carrier 20710. Each needle carrier locking arm 20710K may include a needle carrier retainer 20710L and a rib 20710M. The rib 20710M may engage an inner surface of the shell 20704, thereby forcing the needle carrier locking arm 20710K inward, and the needle carrier retainer 20710L may retain the needle carrier 201102, as described in more detail below. The carrier retainer 20710L may have a triangular shape in side view and a "U" shape 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 shell 20704, as described above. For example, the sensor carrier 20710 may include two locking ledges 20710N. The sensor carrier 20710 may include recesses 207100 disposed proximate each locking ledge 20710N and configured to receive the locking arm interface 20704M during deployment to prevent the locking arm 20704J from engaging the housing 20702 during deployment. The sensor carrier 20710 may include a hole 20710P extending through a center of the base 20710A. The hole 20710P can guide and limit the movement of the needle hub 205014 during insertion. Additionally or alternatively, the sensor carrier 20710 can include a spring positioning 20710Q.

[0054] A bottom surface of the sensor carrier 20710 may include stiffening ribs 20710R and sensor positioning ribs 20710S that may limit the planar movement of the sensor controller 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 controller 20102. Example needle carriers

[0055] The Fig. 6A and Fig. 6B are a proximal perspective view and a side cross-sectional view, respectively, showing one embodiment of the needle carrier 2102. The needle carrier 2102 can grip and hold the needle module 2500 within the applicator 150. It can also automatically retract when one or more springs transition from a preloaded, compressed state to an expanded state during an insertion procedure, as shown in FIGS. Fig. 10A - 10E. Anti-rotation slots 1608 may be provided near a distal end of the needle carrier 2102 to prevent the needle carrier 2102 from rotating when it is located in a central region of the needle carrier locking arms 1524 (as shown in Fig. 9A). The anti-rotation slots 1608 may be disposed between portions of the bevel 1610 of the needle carrier base, thereby ensuring complete retraction of the needle carrier 2102 through the sheath 704 upon retraction of the needle carrier 2102 at the end of the deployment procedure.

[0056] As in Fig. 6B, needle retention arms 1618 may be disposed within an interior of the needle carrier 2102 about a central axis and include a needle retaining clip 1620 at a distal end of each arm 1618. The needle retaining clip 1620 may have a proximal surface that may be nearly perpendicular to the central axis and may abut a distally facing surface of the needle hub 2516.

[0057] For illustrative purposes and without limitation, Fig. 6C and Fig. 6D, an exemplary needle carrier 201102 is illustrated. The needle carrier 201102 may include one or more of the features described herein with respect to needle carriers, with similar features functioning as described herein. For example, the needle carrier 201102 may include a series of features for engaging the three needle carrier locking arms 2071OK of the sensor carrier 20710. The features may include a pre-partial retraction retention surface 201102A and a post-partial retraction retention surface 201102B. The pre-partial retraction retention surface 201102A may engage the needle carrier retention member 20710L prior to partial retraction, such as during transport and storage. The post-partial retraction retention surface 201102B may engage the needle carrier retention member 20710L after partial retraction.For example, when the sheath 20704 initially moves proximally relative to the sensor carrier 20710, the rib 20710M of the support arm 20710L may engage the slot 20704Q of the sheath 20704, allowing the support arm 20710L to move radially outward and the needle carrier retaining member 20710L to release the preliminary partial retraction retaining surface 201102A and engage the post-partial retraction retaining surface 201102B. The height between the end of the preliminary partial retraction surface 201102A and the beginning of the post-partial retraction surface 201102B may correspond to the partial retraction distance. A bearing surface 201102C may be disposed below the retaining surface 201102B for retraction after partial retraction and may slide against the retaining arm 20710L when the needle carrier 201102 is retracted. Alignment walls 201102D may help keep the needle carrier 201102 aligned with the sensor carrier 20704 during partial retraction.The needle carrier 201102 may have a chamfer 201102F, which may have anti-rotation slots 201102E for engagement with the holding arms 20710L on the sensor carrier 20710.

[0058] Internally, the needle carrier 201102 may include needle holding arms 201102G with an insertion surface 2011021 and a needle hub contact surface 201102H. The holding arms 201102G may receive and hold the needle hub 205014. The spring stop 201102J may engage the retraction spring 205612.

[0059] With reference to Fig. 6D, the needle carrier 201102 may also include one or more magnets 201102K for holding a sensor control device in the sensor carrier (e.g., 710 or 20710 of Fig. 5A-5D). To illustrate, the needle carrier 201102 may include one or more magnets 201102K disposed in or on a distally facing surface of the needle carrier 201102. According to one aspect of these embodiments, the one or more magnets 201102K are configured to attract one or more ferromagnetic components disposed in the sensor control device, whereby the sensor control device may be retained in the sensor carrier when the needle carrier 201102 and the sensor carrier are proximate to one another. More specifically, when the needle carrier 201102K and the sensor carrier are coupled, as shown in the Fig. 10A-10C, the one or more magnets 201102K are configured to generate a magnetic field of sufficient strength to exert a "pulling" force on the ferromagnetic components disposed within the sensor control device in a proximal direction such that the sensor control device is retained within the sensor carrier.

[0060] According to another aspect of the embodiments as in Fig. As shown in Figure 10E, the extension of the return spring during needle retraction causes the needle carrier 201102 to detach from the sensor carrier and displace it in a proximal direction. As the needle carrier 201102 moves further away from the sensor carrier, the one or more magnets 201102K no longer exert sufficient magnetic force to retain the sensor control device in the sensor carrier. Subsequently, the sensor control device may detach from the sensor carrier.

[0061] According to some embodiments, the one or more magnets 201102K may be embedded in a distal end of the needle carrier 201102 such that the distal-facing surface is flush with the sensor carrier. In some embodiments, the one or more magnets 201102K may comprise either a single magnetic element or a plurality of discrete magnetic elements. For example, in some embodiments, the one or more magnets 201102K may comprise a single magnetic element having an annular geometry. In other embodiments, the one or more magnets 201102K may comprise two, three, four, five, or more discrete magnetic elements disposed on the distal surface of the needle carrier 201102. In yet other embodiments, at least a portion of the distal end of the needle carrier 201102 itself may be made of a magnetic material.Those skilled in the art will recognize that other configurations and geometries for implementing the one or more magnets for holding a sensor control device in the sensor carrier are possible and are fully within the scope of the present disclosure. Example sensor and connector assemblies

[0062] Fig. 7 is a side view of an example sensor 11900 according to one or more embodiments of the disclosure. The sensor 11900 may be similar in some aspects to any of the sensors described herein and may therefore be used in an analyte monitoring system for detecting specific analyte concentrations. As illustrated, the sensor 11900 includes a tip 11902, a flag 11904, and a neck 11906 interconnecting the tip 11902 and the flag 11904. The tip 11902 contains an enzyme or other chemical or biological substance, and in some embodiments, a membrane may cover the chemical substance. In use, the tip 11902 is received transcutaneously beneath a user's skin, and the chemical substance contained thereon facilitates analyte monitoring in the presence of bodily fluids.

[0063] The tip 11902 may be received within a hollow or recessed portion of a needle (not shown) to at least partially enclose the tip 11902 of the sensor 11900. As illustrated, the tip 11902 may extend at an angle Q offset from the horizontal. In some embodiments, the angle Q may be approximately 85°. Accordingly, unlike other sensor tips, the tip 11902 may not extend perpendicularly from the vane 11904, but rather at an angle offset from the vertical. This may prove advantageous for maintaining the tip 11902 within the recessed portion of the needle.

[0064] The tip 11902 includes a first or lower end 11908a and a second or upper end 11908b opposite the lower end 11908a. A cylinder 11910 may be provided at or near the upper end 11908b and extend vertically upward from where the neck 11906 connects the tip 11902 to the flag 11904. As the needle moves laterally during operation, the cylinder 11910 assists in rotating the tip 11902 toward the needle and otherwise remaining within the recessed portion of the needle. Additionally, in some embodiments, the cylinder 11910 may provide or otherwise define a protrusion 11912 extending laterally therefrom. When the sensor 11900 is connected to the needle and the end 11902 extends within the recessed portion of the needle, the projection 11912 can engage the inner surface of the recessed portion.In operation, the projection 11912 may help to keep the tip 11902 within the recessed portion.

[0065] The tab 11904 may include a generally planar surface with one or more sensor contacts 11914 disposed thereon. The sensor contact(s) 11914 may be configured to align with a corresponding number of compliant, carbon-impregnated polymer modules encapsulated in a connector.

[0066] In some embodiments, as shown, the neck 11906 may form or otherwise define a depression or bend 11916 extending between the flag 11904 and the tip 11902. The bend 11916 may prove advantageous to provide flexibility to the sensor 11900 and prevent bending of the neck 11906.

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

[0068] The Fig. 8A and Fig. 8B are isometric and partially exploded isometric views of an example connector assembly 12000 according to one or more embodiments. As shown, the connector assembly 12000 may include a connector 12002, and Fig. 8C is an isometric bottom view of the connector 12002. The connector 12002 may comprise an injection-molded part used to connect one or more compliant, carbon-impregnated polymer modules 12004 (four in Fig. 8B) to a bracket 12006. More specifically, the connector 12002 can help secure the modules 12004 in position adjacent to the sensor 11900 and in contact with the sensor contacts 11914 ( Fig. 7C) which is attached to flag 11904 ( Fig. 7C). The modules 12004 may be made of a conductive material to enable conductive communication between the sensor 11900 and corresponding circuit contacts (not shown) within the holder 12006.

[0069] How best in Fig. 8C, the connector 12002 may define pockets 12008 that are sized to receive the modules 12004. Furthermore, in some embodiments, the connector 12002 may define one or more recesses 12010 that are configured to engage one or more corresponding flanges 12012 ( Fig. 8B) on the bracket 12006. By mating the recesses 12010 with the flanges 12012, the connector 12002 can be secured to the bracket 12006 via a press fit or the like. In other embodiments, the connector 12002 can be secured to the bracket 12006 with an adhesive or by ultrasonic welding.

[0070] Fig. 8D and Fig. 8E are isometric and partially exploded isometric views of another embodiment of a connector assembly 12100 according to one or more embodiments. As shown, the connector assembly 12100 may include a connector 12102, and Fig. Figure 8F is an isometric bottom view of the connector 12102. The connector 12102 may include an injection-molded part that serves to connect one or more compliant metal contacts 12104 (four in Fig. 8E) to a sensor 11900 on a mount 12106. More specifically, the connector 12102 can help secure the contacts 12104 in position adjacent to the sensor 11900 and in contact with the sensor contacts 11914 ( Fig. 7C) provided on the tab 11904. The contacts 12104 may be formed of a stamped conductive material that provides a conductive connection between the sensor 11900 and corresponding circuit contacts (not shown) within the holder 12106. In some embodiments, the contacts 12104 may, for example, be soldered to a circuit board (not shown) disposed within the holder 12106.

[0071] How best in Fig. 8F, the connector 12102 may define pockets 12108 sized to receive the contacts 12104. Additionally, in some embodiments, the connector 12102 may define one or more recesses 12110 configured to mate with one or more corresponding flanges 12112 on the bracket 12106. Mating the recesses 12110 with the flanges 12112 may help secure the connector 12102 to the bracket 12106 via an interference fit or the like. In other embodiments, the connector 12102 may be attached to the bracket 12106 with an adhesive or by ultrasonic 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 power loss during storage. For example, according to some embodiments, a first portion of the pull tab may be releasably engaged with the sensor 11900 to provide electrical coupling between the sensor contacts 11914, on the one hand, and either the modules 12004 of Fig. 8B or contacts 12104 Fig. 8E on the other hand. Furthermore, in some embodiments, a second portion of the pull tab may be coupled to the needle or needle carrier such that the pull tab is released from the sensor 11900 when the applicator is actuated. In other embodiments, the second portion of the pull tab may be coupled to the needle or needle carrier such that the pull tab is released from the sensor 11900 during or after retraction of the needle.

[0073] According to other embodiments, a first portion of a pull tab (not shown) can be releasably engaged with the power supply (e.g., a battery) to prevent electrical coupling between the power supply and the rest of the sensor electronics (e.g., the circuit board). In these embodiments, the second portion of the pull tab can be coupled to the needle or the carrier for the needle such that the pull tab is released from the power supply either upon actuation of the applicator or during (or after) retraction of the needle. In further embodiments, a first portion of a pull tab (not shown) can be releasably engaged with any component of the sensor electronics in the sensor control unit that would otherwise form a closed circuit with the power supply.Those skilled in the art will recognize that other configurations for preserving battery life and preventing power leakage during storage are possible and are entirely within the scope of the present disclosure. Exemplary embodiments of sensor control devices

[0074] The Fig. 9A and Fig. 9B are side and isometric views, respectively, of an exemplary sensor control device 9102 according to one or more embodiments of the present disclosure. The sensor control device 9102 may, in some aspects, be similar to the sensor control device 102 of Fig. 1 and is therefore best understood by reference thereto. Furthermore, the sensor control device 9102 may be similar to the sensor control device 102 of Fig. 1 and therefore in conjunction with the sensor applicator 102 from Fig. 1, which can deliver the sensor control device 9102 to a target monitoring location on a user's skin.

[0075] As shown, the sensor control device 9102 includes an electronics housing 9104, which may be generally disc-shaped and have a circular cross-section. However, in other embodiments, the electronics housing 9104 may have other cross-sectional shapes, such as egg-shaped, oval, or polygonal, without departing from the scope of the disclosure. The electronics housing 9104 includes a shell 9106 and a bracket 9108 that mates with the shell 9106. The shell 9106 may be attached to the bracket 9108 in a variety of ways, such as a snap fit, an interference fit, ultrasonic 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 attached to the bracket 9108 to form a sealed interface between them.An adhesive patch 9110 may be positioned on or otherwise secured to the underside of the mount 9108. According to one aspect of the embodiments, the adhesive strip 9110 (in . Fig. 9 A in a non-hatched representation) may be configured to fix and hold the sensor control device 9102 in position on the user's skin during operation.

[0076] The sensor control device 9102 may further include a sensor 9112 and a needle 9114 for delivering the sensor 9112 transcutaneously beneath a user's skin during use of the sensor control device 9102. Corresponding portions of the sensor 9112 and the needle 9114 extend distally from the underside of the electronics housing 9104 (e.g., the holder 9108). A needle hub 9116 may be overmolded onto the needle 9114 and configured to secure and support the needle 9114. As best described in Fig. 9A, the needle hub 9116 may include or otherwise define a mating member 9118. Upon assembly of the needle 9114 with the sensor control device 9102, the needle 9114 may be advanced axially through the electronics housing 9104 until the needle hub 9116 engages a top surface of the electronics housing 9104 or an internal component thereof and the mating member 9118 extends distally from the bottom of the retainer 9108. As described below, in at least one embodiment, the needle hub 9116 may sealingly engage an upper portion of a gasket overmolded onto the retainer 9108. When the needle 9114 penetrates the electronics housing 9104, the exposed portion of the sensor 9112 may be received within a hollow or recessed (arc-shaped) portion of the needle 9114. The remaining portion of the sensor 9112 is located inside the electronics housing 9104.

[0077] The sensor control device 9102 may further comprise a sensor cap 9120 which is inserted into the Fig. 9A-9B, separated from the electronics housing 9104. The sensor cap 9120 may help form a tight barrier that surrounds and protects exposed portions of the sensor 9112 and the needle 9114. As illustrated, the sensor cap 9120 may include 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 allow access to an internal chamber 9124 defined within the body. In contrast, the second end 9122b may be closed and provide or otherwise define an engagement member 9126. As described in more detail below, the engagement member 9126 may help connect the sensor cap 9120 to an applicator cap of a sensor applicator (e.g., the sensor applicator 102 of Fig. 1) and may assist in removing the sensor cap 9120 from the sensor controller 9102 when the sensor cap is removed from the sensor applicator.

[0078] The sensor cap 9120 may be removably connected to the electronics housing 9104 at or near the bottom of the mount 9108. More specifically, the sensor cap 9120 may be removably connected to the mating element 9118 that extends distally from the bottom of the mount 9108. For example, in at least one embodiment, the mating element 9118 may include a set of external threads 9128a ( Fig. 9A) which are provided with a set of internal threads 9128b ( Fig. 9B) defined within the inner chamber 9124 of the sensor cap 9120. In some embodiments, the external and internal threads 9128a,b may have a flat thread design (e.g., without a helical bend), but may alternatively have a helical thread engagement. Accordingly, in at least one embodiment, the sensor cap 9120 may be threadably coupled to the mating member 9118 of the needle hub 9116 with the sensor controller 9102. In other embodiments, the sensor cap 9120 may be removably connected to the mating member 9118 via other types of engagements, including, but not limited to, an interference or friction fit, or a frangible member or substance (e.g., wax, an 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 comprise a monolithic (single) structure extending between the first and second ends 9122a,b. However, in other embodiments, the sensor cap 9120 may comprise two or more components. For example, in the illustrated embodiment, 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 to help maintain preferred humidity levels within the interior chamber 9124. In addition, the desiccant cap 9130 may also define or otherwise provide the engagement element 9126 of the sensor cap 9120. In at least one embodiment, the desiccant cap 9130 may include an elastomeric plug inserted into the lower end of the sensor cap 9120.

[0080] In some embodiments, the sensor control device 9102 may also include an adhesive film 9110B (in Fig. 9A) that is connected to an underside of the adhesive patch 9110. Under certain conditions within the housing and cap of the applicator, chemical interactions between the adhesive patch 9110, the enclosed atmosphere, the desiccant, and outgassing of materials may cause the adhesive to degrade during storage or transport of the applicator. Attaching the liner 9110B may mitigate the degradation of the adhesive of the adhesive patch 9110. According to another aspect of the embodiments, the liner 9110B may also be operably connected to the sensor cap 9120 such that removal of the sensor cap 9120 also causes removal of the liner 9110B. Example mechanisms of one-piece and two-piece applicators

[0081] The Fig. 10A-10E depict exemplary details of embodiments of the internal device mechanics for "triggering" the applicator 216 to apply the sensor control device 222 to a user, including safely retracting the needle 1030 into the used applicator 216. Collectively, these drawings depict an exemplary sequence of driving the needle 1030 (carrying a sensor coupled to the sensor control device 222) into a user's skin, retracting the needle while leaving the sensor in operative contact with the user's interstitial fluid, and applying the sensor control device to the user's skin with an adhesive. Modifications of this device for use with the alternative embodiments and components of the applicator assembly will be apparent to those skilled in the art.Furthermore, the applicator 216 may be a sensor applicator having a one-piece or a two-piece architecture as disclosed herein.

[0082] In Fig. 10A, a sensor 1102 is held within the needle 1030 directly above the user's skin 1104. Rails 1106 (optionally three) of an upper guide portion 1108 may be provided to control the movement of the applicator 216 relative to the sheath 318. The sheath 318 is held within the applicator 216 by detents 1110 such that a suitable downward force along the longitudinal axis of the applicator 216 causes the resistance provided by the detents 1110 to be overcome, allowing the needle 1030 and sensor control device 222 to be translated along the longitudinal axis into (and onto) the user's skin 1104. In addition, the catch arms 1112 of the sensor carrier 1022 engage the needle retractor 1024 to hold the needle 1030 in a position relative to the sensor control device 222.

[0083] In Fig. 10B, a user force is applied to overcome or bypass the locking elements 1110, and the sheath 318 collapses into the housing 314, thereby displacing the sensor control device 222 (with associated parts) downward along the longitudinal axis in the direction of arrow L. An inner diameter of the upper guide portion 1108 of the sheath 318 limits the position of the support arms 1112 throughout the stroke of the sensor / needle insertion process. Holding the stop surfaces 1114 of the support arms 1112 against the complementary surfaces 1116 of the needle retractor 1024 maintains the position of the elements with the return spring 1118 fully tensioned.

[0084] In FIG. 10C, the sensor 1102 and the needle 1030 have reached their full penetration depth. At this point, the support arms 1112 pass the inner diameter of the upper guide section 1108. Then, the compressive force of the coil spring 1118 drives the angled stop surfaces 1114 radially outward, releasing force to drive the needle carrier 2102 of the needle retractor 1024 to withdraw the (slotted or otherwise configured) needle 1030 from the user and from the sensor 1102, as indicated by the arrow R in Fig. 10D is displayed.

[0085] When the needle 1030 is fully retracted, as shown in Fig. As shown in Figure 10E, the upper guide portion 1108 of the sheath 318 is provided with a final locking device 1120. The used applicator assembly 216 is then removed from the insertion site, leaving the sensor control device 222 and the needle 1030 securely fastened within the applicator assembly 216. The used applicator assembly 216 can now be discarded.

[0086] The actuation of the applicator 216 upon attachment of the sensor control device 222 is designed such that the user feels that both the insertion and retraction of the needle 1030 are performed automatically by the internal mechanisms of the applicator 216. In other words, the present invention avoids the user feeling like they are manually driving the needle 1030 into their skin. Thus, once the user applies sufficient force to overcome the resistance of the locking devices of the applicator 216, the resulting actions of the applicator 216 are perceived as an automatic response to the applicator being "triggered." The user does not feel like they are exerting additional force to drive the needle 1030 into their skin, even though all of the driving force is provided by the user and no additional biasing / drive means are used to insert the needle 1030. As shown above in FIG.As described in detail in Figure 10C, the retraction of the needle 1030 is automated by the return spring 1118 of the applicator 216.

[0087] Fig. 11A-11C show an alternative embodiment of a spring-loaded retraction mechanism for implementation in a sensor applicator device. According to one aspect of some embodiments, to reduce the number of components in a sensor applicator (and the number of potential mechanical failures), a leaf spring 1118B may be used instead of a coiled return spring 1118 in a sensor applicator, such as the applicator 216 of FIGS. Fig. 10A-10E, can be used.

[0088] With reference to Fig. 11 A is a partial cross-sectional side view of certain sensor applicator components according to some embodiments in a pre-triggering phase (similar to Fig. 10A). In particular, Fig. 11 A, the leaf spring 1118B coupled to the needle 1030B, wherein the needle 1030B is arranged at a distance from the skin surface 1104. As in Fig. 11A, the leaf spring 1118B is illustrated in a first state in which a distally facing surface of the leaf spring 1118B is in a convex configuration relative to the skin surface 1104.

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

[0090] According to another aspect of some embodiments, a plurality of engagement members 1023A, 1023B are configured to secure the leaf spring 1118B to either a sensor carrier (not shown) or a needle retractor (not shown) such that downward movement of the housing, sensor carrier, and needle retractor also causes at least the edge portions of the leaf spring 1118B to move distally.

[0091] Fig. 11B is another partial cross-sectional side view of the above-mentioned sensor applicator components according to some embodiments, wherein the applicator is shown in an insertion phase (similar to FIG. 10C). In particular, Fig. 11B, the needle 1030B after it has pierced the skin surface 1104 and the sensor 1102B has reached a predetermined insertion depth. According to an aspect of some embodiments, during the insertion phase, the adhesive element (not shown) on the underside of the sensor control device 222B is adhered to the skin surface 1104.

[0092] As in Fig. As shown in Figure 11B, the leaf spring 1118B is illustrated in a second state in which the surface of the leaf spring 1118B has transitioned from a convex configuration (relative to the skin surface 1104) to a substantially planar configuration as the housing, sensor carrier, and needle retractor (not shown) of the applicator continue to advance distally. In some embodiments, the substantially planar surface of the leaf spring 1118B may also be configured to exert a force in the distal direction against either the sensor control device 222B or the sensor carrier (not shown).

[0093] Fig. 11C is another partial cross-sectional side view of the aforementioned applicator components according to some embodiments, wherein the applicator is in a retraction phase (similar to Fig. 10D and Fig.10E). In particular, as the applicator housing (not shown) is further displaced distally, the leaf spring 1118B is depicted in a third state in which the surface of the leaf spring 1118B has reached or exceeded a deformation threshold such that the leaf spring 1118B "snaps" into a concave configuration relative to the skin surface 1104. As a result of the concave configuration, according to an aspect of some embodiments, the needle 1030B is retracted proximally from the skin surface 1104 while the sensor 1102B remains below the skin surface 1104. In some embodiments, the concave configuration may also cause the leaf spring 1118B to detach from the sensor controller 222B.

[0094] Subsequently, according to some embodiments, the applicator may be removed from the insertion site, leaving the sensor control device 222B and the needle 1030B securely secured within the applicator assembly. The applicator assembly may now be discarded.

[0095] With respect to all embodiments of the applicator described herein, as well as all of its components, including, but not limited to, the needle, needle module, and sensor module embodiments, it will be apparent to those skilled in the art that these embodiments may be sized and configured for use with sensors designed to detect analyte content in a body fluid in the epidermis, dermis, or subcutaneous tissue of a subject. For example, in some embodiments, the needles and distal portions of analyte sensors disclosed herein may be both sized and configured to be positioned at a specific terminal depth (i.e., the furthest point of penetration into a tissue or layer of the subject's body, e.g., in the epidermis, dermis, or subcutaneous tissue).With respect to some embodiments of applicators, it will be apparent to those skilled in the art that certain embodiments of needles may be sized and configured to be positioned at a different final depth within the subject's body relative to the final depth of the analyte sensor. For example, in some embodiments, a needle may be positioned at a first final depth within the patient's epidermis prior to retraction, while a distal portion of an analyte sensor may be positioned at a second final depth within the patient's dermis. In other embodiments, a needle may be positioned at a first final depth within the subject's dermis prior to retraction, while a distal portion of an analyte sensor may be positioned at a second final depth within the subject's subcutaneous tissue.In further embodiments, a needle may be positioned at a first final depth prior to retraction and the analyte sensor may be positioned at a second final depth, wherein the first final depth and the second final depth are both in the same layer or tissue of the patient's body.

[0096] In addition to the applicator embodiments described herein, it will be apparent to those skilled in the art that an analyte sensor and one or more associated structural components, including, but not limited to, one or more spring mechanisms, may be disposed within the applicator in an off-center position relative to one or more axes of the applicator. For example, in some applicator embodiments, an analyte sensor and a spring mechanism may be disposed in a first off-center position relative to an applicator axis on a first side of the applicator, and the sensor electronics may be disposed in a second off-center position relative to the applicator axis on a second side of the applicator.In other embodiments of the applicator, the analyte sensor, spring mechanism, and sensor electronics may be arranged in an eccentric position relative to an axis of the applicator on the same side. Those skilled in the art will recognize that other permutations and configurations in which the analyte sensor, spring mechanism, sensor electronics, and other components of the applicator are arranged in a centered or off-center position relative to one or more axes of the applicator are possible and entirely within the scope of the present disclosure.

[0097] A variety of deflectable structures are described herein, including, but not limited to, deflectable detents, deflectable locking arms, needle carrier locking arms, needle retaining arms, and module detents. These deflectable structures are constructed of a resilient material such as plastic or metal (or others) and function in a manner known to those skilled in the art. The deflectable structures each have a rest state or position to which the resilient material is biased. When a force is applied that deflects or moves the structure from this rest state or position, the bias of the resilient material causes the structure to return to the rest state or position once the force is removed (or reduced).In many cases, these structures are configured as arms with detents or snap-in closures, but other structures or configurations may be used that provide the same characteristics of deflectability and ability to return to a rest position, including, but not limited to, a leg, a bracket, a latch, a stop member on a deflectable member, and the like.

[0098] Further details of suitable devices, systems, methods and their operation, as well as related features, are provided in International Publication No. WO2018 / 136898 by Rao et al., International Publication No. WO2019 / 236850 by Thomas et al., International Publication No. WO2019 / 236859 by Thomas et al., International Publication No. WO2019 / 236876 by Thomas et al., and US Patent Publication No. 2020 / 0196919, filed June 6, 2019, each of which is incorporated herein by reference in its entirety. Further details regarding embodiments of applicators, their components, and variations are set forth in U.S. Patent Publications Nos. 2012 / 0197222, 2013 / 0150691, 2016 / 0128615, 2016 / 0331283, 2018 / 0235520, 2019 / 0298240, and 2020 / 0397356, all of which are hereby incorporated by reference in their entirety and for all purposes.Further details regarding embodiments of needles, sharps, their components, and variations thereof are described in U.S. Patent No. 2014 / 0171771, which is hereby incorporated by reference in its entirety and for all purposes.

[0099] Exemplary embodiments and features are set forth in the following numbered paragraphs: 1. A sensor applicator assembly comprising: a housing configured to move between a first position and a second position; a sheath slidably connected to the housing; and a sensor carrier connected to the housing; an applicator cap threadably connected to the housing, wherein the applicator cap and the housing form an interior space, and wherein the interior space contains a slightly pressurized inert gas. 2. The sensor applicator assembly of paragraph 1, wherein the housing includes an applicator cap sealing lip configured to engage the applicator cap. 3. The sensor applicator assembly of paragraph 2, wherein the applicator cap includes a sealing surface configured to receive the applicator cap sealing lip of the housing. 4. Sensor applicator assembly according to paragraph 3, wherein the sealing surface and the sealing lip of the applicator cap are configured to form a seal between the housing and the applicator cap. 5. The sensor applicator assembly of paragraph 4, wherein the seal further comprises a sealing collar. 6. A sensor applicator assembly according to paragraph 4 or 5, wherein the slightly pressurised inert gas creates an outward flow across the seal. 7. The sensor applicator assembly of any one of claims 1 to 6, wherein the slightly pressurized gas comprises nitrogen. 8. The sensor applicator assembly of any one of paragraphs 1 to 7, wherein the applicator cap is configured to retain a desiccant. 9. Sensor applicator assembly according to any one of paragraphs 1 to 8, wherein the applicator cap does not contain a desiccant. 10. Sensor applicator assembly according to one of paragraphs 1 to 9, wherein the interior space has a first pressure and wherein an exterior space outside the sensor applicator assembly has a second pressure which is lower than the first pressure. 11. A sensor applicator assembly comprising: a housing configured to move between a first position and a second position; a sheath slidably connected to the housing; a needle carrier comprising one or more magnets; a sensor control device comprising an analyte sensor, sensor electronics, and one or more ferromagnetic components; and a sensor carrier configured to hold the sensor control device, wherein the one or more magnets are configured to exert a magnetic force on the ferromagnetic components in a proximal direction such that the sensor control device is held in the sensor carrier when the housing is in the first position. 12. The sensor applicator assembly of claim 11, wherein the one or more ferromagnetic components are disposed in the sensor control device. 13. Sensor applicator assembly according to claim 11 or 12, wherein the one or more ferromagnetic components are embedded in a housing of the sensor control device. 14. Sensor applicator assembly according to any one of paragraphs 11 to 13, wherein the sensor carrier is configured to hold the sensor control device only by magnetic force. 15. The sensor applicator assembly of any one of paragraphs 11 to 14, wherein the one or more magnets are disposed on a distal surface of the needle carrier. 16. Sensor applicator assembly according to any one of paragraphs 11 to 15, wherein the one or more magnets are embedded in a distal end of the needle carrier. 17. A sensor applicator assembly according to any one of paragraphs 11 to 16, wherein the one or more magnets comprise a single magnetic element. 18. The sensor applicator assembly of claim 17, wherein the single magnetic element has an annular geometry. 19. The sensor applicator assembly of paragraphs 11 to 18, wherein at least a portion of a distal end of the needle carrier comprises a magnetic material. 20. The sensor applicator assembly of paragraphs 11 to 16, wherein the one or more magnets comprise two magnetic elements disposed on a distal surface of the needle carrier. 21. The sensor applicator assembly of paragraphs 11 to 16, wherein the one or more magnets comprise three magnetic elements disposed on a distal surface of the needle carrier. 22. Sensor applicator assembly according to paragraphs 11 to 21, further comprising a return spring. 23. The sensor applicator assembly of paragraph 22, wherein the return spring is configured to extend and move the needle carrier in a proximal direction after the housing reaches the second position. 24. The sensor applicator assembly of paragraph 23, wherein the one or more magnets are configured such that the magnetic force exerted on the ferromagnetic components is insufficient to retain the sensor control device in the sensor carrier after the needle carrier has moved in the proximal direction. 25. The sensor applicator assembly of paragraph 24, wherein the sensor control device is configured to disengage from the sensor carrier after the needle carrier has moved in the proximal direction. 26. A sensor applicator assembly comprising: a housing configured to move between a first position and a second position; a sheath slidably connected to the housing; a needle carrier connected to a needle; a sensor control device comprising: an analyte sensor comprising a plurality of sensor contacts, a connector assembly comprising one or more of a plurality of sensor modules or a plurality of connector contacts, the connector assembly configured to be coupled to the analyte sensor, and a power supply; and a sensor carrier configured to hold the sensor control device, the connector assembly further comprising a pull tab comprising an electrically insulating material. 27. The sensor applicator assembly of paragraph 26, wherein the pull tab includes a first portion releasably engaging the plurality of sensor contacts. 28. The sensor applicator assembly of paragraph 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 applicator assembly of paragraph 27, wherein the first portion of the pull tab is configured to prevent electrical coupling between the sensor contacts and the plurality of connector contacts. 30. The sensor applicator assembly of any one of paragraphs 27 to 29, wherein the pull tab includes a second portion connected to the needle or needle carrier. 31. The sensor applicator assembly of paragraph 30, wherein the pull tab is configured to disengage from the plurality of sensor contacts upon movement of the needle or needle carrier when the sensor applicator assembly is actuated. 32. The sensor applicator assembly of paragraph 30, wherein the pull tab is configured to disengage from the plurality of sensor contacts when the needle or needle carrier is retracted into the sensor applicator assembly. 33. A sensor applicator assembly comprising: a housing configured to move between a first position and a second position; a sheath slidably connected to the housing; a needle carrier connected to a needle; a sensor control device comprising: an analyte sensor comprising a plurality of sensor contacts, a connector configured to be connectable to the analyte sensor, and a power supply; and a sensor carrier configured to hold the sensor control device, the sensor control device further comprising a pull tab connected to the power supply, the pull tab comprising an electrically insulating material. 34. The sensor applicator assembly of paragraph 33, wherein the power supply is a button cell battery. 35. A sensor applicator assembly according to paragraph 33 or 34, wherein the pull tab includes a first portion releasably engaging the power supply. 36. The sensor applicator assembly of paragraph 35, wherein the first portion of the pull tab is configured to prevent electrical coupling between the power supply and the sensor electronics of the sensor control device. 37. A sensor applicator assembly according to paragraph 35 or 36, wherein the pull tab has a second portion connected to the needle or needle carrier. 38. The sensor applicator assembly of paragraph 37, wherein the pull tab is configured to release from the power supply by movement of the needle or needle carrier when the sensor applicator assembly is actuated. 39. The sensor applicator assembly of paragraph 37, wherein the pull tab is configured to disengage from the power supply when the needle or needle carrier is retracted into the sensor applicator assembly. 40. A sensor applicator assembly comprising: a housing configured to move between a first position and a second position; a sleeve slidably coupled to the housing; a needle carrier coupled to a needle; a sensor control device comprising: an electronics housing, sensor electronics disposed within the electronics housing, an analyte sensor coupled to the sensor electronics, an adhesive member disposed on a bottom surface of the electronics housing, and an adhesive film coupled to a bottom surface of the adhesive member; and a sensor carrier configured to hold the sensor control device; and a sensor cap removably coupled to the sensor control device. 41. The sensor applicator assembly of paragraph 40, wherein the adhesive film is operatively connected to the sensor cap such that removal of the sensor cap causes removal of the adhesive film. 42. The sensor applicator assembly of paragraph 41, further comprising an applicator cap threadably engageable with the housing, the applicator cap configured to remove the sensor cap from the sensor applicator assembly when the applicator cap is detached from the housing. 43. The applicator assembly of paragraph 41 or 42, wherein the sensor control device comprises a first opening on a top surface of the electronics housing, the sensor control device comprises a second opening on a bottom surface of the electronics housing, the adhesive patch comprises a third opening, the adhesive film comprises a fourth opening, and the needle extends through the first, second, third, and fourth openings when the housing is in the first position. 44. A sensor applicator assembly comprising: a housing configured to move between a first position and a second position; a sheath slidably connected to the housing, a distal end of the sheath configured to engage a skin surface; a leaf spring connected to a needle; a sensor control device including an analyte sensor connected to sensor electronics; and a sensor support configured to support the sensor control device when the housing is in the first position, the needle 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 needle into the sensor applicator assembly after the housing is moved to the second position. 45. The sensor applicator assembly of paragraph 44, wherein the leaf spring has a convex configuration relative to the skin surface when the housing is in the first position. 46. The sensor applicator assembly of paragraph 44 or 45, wherein the leaf spring is configured to deform as the housing moves between the first position and the second position. 47. A sensor applicator assembly according to any one of paragraphs 44 to 46, wherein the leaf spring has a substantially planar configuration relative to the skin surface before the needle is retracted into the sensor applicator assembly. 48. The sensor applicator assembly of any one of paragraphs 44 to 47, wherein the sensor control device is configured to adhere to the skin surface when the housing is moved to the second position, and wherein the leaf spring has a substantially planar configuration relative to the skin surface when the sensor control device is adhered to the skin surface. 49. The sensor applicator assembly of any one of paragraphs 44 to 48, wherein the leaf spring has a concave configuration relative to the skin surface after the needle has been retracted into the sensor applicator assembly. 50. A sensor applicator assembly according to any one of paragraphs 44 to 49, wherein the leaf spring is connected to the needle by an interference fit. 51. A sensor applicator assembly according to any one of paragraphs 44 to 49, wherein the leaf spring is connected to the needle by ultrasonic welding. 52. Sensor applicator assembly according to any one of paragraphs 44 to 49, wherein the leaf spring is connected to the needle by laser welding. 53. A sensor applicator assembly according to any one of paragraphs 44 to 49, wherein the leaf spring is connected to the needle by one or more mechanical fasteners. 54. The sensor applicator assembly of any one of paragraphs 44 to 53, wherein the leaf spring comprises a first material and the needle comprises a second material different from the first material. 55. A sensor applicator assembly according to any one of paragraphs 44 to 53, wherein the leaf spring and the needle comprise a stainless steel material. 56. The sensor applicator assembly of any one of paragraphs 44 to 55, wherein the leaf spring has a first stiffness and wherein the needle has a second stiffness different from the first stiffness. 57. The sensor applicator assembly of any one of paragraphs 44 to 56, further comprising a plurality of engagement members configured to secure the leaf spring to the sensor carrier. 58. The sensor applicator assembly of any one of paragraphs 44 to 56, further comprising a plurality of engagement members configured to secure the leaf spring to the needle carrier. 59. The sensor applicator assembly of any one of paragraphs 44 to 58, wherein the leaf spring is further configured to exert a force in a distal direction against the sensor control device. 60. The sensor applicator assembly of any one of paragraphs 44 to 59, wherein the leaf spring is further configured to exert a force in a distal direction against the sensor carrier. 61. A method for introducing an inert gas into a sensor applicator assembly comprising a housing and a cap, the method comprising: disposing the sensor applicator assembly in a closed system while the closed system is at a first predetermined temperature, wherein at the first predetermined temperature the housing and the cap form a seal; heating the closed system from the first predetermined temperature to a second predetermined temperature, wherein at the second predetermined temperature thermal expansion of the cap causes the cap to separate from the housing; diffusing the inert gas into an interior space of the sensor applicator assembly; and cooling the closed system from the second predetermined temperature to a third predetermined temperature, wherein at the third predetermined temperature contraction of the cap causes the cap to form the seal with the housing. 62. A process according to paragraph 61, wherein the inert gas is argon. 63. A method according to paragraph 61 or 62, wherein the first predetermined temperature is equal to the third predetermined temperature. 64. The method of any one of paragraphs 61 to 63, wherein diffusing the inert gas into the interior of the sensor applicator assembly comprises maintaining the closed system at the second predetermined temperature for a predetermined period of time. 65. A method according to any one of paragraphs 61 to 64, further comprising introducing the inert gas into the closed system prior to introducing the sensor applicator assembly thereinto. 66. A method according to any one of paragraphs 61 to 64, further comprising introducing the inert gas into the closed system after introducing the sensor applicator assembly therein. 67. A sensor applicator assembly comprising: a housing configured to move between a first position and a second position; a sheath slidably connected to the housing; a sensor control device comprising an analyte sensor, sensor electronics, and one or more ferromagnetic components; and a sensor carrier comprising one or more magnets, the sensor carrier configured to hold the sensor control device, the one or more magnets configured to exert a magnetic force on the ferromagnetic components in a proximal direction such that the sensor control device is held in the sensor carrier when the housing is in the first position. 68. The sensor applicator assembly of paragraph 67, wherein the one or more ferromagnetic components are disposed in the sensor control device. 69. A sensor applicator assembly according to paragraph 67 or 68, wherein the sensor control device further comprises an adhesive patch. 70. A sensor applicator assembly according to paragraph 69, wherein the adhesive patch, when bonded to a skin surface, produces an adhesive force greater than the magnetic force. 71. The sensor applicator assembly of paragraph 70, wherein the adhesive patch is configured such that the adhesive force causes the sensor control device to detach from the sensor carrier when the sensor control device adheres to the skin. 72. A sensor applicator assembly comprising: a housing having an interior space; a sensor carrier configured to hold a sensor control device and moveable between a first position and a second position within the interior space of the housing, the sensor carrier comprising a magnet; the sensor control device comprising a glucose sensor coupled to sensor electronics, the sensor control device being disposed within the interior space of the housing when the sensor carrier is in the first position. 73. The sensor applicator assembly of paragraph 72, further comprising a needle carrier, a needle, and a return spring. 74. The sensor applicator assembly of paragraph 73, wherein the return spring is configured to extend and move the needle carrier in a proximal direction. 75. A sensor control assembly according to paragraph 72, wherein the magnet engages at least a portion of the sensor control device. 76. A sensor control device according to paragraph 72, wherein the sensor control device comprises a material responsive to a magnetic field generated by the magnet of the sensor carrier. 77. The sensor control device of paragraph 72, wherein the sensor control device further comprises an adhesive patch disposed on a bottom surface of the sensor control device.

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

[0101] It should be noted that all features, elements, components, functions, and steps described with respect to an embodiment provided herein are freely combinable and interchangeable with those of any other embodiment. If a particular feature, element, component, function, or step is described only with respect to one embodiment, it should be understood that this feature, element, component, function, or step can be used in any other embodiment described herein, unless expressly stated otherwise.This paragraph therefore serves as prior basis and written support for the introduction of paragraphs at any time that combine features, elements, components, functions, and steps from different embodiments, or that substitute features, elements, components, functions, and steps from one embodiment for those from another embodiment, even if the following description does not expressly state in a particular case that such combinations or substitutions are possible. The foregoing description of specific embodiments of the disclosed subject matter is thus provided for purposes of illustration and description only. It is expressly recognized that an express enumeration of all possible combinations and substitutions would be unduly burdensome, especially since the permissibility of each and every combination and substitution will be readily apparent to one skilled in the art.

[0102] While the embodiments are subject to various modifications and alternative forms, specific examples thereof are illustrated in the drawings and described in detail herein. It will be apparent to those skilled in the art that various modifications and variations may be made to the method and system of the disclosed subject matter without departing from the spirit or scope of the disclosed subject matter. Therefore, the disclosed subject matter is intended to include modifications and variations that are within the scope of the appended claims and their equivalents. Furthermore, any features, functions, steps, or elements of the embodiments may be recited in or added to the claims, as may negative limitations defining the inventive scope of the claims by features, functions, steps, or elements that do not fall within such scope. QUOTES CONTAINED IN THE DESCRIPTION

[0000] This list of documents submitted by the applicant was generated automatically and is included solely for the convenience of the reader. This list is not part of the German patent or utility model application. The DPMA assumes no liability for any errors or omissions. Cited patent literature

[0000] WO 2018 / 136898

[0098] WO 2019 / 236850

[0098] WO 2019 / 236859

[0098] WO 2019 / 236876

[0098] US 2020 / 0196919

[0098] US 2012 / 0197222

[0098] US 2013 / 0150691

[0098] US 2016 / 0128615

[0098] US 2016 / 0331283

[0098] US 2018 / 0235520

[0098] US 2019 / 0298240

[0098] US 2020 / 0397356

[0098] US 2014 / 0171771

[0098]

Claims

[1] An arrangement for introducing a glucose sensor into the body of a person, which arrangement comprises: (1) an applicator consisting of: an applicator housing defining an interior space; a sheath connected to the applicator housing and having a distal end configured for placement on the skin; a needle carrier assembly connected to a needle; a sensor carrier having a cavity formed by a proximal wall and a side wall, with a magnetic component, the cavity configured to receive a sensor control device therein; a spring having a distal end in contact with the sensor carrier; and a cap configured to be connectable to a distal portion of the applicator housing; (2) the sensor control device configured to be worn on the body of the person, the sensor control device comprising: an adhesive element arranged on the underside of the sensor control device and configured to adhere the sensor control device to the skin of the person; The glucose sensor includes: a proximal portion configured to be electrically coupled to electronics; a distal part with an enzyme, wherein the distal part Part is configured to be absorbed transcutaneously under the skin of the user to monitor glucose in a body fluid of the person; and the electronics one or more processors, a memory and Communication circuitry configured to transmit data wirelessly according to a Bluetooth Low Energy protocol, wherein the needle carrier assembly, the needle, the spring, the sensor carrier, the magnet, and the sensor control device are configured to move within the applicator housing by a predetermined distance relative to the sheath and in a linear direction from a proximal position to a distal position, wherein in the proximal position the distal end of the glucose sensor is received in a portion of the needle, wherein the magnetic component of the sensor carrier is configured to exert a magnetic force on one or more ferromagnetic components of the sensor control device, and wherein the sensor carrier is configured to retain the sensor control device in the sensor carrier when the sensor control device is in the proximal position, and wherein the sensor control device in the distal position is configured to adhere to the skin of the person via the adhesive element and to detach from the sensor carrier when the user pulls the applicator away from the skin. [2] The assembly of claim 1, wherein the sensor control device further comprises a sensor control device housing defining an interior of the sensor control device, and wherein the one or more ferromagnetic components are disposed within the interior of the sensor control device. [3] The assembly of claim 2, wherein an adhesive force generated by the adhesive property of the adhesive element is greater than the magnetic force exerted by the magnetic component on the one or more ferromagnetic components. [4] The assembly of claim 3, wherein the spring is configured to retract the needle carrier assembly and the needle proximally into the applicator after the needle carrier assembly, the needle, the spring, the sensor carrier, the magnetic component, and the sensor control device have reached the distal position. [5] The assembly of claim 4, wherein the glucose sensor further comprises a proximal portion having one or more electrical contacts. [6] The assembly of claim 5, wherein the glucose sensor further comprises a bent portion between the proximal portion and the distal portion of the glucose sensor. [7] The arrangement of claim 6, wherein the proximal part of the glucose sensor is arranged perpendicular to the distal part of the glucose sensor. [8] The assembly of claim 7, wherein the distal end of the glucose sensor and a distal portion of the needle extend in a distal direction from the bottom of the sensor control device when the needle support assembly, the needle, the spring, the sensor support, the magnetic component, and the sensor control device are in the proximal position. [9] The assembly of claim 8, wherein the sensor control device further comprises a first opening on a top side of the housing of the sensor control device, wherein the sensor control device further comprises a second opening on the underside of the sensor control device, and wherein the needle is configured to extend through the first opening and the second opening when the needle carrier assembly, the needle, the spring, the sensor carrier, the magnet, and the sensor control device are in the proximal position. [10] The assembly of claim 9, wherein the adhesive member has a third opening, and wherein the needle is configured to extend through the third opening when the needle carrier assembly, the needle, the spring, the sensor carrier, the magnet, and the sensor control device are in the proximal position. [11] The assembly of claim 10, wherein the sensor support does not include one or more spring arms configured to retain the sensor control device. [12] The assembly of claim 11, wherein the applicator further comprises a sealing ring to create a seal between the applicator housing and the cap.

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