Systems and devices for analyte monitoring

Abstract

Arrangement for inserting a glucose sensor into a person's body, which arrangement includes: (1) an applicator consisting of: an applicator housing that defines an interior space; a sheath that is connected to the applicator housing and has a distal end configured for placement on the skin; a needle carrier arrangement connected to a needle; a sensor carrier with a cavity formed by a proximal wall and a side wall, with a magnetic component, wherein the cavity is configured to accommodate a sensor control device therein; a spring with a distal end that is in contact with the sensor carrier; and a cap designed to be connectable to a distal part of the applicator housing; (2) the sensor control device configured to be worn on the person's body, the sensor control device comprising: an adhesive element located on the underside of the sensor control device and configured to allow the sensor control device to adhere to the person's skin; The glucose sensor includes: a proximal part configured to be electrically coupled to an electronics unit; a distal part with an enzyme, wherein the distal part The part is configured to be absorbed transcutaneously under the user's skin to monitor glucose in a person's bodily fluid; and The electronics include one or more processors, memory, and communication circuits configured to transmit data wirelessly according to a Bluetooth or Bluetooth Low Energy protocol. wherein the needle carrier assembly, the needle, the spring, the sensor carrier, the magnetic component, and the sensor control device are configured to move inside the applicator housing a certain distance relative to the casing 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 section 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 hold 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 person's skin via the adhesive element and detach from the sensor carrier when the user pulls the applicator away from the skin.

Description

REFERENCE TO RELATED REGISTRATIONS

[0001] This application claims priority over preliminary US application No. 63 / 222,851, filed on July 16, 2021. AREA

[0002] The subject described here generally refers 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 crucial for 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 blood glucose levels, or when additional glucose is needed to raise them.

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

[0005] To improve patient adherence to a frequent blood glucose monitoring plan, in vivo analyte monitoring systems can be used. These systems involve wearing a sensor control device on the body of the individual requiring analyte monitoring. To enhance comfort and ease of use, the sensor control device can be small and assembled and attached by the individual using a sensor applicator. The application process involves inserting a sensor using an applicator or insertion mechanism, bringing the sensor into contact with a bodily fluid. The sensor control device can also be configured to transmit analyte data to another device, allowing the individual or their healthcare provider (HCP) to review the data and make treatment decisions.

[0006] While current sensors are convenient for users, they 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 problems. This can be particularly true for analyte monitoring systems that use in vivo analyte sensors to measure analyte levels in an interstitial fluid (ISF) and that are inserted using sharp instruments (also known as "insertion aids" or "needles"). For example, some prior art systems may have certain mechanisms and features that are susceptible to failure or reduced effectiveness under adverse conditions.These and other challenges described herein can lead to improperly inserted or damaged sensors and consequently to faulty monitoring of the patient's analyte levels.

[0007] Therefore, there is a need for more reliable sensor insertion devices and related systems and procedures that are easy for the patient to use, less prone to errors, 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 become apparent through its practical application. Further advantages of the disclosed subject matter are realized and achieved through the methods and systems particularly highlighted 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 generally described, the disclosed subject matter is directed towards an applicator for delivering a sensor control device. The applicator may comprise 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 connected to sensor electronics; and a sensor carrier.

[0010] In some embodiments, the applicator may include an applicator cap that can be screwed onto 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 include one or more magnets, wherein the sensor control device further includes 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 held in the sensor carrier when the housing is in the first position.

[0012] In some embodiments, the sensor control device may comprise a connector arrangement with a pull tab, wherein the pull tab is made of an electrically insulating material and is detachably engaged with 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 comprise an adhesive film that is connected to the 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 part of the analyte sensor under a skin surface when the housing is moved into the second position, and wherein the leaf spring is configured to retract the needle into the applicator after the housing has been moved into the second position.

[0014] Other systems, devices, methods, features, and advantages of the subject matter described herein will be or become obvious to a person skilled in the art upon examination of the following figures and the detailed description. It is intended that all such additional systems, devices, methods, features, and advantages are included in this description, fall within the scope of the subject matter described herein, and are protected by the accompanying claims. The features of the exemplary embodiments are in no way to be construed as limiting the accompanying claims, unless such features are expressly mentioned in the claims. BRIEF DESCRIPTION OF THE FIGURES

[0015] The details of the object described herein, both in terms of its structure and its function, can be seen by examining the accompanying figures, in which the same reference symbols denote the same parts. The components in the figures are not necessarily to scale; rather, the emphasis is on illustrating the principles of the object. Furthermore, all illustrations serve to convey concepts, whereby relative sizes, shapes, and other detailed features may be represented 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. Figure 2A is a block diagram illustrating an embodiment of a reading device. Fig. 2B and Fig. 2C are block diagrams that illustrate embodiments of sensor control devices. Fig. Figures 3A-3G are successive views of an exemplary embodiment of the assembly and application of an in vivo analyte monitoring system with a two-part architecture. Fig. Figure 4A is a side view showing an embodiment of an application device connected to a cap. Fig. Figure 4B is a side perspective view showing an embodiment of an application device and a cap that are separated from each other. Fig. Figure 4C is a perspective view showing an embodiment of a distal end of an application device and an electronics housing. Fig. Figure 4D is a top view of an exemplary applicator device according to the disclosed subject matter. Fig. 4E is a bottom view of the applicator device made of Fig. 4D. Fig. 4F is an exploded view of the applicator device made of Fig. 4D. Fig. 4G is a side sectional view of the applicator device made of Fig. 4D. Fig. 5A is a proximal perspective view showing one embodiment of a sensor carrier. Fig. Figure 5B is a distal perspective view showing one embodiment of a sensor carrier. Fig. 5C is a top view of a sensor carrier according to the disclosed subject matter. Fig. 5D is a bottom view of the sensor carrier made of Fig. 5C. Fig. Figure 6A is a perspective view of a needle holder according to the disclosed object. Fig. 6B is a side sectional view of the needle carrier made of Fig. 6A. Fig. Figure 6C is a perspective view of a needle holder according to the disclosed object. Fig. 6D is a side sectional view of the needle carrier made of Fig. 6C. Fig. Figure 7 is a side view of an exemplary sensor according to one or more embodiments of the disclosure. Fig. 8A and Fig. Figure 8B shows isometric and partially exploded isometric views of an exemplary connector arrangement according to one or more embodiments. Fig. 8C is an isometric bottom view of the connector made of Fig. 8A-8B. Fig. 8D and Fig. Figure 8E are isometric and partially exploded isometric views of another exemplary connector arrangement according to one or more embodiments. Fig. 8F is an isometric view from below of the connector. Fig. 8D-8E. Fig. 9A and Fig. Figure 9B are side views or isometric views of an exemplary sensor control device according to one or more embodiments of the present disclosure. The Fig. Figures 10A-10E show cross-sectional views illustrating an embodiment of an applicator in various stages of insertion. The Fig. Figures 11A - 11C are side views of a leaf spring and a needle assembly according to one or more embodiments of the present disclosure. DETAILED DESCRIPTION

[0016] Before the present subject matter is described in detail, it should be noted that this disclosure is not limited to the specific embodiments described, as these can naturally vary. It should also be noted that the terminology used here serves only to describe certain embodiments and is not limiting, since the scope of this disclosure is limited only by the accompanying claims.

[0017] As used herein and in the attached claims, the singular forms “a”, “an”, and “the” encompass multiple references unless the context clearly requires otherwise.

[0018] The publications discussed herein serve solely for prior disclosure to the filing date of the present application. Nothing herein shall be construed as an admission that the present disclosure cannot be backdated to this publication due to a prior disclosure. Furthermore, the stated publication dates may differ from the actual publication dates, which may require independent verification.

[0019] In general, embodiments of the present disclosure comprise 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 sterile packaging containing an electronic housing for the sensor control device. According to some embodiments, the user may also be provided with a separate structure, such as a container, as sterile packaging containing a sensor module and a needle module. The user can connect the sensor module to the electronic housing and connect the needle to the applicator, inserting the applicator into the container using a specific method. 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 carrier's body fluid. Some embodiments described herein are improvements for maintaining the sterility of the applicator, the sensor control device, and / or the analyte sensor during storage. Some embodiments described herein reduce the susceptibility of the applicator, the sensor control device, and / or the analyte sensor to malfunctions and mechanical failures. Further 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 part of the sensor is, or can be, positioned within a user's body to obtain information about at least one analyte of the body. It should be noted, however, that the embodiments disclosed herein can be used with in vivo analyte monitoring systems that incorporate in vitro capabilities, as well as with purely in vitro or ex vivo analyte monitoring systems, including systems that are completely non-invasive.

[0021] Furthermore, for each individual embodiment of a method disclosed herein, systems and devices capable of performing each of these embodiments fall within the scope of this disclosure. For example, embodiments of sensor control devices are disclosed, and these devices may include one or more sensors, analyte monitoring circuits (e.g., an analog circuit), memories (e.g., for storing instructions), power sources, communication circuits, transmitters, receivers, processors, and / or controllers (e.g., for executing instructions) that can perform all method steps or facilitate the execution of all 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 all methods described herein.

[0022] As mentioned, this document describes a number of embodiments of systems, devices, and methods that offer improvements to sensor insertion devices and sensor control devices for use with in vivo analyte monitoring systems. In particular, several embodiments of this disclosure are designed to improve the durability of certain components of a sensor application device and to reduce their susceptibility to mechanical failure. Some embodiments, for example, include a pull tab comprising an electrically insulating material coupled to one or more of the following elements: 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 the power supply 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 yet another embodiment, multiple magnetic elements are used to hold 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 control units.

[0023] Before these aspects of the embodiments are described in detail, it is desirable to first describe examples of devices that may be present, for example, in an in vivo analyte monitoring system, as well as examples of their operation, all of which can be used with the embodiments described here.

[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, such as automatically according to a schedule. Flash analyte monitoring systems (or flash glucose monitoring systems or simply flash systems), on the other hand, can transmit data from a sensor controller in response to a scan or data request from a reader, for example, using a near-field communication (NFC) or radio-frequency identification (RFID) protocol. In vivo analyte monitoring systems can also operate without fingerstick calibration.

[0025] In vivo analyte monitoring systems differ from "in vitro" systems, which come into contact with a biological sample outside the body (or "ex vivo") and typically include a measuring device with a port for receiving 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, comes into contact with the user's body fluid and measures the analyte concentrations contained 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 the analyte measurement. The sensor control device and variations thereof may also be referred to as a "sensor control unit," "body-attached electronic device or unit," "body-attached 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 and / or displays this measured analyte data to the user in any desired form. This device and variations 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. Exemplary in vivo analytical monitoring system

[0028] Fig. Figure 1 is a conceptual diagram illustrating an embodiment of an analyte monitoring system 100, comprising a sensor applicator 150, a sensor control device 102, and a reader 120. Here, the sensor applicator 150 can be used to deliver the sensor control device 102 to a monitoring site on a user's skin, where a sensor 104 is held in position by an adhesive patch 105 for a specific period of time. The sensor control device 102 is located in the Fig. 2B and Fig. 2C is described in more detail and can communicate with the reader device 120 via a communication path 140 using 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 screen 122 and the input device 121, and the device's battery can be recharged via the power port 123. The reader 120 can communicate with the local computer system 170 via a communication path 141 using wired or wireless technology.The local computer system 170 can include one or more of the following components: laptop, desktop, tablet, phablet, smartphone, set-top box, video game console, or other computer devices, and wireless communication can include any number of suitable wireless network protocols, including Bluetooth, Bluetooth Low Energy (BTLE), Wi-Fi, or others. The local computer system 170 can communicate with a network 190 via communication path 143, similar to how the reader 120 can communicate with the network 190 via communication path 142, using either a wired or wireless technique as previously described. The network 190 can 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 can include a server and provide authentication services and secure data storage, and communicate with the network 190 via a communication path 144 using wired or wireless technology. Example reading device

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

[0030] The Fig. These are block diagrams showing example embodiments of the sensor control device 102 with an analyte sensor 104 and sensor electronics 160 (including an analyte monitoring circuit), which can provide most of the processing power for supplying final result data suitable for display to the user. Fig. Figure 2B shows a single semiconductor chip 161, which may be an application-specific integrated circuit (ASIC). Within the ASIC 161, certain high-level functional units are shown, including an analog front-end circuit (AFE) 162, a power management (or control) circuit 164, a processor 166, and a communication circuit 168 (which may be implemented as a transmitter, receiver, transceiver, passive circuit, or otherwise according to the communication protocol). In this embodiment, both AFE 162 and processor 166 are used as analyte monitoring circuits, but in other embodiments, either circuit can perform the analyte monitoring function.The processor 166 can comprise one or more processors, microprocessors, controllers and / or microcontrollers, each of which can be a discrete chip or distributed across several different chips (and form part of them).

[0031] A memory 163 is also included in ASIC 161 and can be shared by the various functional units present in ASIC 161 or distributed across two or more of them. The memory 163 can also be a separate chip. The memory 163 can be volatile and / or non-volatile memory. In this embodiment, the ASIC 161 is coupled to a power source 173, which can be a coin cell battery or the like. The AFE 162 is connected to the in vivo analyte sensor 104, receives measurement data from it, 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 can 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 only needs minimal further processing by the resident software application to display the data.

[0032] Fig. 2C is similar Fig. 2B, however, contains 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 a power management circuit 164 and a communication circuit 168 on chip 174. AFE 162 includes a memory 163, and chip 174 includes a memory 165, which can be isolated or distributed. In one embodiment, AFE 162 is combined with a power management circuit 164 and a processor 166 on a single chip, while the communication circuit 168 is located on a separate chip. In another embodiment, both AFE 162 and the communication circuit 168 are located on a single chip, and the processor 166 and the power management circuit 164 are located on a separate chip.It should be noted that other chip combinations are possible, including three or more chips, each of which is responsible for the separate functions described or shares one or more functions for fail-safe redundancy. Exemplary assembly processes for sensor control devices

[0033] The components of the sensor control device 102 can be purchased by a user in several packages, which must be assembled by the user before delivery to a suitable user location. Fig. Figures 3A and 3D show an embodiment of an assembly process for the sensor control device 102 by a user, including the preparation of separate components prior to joining the components to prepare the sensor for delivery. Fig. Figures 3E-3F show an embodiment of the delivery of the sensor control device 102 to a suitable user location by selecting the appropriate delivery location and attaching the device 102 at that location.

[0034] Fig. Figure 3A is a proximal perspective view showing an embodiment of a user preparing a container 810, configured here as a tray (although other packaging can also be used), for an assembly process. The user can perform this preparation by removing the lid 812 from the tray 810 to expose the platform 808, for example, by peeling off a non-adherent part of the lid 812 from the tray 810, thus removing the adhesive parts of the lid 812. Removing the lid 812 may be appropriate in various embodiments, as long as the platform 808 is sufficiently exposed within the tray 810. The lid 812 can then be set aside.

[0035] Fig. Figure 3B is a side view showing an 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. Preparing the applicator device 150 may involve separating the housing 702 from the cap 708 to expose the sleeve 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. Figure 3C is a proximal perspective view showing an embodiment of a user inserting an applicator device 150 into a shell 810 during assembly. Initially, the user can insert the sleeve 704 into the platform 808 within the shell 810 after aligning the housing alignment feature 1302 (or slot or recess) and the shell alignment feature 924 (a stop or detent). Inserting the sleeve 704 into the platform 808 temporarily unlocks the sleeve 704 relative to the housing 702 and also temporarily unlocks the platform 808 relative to the shell 810. At this stage, removing the applicator device 150 from the shell 810 results in the same state as before the applicator device 150 was first inserted into the shell 810 (i.e., the operation can be reversed or aborted at this point and then repeated without consequence).

[0037] The sheath 704 can maintain its position within the platform 808 relative to the housing 702 while the housing 702 is advanced distally, coupled to the platform 808 to advance the platform 808 distally relative to the shell 810. This step unlocks and folds the platform 808 within the shell 810. The sheath 704 can come into contact with and release locking elements (not shown) within the shell 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 a sensor (not shown) inside the shell 810 can be coupled to an electronics housing (not shown) inside the housing 702 at the end of the distal forward movement 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. Figure 3D is a proximal perspective view showing an embodiment in which a user removes an applicator 150 from a tray 810 during assembly. A user can remove the applicator 150 from the tray 810 by sliding the housing 702 proximally relative to the tray 810 or by performing other movements that have the same end effect, namely decoupling the applicator 150 from the tray 810. The applicator 150 is removed with the sensor control device 102 (not shown) (needle, sensor, electronics) fully assembled inside and in position for dispensing.

[0039] Fig. Figure 3E is a proximal perspective view showing an embodiment of a patient applying the sensor control device 102 to a target area of ​​the skin, for example, the abdomen or another suitable location, using the applicator device 150. Distal advancement of the housing 702 folds the sheath 704 inside the housing 702, applying the sensor to the target area 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 an 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 in the Fig. 3A - 3F and System 100 described elsewhere herein can reduce or eliminate the probability of accidental breakage, permanent deformation, or incorrect assembly of applicator components compared to prior art systems. Because the applicator housing 702 engages directly with the platform 808 while the sleeve 704 is unlocked, rather than indirectly via the sleeve 704, the relative angular position 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 with conventional devices) during assembly is reduced, which in turn decreases the probability of incorrect assembly by the user. Exemplary sensor applicator devices

[0042] Fig. Figure 4A is a side view showing an embodiment of an applicator device 150 connected to a screw cap 708. This is an example of how the applicator 150 is sent to and received by a user before being assembled by the user with a sensor. Fig. 4B is a side perspective view showing the applicator 150 and the cap 708 after separation. Fig. Figure 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 inside the sensor carrier 710 of the casing 704 if the cap 708 had been attached.

[0043] For illustrative purposes and without limitation to Fig. Referring to 4D-G, the 20150 applicator device can be provided to a user as a single integrated assembly. Fig. 4D and Fig. Figures 4E each show a perspective top view and a perspective bottom view of the applicator device 20150, Fig. Figure 4F shows an exploded view of the applicator device 20150 and Fig. Figure 4G shows a side sectional view. The perspective views illustrate how the 20150 applicator is shipped to and received by a user. The exploded and sectional views illustrate the components of the 20150 applicator device. The 20150 applicator device 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. Upon receipt by the user, only the housing 20702, the cap 20708, the tamper protection 20712 and the label 20709 are visible.The tamper protection feature 20712 can, for example, be a sticker affixed to the housing 20702 and the cap 20708, and the tamper protection feature 20712 can, 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 have previously been 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 can be slightly pressurized with an inert gas during assembly. According to one 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 can be used either instead of 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 can also bias the material flow outwards over the seal formed by the housing 20702 and the cap 20708 and reduce the likelihood of unwanted contaminants ingress.Furthermore, as an additional advantage of some embodiments, a slight escape 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 damaged during transport and / or storage.

[0045] According to another aspect of some embodiments, an inert gas can be introduced into the interior of the housing 20702 using a closed, temperature-controlled system (not shown). First, one or more applicator devices 20150 can be inserted into the closed system while the closed system is at a first predetermined temperature. In some embodiments, the closed system can already be filled with the inert gas before the applicator devices 20150 are placed in it. In other embodiments, the closed system can be filled with the inert gas after the applicator devices 20150 have been placed in it. The closed system is sealed so that the inert gas cannot escape and other external gases cannot penetrate.According to one 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 preceding sections. Subsequently, the closed system is heated to a second predetermined temperature, which is higher than the first predetermined temperature. According to another aspect of some embodiments, at the second predetermined temperature, the thermal expansion of the cap 20708 for each of the one or more applicator devices 20150 may differ (e.g., be greater or lesser) from 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 housing 20702, the temperature of the closed system can then be lowered. In some embodiments, the lower temperature may be the first predetermined temperature. In other embodiments, the lower temperature may be a third predetermined temperature, different from the first but also lower than the second predetermined temperature. At the lower temperature, the cap 20708 can contract, thus restoring the seal with the housing 20702. Finally, the one or more applicators can be removed from the closed system. Exemplary sensor carriers

[0046] Fig. Figure 5A is a proximal perspective view showing an 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 generally has a hollow, round, flat, cylindrical shape and can include one or more deflectable needle carrier locking arms 1524 (e.g., three) extending proximal to 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 retaining device 1526 at or near its proximal end. The shock protection 1534 can be a tab that protrudes outwards on an outer circumference of the sensor carrier 710 and can lock the sensor carrier 710 before triggering for additional safety.The rotation limiter 1506 can be a proximally extending, relatively short projection on a proximal surface of the sensor carrier 710, which limits the rotation of the carrier 710. The needle carrier locking arms 1524 can engage with the needle carrier 2102, as shown in the following. Fig. 6A-6D described.

[0047] Fig. Figure 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 into 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 it is located in the recess or cavity 1521. In certain embodiments, after the sensor control device 102 has been adhered to the skin with the applicator 150, 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 outwards and release the locking devices 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 following is shown in the Fig. 5C and Fig. Figure 5D shows an exemplary sensor carrier 20710. The sensor carrier 20710 may have one or more of the features described herein with respect to sensor carriers, with similar features functioning as described herein. For example, the sensor carrier 20710 may comprise a base 20710A and a first and a second support arm 20710B. Each support arm 20710B may comprise a first end section 20710C connected to the base 20710A and a free end section 20710D. For example, each support arm 20710B may be connected to the base 20710A at a first half, and the free end section 20710D may extend toward a second half of the base 20710A. Each support arm 20710B can have a sensor holding device 20710E arranged on an inner surface of the support arm 20710B. The sensor holding device 20710E can be arranged on the free end section 20710D.The sensor holding device 20710E can be configured to hold the sensor control device 20102 within the housing 20702. The holding device 20710E can have a conical surface and an angled parting line that allows the sensor control device 20102 to be released upon delivery. Each holding arm 20710 can have a locking interface 2071 OF located on an outer surface of the holding arm 20710B. The locking interface 20710F can engage in the rib 20704U on the housing 20704. As described above, the rib 20704U can prevent the sensor holding arm 2071 OB from bending outwards, for example in the event of an impact, and thus keep the holding 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) can be held in the sensor carrier (e.g., 710 or 20710) by one or more magnets (not shown) arranged on a needle carrier. According to one aspect of some embodiments, and as further described below with respect to the Fig. As described in more detail in Figures 6A-6D, one or more magnets arranged in the needle carrier can be configured to attract one or more ferromagnetic components arranged in the sensor control device (e.g., 102 or 20102) and thereby hold 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 can be arranged in a housing of the sensor control device (e.g., 102 or 20102). In some embodiments, the one or more magnets can be either in addition to or instead of the one or more retaining springs 1518 for the sensor electronics and the corresponding locking lugs 1519 of the sensor carrier 710 ( Fig. 5A - 5B) or the retaining arms 20710B with the corresponding sensor retaining 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 holding devices 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) can be held in the sensor carrier (e.g., 710 or 20710) by one or more magnets arranged in the sensor carrier itself. According to one aspect of some embodiments, an advantage lies in arranging the one or more magnets in the sensor carrier (e.g., 710 or 20710) in close proximity to the sensor control device (e.g., 102 or 20102). This may reduce the magnetic force required, since in some embodiments the one or more magnets in the sensor carrier can be configured to engage directly with at least one part of the sensor control device (e.g., an upper part).Furthermore, according to another aspect of some embodiments, the adhesive patch can be configured such that its adhesive strength is greater than the magnetic force between the one or more magnets and the sensor control device. Accordingly, once the sensor control unit has reached its distal position and the adhesive patch is bonded to the skin, it 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. In 5D, the sensor carrier 20710 can have multiple housing mounting features 20710F1. In some embodiments, for example, the sensor carrier 20710 can have three housing mounting features 20710F1. In other embodiments, the sensor carrier 20710 can include two, four, five, six, or more housing mounting features 20710F. The housing mounting features 20710F1 can be arranged at equal intervals on the sensor carrier 20710 and extend upward from a top surface of the sensor carrier 20710. Each housing mounting feature 20710F1 can include a housing snap fastener 20710G, a housing positioning feature 20710H, a preloading feature 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.The housing clip 20710G can engage in the sensor carrier mounting slots 20702K on the housing 20702 to connect the sensor carrier 20710 to the housing 20702. The preload device 207101 can engage in the sensor carrier preload device 20702M on the housing 20702, which is configured to eliminate play between the sensor carrier 20710 and the housing 20702.

[0052] The sensor carrier 20710 can further comprise several needle carrier locking arms 20710K, for example, three needle carrier locking arms 20710K. The needle carrier locking arms 20710K can be arranged at equal intervals on the sensor carrier 20710 and extend upwards from a top surface of the sensor carrier 20710. Each needle carrier locking arm 20710K can comprise a needle carrier retaining device 20710L and a rib 20710M. The rib 20710M can engage an inner surface of the shell 20704, thereby pressing the needle carrier locking arm 20710K inwards and the needle carrier retaining device 20710L holding the needle carrier 207102, as described in more detail below. The carrier retaining device 20710L can have a triangular shape in side view and a U-shape in top view.

[0053] According to the disclosed object, the sensor carrier 20710 can have multiple locking bars 20710N configured to engage with the locking arm interface 20704M of the housing 20704, as described above. For example, the sensor carrier 20710 can have two locking bars 20710N. The sensor carrier 20710 can have recesses 207100 located near each locking bar 20710N and configured to receive the locking arm interface 20704M during triggering to prevent the locking arm 20704J from engaging with the housing 20702 during triggering. The sensor carrier 20710 can have a hole 20710P extending through the 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 have a spring positioning device 20710Q.

[0054] The underside of the sensor carrier 20710 can have stiffening ribs 20710R and sensor positioning ribs 20710S, which can limit the planar movement of the sensor control device 20102 relative to the sensor carrier 20710. The underside of the sensor carrier 20710 can have a sensor support surface 20710T, which is configured to support the sensor control device 20102. Exemplary needle holders

[0055] The Fig. 6A and Fig. Figure 6B shows a proximal perspective view and a side cross-sectional view, respectively, illustrating an 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 retract automatically when one or more springs transition from a pre-tensioned, compressed state to an expanded state during an insertion process, as shown in the Fig. 10A - 10E described. Near a distal end of the needle carrier 2102, anti-rotation slots 1608 may be provided which prevent the needle carrier 2102 from rotating when it is in a central region of the needle carrier locking arms 1524 (as described in Fig. 9A shown). The anti-rotation slots 1608 can be arranged between sections of the chamfer 1610 of the needle carrier base, thereby ensuring complete retraction of the needle carrier 2102 through the casing 704 when retracting the needle carrier 2102 at the end of the insertion process.

[0056] As in Fig. As shown in Figure 6B, needle retention arms 1618 can be arranged inside the needle carrier 2102 around a central axis and have a needle retention clip 1620 at a distal end of each arm 1618. The needle retention clip 1620 can have a proximal surface that is almost perpendicular to the central axis and can bear against a distally directed surface of the needle hub 2516.

[0057] For illustrative purposes and without limitation, the following is shown in the Fig. 6C and Fig. Figure 6D shows an exemplary needle carrier 201102. The needle carrier 201102 may have one or more of the features described herein relating to needle carriers, with similar features functioning as described herein. For example, the needle carrier 201102 may include a set of features for engaging with the three needle carrier locking arms 2071 OK of the sensor carrier 20710. The features may include a retaining surface 201102 A prior to partial retraction and a retaining surface 201102B post-partial retraction. The retaining surface 201102 A prior to partial retraction may engage with the needle carrier retaining element 20710L prior to partial retraction, for example, during transport and storage. The retaining surface 201102 B post-partial retraction may engage with the needle carrier retaining element 20710L post-partial retraction.For example, if the casing 20704 initially moves proximally relative to the sensor carrier 20710, the rib 20710M of the retaining arm 20710L can engage in the slot 20704Q of the casing 20704, allowing the retaining arm 20710L to move radially outward and the needle carrier retaining element 20710L to release the preliminary partial retraction retaining surface 201102A and engage in 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 can correspond to the distance of the partial retraction. A running surface 201102C can be arranged below the holding surface 201102B for retraction after partial retraction and can slide against the holding arm 20710L when the needle carrier 201102 is retracted. Alignment walls 201102D can help to keep the needle carrier 201102 aligned with the sensor carrier 20704 during partial retraction.The needle carrier 201102 can have a chamfer 201102F which can have anti-rotation slots 201102E for engagement with the retaining arms 20710L on the sensor carrier 20710.

[0058] Internally, the needle carrier 201102 can have needle retaining arms 201102G with an insertion surface 2011021 and a needle hub contact surface 201102H. The retaining arms 201102G can receive and hold the needle hub 205014. The spring stop 201102J can engage with the return spring 205612.

[0059] With reference to Fig. 6D, the needle carrier 201102 can, according to some embodiments, also accommodate one or more magnets 201102K for holding a sensor control device in the sensor carrier (e.g. 710 or 20710). Fig. 5A-5D). For illustration, the needle carrier 201102 may include one or more magnets 201102K arranged 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 arranged in the sensor control device, thereby enabling the sensor control device to be held in the sensor carrier when the needle carrier 201102 and the sensor carrier are close to each other. More precisely, when the needle carrier 201102K and the sensor carrier are coupled, as in the Fig. Figure 10A - I0C shows one or the magnets 201102K configured to generate a magnetic field of sufficient strength to exert a “pulling” force on the ferromagnetic components arranged in the sensor control device in a proximal direction, so that the sensor control device is held in 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 be displaced 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 hold the sensor control device in the sensor carrier. Subsequently, the sensor control device can detach from the sensor carrier.

[0061] According to some embodiments, the one or more magnets 201102K can be embedded in a distal end of the needle carrier 201102, such that the distally facing surface is flush with the sensor carrier. In some embodiments, the one or more magnets 201102K can comprise either a single magnetic element or a plurality of discrete magnetic elements. For example, in some embodiments, the one or more magnets 201102K can comprise a single magnetic element with an annular geometry. In other embodiments, the one or more magnets 201102K can comprise two, three, four, five, or more discrete magnetic elements arranged on the distal surface of the needle carrier 201102. In still other embodiments, at least a portion of the distal end of the needle carrier 201102 itself can be made of a magnetic material.Experts 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 fall entirely within the scope of this disclosure. Exemplary sensor and connector assemblies

[0062] Fig. Figure 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 shown, the sensor 11900 comprises a tip 11902, a flag 11904, and a neck 11906 connecting 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 inserted transcutaneously under the skin of a user, and the chemical substance contained therein facilitates the monitoring of the analyte in the presence of body fluids.

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

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

[0065] The flag 11904 can comprise a generally flat surface with one or more sensor contacts 11914 arranged on it. The sensor contact(s) 11914 can be configured to be aligned with a corresponding number of compliant, carbon-impregnated polymer modules encapsulated in a connector.

[0066] In some embodiments, the neck 11906, as shown, can form or otherwise define a depression or bend 11916 extending between the flag 11904 and the tip 11902. The bend 11916 can prove advantageous in providing flexibility to the sensor 11900 and preventing 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 can provide flexibility and tolerance to the sensor 11900 when the sensor 11900 is attached to the holder. More specifically, the notch 11918 can help to absorb disruptive forces that may occur when the sensor 11900 is mounted in the holder.

[0068] The Fig. 8A and Fig. Figure 8B shows 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. Figure 8C is an isometric bottom view of connector 12002. Connector 12002 can comprise an injection-molded part that serves to connect one or more compliant, carbon-impregnated polymer modules 12004 (four in Fig. (shown in Figure 8B) to attach to a bracket 12006. More precisely, the connector 12002 can help to position the modules 12004 next to the sensor 11900 and in contact with the sensor contacts 11914 ( Fig. 7) to secure the flag 11904 ( Fig. 7) are provided. The modules 12004 can 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 to Fig. As can be seen in Figure 8C, the connector 12002 can define pockets 12008 that are dimensioned to accommodate the modules 12004. Furthermore, in some embodiments, the connector 12002 can define one or more recesses 12010 that are configured to align with one or more corresponding flanges 12012 ( Fig. 8B) fit together on the bracket 12006. By joining the recesses 12010 with the flanges 12012, the connector 12002 can be attached to the bracket 12006 by means of an interference fit or the like. In other embodiments, the connector 12002 can be attached to the bracket 12006 with an adhesive or by ultrasonic welding.

[0070] Fig. 8D and Fig. Figure 8E shows isometric and partially exploded isometric views of a further embodiment of a connector arrangement 12100 according to one or more embodiments. As shown, the connector arrangement 12100 may comprise a connector 12102, and Fig. 8F is an isometric bottom view of connector 12102. Connector 12102 can comprise an injection-molded part that serves to connect one or more compliant metal contacts 12104 (four in Fig. (8E shown) to attach a sensor 11900 to a bracket 12106. More precisely, the connector 12102 can help to position the contacts 12104 next to the sensor 11900 and in contact with the sensor contacts 11914 ( Fig. 7) to secure the contacts provided on the flag 11904. The contacts 12104 can consist of a stamped conductive material that establishes a conductive connection between the sensor 11900 and corresponding circuit contacts (not shown) within the holder 12106. In some embodiments, the contacts 12104 can, for example, be soldered to a circuit board (not shown) arranged within the holder 12106.

[0071] How best to Fig. As shown in Figure 8F, the connector 12102 can define pockets 12108 dimensioned to accommodate the contacts 12104. Furthermore, in some embodiments, the connector 12102 can define one or more recesses 12110 configured to mate with one or more corresponding flanges 12112 on the bracket 12006. The engagement of the recesses 12110 with the flanges 12112 can facilitate the attachment of the connector 12102 to the bracket 12106 via an interference fit or the like. In other embodiments, the connector 12102 can be attached to the bracket 12106 using an adhesive or by ultrasonic welding.

[0072] In some embodiments, the connector arrangement (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. According to some embodiments, for example, a first section of the pull tab may be detachably engaged with the sensor 11900 to establish electrical coupling between the sensor contacts 11914 on the one hand and either the modules 12004 made of Fig. 8B or the contacts 12104 from Fig. 8E, on the other hand, to prevent. Furthermore, in some embodiments, a second section of the pull tab can be coupled to the needle or needle carrier, so that the pull tab is released from the sensor 11900 when the applicator is actuated. In other embodiments, the second section of the pull tab can be coupled to the needle or needle carrier, so that the pull tab is released from the sensor 11900 during or after the needle is retracted.

[0073] According to other embodiments, a first section of a pull tab (not shown) can be detachably 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 part of the pull tab can be coupled to the needle or the needle carrier such that the pull tab is released from the power supply either when the applicator is actuated or during (or after) retraction of the needle. In further embodiments, a first section of a pull tab (not shown) can be detachably engaged with any component of the sensor electronics in the sensor control unit that would otherwise form a closed circuit with the power supply.Experts will recognize that other configurations for preserving battery life and preventing power leakage during storage are possible and are fully within the scope of this disclosure. Exemplary embodiments of sensor control devices

[0074] The Fig. 9A and Fig. Figure 9B shows side or isometric views of an exemplary sensor control device 9102 according to one or more embodiments of the present disclosure. The sensor control device 9102 may differ in some aspects from the sensor control device 102. Fig. 1 is similar and is therefore best understood by reference to it. Furthermore, the sensor control device 9102 can control the sensor control device 102 from Fig. Replace 1 and therefore in conjunction with the sensor applicator 102 from Fig. 1 can be used, which can bring the sensor control device 9102 to a target monitoring point on the skin of a user.

[0075] As shown, the sensor control device 9102 comprises an electronics housing 9104, which can generally be disk-shaped and have a circular cross-section. In other embodiments, however, the electronics housing 9104 can have other cross-sectional shapes, for example, egg-shaped, oval, or polygonal, without deviating from the scope of the disclosure. The electronics housing 9104 comprises a shell 9106 and a mount 9108 that is compatible with the shell 9106. The shell 9106 can be attached to the mount 9108 in various ways, for example, by 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 can be attached to the mount 9108 such that a sealed interface is formed between them.An adhesive strip 9110 can be positioned on the underside of the holder 9108 or otherwise attached to it. According to one aspect of the embodiments, the adhesive strip 9110 (in . Fig. 9 A shown in unhatched illustration) be configured to fix and hold the sensor control device 9102 in its position on the user's skin during operation.

[0076] The sensor control device 9102 may further comprise a sensor 9112 and a needle 9114, which serve to deliver the sensor 9112 transcutaneously under the skin of a user during application of the sensor control device 9102. Corresponding sections 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 injection-molded onto the needle 9114 and configured to secure and support the needle 9114. As best as in Fig. As shown in Figure 9A, the needle hub 9116 can include or otherwise define a counterpart 9118. During assembly of the needle 9114 with the sensor control device 9102, the needle 9114 can 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 counterpart 9118 extends distally from the bottom surface of the holder 9108. As described below, in at least one embodiment, the needle hub 9116 can engage sealingly in an upper portion of a seal injection-molded onto the holder 9108. When the needle 9114 penetrates the electronics housing 9104, the exposed portion of the sensor 9112 can be received in a hollow or recessed (arc-shaped) portion of the needle 9114. The remaining section of sensor 9112 is located inside the electronics housing 9104.

[0077] The sensor control device 9102 can further comprise a sensor cap 9120, which is located in the Fig. 9A - 9B are shown separately from the electronics housing 9104. The sensor cap 9120 can help to form a tight barrier that surrounds and protects exposed parts of the sensor 9112 and the needle 9114. As shown, the sensor cap 9120 can comprise a generally cylindrical body with a first end 9122a and a second end 9122b opposite the first end 9122a. The first end 9122a can be open to allow access to an internal chamber 9124 defined within the body. In contrast, the second end 9122b can be closed and provide or otherwise define an engagement element 9126. As described in more detail below, the engagement element 9126 can help to connect the sensor cap 9120 to an applicator cap of a sensor applicator (e.g., the sensor applicator 102 from [reference missing]). Fig. 1) to engage, and can help to remove the sensor cap 9120 from the sensor control device 9102 when the sensor cap is removed from the sensor applicator.

[0078] The sensor cap 9120 can be detachably connected to the electronics housing 9104 at or near the underside of the holder 9108. More precisely, the sensor cap 9120 can be detachably connected to the mating element 9118, which extends distally from the underside of the holder 9108. In at least one embodiment, for example, the mating element 9118 can have a set of external threads 9128a ( Fig. 9A) define, which with a set of internal threads 9128b ( Fig. 9B) fit together, which are 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 helical curvature), but alternatively, they may also have a helical thread engagement. Accordingly, in at least one embodiment, the sensor cap 9120 may be screwably coupled to the mating element 9118 of the needle hub 9116 with the sensor control device 9102. In other embodiments, the sensor cap 9120 may be detachably connected to the mating element 9118 by other types of engagement, including, but not limited to, an interference or friction fit, or a breakable element or substance (e.g., wax, an adhesive, etc.) that can be broken with minimal separating 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. In other embodiments, however, the sensor cap 9120 may comprise two or more components. In the illustrated embodiment, for example, the body of the sensor cap 9120 may comprise a desiccant cap 9130 arranged at the second end 9122b. The desiccant cap 9130 may contain or include a desiccant to help maintain preferred humidity levels within the inner chamber 9124. Furthermore, 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 can also include an adhesive film 9110B (in Fig. (9 A, shown hatched) comprise an liner 9110B, which is connected to the 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 from materials can cause the adhesive to degrade during storage or transport of the applicator. The inclusion of the liner 9110B can mitigate the degradation of the adhesive of the adhesive patch 9110. According to another aspect of the embodiment, the liner 9110B can also be functionally connected to the sensor cap 9120, such that removing the sensor cap 9120 also removes the liner 9110B. Exemplary mechanisms of one-piece and two-piece applicators

[0081] The Fig. Figures 10A-10E show exemplary details of embodiments of the internal device mechanism for "triggering" the applicator 216 to attach the sensor control device 222 to a user, including the safe retraction of the needle 1030 into the used applicator 216. Overall, these drawings illustrate 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 the sensor remains in functional contact with the user's interstitial fluid, and attaching 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 are readily understandable to those skilled in the art.Furthermore, the applicator 216 can be a sensor applicator with a one-piece or a two-piece architecture, as disclosed herein.

[0082] In Fig. 10A is a sensor 1102 held within the needle 1030 directly above the user's skin 1104. Rails 1106 (optionally three) of an upper guide section 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 overcomes the resistance provided by the detents 1110, allowing the needle 1030 and the sensor control device 222 to be moved along the longitudinal axis into (and onto) the user's skin 1104. Additionally, the grasping arms 1112 of the sensor carrier 1022 engage in the needle retraction device 1024 to hold the needle 1030 in a position relative to the sensor control device 222.

[0083] In Fig. 10B, a force is applied by the user to overcome or bridge the locking elements 1110, and the sleeve 318 folds 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 section 1108 of the sleeve 318 limits the position of the support arms 1112 throughout the entire stroke of the sensor / needle insertion operation. Holding the stop surfaces 1114 of the support arms 1112 against the complementary surfaces 1116 of the needle retraction device 1024 maintains the position of the elements with the return spring 1118 fully compressed.

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

[0085] When the needle 1030 is fully retracted, as in Fig. As shown in Figure 10E, the upper guide section 1108 of the casing 318 is fitted with a final locking device 1120. The used applicator assembly 216 is then removed from the insertion point, leaving the sensor control device 222 behind and the needle 1030 securely attached to the applicator assembly 216. The used applicator assembly 216 can now be disposed of.

[0086] The actuation of the applicator 216 when attaching the sensor control device 222 is designed such that the user perceives both the insertion and withdrawal of the needle 1030 as being performed automatically by the internal mechanisms of the applicator 216. In other words, the present invention prevents the user from feeling as if they are manually driving the needle 1030 into their skin. Thus, as soon as 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 "triggering" of the applicator. The user does not feel that they are applying additional force to drive the needle 1030 into their skin, even though all the driving force is provided by the user and no additional pre-tensioning / driving means are used to insert the needle 1030. As shown above in FIG.As described in detail in I0C, the retraction of the needle 1030 is automated by the return spring 1118 of the applicator 216.

[0087] Fig. Figures 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, in order to reduce the number of components in a sensor applicator (and the number of potential mechanical failures), a leaf spring 1118B can be used instead of a helical return spring 1118 in a sensor applicator, such as the applicator 216 from the 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-release phase (similar to in Fig. 10A). In particular, it shows Fig. 11 A the leaf spring 1118B, which is coupled to the needle 1030B, the needle 1030B being arranged at a distance from the skin surface 1104. As in Fig. As further shown in Figure 11 A, the leaf spring 1118B is shown 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 can be connected to a central part of the leaf spring 1118B by an interference fit, ultrasonic welding, laser welding, one or more mechanical fasteners (e.g., screws), a seal, an adhesive, or any combination thereof. In some embodiments, the leaf spring 1118B can be made of the same material (e.g., stainless steel) as the needle 1030B. In other embodiments, the leaf spring 1118B can be made of a first material (e.g., stainless steel) with a first stiffness, and the needle 1030B can be made of a second material (e.g., plastic) with a second stiffness that differs from the first stiffness. According to another aspect of some embodiments, such as that described in Fig. In the embodiment shown in Figure 10A, the needle 1030B can extend through the sensor control device 222B, and part of the glucose sensor 1102B can be coupled to or partially arranged in a distal part of the needle 1030B.

[0090] According to another aspect of some embodiments, several engagement elements 1023 A, 1023B are configured to attach the leaf spring 1118B either to a sensor carrier (not shown) or to a needle retraction device (not shown), so that the downward movement of the housing, the sensor carrier and the needle retraction device also causes at least the edge sections of the leaf spring 1118B to move in a distal direction.

[0091] Fig. Figure 1 IB 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 introduction phase (similar to FIG. IOC). In particular, it shows Fig. 11B the needle 1030B after it has penetrated the skin surface 1104 and the sensor 1102B has reached a predetermined insertion depth. According to one aspect of some embodiments, during the insertion phase the adhesive element (not shown) is attached to the underside of the sensor control device 222B and adheres to the skin surface 1104.

[0092] As in Fig. As shown in Figure 11B, the leaf spring 1118B is depicted 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, while the housing, sensor carrier, and needle retraction device (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 distally either against the sensor control device 222B or against 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 that in Fig. 10D and Fig.10E). In particular, when the applicator housing (not shown) is moved further distally, the leaf spring 1118B is shown in a third state in which the surface of the leaf spring 1118B has reached or exceeded a deformation threshold, causing the leaf spring 1118B to "snap" into a concave configuration relative to the skin surface 1104. As a result of the concave configuration, according to one aspect of some embodiments, the needle 1030B is retracted proximal to the skin surface 1104, while the sensor 1102B remains beneath the skin surface 1104. In some embodiments, the concave configuration may also cause the leaf spring 1118B to detach from the sensor control device 222B.

[0094] Subsequently, according to some embodiments, the applicator can be removed from the insertion site, leaving the sensor control device 222B behind and the needle 1030B securely attached to the applicator assembly. The applicator assembly can then be disposed of.

[0095] With regard to all embodiments of the applicator described herein, as well as all its components, including but not limited to the embodiments of the needle, needle module, and sensor module, it will be clear to those skilled in the art that these embodiments can be dimensioned and configured to be used with sensors designed to detect analyte levels in body fluids located in the epidermis, dermis, or subcutaneous tissue of a subject. For example, in some embodiments, the needles and distal sections of analyte sensors disclosed herein can be both dimensioned 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, such as the epidermis, dermis, or subcutaneous tissue).With regard to some embodiments of applicators, it will be clear to those skilled in the art that certain embodiments of needles may be dimensioned and configured such that they can be positioned at a different final depth in the subject's body relative to the final final depth of the analyte sensor. In some embodiments, for example, a needle may be positioned in the patient's epidermis at a first final depth before withdrawal, while a distal portion of an analyte sensor may be positioned in the patient's dermis at a second final depth. In other embodiments, a needle may be positioned in the subject's dermis at a first final depth before withdrawal, while a distal portion of an analyte sensor may be positioned in the subject's subcutaneous tissue at a second final depth.In further embodiments, a needle can be positioned at a first final depth before withdrawal, and the analyte sensor can be positioned at a second final depth, wherein the first final depth and the second final depth are both located in the same layer or tissue of the patient's body.

[0096] In addition to the embodiments of the applicator described herein, it will be clear 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 arranged within the applicator in an off-center position relative to one or more axes of the applicator. For example, in some embodiments of the applicator, an analyte sensor and a spring mechanism may be arranged in a first off-center position relative to an axis of the applicator on a first side of the applicator, and the sensor electronics may be arranged in a second off-center position relative to the axis of the applicator on a second side of the applicator.In other embodiments of the applicator, the analyte sensor, the spring mechanism, and the sensor electronics can 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, the spring mechanism, the sensor electronics, and other components of the applicator are arranged in a centered or eccentric position relative to one or more axes of the applicator, are possible and entirely within the scope of this disclosure.

[0097] This document describes a number of deflectable structures, including deflectable detent lugs, deflectable locking arms, needle carrier locking arms, needle retaining arms, and module detent lugs. These deflectable structures are made of an elastic material such as plastic or metal (or other materials) and function in a manner known to those skilled in the art. Each deflectable structure has a rest state or equilibrium position to which the elastic material is pre-stressed. When a force is applied that deflects or moves the structure from this rest state or equilibrium position, the pre-stress of the elastic material causes the structure to return to the rest state or equilibrium position as soon as the force is removed (or reduced).In many cases, these structures are designed as arms with locking mechanisms or snap fasteners; however, other structures or configurations can also be used that have the same properties of deflectability and the ability to return to a resting position, including but not limited to a leg, a clamp, a locking mechanism, a stop element on a deflectable element, and the like.

[0098] Further details concerning suitable devices, systems, methods and their operation, as well as related features, are set out 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 on June 6, 2019, which are incorporated herein in their entirety by reference. Further details concerning embodiments of applicators, their components and variants are set forth in US 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 concerning embodiments of needles, sharp objects, their components and variants thereof are described in US Patent No. 2014 / 0171771, which is hereby incorporated by reference in its entirety and for all purposes.

[0099] Exemplary embodiments and features are set out 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 screwably 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. Sensor applicator arrangement according to paragraph 1, wherein the housing includes an applicator cap sealing lip configured to engage with the applicator cap. 3. Sensor applicator arrangement according to paragraph 2, wherein the applicator cap comprises a sealing surface configured to accommodate the applicator cap sealing lip of the housing. 4. Sensor applicator arrangement according to paragraph 3, wherein the sealing surface and the sealing lip of the applicator cap are designed to form a seal between the housing and the applicator cap. 5. Sensor applicator arrangement according to paragraph 4, wherein the seal further comprises a sealing sleeve. 6. Sensor applicator arrangement according to paragraph 4 or 5, wherein the slightly pressurized inert gas generates an outward flow over the seal. 7. Sensor applicator assembly according to any one of claims 1 to 6, wherein the slightly pressurized gas comprises nitrogen. 8. Sensor applicator assembly according to 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 arrangement according to any one of paragraphs 1 to 9, wherein the interior has a first pressure and wherein an exterior space outside the sensor applicator arrangement has a second pressure which is lower than the first pressure. 11. Sensor applicator arrangement 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, the one or more magnets being 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. Sensor applicator arrangement according to paragraph 11, wherein the one or more ferromagnetic components are arranged in the sensor control device. 13. Sensor applicator arrangement according to paragraph 11 or 12, wherein the one or more ferromagnetic components are embedded in a housing of the sensor control device. 14. Sensor applicator arrangement according to any one of paragraphs 11 to 13, wherein the sensor carrier is configured to hold the sensor control device by magnetic force only. 15. Sensor applicator arrangement according to any one of paragraphs 11 to 14, wherein the one or more magnets are arranged on a distal surface of the needle carrier. 16. Sensor applicator arrangement according to any one of paragraphs 11 to 15, wherein one or more magnets are embedded in a distal end of the needle carrier. 17. Sensor applicator arrangement according to any one of paragraphs 11 to 16, wherein one or the magnets comprise a single magnetic element. 18. Sensor applicator arrangement according to claim 17, wherein the single magnetic element has a ring-shaped geometry. 19. Sensor applicator arrangement according to paragraphs 11 to 18, wherein at least part of a distal end of the needle carrier comprises a magnetic material. 20. Sensor applicator arrangement according to paragraphs 11 to 16, wherein the one or more magnets comprise two magnetic elements arranged on a distal surface of the needle carrier. 21. Sensor applicator arrangement according to paragraphs 11 to 16, wherein the one or more magnets comprise three magnetic elements arranged on a distal surface of the needle carrier. 22. Sensor applicator arrangement according to paragraphs 11 to 21, further comprising a return spring. 23. The sensor applicator arrangement according to paragraph 22, wherein the return spring is configured to extend and move the needle carrier in a proximal direction after the housing has reached the second position. 24. The sensor applicator arrangement according to paragraph 23, wherein the one or more magnets are configured such that the magnetic force exerted on the ferromagnetic components is insufficient to hold the sensor control device in the sensor carrier after the needle carrier has moved in the proximal direction. 25. Sensor applicator arrangement according to paragraph 24, wherein the sensor control device is configured to detach from the sensor carrier after the needle carrier has moved in the proximal direction. 26. Sensor applicator arrangement 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 multiple sensor contacts, a connector arrangement comprising one or more of a plurality of sensor modules or a plurality of connector contacts, the connector arrangement being configured to couple with the analyte sensor, and a power supply; and a sensor carrier configured to hold the sensor control device, the connector arrangement further comprising a pull tab comprising an electrically insulating material. 27. Sensor applicator arrangement according to paragraph 26, wherein the pull tab comprises a first section which is detachably engaged with the multiple sensor contacts. 28. Sensor applicator arrangement according to paragraph 27, wherein the first section of the pull tab is configured to prevent electrical coupling between the sensor contacts and the multiple sensor modules. 29. Sensor applicator arrangement according to paragraph 27, wherein the first section of the pull tab is configured to prevent electrical coupling between the sensor contacts and the multiple connector contacts. 30. Sensor applicator arrangement according to any one of paragraphs 27 to 29, wherein the pull tab comprises a second section connected to the needle or needle carrier. 31. Sensor applicator arrangement according to paragraph 30, wherein the pull tab is configured to detach from the multiple sensor contacts by movement of the needle or needle carrier when the sensor applicator arrangement is actuated. 32. Sensor applicator arrangement according to paragraph 30, wherein the pull tab is configured to detach from the multiple sensor contacts when the needle or needle carrier is retracted into the sensor applicator arrangement. 33. Sensor applicator arrangement 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 multiple sensor contacts, a connection device configured to connect 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. Sensor applicator arrangement according to paragraph 33, wherein the power supply is a button cell battery. 35. Sensor applicator arrangement according to paragraph 33 or 34, wherein the pull tab comprises a first section which is detachably engaged with the power supply. 36. Sensor applicator arrangement according to paragraph 35, wherein the first section of the pull tab is configured to prevent electrical coupling between the power supply and the sensor electronics of the sensor control device. 37. Sensor applicator arrangement according to paragraph 35 or 36, wherein the pull tab has a second section which is connected to the needle or needle carrier. 38. Sensor applicator arrangement according to paragraph 37, wherein the pull tab is configured to detach from the power supply by movement of the needle or needle carrier when the sensor applicator arrangement is actuated. 39. Sensor applicator arrangement according to paragraph 37, wherein the pull tab is configured to detach from the power supply when the needle or needle carrier is retracted into the sensor applicator arrangement. 40. 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 electronics housing, sensor electronics arranged within the electronics housing, an analyte sensor coupled to the sensor electronics, an adhesive element arranged on a bottom of the electronics housing, and an adhesive film coupled to a bottom of the adhesive element; and a sensor carrier configured to hold the sensor control device; and a sensor cap detachably coupled to the sensor control device. 41. Sensor applicator arrangement according to paragraph 40, wherein the adhesive film is functionally connected to the sensor cap such that removing the sensor cap causes the adhesive film to be removed. 42. Sensor applicator assembly according to paragraph 41, further comprising an applicator cap that can be screwed onto the housing, wherein the applicator cap is configured to remove the sensor cap from the sensor applicator assembly when the applicator cap is detached from the housing. 43. The applicator arrangement according to paragraph 41 or 42, wherein the sensor control device comprises a first opening on a top side of the electronics housing, wherein the sensor control device comprises a second opening on the bottom side of the electronics housing, wherein the adhesive patch comprises a third opening, wherein the adhesive film comprises a fourth opening, and wherein the needle extends through the first, second, third, and fourth openings when the housing is in the first position. 44. Sensor applicator assembly comprising: a housing configured to move between a first position and a second position; a sheath slidably connected to the housing, the distal end of the sheath configured to rest against a skin surface; a leaf spring connected to a needle; a sensor control device comprising an analyte sensor connected to sensor electronics; and a sensor carrier configured to hold the sensor control device when the housing is in the first position, the needle being 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 being configured to retract the needle into the sensor applicator assembly after the housing has been moved to the second position. 45. Sensor applicator arrangement according to paragraph 44, wherein the leaf spring has a convex configuration relative to the skin surface when the housing is in the first position. 46. ​​Sensor applicator assembly according to 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. 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. Sensor applicator arrangement according to 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 into the second position, and wherein the leaf spring has a substantially planar configuration relative to the skin surface when the sensor control device adheres to the skin surface. 49. Sensor applicator arrangement according to 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 arrangement. 50. Sensor applicator arrangement according to any one of paragraphs 44 to 49, wherein the leaf spring is connected to the needle by an interference fit. 51. Sensor applicator arrangement according to any one of paragraphs 44 to 49, wherein the leaf spring is connected to the needle by ultrasonic welding. 52. Sensor applicator arrangement according to any one of paragraphs 44 to 49, wherein the leaf spring is connected to the needle by laser welding. 53. Sensor applicator arrangement 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. Sensor applicator arrangement according to any one of paragraphs 44 to 53, wherein the leaf spring comprises a first material and the needle comprises a second material which differs from the first material. 55. Sensor applicator arrangement according to any one of paragraphs 44 to 53, wherein the leaf spring and the needle comprise a stainless steel material. 56. Sensor applicator arrangement according to any one of paragraphs 44 to 55, wherein the leaf spring has a first stiffness and wherein the needle has a second stiffness which differs from the first stiffness. 57. Sensor applicator arrangement according to any one of paragraphs 44 to 56, further comprising several engagement elements configured to secure the leaf spring to the sensor carrier. 58. Sensor applicator arrangement according to any one of paragraphs 44 to 56, further comprising several engagement elements configured to attach the leaf spring to the needle carrier. 59. Sensor applicator arrangement according to 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. Sensor applicator arrangement according to 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: arranging 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 detach from the housing; diffusing the inert gas into an interior 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 a seal with the housing. 62. Method according to paragraph 61, wherein the inert gas is argon. 63. Method according to paragraph 61 or 62, wherein the first predetermined temperature is equal to the third predetermined temperature. 64. Method according to 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 arrangement into it. 66. A method according to any one of paragraphs 61 to 64, further comprising introducing the inert gas into the closed system after the sensor applicator arrangement has been inserted therein. 67. Sensor applicator arrangement 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 being configured to hold the sensor control device, the one or more magnets being 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. Sensor applicator arrangement according to paragraph 67, wherein the one or more ferromagnetic components are arranged in the sensor control device. 69. Sensor applicator arrangement according to paragraph 67 or 68, wherein the sensor control device further comprises an adhesive patch. 70. Sensor applicator arrangement according to paragraph 69, wherein the adhesive patch, when connected to a skin surface, generates an adhesive force which is greater than the magnetic force. 71. Sensor applicator arrangement according to 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. Sensor applicator arrangement comprising: a housing with an interior; a sensor carrier configured to hold a sensor control device and to move between a first position and a second position within the interior 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 located within the interior of the housing when the sensor carrier is in the first position. 73. Sensor applicator arrangement according to paragraph 72, further comprising a needle carrier, a needle and a return spring. 74. Sensor applicator arrangement according to paragraph 73, wherein the return spring is configured to extend and move the needle carrier in a proximal direction. 75. Sensor control arrangement according to paragraph 72, wherein the magnet engages at least a part of the sensor control device. 76. Sensor control device according to paragraph 72, wherein the sensor control device comprises a material that responds to a magnetic field generated by the magnet of the sensor carrier. 77. Sensor control device according to paragraph 72, wherein the sensor control device further comprises an adhesive patch arranged on an underside of the sensor control device.

[0100] The description includes and explicitly provides for procedures that are non-surgical, non-invasive, and performed outside the body. These procedures are typically performed by a user who does not need to be a medical professional.

[0101] It should be noted that all features, elements, components, functions, and steps described in relation to any 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 in relation to one embodiment, it should be understood that this feature, element, component, function, or step may be used in any other embodiment described herein, unless expressly stated otherwise.This paragraph therefore serves as a preliminary basis and written support for the introduction, at any time, of paragraphs that combine features, elements, components, functions, and steps from different embodiments or replace features, elements, components, functions, and steps from one embodiment with those from another embodiment, even if the following description does not expressly state in a particular case that such combinations or replacements are possible. The preceding description of specific embodiments of the disclosed subject matter thus serves only for illustration and description. It is expressly acknowledged that an explicit enumeration of all possible combinations and replacements would be excessively burdensome, especially since the permissibility of each individual combination and replacement is readily apparent to the person skilled in the art.

[0102] Although the embodiments are subject to various modifications and alternative forms, specific examples are illustrated in the drawings and described in detail herein. It will be clear to those skilled in the art that various modifications and variations can 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 listed in or added to the claims, as well as negative limitations that define the inventive scope of the claims by features, functions, steps, or elements that are not included in that scope. QUOTES INCLUDED IN THE DESCRIPTION

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

[0000] US 63 / 222,851

[0001] 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] Arrangement for inserting a glucose sensor into the body of a person, which arrangement includes: (1) an applicator consisting of: an applicator housing that defines an interior space; a sheath that is connected to the applicator housing and has a distal end configured for placement on the skin; a needle carrier arrangement connected to a needle; a sensor carrier with a cavity formed by a proximal wall and a side wall, with a magnetic component, wherein the cavity is configured to accommodate a sensor control device therein; a spring with a distal end that is in contact with the sensor carrier; and a cap designed to be connectable to a distal part of the applicator housing; (2) the sensor control device configured to be worn on the person's body, the sensor control device comprising: an adhesive element located on the underside of the sensor control device and configured to allow the sensor control device to adhere to the person's skin; The glucose sensor includes: a proximal part configured to be electrically coupled to an electronics unit; a distal part with an enzyme, wherein the distal part The part is configured to be absorbed transcutaneously under the user's skin to monitor glucose in a person's bodily fluid; and The electronics include one or more processors, memory, and communication circuits configured to transmit data wirelessly according to a Bluetooth or Bluetooth Low Energy protocol. wherein the needle carrier assembly, the needle, the spring, the sensor carrier, the magnetic component, and the sensor control device are configured to move inside the applicator housing a certain distance relative to the casing 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 section 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 hold 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 person's skin via the adhesive element and detach from the sensor carrier when the user pulls the applicator away from the skin. [2] Arrangement according to claim 1, wherein the spring is configured to retract the needle carrier assembly and the needle in a proximal direction 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. [3] Arrangement according to claim 1 or 2, wherein a proximal section of the glucose sensor comprises one or more electrical contacts. [4] Arrangement according to one of claims 1 to 3, wherein the glucose sensor further comprises a curved section between the proximal part and the distal part of the glucose sensor. [5] Arrangement according to any one of claims 1 to 4, wherein the proximal part of the glucose sensor is arranged perpendicular to the distal part of the glucose sensor. [6] Arrangement according to any one of claims 1 to 5, wherein the distal end of the glucose sensor and a distal section of the needle extend in a distal direction from the underside of the sensor control device when the needle carrier arrangement, the needle, the spring, the sensor carrier, the magnetic component and the sensor control device are in the proximal position. [7] Arrangement according to any one of claims 1 to 6, 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, needle, spring, sensor carrier, magnetic component and sensor control device are in the proximal position. [8] Arrangement according to claim 7, wherein the adhesive element has a third opening and wherein the needle is configured to extend through the third opening when the needle carrier arrangement, the needle, the spring, the sensor carrier, the magnet and the sensor control device are in the proximal position. [9] Arrangement according to any one of claims 1 to 8, wherein the sensor carrier does not have one or more spring arms configured to hold the sensor control device. [10] Arrangement according to any one of claims 1 to 9, wherein the applicator further comprises a sealing ring to create a seal between the applicator housing and the cap. [11] Arrangement according to any one of claims 1 to 10, wherein the sensor control device further comprises a housing of the sensor control device which defines an interior space of the sensor control device, and wherein one or more ferromagnetic components are arranged in the interior space of the sensor control device. [12] Arrangement according to claim 11, wherein an adhesive force generated by an adhesive property of the adhesive patch is greater than the magnetic force exerted by the magnetic component on the one or more ferromagnetic components.

Images