System, apparatus and method for analyte monitoring

Abstract

To provide a reliable sensor insertion device which is easy for a patient to use and suppresses occurrence of error.SOLUTION: An applicator includes: a housing; a sensor carrier connected to the housing and having a first locking interface; a sheath slidably connected to the housing and having a first locking arm with an attachment distal end and a free proximal end, the free proximal end having a first locking arm interface disposed on an inner surface of the first locking arm and a first sharp edge disposed on an outer surface of the first locking arm; and a cap threadedly connected to the housing and having a plurality of first compression ridges disposed on an inner surface. The inner surface of the cap is configured to bias the first locking arm inwardly such that the first locking arm interface engages the first locking interface surface, and the first sharp edge is configured to engage the plurality of first compression ridges during an impact event.SELECTED DRAWING: Figure 7N

Description

[Technical Field]

[0001] The subject matter described herein broadly relates to systems, devices, and methods for in vivo analyte monitoring. [Background technology]

[0002] The detection and / or monitoring of analyte levels, such as glucose, ketones, lactate, oxygen, hemoglobin A1C, etc., can be critical to the health of individuals with diabetes. Patients with diabetes can experience complications such as loss of consciousness, cardiovascular disease, retinopathy, neuropathy, and nephropathy. Diabetic patients typically need to monitor their glucose to ensure it remains within a clinically safe range and may use this information to determine whether and / or when insulin is needed to lower their glucose levels or when additional glucose is needed to raise their glucose levels.

[0003] A growing body of clinical data demonstrates a strong correlation between frequency of blood glucose monitoring and glycemic control. However, despite this correlation, many individuals diagnosed with diabetic conditions do not monitor their glucose as frequently as necessary due to a combination of factors, including convenience, testing latitude, pain associated with blood glucose testing, and cost.

[0004] To improve patient adherence to frequent blood glucose monitoring regimens, in-vivo analyte monitoring systems can be utilized in which a sensor control device is worn on the body of an individual requiring analyte monitoring. To improve individual comfort and convenience, the sensor control device has a small physical form factor and can be assembled and applied by an individual carrying a sensor applicator. The application involves inserting a sensor that senses analyte levels in bodily fluids within the human body and contacting the sensor with the bodily fluid using an applicator or insertion mechanism. The sensor control device is configured to transmit analyte data to another device, from which the individual or their healthcare provider (“HCP”) can view the data and make treatment decisions.

[0005] While current sensors may be convenient for users, they are also susceptible to malfunction due to improper insertion. Such malfunctions can occur due to user error, lack of proper training, poor user coordination, overly complicated procedures, and other issues. This may be particularly true for analyte monitoring systems that include sensors used to measure analyte levels in interstitial fluid (“ISF”), which are inserted using a sharpened tip (known as an “introducer” or “needle”). For example, some prior art systems may be overly reliant on individual users to precisely assemble and deploy the sensor control device and applicator. Other prior art systems may utilize sharpened tip insertion and retraction mechanisms that are prone to premature withdrawal of the sensor before it is properly implanted. Furthermore, some prior art systems may utilize sharpened tips that are not optimally configured to create an insertion path without causing trauma to surrounding tissue. These and other issues described herein can lead to improper insertion or damage to the sensor, which can result in failure to properly monitor a patient's analyte levels. Summary of the Invention [Problem to be solved by the invention]

[0006] Therefore, there is a need for more reliable sensor insertion devices, systems, and methods that are easier for patients to use and less prone to error. [Means for solving the problem]

[0007] The objects and advantages of the presently disclosed subject matter will be set forth in and obvious from the following description, as well as may be learned by practice of the presently disclosed subject matter. Additional advantages of the presently disclosed subject matter will be realized and attained by the methods and systems particularly pointed out in the written description and claims hereof, as well as shown in the accompanying drawings.

[0008] To achieve these and other advantages, and in accordance with the purposes of the presently disclosed subject matter, as embodied and broadly described, the presently disclosed subject matter is directed to an applicator for delivering a sensor control device, the applicator including: a housing; a sensor carrier connected to the housing and having a first locking interface; a sheath slidably connected to the housing for movement between an extended position and a collapsed position, the sheath having a first locking arm with an attached distal end and a free proximal end, the first locking arm interface of the free proximal end disposed on an inner surface of the first locking arm and a first edge, e.g., a first sharp edge, of the free end disposed on an outer surface of the first locking arm; and a cap threadably connected to the housing and having a plurality of first protrusions, e.g., compression ridges, on an inner surface thereof. When the cap is connected to the housing, the inner surface of the cap is configured to bias the first locking arm inward so that the first locking arm interface engages the first locking interface, and the first sharp edge is configured to engage the first plurality of compression ridges during an impact event.

[0009] The sensor carrier may be provided with a second locking interface, and the sheath may have a second locking arm with a distal attachment end and a free proximal end. The free proximal end has a second locking arm interface disposed on an inner surface of the second locking arm and a second edge, such as a second sharp edge, disposed on an outer surface of the second locking arm. When connected to the housing, the inner surface of the cap is configured to bias the second locking arm inward, thereby urging the second locking arm interface to engage with the second locking interface. The cap may be provided with a plurality of second compression ridges, the second sharp edge configured to engage with the plurality of second compression ridges during an impact event. The first locking arm interface may be U-shaped. The first locking interface may be disposed around the sensor carrier.

[0010] The applicator includes a housing skirt connected to the housing by a plurality of skirt reinforcing ribs. A used-up indicator feature may be connected to each of the housing skirt and the cap. The used-up indicator feature may be a sticker. The housing may be a cyclic olefin copolymer. The sheath may be Delrin (a polyoxymethylene acetal homopolymer resin). The cap may be high-density polyethylene.

[0011] According to the subject matter of the present disclosure, the sensor carrier may comprise a base comprising a first half and a second half, a first sensor retaining arm connected at its first end to the first half of the base and having its second free end extending towards the second half of the base, the first sensor retaining arm having a first sensor retaining feature on its inner surface, and the first locking interface may be located on an outer surface of the first sensor retaining arm.

[0012] The sensor carrier may include three equally spaced housing mounting features extending upwardly from the top surface of the base, each housing mounting feature including a housing fastener, a housing positioning feature, and a housing biasing feature. The housing may include three sensor carrier mounting features, each configured to mate with the others.

[0013] The cap includes a sheath support surface configured to engage the sheath and limit movement of the sheath during an impact event. Additionally or alternatively, the cap includes a raised ridge configured to limit movement of the sensor carrier during an impact event.

[0014] In accordance with the presently disclosed subject matter, a sensor carrier for use in an applicator for delivering a sensor control device is presented, the sensor carrier comprising a base having first and second halves, a first sensor retaining arm connected at a first end to the first base half and with a second free end extending toward the second base half, the first sensor retaining arm having a first sensor retaining feature on an inner surface thereof and a first locking interface on an outer surface thereof, and a second sensor retaining arm connected at a first end to the first base half and with a second free end extending toward the second base half, the second sensor retaining arm having a second sensor retaining feature on an inner surface thereof and a second locking interface on an outer surface thereof.

[0015] The sensor carrier may include three equally spaced housing mounting features extending upwardly from a top surface of the base. Each housing mounting feature may include a housing fastener, a housing locating feature, and a housing biasing feature. A first of the three housing mounting features may be located on the second base half. A second and a third of the three housing mounting features may be located on the first base half.

[0016] The sensor carrier may include three equally spaced sharpened member carrier locking arms extending upward from the top surface of the base. Each sharpened member carrier locking arm may include a sharpened member carrier retention mechanism and a sharpened member carrier retention mechanism rib. A first sharpened member carrier locking arm of the three sharpened member carrier locking arms may be disposed on the first base half. A second sharpened member carrier locking arm and a third sharpened member carrier locking arm of the three sharpened member carrier locking arms may be disposed on the second base half.

[0017] The sensor carrier may be provided with a first locking ledge and a second locking ledge. The sensor carrier may be provided with a hole extending through the center of the base.

[0018] In accordance with another aspect of the presently disclosed subject matter, an applicator for delivering a sensor control device is presented, the applicator including a housing, a sensor carrier connected to the housing, a sheath slidably connected to the housing for movement between an extended position and a collapsed position, and a sharpened member carrier movable between a distal position relative to the sheath and a proximal position relative to the sheath, the sheath further including a noise attenuator configured to engage and reduce the velocity of the sharpened member carrier as the sharpened member carrier moves from the distal position to the proximal position.

[0019] The applicator may include a cap threadably connected to the housing, the cap being configured to reduce noise caused by movement of the sharpened member carrier from a distal position to a proximal position.

[0020] In accordance with the subject matter of the present disclosure, an applicator for delivering a sensor control device is provided, the applicator including a housing, a sensor carrier connected to the housing, a sensor control device releasably connected to the sensor carrier, a sensor extending from the sensor control device, the sensor having a distal end and a proximal end at a tail, a sharpened tip carrier movable between a distal position relative to the sensor control device and a proximal position relative to the sensor control device, and a sharpened tip disposed inside the sharpened tip carrier, wherein when the sharpened tip carrier is in the distal position, the sharpened tip engages the proximal end of the tail to bias the distal end of the tail toward the sharpened tip, and when the sharpened tip carrier is in the proximal position, the sharpened tip does not engage the proximal end of the tail.

[0021] The proximal end of the sensor may include a protrusion. The sharpened tip may include a window, and the proximal end of the tail may overhang the window in the sharpened tip when the sharpened tip is in the distal position. The sharpened tip carrier may be in the distal position before delivery. The sharpened tip carrier may be in the proximal position during delivery of the sensor. The applicator may include a sheath slidably connected to the housing for movement between an extended position and a collapsed position. The sharpened tip may define a passageway. The distal end of the tail may be received within the passageway of the sharpened tip when the sharpened tip is engaged with the proximal end of the tail. [Brief explanation of the drawings]

[0022] The details of the subject matter set forth herein, both as to its structure and operation, will become apparent from examination of the accompanying drawings, in which like reference numerals refer to like components. The components in the drawings are not necessarily to scale, emphasis instead being placed upon illustrating the principles of the subject matter. Furthermore, all illustrations are intended to convey concepts, and relative dimensions, shapes, and other detailed attributes may be illustrated schematically, rather than literally or precisely. [Figure 1] System schematic of sensor applicator, reader, monitoring system, network, and remote system. [Figure 2A] FIG. 2 is a block diagram illustrating an exemplary embodiment of a reader; [Figure 2B] FIG. 2 is a block diagram illustrating an exemplary embodiment of a sensor control device. [Figure 2C] FIG. 2 is a block diagram illustrating an exemplary embodiment of a sensor control device. [Figure 3A] FIG. 10 is a close-up perspective view of an exemplary embodiment depicting a user preparing a tray for an assembly. [Figure 3B] 10 is a side view illustrating an exemplary embodiment of a user preparing the applicator device for the assembly. [Figure 3C] 10 is a close-up perspective view of an exemplary embodiment depicting a user inserting an applicator device into a tray during assembly. [Figure 3D] 10 is a close-up perspective view depicting an exemplary embodiment of a user removing the applicator device from the tray during assembly. [Figure 3E] 10 is a close-up perspective view illustrating an exemplary embodiment of a patient applying a sensor using an applicator device. [Figure 3F] FIG. 10 is a close-up perspective view of an exemplary embodiment in which a patient has completed sensor application and is holding a used applicator device. [Figure 4A] 10 is a side view illustrating an exemplary embodiment of an applicator device connected with a cap. [Figure 4B] 10 is a side perspective view illustrating an exemplary embodiment in which the applicator device and cap are disconnected. FIG. [Figure 4C] 10 is a perspective view illustrating an exemplary embodiment of the distal end of the applicator device and electronics covering member. FIG. [Figure 4D] 1 is a top perspective view of an exemplary applicator device in accordance with the presently disclosed subject matter; [Figure 4E] FIG. 4E is a bottom perspective view of the applicator device of FIG. 4D. [Figure 4F] FIG. 4E is an exploded view of the applicator device of FIG. 4D. [Figure 4G] FIG. 4E is a side cutaway view of the applicator device of FIG. 4D. [Figure 5] FIG. 10 is a close-up perspective view depicting an exemplary embodiment in which a tray is connected to a sterilization lid. [Figure 6A] FIG. 10 is a close-up cutaway view illustrating an exemplary embodiment in which a tray is provided with various components for sensor delivery. [Figure 6B] FIG. 1 is a close-up perspective view depicting various components for sensor delivery. [Figure 7A] FIG. 10 is a side view illustrating an exemplary embodiment of a housing. [Figure 7B] 10A and 10B are close-up views of exemplary embodiments of the distal end of the housing. [Figure 7C] 1 is a longitudinal cross-sectional view illustrating an exemplary embodiment of a housing. [Figure 7D] FIG. 10 is a longitudinal cross-sectional view of a locking protrusion of an exemplary embodiment of a housing together with a portion of a sheath member. [Figure 7E] FIG. 10 is a longitudinal cross-sectional view of a locking protrusion of an exemplary embodiment of a housing together with a portion of a sheath member. [Figure 7F] FIG. 10 is a longitudinal cross-sectional view illustrating a locking protrusion and a portion of a sheath member of another exemplary embodiment of the housing. [Figure 7G] FIG. 10 is a longitudinal cross-sectional view illustrating a locking protrusion and a portion of a sheath member of another exemplary embodiment of the housing. [Figure 7H] FIG. 10 is a longitudinal cross-sectional view illustrating a locking protrusion and a portion of a sheath member of yet another exemplary embodiment of the housing. [Figure 7I] FIG. 10 is a longitudinal cross-sectional view illustrating a locking protrusion and a portion of a sheath member of yet another exemplary embodiment of the housing. [Figure 7J] FIG. 2 is a side view of an exemplary housing according to the subject matter of the present disclosure. [Figure 7K] FIG. 7J is a bottom perspective view of the housing of FIG. 7J. [Figure 7L] FIG. 7J is a side cutaway view of the housing of FIG. 7J. [Figure 7M] FIG. 2 is a bottom perspective view of a cap according to the present disclosure. [Figure 7N] A side cutaway view of the cap of Figure 7M. [Figure 7O] Top view of the cap in Figure 7M. [Figure 7P] 1 is an enlarged longitudinal cross-sectional view of the interface between the housing and the cap in accordance with the present disclosure; [Figure 7Q] 1 is an enlarged longitudinal cross-sectional view of the interface between the housing and the cap in accordance with the present disclosure; [Figure 7R] 1 is an enlarged longitudinal cross-sectional view of a housing according to the present disclosure; [Figure 7S] 1 is an enlarged longitudinal cross-sectional view of a cap according to the present disclosure; [Figure 7T] A side cutaway view of the cap of Figure 7M. [Figure 7U] A side cutaway view of the cap of Figure 7M. [Figure 8A] FIG. 10 is a side view illustrating an exemplary embodiment of a sheath. [Figure 8B] 10 is a perspective view illustrating an exemplary embodiment of the proximal end of a sheath. FIG. [Figure 8C] FIG. 10 is a close-up perspective view of an exemplary embodiment of the distal side of the detent snap fitting of the sheath. [Figure 8D] FIG. 10 is a side view illustrating an exemplary embodiment of features of a sheath member. [Figure 8E] 10 is an end view illustrating an exemplary embodiment of the proximal end of the sheath. [Figure 8F] 10A-10C are perspective views illustrating various stages of assembling another exemplary embodiment of a sheath with the remaining components of an applicator. [Figure 8G] 10A-10C are perspective views illustrating various stages of assembling another exemplary embodiment of a sheath with the remaining components of an applicator. [Figure 8H]10A-10C are perspective views illustrating various stages of assembling another exemplary embodiment of a sheath with the remaining components of an applicator. [Figure 8I] FIG. 2 is a side view of a sheath according to the presently disclosed subject matter. [Figure 8J] FIG. 8J is a close-up view of the detent snap fitting of the sheath of FIG. 8I. [Figure 8K] FIG. 8I is a top view of the sheath of FIG. 8I. [Figure 8L] FIG. 8I is a perspective view of the sheath of FIG. 8I. [Figure 8M] FIG. 8I is a side cutaway view of the sheath of FIG. 8I. [Figure 8N] 8I is a close-up view of the locking arms of the sheath of FIG. 8I mated with the cap and sensor carrier in accordance with the presently disclosed subject matter. [Figure 8O] 8I is a close-up view of the ridges of the sheath of FIG. 8I mating with the sensor carrier in accordance with the presently disclosed subject matter. [Figure 9A] 1 is a proximal perspective view illustrating an exemplary embodiment of a sensor carrier. [Figure 9B] 1A and 1B are perspective distal views illustrating exemplary embodiments of sensor carriers. [Figure 9C] FIG. 10 is a distal perspective view illustrating another exemplary embodiment of a sensor carrier. [Figure 9D] 1 is a top perspective view of a sensor carrier in accordance with the presently disclosed subject matter; [Figure 9E] FIG. 9E is a bottom view of the sensor carrier of FIG. 9D. [Figure 10A] 1 is a perspective view of a pointed carrier in accordance with the presently disclosed subject matter; [Figure 10B] FIG. 10B is a side cutaway view of the pointed carrier of FIG. 10A. [Figure 10C] 1 is a perspective view of a pointed carrier in accordance with the presently disclosed subject matter; [Figure 10D] FIG. 10D is a side cutaway view of the pointed carrier of FIG. 10C. [Figure 11A] FIG. 1 is a top view depicting an exemplary embodiment of a sensor module. [Figure 11B] FIG. 10 is a bottom view depicting an exemplary embodiment of a sensor module. [Figure 12A]FIG. 10 is a perspective view illustrating an exemplary embodiment of a sensor connector. [Figure 12B] FIG. 10 is a perspective view illustrating a compressed state of an exemplary embodiment of a sensor connector. [Figure 13] 1 is a perspective view illustrating an exemplary embodiment of a sensor. [Figure 14A] FIG. 10 is a bottom perspective view of an exemplary embodiment of a sensor module assembly. [Figure 14B] FIG. 1 is a top perspective view of an exemplary embodiment of a sensor module assembly. [Figure 15A] FIG. 10 is a close-up partial view of an exemplary embodiment of a sensor module assembly. [Figure 15B] FIG. 10 is a close-up partial view of an exemplary embodiment of a sensor module assembly. [Figure 15C] FIG. 2 is a side view of an exemplary sensor according to an embodiment of the present disclosure. [Figure 15D] FIG. 10 is a side view of an exemplary sensor according to another embodiment of the present disclosure. [Figure 15E] FIG. 10 is a side view of an exemplary sensor according to another embodiment of the present disclosure. [Figure 15F] FIG. 10 is a side view of an exemplary sensor according to yet another embodiment of the present disclosure. [Figure 15G] FIG. 10 is a side view of an exemplary sensor according to another embodiment of the present disclosure. [Figure 16A] 1 is an isometric view of an exemplary connector assembly, according to an embodiment. [Figure 16B] 10 is a partially exploded isometric view of an exemplary connector assembly according to another embodiment. [Figure 16C] FIG. 16C is an isometric bottom view of the connector of FIGS. 16A and 16B. [Figure 16D] 10 is an isometric view of another exemplary connector assembly according to an embodiment. [Figure 16E] 10 is a partially exploded isometric view of another exemplary connector assembly according to another embodiment. [Figure 16F] FIG. 16D is an isometric bottom view of the connector of FIGS. 16E and 16F. [Figure 17A]10A and 10B are perspective views illustrating exemplary embodiments of sharpening members modules. [Figure 17B] FIG. 10 is a perspective view of another exemplary embodiment of a sharp member module. [Figure 17C] 17C is a schematic diagram depicting the sharpening element module of FIG. 17B. [Figure 17D] 17C is a schematic diagram depicting the sharpening element module of FIG. 17B. [Figure 17E] FIG. 17C is a side schematic view of the tip module of FIG. 17B when assembled with a sensor module. [Figure 17F] 17C is a top-down schematic view of the tip module of FIG. 17B when assembled with a sensor module. [Figure 17G] FIG. 10 is a perspective view of another embodiment of a sharp member module. [Figure 17H] FIG. 17H is a side schematic view illustrating the sharp member module of FIG. 17G. [Figure 17I] FIG. 17G is a longitudinal cross-sectional view of the sharpened member module of FIG. 17G when assembled with a sensor module. [Figure 17J] FIG. 17H is a side view of the sharp member module of FIG. 17G when assembled with a sensor module. [Figure 18A] FIG. 10 is an isometric view of another exemplary sensor control device. [Figure 18B] FIG. 10 is a side view of a sensor control device according to another embodiment. [Figure 19A] FIG. 18C is an exploded isometric top view of the sensor control device of FIGS. 18A and 18B. [Figure 19B] FIG. 18C is an exploded isometric bottom view of the sensor control device of FIGS. 18A and 18B. [Figure 20] 1 is a longitudinal cross-sectional view of an assembled sealed assembly according to one or more embodiments. [Figure 21A] 21B is a longitudinal cross-sectional view illustrating the assembly of a sensor applicator with the sensor control device of FIGS. 18A and 18B. [Figure 21B] 21A through 21C are longitudinal cross-sectional views illustrating the assembly of a sensor applicator with the sensor control device of FIGS. 18A and 18B. [Figure 21C] 21B is a longitudinal cross-sectional view continuing from FIG. 21B illustrating the assembly of the sensor applicator with the sensor control device of FIGS. 18A and 18B. [Figure 22A] FIG. 21D is a perspective view of the cap post of FIG. 21C, according to one or more additional embodiments. [Figure 22B] FIG. 21D is a top view of the cap post of FIG. 21C, according to one or more additional embodiments. [Figure 23] FIG. 18C is a longitudinal cross-sectional view of the sensor control device of FIGS. 18A and 18B. [Figure 24A] FIG. 10 is a longitudinal cross-sectional view of the sensor applicator with the sensor control device ready to be deployed at the target monitoring site. [Figure 24B] FIG. 10 is a longitudinal cross-sectional view of the sensor applicator with the sensor control device ready to be deployed at the target monitoring site. [Figure 25A] 25B, illustrating an assembly or disassembly of an exemplary embodiment of a sensor applicator incorporating the sensor control device of FIGS. 18A and 18B. [Figure 25B] A longitudinal cross-sectional view continuing from Figure 25A to Figure 25C, or from Figure 25C to Figure 25A, illustrating the assembly or disassembly of a specific embodiment of a sensor applicator equipped with the sensor control device of Figures 18A and 18B. [Figure 25C] 25B, illustrating an assembly or disassembly of an exemplary embodiment of a sensor applicator incorporating the sensor control device of FIGS. 18A and 18B. [Figure 26A] FIG. 1 is an isometric bottom view of a housing according to one or more embodiments. [Figure 27A] FIG. 10 is an isometric bottom view of the housing with the sheath and various other components at least partially disposed therein. [Figure 28] 1 is an enlarged cross-sectional view of an exemplary sensor applicator with a sensor control device installed therein, according to one or more embodiments. [Figure 29A] FIG. 1 is an isometric top view of a cap according to one or more embodiments. [Figure 29B] 1 is an enlarged vertical cross-sectional view of a mating portion of a cap and a housing according to one or more embodiments. [Figure 30A] 1 is an isometric view of a sensor cap according to one or more embodiments. [Figure 30B] 1 is an isometric view of an annular member according to one or more embodiments. [Figure 31A] 1 is a side view of an exemplary sensor control device in accordance with one or more embodiments of the present disclosure. [Figure 31B] 1 is an isometric view of an exemplary sensor control device in accordance with one or more embodiments of the present disclosure. [Figure 32A] 3 is an exploded isometric top view of the sensor control device of FIG. 2 according to one or more embodiments. [Figure 32B] 3 is an exploded isometric bottom view of the sensor control device of FIG. 2 according to one or more embodiments. [Figure 33] 31A and 31B and 32A and 32B according to one or more embodiments. FIG. [Figure 33A] 31A and 31B and 32A and 32B are exploded isometric views of portions of another embodiment of FIGS. [Figure 34A] FIG. 32C is an isometric bottom view of the pedestal portion of FIGS. 31A and 31B and 32A and 32B. [Figure 34B] 31A and 31B and 32A and 32B are isometric top views of the sensor caps of FIGS. 31A and 31B and 32A and 32B. [Figure 35A] 1 is a side view of an exemplary sensor applicator according to one or more embodiments. [Figure 35B] 1 is a longitudinal cross-sectional view of an exemplary sensor applicator according to one or more embodiments. [Figure 36A] FIG. 35C is a perspective view of the cap post of FIG. 35B according to one or more embodiments. [Figure 36B] FIG. 35C is a top view of the cap post of FIG. 35B according to one or more embodiments. [Figure 37] 1 is a longitudinal cross-sectional view illustrating a sensor control device positioned inside an applicator cap according to one or more embodiments. [Figure 38A] 1 is a longitudinal cross-sectional view illustrating an exemplary interface between a sensor and a sharpened member in a sensor control device. [Figure 38B] 1 is a longitudinal cross-sectional view illustrating a sharpened member hub, sharpened member, and sensor with the sensor in an unbiased position in accordance with the disclosed subject matter; [Figure 38C] 1 is a longitudinal cross-sectional view illustrating a sharpened member hub, sharpened member, and sensor with the sensor in a biased position in accordance with the disclosed subject matter; [Figure 38D] 1 is a close-up view of a portion of a sharpened member in accordance with the presently disclosed subject matter. [Figure 39A] 1A-1C are cross-sectional views depicting exemplary embodiments of applicators during certain stages of deployment. [Figure 39B] 1A-1C are cross-sectional views depicting exemplary embodiments of applicators during certain stages of deployment. [Figure 39C] 1A-1C are cross-sectional views depicting exemplary embodiments of applicators during certain stages of deployment. [Figure 39D] 1A-1C are cross-sectional views depicting exemplary embodiments of applicators during certain stages of deployment. [Figure 39E] 1A-1C are cross-sectional views depicting exemplary embodiments of applicators during certain stages of deployment. [Figure 39F] 1A and 1B are perspective views illustrating an exemplary embodiment of an applicator during a stage of deployment. DETAILED DESCRIPTION OF THE INVENTION

[0023] Before describing the present subject matter in detail, it is to be understood that the present disclosure is not limited to particular embodiments described, as such may, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting, as the scope of the present disclosure will be limited only by the appended claims.

[0024] As used in this specification and the appended claims, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise.

[0025] The various publications discussed herein are provided solely for their disclosure prior to the filing date of the present application. Nothing herein should be construed as an admission that the present disclosure is not entitled to antedate such publication by virtue of prior disclosure. Further, the publication dates provided may be different from the actual publication dates, which must be independently confirmed.

[0026] In general, embodiments of the present disclosure include systems, devices, and methods for using an analyte sensor insertion applicator intended for use with an in-vivo analyte monitoring system. The applicator can be provided to a user in a sterile package containing a sensor control device and an electronics enclosure. In some embodiments, a separate structure, such as a container, is provided to a user in a sterile package containing a sensor module and a sharpening module. The user can couple the sensor module to the electronics enclosure and couple the sharpening module to the applicator in an assembly process that involves inserting the applicator into the container in a specified manner. In other embodiments, the applicator, sensor control device, sensor module, and sharpening module can be provided in a single package. The applicator can be used to place the sensor control device on a human body, placing the sensor in contact with the device wearer's bodily fluids. The embodiments presented herein are improvements intended to reduce the likelihood of improper insertion or damage to the sensor or the potential for eliciting an adverse physiological response. Other improvements and advantages are presented as well. Various configurations of these devices will be described in detail in various embodiments, which are illustrative only.

[0027] Additionally, many embodiments include an in vivo analyte sensor that is structurally configured to provide information regarding at least one analyte in a body by disposing or enabling at least a portion of the sensor to be disposed within the body of a user. However, it should be noted that the embodiments disclosed herein can be used with in vivo analyte monitoring systems that incorporate in vitro functionality, as well as with purely ex vivo analyte monitoring systems, e.g., completely noninvasive systems.

[0028] Additionally, systems and devices capable of implementing any of the method embodiments disclosed herein are within the scope of this disclosure. For example, while sensor control device embodiments are disclosed, these devices may include one or more sensors, one or more analyte monitoring circuits (e.g., analog circuits), one or more memory devices (e.g., for storing instructions), one or more power sources, one or more communications circuits, one or more transceivers, one or more receivers, one or more processors, one or more controllers (e.g., for executing instructions), or various combinations thereof, that enable or facilitate the performance of any of the method steps. Each of these sensor control device embodiments may be used, or have functionality suitable for use, in implementing the steps performed by the sensor control device according to any and all of the methods described herein.

[0029] As mentioned above, numerous embodiments of systems, devices, and methods are described herein that provide improved assembly and use of sensor insertion devices for use with in-vivo analyte monitoring systems. In particular, some embodiments of the present disclosure are designed to improve methods of sensor insertion with in-vivo analyte monitoring systems, particularly to prevent premature retraction of the insertion tip during the sensor insertion process. For example, some embodiments include a sensor insertion mechanism that increases firing rate and delays tip retraction. In other embodiments, the tip retraction mechanism may be motion-sensitive, preventing tip retraction until the user pulls the applicator away from the skin. These embodiments may therefore reduce the likelihood of premature withdrawal of the insertion tip during the sensor insertion process, reduce the likelihood of improper sensor insertion, and reduce the likelihood of sensor damage during the sensor insertion process, to name a few advantages. Some embodiments of the present disclosure also provide an improved insertion tip module. Additionally, some embodiments of the present disclosure are designed to prevent undesired axial and / or rotational movement of the applicator components during sensor insertion. These embodiments may therefore reduce the likelihood of instability of the deployed sensor, irritation at the insertion site, and damage to surrounding tissue, among other benefits. Additionally, to mitigate potentially inaccurate sensor measurements due to trauma at the insertion site, some embodiments of the present disclosure may reduce the final penetration depth of the needle relative to the sensor tip during insertion.

[0030] However, before describing these aspects of each embodiment in detail, it is desirable to first describe specific examples of various devices that may be present in an in vivo analyte monitoring system, as well as examples of their operation, that can be used in conjunction with each embodiment described herein.

[0031] There are various types of in vivo analyte monitoring systems. For example, a "continuous analyte monitoring" system (or a "continuous glucose monitoring" system) can transmit data from the sensor controller to the reader continuously, e.g., automatically, according to a schedule, without user prompting. As another example, a "flash analyte monitoring" system (or a "flash glucose monitoring" system, or simply a "flash" system) can transfer data from the sensor controller in response to a scan or data request by the reader used, e.g., utilizing near field communication (NFC) or radio frequency identification (RFID) protocols. In vivo analyte monitoring systems can also operate without the need for a fingerstick biopsy.

[0032] In vivo analyte monitoring systems are distinguished from "ex vivo" systems, which typically involve contacting a biological sample outside the body (i.e., "ex vivo") and include a metering device with a port for receiving an analyte test strip containing a user's bodily fluid that can be analyzed to determine the user's blood glucose level.

[0033] An in-vivo monitoring system can include a sensor that contacts a user's bodily fluids and senses analyte levels therein while positioned in vivo. The sensor can be part of a sensor control device that resides on the user's body and includes electronics and a power source that enable and control analyte sensing. Sensor control devices and their various variations are sometimes referred to as "sensor control units," "body-worn electronics" devices or units, "body-worn" devices or units, or "sensor data communication" devices or units, to name a few.

[0034] In-vivo monitoring systems may also include devices that receive sensed analyte data from the sensor control device, process the sensed analyte data, and / or display the sensed analyte data to a user in any format. These devices and their variations may be referred to as "handheld reading devices," "reading devices" (or simply "readers"), "handheld electronic devices" (or simply "handhelds"), "portable data processing" devices or units, "data receivers," "receiver" devices or units (or simply "receivers"), or "remote" devices or units, to name a few. Other devices, such as personal computers, are already used with or incorporated into in-vivo and in-vitro monitoring systems.

[0035] Exemplary In Vivo Analyte Monitoring System FIG. 1 is a conceptual diagram illustrating an exemplary embodiment of an analyte monitoring system 100 including a sensor applicator 150, a sensor control unit 102, and a reader 120. Here, the sensor applicator 150 can be used to deliver the sensor control unit 102 to a monitoring site on a user's skin, where a sensor 104 is maintained in place for a period of time by an adhesive patch 105. The sensor control unit 102 can communicate with the reader 120 via a communication path 140 using wired or wireless technologies, as further illustrated in FIGS. 2B and 2C. Example wireless protocols include Bluetooth®, Bluetooth Low Energy (BLE, BTLE, Bluetooth SMART, etc.), Near Field Communication (NFC), etc. A user can monitor applications installed on the reader 120's storage device using a display screen 122 and input components 121, and the device battery can be recharged using a power port 123. Further details about the reader 120 are provided below with respect to FIG. 2A. The reader 120 can communicate with a local computer system 170 via a communication path 141 using wired or wireless technologies. The local computer system 170 can include one or more of a laptop, desktop, tablet, phablet, smartphone, set-top box, video game console, or other computing device, and the wireless communication can include any of a variety of applicable wireless network protocols, such as Bluetooth, Bluetooth Low Energy (BTLE), Wi-Fi, etc. The local computer system 170 can communicate with the network 190 via communication path 143, similar to the manner in which the reader 120 can communicate with the network 190 via communication path 142 using wireless or wired technology as described above.Network 190 may be any of a variety of networks, such as private and public networks, local area networks and wide area networks, etc. Trusted computer system 180 may include a server to provide authentication services and secure data storage, and may communicate with network 190 via communications path 144 using wired or wireless technologies.

[0036] Illustrative reader 2A is a block diagram illustrating an exemplary embodiment of a reading device configured as a smartphone. Here, reading device 120 includes display screen 122, input component 121, and processing core 206, which includes communication processor 222 connected to storage 223 and application processor 224 connected to storage 225. Separate storage 230, wireless transceiver 228 with associated antenna 229, and power supply 226 with power management module 238 may also be included. Additionally, multi-function transceiver 232 may be included, capable of communicating via Wi-Fi, NFC, Bluetooth, BTLE, and GPS using antenna 234. Those skilled in the art will appreciate that these various components are electrically and communicatively connected to provide a functional device.

[0037] Specific sensor control device 2B and 2C are block diagrams illustrating an exemplary embodiment of a sensor control device 102, which includes an analyte sensor 104 and sensor electronics 160 (including analyte monitoring circuitry) with most of the processing power ready to render final result data suitable for display to a user. FIG. 2B depicts a single semiconductor chip 161, which may be a custom application-specific integrated circuit (ASIC). Shown within the ASIC 161 are various high-level functional units, such as an analog front-end (AFE) 162, a power management circuit (or power control circuit) 164, a processing unit 166, and a communications circuit 168 (which may be implemented as a transmitter, receiver, transceiver, or passive circuitry, or otherwise implemented according to a communications protocol). While both the AFE 162 and the processing unit 166 are used as analyte monitoring circuitry in this embodiment, in other embodiments, either circuitry may perform the analyte monitoring function. The processor 166 may be comprised of one or more processors, microprocessors, controllers, microcontrollers, or various combinations thereof, each of which may be a separate chip or may be distributed among multiple chips (or a subset of chips).

[0038] Memory 163 is also included within application specific integrated circuit (ASIC) 161 and may be shared by various functional units present within ASIC 161 or may be distributed among two or more of the functional units. Memory 163 may be a separate chip. Memory 163 may be volatile memory, non-volatile memory, or a combination of both. In this embodiment, ASIC 161 is connected to power source 170, which may be a coin cell battery or the like. Analog front end (AFE) 162 acts as an interface with in-vivo analyte sensor 104, receiving measurement data from the sensor and outputting the data in digital form to processor 166, which in turn processes the data to arrive at final results such as discrete glucose values ​​and trend values. This data is then provided to communication circuitry 168 for transmission, for example, via antenna 171, to reader 120 (not shown), with minimal further processing by a resident software application required for the data to be displayed.

[0039] FIG. 2C is similar to FIG. 2B but instead includes two separate semiconductor chips, 162 and 174, which may be packaged together or separately. Here, AFE 162 resides on ASIC 161. Processing unit 166 is integrated on chip 174 with power management circuitry 164 and communications circuitry 168. AFE 162 includes memory 163, and chip 174 includes memory 165, which may be isolated or distributed internally. In one exemplary embodiment, AFE 162 is integrated with power management circuitry 164 and processing unit 166 on a single chip, while communications circuitry 168 is on a separate chip. In another exemplary embodiment, both AFE 162 and communications circuitry 168 are on a single chip, with processing unit 166 and power management circuitry 164 on another chip. It should be noted that other chip combinations are possible, consisting of three or more chips, each performing a distinct function as described or sharing one or more functions for fail-safe redundancy.

[0040] Integration process of an exemplary sensor control device The various components of the sensor control device 102 are available to the user in multiple packages that require final assembly by the user before delivery to the user site. Figures 3A-3D depict an exemplary embodiment of a user assembly process for the sensor control device 102, including preparing each separate component before joining them to prepare the sensor for delivery. Figures 3E-3F depict an exemplary embodiment of delivery of the sensor control device 102 to the appropriate user site by selecting the appropriate delivery site and applying the device 102 to the site.

[0041] 3A is a proximal perspective view depicting an exemplary embodiment in which a user prepares a container 810, here configured as a tray (although other packaging groups can be used), for the assembly process. The user may accomplish this preparation by removing the lid 812 from the tray 810 to expose the platform 808, for example, by peeling the unattached portion of the lid 812 from the tray 810, thereby allowing the adhesive portion of the lid 812 to be removed. Removal of the lid 812 may also be appropriate in various other embodiments, so long as the platform 808 is appropriately exposed inside the tray 810. The lid 812 may then be set aside.

[0042] 3B is a side view depicting an exemplary embodiment of a user preparing applicator device 150 for assembly. Applicator device 150 may be provided in a sterile package sealed with cap 708. Preparing applicator device 150 may include unscrewing housing 702 from cap 708 to expose sheath 704 (FIG. 3C). This may be accomplished by unscrewing (or otherwise detaching) cap 708 from housing 702. Cap 708 may then be set aside.

[0043] 3C is a proximal perspective view depicting an exemplary embodiment in which a user inserts applicator device 150 into tray 810 during assembly. First, a user can insert sheath 704 into platform 808 inside tray 810 after aligning housing orientation feature 1302 (or slot or recess) and tray orientation feature 924 (abutment or detent). Inserting sheath 704 into platform 808 temporarily unlocks sheath 704 from housing 702 and temporarily unlocks platform 808 from tray 810. At this stage, removing applicator device 150 from tray 810 leaves it in the same state as it was before initial insertion into tray 810 (i.e., the previous steps can be reversed, stopped at this point, and repeated without consequence).

[0044] As the housing 702 advances distally, it engages with the platform 808, allowing the sheath 704 to maintain its position inside the platform 808 relative to the housing 702. This process unlocks and crushes the platform 808 inside the tray 810. As the housing 702 continues to advance the platform 808 distally, the sheath 704 contacts and disengages a locking feature (not shown) inside the tray 810, unlocking the sheath 704 from the housing 702 and preventing it from moving (relatively). Once the housing 702 has completed its distal advancement, a sharpened tip and sensor (not shown) inside the tray 810 can be engaged with an electronics receptacle (not shown) within the housing 702. The operation and interaction of the applicator device 150 and tray 810 are further described below.

[0045] 3D is a proximal perspective view depicting an exemplary embodiment in which a user removes applicator device 150 from tray 810 during assembly. Removal of applicator device 150 by a user from tray 810 can be accomplished by advancing housing 702 proximally relative to tray 810, or by some other action that has the same end effect of disconnecting applicator 150 from tray 810. Applicator device 150 is removed with the fully assembled sensor control device 102 (not shown) (including sharpened tip, sensor, and electronics) contained therein and then positioned for delivery.

[0046] 3E is a proximal perspective view illustrating an exemplary embodiment in which a patient uses applicator device 150 to apply sensor control unit 102 to a target skin area, such as on the abdomen or other suitable site. Distal advancement of housing 702 collapses sheath 704 within housing 702, applying the sensor to the target site and causing the adhesive layer on the bottom of sensor control unit 102 to adhere to the skin. When housing 702 is fully advanced, the sharpened tip automatically retracts, leaving the sensor (not shown) in place to measure an analyte value.

[0047] 3F is a proximal perspective view depicting an exemplary embodiment in which the patient is holding the sensor control unit 102 in an application position, at which point the user may remove the applicator 150 from the application site.

[0048] 3A-3F and elsewhere herein, system 100 reduces or eliminates the possibility of accidental breakage, permanent deformation, or improper assembly of applicator components compared to prior art systems. Because applicator housing 702 directly engages platform 808 while sheath 704 is unlocked, rather than indirectly through sheath 704, the relative angle between sheath 704 and housing 702 does not result in breakage or permanent deformation of the arms or other components. This reduces the potential for relatively high forces during assembly (as in prior devices), which in turn reduces the likelihood of user-initiated assembly failure.

[0049] Exemplary Sensor Applicator Device Figure 4A is a side view of an exemplary embodiment of applicator device 150 connected with screw cap 708. This is an example of the applicator 150 during shipping and receipt for a user, prior to assembly with a sensor by the user. Figure 4B is a side perspective view of applicator 150 and cap 708 after they have been disconnected. Figure 4C is a perspective view of an exemplary embodiment of the distal end of applicator device 150, with electronics shroud 706 with adhesive patch 105 removed from their respective positions inside sensor carrier 710 of electronics sheath 704 when cap 708 is in place.

[0050] 4D-4G, for purposes of illustration and not limitation, the applicator device 20150 can be provided to a user as a single, integrated assembly. FIG. 4D provides a top perspective view of the applicator device 20150, FIG. 4E provides a bottom perspective view thereof, FIG. 4F provides an exploded view of the applicator device 20150, and FIG. 4G provides a side cutaway view thereof. The perspective views show the applicator 20150 as it is being shipped and received by a user. The exploded and cutaway views illustrate the various components of the applicator device 20150. The applicator device 20150 includes a housing 20702, a gasket 20701, a sheath member 20704, a sharpened member carrier 201102, a spring 205612, a sensor carrier 20710 (also referred to as a "puck carrier"), a sharpened member 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 number label 20709, a used indication feature 20712, and the like. Only the housing 20702, the cap 20708, the used indication feature 20712, and the label 20709 are visible to the user upon receipt. The used-indicating feature 20712 may be, for example, a sticker connecting the housing 20702 and the cap 20708, or the like, which may notify the user that the housing 20702 and the cap 20708 have previously been separated, for example, by being irreparably damaged by separating the housing 20702 and the cap 20708. These features are described in more detail below.

[0051] Illustrative Tray and Sensor Module Assembly FIG. 5 is a proximal perspective view depicting an exemplary embodiment of a tray 810 and a sterilization lid 812 removably connected thereto, which is a proximal perspective view of an exemplary embodiment of 810, presumably showing the package in a pre-assembly state during shipment and receipt for the user.

[0052] 6A is a proximal perspective cutaway view depicting the sensor delivery components inside tray 810. Platform 808 is slidably connected within tray 810. Desiccant 502 is stationary relative to tray 810. Sensor module 504 is mounted inside tray 810.

[0053] 6B is a proximal perspective view depicting sensor module 504 in greater detail, where retention arm overhang 1834 of platform 808 removably secures sensor module 504 in place. Module 2200 is connected to connector 2300, tip module 2500, and sensor (not shown) so that they can be removed together as sensor module 504 during assembly.

[0054] Exemplary Applicator Housing and Cap FIG. 7A is a side view of an exemplary embodiment of an applicator housing 702 having an internal cavity and multiple support structures for applicator function. The user initiates the applicator assembly process by pushing the housing 702 distally, allowing the sensor control unit 102 to be delivered, after which the cavity in the housing 702 can act as a receiver for a sharps member. The exemplary embodiment illustrates various features, including a housing orientation feature 1302 for orienting the device during assembly and use. The used-indicating annular groove 1304 is a recessed portion disposed around the circumference of the housing 702, distal to the used-indicating annular protective member 1314 and proximal to the used-indicating annular locking member 1304. The used-indicating annular groove 1304 secures a used-indicating ring, allowing the user to identify whether the device has been tampered with or otherwise used. The housing threads 1310 secure the housing 702 to complementary threads on the cap (FIGS. 4A and 4B) by aligning the threads with the complementary cap threads and then rotating them clockwise or counterclockwise. A side gripping zone 1316 on the housing 702 preferably provides an exterior area by which a user can grip the housing 702 for use. The gripping ledge 1318 is a slightly raised protrusion relative to the side gripping zone 1316, which aids in easy removal of the housing 702 from the cap 708. The shark teeth 1320 have a flat surface on the clockwise end of the protrusion that can shear off a used indicator ring (not shown) and hold the used indicator ring in place after the user unscrews the cap 708 and housing 702. In the exemplary embodiment, four shark teeth 1320 are used, although more or fewer may be employed as desired.

[0055] FIG. 7B is a perspective view of the distal end of the housing 702. Here, three housing guide structures (or “guide protrusions”) 1321 are arranged at a 120-degree angle relative to each other and a 60-degree angle relative to the locking structures (or “locking protrusions”) 1340, three of which are at 120 degrees relative to each other. Other angular orientations, both symmetrical and asymmetrical, as well as any number of structures 1321, 1340, may be used. Here, the structures 1321 and 1340 each have the shape of a flat protrusion, although other shapes may also be used. Each guide protrusion 1321 has a guide edge (also referred to as a “sheath guide rail”) 1326 that can pass along the surface of the sheath 704 (e.g., the guide rail 1418 described in connection with FIG. 8A ). The hard insertion stop 1322 provides a surface for the sensor carrier travel limiting surface 1420 (FIG. 8B) of the sheath 704 to abut during use, preventing further proximal advancement of the sensor carrier travel limiting surface 1420. The carrier interface post 1327 passes through an opening 1510 (FIG. 9A) in the sensor carrier 710 during assembly. The sensor carrier interface 1328 may be the rounded, distally facing surface of the housing guide protrusion 1321 that interfaces with the sensor carrier 710.

[0056] 7C is a longitudinal cross-sectional view depicting an exemplary embodiment of the housing. In this exemplary embodiment, the longitudinal cross-sectional profiles of the housing guide protrusion 1321 and the locking protrusion 1340 are illustrated. The locking protrusion 1340 includes a sheath snap fitting retraction feature 1330 near its distal end, which flares outward distally from the central axis 1346 of the housing 702. The sheath snap fitting retraction features 1330 each cause the detent snap fitting curved surface 1404 of the detent snap fitting 1402 of the sheath 704 to bend inward toward the central axis 1346 as the sheath 704 moves toward the proximal end of the housing 702, as shown in FIG. 8C . Once detent snap fitting 1402 of sheath 704 has passed the distal point of sheath snap fitting retraction feature 1330, it is locked in place in locking groove 1332. In this manner, detent snap fitting 1402 cannot be easily moved distally due to a surface having a plane generally perpendicular to central axis 1346, illustrated in FIG. 8C as detent snap fitting flat 1406.

[0057] As the housing 702 moves further distally toward the skin surface, and as the sheath 704 advances toward the proximal end of the housing 702, the detent snap fitting 1402 repositions into the unlocking groove 1334, placing the applicator 150 in the "armed" position and ready for use. As the user applies more force to the proximal end of the housing 702, the detent snap fitting 1402 advances over the firing detent 1344 while the sheath 704 is pressed against the skin. This initiates a firing sequence (e.g., as described in connection with FIGS. 12A-12D ) due to the release of energy stored in the curved detent snap fitting 1402, which moves proximally relative to the skin surface toward the sheath stop ramp 1338, which flares slightly outward relative to the central axis 1346 and slows the movement of the sheath 704 during the firing sequence. The next groove encountered after the detent snap fitting 1402 enters the unlocking groove 1334 is the final blocking recess 1336 into which the detent snap 1402 enters at the end of the stroke or pushing sequence performed by the final user. Final blocking recess 1336 is a proximally facing surface perpendicular to central axis 1346 that engages detent snap fitting flat 1406 after detent snap fastener 1402 has passed, firmly holding sheath 704 in place relative to housing 702 and preventing the device from being reused. Hard insertion stop 1322 of housing guide protrusion 1321 engages sensor carrier travel limiting surface 1420, preventing proximal advancement of sheath 704 relative to housing 702.

[0058] 7D and 7E are close-up longitudinal cross-sectional views of an exemplary embodiment of the detent snap fitting 1402 of the sheath 704 on the locking protrusion 1340 of the applicator housing 702 as it moves toward the proximal end of the housing 702. Figure 7D illustrates the sheath 704 in a "locked" state, where the detent snap fitting curved portion 1404 of the detent snap fitting 1402 has already cleared the sheath snap fitting retraction feature 1330 and is positioned within the locking groove 1332 of the locking protrusion 1340. When a force is applied to the proximal end of the housing 702, the detent snap fitting curved portion 1404 advances proximally into the unlocking groove 1334, placing the applicator 150 in the "armed" position. If further force is applied to the proximal end of housing 702, applicator 150 is "fired" as detent snap-fit ​​curved portion 1404 advances proximally from unlocking groove 1334 and clears firing detent 1344. Further proximal advancement of sheath 704 then results in detent snap-fit ​​curved portion 1404 slidably advancing over firing surface 1337, as illustrated in FIG. 7E . In this embodiment, firing surface 1337 is generally parallel to central axis 1346. As sheath 704 continues to advance proximally, detent snap-fit ​​curved portion 1404 encounters sheath stop ramp 1338, which slows the rate of travel of sheath 704. When the detent snap fit curved surface 1404 reaches the final blocking recess 1336 , it engages the detent snap fit flats 1406 (not shown) to hold the sheath 704 firmly in place relative to the housing 702 .

[0059] 7F and 7G are close-up longitudinal cross-sectional views of an alternative embodiment of a locking protrusion 2340 designed to improve the firing rate of the sharpened member from the sensor applicator. Here, the locking protrusion 2340 includes an inward detent ramp 2335 to reduce friction between the sheath 704 and the housing 2702 during firing. The locking protrusion 2340 also includes a sheath stop ramp 2338 at the proximal end of the firing face 2337. In FIG. 7F, the sheath 704 is illustrated initially in a “locked” state, where the detent snap fit curved surface 1404 of the detent snap fit 1402 has already passed the sheath snap fit retraction feature 2330 and is positioned within the locking groove 2332. When a force is applied to the proximal end of the housing 2702, the detent snap fitting curved portion 1404 advances into the unlocking groove 2334, placing the applicator 150 in the "armed" position. When further force is applied to the proximal end of the housing 2702, the detent snap fitting curved portion 1404 overcomes the firing detent 2344, causing the applicator 150 to be "fired."

[0060] 7G, detent snap fit curved portion 1404 then advances in a "free flight" manner toward the proximal end of housing 2702, where detent snap fit curved portion 1404 passes inward detent ramp 2335. During its "free flight" advancement proximally, detent snap fit curved portion 1404 may remain disconnected from, i.e., out of contact with, inward detent ramp 2335 and firing surface 2337. In this regard, little or no friction between detent snap fit curved portion 1404 and inward detent ramp 2335, and the former and firing surface 2337, allows detent snap fit curved portion 1404 to be advanced easily and quickly, thereby increasing the firing rate of the pointed member from the applicator. The sheath stop ramp 2338 is positioned further proximally along the locking projection 2340 than the embodiment illustrated in FIGS. 7D and 7E , but has some kind of edge to frictionally engage the detent snap-fit ​​curved surface 1404 to slow the rate of movement of the sheath 704. The sheath stop ramp 2338 may be sloped to increase frictional contact as the detent snap-fit ​​curved surface 1404 advances proximally. Eventually, when the detent snap-fit ​​curved surface 1404 reaches the final blocking recess 2336, the detent snap-fit ​​flat 1406 (not shown) engages, firmly holding the sheath 704 in place relative to the housing 2702. This embodiment exhibits a faster firing rate than the embodiment depicted in FIGS. 7A and 7E and also helps prevent premature withdrawal of the tip.

[0061] 7H is a close-up longitudinal cross-sectional view of an alternative embodiment of a locking protrusion 6340 designed to maintain a downward force on the sheath 6704 during firing, thereby preventing undesired movement of the sheath 6704 during the sensor insertion process. Here, the sheath 6704 is illustrated in a “locked” state, with the detent snap fitting curved portion 6404 of the detent snap fitting 6402 positioned within the locking groove 6332. When force is applied to the proximal end of the housing 6702, the detent snap fitting curved portion 6404 advances into the unlocking groove 6334, placing the applicator in an “armed” position. When further force is applied to the proximal end of the housing 6702, the applicator is “fired,” with the detent snap fitting curved portion 6404 advancing over the angled firing surface 6338 toward the proximal end of the housing 6702. The slope of the angled firing surface 6338 toward the central axis 1346 increases the resulting downward force on the sheath 6704 as the detent snap fit curved portion 6404 advances proximally. In the illustrated embodiment, the detent snap fit curved portion 6404 is in engaging contact with the angled firing surface 6338. The blocking recess 6336 prevents the detent snap fit curved portion 6404 and the sheath 6704 from backing out, i.e., moving distally. This embodiment exhibits a slower firing rate than the previous embodiments, but may be used in conjunction with the motion-sensitive tip retraction process described, for example, in connection with FIGS. 14A-14C and 15A-15B.

[0062] 71 is a close-up longitudinal cross-sectional view of another alternative embodiment in which the locking protrusion 7340 is also designed to maintain a downward force on the sheath 6704 during firing, thereby preventing undesired movement of the sheath 6704 during the sensor insertion process. Here, the sheath 6704 is illustrated in the “fired” state, with the detent snap fitting curved portion 6404 of the detent snap fitting 6402 positioned within the two-way blocking recess 7336. Once the detent snap fitting curved portion 6404 advances into the two-way blocking recess 7336, further movement of the sheath 6704 in either the proximal or distal direction is prevented. This reduces undesired movement of the sheath 6704 during the sensor insertion process. Additionally, in some embodiments, the bidirectional blocking recess 7336 immobilizes the sheath 6704 during the motion-sensitive tip retraction process, as described in connection with Figures 14A-14C and 15A-15B. As seen in Figure 7I, the angled firing surface 7338 slopes toward the central axis 1346, thereby providing a detent snap-fitting bend. As the surface 6404 advances proximally, the resulting downward force on the sheath 6704 increases. In the depicted embodiment, the detent snap fit curved surface 6404 is in engaging contact with the angled firing surface 7338.

[0063] 7J-7L, a housing 20702 according to the presently disclosed subject matter is shown for purposes of illustration and not limitation. The housing 20702 may be made of various suitable materials, such as cyclic olefin copolymer or other suitable materials, such as polycarbonate or high-density polyethylene (HDPE). The housing 20702 may include one or more of the features described in connection with various housings in which features similar to those described herein can function as described herein. For example, the housing 20702 may include a grip ledge 20702A that allows a user to firmly grip the housing 20702. The housing 20702 may include additional grip ledges 20702A, such as two grip ledges 20702A on either side of the housing 20702. The housing 20702 may include a side grip zone 20702B directly below the grip ledge 20702A. The side gripping zones 20702B may be textured to improve a user's grip. The housing 20702 may be provided with additional side gripping zones 20702B, for example, two side gripping zones 20702B on either side of the housing 20702, each located directly below a grip visor 20702A.

[0064] The housing 20702 may be provided with a housing skirt 20702C, which provides a surface for the used-indicating feature 20712. The housing skirt 20702C may be supported by a plurality of skirt reinforcing ribs 20702D. The skirt reinforcing ribs 20702D support the housing skirt 20702C and may help protect the applicator device 20150 during an impact event, such as a drop. Additionally, the skirt reinforcing ribs 20702D may be used to support the housing 20702 during manufacturing. The housing skirt 20702C and skirt reinforcing ribs 20702D may provide rigidity to resist forces resulting from gasket compression and may also help maintain compression of the gasket 20701 throughout its shelf life. The housing 20702 may include a gasket retaining ring 20702E and multiple gasket retaining pockets 20702F, which may retain the gasket 20701 relative to the housing 20702. For example, the gasket retaining ring 20702E may prevent lateral, axial, or both movement of the gasket 20701, and the gasket retaining pockets 20702E may prevent the gasket 20701 from rotating. The housing 20702 may include multiple gasket retaining pockets, for example, 14 gasket retaining pockets 20702E. The gasket sealing surface 20702N may compress the gasket 20701 to provide a seal. The housing 20702 may additionally or alternatively include an applicator cap sealing lip 20702U, which may act as an interface with the cap 20708, as described in more detail below. The housing 20702 may be provided with an inner surface 20702T that may receive the sheath 20704.

[0065] The housing 20702 may include threads 20702G configured to mate with threads 20708D on the cap 20708. The threads may include radial limiting features 20702H that can limit radial deformation of the cap 20708 (e.g., portions 20708D, 20708F, 20708G, etc.) during an impact event, such as a drop. The housing 20702 may include multiple radial limiting features 20702H, such as six radial limiting features 20702H. The radial limiting features 20702H may be multiple protrusions extending from the housing that can fill gaps in the threads 20708D on the cap. This can limit oval deformation of the cap 20708 during an impact event, such as a drop. Preventing oval deformation of the cap 20708 in turn ensures that the locking arms 20704J of the sheath 20704 remain locked between the cap 20708 and the sensor carrier 20710 (e.g., locking ledge 20710N), and can limit movement of the sheath 20704 prior to removal of the cap 20708 (as described in more detail below). The housing 20702 may further include relief notches 20702I for relief of the sheath arms during firing.

[0066] The interior of the housing 20702 may include a plurality of sensor carrier mounting features to receive, align, and limit movement of the sensor carrier 20710. For example, the housing 20703 may include sheath guide rails 20702J that help align and guide the sheath 20704 as it moves relative to the housing 20702. The housing 20702 may include a plurality of sensor carrier mounting slots 20702K that may engage and retain the sensor carrier 20710, and a hard sensor carrier stop 20702L that may limit axial movement of the sensor carrier 20710 relative to the housing 20702. The housing 20702 may be provided with a sensor carrier biasing feature 20702M that can eliminate tilt between the sensor carrier 20710 and the housing 20702 after assembly, and a sensor carrier radial limiting feature 20702O that can keep the sensor carrier in radial alignment with the housing 20702. Flat horizontal surfaces between the sensor carrier mounting slot 20702K and the sensor carrier radial limiting feature 20702O can be used to stop the sheath 20704 at the end of a blow. Similar features on the sheath 20704 may interact with these surfaces. The sensor carrier biasing feature 20702M can further limit rotation of the sensor carrier 20710 relative to the housing 20702. The housing 20702 may be provided with one or more of each of the sheath member guide rail 20702J, sensor carrier mounting slot 20702K, sensor carrier hard stop portion 20702L, sensor carrier radial limiting function portion 20702O, and sensor carrier biasing function portion 20702M, for example, three of each.

[0067] The interior of the housing 20702 further includes a plurality of sheath projections 20702S that engage with the sheath 20704 to prepare it for insertion, as described herein. The housing 20702 may include one or more sheath projections 20702S, for example, three. Each sheath projection 20702S may include a sheath snap-fit ​​retraction feature 20702P configured to initially retract the detent snap-fit ​​portion 20704A of the sheath 20704 into the correct position. The housing 20702 may include a firing detent 20702Q. After the detent snap-fit ​​portion 20704A of the sheath 20704 clears the firing detent 20702Q, the firing sequence can begin and the sheath 20704 can move toward the sheath stop ramp 20702R. The sheath stop ramp 20702 can slow down the velocity of the sheath 20704 at the end of the shot.

[0068] 7M-7U, an exemplary cap 20708 is shown for illustrative purposes. The cap 20708 may include one or more of the features described in connection with various caps, where features similar to those described herein may function as described herein. The cap 20708 may be made of high-density polyethylene (HDPE) or any suitable material, such as polypropylene or low-density polyethylene (LDPE). The cap 20708 may include a label surface 20708A configured to receive a label 20709. The cap 20708 may include ridges 20708B, which may provide strength and a better gripping surface for the user. The cap 20708 may include a used-indicating label ring 20708C, which may be capable of receiving a used-indicating feature 20712. The cap 20708 may include a gasket sealing surface 20708G configured to engage the gasket 20701.

[0069] Internally, the cap 20708 may include threads 20708D that may be adapted to threadably mate with threads 20702G on the housing 20702. The cap 20708 may include a sealing interface 20708E that may be configured to receive an applicator cap sealing lip 20702U to provide a seal between the housing 20702 and the cap 20709.

[0070] 7P-7S are enlarged longitudinal cross-sectional views of the interface between the housing 20702 and the cap 20708. As shown, the applicator cap closure lip 20702U of the housing 20702 defines a first axial extension 2002a, and the closure interface 20708E of the cap 20708 defines a cavity 2002d that mates with the first axial extension 2002a. In the illustrated embodiment, the diameter of the cavity 2002d formed by the second axial extension 2002b and the third axial extension 2002c of the cap 20708 is sized to receive the diameter of the first axial extension 2002a of the housing 20702 within the cavity 2002d. For example, as shown in FIG. 7R, the axial extension 2002a may have a height H1 and a thickness D1, as measured from its distal end. Similarly, the second axial extension 2002c can have a height H3 and a thickness D5, measured from the proximal end of the cap 20708, and the cavity 2002d can have heights H2, H3, and H4 with thicknesses D2, D3, and D4, respectively, measured from the proximal end of the cap 20708. In one embodiment, the thickness D1 is measured at 1 mm with a tolerance of ±0.03 mm. While D2, D3, and D4 can be any suitable dimensions, the height H1 is measured at 1.66 mm with a tolerance of ±0.1 mm, H2 is measured at 8.25 mm with a tolerance of ±0.1 mm, H3 is measured at 9.25 mm with a tolerance of ±0.1 mm, and H4 is measured at 9.75 mm with a tolerance of ±0.1 mm. However, in other embodiments, the reversed values ​​may be used, in which case the diameter of the first axial extension 2002a may be sized to receive the diameter of the second axial extension 2002b without departing from the scope of the present disclosure.

[0071] In each embodiment, the two radial seals 2004, 2006 may be defined at the interface between the first axial extension 2002a and the second axial extension 2002b, or may be otherwise provided, but the radial seals 2004, 2006 help prevent fluid and contaminant migration across the interface in either axial direction. Additionally, the dual radial seals described herein can accommodate tolerance and thermal variations combined with unnecessary sealing stress relief. In the illustrated embodiment, the dual radial seals 2004, 2006 utilize a "wedge" effect to effectively seal between the first axial extension 2002a and the second axial extension 2002b.

[0072] The cap 20708 may include one or more sets of ribs 20708F (see FIG. 7N), for example, two sets of ribs 20708F. The crush ribs 20708F may be configured to engage with an edge 20704N of the locking arm 20704J during an impact event, such as a drop, as described in more detail below (see, for example, FIG. 8N). According to many embodiments, the edge 20704N may be a sharp edge.

[0073] In accordance with the subject matter of the present disclosure, cap 20708 includes one or more desiccant retaining clips 20708H to retain desiccant 20502 within cap 20708 and limit rotation of desiccant 20502. Cap 20708 includes a pawl 20708I, described in more detail below, that engages with and allows removal of the sensor cap when cap 20708 is removed from housing 20702. Cap 20708 may also include a plurality of protrusions 20708J for strength.

[0074] 7T and 7U, by way of example and not by way of limitation, in accordance with the subject matter of the present disclosure, the cap 20708 may include one or more surfaces that engage with other components of the applicator device 20150 to provide support, i.e., limit movement, in the event of an impact event, such as a drop. For example, the cap may include a sheath support surface 20708K configured to support the sheath 20704 during an impact event. The sheath support surface 20708K may limit distal movement of the sheath 20704 during an impact event, thereby reducing stress on the sensor carrier 20710 and the sensor control device 20102 and reducing the risk of the sensor control device 20102 becoming detached from the sensor carrier 20710. Additionally or alternatively, the cap 20708 may include a raised protrusion 20708L. The raised protrusion 20708L may mate with a plug 9130A, such as the elastomeric plug 9130A (the interface being connected to, for example, a sensor cap or desiccant cap). This may also provide support to the sharp member carrier 1102, the sensor carrier 20710, and the sensor control unit 20102, thereby preventing the sensor control unit 20102 from disengaging from the sensor carrier 20710 during an impact event. Additionally, the additional support for the elastomeric plug 9130A and other features may increase the stress applied to the various sealing features of the applicator device 20150, thereby improving the seal before removing the cap 20708 from the housing.

[0075] Exemplary Applicator Sheath 8A and 8B are side and perspective views, respectively, depicting an exemplary embodiment of the sheath 704. In this exemplary embodiment, the sheath 704 allows for final operational check of the sensor control unit 102 before use above the user's skin surface. The sheath 704 may include features to help hold the tip in position for proper sensor application, determine the force required to apply the sensor, and guide the sheath 704 relative to the housing 702 during application. A detent snap fitting 1402 is located near the proximal end of the sheath 704 and is further described below with respect to FIG. 8C. The sheath 704 has a generally cylindrical cross-section, with a first radius of its proximal section (near the top of the figure) being shorter than a second radius of its distal section (near the bottom of the figure). Multiple detent voids 1410 are also shown, three in this exemplary embodiment. The sheath 704 may have one or more detent voids 1410, each of which may be a cutout with space for the sheath snap-fit ​​retraction feature 1330 to pass distally until the distal surface of the locking protrusion 1340 contacts the proximal surface of the detent void 1410.

[0076] The guide rails 1418 are disposed between a sensor carrier travel limiting surface 1420 at the proximal end of the sheath 704 and a cutout around the locking arm 1412. The guide rails 1418 may each be a groove between two ridges, within which the guide edge 1326 of the housing guide projection 1321 can slide distally relative to the sheath 704.

[0077] The locking arms 1412 are positioned near the distal end of the sheath 704 and may have an attached distal end and a free proximal end, which may include a locking arm interface 1416. When the locking interface 1416 of the locking arm 1412 engages the locking interface 1502 of the sensor carrier 710, the locking arms 1412 can lock the sensor carrier 710 to the sheath 704. A locking arm reinforcing rib 1414 may be positioned near the center of each locking arm 1412 to act as a strengthening point for an otherwise weak point in each locking arm 1412, preventing the locking arms 1412 from over-bending and breaking.

[0078] The detent reinforcement feature 1422 may be located along a distal section of the detent snap fitting 1402 and may reinforce the detent snap fitting 1402. The alignment notch 1424 is a cutout near the distal end of the sheath 704 that provides an opening that allows a user to align it with the sheath orientation feature on the platform 808. The reinforcement protrusion 1426 may be buttressed, in this case triangular in shape, to support the detent base 1436. The housing guide rail gap 1428 may be a cutout that allows the distal surface of the housing guide protrusion 1321 to slide against during use.

[0079] 8C is a close-up perspective view of an exemplary embodiment of the detent snap fitting 1402 of the sheath 704. The detent snap fitting 1402 may include a detent snap fitting bridge 1408 at or near its proximal end. The detent snap fitting 1402 may also include a detent snap fitting flat 1406 distal to the detent snap fitting bridge 1408. The exterior surface of the detent snap fitting bridge 1408 may include a detent snap fitting curved surface 1404, which is a rounded surface that allows the detent snap fitting bridge 1408 to more easily move across the interior surface of the housing, such as the locking protrusion 1340.

[0080] 8D is a side view depicting an exemplary embodiment of sheath 704. Here, alignment notch 1424 may be located relatively close to detent void 1410. Detent void 1410 is located at a relatively proximal portion of the distal portion of sheath 704.

[0081] 8E is an end view depicting an exemplary embodiment of the proximal end of sheath 704, where the rear wall of guide rail 1446 acts as a groove to slidably connect with housing guide protrusion 1321 of housing 702. Sheath rotation limiting member 1448 may be a plurality of notches that reduce or prevent rotation of sheath 704.

[0082] Figures 8F-8H are perspective views of various stages of assembly of an alternative embodiment of a sheath 6704 with the remaining components of the applicator. As illustrated in Figure 8F, the sheath 6704 may include many of the same features as sheath 704, which were previously described in connection with Figures 8A-8C. For example, the sheath 6704 may include one or more detent snap-fit ​​portions 6404 having one or more detent curved portions 6402 attached thereto. However, the sheath 6704 may have a shorter overall length compared to the sheath 704. Additionally, the sheath 6704 may include one or more inner sheath ridges 6425 on its inner surface that project inwardly toward the central axis of the sheath 6704.

[0083] 8G , a perspective view illustrates a stage in which the sheath 6704 is assembled with the applicator housing 6702 and the sensor carrier 6710. One or more inner sheath ridges 6425 of the sheath 6704 may align with one or more mating ridge notches 6519 of the sensor carrier 6710. The snug interface between the corresponding ridges 6425 and notches 6519 helps to maintain axial alignment of the sheath 6704 and the sensor carrier 6710 throughout the sensor insertion process. Furthermore, the interface between the ridges 6425 and notches 6519 can reduce lateral and rotational movement between the various components of the applicator, which in turn can reduce the likelihood of improper sensor insertion.

[0084] 8H, a perspective view illustrates a stage in which the sheath 6704 is assembled with the applicator housing 6702 and electronics shroud 706, which has already been inserted into the sensor carrier 6710. The inner sheath ribs 6425 are also shown.

[0085] It should be noted that while six inner sheath ribs 6425 and six corresponding mating rib notches 6519 are depicted, any number of ribs and notches is fully within the scope of the present disclosure. Furthermore, while the ribs 6425 are depicted as having rounded surface edges, in other embodiments, the ribs 6425 may be rectangular or triangular in shape, and the mating rib notches 6519 may have a corresponding receiving shape to accommodate the ribs 6425. Additionally, while the ribs 6425 are depicted as being located on the inner circumferential surface of the sheath 6704, they may be located on any other surface or portion of the sheath 6704 that contacts the sensor carrier.

[0086] 8I-8O, for purposes of illustration and not limitation, a sheath 20704 is presented in accordance with the subject matter of the present disclosure. The sheath 20704 may be made of Delrin or any other suitable material, such as any other low-friction polymer. The sheath 20704 may include one or more of the features described in connection with various housings where features similar to those described herein can function as described herein. For example, the sheath 20704 includes a detent snap-fit ​​portion 20704A having a free proximal end configured to engage with the sheath protrusion 20702S during firing. FIG. 8J illustrates a close-up view of the free proximal end of the detent snap-fit ​​portion 20704A. The detent snap fitting 20704A may have a curved portion 20704B for engaging the sheath projection 20702S and a flat portion 20704C for final blocking on the housing 20704 after use. The curved portion 20704B may have a molded parting line misalignment 20704D to prevent a force return burr during firing. The detent snap fitting 20704A may be connected to the sheath 20704 at its flared distal end 20704E, which may provide support for the detent snap fitting 20704. The sheath 20704 may have multiple detent snap fittings 20704A, such as three. The sheath 20704 may be provided with a plurality of housing cavities 20704F, e.g., three, which allow the sheath 20704 to empty the housing 20702 at the end of firing. In accordance with the subject matter of the present disclosure, the sheath 20704 may further be provided with a plurality of (e.g., six) reinforcing protrusions P, which may reinforce the sheath 20704.

[0087] The sheath 20704 may include a plurality of guides 20704G for engagement with the sheath guide rails 20702J of the housing 20702. The sheath 20704 further includes a slot 20704H with a stop 20704I at its distal end configured to engage the sheath guide rails 20702J of the sheath 20702 to prevent further proximal movement of the sheath 20704 relative to the housing 20702 at the end of firing. The sheath 20704 also includes a gap 20704T to allow passage of a sensor carrier biasing feature 20702M located on the sheath guide rails 20702J of the housing 20702.

[0088] In accordance with the disclosed subject matter, the sheath 20704 can include a locking arm 20704J. The locking arm 20704J can be configured to engage with the sensor carrier 20710 to limit movement of the sensor carrier 20710 or the sheath 20704 prior to firing. The locking arm 20704J has a free proximal end 20704K and an attached distal end 20704L. The free proximal end 20704K has a locking arm interface 20704M thereon, which is disposed on an interior surface of the locking arm 20704J. The locking arm interface 20704M can engage with a locking ledge 20710N on the sensor carrier 20710. For example, when the cap 20708 is connected to the housing 20702, the cap 20708 can bias the locking arm 20704J inward, causing the locking arm interface 20704M to engage the sensor carrier 20710. That is, the locking arm 20704J can provide a wedging action between the cap 20708 and the sensor carrier 20710. Thus, when the cap 20708 is connected to the housing 20702, the locking arm 20704J can limit the proximal movement of the sheath 20704. This engagement can limit the movement of the sheath 20704 during an impact event, such as a drop. The locking arm interface 20704M can be triangular in shape when viewed from a side view (e.g., FIG. 8N) and “U” shaped when viewed from a top view (e.g., FIG. 8K). This shape of the locking arm interface 20704M can provide benefits during manufacturing. For example, the shape of the locking arm interface 20704M allows the sheath 20704 to be forcibly ejected from the mold during its manufacture. Forcibly ejecting the sheath 20704 may, for example, allow for a simplified core / cavity design to be utilized to further simplify the manufacturing process, and may also eliminate additional mold parting lines and / or complex lifters and / or slides to create non-releasable features in the plastic member. The rough surface created by the mold parting lines may catch on the sensor carrier 20710 during firing, and the mold parting lines may also present potential return flash from the firing force.Therefore, the simplified mold design utilizing forced ejection facilitates the creation of a smoother locking arm interface 20704M and can prevent potential firing force return flash due to mold parting lines.

[0089] The proximal free end of the locking arm 20704J may further include an edge 20704N (e.g., a sharpened edge) on its outer surface. The sharpened edge 20704N may be configured to engage with a ridge 20708F (e.g., comprised of a plurality of crushed ridges) disposed on the cap 20708 during an impact event. The sharpened edge 20704N may penetrate the crushed ridge 20708F, permanently deforming the crushed ridge 20708F, thereby absorbing energy during an impact event and preventing the sheath 20704 from collapsing. The shaped locking arm interface 20704M may also be beneficial for drop protection. Its sloped portion may allow the locking arm 20704J to move radially when the sheath 20704 collapses during a drop event. This allows the sharp edges 20704N to protrude into the crush ridges 20708F and helps stop the sheath 20704 from collapsing. The sheath 20704 may include multiple locking arms 20704J, for example, two locking arms 20704J.

[0090] Additionally or alternatively, the sheath 20704 may include ribs 20704U configured to engage with a locking interface 20710F of the sensor holding arm 20710B on the sensor carrier 20710. The ribs 20704U may prevent the sensor holding arm 20710B from bending outward, for example, during an impact event, and therefore may prevent the sensor control device 20102 from moving during an impact event. The height (i.e., length along the longitudinal axis) of the ribs 20704U is selected such that, even if the sheath 20704 moves proximally or distally during an impact event, the ribs 20704U remain engaged with the locking interface 20710F of the sensor holding arm 20710B on the sensor carrier, thereby preventing the sensor control device 20102 from becoming dislodged from the sensor carrier 20710.

[0091] The sheath 20704 may include a noise damping member 20704O configured to engage with the sharp element carrier 201102 when the sharp element carrier 201102 is retracted and its speed of movement slows, thereby reducing noise generated by the sharp element carrier 201102 engaging with the sheath 20704. In exemplary embodiments, the damping member 20704O includes a sloped portion extending from the inner surface of the sheath 20704, although any other suitable shape may be used.

[0092] In accordance with the subject matter of the present disclosure, the sheath 20704 may include a slot 20704Q configured to receive a sharp member carrier retention feature 20710L disposed on the sensor carrier 20710, thereby allowing the sharp member carrier 201102 to be partially retracted during deployment (as described in more detail below). The sheath 20704 may also include a cap lead-in 20704R, an alignment notch 20704S, and a skin interface 20704T.

[0093] Exemplary Sensor Carriers FIG. 9A is a proximal perspective view of an exemplary embodiment of a sensor carrier 710 capable of holding sensor electronics within the applicator 150. It can also hold a sharpener carrier 2102 along with a sharpener module 2500. In an exemplary embodiment, the sensor carrier 710 has a generally hollow, round, flattened, cylindrical shape with one or more (e.g., three) deflectable sharpener carrier locking arms 1524 extending proximally from the proximal face and surrounding a centrally located spring alignment protrusion 1516 for maintaining alignment of the spring 1104. Each locking arm 1524 has a detent or retention feature located at or near its proximal end. An impact lock 1534, preferably an outwardly extending tab located around the periphery of the sensor carrier 710, can lock the sensor carrier 710 for added security prior to firing. The rotation limiting member 1506 may be a relatively short protruding proximally extending projection on the proximal face of the sensor carrier 710, which limits the rotation of the sensor carrier 710. As will be described below with reference to Figures 10A-10E, the sharp member carrier locking arm 1524 may be aligned with the sharp member carrier 2102.

[0094] 9B is a distal perspective view of the sensor carrier 710. Here, one or more (e.g., three) sensor electronics retention spring arms 1518 are normally biased toward the position shown, but are provided with detents 1519 that, once seated within recesses or cavities 1521, allow them to pass over the distal surface of the electronics housing 706 of the device 102. In one embodiment, after using the applicator 150 to attach the sensor control unit 102 to the skin, the user pulls the applicator 150 proximally, i.e., away from the skin. The adhesive forces hold the sensor control unit 102 on the skin and overcome the lateral force exerted by the spring arms 1518. As a result, the spring arms 1518 deflect radially outward, disengaging the detents 1519 from the sensor control unit 102, thereby releasing the sensor control unit 102 from the applicator 150.

[0095] Figure 9C is a perspective view of an alternative embodiment of a sensor carrier 6710. As illustrated in Figure 9C, the sensor carrier 6710 may include many of the same features as the sensor carrier 710 described above with respect to Figures 9A and 9B. Additionally, the sensor carrier 6710 also includes one or more counter-notched ribs 6519 along its outer periphery. As best seen in Figures 8F-8H, the counter-notched ribs 6519 are configured to align with the inner sheath projections 6425 to maintain axial alignment of the sheath and sensor carrier and to reduce lateral and rotational movement between the applicator components during the sensor insertion process.

[0096] 9D and 9E, an exemplary sensor carrier 20710 is shown for purposes of illustration and not limitation. The sensor carrier 20710 may include one or more of the features described in connection with various sensor carriers, where features similar to those described herein may perform the functions described herein. For example, the sensor carrier 20710 may include a base 20710A and first and second retaining arms 20710B. Each retaining arm 20710B may include a first end 20710C connected to the base 20710A and a free end 20710D. For example, each retaining arm 20710B may be connected to the base 20710A at a first half of the base 20710A, while the free end 20710D may extend toward the second half of the base 20710A. Each of the retention arms 20710B can include a sensor retention feature 20710E on its inner surface. The sensor retention feature 20710E can be located at the free end 20710D. The sensor retention feature 20710E can be configured to retain the sensor control device 20102 within the housing 20702. The sensor retention feature 20710E can include a conical surface and a beveled mold parting line, which can facilitate release of the sensor control device 20102 during delivery. Each of the retention arms 20710B can include a locking interface 20710F on its outer surface. The locking interface 20710F can engage with a rib 20704U on the sheath 20704. As described above, the rib portion 20704U can, for example, prevent the sensor holding arm 20710B from bending outward during an impact event, and therefore can maintain the sensor holding feature 20710E in engagement with the sensor control device 20102, thereby preventing movement of the sensor control device 20102 during an impact event.

[0097] The sensor carrier 20710 may include multiple housing mounting features 20710F1. In some embodiments, for example, the sensor carrier 20710 may include three housing mounting features 20710F1. In other embodiments, the sensor carrier 20710 may include two, four, five, six, or more housing mounting features 20710F1. The housing mounting features 20710F1 may be equally spaced on the sensor carrier 20710 and may extend upwardly from the top surface of the sensor carrier 20710. Each sensor housing mounting feature 20710F1 may include a housing snap-fit ​​feature 20710G, a housing positioning feature 20710H, a biasing feature 20710I, and a housing stop 20710J. Housing positioning feature 20710H can axially position sensor carrier 20710 relative to its corresponding housing 20702 when the two are connected together. Housing snap-fit ​​feature 20720G can engage with sensor carrier mounting slot 20702K on housing 20702 to connect sensor carrier 20710 to housing 20702. Biasing feature 20710I can engage with sensor carrier biasing feature 20702M on housing 20702, which is configured to eliminate canting between sensor carrier 20710 and housing 20702. Housing stop 20710J can axially position sensor carrier 20710 relative to housing 20702.

[0098] The sensor carrier 20710 may further include a plurality of sharp member carrier locking arms 20710K, for example, three sharp member carrier locking arms 20710K. The sharp member carrier locking arms 20710K may be equally spaced on the sensor carrier 20710 and may extend upward from the upper surface of the sensor carrier 20710. Each sharp member carrier locking arm 20710K may include a sharp member carrier retaining feature 20710L and a ridge 20710M. The ridge 20710M may engage with the inner surface of the sheath 20704, which biases the sharp member carrier locking arms 20710K inward and allows the sharp member carrier retaining feature 20710L to retain the sharp member carrier 201102, as described in more detail below. The carrier retention mechanism 20710L may be triangular in shape when viewed from the side, but may have a "U" shape when viewed from the top.

[0099] In accordance with the subject matter of the present disclosure, as previously described herein, the sensor carrier 20710 may include a plurality of locking ledges 20710N configured to engage with the locking arm interfaces 20704M of the sheath 20704. For example, the sensor carrier 20710 may include two locking ledges 20710N. The sensor carrier 20710 may include recesses 20710O located proximal to each of the locking ledges 20710N to receive the locking arm interfaces 20704M during firing, thereby preventing the locking arms 20704J from engaging the housing 20702 during firing. The sensor carrier 20710 may include an opening 20710P extending through the center of the base 20710A. The opening 20710P may guide the tip hub 205014 and limit its movement during insertion. Additionally or alternatively, the sensor carrier 20710 may be provided with a spring positioning member 20710Q.

[0100] The bottom surface of the sensor carrier 20710 may include reinforcing ribs 20710R and sensor positioning ridges 20710S to limit planar movement of the sensor control device 20102 relative to the sensor carrier 20710. The bottom surface of the sensor carrier 20710 may include a sensor support surface 20710T configured to support the sensor control device 20102.

[0101] Illustrative sharpened member carriers 10A and 10B are proximal perspective and longitudinal cross-sectional views, respectively, depicting an exemplary embodiment of the tip carrier 2102. The tip carrier 2102 can grip and hold the tip module 2500 inside the applicator 150. The module may automatically retract as a result of one or more springs transitioning from a preloaded compressed state to an expanded state over the course of the insertion process, as described in connection with FIGS. 39A-39F. An anti-rotation slot 1608 is located near the distal end of the tip carrier 2102 to prevent the tip carrier 2102 from rotating when positioned within the central region (as shown in FIG. 9A) of the tip carrier locking arm 1524. Anti-rotation slots 1608 may be positioned between each section of the sharp member carrier base chamfer 1610 to ensure that the sharp member carrier 2102 is fully retracted through the sheath 704 when the sharp member carrier 2102 is retracted at the end of the deployment procedure.

[0102] 10B, a plurality of sharpened retaining arms 1618 may be arranged within the sharpened member carrier 2102 about a central axis, each of which may have a distal end provided with a sharpened retaining clip 1620. The sharpened retaining clip 1620 has a proximal surface that is generally perpendicular to the central axis and that may abut against a distally facing surface of the sharpened member hub 2516 (FIG. 17A).

[0103] 10C and 10D, an exemplary sharpened member carrier 201102 is shown for purposes of illustration and not limitation. The sharpened member carrier 201102 may include one or more features similar to those described in connection with various sharpened member carriers, which may function as described herein. For example, the sharpened member carrier 201102 may include a series of features for engaging with the three sharpened member carrier locking arms 20710K of the sensor carrier 20710. These features may include a pre-partial retraction holding surface 201102A and a post-partial retraction holding surface 201102B. Before partial retraction occurs, such as during shipping or storage, the pre-partial retraction holding surface 201102A may engage with the sharpened member carrier holding feature 20710L. After partial retraction has occurred, the post-partial retraction retention surface 201102B may engage with the sharp member carrier retention feature (arm) 20710L. For example, as the sheath 20704 initially moves proximally relative to the sensor carrier 20710, the ridges 20710M of the retention arms 20710L may engage with the slots 20704Q of the sheath 20704, thereby allowing the retention arms 20720L to move radially outward and the sharp member carrier retention feature (arm) 20710L to pass the pre-partial retraction retention surface 201102A and engage with the post-partial retraction retention surface 201102B. The height difference between the end of the pre-partial retraction retention surface 201102A and the beginning of the post-partial retraction retention surface 201102B is the partial retraction distance. The moving surface 201102C may be disposed immediately below the retaining surface 201102B after partial retraction, allowing the sharp member carrier 201102 to slide against the pressure of the retaining arm 20710L as it is retracted. The alignment wall 201102D helps to keep the sharp member carrier 201102 aligned with the sensor carrier 20704 during sustained partial retraction. The sharp member carrier 201102 may be provided with a chamfer 201102F, which may be provided with an anti-rotation slot 201102E for engagement with the retaining arm 20710L on the sensor carrier 20710.

[0104] Looking internally, the sharpened member carrier 201102 is provided with a sharpened retaining arm 201102G having a lead-in surface 2011021 and a sharpened member hub contact surface 201102H. The retaining arm 201102G is capable of receiving and retaining the sharpened member hub 205014. The spring stop 201102J is capable of engaging the retaining spring 205612.

[0105] Example Sensor Module FIGS. 11A and 11B are top and bottom perspective views, respectively, depicting an exemplary embodiment of a sensor module 504. The module 504 can hold a connector 2300 (FIGS. 12A and 12B) and a sensor 104 (FIG. 13). The module 504 can be rigidly connected to the electronics housing 706. One or more deflectable arms or module snap-fit ​​portions 2202 can snap into corresponding functional portions 2010 of the housing 706. The sharpened slot 2208 can provide a location where the tip 2502 can pass through but the sharpened shaft 2504 can temporarily rest. The sensor ledge 2212 can position the sensor in a horizontal plane, prevent the sensor from lifting the connector 2300 off the post, and maintain the sensor 104 parallel to the plane of the connector closure. The ledge may also define the sensor's bending geometry and minimum bend radius. The ledge may limit the sensor's vertical movement to prevent the tower from protruding above the surface of the electronics housing, and may define the length of the sensor's tail below the patch curve. Sensor walls 2216 may constrain the sensor and define the sensor's bending geometry and minimum bend radius.

[0106] 12A and 12B are perspective views depicting an exemplary embodiment of connector 2300 in an open and closed state, respectively. Connector 2300, which may be made of silicone rubber, encapsulates a flexible carbon-impregnated polymer module that acts as a conductive contact 2302 between sensor 104 and the electrical circuit contacts of the electronics within housing 706. The connector can also act as a moisture barrier for the sensor when in its assembled, compressed state after transfer from the container to the applicator and application to the user's skin. Multiple sealing surfaces 2304 can provide a watertight seal for the electrical and sensor contacts. One or more hinges 2308 can connect the two portions of connector 2300, the distal and proximal portions.

[0107] FIG. 13 is a perspective view illustrating an exemplary embodiment of the sensor 104. The neck 2406 may be a region that allows the sensor to be folded back, for example, 90 degrees. The membrane of the tail 2408 may cover the active analyte sensing element of the sensor 104. The tail 2408 may be the portion of the sensor 104 that resides subcutaneously in the user's skin after insertion. The flag 2404 may include contacts and a sealing surface. The bias tower 2412 may be a tab that biases the tail 2408 into the pointed slot 2208. The bias fulcrum 2414 may be an increased width portion of the bias tower 2412 that contacts the inner surface of the needle to bias the tail into the slot. The bias adjustment 2416 may reduce localized bending of the connection portion of the tail, preventing damage to the sensor track. Each contact 2418 can electrically connect the active portion of the sensor to the connector 2300. A communication loop branch 2420 can turn the electrical path 90 degrees from vertical to engage the sensor ledge 2212 (FIG. 11B).

[0108] 14A and 14B are bottom and top perspective views, respectively, depicting an exemplary embodiment of a sensor module assembly including a sensor module 504, a connector 2300, and a sensor 104. According to one aspect of the described embodiment, during or after insertion, the sensor 104 is subjected to an axial force, shown as force F1 in FIG. 14A , that pushes the sensor 104 proximally and into the sensor module 504. In some embodiments, this applies a counter-force F2 to the neck 2406 of the sensor 104, which in turn translates to a counter-force F3 on the communication loop branch 2420 of the sensor 104. In some embodiments, the axial force F1 is the result of a sensor insertion mechanism designed to push the sensor through tissue, a tip retraction mechanism during insertion, or a physiological response generated by the tissue surrounding the sensor 104 (e.g., after insertion).

[0109] 15A and 15B are close-up partial views of exemplary embodiments of a sensor module assembly including an axial stiffening feature. In a general sense, the embodiments described herein aim to reduce the effects of axial forces applied to a sensor as a result of an insertion mechanism, a retraction mechanism, or both, or due to physiological responses to the sensor once inside the body. As can be seen in FIGS. 15A and 15B, according to one aspect of the embodiment, the sensor 3104 includes a hook feature 3106 at its proximal portion that is configured to engage with a catch feature 3506 on the sensor module 3504. In some embodiments, the sensor module 3504 includes a void region 3508 that allows a distal portion of the sensor 3104 to swing back during assembly, allowing the hook feature 3106 of the sensor 3104 to pass over and into the catch feature 3506 of the sensor module 3504.

[0110] According to another aspect of the embodiment, the hook feature 3106 and catch feature 3506 operate in the following manner. The sensor 3104, as described above, comprises a proximal sensor portion connected to the sensor module 3504 and a distal sensor portion disposed below the skin surface in contact with bodily fluids. As seen in FIGS. 15A and 15B , the proximal sensor portion includes a hook feature 3106 adjacent to the catch feature 3506 of the sensor module 3504. During or after insertion of the sensor, one or more forces are applied proximally along the longitudinal axis of the sensor 3104. In response to the one or more forces, the hook feature 3106 engages the catch feature 3506, thereby preventing displacement of the sensor 3104 proximally along the longitudinal axis.

[0111] According to another aspect of the embodiment, the sensor 3104 may be assembled with the sensor module 3504 in the following manner: The sensor 3104 is loaded into the sensor module 3504 by laterally displacing the proximal sensor portion to place the hook feature 3106 proximal to the catch feature 3506 of the sensor module 3504. More specifically, laterally displacing the proximal sensor portion causes the proximal sensor portion to enter the void region 3508 of the sensor module 3504.

[0112] 15A and 15B depict the hook feature 3106 as part of the sensor 3104 and the catch feature 3506 as part of the sensor module 3504, those skilled in the art will appreciate that the hook feature 3106 may alternatively be part of the sensor module 3504, and similarly, the catch feature 3506 may alternatively be part of the sensor 3106. Likewise, those skilled in the art will appreciate that various other mechanisms (e.g., detents, latches, fasteners, screws, etc.) mounted to the sensor 3104 and sensor module 3504 to prevent axial displacement of the sensor 3104 may be utilized and are within the scope of the present disclosure.

[0113] 15C is a side view of an exemplary sensor 11900 in accordance with one or more embodiments of the present disclosure. The sensor 11900 may be similar in some respects to any of the sensors described herein and, therefore, may be used in an analyte monitoring system to detect specific analyte concentrations. As shown, the sensor 11900 includes a tail 11902, a flag 11904, and a neck 11906 interconnecting the tail 11902 and the flag 11904. The tail 11902 includes an enzyme or other chemical or biological substance, and in some embodiments, a membrane coats the chemical. In use, the tail 11902 is transdermally received under the skin of a user, and the chemical contained in the tail helps facilitate analyte monitoring in the presence of bodily fluids.

[0114] The tail 11902 is received within a hollow or recess in a tip (not shown), thereby surrounding at least a portion of the tail 11902 of the sensor 11900. As shown, the tail 11902 may extend at an offset angle Q from the horizontal. In some embodiments, the angle Q is approximately 85°. Thus, in contrast to other sensor tails, the tail 11902 may not extend perpendicularly from the flag 11904, but may instead be at an offset angle relative to the vertical. It is contemplated that this may prove advantageous in helping to maintain the tail 11902 within the recess in the tip.

[0115] The tail portion 11902 has a first or lower end 11908a and a second or upper end 11908b opposite the lower end 11908a. A tower 11910 can be located at or near the upper end 11908b and can extend vertically upward from where the neck 11906 interconnects the tail portion 11902 to the flag portion 11904. In operation, as the point moves laterally, the tower 11910 helps the tail portion 11902 pivot toward the point and otherwise remain within a recess in the point. Additionally, in some embodiments, the tower 11910 includes or is otherwise defined by a protrusion 11912 extending laterally therefrom. When the sensor 11900 is mated with a tip and the tail 11902 overhangs the inside of a recess in the tip, the protrusion 11912 can engage the inner surface of the recess. During operation, the protrusion 11912 helps to hold the tail 11902 inside the recess.

[0116] The flag 11904 can have a generally flat surface on which one or more sensor contacts 11914 are disposed. The sensor contact(s) 11914 can be configured to align with a corresponding number of flexible carbon-impregnated polymer modules enclosed within the connector.

[0117] In some embodiments, as shown, neck 11906 may include or otherwise define a downwardly tapered or bent portion 11916 that extends between flag 11904 and tail 11902. It is contemplated that bend 11916 may prove advantageous in that it adds flexibility to sensor 11900 and helps prevent bending of neck 11906.

[0118] In some embodiments, a notch 11918 (shown in dashed lines) is selectively defined in the flag portion near the neck portion 11906. When the sensor 11900 is mounted in a cradle, the notch 11918 can add flexibility and resistance to the sensor 11900. More specifically, the notch 11918 helps to absorb interference forces that may occur when the sensor 11900 is mounted within the cradle.

[0119] In some embodiments, as illustrated in Figures 15D-15G, the neck may include or otherwise define a nonlinear feature, such as a downward slope or bend 11920a-d with multiple turns, e.g., 11921a and 11921b, extending between the flag 11904 and the tail 11902. The bends 11920a-d advantageously reduce the in-situ stiffness of the sensor 11900 by adding flexibility to the sensor 11900 in both vertical and horizontal orientations. This added flexibility can provide the sensor 11900 with a multi-directional spring-like structure, which helps limit deformation of the neck 11906 while ensuring that the tail 11902 and flag 11904 remain in their expected or fixed positions. The spring-like structure also increases the flexibility of the sensor 11900 while reducing the stress applied to the overall structure.

[0120] Broadly, the sensor may be understood to have a tail, flag, and neck aligned along a plane having a vertical axis and a horizontal axis. The spring-like structure may be created by varying the orientation of the turns at the bend in the neck of the sensor. Between the tail and flag, the neck may have at least two turns relative to the vertical axis to provide the spring-like structure. The at least two turns may provide the neck with an overlapping layer structure, such that the neck itself is continuous relative to the axis of the plane shared by the tail, flag, and neck. These overlapping turns constitute the spring-like structure. In some embodiments, the necks of the overlapping layers are vertically oriented. In other embodiments, the necks of the overlapping layers are horizontally oriented.

[0121] 15D illustrates an embodiment in which the sensor 11900 includes a neck portion between the flag portion 11904 and the tail portion 11902, with a bend 11920a including a redirection portion 11921a and a redirection portion 11921b. In the illustrated embodiment, at least one redirection portion 11921a abuts the top end of the tail portion of the sensor 11900 or possibly the top end of the tower portion 11910. This orientation is advantageous because it reduces the overall footprint of the sensor, even when additional material is used to create the bend 11920a. This configuration allows for multiple overlapping, vertically aligned, horizontal layers between redirections.

[0122] 15E illustrates an embodiment in which the sensor 11900 includes a neck with at least three redirections 11923a, 11923b, and 11923c at a bend 11920b that forms a general spiral pattern between the flag 11904 and the tail 11902. In this embodiment, the redirections again abut the top of the tail or tower 11910 of the sensor 11900. This orientation can provide further balance in horizontal and vertical stresses in addition to maintaining the overall footprint of the sensor. The overlapping layers with redirections arranged in this manner are generally balanced along both the horizontal and vertical axes.

[0123] 15F illustrates another embodiment of the sensor 11900, including a neck portion between the flag portion 11904 and the tail portion 11902, with redirection portions 11925a, 11925b, and 11925c at the bend portion 11920c. In the illustrated embodiment, the redirection portion 11925c connects the region of the tail portion 11902 near the top of the tail or tower portion 11910 of the sensor to the continuation of the bend portion 11920c. In addition to reducing the overall footprint of the sensor, this orientation is believed to provide additional flexibility along the horizontal axis of orientation. This arrangement allows for multiple overlapping, horizontally aligned, vertical layers between redirection portions.

[0124] 15G illustrates another embodiment of sensor 11900 including a neck portion with turns 11927a, 11927b, and 11927c at bend 11920d between flag 11904 and tail 11902. In the illustrated embodiment, bend 11920d occurs primarily at tail 11902 of the sensor and connects tail 11902 to tower 11910, but does not generally interrupt the extent of the sensor between tower 11910 and flag 11904. Turn 11927a generally connects tower 11910 to the continuation of bend 11920d, while turn 11927c connects tail 11902 to the continuation of bend 11920d. This orientation is believed to provide additional flexibility to the vertical orientation axis. In this arrangement, multiple overlapping horizontally aligned vertical layers can be provided between one turn and another.

[0125] The neck bends may be created by folding the sensor neck from a larger neck structure, laser cutting the sensor from a sheet of material containing the sensor, printing the sensor with a shape that includes multiple bends, stamping the sensor from a sheet of material containing the sensor, or by any other manufacturing process suitable for creating precision bends in the neck.

[0126] 16A and 16B are isometric and partially exploded isometric views of an exemplary connector assembly 12000, according to one or more embodiments. As shown, assembly 12000 may include connector 12002, and FIG. 17C is an isometric bottom view of connector 12002. Connector 12002 comprises an injection molded member that is used to help secure one or more flexible carbon-impregnated polymer modules 12004 (four are shown in FIG. 16B ) to mount 12006. More specifically, connector 12002 helps secure module 12004 in place adjacent sensor 11900 and in contact with sensor contacts 11914 ( FIG. 15C ) located on flag 11904 ( FIG. 15C ). The module 12004 may be made of a conductive material to provide conductive communication between the sensor 11900 and corresponding circuit contacts (not shown) located within the base portion 12006.

[0127] As best seen in FIG. 16C , the connector 12002 may define a pocket 12008 that is sized to receive the module 12004. Additionally, in some embodiments, the connector 12002 may further define one or more recesses 12010 that are configured to mate with one or more corresponding flanges 12012 ( FIG. 16B ) on the base portion 12006. The recesses 12010 may mate with the flanges 12012 to secure the connector 12002 to the base portion 12006, such as by an interference fit. In other embodiments, the connector 12002 may be secured to the base portion 12006 using an adhesive or by ultrasonic welding.

[0128] 16D and 16E are isometric and partially exploded isometric views of another exemplary connector assembly 12100 according to one or more embodiments. As shown, the connector assembly 12100 can include a connector 12102, and FIG. 16F is an isometric bottom view of the connector 12102. The connector 12102 includes an injection molded member that serves to help secure one or more flexible metal contacts 12104 (four shown in FIG. 16E ) against the sensor 11900 on the mounting portion 12006. More specifically, the connector 12102 serves to secure the contacts 12104 in place adjacent the sensor 11900 and in contact with the sensor contacts 11914 ( FIG. 15C ) located on the flag 11904. Contacts 12104 may be made from stamped and formed conductive material that provides conductive communication between sensor 11900 and corresponding circuit contacts (not shown) located within base portion 12106. In some embodiments, for example, contacts 12104 are soldered to a PCB (not shown) located within base portion 12106.

[0129] As best seen in FIG. 16F , the connector 12102 may define a pocket 12108 that is dimensioned to receive the contacts 12104. Additionally, in some embodiments, the connector 12102 further defines one or more recesses 12110 that are configured to mate with one or more corresponding flanges 12112 ( FIG. 16E ) on the base portion 12106. The mating of the recesses 12110 with the flanges 12112 serves to secure the connector 12102 to the base portion 12106, such as by an interference fit. In other embodiments, the connector 12102 may be secured to the base portion 12106 using an adhesive or by ultrasonic welding.

[0130] Illustrative sharpened member module FIG. 17A is a perspective view depicting an exemplary embodiment of the tip module 2500 prior to assembly within the sensor module 504 (FIG. 6B). The tip 2502 may have a distal tip 2506 capable of piercing the skin while supporting the sensor within a hollow or recessed portion of the tip shaft 2504, allowing the active surface of the sensor tail to contact bodily fluids. The hub push cylinder 2508 may provide a surface against which the tip carrier pushes during insertion. The hub small cylinder 2512 may provide space for the protruding portion of the tip hub contact surface 1622 (FIG. 10B). The hub snap claw positioning cylinder 2514 may provide a distally facing surface for the hub snap claw 2516 against which the tip hub contact surface 1622 abuts. The hub snap claw 2516 may have a conical surface that opens the clip 1620 during installation of the tip module 2500.

[0131] 17B-17H illustrate various exemplary embodiments of the tip module in various stages of assembly and ready for use in inserting a skin analyte sensor. According to one aspect of the embodiment, the sensor, the insertion tip, or both, may be beveled relative to a reference point to allow co-localization of the insertion needle tip and the sensor tip and further provide a single point of contact with the skin surface. In this manner, when the sensor is inserted into a subject, the tip is the leading edge at the skin surface, forming an insertion path for the sensor into the dermis layer. In some embodiments, for example, the sensor tip, the skin sensor, or both, may be beveled relative to a reference point for insertion (e.g., relative to each other, the surface of the skin, or the base of the applicator), where the bevel of the tip is different from the bevel of the sensor. For example, the reference point may be the skin surface to be breached for dermal insertion, or may be a reference point or a component of a sensor-applicator set. In some embodiments, the sharpened tip can be positioned at an angle relative to the sensor. For example, if the sharpened tip is designed to be angled relative to the sensor, the needle will be the leading edge of the sensor during operation of the applicator set. Furthermore, the needle design itself and its positioning relative to the sensor may be implemented in any desired configuration, including all of the configurations disclosed in U.S. Patent Application Publication No. 2014 / 0171771, which is incorporated herein by reference in its entirety for all purposes.

[0132] Furthermore, while most of the exemplary embodiments described with respect to Figures 17B through 17J refer to cutaneous analyte sensors and cutaneous insertion, those skilled in the art will understand that any of these embodiments can be sized and shaped to be suitable for use with analyte sensors that can be placed beyond the cutaneous space, for example, within (or completely through) the subcutaneous tissue (e.g., 3 mm to 10 mm below the skin surface, depending on the location of the skin on the body).

[0133] Figure 17B is a perspective view depicting an exemplary embodiment of a tip module 2550 that can be used to insert a skin sensor. The tip module 2550 is shown prior to assembly with the sensor module 504 (Figure 6B) and may include components similar to those of the embodiment described with reference to Figure 17A, such as a tip 2552, a tip shaft 2554, a distal tip 2556, a hub push barrel 2558, a hub small barrel 2562, a hub snap tab 2566, and a hub snap tab positioning barrel 2564. The tip 2552 is located inside the tip module 2550 and may be eccentrically positioned relative to a longitudinal axis 2545 that extends through the centers of the hub snap tab 2566, the hub small barrel 2562, and the hub push barrel 2558. Additionally, the tip module 2550 can include a tip spacer 2568 parallel to and adjacent to a portion of the tip 2552. The tip spacer 2568 can be located along a proximal portion of the tip 2552 between the sensor 104 (not shown) and the tip 2552, ensuring that the sensor 104 and the tip 2552 are maintained apart at the proximal portion of the tip 2552. The tip 2552 can be eccentrically positioned during a molding process together with the hub components 2558, 2562, 2566, each of which can be constructed from a hard plastic material.

[0134] 17C and 17D are two side views of the sharpened member module 2550, including the sharpened member 2552, spacer 2568, hub push cylinder 2558, hub small cylinder 2562, and hub snap pawl 2566, prior to assembly with sensor module 504 (FIG. 6B). In some embodiments, the relative distances between the sharpened member 2552 and various components of the hub are as follows: For example, the distance S1 between the sharpened member 2552 and the midpoint of the radius of the hub can be in the range of 0.50 mm to 1 mm (e.g., 0.89 mm). The height S2 of the sharpened spacer 2568 can be in the range of 3 mm to 5 mm (e.g., 3.26 mm). The height S3 of the hub can be in the range of 5 mm to 10 mm (e.g., 6.77 mm). The length S4 of the sharpened member 2552 is expected to be in the range of 1.5 mm to 25 mm (eg, 8.55 mm), depending on the location of the insertion site on the subject.

[0135] FIG. 17E is a longitudinal cross-sectional view of the sharpened tip module 2550, including the sharpened tip 2552, spacer 2568, and hub components (hub snap tab 2566, hub small cylindrical portion 2562, and hub push cylindrical portion 2558) assembled with the sensor module 504. As can be seen in FIG. 17E, the sharpened tip 2552 is positioned within the sharpened slot 2208 of the sensor module 504, which has a curved inner surface 2250 at its distal end. The curved inner surface 2250 of the sensor module 504 can contact and deflect a portion of the sharpened tip 2552 so that the distal tip 2556 is oriented toward the central longitudinal axis 2545. As best seen in FIG. 17H, the sharpened tip 2552 can be positioned such that its distal portion and the central longitudinal axis 2545 form an acute angle S, preferably between 5° and 20°. θ In some embodiments, for example, S θ may be in the range of 5° to 17°, or 7° to 15°, or in the range of 9° to 13°, e.g., 9°, 10°, 11°, 12°, or 13°.

[0136] With further reference to FIG. 17E , protrusions 2251 are located near the distal end of sensor module 504, which can promote perfusion of bodily fluids, such as skin fluids. While illustrated as curved in FIG. 17E , protrusions 2251 may be shaped in any desired manner. Additionally, some embodiments may include multiple protrusions. U.S. Patent Application Publication No. 2014 / 0275907, which is incorporated herein by reference in its entirety, describes various sensor devices with various protrusion shapes, each of which can be implemented using the embodiments described herein. While most of the embodiments described herein are illustrated with a needle extending from the protrusion, in other embodiments, the needle extends from the base of the sensor device adjacent the protrusion and then extends beyond the tip of sensor 104.

[0137] 17E and 17F, the sensor 104 may be a skin sensor, and the sensor tail 2408 may be positioned distally of the sensor 104, and may be oriented generally parallel to the central longitudinal axis 2545. The distal end of the sensor tail 2408 is proximal to the distal tip 2556 and may be in spaced relation to, rest against, or press against a portion of the sharpened shaft 2554. As further depicted in FIG. 17E, a sharpened spacer 2568 provides a spaced-apart relationship between the proximal portion of the sharpened member 2552 and the sensor 104 to prevent contact therebetween. The sensor module 504 may further include a sensor connector 2300 for receiving a proximal portion of the sensor 104 that is perpendicular to the distal end of the sensor 104.

[0138] 17F is a top-down schematic view of the sensor module 504. The sensor module 504 may include one or more sensor module snap-fits 2202 for connecting to a cover (not shown) of the sensor control unit 102. The sensor module 504 may include a sensor connector 2300, which may include sensor contacts 2302 for connecting to a proximal portion of the sensor 104. The sensor connector 2300 may be made of silicone rubber and encapsulates a flexible carbon-impregnated polymer module that serves as the conductive contacts 2302 between the sensor 104 and the electrical circuit contacts of the electronics within the sensor control unit 102. The connector may also act as a moisture barrier for the sensor 104 when in its assembled, compressed state after transfer from the container to the applicator and application to the user's skin. Although three contacts 2302 are depicted, it should be understood that the connector 2300 may have fewer (e.g., two) or more (e.g., four, five, six, etc.) contacts depending on the particular type or configuration of the sensor 104. The sensor connector 2300 may further be connected to the sensor module 504 by means of two connector posts 2206 installed through a like number of openings in the connector 2300. Although two posts 2206 are depicted, it should be understood that any number of connector posts 2206 may be used to connect the connector 2300 to the sensor module 504.

[0139] 17G and 17H are perspective and side views, respectively, of another exemplary embodiment of a tip module 2600 that can be used for skin sensor insertion. The tip module 2600 is shown in this figure prior to assembly with the sensor module 504 (FIG. 6B), but may include components similar to those of the embodiments described with reference to FIGS. 17A and 17B, such as the tip 2602, the sharpened shaft 2604, the sharpened distal tip 2606, the hub push barrel 2608, the hub small barrel 2612, the hub snap tab 2616, and the hub snap tab positioning barrel 2614. In some embodiments, the tip 2602 may be a "pre-bent" needle, with a proximal portion 2603 that begins at a point on the exterior of the tip module 2600 and intersects the center point of the hub at an angle (e.g., passing through the hub push barrel 2608). The tip 2602 may have a distal portion 2605 that extends distally from a point near the distal end of the hub at an angle to the insertion point on the user's skin. As illustrated in FIG. 17H, the tip 2602 may have a curved portion 2607 located outside the hub push barrel 2608, which may form an approximately 90° angle between the proximal 2603 and distal 2605 portions of the tip 2602. The tip module 2600 may also have a bend fin guide 2620 to maintain the "pre-bent" tip 2602 in place during assembly, use, or both, and to prevent lateral or rotational movement of the tip 2602 relative to the hub components. The proximal portion 2603 of the tip 2602 is "trimmed" from the hub after the molding process is complete and before assembling the tip module 2600 with the sensor module 504.

[0140] 17I and 17J illustrate a longitudinal cross-sectional view and a side view, respectively, of the tip module 2600 (including the hub snap tab 2616, the hub small cylindrical portion 2612, the hub push cylindrical portion 2608, etc.) when assembled with the sensor module 504. As can be seen in FIG. 17I, the sensor module 504 is provided with a tip slot 2208 through which the tip 2602 can extend distally at an angle. As previously described, the proximal portion of the tip 2602 passes through a bend fin guide 2620, which is connected to the distal portion of the sensor module 504. The sensor module 504 can include a sensor 104, which can be a skin sensor. As can be seen in FIG. 17I, the tip 2602 and the sensor tail 2408 meet at an acute angle S at the point where their respective longitudinal axes converge. θ It is recommended to form an angle S. θ S0 may range between 5° and 20°. In some embodiments, for example, S0 may range between 5° and 17°, or between 7° and 15°, or in other embodiments, between 9° and 13°, e.g., 9°, 10°, 11°, 12°, or 13°. In some embodiments, the distal tip 2606 is positioned at a distance S6, which is proximal to the end of the sensor tail 2408. Distance S6 may range between 0.02 mm and 0.10 mm, e.g., 0.05 mm, 0.06 mm, or 0.07 mm.

[0141] 17I and 17J, the sensor module 504 may also include a sensor connector 2300 for receiving a proximal portion of the sensor 104 that is perpendicular to the distal end of the sensor 104. The sensor module 504 may further include one or more sensor module snap-fit ​​portions 2202 for connecting with a cover member (not shown) of the sensor control unit 102. The sensor connector 2300 may include various structures similar to those described with respect to FIG.

[0142] In each of the above-described embodiments, the sharpened tip may be made of stainless steel or a similar flexible material (e.g., a material used to manufacture needles) and may be sized to allow the applicator to insert at least a portion of the skin sensor into the skin layer but not penetrate the dermis layer. According to some embodiments, the sharpened tip has a cross-sectional diameter (width) of 0.1 mm to 0.5 mm. For example, the sharpened tip may have a diameter of 0.1 mm to 0.3 mm, such as 0.15 mm to 0.25 mm, or may have a diameter of 0.16 mm to 0.22 mm. A given sharpened tip may have a constant width along its entire length, or may have a different width along a portion of its length, such as the tip used to pierce the surface of the skin, such as a varying width. For example, with respect to the embodiment illustrated in FIG. 17I, the width of the pointed member 2602 may be narrowed along the distal portion between the flexure fin guide 1620 and the distal pointed tip 2606.

[0143] The tip may also have a length sufficient to insert the skin sensor only slightly into the dermis layer. The insertion depth may be limited by the length of the tip, the shape of the base, other applicator components that limit insertion depth, or various combinations thereof. The tip may have a length between 1.5 mm and 25 mm. For example, the tip may be 1 mm to 3 mm, 3 mm to 5 mm, 5 mm to 7 mm, 7 mm to 9 mm, 9 mm to 11 mm, 11 mm to 13 mm, 13 mm to 15 mm, 15 mm to 17 mm, 17 mm to 19 mm, 19 mm to 21 mm, 21 mm to 23 mm, or 23 mm to 25 mm, or may be greater than 25 mm. It will be appreciated that the tip may have a length up to 25 mm, but in certain embodiments, the entire length of the tip is not inserted into the subject because it would penetrate beyond the skin space. The uninserted length of the sharpened member can provide for manipulation and steering of the sharpened member in the applicator set. Thus, while the sharpened member may have a length of up to 25 mm, the depth of insertion of the sharpened member into the subject's skin in each of the specific embodiments described above is limited to the dermal layer, e.g., approximately 1.5 mm to 4 mm, depending on the location of the skin, as described in more detail below. However, in all embodiments disclosed herein, the sharpened member may be configured to penetrate deeper than the dermal space, e.g., to extend into (or even completely through) the subcutaneous tissue (e.g., 3 mm to 10 mm below the skin, depending on the location of the skin on the body). Additionally, in some specific embodiments, the sharpened members described herein may be hollow or partially hollow insertion needles with an internal space or lumen. However, in other embodiments, the sharpened members described herein may be solid insertion needles that lack an internal space, lumen, or both. Additionally, the sharpened members of the subject applicator sets may or may not be bladed.

[0144] Similarly, in each of the above embodiments, the skin sensor is sized so that at least a portion of the sensor is placed just within the dermal layer, or in transcutaneously placed embodiments, so that a portion remains outside the skin. That is, the skin sensor is sized so that when the skin sensor is fully or substantially fully inserted into the dermal layer, the most distal portion (insertion portion or insertion length) of the sensor is located within the subject's dermis, and when the sensor is operably placed on the skin, no portion of the sensor is inserted deeper than the subject's dermal layer.

[0145] The dimensions (e.g., length) of the sensor may be selected according to the location on the subject's body where the sensor will be inserted, since the depth or thickness of the epidermis and dermis varies to some extent depending on the location of the skin. For example, the epidermis is only about 0.05 mm thick on the eyelid, but about 1.5 mm on the palm and sole of the foot. The dermis is the thickest of the three layers of skin, ranging from about 1.5 mm to 4 mm, depending on the location of the skin. To ensure that the distal end of the sensor embeds but does not penetrate the subject's dermal layers, the length of the inserted portion of the skin sensor should be greater than the thickness of the epidermis, but should not exceed the combined thickness of the epidermis and dermis. One approach is to determine the insertion site on the user's body and then select an applicator set appropriately sized for that location.

[0146] In certain aspects, the sensor is an elongate sensor having a longest dimension (or "length") of 0.25 mm to 4 mm. In embodiments in which only a portion of the sensor is inserted into the skin, the inserted length of the sensor ranges from 0.5 mm to 3 mm, more particularly, such as 1 mm to 2 mm, e.g., 1.5 mm. The dimensions of the sensor can also be expressed in terms of its aspect ratio. In certain embodiments, the skin sensor has a length-to-width (diameter) aspect ratio of about 30:1 to about 6:1. For example, the aspect ratio may be about 25:1 to about 10:1, e.g., 20:1 and 15:1. The inserted portion of the skin sensor contains the sensitive chemical.

[0147] However, all of the embodiments disclosed herein may be configured such that at least a portion of the sensor is located below the dermal layer, such as in (or through) subcutaneous tissue (or fat). For example, the sensor may be sized such that when fully or substantially fully inserted into the body, its distal-most portion (insertion portion or insertion length) is located within the subcutaneous tissue (below the dermis of the subject), and yet when operably positioned, no portion of the sensor is inserted below the subcutaneous tissue of the subject. As previously mentioned, the subcutaneous tissue is typically located between 3 mm and 10 mm below the external skin surface, depending on the location of the skin on the body.

[0148] Exemplary applicator and sensor control device for one-piece construction Referring briefly again to FIGS. 1 through 3A-3G, to provide a two-piece system, the sensor tray 202 and the sensor applicator 102 are provided to the user in separate packages, requiring the user to open each package before final assembly. In some applications, the separate sealed packages allow the sensor tray 202 and the sensor applicator 102 to be sterilized using separate sterilization processes specific to the contents of each package, but which may otherwise be incompatible with each other's contents. More specifically, the sensor tray 202, including the plug assembly 207 containing the sensor 110 and the sharpened member 220, may be sterilized using radiation sterilization, such as electron beam (or "e-beam") irradiation. However, radiation sterilization may damage electrical components located inside the electronics enclosure of the sensor control device 102. As a result, the sensor applicator 102, including the electronics enclosure of the sensor control device 102, may be sterilized by some other method, such as gas chemical sterilization using ethylene oxide. However, gas chemical sterilization may destroy enzymes or other chemical or biological materials contained in the sensor 110. Due to this sterilization incompatibility, the sensor tray 202 and the sensor applicator 102 are typically sterilized in separate sterilization processes and then packaged separately, requiring the user to ultimately assemble the packages for use.

[0149] According to embodiments of the present disclosure, the sensor control device 102 can be modified to have a one-piece construction, which can be subjected to sterilization techniques specifically designed for one-piece sensor control devices. The one-piece construction allows the sensor applicator 150 and sensor control device 102 to be shipped to the user in a single, sealed package that does not require any assembly steps by the end user. Instead, the user only needs to open one package and subsequently deliver the sensor control device 102 to the target monitoring site. The one-piece system construction described herein can prove advantageous in eliminating multiple components, various manufacturing process steps, and user assembly steps. This results in reduced packaging and waste, and mitigates the potential for user error and system contamination.

[0150] 18A and 18B are isometric and side views, respectively, of another exemplary sensor control device 5002, in accordance with one or more embodiments of the present disclosure. The sensor control device 5002 may be similar in some respects to the sensor control device 102 of FIG. 1 and, therefore, may be best understood with reference to that control device. Furthermore, the sensor control device 5002 may replace the sensor control device 102 of FIG. 1 and, therefore, may be used in conjunction with the sensor applicator 102 of FIG. 1, which may deliver the sensor control device 5002 to a target monitoring site on a user's skin.

[0151] However, unlike the sensor control device 102 of FIGURE 1, the sensor control device 5002 is comprised of a one-piece system construction, eliminating the need for a user to open multiple packages and perform final assembly of the sensor control device 5002 prior to application. Instead, upon receipt by the user, the sensor control device 5002 is already fully assembled and properly positioned within the sensor applicator 150 (FIGURE 1). To use the sensor control device 5002, the user need only open a single barrier (e.g., applicator cap 708 of FIGURE 3B) before immediately delivering the sensor control device 5002 to the target monitoring site for use.

[0152] As shown, the sensor control unit 5002 includes an electronics covering 5004, which appears to be generally disc-shaped and have a circular cross-section. However, in other embodiments, the electronics covering 5004 may have various other cross-sectional shapes, such as oval or polygonal, without departing from the scope of the present disclosure. The electronics covering 5004 may be configured to house or otherwise accommodate various electrical components used to operate the sensor control unit 5002. In at least one embodiment, an adhesive patch (not shown) may be disposed on the bottom surface of the electronics covering 5004. The adhesive patch may be similar to adhesive patch 105 of FIG. 1 and thus serves to adhere the sensor control unit 5002 to a user's skin and prepare it for use.

[0153] As shown, the sensor control device 5002 includes an electronics enclosure 5004 having a shell 5006 and a mounting portion 5008 that is matable with the shell 5006. The shell 5006 may be secured to the mounting portion 5008 by a snap-fit ​​engagement, an interference fit, ultrasonic welding, one or more mechanical fasteners (e.g., screws), a gasket, an adhesive, or some combination thereof. In some cases, the shell 5006 may be secured to the mounting portion 5008 to create a sealed interface therebetween.

[0154] The sensor control device 5002 further includes a sensor 5010 (partially visible in the figure) and a sharpened tip 5012 (partially visible in the figure), which are used to aid in transcutaneous delivery of the sensor 5010 subcutaneously to a user's skin during application of the sensor control device 5002. As shown, corresponding portions of the sensor 5010 and sharpened tip 5012 extend distally from a bottom surface (e.g., base portion 5008) of the electronics housing 5004. The sharpened tip 5012 may include a sharpened tip hub 5014 configured to securely hold the sharpened tip 5012. As best seen in FIG. 18B , the sharpened tip hub 5014 may include or be otherwise defined by a mating member 5016. To connect the tip 5012 to the sensor control unit 5002, the tip 5012 can be advanced axially through the electronics shroud 5016 until the tip hub 5014 engages the top surface of the shell 5006 and the mating member 5016 extends distally from the bottom surface of the base portion 5008. As the tip 5012 pierces the electronics shroud 5004, the exposed portion of the sensor 5010 is received within the hollow or recessed (arcuate) portion of the tip 5012. The remainder of the sensor 5010 is disposed within the interior of the electronics shroud 5004.

[0155] The sensor control device 5002 further includes a sensor cap 5018, which is shown in FIGS. 18A and 18B in an exploded state, i.e., removed from the electronics enclosure 5004. The sensor cap 5018 may be removably connected to the sensor control device 5002 (e.g., the electronics enclosure 5004) at or near the bottom of the base portion 5008. The sensor cap 5018 serves to provide a hermetic barrier surrounding the exposed portions of the sensor 5010 and the sharpened tip 5012, protecting them from gaseous chemical disinfection. As shown, the sensor cap 5018 may include a generally cylindrical body having a first end 5020a and a second end 5020b opposite the first end 5020a. The first end 5020a may be open to provide access to an interior chamber 5022 defined within the body. In contrast, the second end 5020b may be closed and may include or otherwise define an engagement feature 5024. As described herein, the engagement feature 5024 aids in mating the sensor cap 5018 with a cap (e.g., applicator cap 708 of FIG. 3B) of a sensor applicator (e.g., sensor applicator 105 of FIGS. 1 and 3A-3G) and aids in removing the sensor cap 5018 from the sensor control device 5002 when the sensor cap 5018 is removed from the sensor applicator.

[0156] The sensor cap 5018 may be removably connected to the electronics enclosure 5004 at or near the bottom of the base portion 5008. More specifically, the sensor cap 5018 may be removably connected to a mating member 5016 that extends distally from the bottom of the base portion 5008. In at least one embodiment, for example, the mating member 5016 may define a set of external threads 5026a (FIG. 18B) that are matable with a set of internal threads 5026b (FIG. 18A) defined by the sensor cap 5018. In some embodiments, the external threads 5026a and internal threads 5026b comprise a flat thread design (e.g., lacking a helical curvature), which has been shown to be advantageous when molding the respective parts. Alternatively, the external threads 5026a and internal threads 5026b may comprise helical thread engagements. Thus, the sensor cap 5018 may be threadably connected to the sensor control unit 5002 by the mating member 5016 of the sharpened member hub 5014. In other embodiments, the sensor cap 5018 may be removably connected to the mating member 5016 by other types of engagement, including, but not limited to, an interference fit, a friction fit, or a frangible member or material that can be broken with minimal separation force (e.g., axial or rotational force).

[0157] In some embodiments, the sensor cap 5018 comprises a unitary structure extending between the first end 5020a and the second end 5020b. However, in other embodiments, the sensor cap 5018 may be comprised of two or more components. In the illustrated embodiment, for example, the sensor cap 5018 may include a sealing ring 5028 disposed at the first end 5020a and a desiccant cap 5030 disposed at the second end 5020b. The sealing ring 5028 may be configured to help seal the internal chamber 5022, as described in more detail below. In at least one embodiment, the sealing ring 5028 may comprise an elastomeric O-ring. The desiccant cap 5030 may store or contain a desiccant to help maintain a desired humidity level within the internal chamber 5022. The desiccant cap 5030 may also define or be separate from the engagement feature 5024 of the sensor cap 5018.

[0158] 19A and 19B are exploded isometric top and bottom views, respectively, of a sensor controller 5002, in accordance with one or more embodiments. The shell 5006 and base 5008 act as opposing halves of a clamshell, enclosing or otherwise generally enclosing various electronic components of the sensor controller 5002. More specifically, each electronic component may include, but is not limited to, a printed circuit board (PCB), one or more resistors, one or more transistors, one or more capacitors, one or more inductors, one or more diodes, and one or more switches. A data processing unit and battery may be mounted on or otherwise interact with the printed circuit board. The data processing unit may include, for example, an application specific integrated circuit (ASIC) configured to implement one or more functions or routines associated with the operation of the sensor controller 5002. More specifically, the data processing unit may be configured to perform various data processing functions, including, but not limited to, filtering and encoding data signals, each corresponding to the user's sampled analyte level. The data processing unit may also include an antenna for communicating with the reader 120 (FIG. 1) or may be capable of separate communication. A battery may provide power to the sensor control unit 5002, particularly to the electronic components on the printed circuit board. Although not shown, the sensor control unit 5002 may be provided with an adhesive patch that is applied to the bottom surface 5102 (FIG. 19B) of the base portion 5008 to help adhere the sensor control unit 5002 to the user's skin and prepare it for use.

[0159] The sensor control device 5002 includes or is otherwise provided with a sealed subassembly that includes, among other components, a shell 5006, a sensor 5010, a sharpened tip 5012, and a sensor cap 5018. The sealed subassembly of the sensor control device 5002 helps isolate the sensor 5010 and sharpened tip 5012 within an internal chamber 5022 (FIG. 19A) of the sensor cap 5018 during a gas chemical sterilization process that might otherwise adversely affect chemicals disposed on the sensor 5010.

[0160] The sensor 5010 may have a tail 5104 that extends out of an opening 5106 ( FIG. 19B ) defined in the base portion 5008 for transcutaneous reception under the user's skin. The tail 5104 may include an enzyme or other chemical thereon to facilitate monitoring of an analyte. The pointed member 5012 may have a tip 5108 that may extend through an opening 5110 ( FIG. 19A ) defined by the shell 5006, the opening 5110 being coaxially aligned with the opening 5106 in the base portion 5008. When the tip 5108 pierces the electronics housing 5004, the tail 5104 of the sensor 5010 is received within a hollow or recessed portion of the tip 5108. Point 5108 is configured to pierce the skin while retaining tail 5104, thereby allowing the active chemical in tail 5104 to come into contact with bodily fluids.

[0161] The tip 5108 can be advanced through the electronics enclosure 5004 until the tip hub 5014 engages the top surface of the shell 5006 and the mating member 5016 extends out of the opening 5106 in the bottom surface 5102 of the base portion 5008. In some embodiments, a member (not shown), such as an O-ring or sealing ring, is interposed between the tip hub 5014 and the top surface of the shell 5006 to help seal the interface between the two components. In some embodiments, the sealing member comprises a separate component, or may instead form an integral part of the shell 5006, such as a co-molded or over-molded component.

[0162] The sealed subassembly further includes a collar 5112 that is disposed inside the electronics shroud 5004 and that extends at least partially into the opening 5106. The collar 5112 may be a generally annular structure that defines or otherwise includes an annular ridge 5114 on its uppermost surface. In some embodiments, as shown, a groove 5116 is defined in the annular ridge 5114 that may be configured to accommodate or otherwise receive a portion of the sensor 5010 that extends laterally inside the electronics shroud 5004.

[0163] When the sealed subassembly is assembled, the bottom surface 5118 of the collar 5112 is exposed at the opening 5106 and can sealingly engage the first end 5020a of the sensor cap 5018, and more specifically, the sealing ring 5028. In contrast, the annular ridge 5114 at the top of the collar 5112 can sealingly engage the inner surface (not shown) of the shell 5006. In at least one embodiment, a sealing member (not shown) can be interposed between the annular ridge 5114 and the inner surface of the shell 5006 to form a sealed interface. In such an embodiment, the sealing member can also extend (flow) into the defined groove 5116 of the annular ridge 5114, thereby sealing around the sensor 5010, which extends laterally inside the electronics enclosure 5004. The sealing member, which may consist of, for example, an adhesive, a gasket, or an ultrasonic weld, helps to isolate enzymes and other chemicals contained in tail portion 5104.

[0164] FIG. 20 is a longitudinal cross-sectional view of an assembled sealed subassembly 5200 according to one or more embodiments. The sealed subassembly 5200 forms part of the sensor control device 5002 of FIGS. 18A and 18B and 19A-20B and may be comprised of components such as a shell 5006, a sensor 5010, a tip 5012, a sensor cap 5018, and a collar 5112. The sealed subassembly 5200 can be assembled in a variety of ways. In one assembly process, the tip 5012 can be connected to the sensor control device 5002 by passing the tip 5108 through an opening 5110 defined in the top of the shell 5006 and then advancing the tip 5012 until the tip hub 5014 engages the top of the shell 5006 and the mating member 5016 extends distally from the shell 5006. In some embodiments, as described above, a sealing member 5202 (e.g., an O-ring or sealing ring) is interposed between the tip hub 5014 and the upper surface to help seal the interface between these two components.

[0165] The collar 5112 may then be received over (around) the fitting 5016 and advanced toward the inner surface 5204 of the shell 5006, allowing the annular ridge 5114 to engage the inner surface 5204. The seal member 5206 may be interposed between the annular ridge 5114 and the inner surface 5204 to form a sealed interface. The seal member 5206 may also extend into (flow into) a defined groove 5116 ( FIGS. 19A-20B ) in the annular ridge 5114, thereby sealing around the sensor 5010, which extends laterally inside the electronics enclosure 5004 ( FIGS. 19A-20B ). However, in other embodiments, the collar 5112 may first seal against the inner surface 5204 of the shell 5006, followed by passage of the sharpened tip 5012 and sharpened tip hub 5014 through the opening 5110, as described above.

[0166] The sensor cap 5018 may be removably connected to the sensor control device 5002 by threading its internal threads 5026b with the external threads 5026a of the fitting 5016. Tightening (rotating) the mating engagement between the sensor cap 5018 and the fitting 5016 may urge the first end 5020a of the sensor cap 5018 into sealing engagement with the bottom surface 5118 of the collar 5112. Furthermore, tightening the mating engagement between the sensor cap 5018 and the fitting 5016 may improve the interface seal between the sharp member hub 5014 and the top of the shell 5006, and between the annular ridge 5114 and the inner surface 5204 of the shell 5006.

[0167] The internal chamber 5022 may be sized or otherwise configured to receive the tail 5104 and tip 5108. Additionally, the internal chamber 5022 may be sealed to isolate the tail 5104 and tip 5108 from various substances that may adversely interact with the chemicals in the tail 5104. In some embodiments, a desiccant 5208 (shown in dashed lines) may be present within the internal chamber 5022 to maintain an appropriate humidity level.

[0168] Once properly assembled, the sealed subassembly 5200 may be subjected to any of the various radiation sterilization processes mentioned herein to properly sterilize the sensor 5010 and sharpened tip 5012. This sterilization process may be undertaken separately from the remainder of the sensor control unit (FIGS. 18A and 18B and 19A-20B) to prevent damage to sensitive electrical components. The sealed subassembly 5200 may be subjected to radiation sterilization either before or after connecting the sensor cap 5018 to the sharpened tip hub 5014. If the sensor cap 5018 is sterilized after connecting it to the sharpened tip hub 5014, the sensor cap 5018 may be made of a material that allows radiation to propagate therethrough. In some embodiments, the sensor cap 5018 is transparent or translucent, although it may otherwise be opaque without departing from the scope of this disclosure.

[0169] 21A-21C are progressive longitudinal cross-sectional views illustrating the assembly of a sensor applicator 102 with a sensor control device 5002, according to one or more embodiments. Once fully assembled, the sensor control device 5002 is loaded into the sensor applicator 102. Referring to FIG. 21A, the sharpened member hub 5014 may be provided with or may be separately defined with hub snap tabs 5302 configured to assist in connecting the sensor control device 5002 to the sensor applicator 102. More specifically, the sensor control device 5002 may be advanced into the sensor applicator 102 such that the hub snap tabs 5302 are received by corresponding arms 5304 of a sharpened member carrier 5306 disposed within the sensor applicator 102.

[0170] 21B, the sensor control device 5002 is illustrated as being received by a sharpened member carrier 5306 and therefore secured inside the sensor applicator 102. Once the sensor control device 5002 is loaded into the sensor applicator 102, the applicator cap 210 can be connected to the sensor applicator 102. In some embodiments, the applicator cap 210 and the housing 208 are provided with mating sets of threads 5308 that allow the applicator cap 210 to be threaded onto the housing 208 in a clockwise (or counterclockwise) direction, thereby securing the applicator cap 210 to the sensor applicator 102.

[0171] As shown, the sheath 212 is also disposed inside the sensor applicator, and the sensor applicator 102 may include a sheath locking mechanism 5310 configured to ensure that it does not prematurely collapse during an impact event. In the illustrated embodiment, the sheath locking mechanism 5310 may include a threaded engagement between the applicator cap 210 and the sheath 212. More specifically, one or more internal threads 5312a may be defined or separately provided on the interior surface of the applicator cap 210, and one or more external threads 5312b may be defined or separately provided on the sheath 212. The internal threads 5312a and external threads 5312b may be configured to threadably engage when the applicator cap 210 is threaded onto the sensor applicator 102 at the threaded portion 5308. Internal threads 5312 a and external threads 5312 b may have the same thread pitch as threaded portion 5308 , allowing applicator cap 210 to be threadably secured to housing 208 .

[0172] 21C illustrates applicator cap 210 fully threaded onto housing 208. As shown, applicator cap 210 may further include, or may be otherwise defined as, a cap post 5314 that is centrally located within the interior of applicator cap 210 and extends proximally from the bottom surface of the cap. Cap post 5314 may be configured to receive at least a portion of sensor cap 5018 when applicator cap 210 is threaded onto housing 208.

[0173] With the sensor control device 5002 loaded into the sensor applicator 102 and the applicator cap 210 properly secured, the sensor control device 5002 can be subjected to gaseous chemical sterilization, which is configured to sterilize the electronics enclosure 5004 and any other exposed portions of the sensor control device 5002. Because the distal portions of the sensor 5010 and the tip 5012 are sealed inside the sensor cap 5018, the various chemical agents used during the gaseous chemical sterilization process cannot interact with other sensor components, such as the enzymes, chemicals, and biological agents coated on the tail 5104, as well as the membrane coating that regulates the influx of analytes.

[0174] 22A and 22B are perspective and top views, respectively, of a cap post 5314 according to one or more additional embodiments. In the illustrated view, a portion of the sensor cap 5018 is received inside the cap post 5314, and more specifically, the desiccant cap 5030 of the sensor cap 5018 is disposed inside the cap post 5314.

[0175] As shown, the cap post 5314 may define a receiving feature 5402 that is configured to receive the engagement feature 5024 of the sensor cap 5018 upon connecting (e.g., screwing) the applicator cap 210 ( FIG. 21C ) to the sensor applicator 102 ( FIGS. 21A-21C ). However, upon removing the applicator cap 210 from the sensor applicator 102, the receiving feature 5402 may prevent the engagement feature 5024 from moving in the opposite direction, thereby preventing the sensor cap 5018 from separating from the cap post 5314. Instead, removing the applicator cap 210 from the sensor applicator 102 simultaneously disconnects the sensor cap 5018 from the sensor control device 5002 (FIGS. 18A and 18B and 21A-21C), thereby exposing the distal portions of both the sensor 5010 (FIGS. 21A-21C) and the tip 5012 (FIGS. 21A-21C).

[0176] Numerous design variations of the receiving feature 5402 may be employed without departing from the scope of the present disclosure. In the illustrated embodiment, the receiving feature 5402 includes one or more (two shown) flexible members 5404 that are expandable or flexible enough to receive the engagement feature 5024 ( FIGS. 18A and 18B ). The engagement feature 5024 may comprise, for example, an enlarged head, and the flexible member(s) 5404 may comprise a collet-type device including a plurality of flexible fingers configured to flex radially outward to receive the enlarged head.

[0177] The flexible member 5404 may further include or define corresponding ramped surfaces configured to interact with one or more opposing camming surfaces 5408 on the outer wall of the engagement feature 5024. The ramped surface(s) 5406 and the opposing camming surface(s) 5408 are shaped and aligned such that the applicator cap 210 can rotate in a first direction A (e.g., clockwise) relative to the sensor cap 5018, but when the applicator cap 210 is rotated in a second direction B (e.g., counterclockwise), the cap posts 5314 press against and secure the sensor cap 5018. More specifically, when applicator cap 210 (and thus cap posts 5314) is rotated in a first direction A, cam surface 5408 engages ramp surface 5406, which urges flexible member 5404 to bend or otherwise deflect radially outward, resulting in a ratcheting effect. However, rotating applicator cap 210 (and thus cap posts 5314) in a second direction B forces angled surface 5410 of cam surface 5408 into opposing angled surface 5412 of ramp surface 5406, resulting in sensor cap 5018 compressing and securing flexible member(s) 5404.

[0178] 23 is a longitudinal cross-sectional view of a sensor control device 5002 disposed inside the applicator cap 210, in accordance with one or more embodiments. As shown, the opening to the receiving feature 5402 exhibits a first diameter D3, while the engagement feature 5024 of the sensor cap 5018 exhibits a second diameter D4 that is larger than the first diameter D3 and larger than the outer diameter of the remainder of the sensor cap 5018. When the sensor cap 5018 extends into the cap post 5314, the flexible member 5404 of the receiving feature 5402 flexes (expands) radially outward to receive the engagement feature 5024. In some embodiments, as shown, the engagement feature 5024 may have or otherwise define an angled or frustoconical outer surface that serves to bias the flexible member 5404 radially outward. Once the engagement feature 5024 has slipped through the receiving feature 5402, the flexible member(s) 5404 are able to contract and return to (or move towards) their natural state, thereby locking the sensor cap 5018 inside the cap post 5314.

[0179] As applicator cap 210 is threaded onto housing 208 (FIGS. 21A-21C) in a first direction A, cap post 5314 rotates in the same direction, gradually introducing sensor cap 5018 into cap post 5314. As cap post 5314 rotates, angled surface 5406 of flexible member 5404 gradually moves against an opposing pawl that presses against cam surface 5408 on sensor cap 5018. In some embodiments, this ratcheting action occurs over two full rotations of applicator cap 210 before applicator cap 210 reaches its final position.

[0180] To remove the applicator cap 210, the applicator cap 210 is rotated in the second direction B, which correspondingly rotates the cap post 5314 in the same direction, causing the cam surface 5408 (i.e., angled surface 5410 in FIGS. 22A and 22B ) to press against and secure the ramp surface 5406 (i.e., angled surface 5412 in FIGS. 22A and 22B ). As a result, continued rotation of the applicator cap 210 correspondingly rotates the sensor cap 5018 in the same direction, thereby unscrewing it from the mating member 5016 and allowing the sensor cap 5018 to be removed from the sensor control device 5002. Disconnecting the sensor cap 5018 from the sensor control device 5002 exposes both the sensor 5010 and the distal portions of the sharpened member 5012, thus placing the sensor control device 5002 in position and ready for firing (use).

[0181] 24A and 24B are longitudinal cross-sectional views of the sensor applicator 102 ready to deploy the sensor control device 5002 at a target monitoring location, according to one or more embodiments. More specifically, FIG. 24A depicts the sensor applicator 102 ready to deploy (fire) the sensor control device 5002, and FIG. 24B depicts the sensor applicator 102 in the process of deploying (firing) the sensor control device 5002. As shown, the applicator cap 210 (FIGS. 21A-21C and 23) has been removed, and the sensor cap 5018 (FIGS. 21A-21C and 23) has been correspondingly removed, thereby exposing the tail 5104 of the sensor 5010 and the pointed end 5108 of the tip 5012, as described above. In addition to the sheath member 212 and the tip carrier 5306, the sensor applicator 102 also includes a sensor carrier 5602 (alternatively referred to as a "puck" carrier), which serves to position and secure the sensor control device 5002 inside the sensor applicator 102.

[0182] Referring first to FIG. 24A , as shown, the sheath 212 is provided with one or more sheath arms 5604 (not shown) configured to interact with one or more corresponding detents 5606 (one shown) defined within the interior of the housing 208. The detent(s) 5606 are alternatively referred to as “firing” detents. When the sensor control device 5002 is initially installed on the sensor applicator 102, the sheath arms 5604 are received within the detents 5606, thereby placing the sensor applicator 102 in the fired position. In the fired position, the engaging member 5016 extends distally beyond the bottom surface of the sensor control device 5002. As discussed below, the process of firing the sensor applicator 102 retracts the engaging member 5016, preventing it from contacting the user's skin.

[0183] The sensor carrier 5602 may have one or more carrier arms 5608 (one shown) configured to interact with one or more corresponding grooves 5610 defined in the tip carrier 5306. A spring 5612 may be disposed within a cavity defined by the tip carrier 5306 and may passively bias the tip carrier 5306 upwardly within the housing 208. When the carrier arm(s) 5608 are properly received within the groove(s) 5610, the tip carrier 5306 is maintained in place and prevented from moving upwardly. The carrier arm(s) 5608 are interposed between the sheath member 212 and the tip carrier 5306, and a radial shoulder 5614 defined on the sheath member 212 is sized to maintain the carrier arm(s) 5608 fitted within the groove(s) 5610, thereby maintaining the tip carrier 5306 in place.

[0184] In Figure 24B, the sensor applicator 102 is in the process of being fired. As discussed herein with reference to Figures 3E and 3F, this can be accomplished by advancing the sensor applicator 102 toward the target monitoring site until the sheath 212 engages the user's skin. Continued pressure on the sensor applicator 102 against the skin disengages the sheath arm(s) 5604 from their corresponding detent(s) 5606, thereby collapsing the sheath 212 into the housing 208. As the sheath 212 begins to collapse, the radial shoulder 5614 eventually disengages from the carrier arm(s) 5608, allowing the carrier arm(s) 5608 to disengage from the groove(s) 5610. The passive spring force of the spring 5612 is now released, pushing the sharpened member carrier 5306 upward, thereby forcing the carrier arm(s) 5608 out of engagement with the groove(s) 5610, allowing the sharpened member carrier 5306 to move slightly upward inside the housing 208. In some embodiments, the spring 5612 is designed to incorporate a reduced number of coils to increase the spring force required to overcome engagement between the carrier arm(s) 5608 and the groove(s) 5610. In at least one embodiment, one or both of the carrier arm(s) 5608 and the groove(s) 5610 are tapered to help facilitate disengagement.

[0185] As the sharpener carrier 5306 moves upward inside the housing 208, the sharpener hub 5014 correspondingly moves in the same direction, causing the engaging member 5016 to partially retract so that the engaging member is flush, generally flush, or semi-flush with the bottom surface of the sensor control unit 5002. As will be appreciated, this prevents the engaging member 5016 from contacting the user's skin, which could otherwise adversely affect sensor insertion, cause undue pain, or prevent an adhesive patch (not shown) located on the bottom surface of the sensor control unit 5002 from properly adhering to the skin.

[0186] 25A-25C are progressive longitudinal cross-sectional views showing assembly and disassembly of an alternative embodiment of a sensor applicator 102 having a sensor control device 5002, according to one or more additional embodiments. The fully assembled sensor control device 5002 can be loaded into the sensor applicator 102 by connecting the hub snap claws 5302 to the interior of the arms 5304 of a sharp member carrier 5306 located within the sensor applicator 102.

[0187] In the illustrated embodiment, the sheath arm 5604 of the sheath 212 can be configured to interact with first and second detents 5702a and 5702b defined inside the housing 208. The first detent 5702a can alternatively be referred to as a “lock” detent, and the second detent 5702b can alternatively be referred to as a “fire” detent. When the sensor control device 5002 is initially installed in the sensor applicator 102, the sheath arm 5604 is received within the first detent 5702a. As described below, actuation of the sheath 212 can move the sheath arm 5604 to the second detent 5702b, thereby placing the sensor applicator 102 in the fired position.

[0188] In FIG. 25B , applicator cap 210 is aligned with housing 208 and then advanced toward housing 208 so that sheath 212 is received inside applicator cap 210. Instead of rotating applicator cap 210 relative to housing 208, applicator cap 210 can be connected to housing 208 by snapping the threads of applicator cap 210 onto the corresponding threads of housing 208. Axial cutouts or slots 5703 (one shown) defined in applicator cap 210 allow portions of applicator cap 210 near its threaded portion to flex outward into snap-fit ​​engagement with the threaded portion of housing 208. Snapping applicator cap 210 onto housing 208 correspondingly snaps sensor cap 5018 into cap posts 5314.

[0189] 21A-21C , sensor applicator 102 may include a sheath locking mechanism configured to ensure that sheath 212 does not prematurely collapse during an impact event. In the illustrated embodiment, sheath locking mechanism includes one or more (one shown) protrusions 5704 defined near the base of sheath 212 and configured to interconnect with one or more (two shown) protrusions 5706, and a shoulder 5708 defined near the base of applicator cap 210. Protrusion 5704 may be configured to interlock between protrusion 5706 and shoulder 5708 when applicator cap 210 is attached to housing 208. More specifically, once applicator cap 210 is snapped onto housing 208, applicator cap 210 can be rotated (e.g., clockwise) to position protrusion 5704 of sheath 212 between protrusion 5706 and shoulder 5708 of applicator cap 210, thereby "locking" applicator cap 210 until a user removes applicator cap 210 for use by counter-rotating applicator cap 210. The engagement of protrusion 5704 between protrusion 5706 and shoulder 5708 of applicator cap 210 can also prevent sheath 212 from prematurely collapsing. 25C, the applicator cap 210 has been removed from the housing 208. As with the embodiment of FIGS. 21A-21C, the applicator cap 210 can be removed by rotating it in the opposite direction, which correspondingly rotates the cap post 5314 in the same direction to unscrew the sensor cap 5018 from the fitting 5016, as outlined above. Furthermore, removing the sensor cap 5018 from the sensor control device 5002 exposes the distal portions of both the sensor 5010 and the tip 5012. When applicator cap 210 is unscrewed from housing 208, each protrusion 5704 defined on sheath 212 can slidably engage the top of a protrusion 5706 defined on applicator cap 210. The top of protrusion 5706 has a corresponding angled surface such that when applicator cap 210 is rotated, sheath 212 is displaced upward, causing sheath arm 5604 to bend out of engagement with first detent 5702a and be received within second detent 5702b. As the sheath 212 moves to the second detent 5702b, the radial shoulder 5614 moves out of radial engagement with the carrier arm(s) 5608, which causes the passive spring force of the spring 5612 to push the sharp member carrier 5306 upward and force the carrier arm(s) 5608 out of engagement and out of the groove(s) 5610. As the sharp member carrier 5306 moves upward inside the housing 208, the engaging member 5016 can correspondingly retract until it is flush, nearly flush, or semi-flush with the bottom surface of the sensor control device 5002. At this point, the sensor applicator 102 is in the fired position. Thus, in this embodiment, removing the applicator cap 210 causes the engaging member 5016 to retract accordingly.

[0190] 26A is an isometric bottom view of the housing 208, according to one or more embodiments. As shown, one or more (four shown) longitudinal ribs 5802 can be defined within the interior of the housing 208. The ribs 5802 can be equidistantly or non-equidistantly spaced apart from one another and extend generally parallel to the central axis of the housing 208. A first detent 5702a and a second detent 5702b can be provided on one or more of the longitudinal ribs 5802.

[0191] 27A is an isometric bottom view of the housing 208 within which the sheath 212 and other components are at least partially disposed. As shown, the sheath 212 may include or otherwise define one or more longitudinal slots 5804 configured to mate with longitudinal ribs 5802 of the housing 208. As outlined above, when the sheath 212 collapses into the housing 208, the ribs 5802 are received within the slots 5804, thereby helping to maintain the sheath 212 aligned with the housing during its movement. As will be appreciated, this allows for tighter circumferential and radial alignment within the housing 208 given the same dimensional and tolerance limitations.

[0192] In the illustrated embodiment, the sensor carrier 5602 may be configured to hold the sensor control device 5002 in place both axially (e.g., after the sensor cap 5018 is removed) and circumferentially. To accomplish this, the sensor carrier 5602 may include or otherwise define one or more support ridges 5806 and one or more flexible arms 5808. The support ridges 5806 extend radially inward to provide radial support to the sensor control device 5002. A portion of the flexible arm 5808 extends around the periphery of the sensor control device 5002, and an end of the flexible arm 5808 may be received within a corresponding groove 5810 defined in a side of the sensor control device 5002. The flexible arm 5808 may thus provide axial and radial support to the sensor control device 5002. In at least one embodiment, the end of the flexible arm 5808 may be biased into a groove 5810 in the sensor control device 5002 and otherwise locked in place using a corresponding sheath locking protrusion 5812 on the sheath 212.

[0193] In some embodiments, the sensor carrier 5602 may be ultrasonically welded to the housing 208 at one or more points 5814. However, in other embodiments, the sensor carrier 5602 may instead be connected to the housing 208 by a snap-fit ​​engagement without departing from the scope of the present disclosure. This helps to hold the sensor control unit 5002 in place during transport and firing.

[0194] 28 is an enlarged longitudinal cross-sectional view of the sensor applicator 102 with the sensor control device 5002 installed, according to one or more embodiments. As mentioned above, the sensor carrier 5602 can include one or more (two shown) carrier arms 5608 that can engage the sharpened member carrier 5306 with corresponding grooves 5610. In at least one embodiment, the grooves 5610 can be defined by pairs of protrusions 5902 on the sharpened member carrier 5306. Receiving the carrier arms 5608 within the grooves 5610 helps stabilize the sharpened member carrier 5306 and prevent undesired tilting throughout the entire retraction (firing) phase.

[0195] In the illustrated embodiment, the arms 5304 of the sharpener carrier 5306 may be stiff enough to allow for greater control over radial and two-axial movement of the sharpener hub 5014. In some embodiments, for example, the gap between the sharpener hub 5014 and each arm 5304 may be more constrained in both axes because relative control of the height of the sharpener hub 5014 may be more critical to the design.

[0196] In the illustrated embodiment, the sensor carrier 5602 defines or includes a central boss 5904 sized to receive the sharpening member hub 5014. In some embodiments, as shown, the sharpening member hub 5014 includes one or more (two shown) radial projections 5906. In at least one embodiment, the inner diameter of the central boss 5904 helps provide radial and tilting support to the sharpening member hub 5014 throughout the life of the sensor applicator 102 and prior to operation and assembly. Additionally, having multiple radial projections 5906 increases the length-to-width ratio of the sharpening member hub 5014, providing improved tilting support.

[0197] 29A is an isometric top view of applicator cap 210, according to one or more embodiments. In the illustrated embodiment, two axial slots 5703 are depicted that separate the upper portions of applicator cap 210 near the threads of the cap. As mentioned above, slots 5703 allow applicator cap 210 to flex outward to snap into engagement with housing 208 (FIG. 25B). In contrast, applicator cap 210 is unscrewed from housing 208 by an end user by twisting it.

[0198] 29A also depicts protrusions 5706 (one visible in the figure) defined on applicator cap 210. By interlocking with protrusions 5704 (FIG. 25C) defined on sheath 212 (FIG. 25C), protrusions 5706 help lock sheath 212 in all directions to prevent premature collapse in the event of an impact, drop, or the like. Sheath 212 can be unlocked by the user twisting applicator cap 210 off the housing, as outlined above. As described herein, the top of each protrusion 5706 is provided with a corresponding ramp 6002 such that, when applicator cap 210 is rotated to unscrew from housing 208, protrusions 5704 defined on sheath 212 can slidably engage ramp 6002, thereby displacing sheath 212 upward into housing 208.

[0199] In some embodiments, additional features are provided within the interior confines of applicator cap 210 to retain a desiccant component that maintains appropriate moisture levels over the shelf life. Such additional features are contemplated to include snap fasteners, press-fit posts, heat stakes, ultrasonic welds, and the like.

[0200] 29B is an enlarged cross-sectional view of the engagement between applicator cap 210 and housing 208, according to one or more embodiments. As shown, applicator cap 210 may define a set of internal threads 6004, and housing 208 may define a set of external threads 6006 that are threadably mateable with the internal threads 6004. As mentioned herein, applicator cap 210 may be snapped onto housing 208 by axially advancing internal threads 6004 over external threads 6006 in the direction indicated by the arrow, which causes applicator cap 210 to flex outward. To help facilitate this transition, corresponding surfaces 6008 of internal threads 6004 and external threads 6006 may be curved, angled, or chamfered, as shown. Corresponding flats 6010 may be provided on each of the screws 6004 and 6006 and configured to matingly engage once the applicator cap 210 is properly snapped into place on the housing 208. As a user twists and unscrews the applicator cap 210 from the housing 208, the flats 6010 may slidingly engage with one another.

[0201] The threaded engagement between applicator cap 210 and housing 208 results in a sealed engagement that protects the internal components from moisture, dust, and the like. In some embodiments, housing 208 may have a stabilizing feature 6012 defined therein or provided therein that is configured to be received within a corresponding groove 6014 defined in applicator cap 210. Once applicator cap 210 is snapped onto housing 208, stabilizing feature 6012 helps to stabilize and reinforce applicator cap 210. This also helps to increase the removal torque of applicator cap 210.

[0202] 30A and 30B are isometric views of a sensor cap 5018 and a collar 5112, respectively, according to one or more embodiments. Referring to FIG. 30A, in some embodiments, the sensor cap 5018 is comprised of an injection-molded part. This illustrates that it may be advantageous to mold the internal threads 5026a defined inside the internal chamber 5022, as opposed to attaching a threaded core or drilling the internal threads into the internal chamber 5022. In some embodiments, one or more locking protrusions 6102 (visible in the figures) are defined inside the internal chamber 5022 to prevent excessive movement of the cap relative to the mating member 5016 of the sharp member hub 5014 (FIGS. 18A and 18B).

[0203] 30A and 30B, in some embodiments, one or more (two in the figures) protrusions 6104 are defined on the first end 5020a of the sensor cap 5018 and are configured to mate with one or more (two in the figures) corresponding indentations 6106 defined on the collar 5112. However, in other embodiments, the protrusions 6104 may instead be defined on the collar 5112 and the indentations 6106 may instead be defined on the sensor cap 5018 without departing from the scope of the present disclosure.

[0204] The interlocking projections 6104 and indentations 6106 advantageously rotationally lock the sensor cap 5018 against inadvertent twisting of the sensor cap 5018 from the collar 5112 (and therefore from the sensor control device 5002) during the life of the sensor applicator 102 and during operation and assembly. In some embodiments, the indentations 6106 may be formed in the general shape of a kidney bean, as shown, or may be otherwise defined. This advantageously allows for some over-rotation of the sensor cap 5018 relative to the collar 5112. Alternatively, the same benefit can be achieved with a flat-ended threaded engagement between the two portions.

[0205] Embodiments of the present disclosure include: A. A sensor control device comprising: an electronics covering; a sensor disposed within the electronics covering and having a tail extending beyond the bottom surface of the electronics covering; a pointed member extending through the electronics covering and having a pointed end extending beyond the bottom surface of the electronics covering; and a sensor cap removably connected to the bottom surface of the electronics covering and defining a sealed internal chamber for receiving the tail and the pointed member.

[0206] B. An analyte monitoring system comprising: a sensor applicator; a sensor control device disposed within the sensor applicator and comprising an electronics covering; a sensor disposed within the electronics covering and having a tail extending beyond the bottom surface of the electronics covering; a pointed member extending through the electronics covering and having a pointed end extending beyond the bottom surface of the electronics covering; and a sensor cap removably connected to the bottom surface of the electronics covering and defining an engagement feature and a sealed interior chamber that receives the tail and the pointed member. The analyte monitoring system further comprises a cap connected to the sensor applicator and having a cap post defining a receiving feature that receives the engagement feature when the cap is connected to the sensor applicator, and wherein removing the cap from the sensor applicator separates the sensor cap from the electronics covering, thereby exposing the tail and the pointed end.

[0207] C. A method of preparing an analyte monitoring system, the method including loading a sensor control device into a sensor applicator, the sensor control device including: an electronics enclosure; a sensor disposed within the electronics enclosure and having a tail extending beyond a bottom surface of the electronics enclosure; a pointed member extending through the electronics enclosure and having a pointed member extending beyond the bottom surface of the electronics enclosure; and a sensor cap removably connected to the bottom surface of the electronics enclosure and defining a sealed interior chamber receiving the tail and the pointed member. The method further includes securing the cap to the sensor applicator, sterilizing the sensor control device with a gas chemical disinfectant while the sensor control device is disposed within the sensor applicator, and isolating the tail and the pointed member inside the interior chamber from the gas chemical disinfectant.

[0208] Embodiments A, B, and C may each include one or more of the following additional elements in any combination: Element 1) The sensor cap comprises a cylindrical body having a first end open to access the interior chamber and a second end opposite the first end with an engagement feature engageable with a cap of a sensor applicator, such that removal of the cap from the sensor applicator responsively removes the sensor cap from the electronics encasement, thereby exposing the tail and the point; Element 2) The electronics encasement includes a shell mateable with the base, and the sensor control device further includes a sharpened tip / sensor positioning member defined on an inner surface of the shell and a collar received around the sharpened tip / sensor positioning member, and the sensor cap is removably connected to the collar; Element 3) The sensor cap is removably connected to the collar by one or more of an interference fit, a threaded engagement, a frangible member, a frangible material, or the like. Element 4) An annular ridge surrounds the sharpening element / sensor positioning element, the collar having a post and an annular shoulder extending radially outward from the post, with a seal interposed between the annular shoulder and the annular ridge to form a sealed interface. Element 5) The annular ridge defines a groove, with a portion of the sensor seated in the groove and the seal extending into the groove to seal around that portion of the sensor. Element 6) The seal is a first seal, and the sensor control unit further includes a second seal interposed between the annular shoulder and a portion of the base to form a sealing interface. Element 7) The electronics enclosure includes a shell mateable with the base, with the sensor control unit further including a sharpening element hub that holds the sharpening element and is engageable with a top surface of the shell, and a mating element defined by the sharpening element hub and extending from a bottom surface of the electronics enclosure, with the sensor cap removably connected to the mating element. Element 8) further comprises a collar at least partially receivable within the opening defined in the mount portion and sealingly engaging the sensor cap and the inner surface of the shell. Element 9) a seal member interposed between the collar and the inner surface of the shell to form a sealed interface.Element 10) The collar defines a groove, a portion of the sensor is seated in the groove, and a seal member extends into the groove to seal around the portion of the sensor.

[0209] Element 11) the receiving feature comprises one or more flexible members that flex to receive the engaging feature, the one or more flexible members preventing the engaging feature from coming off the cap post while removing the cap from the sensor applicator. Element 12) further comprises a ramped surface defined on at least one of the one or more flexible members and one or more cam surfaces provided by the engaging feature and engageable with the ramped surface, the ramped surface and the one or more cam surfaces allowing the cap and cap post to rotate in a first direction relative to the sensor cap but preventing the cap and cap post from rotating in a second direction opposite the first direction relative to the sensor cap. Element 13) The electronics covering member has a shell mateable with the base portion, the sensor control device further comprising a sharpening member hub that holds the sharpening member and is engageable with a top surface of the shell, and a mating member defined by the sharpening member hub and extending from a bottom surface of the electronics covering member, the sensor cap being removably connected to the mating member, and rotating the cap in a second direction removes the sensor cap from the mating member. Element 14) The electronics covering member has a shell mateable with the base portion, the sensor control device further comprising a sharpening member / sensor positioning member defined on an inner surface of the shell and a collar received around the sharpening member / sensor positioning member, the sensor cap being removably connected to the collar.

[0210] Element 15) The cap is provided with cap posts defining receiving features, and the sensor cap defines engaging features, the method further including receiving the engaging features with the receiving features when the cap is secured to the sensor applicator. Element 16) The method further includes removing the cap from the sensor applicator and engaging the engaging features on the receiving features when the cap is removed, thereby removing the sensor cap from the electronics enclosure and exposing the tail and tip. Element 17) Before loading the sensor control device into the sensor applicator, the tail and tip are sterilized with radiation disinfection and the tail and tip are sealed within the internal chamber.

[0211] By way of non-limiting example, specific combinations applicable to embodiment A, embodiment B, and embodiment C include the following: element 2 in combination with element 3, element 2 in combination with element 4, element 4 in combination with element 5, element 4 in combination with element 6, element 7 in combination with element 8, element 8 in combination with element 9, element 9 in combination with element 10, element 11 in combination with element 12, and element 15 in combination with element 16.

[0212] Exemplary embodiments of seal configurations for analyte monitoring systems 31A and 31B are side and isometric views, respectively, of an exemplary sensor control device 9102, in accordance with one or more embodiments of the present disclosure. The sensor control device 9102 may be similar in some respects to the sensor control device 102 of FIG. 1 and, therefore, may be best understood with reference to that figure. Additionally, the sensor control device 9102 may replace the sensor control device 102 of FIG. 1 and, therefore, may be used in conjunction with the sensor applicator 102 of FIG. 1, which can deliver the sensor control device 9102 to a target monitoring site on a user's skin.

[0213] As shown, the sensor control device 9102 includes an electronics enclosure 9104, which may be generally disc-shaped and have a circular cross-section. However, in other embodiments, the electronics enclosure 9104 may have other cross-sectional shapes, such as oval, elliptical, polygonal, etc., without departing from the scope of this disclosure. The electronics enclosure 9104 includes a shell 9106 and a base 9108 that is matable with the shell 9106. The shell 9106 may be secured to the base 9108 by a variety of methods, such as a snap-fit ​​engagement, an interference fit, ultrasonic welding, laser welding, one or more mechanical fasteners (e.g., screws), a gasket, an adhesive, or any combination thereof. In some cases, the shell 9106 may be secured to the base 9108 to create a sealed interface therebetween. An adhesive patch 9110 may be disposed on the underside of the base 9108 or may be separately attached. Similar to adhesive patch 108 of FIG. 1, adhesive patch 9110 may be configured to maintain sensor control unit 9102 fixedly in place on a user's skin during operation.

[0214] The sensor control device 9102 may further include a sensor 9112 and a sharpened tip 9114 that is used to facilitate transcutaneous delivery of the sensor 9112 subcutaneously to a user's skin during application of the sensor control device 9102. The sensor 9112 and a corresponding portion of the sharpened tip 9114 extend distally from a bottom surface of the electronics covering 9104 (e.g., the base portion 9108). A sharpened tip hub 9116 may be overmolded onto the sharpened tip 9114 and configured to securely hold the sharpened tip 9114. As best seen in FIG. 31A , the sharpened tip hub 9116 may include or be otherwise defined by a mating member 9118. To modify the tip hub 9114 to the sensor control device 9102, the tip hub 9114 can be advanced axially through the electronics housing 9104 until the tip hub 9116 engages the top surface or an interior component of the electronics housing 9104, or until the mating member 9118 extends distally from the bottom surface of the base portion 9108. As described herein below, in at least one embodiment, the tip hub 9116 can sealingly engage the top of a seal overmolded onto the base portion 9108. When the tip 9114 pierces the electronics housing 9104, the exposed portion of the sensor 9112 is received within the hollow or recessed (arcuate) portion of the tip 9114. The remainder of the sensor 9112 is disposed within the interior of the electronics housing 9104.

[0215] The sensor control device 9102 may further include a sensor cap 9120, which is illustrated in FIGS. 31A and 31B removed from the electronics enclosure 9104. The sensor cap 9120 may help provide a hermetic barrier that encloses and protects the exposed portion of the sensor 9112 and the pointed member 9114. As shown, the sensor cap 9120 comprises a generally cylindrical body having a first end 9122a and a second end 9122b opposite the first end 9122a. The first end 9122a may be open to provide access to an interior chamber 9124 defined within the body. In contrast, the second end 9122b may be closed and may include or otherwise define an engagement feature 9126. As described in more detail below, the engagement feature 9126 can assist in fitting the sensor cap 9120 to an applicator cap of a sensor applicator (e.g., sensor applicator 102 of FIG. 1) and can also assist in removing the sensor cap 9120 from the sensor control device 9102 while simultaneously removing the sensor cap from the sensor applicator.

[0216] The sensor cap 9120 can be removably connected to the electronics enclosure 9104 at or near the bottom of the base portion 9108. More specifically, the sensor cap 9120 can be removably connected to a mating member 9118, which extends distally from the bottom of the base portion 9108. In at least one embodiment, for example, the mating member 9118 can define a set of external threads 9128a ( FIG. 31A ) that can mate with a set of internal threads 9128b ( FIG. 31B ) defined inside the interior chamber 9124 of the sensor cap 9120. In some embodiments, the external threads 9128a and internal threads 9128b comprise a flat thread design (e.g., lacking a helical curvature), although in alternative examples, they can include helically threaded engagement portions. Thus, in at least one embodiment, the sensor cap 9120 may be threadably connected to the sensor control device 9102 by the mating member 9118 of the sharpened member hub 9116. In other embodiments, the sensor cap 9120 may be removably connected to the mating member 9118 using other types of engagement, including, but not limited to, an interference or friction fit, or a frangible member or frangible substance (e.g., wax, adhesive, etc.) that can be broken with minimal separation force (e.g., axial or rotational force).

[0217] In some embodiments, the sensor cap 9120 may be comprised of a unitary (single) structure extending between the first end 9122a and the second end 9122b. However, in other embodiments, the sensor cap 9120 may be comprised of two or more components. For example, in the illustrated embodiment, the body of the sensor cap 9120 may include a desiccant cap 9130 disposed at the second end 9122b. The desiccant cap 9130 may house or accommodate a desiccant to help maintain a desired humidity level within the interior chamber 9124. Additionally, the desiccant cap 9130 may define or otherwise include an engagement feature 9126 for the sensor cap 9120. In at least one embodiment, the desiccant cap 9130 may comprise an elastomeric plug that is inserted into the bottom end of the sensor cap 9120.

[0218] 32A and 32B are exploded isometric top and bottom views, respectively, of the sensor control unit 9102, in accordance with one or more embodiments. The shell 9106 and base portion 9108 act as opposing halves of a clamshell and surround or otherwise generally enclose various electronic components (not shown) of the sensor control unit 9102. Example electronic components that may be disposed between the shell 9106 and base portion 9108 include, but are not limited to, batteries, resistors, transistors, capacitors, inductors, diodes, switches, etc.

[0219] The shell 9106 may define a first opening 9202a, and the base portion 9108 may define a second opening 9202b, which are aligned when the shell 9106 is properly attached to the base portion 9108. As best seen in FIG. 32A , the base portion 9108 may include or otherwise define a seat 9204 that protrudes from an inner surface of the base portion 9108 at the second opening 9202b. The seat 9204 may define at least a portion of the second opening 9202b. Additionally, a channel 9206 may be defined on the inner surface of the base portion 9108 and surround the seat 9202. In the illustrated embodiment, the channel 9206 is circular in shape, but alternatively may be other shapes, such as elliptical, oval, or polygonal.

[0220] The base portion 9108 may comprise a molded part made of a rigid material such as plastic or metal. In some embodiments, the sealing portion 9208 is overmolded onto the base portion 9108 and may be made of an elastomer, rubber, polymer, or other pliable material suitable for facilitating an interface seal. In embodiments in which the base portion 9108 is made of a plastic material, the base portion 9108 may be molded in a first "shot" of injection molding, and the sealing portion 9208 may be overmolded onto the base portion 9108 in a second "shot" of injection molding. Thus, the base portion 9108 may be referred to as a "two-shot base portion" or otherwise characterized.

[0221] In the illustrated embodiment, the seal portion 9208 may be overmolded onto the base portion 9108 at the base 9204 and may also be overmolded onto the bottom surface of the base portion 9108. More specifically, the seal portion 9208 may define or separately include a first seal member 9210a overmolded onto the base 9204 and a second seal member 9210b ( FIG. 32B ) interconnected to the first seal member 9210a and overmolded onto the base portion 9108 at the bottom surface of the base portion 9108. In some embodiments, one or both of the seal members 9210a and 9210b may serve to define corresponding portions of the second opening 9202b. Although sealing portion 9208 is described herein as being overmolded onto base portion 9108, one or both of sealing member 9210a and sealing member 9210b may be comprised of an elastomeric component, such as an O-ring or gasket, that is separate from base portion 9208.

[0222] The sensor control device 9102 may further include a collar 9212, which may be a generally annular structure defining a central opening 9214. The central opening 9214 may be sized to receive the first seal member 9210a and may be aligned with both the first opening 9202a and the second opening 9202b when the sensor control device 9102 is properly assembled. The shape of the central opening 9214 may generally match the shape of the second opening 9202b and the shape of the first seal member 9210a.

[0223] In some embodiments, the collar 9212 has an annular lip 9216 defined or otherwise provided on its bottom surface, which may be dimensioned or otherwise configured to mate with or be received within a channel 9206 defined on the inner surface of the base portion 9108. In some embodiments, a groove 9218 is defined on the annular lip 9216 and configured to accommodate or otherwise receive a portion of the sensor 9112 that extends laterally inside the base portion 9108. In some embodiments, the collar 9212 further has an annular channel 9220 ( FIG. 32A ) defined or otherwise provided on its top surface, which may be dimensioned to receive or otherwise mate with an annular ridge 9222 ( FIG. 32B ) defined on the inner surface of the shell 9106 when the sensor control device 9102 is properly assembled.

[0224] The sensor 9112 has a tail 9224 that extends through a second opening 9202b defined in the base 9108 for transcutaneous reception under the skin of a user. The tail 9224 may include an enzyme or other chemical thereon to facilitate monitoring of an analyte. The pointed member 9114 has a tip 9226 that extends through a first opening 9202a defined in the shell 9106. When the tip 9226 pierces the electronics housing 9104, the tail 9224 of the sensor 9112 is received within a hollow or recessed portion of the tip 9226. The tip 9226 is configured to pierce the skin while retaining the tail 9224, thereby allowing the active chemical in the tail 9224 to contact bodily fluids.

[0225] The sensor control device 9102 includes a sealed subassembly that includes, among other components, a shell 9106, a sensor 9112, a tip 9114, a seal 9208, a collar 9212, and a sensor cap 9120. The sealed subassembly serves to isolate the sensor 9112 and the tip 9114 within an interior chamber 9124 (FIG. 32A) of the sensor cap 9120. To assemble the sealed subassembly, the tip 9226 is advanced through the electronics enclosure 9104 until the tip hub 9116 engages the seal 9208, and more specifically, the first seal 9210a. A mating member 9118 on the bottom surface of the sharpened member hub 9116 can extend out of the second opening 9202b in the bottom surface of the base portion 9108, and the sensor cap 9120 can be connected to the sharpened member hub 9116 with the mating member 9118. Connecting the sensor cap 9120 to the sharpened member hub 9116 with the mating member 9118 can cause a first end 9122a of the sensor cap 9120 to sealingly engage with the seal portion 9208, and more specifically, with a second seal member 9210b on the bottom of the base portion. In some embodiments, when the sensor cap 9120 is connected to the pointed member hub 9116, a portion of the first end 9122a of the sensor cap 9120 presses against (engages with) the bottom surface of the base portion 9108, but the sealed engagement between the sensor hub 9116 and the first seal member 9210a can accommodate any tolerance variations between the functional portions.

[0226] 33 is a longitudinal cross-sectional view of a sensor control device 9102 according to one or more embodiments. As previously indicated, the sensor control device 9102 may include or separately incorporate a sealed subassembly 9302, which is useful for isolating the sensor 9112 and sharpened member 9114 within the interior chamber 9124 of the sensor cap 9120. To assemble the sealed subassembly 9302, the sensor 9112 may be positioned within the base portion 9108 such that the tail 9224 extends through the second opening 9202b in the bottom surface of the base portion 9108. In at least one embodiment, a locating feature 9304 is defined on the interior surface of the base portion 9108, and the sensor 9112 defines a groove 9306 that can mate with the locating feature 9304 to properly position the sensor 9112 within the base portion 9108.

[0227] Once the sensor 9112 is properly positioned, the collar 9212 can be attached to the base portion 9108. More specifically, the collar 9212 can be positioned such that the first seal member 9210a of the seal portion 9208 is received inside the central opening 9214 defined by the collar 9212 and the first seal member 9210a presses against the collar 9212 at the central opening 9214 to create a radial seal. Furthermore, an annular lip 9216 defined on the collar 9212 is received within a channel 9206 defined on the base portion 9108, and a groove 9218 defined through the annular lip 9216 aligns to receive the portion of the sensor 9112 that transversely traverses the channel 9206 inside the base portion 9108. In some embodiments, an adhesive can be injected into the channel 9206 to secure the collar 9212 to the base portion 9108. The adhesive can also facilitate sealing the interface between the two components and create a seal around the sensor 9112 in the groove 9218, which can isolate the tail portion 9224 from the electronics enclosure 9104.

[0228] The shell 9106 may then be mated or otherwise connected to the base portion 9108. In some embodiments, as shown, mating of the shell 9106 to the base portion 9108 may be accomplished by a tip-and-groove mating portion 9308 on the outer periphery of the electronics enclosure 9104. An adhesive may be injected into the groove of the mating portion 9308 to secure the shell 9106 to the base portion 9108 and further provide a sealed mating interface. Mating the shell 9106 to the base portion 9108 allows an annular ridge 9222 defined on the inner surface of the shell 9106 to be received within an annular channel 9220 defined in the top surface of the collar 9212. In some embodiments, injecting an adhesive into the annular channel 9220 may secure the shell 9106 to the collar 9212 and further facilitate sealing the interface between the two components at that location. When the shell 9106 is mated with the mount portion 9108, the first seal member 9210a can extend at least partially through (into) a first opening 9202a defined in the shell 9106.

[0229] The tip 9114 can then be connected to the sensor control device 9102 by passing the tip 9226 through aligned first and second openings 9202a and 9202b defined in the shell 9106 and base 9108, respectively. The tip 9114 can be advanced until the tip hub 9116 engages the seal 9208, and more specifically, until it engages the first seal member 9210a. When the tip hub 9116 engages the first seal member 9210a, the mating member 9118 can extend out of the second opening 9202b in the bottom surface of the base 9108.

[0230] The sensor cap 9120 can then be removably connected to the sensor control device 9102 by threading the internal threads 9128b of the sensor cap 9120 with the external threads 9128a of the fitting 9118. The internal chamber 9124 can be sized or otherwise configured to receive the tail 9224 and tip 9226 so that they overhang the bottom surface of the base 9108. Furthermore, the internal chamber 9124 can be sealed to isolate the tail 9224 and tip 9226 from materials that may adversely interact with the chemicals in the tail 9224. In some embodiments, a desiccant (not shown) can be present within the internal chamber 9124 to maintain an appropriate humidity level.

[0231] Tightening (rotating) the mating engagement between the sensor cap 9120 and the fitting member 9118 can urge the first end 9122a of the sensor cap 9120 into sealing engagement with the second seal member 9310b in the axial direction (e.g., along the centerline of the openings 9202a and 9202b) and can further improve the axial interface seal between the sharp member hub 9116 and the first seal member 9210a. Furthermore, tightening the mating engagement between the sensor cap 9120 and the fitting member 9118 can compress the first seal member 9210a, which results in improved radial sealing engagement at the central opening 9214 between the first seal member 9210a and the collar 9212. Thus, in at least one embodiment, the first seal member 9210a helps to promote axial and radial sealing engagement.

[0232] As described above, the first seal member 9210a and the second seal member 9210b may be overmolded onto the base portion 9108, or may be physically coupled or otherwise interconnected. Consequently, a single injection molding shot can flow through the second opening 9202b of the base portion 9108 to form both ends of the seal portion 9208. This advantageously allows for multiple sealed interfaces to be created with just one injection molding shot. A further benefit of the two-shot molding design is that, as opposed to utilizing multiple separate elastomeric components (e.g., O-rings, gaskets), the interface between the first and second shots provides a more reliable joint than a mechanical seal. This effectively cuts the effective number of mechanical seal barriers in half. Furthermore, two-shot molding components containing a single elastomeric shot are expected to minimize the number of two-shot molding components required to achieve all the necessary sterility barriers. Once properly assembled, the sealed subassembly 9302 can be subjected to a radiation sterilization process to sterilize the sensor 9112 and sharp tip 9114. The sealed subassembly 9302 can be subjected to radiation sterilization either before or after connecting the sensor cap 9120 to the sharp tip hub. If the sensor cap 9120 is sterilized after being coupled to the sharp tip hub 9116, the sensor cap 9120 can be made of a material that allows radiation to propagate therethrough. In some embodiments, the sensor cap 9120 can be transparent or translucent, but can also be opaque without departing from the scope of the present disclosure.

[0233] FIG. 33A is an exploded isometric view of a portion of another embodiment of the sensor control device 9102 of FIGS. 31A and 31B and 32A and 32B. In the descriptions of the preceding embodiments, the mounting portion 9108 and the sealing portion 9208 are manufactured using a two-shot injection molding process. However, in other embodiments, as briefly discussed above, one or both of the sealing members 9210a and 9210b of the sealing portion 9208 may include elastomeric components separate from the mounting portion 9208. In the illustrated embodiment, for example, the first sealing member 9210a may be overmolded onto the collar 9212, and the second sealing member 9210b may be overmolded onto the sensor cap 9120. Alternatively, the first seal member 9210a and the second seal member 9210b may comprise separate components, such as gaskets or O-rings, that are respectively placed on the collar 9212 and the sensor cap 9120. Tightening (rotating) the mating engagement between the sensor cap 9120 and the mating member 9118 can axially bring the second seal member 9210b into sealing engagement with the bottom surface of the base portion 9108 and can improve the axial interface seal between the sharp member hub 9116 and the first seal member 9210a.

[0234] FIG. 34A is an isometric bottom view of the base portion 9108, and FIG. 34B is an isometric top view of the sensor cap 9120, according to one or more embodiments. As shown in FIG. 34A, the base portion 9108 can have one or more indentations or pockets 9402 at or near the opening to the second opening 9202b. As illustrated in FIG. 34B, the sensor cap 9120 can have one or more protrusions 9404 at or near the first end 9122a of the sensor cap 9120. The protrusions 9404 are received within the pockets 9402 when the sensor cap 9120 is connected to the sharp member hub 9116 (FIGS. 32A and 32B and 33). More specifically, as described above, when the sensor cap 9120 is connected to the mating member 9118 (FIGS. 32A and 32B and 33) of the sharp member hub 9116, the first end 9122a of the sensor cap 9120 sealingly engages with the second seal member 9210b. In this process, the protrusion 9404 is also received inside the pocket 9402, which helps prevent the sensor cap 9120 from being prematurely unscrewed from the sharp member hub 9116.

[0235] 35A and 35B are side and longitudinal cross-sectional views, respectively, of an exemplary sensor applicator 9502, according to one or more embodiments. The sensor applicator 9502 may be similar in some respects to the sensor applicator 102 of FIG. 1, and as such, may be designed to deliver a sensor control device, such as the sensor control device 9102. FIG. 35A depicts the sensor applicator 9502 as shipped and received by a user, while FIG. 35B depicts the sensor control device 9102 positioned within the interior of the sensor applicator 9502.

[0236] 35A , the sensor applicator 9502 includes a housing 9504 and an applicator cap 9506 that is removably connected to the housing 9504. In some embodiments, the applicator cap 9506 may be threaded onto the housing 9504 and may include a used-indicating ring (tamper ring) 9508. Upon rotating the applicator cap 9506 relative to the housing 9504 (e.g., by unscrewing it), the used-indicating ring 9508 shears, thereby releasing the applicator cap 9506 from the sensor applicator 9502.

[0237] 35B, the sensor control device 9102 is located inside the sensor applicator 9502. Once fully assembled, the sensor control device 9102 can be loaded into the sensor applicator 9502 and the applicator cap 9506 can be connected to the sensor applicator 9502. In some embodiments, the applicator cap 9506 and housing 9504 are provided with a mating set of threads that allow the applicator cap 9506 to be twisted clockwise (or counterclockwise) onto the housing 9504, thereby securing the applicator cap 9506 to the sensor 9502.

[0238] Securing the applicator cap 9506 to the housing 9504 causes the second end 9122b of the sensor cap 9120 to be received within the cap post 9510, which is disposed within the interior of the applicator cap 9506 and extends proximally from a bottom surface thereof. The cap post 9510 can be configured to receive at least a portion of the sensor cap 9120 when the applicator cap 9506 is connected to the housing 9504.

[0239] 36A and 36B are perspective and top views, respectively, of a cap post 9510 according to one or more further embodiments. In the depicted depiction, a portion of the sensor cap 9120 is received inside the cap post 9510, and more specifically, the desiccant cap 9130 of the sensor cap 9120 is disposed inside the cap post 9510. The cap post 9510 may define a receiving feature 9602 configured to receive an engaging feature 9126 of the sensor cap 9120 when the applicator cap 9506 ( FIG. 35B ) is connected (e.g., threaded) to the sensor applicator 9502 ( FIGS. 35A and 35B ). However, when the applicator cap 9506 is removed from the sensor applicator 9502, the receiving feature 9602 prevents the engagement feature 9126 from moving in the opposite direction, thus preventing the sensor cap 9120 from separating from the cap post 9510. Alternatively, removing the applicator cap 9506 from the sensor applicator 9502 simultaneously disconnects the sensor cap 9120 from the sensor control device 9102 ( FIGS. 31A and 31B and 32A and 32B ), thereby exposing the distal portion of the sensor 9112 ( FIGS. 32A and 32B ) and the pointed member 9114 ( FIGS. 32A and 32B ).

[0240] Numerous design variations of the receiving feature 9602 may be employed without departing from the scope of the present disclosure. In the illustrated embodiment, the receiving feature 9602 includes one or more (two in the illustrated example) flexible members 9604 that are expandable or flexible enough to receive the engagement feature 9126. The engagement feature 9126 may include, for example, an enlarged head, and the flexible member(s) 9604 may include a collet-type device with multiple flexible fingers configured to flex radially outward to receive the enlarged head.

[0241] The flexible member(s) may further include or separately define corresponding ramped surfaces 9606 configured to interact with one or more opposing cam surfaces 9608 on the outer wall of the engagement feature 9126. The ramped surfaces 9606(s) and opposing cam surfaces 9608(s) are configured and aligned such that the applicator cap 9506 can be rotated in a first direction A (e.g., clockwise) relative to the sensor cap 9120, but when the applicator cap 9506 is rotated in a second direction B (e.g., counterclockwise), the cap posts 9510 press against and secure the sensor cap 9120. More specifically, when the applicator cap 9506 (and thus the cap post 9510) is rotated in a first direction A, the cam surface 9608 engages the ramp surface 9606, which causes the flexible member 9604 to bend radially outward or otherwise deflect, resulting in a ratcheting effect. However, rotating the applicator cap 9506 (and thus the cap post 9510) in a second direction B forces the angled surface 9610 of the cam surface 9608 into the opposing angled surface 9612 of the ramp surface 9606, resulting in the sensor cap 9120 pressing against and securing the flexible member(s) 9604.

[0242] 37 is a longitudinal cross-sectional view of the sensor control device 9102 disposed within the applicator cap 9506, in accordance with one or more embodiments. As shown, the opening to the receiving feature 9602 exhibits a first diameter D3, while the engagement feature 9126 of the sensor cap 9120 exhibits a second diameter D4 that is larger than the first diameter D3 and larger than the outer diameter of the remainder of the sensor cap 9120. As the sensor cap 9120 extends within the cap post 9510, the flexible members 9604(s) of the receiving mechanism 9602 flex (expand) radially outward to receive the engagement features 9126. In some embodiments, as shown, the engagement features 9126 have angled or otherwise defined outer surfaces that help bias the flexible members 9604(s) radially outward. Once the engagement feature 9126 has slipped through the receiving feature 9602, the flexible member(s) 9604 are able to bend back to (or move towards) their natural state, thereby locking the sensor cap 9120 inside the cap post 9510.

[0243] As the applicator cap 9506 threads onto the housing 9504 ( FIGS. 35A and 35B ) in a first direction A, the cap post 9510 rotates in the same direction, gradually introducing the sensor cap 9120 into the cap post 9510. As the cap post 9510 rotates, the angled surface 9606 of the flexible member 9604 gradually moves the opposing pawl that presses against the cam surface 9608 of the sensor cap 9120. This continues until the applicator cap 9506 is fully threaded onto the housing 9504. In some embodiments, this ratcheting action occurs over two full rotations of the applicator cap 9504 before the applicator cap 9506 reaches its final position.

[0244] To remove the applicator cap 9506, the applicator cap 9506 is rotated in the second direction B, which correspondingly rotates the cap post 9510 in the same direction, causing the cam surface 9608 (i.e., angled surface 9610 in FIGS. 36A and 36B ) to press against and secure the ramp surface 9606 (i.e., angled surface 9612 in FIGS. 36A and 36B ). As a result, continued rotation of the applicator cap 9506 correspondingly rotates the sensor cap 9120 in the same direction, thereby unscrewing it from the mating member 9118 and allowing the sensor cap 9120 to be removed from the sensor control device 9102. Disconnecting the sensor cap 9120 from the sensor control device 9102 exposes both the sensor 9112 and the distal portions of the sharpened member 9114, thus positioning the sensor control device 9102 in position and ready for firing (use).

[0245] Figure 38A is a cross-sectional view showing an example interaction between a sensor and a tip in a sensor control device 9800. After assembly of the tip, the sensor must be placed into the channel defined in the tip. Although the sensor control device in Figure 9 does not depict the sensor biased inward or otherwise fully aligned with the tip, this may be the case upon full assembly, as the sensor may experience a slight biasing force at each position indicated by the two arrows A. Biasing the sensor and pressing against the tip is advantageous because any relative movement between the sensor and tip during subcutaneous insertion will not expose the sensor tip (i.e., tail) outside the tip channel, potentially causing insertion failure.

[0246] 38B-38D illustrate an exemplary tip hub 205014 and tip 209114 configured to prevent biasing of the sensor 11900 prior to subcutaneous delivery, e.g., during shipping and storage (FIG. 15B), and to bias the sensor 11900 during subcutaneous delivery of the sensor (FIG. 38C). Storing and shipping the sensor in an unbiased (relaxed, i.e., unstressed) position can extend the sensor's shelf life and reduce overall stress. Furthermore, storing and shipping the sensor in an unbiased position can reduce stress relaxation over storage years, thereby limiting loss of bias force due to stress relaxation. Therefore, the sensor's bias force during subcutaneous delivery is more predictable and maintains its designed bias during subcutaneous delivery. The tip 209114 may include a window 209114A. Prior to use, the window 209114A can be aligned with the protrusion 11912 on the top end 11908b of the sensor 11900, allowing the protrusion 11912 to extend through the window 209114. In such a configuration, the bottom end 11908a is not biased toward the tip, and thus the sensor 11900 is in a relaxed state. During firing, the needle carrier 201102 can be partially retracted, thereby pulling the tip 209114 into a partially retracted position. The partial retraction can occur when the sheath 20704 first moves proximally relative to the sensor carrier 20710 during firing. When the ribs 20710M of the retention arms 20710L engage with their respective slots 20704Q (see FIG. 8M) in the sheath 20704, the tip carrier locking arms 20710K (see FIG. 9D) of the sensor carrier 20710 can each extend radially outward, allowing the tip carrier retention feature (retention arm) 20710L to pass the pre-partially retracted retention surface 201102A and engage the post-partially retracted retention surface 201102B (see FIG. 10C) of the tip carrier 201102. In the partially retracted position, the window 209114A no longer receives the protrusion 11912, but the tip 209114 engages the protrusion 11912, thereby biasing the bottom end 11908a towards the tip 209114 and into a position suitable for subcutaneous delivery, as described above.

[0247] Embodiments of the present disclosure include: D. A sensor control device includes an electronics enclosure having a shell defining a first opening and a base defining a second opening, the second opening being aligned with the first opening when the shell is mated with the base; the sensor control device further includes a seal overmolded onto the base at the second opening, the seal consisting of a first seal overmolded onto a base protruding from an inner surface of the base and a second seal interconnected with the first seal and overmolded onto a bottom surface of the base; the sensor control device further includes a sensor positioned inside the electronics enclosure, the sensor having a tail extending through the second opening and extending beyond the bottom surface of the base; and the sensor control device further includes a pointed member extending through the first and second openings and extending beyond the bottom surface of the electronics enclosure.

[0248] E. The assembly includes a sensor applicator and a sensor control device disposed within the sensor applicator, the sensor control device including an electronics enclosure having a shell defining a first opening and a base defining a second opening, the second opening being aligned with the first opening when the shell is mated with the base, the sensor control device further including a seal overmolded onto the base at the second opening, the seal configured to be attached to an inner surface of the base. the sensor control unit further comprises a sensor disposed inside the electronics enclosure with a tail extending through the second opening and extending beyond the bottom surface of the electronics enclosure; the sensor control unit further comprises a sharpened member, the sharpened member extending through the first and second openings and extending beyond the bottom surface of the electronics enclosure; the assembly further comprises a sensor cap, the sensor cap removably connected to the sensor control unit at the bottom surface of the enclosure and defining a sealed internal chamber for receiving the tail and the sharpened member; and the assembly further comprises an applicator cap connected to the sensor applicator.

[0249] Embodiments D and E may each include one or more of the following additional elements in any combination: Element 1) the base portion comprises a first injection-molded part formed in a first shot, and the seal portion comprises a second injection-molded part overmolded onto the first injection-molded part in a second shot; Element 2) the assembly further comprises a sharpening member hub, the sharpening member hub retaining the sharpening member and sealingly engaging the first sealing member, and the assembly further comprises a sensor cap, the sensor cap removably connected to the sharpening member hub at a bottom surface of the base portion, sealingly engaging the second sealing member, and defining an internal chamber for receiving the tail and the sharpening member; Element 3) the sharpening member hub is provided with a fitting that extends beyond the bottom surface of the base portion, the sensor cap being removably connected to the fitting member. Element 4) further comprising one or more pockets defined on the bottom surface of the base portion at the location of the second opening, and one or more protrusions defined on an end of the sensor cap, which can be received within the one or more pockets when the sensor cap is connected to the sharpened member hub. Element 5) further comprising a collar disposed inside the electronics enclosure and defining a central opening, which receives and radially sealingly engages the first seal member. Element 6) further comprising a channel defined on the inner surface of the base portion and surrounding the base, an annular lip defined on the underside of the collar and matable with the channel, and adhesive applied to the channel to securely seal the collar in place in the channel of the base portion. Element 7) further comprising a groove defined through the annular lip for receiving a portion of the sensor extending laterally inside the base portion. Element 8) further comprising an annular channel defined in the top surface of the collar, an annular ridge defined in the inner surface of the shell that is mateable with the annular channel, and adhesive applied to the annular channel to secure and seal the shell to the collar. Element 9) one or both of the first and second seal members define at least a portion of a second opening. Element 10) when the shell is connected to the mount portion, the first seal member extends at least partially through the first opening.

[0250] Element 11) The sensor control device further includes a sharpening member hub that retains the sharpening member and sealingly engages the first seal, and a sensor cap that is removably connected to the sharpening member hub on the bottom surface of the base and sealingly engages the second seal. Element 12) The sensor control device further includes one or more pockets defined on the bottom surface of the base at the location of the second opening and one or more protrusions defined on an end of the sensor cap that are receivable within the one or more pockets when the sensor cap is connected to the sharpening member hub. Element 13) The sensor control device further includes a collar positioned inside the electronics enclosure and defining a central opening that receives and radially sealingly engages the first seal. Element 14) The sensor control device further comprises a channel defined in the inner surface of the base portion surrounding the seat, an annular lip defined in the lower surface of the collar mateable with the channel, and adhesive applied to the channel to securely seal the collar in place in the channel of the base portion. Element 15) The sensor control device further comprises a groove defined through the annular lip to receive a portion of the sensor extending laterally inside the base portion, the adhesive sealing around the sensor in place in the groove. Element 16) The sensor control device further comprises an annular channel defined in the upper surface of the collar, an annular ridge defined in the inner surface of the shell mateable with the annular channel, and adhesive applied to the annular channel to securely seal the shell to the collar. Element 17) One or both of the first and second seal members define at least a portion of a second opening. Element 18) The first seal member at least partially extends through the first opening.

[0251] Specific, non-limiting examples of combinations applicable to embodiments D and E include the following: element 2 in combination with element 3, element 2 in combination with element 4, element 5 in combination with element 6, element 6 in combination with element 7, element 5 in combination with element 8, element 11 in combination with element 12, element 13 in combination with element 14, element 14 in combination with element 15, and element 13 in combination with element 16.

[0252] Exemplary firing mechanisms for one-piece and two-piece applicators 39A-39F show detailed views of an exemplary embodiment of the internal device mechanics, including "firing" the applicator 216 to affix the sensor control unit 222 to the user and retracting the sharpened tip 1030 to safely return it to the used applicator 216. Collectively, these figures depict an exemplary sequence of driving the sharpened tip 1030 (carrying a sensor connected to the sensor control unit 222) into the user's skin, withdrawing the sharpened tip while leaving the sensor in operative contact with the user's interstitial fluid, and adhesively adhering the sensor control unit to the skin. Modifications of such actions for use with alternative applicator assembly embodiments and various components can be appreciated by those skilled in the art with reference to these figures. Additionally, the applicator 216 may be a sensor applicator having a one-piece or two-piece construction, as disclosed herein.

[0253] 39A , the sensor 1102 resides within the sharpened member 1030 and is supported directly above the user's skin 1104. The rails 1106 (optionally three) of the upper guide section 1108 can be provided to control the movement of the applicator 216 relative to the sheath 318. The sheath 318 can be held by a detent feature 1110 inside the applicator 216 such that an appropriate downward force along the longitudinal axis of the applicator 216 overcomes the resistance provided by the detent feature 1110, thereby allowing the sharpened member 1030 and sensor control unit 222 to translate along the longitudinal axis and move below (and above) the user's skin 1104. Additionally, the carrier arm 1112 of the sensor carrier 1022 engages the sharpened member storage assembly 1024, thereby maintaining the sharpened member 1030 in position relative to the sensor control unit 222.

[0254] 39B, a user force is applied to overcome or release the control of the detent feature 1110, causing the sheath 318 to collapse into the housing 314 and translate the sensor control device 222 (together with its associated components) downward along its longitudinal axis as shown by arrow L. The inner diameter of the upper guide section 1108 of the sheath 318 constrains the position of the carrier arm 1112 throughout the sensor and sharp insertion process. A return spring 1118 maintains the position of each component under full bias by holding the stop surface 1114 of the carrier arm 1112 against a complementary surface 1116 of the sharp storage assembly 1024.

[0255] In Figure 39C, the sensor 1102 and sharpening member 1030 have reached their full insertion depth. In doing so, the carrier arm 1112 clears the inner diameter of the upper guide section 1108. The compressive force of the coil return spring 1118 then urges the angled stop surface 1114 radially outward, and the release of the force actuates the sharpening member carrier 2102 of the sharpening member storage assembly 1024, pulling the sharpening member 1030 (slotted or otherwise) away from the user and away from the sensor 1102, as shown by arrow R in Figure 39D.

[0256] Once the sharpened tip 1030 is fully retracted as shown in Figure 39E, the upper guide section 1108 of the sheath 318 is secured by the final locking feature 1120. As can be seen in Figure 39F, the used applicator assembly 216 is removed from the insertion site, leaving behind the sensor control unit 222 and the sharpened tip 1030 safely secured within the applicator assembly 216. At this point, the used applicator assembly 216 is ready for disposal.

[0257] The movement of the applicator 216 when applying the sensor control device 222 is designed to provide the user with the sensation that both the insertion and retraction of the sharpened tip 1030 are being performed automatically by the internal mechanisms of the applicator 216. In other words, the present invention avoids the user experiencing the sensation of manually driving the sharpened tip 1030 into their skin. Thus, when the user applies sufficient force to overcome the resistance from the detent features of the applicator 216, the resulting movement of the applicator 216 is perceived as an automatic response to the applicator being "triggered." The user is unaware that they are providing additional force to drive the sharpened tip 1030 and pierce the skin, even though all of the driving force is provided by the user and no additional biasing or driving means are used to insert the sharpened tip 1030. As detailed above in FIG. 39C, retraction of the pointed member 1030 is automated by a coil return spring 1118 in the applicator 216.

[0258] Those skilled in the art will appreciate that any one of the applicator embodiments described herein, as well as any of its various components, including, but not limited to, the sharpened tip, sharpened tip module, and sensor module, can be sized and configured to be suitable for use with various sensors configured to sense analyte levels in bodily fluids in the epidermis, dermis, or subcutaneous tissue of a subject. In some embodiments, for example, both the sharpened tip and distal portions of the analyte sensors disclosed herein can be sized and configured to be positioned at a particular endpoint depth (i.e., the deepest penetration point in a tissue or layer of a subject's body, e.g., the epidermis, dermis, or subcutaneous tissue). Those skilled in the art will appreciate that for some applicator embodiments, a particular embodiment of the sharpened tip may be sized and configured to be positioned at a different endpoint depth in the subject's body compared to the final endpoint depth of the analyte sensor. For example, in some embodiments, the sharpened member may be positioned at a first endpoint depth within the subject's epidermis before retraction, while a distal portion of the analyte sensor may be positioned at a second endpoint depth within the subject's dermis. In other embodiments, the sharpened member may be positioned at a first endpoint depth within the subject's dermis before retraction, while a distal portion of the analyte sensor may be positioned at a second endpoint depth within the subject's subcutaneous tissue. In yet other embodiments, the sharpened member may be positioned at a first endpoint depth and the analyte sensor may be positioned at a second endpoint depth before retraction, where both the first and second endpoint depths are in the same layer or tissue of the subject's body.

[0259] Additionally, for any of the applicator embodiments described herein, one skilled in the art will appreciate that the analyte sensor as well as one or more structural components connected thereto, including, but not limited to, one or more spring mechanisms, can be disposed within the applicator at an off-center position relative to one or more axes of the applicator. In some applicator embodiments, for example, the analyte sensor and spring mechanism can be disposed on a first side of the applicator at a first off-center position relative to the applicator axis, and the sensor electronics can be disposed on a second side of the applicator at a second off-center position relative to the applicator axis. In other applicator embodiments, the analyte sensor, spring mechanism, and sensor electronics can be disposed on the same side at an off-center position relative to the applicator axis. Those skilled in the art will appreciate that other arrangements and configurations in which the analyte sensor, spring mechanism, sensor electronics, and any and all other components of the applicator are positioned in central or off-center positions relative to one or more axes of the applicator are contemplated and fully within the scope of the present disclosure.

[0260] Numerous deflectable structures are described herein, including, but not limited to, deflectable detent snap-fit ​​1402, deflectable locking arm 1412, tip carrier locking arm 1524, tip retaining arm 1618, and modular snap-fit ​​2202. These deflectable structures are constructed from a resilient material, such as plastic or metal (or others), and operate in a manner well known to those skilled in the art. Each deflectable structure has a rest state or position that the resilient material assumes after being biased. If a force is applied to deflect or shift the structure from this rest state or position, when such force is removed (or weakened), the bias of the resilient material causes the structure to return to the rest state or position. Often these structures are configured as arms with detents or snap-fits, but a variety of other structures and configurations can also be used, including but not limited to legs, clips, clasps, supports, etc., that maintain the same characteristics of deflectability and ability to return to a resting position.

[0261] Further details of suitable devices, systems, methods, components, and their operation, along with their associated characteristics, are set forth in WO 2018 / 135898 to Rao et al., WO 2019 / 236850 to Thomas et al., WO 2019 / 236859 to Thomas et al., WO 2019 / 236876 to Thomas et al., and U.S. Patent Application Publication No. 2020 / 0196919, filed June 6, 2019, each of which is incorporated herein by reference in its entirety. Further details regarding various applicators, their respective components, and various variant embodiments thereof are described in U.S. Patent Application Publication Nos. 2013 / 0150691, 2016 / 0331283, and 2018 / 0235520, each of which is incorporated herein by reference in its entirety. Further details regarding tip modules, tip members, their various components, and various variant embodiments thereof are described in U.S. Patent Application Publication No. 2014 / 0171771, each of which is incorporated herein by reference in its entirety.

[0262] It should be noted that all features, elements, components, functions, and steps described with respect to any embodiment presented herein should be construed as being freely combinable and interchangeable with those from any other embodiment. When a feature, element, component, function, or step is described with respect to only one embodiment, it should be understood that that feature, element, component, function, or step may also be used with all other embodiments described herein, unless expressly stated otherwise. Accordingly, this paragraph serves as a prerequisite and written support for the introductory portion of each claim that combines features, elements, components, functions, and steps from different embodiments, or substitutes features, elements, components, functions, and steps from one embodiment for those from another embodiment, even if the following description in the introductory portion does not explicitly state that such various combinations and substitutions are possible in a particular instance. Accordingly, the preceding descriptions of specific embodiments of the disclosed subject matter have been presented for purposes of illustration and description. It is expressly recognized that it would be unduly burdensome to explicitly list every possible combination and permutation, especially given that one of ordinary skill in the art would readily recognize the permissibility of each and every such combination and permutation.

[0263] While each embodiment is susceptible to various modifications and alternative forms, specific examples thereof are shown in the drawings and described in detail herein. It will be apparent to those skilled in the art that various modifications and variations can be made in the methods and systems of the disclosed subject matter without departing from the spirit or scope of the disclosed subject matter. Accordingly, the disclosed subject matter is intended to include modifications and variations that come within the scope of the appended claims and their equivalents. Furthermore, any feature, function, step, or element of each embodiment may be recited or added to the claims, as well as any negative limitations that define the scope of the claims by any feature, function, step, or element not included in the scope of the claims. [Explanation of symbols]

[0264] 9202a 1st opening 9202b 2nd opening 9204 Base 9206 Channel (Moat) 11900 Sensor 20105 Adhesive Patch 201102 Sharp component carrier 20150 Applicator device 205014 Sharpened part hub 20702 Housing 20702C Case skirt 20702D Skirt reinforcement rib section 20702G Screw 20704 Sheath member 20704J Locking Arm 20704M Locking Arm Interface 20704N Sharp Edge 20708 Cap 20708D Screw 20708E Sealed interface 20708F Compressed ridges 20708H Desiccant Retaining Clip 20708I Brake 20708J Protrusion 20710 Sensor carrier 20710B Sensor Holding Arm 20710K Sharp Component Carrier Locking Arm 20710N Locking shelf 20712 Used explicit function part 209114 Sharpened parts

Claims

1. 1. A sensor carrier delivering a sensor control device for use in an applicator, the sensor carrier comprising: a base provided with a first half and a second half; a first sensor retaining arm connected at a first end to the first half of the base and having a second free end that overhangs towards the second half of the base, the first sensor retaining arm having a first sensor retaining feature on an inner surface thereof and a first locking interface on an outer surface thereof; a second sensor retaining arm connected at a first end to the first half of the base and having a second free end that overhangs the second half of the base, the second sensor retaining arm having a second sensor retaining feature on an inner surface thereof and a second locking interface on an outer surface thereof; and three equally spaced housing attachment features extending upwardly from a top surface of the base, each housing attachment feature comprising: Housing fasteners, Housing positioning function, and Housing biasing function part, A sensor carrier comprising:

2. a first housing attachment feature of the three housing attachment features is disposed on the second half of the base; The sensor carrier of claim 1 , wherein a second housing mounting feature and a third housing mounting feature of the three housing mounting features are disposed on a first half of the base.

3. 2. The sensor carrier of claim 1, further comprising three equally spaced pointed member carrier locking arms projecting upwardly from said top surface of said base.

4. 4. The sensor carrier according to claim 3, wherein each of the three sharpened member carrier locking arms includes a sharpened member carrier holding mechanism and a sharpened member carrier holding mechanism ridge.

5. 4. The sensor carrier according to claim 3, wherein a first of the three sharpened member carrier locking arms is disposed on the first half of the base.

6. 4. The sensor carrier according to claim 3, wherein a second sharpened member carrier locking arm and a third sharpened member carrier locking arm of the three sharpened member carrier locking arms are disposed on the second half of the base.

7. 10. The sensor carrier of claim 1, further comprising a first locking ledge and a second locking ledge.

8. The sensor carrier of claim 1 further comprising a hole extending through the center of the base.

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