Systems, devices, and methods for analyte monitors

Abstract

An analyte monitor system having a sensor control device including an electronics housing. The housing can include a shell disposed opposite a mount, each including an opening axially aligned with the opening of the other. The inner surfaces are aligned and a seal is disposed within the interior space. The housing also includes a circuit board disposed within the interior space of the housing and an analyte sensor having a proximal portion and a distal portion, the proximal portion coupled to the circuit board and the distal portion extending from a bottom of the electronics housing and configured to measure glucose levels in a bodily fluid.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Patent Application No. 63 / 388,053, filed July 11, 2022, and U.S. Provisional Patent Application No. 63 / 442,743, filed February 1, 2023, which are hereby incorporated by reference in their entireties.

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

[0003] Detecting and / or monitoring analyte levels, such as glucose, ketones, lactate, oxygen, or hemoglobin A1C, can be very important to the health of individuals with diabetes. Patients with diabetes mellitus can experience complications, including loss of consciousness, cardiovascular disease, retinopathy, neuropathy, and nephropathy. Diabetic patients are generally required to monitor their glucose levels to ensure that their glucose levels are maintained within a clinically safe range, and may also use this information to determine if and / or when they need insulin to reduce their glucose levels or when they need additional glucose to increase their glucose levels.

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

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

[0006] While current sensors can be convenient for users, they are also prone to causing discomfort to some users. For example, analyte monitoring systems that are manufactured using adhesives to assemble the various mechanical components of the analyte monitoring system can cause discomfort to users because some adhesives can cause skin irritation to users. Isobornyl acrylate ("IBOA") is an exemplary adhesive that can cause irritation to users.

[0007] Furthermore, the use of adhesives can be disadvantageous from a mechanical standpoint. For example, the time required to cure the adhesive can increase manufacturing time and costs. Adhesives can be light sensitive and can have a relatively short shelf life, thereby affecting their ability to be stored and used safely at a later time. Summary of the Invention [Problem to be solved by the invention]

[0008] Thus, there is a need for reliable sensor insertion devices, systems, and methods, particularly for use with skin sensors, that are easy for patients to use and are not prone to causing user discomfort. Additionally, there is a need for sensor insertion devices, systems, and methods that provide moisture control and extended storage stability. [Means for solving the problem]

[0009] The objects and advantages of the presently disclosed subject matter will be set forth in and obvious from the description which follows, as well as be learned by practice of the presently disclosed subject matter. Additional advantages of the presently disclosed subject matter will be realized and obtained by the methods and systems particularly pointed out in the specification and claims hereof, as well as from the accompanying drawings.

[0010] To achieve these and other advantages and in accordance with the objectives of the presently disclosed subject matter, as embodied and broadly described, the presently disclosed subject matter relates to an analyte monitoring system. The analyte monitoring system includes a sensor control device having an electronics housing. The electronics housing includes an interior space. The interior space is defined between a mount and a shell of the electronics housing when the mount and the shell are positioned opposite each other. The interior space can exist between an inner surface of the mount and an inner surface of the shell, with the inner surface of the mount facing the inner surface of the shell. The sensor control device further includes at least one seal at least partially disposed within the interior space. For example, the seal can be partially or entirely enclosed within the interior space. The interior space can be defined between an outer periphery of the mount and an outer periphery of the shell when they are coupled together. The interior space can optionally be divided into one or more portions. The portion of the interior space enclosing the at least one seal can be defined by one or more channels in an inner interface of the mount and / or the shell. The portion of the interior space enclosing the at least one seal can be fluidly coupled to the portion of the interior space enclosing the circuit board. The sensor control device may further include a circuit board and an analyte sensor. The circuit board may be disposed within the interior space of the electronics housing. The circuit board may be completely enclosed within the interior space of the electronics housing. The analyte sensor may be disposed within the interior space of the electronics housing. The analyte sensor may be partially enclosed within the interior space of the electronics housing. Furthermore, the analyte sensor may include a proximal portion and a distal portion, whereby a portion of the proximal portion extends into the interior of the electronics housing and has one or more sensor contacts electrically coupled to the circuit board, and the distal portion is configured to measure glucose levels in the bodily fluid and extends from the bottom of the electronics housing.The sensor control device may also include at least one seal disposed in the interior space of the electronics housing proximate the first and second openings and configured to provide a seal around at least a portion of the proximal portion of the analyte sensor extending into the interior of the electronics housing and configured to seal one or more sensor contacts within the electronics housing. The distal portion may refer to the tail of the sensor herein. The adhesive patch is an optional feature of the sensor control device and may be attached to the bottom of the mount, such as for purposes of embodiments permanently attached to the bottom of the mount. References to "top" and "bottom" herein refer to the configuration of the system in use. As described herein, the top of the mount is opposite the bottom of the mount and is coupled to the shell.

[0011] In some embodiments, the analyte monitor system may also include a collar disposed in the interior space between the shell and the at least one seal so as to be axially aligned with each of the first and second openings.

[0012] In some embodiments, the electronics housing includes a shell having a first opening and a mount secured to the shell to define an interior space, the mount having a second opening axially aligned with the first opening. The electronics housing can also include at least one seal having a slit axially aligned with the first and second openings. Further, a proximal portion of the analyte sensor can extend through the slit in the at least one seal. In one embodiment, the circuit board can be positioned radially outward from the first and second openings, e.g., laterally spaced from the first and second openings. In this embodiment, the analyte sensor can extend laterally from the circuit board to the first and second openings and then axially through the first and second openings. The proximal portion of the analyte sensor can extend laterally from the circuit board, and the distal portion of the analyte sensor can extend axially through the first and second openings. The proximal portion of the analyte sensor can be disposed in a plane intersecting the plane of the distal portion of the analyte sensor, such as in a vertical configuration.

[0013] In some embodiments, the at least one seal can be compressed between the shell and the mount. In yet another embodiment, the at least one seal can include a first seal and a second seal, such that the first and second seals are matable. Furthermore, in some embodiments, the slit can be defined in at least one of the first seal and the second seal. Alternatively, in some embodiments, the slit can be defined in an interface between the first seal and the second seal. In yet another embodiment, the shell can include a first interface extending into the interior space, the first interface defining a first channel circumferentially positioned about the first opening, and the mount can include a second interface extending into the interior space, the second interface defining a second channel circumferentially positioned about the second opening, the first seal being integrated into the first channel and the second seal being integrated into the second channel. The first interface can be an inner surface of the shell, and the second interface can be an inner surface of the mount, and the first interface can be opposite the second interface. The first and second channels can define a portion of the interior space that encloses at least one seal. In some embodiments, the first and second interfaces can be configured to mate with each other. In yet other embodiments, the first interface can be welded to the second interface. In some embodiments disclosed herein, the first seal can include a first sealing surface, and the second seal can include a second sealing surface, where the first and second sealing surfaces can contact each other and be configured to isolate the interior space from foreign matter. More specifically, the first and second sealing surfaces can be configured to isolate at least a portion of the interior space that encloses the circuit board from foreign matter. According to the subject matter of the present disclosure, therefore, a seal can be formed by compressing the first sealing surface against the second sealing surface.In one embodiment, the first sealing surface can include a first rib, and in another embodiment, the second sealing surface can include either a second rib that contacts the first rib or a channel sized to receive the first rib. Alternatively, in some embodiments, the second sealing surface can include the first rib, and in other embodiments, the first sealing surface can include either a second rib that contacts the first rib or a channel sized to receive the first rib. In some embodiments, at least one seal is elastically deformable. In some embodiments, at least one seal can be made from at least one of elastomer, rubber, polymer, ultraviolet-curable silicone, room-temperature vulcanizing silicone, and ultraviolet-curable urethane. Furthermore, at least one seal can be made from a self-healing material configured to self-bond by heat activation. In some embodiments, the first seal can have a first seal opening, and the second seal can have a second seal opening, and both the first and second seal openings can be axially aligned with the first and second openings, respectively. In yet another embodiment, the at least one seal can be configured to provide a moisture barrier to seal a distal portion of the glucose sensor extending from a bottom of the electronics housing. More specifically, the at least one seal can be configured to provide a moisture barrier to seal the distal portion of the glucose sensor from an interior space of the electronics housing that encloses the circuit board.

[0014] According to the subject matter of the present disclosure, the seal can be compressed between the shell and the mount. In another embodiment, the shell includes a first inner surface, the mount includes a second inner surface, the distance between the first inner surface and the second inner surface defines a first height, and the seal has a second height greater than the first height. The first height can be the height of a portion of the interior space of the electronic device housing that encloses the at least one seal. Furthermore, in one embodiment, the seal has a first surface that can be adjacent to the first channel, a second surface that can be adjacent to the second channel, and at least one rib on each of the first and second surfaces. In yet another embodiment, the first inner surface of the shell can be adjacent to the first surface of the seal, and the second inner surface of the mount can be adjacent to the second surface of the seal, each inner surface including at least one rib contacting the first and second surfaces of the seal. In some embodiments, the seal can be disposed in at least one of the first channel and the second channel.

[0015] In accordance with the presently disclosed subject matter, the seal can have a one-piece construction. In one embodiment, the seal can also include a centering slit for receiving a proximal portion of the analyte sensor. In another embodiment, the seal can include a decentering slit for receiving a proximal portion of the analyte sensor. Furthermore, in one embodiment, the seal can have a two-piece construction. In yet another embodiment, the slit can have an interlocking interface. In some embodiments, the seal can at least partially isolate the electronics housing from movement of the analyte sensor. For example, the seal can surround at least a portion of the analyte sensor so that stress on the sensor is not transmitted to the circuit board. In some embodiments, the seal can reduce stress on the analyte sensor. For example, the seal can be elastically deformable and therefore configured to absorb shock. The seal can also provide a moisture barrier to seal off a distal portion of the glucose sensor extending from the bottom of the electronics housing.

[0016] In some embodiments, the mount can be coupled to the shell using one of ultrasonic welding and laser welding. In yet other embodiments, this can be achieved by welding the mount to the shell along at least one weld joint that aligns with the first and second channels. In some embodiments, this can be achieved without fusing the seal.

[0017] In some embodiments, the system may further include an applicator that delivers the analyte sensor. The applicator may include an applicator housing having a sensor carrier configured to secure the sensor control device within an interior of the applicator, and an applicator cap removably coupled to the applicator housing to seal the interior of the applicator. The applicator cap may also include a collimator having a distal end and a proximal end, the distal end positioned adjacent the mount such that an interface between the distal end and the mount is sealed, and the proximal end having an opening.

[0018] In some embodiments, the collimator can have a cross-sectional shape selected from the group consisting of a cone, a frusto-cone, a pyramid, a circle, a cube, a rectangle, and any combination thereof. In yet another embodiment, the opening of the collimator can include a label that prevents moisture from passing into the collimator while still allowing electron beam radiation to pass through the collimator. The label may be referred to herein as a barrier. The barrier can cover the opening of the collimator. In some embodiments, the label can be made from Tyvek. In some embodiments, the collimator can be axially aligned with at least one of the analyte sensor and the second opening.

[0019] As further disclosed herein, the presently disclosed subject matter can relate to an analyte monitor system including a sensor control device having an electronics housing. The electronics housing includes a shell having a first opening and a mount secured to the shell to define an interior space, the mount having a second opening axially aligned with the first opening. The electronics housing can also include at least one seal having a slit axially aligned with the first and second openings. The sensor control device can further include a circuit board and an analyte sensor, each disposed within the interior space. Furthermore, the analyte sensor can include a proximal portion and a distal portion, whereby at least a portion of the proximal portion extends through the slit in the at least one seal and is coupled to the circuit board, and the distal portion is configured to measure glucose levels in bodily fluids and extends from a bottom of the electronics housing. The sensor control device can also include an adhesive patch attached to the bottom of the mount, configured to secure the electronics housing to a user's skin. The system may also include a sharpened hub that engages the upper exterior surface of the shell and includes the sharpened hub and a second mating member that extends into the first opening and is configured to mate with a first mating member of the electronics housing extending through the first opening to define a first sterility barrier. The system may further include an applicator for delivery of the analyte sensor, the applicator including an applicator housing having a sensor carrier configured to secure the sensor control device within an interior of the applicator. The system may further include an applicator cap that is removably coupled to the applicator housing and seals the interior of the applicator.

[0020] Also disclosed herein are methods of producing an analyte sensor system according to the above-disclosed embodiments. [Brief explanation of the drawings]

[0021] Details of the subject matter enumerated herein, both as to its structure and operation, will be apparent from consideration of the accompanying drawings, in which like reference numerals refer to like parts. The components in these figures are not necessarily to scale, emphasis instead being placed upon illustrating the principles of the inventive subject matter. Moreover, all figures are intended to convey concepts, and relative sizes, shapes, and other detailed attributes may be illustrated generally, rather than precisely or precisely.

[0022] [Figure 1] 1 is a system schematic diagram of a sensor applicator, a reader device, a monitor system, a network, and a remote system. [Figure 2A] FIG. 2 is a block diagram illustrating an exemplary embodiment of a reader device. [Figure 2B] FIG. 1 is a block diagram illustrating an exemplary embodiment of a sensor control device. [Figure 2C] FIG. 1 is a block diagram illustrating an exemplary embodiment of a sensor control device. [Figure 3A] FIG. 10 is a proximal perspective view depicting an exemplary embodiment in which a user prepares a tray for assembly. [Figure 3B] FIG. 10 is a side view depicting an exemplary embodiment in which a user prepares the applicator device for assembly. [Figure 3C] FIG. 10 is a proximal perspective view depicting an exemplary embodiment in which a user inserts an applicator device into a tray during assembly. [Figure 3D] FIG. 10 is a proximal perspective view depicting an exemplary embodiment in which a user removes the applicator device from the tray during assembly. [Figure 3E] FIG. 10 is a proximal perspective view depicting an exemplary embodiment in which a patient applies a sensor using an applicator device. [Figure 3F] FIG. 1 is a proximal perspective view depicting an exemplary embodiment of a patient with an attached sensor and an applicator device in use. [Figure 4A] 1 is a side view depicting an exemplary embodiment of an applicator device coupled to a cap. [Figure 4B]FIG. 10 is a side perspective view depicting an exemplary embodiment of an applicator device and cap separated. [Figure 4C] FIG. 1 is a perspective view depicting an exemplary embodiment of the distal end of the applicator device and electronics housing. [Figure 4D] FIG. 1 is a top perspective view of an exemplary applicator device in accordance with the subject matter of the present disclosure. [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. 1 is a proximal perspective view depicting an exemplary embodiment of a tray with a sterilization lid attached. [Figure 6A] FIG. 10 is a proximal perspective cutaway view depicting an exemplary embodiment of a tray having a sensor delivery component. [Figure 6B] FIG. 10 is a proximal perspective view depicting a sensor delivery component. [Figure 7A] FIG. 1 is a side view depicting an exemplary embodiment of a housing. [Figure 7B] 1 is a perspective view depicting an exemplary embodiment of a distal end of a housing. FIG. [Figure 7C] FIG. 2 is a side cross-sectional view depicting an exemplary embodiment of a housing. [Figure 7D] FIG. 10 is a side cross-sectional view depicting a locking rib portion of an exemplary embodiment of a housing along with a portion of a sheath. [Figure 7E] FIG. 10 is a side cross-sectional view depicting a locking rib portion of an exemplary embodiment of a housing along with a portion of a sheath. [Figure 7F] FIG. 10 is a side cross-sectional view depicting a locking rib portion and a portion of a sheath of another exemplary embodiment of a housing. [Figure 7G] FIG. 10 is a side cross-sectional view depicting a locking rib portion and a portion of a sheath of another exemplary embodiment of a housing. [Figure 7H]FIG. 10 is a side cross-sectional view depicting a locking rib portion and a portion of a sheath of another exemplary embodiment of a housing. [Figure 7I] FIG. 10 is a side cross-sectional view depicting a locking rib portion and a portion of a sheath of another exemplary embodiment of a housing. [Figure 7J] FIG. 1 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. 7D is a side cutaway view of the housing of FIG. 7J. [Figure 7M] FIG. 1 is a bottom perspective view of a cap in accordance with the subject matter of the present disclosure. [Figure 7N] FIG. 7B is a side cutaway view of the cap of FIG. 7M. [Figure 7O] FIG. 7B is a top view of the cap of FIG. 7M. [Figure 7P] FIG. 10 is a cutaway view of a desiccant in a cap in accordance with the subject matter of the present disclosure. [Figure 7Q] FIG. 1 is a bottom perspective view of an exemplary desiccant according to the presently disclosed subject matter. [Figure 7R] FIG. 1 is a top perspective view of an exemplary desiccant according to the presently disclosed subject matter. [Figure 7S] FIG. 1 is an enlarged cross-sectional side view of the interface between the housing and the cap in accordance with the subject matter of the present disclosure. [Figure 7T] FIG. 1 is an enlarged cross-sectional side view of the interface between the housing and the cap in accordance with the subject matter of the present disclosure. [Figure 7U] FIG. 2 is an enlarged cross-sectional side view of a housing according to the subject matter of the present disclosure. [Figure 7V] FIG. 1 is an enlarged cross-sectional side view of a cap in accordance with the subject matter of the present disclosure. [Figure 7W] FIG. 7B is a side cutaway view of the cap of FIG. 7M. [Figure 7X] FIG. 7B is a side cutaway view of the cap of FIG. 7M. [Figure 7Y] FIG. 1 illustrates a top perspective view of an exemplary elastomeric plug according to one or more embodiments. [Figure 7Z]FIG. 1 is a partial cross-sectional perspective view of an exemplary sensor cap and elastomeric plug according to one or more embodiments. [Figure 8A] FIG. 1 is a side view depicting an exemplary embodiment of a sheath. [Figure 8B] FIG. 1 is a perspective view depicting an exemplary embodiment of the proximal end of a sheath. [Figure 8C] FIG. 10 is an enlarged perspective view depicting an exemplary embodiment of the distal side of a detent snap of the sheath. [Figure 8D] 10A-10C are side views depicting exemplary embodiments of features of a sheath. [Figure 8E] FIG. 10 is an end view of an exemplary embodiment of the proximal end of the sheath. [Figure 8F] 10A-10C are perspective views depicting another exemplary embodiment of a sheath in various stages of assembly with other applicator components. [Figure 8G] 10A-10C are perspective views depicting another exemplary embodiment of a sheath in various stages of assembly with other applicator components. [Figure 8H] 10A-10C are perspective views depicting another exemplary embodiment of a sheath in various stages of assembly with other applicator components. [Figure 8I] FIG. 1 is a side view of a sheath in accordance with the subject matter of the present disclosure. [Figure 8J] FIG. 8I is a close-up view of the detent snap 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. 8J is a side cutaway view of the sheath of FIG. 8I. [Figure 8N] 8I is an enlarged view of the locking arm of the sheath of FIG. 8I and its engagement with the cap and sensor carrier in accordance with the subject matter of the present disclosure. [Figure 8O] FIG. 8I is an enlarged view of the ribs of the sheath of FIG. 8I and the engagement of the ribs with the sensor carrier in accordance with the subject matter of the present disclosure. [Figure 9A] FIG. 1 is a proximal perspective view depicting an exemplary embodiment of a sensor carrier. [Figure 9B] FIG. 1 is a distal perspective view depicting an exemplary embodiment of a sensor carrier. [Figure 9C] FIG. 10 is a distal perspective view depicting another exemplary embodiment of a sensor carrier. [Figure 9D] FIG. 1 is a top perspective view of a sensor carrier according to the subject matter of the present disclosure. [Figure 9E] FIG. 9E is a bottom view of the sensor carrier of FIG. 9D. [Figure 10A] FIG. 1 is a perspective view of a sharps carrier in accordance with the subject matter of the present disclosure. [Figure 10B] FIG. 10B is a side cutaway view of the sharp body carrier of FIG. 10A. [Figure 10C] FIG. 1 is a perspective view of a sharps carrier in accordance with the subject matter of the present disclosure. [Figure 10D] FIG. 10D is a side cutaway view of the sharp body carrier of FIG. 10C. [Figure 11A] FIG. 1 is a top perspective view illustrating an exemplary embodiment of a sensor module. [Figure 11B] FIG. 1 is a bottom perspective view illustrating an exemplary embodiment of a sensor module. [Figure 12A] FIG. 1 is a perspective view depicting an exemplary embodiment of a sensor connector. [Figure 12B] FIG. 1 is a condensed view depicting an exemplary embodiment of a sensor connector. [Figure 13] FIG. 1 is a perspective view depicting an exemplary embodiment of a sensor. [Figure 14A] FIG. 1 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. 2 is an enlarged partial view of an exemplary embodiment of a sensor module assembly. [Figure 15B] FIG. 2 is an enlarged partial view of an exemplary embodiment of a sensor module assembly. [Figure 15C] FIG. 1 is a side view of an exemplary sensor according to one or more embodiments of the present disclosure. [Figure 15D] FIG. 1 is a side view of an exemplary sensor according to one or more embodiments of the present disclosure. [Figure 15E] FIG. 1 is a side view of an exemplary sensor according to one or more embodiments of the present disclosure. [Figure 15F] FIG. 1 is a side view of an exemplary sensor according to one or more embodiments of the present disclosure. [Figure 15G] FIG. 1 is a side view of an exemplary sensor according to one or more embodiments of the present disclosure. [Figure 16A] FIG. 1 is an isometric view of an exemplary connector assembly according to one or more embodiments of the present disclosure. [Figure 16B] FIG. 1 is a partially exploded isometric view of an exemplary connector assembly according to one or more embodiments of the present disclosure. [Figure 16C] FIG. 16C is an isometric bottom view of the connector of FIGS. 16A-16B. [Figure 16D] FIG. 10 is an isometric view of another exemplary connector assembly according to one or more embodiments. [Figure 16E] FIG. 10 is a partially exploded isometric view of another exemplary connector assembly according to one or more embodiments. [Figure 16F] FIG. 16C is an isometric bottom view of the connector of FIGS. 16D-16E. [Figure 17A] FIG. 1 is a perspective view depicting an exemplary embodiment of a sharps module. [Figure 17B] FIG. 10 is a perspective view of another exemplary embodiment of a sharps module. [Figure 17C] FIG. 17C is a schematic diagram depicting the sharp body module of FIG. 17B. [Figure 17D] FIG. 17C is a schematic diagram depicting the sharp body module of FIG. 17B. [Figure 17E] FIG. 17C is a schematic side view of the sharp body module of FIG. 17B assembled with a sensor module. [Figure 17F] FIG. 17C is a top view of the sharp body module of FIG. 17B assembled with a sensor module. [Figure 17G] FIG. 10 is a perspective view of another exemplary embodiment of a sharps module. [Figure 17H] FIG. 17F is a schematic side view depicting the sharpened body module of FIG. 17G. [Figure 17I] FIG. 17F is a side cross-sectional view of the sharp body module of FIG. 17G assembled with a sensor module. [Figure 17J] FIG. 17F is a side view of the sharp body module of FIG. 17G 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 another exemplary sensor control device. [Figure 19A] FIG. 18C is an exploded isometric top view of the sensor control device of FIGS. 18A-18B. [Figure 19B] FIG. 18C is an exploded isometric bottom view of the sensor control device of FIGS. 18A-18B. [Figure 19C] 1 is a top perspective view of a cell battery in accordance with the subject matter of the present disclosure; FIG. [Figure 20] FIG. 1 is a cross-sectional side view of an assembled seal subassembly according to one or more embodiments. [Figure 21A] 18A-18B. FIG. 18B is a cross-sectional side view illustrating the assembly of a sensor applicator with the sensor control device of FIGS. [Figure 21B] 18A-18B. FIG. 18B is a cross-sectional side view illustrating the assembly of a sensor applicator with the sensor control device of FIGS. [Figure 21C] 18A-18B. FIG. 18B is a cross-sectional side view illustrating the assembly of a sensor applicator with the sensor control device of FIGS. [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 cross-sectional side view of the sensor control device of FIGS. 18A-18B. [Figure 24A] FIG. 10 is a cross-sectional side view of a sensor applicator waiting to deploy a sensor control device at a target monitoring location. [Figure 24B]FIG. 10 is a cross-sectional side view of a sensor applicator waiting to deploy a sensor control device at a target monitoring location. [Figure 25A] 18A-18B. FIG. 18B is a cross-sectional side view illustrating the assembly and disassembly of an exemplary embodiment of a sensor applicator and sensor control device of FIGS. [Figure 25B] 18A-18B. FIG. 18B is a cross-sectional side view illustrating the assembly and disassembly of an exemplary embodiment of a sensor applicator and sensor control device of FIGS. [Figure 25C] 18A-18B. FIG. 18B is a cross-sectional side view illustrating the assembly and disassembly of an exemplary embodiment of a sensor applicator and sensor control device of FIGS. [Figure 26A] FIG. 10 is an isometric bottom view of a housing according to one or more embodiments. [Figure 27A] FIG. 1 is an isometric bottom view of a housing with a sheath and other components at least partially positioned therein. [Figure 28] FIG. 2 is an enlarged cross-sectional side view of a sensor applicator having 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] FIG. 10 is an enlarged cross-sectional view of the engagement between the cap and the housing according to one or more embodiments. [Figure 30A] FIG. 1 is an isometric view of a sensor cap according to one or more embodiments. [Figure 30B] FIG. 1 is an isometric view of a collar according to one or more embodiments. [Figure 31A] FIG. 1 is a side view of an exemplary sensor control device in accordance with one or more embodiments of the present disclosure. [Figure 31B] FIG. 1 is an isometric view of an exemplary sensor control device in accordance with one or more embodiments of the present disclosure. [Figure 32A] FIG. 3 is an exploded isometric top view of the sensor control device of FIG. 2 according to one or more embodiments. [Figure 32B]FIG. 3 is an exploded isometric bottom view of the sensor control device of FIG. 2 according to one or more embodiments. [Figure 32C] FIG. 32C is a top perspective view of the collar of FIGS. 32A-32B according to one or more embodiments. [Figure 32D] FIG. 3 is an isometric top view of the sensor control device of FIG. 2 according to one or more embodiments. [Figure 32E] FIG. 3 is an isometric top view of the sensor control device of FIG. 2 according to one or more embodiments. [Figure 33] 31A-31B and 32A-32B according to one or more embodiments. FIG. [Figure 33A] FIG. 32C is an exploded isometric view of a portion of another embodiment of the sensor control device of FIGS. 31A-31B and 32A-32B. [Figure 33B] FIG. 33B is a cross-sectional view of the sharp body hub and mount of FIG. 33A according to one or more embodiments. [Figure 34A] FIG. 32C is an isometric bottom view of the mount of FIGS. 31A-31B and 32A-32B. [Figure 34B] FIG. 32C is an isometric top view of the sensor cap of FIGS. 31A-31B and 32A-32B. [Figure 35A] FIG. 1 is a side view of an exemplary sensor applicator according to one or more embodiments. [Figure 35B] FIG. 1 is a cross-sectional side 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] FIG. 1 is a cross-sectional side view of a sensor control device positioned within an applicator cap according to one or more embodiments. [Figure 38A] 1 is a cross-sectional view of a sensor control device illustrating an exemplary interaction between a sensor and a sharp object. [Figure 38B]FIG. 10 is a side cross-sectional view of a sharp hub, sharp, and sensor with the sensor in an unactuated position in accordance with the subject matter of the present disclosure. [Figure 38C] FIG. 10 is a side cross-sectional view of a sharp hub, sharp, and sensor with the sensor in a biased position in accordance with the subject matter of the present disclosure. [Figure 38D] FIG. 1 is an enlarged view of a portion of a sharp in accordance with the subject matter of the present disclosure. [Figure 39A] 1A-1C are cross-sectional views depicting an exemplary embodiment of an applicator during stages of deployment. [Figure 39B] 1A-1C are cross-sectional views depicting an exemplary embodiment of an applicator during stages of deployment. [Figure 39C] 1A-1C are cross-sectional views depicting an exemplary embodiment of an applicator during stages of deployment. [Figure 39D] 1A-1C are cross-sectional views depicting an exemplary embodiment of an applicator during stages of deployment. [Figure 39E] 1A-1C are cross-sectional views depicting an exemplary embodiment of an applicator during stages of deployment. [Figure 39F] 1A-1C are cross-sectional views depicting an exemplary embodiment of an applicator during stages of deployment. [Figure 40A] FIG. 1 is a block diagram of a body-worn subassembly. [Figure 40B] FIG. 1 is a block diagram of a body-worn subassembly. [Figure 40C] FIG. 1 is a block diagram of a body-worn subassembly. [Figure 40D] FIG. 1 is a block diagram of a body-worn subassembly. [Figure 40E] FIG. 1 is a perspective view of a full body worn electronics subassembly. [Figure 41A] FIG. 40F illustrates a process for co-molding or overmolding the assembly of FIG. 40E. [Figure 41B] FIG. 40F illustrates a process for co-molding or overmolding the assembly of FIG. 40E. [Figure 41C] FIG. 40F illustrates a process for co-molding or overmolding the assembly of FIG. 40E. [Figure 41D]FIG. 40F illustrates a process for co-molding or overmolding the assembly of FIG. 40E. [Figure 42A] FIG. 40F is an assembly view of an alternative inter-snap fastening technique for the assembly of FIG. 40E. [Figure 42B] FIG. 40F is a cross-sectional view of an alternative inter-snap fastening technique for the assembly of FIG. 40E. [Figure 42C] FIG. 40F is a cross-sectional view of an alternative inter-snap fastening technique for the assembly of FIG. 40E. [Figure 43A] FIG. 40F is a cross-sectional view of an alternative ultrasonic welding technique with the assembly of FIG. 40E. [Figure 43B] 1 is a flow diagram of a method for constructing an analyte monitor system using ultrasonic welding. [Figure 43C] 10A-10C illustrate joint types that can be used to join the shell and mount at the joining interface. [Figure 44A] FIG. 44D is an assembly diagram showing the addition of an adhesive backing to produce the final body worn device ready for use as shown in FIG. 44C. [Figure 44B] FIG. 44D is an assembly diagram showing the addition of an adhesive backing to produce the final body worn device ready for use as shown in FIG. 44C. [Figure 45A] FIG. 10 is a cross-sectional view of a body worn assembly having an elastomeric seal in a compressed state between the shell and the mount of the body worn assembly. [Figure 45B] FIG. 10 is a cross-sectional view of a body worn assembly having an elastomeric seal in a compressed state between the shell and the mount of the body worn assembly. [Figure 45C] FIG. 10 is a cross-sectional view of a body worn assembly having an elastomeric seal in a compressed state between the shell and the mount of the body worn assembly. [Figure 45D] FIG. 10 is a cross-sectional view of a body worn assembly having an elastomeric seal in a compressed state between the shell and the mount of the body worn assembly. [Figure 45E] FIG. 1 is a cross-sectional view of a body worn assembly having an elastomeric seal in a compressed state within a conduit created by the shell and mount of the body worn assembly. [Figure 45F] FIG. 1 is a cross-sectional view of a body worn assembly having an elastomeric seal in a compressed state within a conduit created by the shell and mount of the body worn assembly. [Figure 45G] 1 is an assembly and cross-sectional view of a body worn assembly having a dispense-in-place elastomeric seal in a compressed state around the sensor and between the shell and mount of the body worn assembly. FIG. [Figure 45H] 1 is an assembly and cross-sectional view of a body worn assembly having a dispense-in-place elastomeric seal in a compressed state around the sensor and between the shell and mount of the body worn assembly. FIG. [Figure 45I] 1 is an assembly and cross-sectional view of a body worn assembly having a dispense-in-place elastomeric seal in a compressed state around the sensor and between the shell and mount of the body worn assembly. FIG. [Figure 46A] FIG. 1 is a cross-sectional and exploded view of a body worn assembly having an elastomeric seal in a compressed state within an interior space created by the shell and mount of the body worn assembly. [Figure 46B] 46A and 46C-46D depict different configurations of an elastomeric seal for the body worn assembly depicted in FIGS. 46A and 46C-D. [Figure 46C] FIG. 1 is a cross-sectional and exploded view of a body worn assembly having an elastomeric seal in a compressed state within an interior space created by the shell and mount of the body worn assembly. [Figure 46D] FIG. 1 is a cross-sectional and exploded view of a body worn assembly having an elastomeric seal in a compressed state within an interior space created by the shell and mount of the body worn assembly. [Figure 47] 1 is an exemplary perspective view of an elastomeric seal according to the subject matter of the present disclosure. [Figure 48A] FIG. 10 is a cross-sectional view of an exemplary sensor cap assembly including a cap with a collimator configured to seal a body-mounted unit during sterilization. [Figure 48B] FIG. 10 is a cross-sectional view of an exemplary sensor cap assembly including a cap with a collimator configured to seal a body-mounted unit during sterilization. [Figure 48C] FIG. 10 is a cross-sectional view of an exemplary sensor cap assembly including a cap with a collimator configured to seal a body-mounted unit during sterilization. [Figure 48D] FIG. 10 is a cross-sectional view of an exemplary sensor cap assembly including a cap with a collimator configured to seal a body-mounted unit during sterilization. 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 can, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, since the scope of the present disclosure is not limited except as by the claims.

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

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

[0026] Generally, embodiments of the present disclosure include systems, devices, and methods for use of an analyte sensor insertion applicator for use with an in-vivo analyte monitor system. The applicator can be provided to a user in a sterile package that encloses the electronics housing of a sensor control device. According to some embodiments, a structure separate from the applicator, such as a container, can also be provided to a user in a sterile package that encloses a sensor module and a sharps module. The user can couple the sensor module to the electronics housing and further couple the sharps to the applicator through 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 sharps module can be provided in a single package. The applicator can be used to position the sensor control device on the human body with the sensor in contact with the wearer's bodily fluids. The embodiments provided herein are improvements that reduce the likelihood of the sensor being improperly inserted, damaged, or eliciting an adverse physiological response. Other improvements and advantages are also provided. Different configurations of these devices are described in detail using exemplary embodiments only.

[0027] Additionally, many embodiments include in vivo analyte sensors that are structurally configured such that at least a portion of the sensor is or can be positioned on the body of a user to obtain information regarding at least one analyte in the body. However, it should be noted that the embodiments disclosed herein can be used with in vivo analyte monitoring systems that incorporate in vitro functionality, as well as purely in vitro or ex vivo analyte monitoring systems, including completely non-invasive systems.

[0028] Furthermore, for each and every embodiment of the methods disclosed herein, systems and devices capable of performing each of these embodiments are encompassed by the present disclosure. For example, sensor control device embodiments are disclosed, which can include one or more sensors, analyte monitor circuitry (e.g., analog circuitry), memory (e.g., for storing instructions), power sources, communication circuitry, transmitters, receivers, processors, and / or controllers (e.g., for executing instructions) that can perform or facilitate the performance of any and all method steps. These sensor control device embodiments can be used to, and can be functional to, perform steps performed by the sensor control device from any and all methods described herein.

[0029] As mentioned above, several embodiments of systems, devices, and methods are described herein to enable improved assembly and use of skin sensor insertion devices for use with in-vivo analyte monitoring systems. In particular, several embodiments of the present disclosure are designed to improve sensor insertion methods associated with in-vivo analyte monitoring systems, particularly to prevent premature retraction of the insertion sharp during the sensor insertion process. For example, some embodiments include a skin sensor insertion mechanism with an increased firing rate and delayed sharp retraction. In other embodiments, the sharp retraction mechanism can be motion-activated such that the sharp does not retract until the user pulls the applicator away from the skin. As a result, these embodiments can reduce the likelihood of premature removal of the insertion sharp during the sensor insertion process, reduce the likelihood of incorrect sensor insertion, and reduce the likelihood of damaging the sensor during the sensor insertion process, to name a few advantages. Some embodiments of the present disclosure also enable improved insertion sharp modules that account for the small scale of skin sensors and the relatively shallow insertion path present in a subject's dermal layer. Furthermore, some embodiments of the present disclosure are designed to prevent undesired axial and / or rotational movement of applicator components during sensor insertion. These embodiments may therefore reduce the likelihood of capillary disruption resulting in instability of the positioned skin sensor, irritation at the insertion site, damage to surrounding tissue, and contamination of skin fluids with blood, to name a few advantages. Additionally, to mitigate inaccurate sensor readings that may be caused by trauma at the insertion site, some embodiments of the present disclosure may shorten the distal depth penetration of the needle relative to the sensor tip during insertion.

[0030] However, before describing the above aspects of the embodiments in detail, it is desirable to first describe examples of devices and their operation that may be present, for example, in an in vivo analyte monitor system, all of which may be used in conjunction with the embodiments described herein.

[0031] Various types of in-vivo analyte monitor systems exist. A "continuous analyte monitor" system (or "continuous glucose monitor" system), for example, can transmit data continuously, e.g., automatically according to a schedule, from the sensor control device to the reader device without requiring an acknowledgement. As another example, an "instant analyte monitor" system (or "instant glucose monitor" system or simply "instant" system) can communicate data from the sensor control device using near-field communication (NFC) protocols or radio frequency identification (RFID) protocols, etc., upon scanning by the reader device or upon data need. An in-vivo analyte monitor system can operate without the need for fingerstick calibration.

[0032] In vivo analyte monitor systems can be distinguished from "ex vivo" systems, which contact a biological sample outside the body (or "ex vivo") and typically include a measurement device having a port for accepting an analyte test strip that can carry a user's bodily fluid and be analyzed to determine the user's blood glucose level.

[0033] An in-vivo monitoring system may include a sensor that contacts a user's bodily fluid while positioned in vivo and senses the analyte level trapped therein. The sensor may be part of a sensor control device that resides on the user's body, the sensor control device including the electronics and power source that enable and control the analyte sensing. Sensor control devices and variations thereof may be referred to as "sensor control units," "on-body electronics" devices or units, "on-body" devices or units, or "sensor data communication" devices or units, to name a few.

[0034] An in-vivo monitoring system may include a device that receives sensed analyte data from the sensor control device and processes and / or displays it to a user in any number of forms. This device and variations thereof may be referred to as a "handheld reader device," "reader device," (or simply "reader"), "handheld electronic device" (or simply "handheld"), "portable data processing" device or unit, "data receiver," "receiver" device or unit (or simply "receiver"), or "remote" device or unit, to name a few. Other devices, such as personal computers, may also be used in conjunction with or incorporated into in-vivo or in-vitro monitoring systems.

[0035] Exemplary In-Vivo Analyte Monitor 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 device 102, and a reader device 120. Here, the sensor applicator 150 can be used to deliver the sensor control device 102 to a monitoring location on a user's skin, where the sensor 104 is held stationary for a period of time by an adhesive patch 105. The sensor control device 102, described in more detail in FIGS. 2B and 2C, can communicate with the reader device 120 over a communication path 140 using wired or wireless technology. Exemplary wireless protocols include Bluetooth, Bluetooth Low Energy (such as BLE, BTLE, or Bluetooth Smart), Near Field Communication (NFC), and others. A user can monitor applications installed in memory on the reader device 120 using a screen 122 and input 121, and the device's battery can be recharged using a power port 123. Further details regarding the reader device 120 are provided below in connection with FIG. 2A . The reader device 120 can communicate with a local computer system 170 over a communication path 141 using wired or wireless technology. The local computer system 170 can include one or more of a laptop, desktop, tablet, phablet, smart phone, set-top box, video game console, or other computing device, and the wireless communication can include any of several applicable wireless network connection protocols, including Bluetooth, Bluetooth Low Energy (BTLE), Wi-Fi, or others. The local computer system 170 can communicate with the network 190 over a communication path 143 using wired or wireless technology as described above in a manner similar to the manner in which the reader device 120 can communicate with the network 190 over communication path 142. The network 190 can be any of several networks, such as private and public networks, local area networks, wide area networks, etc.The trusted computer system 180 may include a server, may provide authentication services and secure data storage, and may communicate with the network 190 through a communications path 144 using wired or wireless technology.

[0036] Exemplary Reader Device 2A is a block diagram illustrating an exemplary embodiment of a reader device configured as a smart phone. Here, reader device 120 can include a display 122, input components 121, a processing core 206 including a communication processor 222 coupled to memory 223, and an application processor 224 coupled to memory 225. Also included can be a separate memory 230, an RF transceiver 228 having an antenna 229, and a power supply 226 having a power management module 238. Additionally, a multi-function transceiver 232 capable of communicating via Wi-Fi, NFC, Bluetooth, BTLE, and GPS using antenna 234 can be included. As will be appreciated by those skilled in the art, these components are electrically and communicatively coupled in a manner to create a functional device.

[0037] Exemplary Sensor Control Device 2B and 2C are block diagrams illustrating an exemplary embodiment of a sensor control device 102 having an analyte sensor 104 and sensor electronics 160, which may contain most of the processing functionality for rendering final result data suitable for display to a user. FIG. 2B shows a single semiconductor chip 161, which may be a custom application-specific integrated circuit (ASIC). Within the ASIC 161, certain high-level functional units are shown, including an analog front-end (AFE) 162, a power management (or control) circuit 164, a processor 166, and a communications circuit 168 (which may be embodied as a transmitter, receiver, transceiver, passive circuitry, or other communications protocol). In this embodiment, both the AFE 162 and the processor 166 are used as analyte monitoring circuitry, although in other embodiments, either circuitry may perform the analyte monitoring function. The processor 166 may include one or more processors, microprocessors, controllers, and / or microcontrollers, each of which may be separate chips or distributed among (and be part of) several different chips.

[0038] Also included within ASIC 161 is memory 163, which may be shared by various functional units present within ASIC 161 or distributed among two or more of these functional units. Memory 163 may be a separate chip. Memory 163 may be volatile and / or non-volatile memory. In this embodiment, ASIC 161 is coupled to power source 170, which may be a coin cell battery or the like. AFE 162 interconnects with and receives measurement data from in-vivo analyte sensor 104 and outputs these data in digital form to processor 166, which further processes these data to provide final resultant glucose individual values and glucose trend values, etc. These data may then be provided to communication circuitry 168 for transmission via antenna 171 to, for example, reader device 120 (not shown), where little further processing is required by a resident software application to display the data.

[0039] FIG. 2C is similar to FIG. 2B but includes two separate semiconductor chips 162 and 174, which can be packaged together or separately. Here, AFE 162 resides on ASIC 161. Processor 166 is integrated with power management circuitry 164 and communication circuitry 168 on chip 174. AFE 162 includes memory 163, and chip 174 includes memory 165, which can be isolated or distributed within it. In one exemplary embodiment, AFE 162 is combined with power management circuitry 164 and processor 166 on one chip, while communication circuitry 168 is on a separate chip. In another exemplary embodiment, both AFE 162 and communication circuitry 168 are on one chip, while processor 166 and power management circuitry 164 are on another chip. It should be noted that other chip combinations are possible, including three or more chips, each performing separate functions as described, or sharing one or more functions to achieve fail-safe redundancy.

[0040] Exemplary Assembly Process for Sensor Control Device The 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 appropriate user location. Figures 3A-3D depict an exemplary embodiment of a user assembly process for the sensor control device 102, including preparation of the individual components before bonding them together to prepare the sensor for delivery. Figures 3E-3F depict an exemplary embodiment of delivery of the device 102 to the appropriate user location by selecting the appropriate delivery location and attaching the sensor control device 102 to that location.

[0041] 3A is a proximal perspective view depicting an exemplary embodiment in which a user provides a container 810, in this case configured as a tray for the assembly process (although other packaging can be used). The user can accomplish this preparation by removing the lid 812 from the tray 810 to expose the platform 808, for example, by peeling the non-adhesive portion of the lid 812 from the tray 810 so that the adhesive portion of the lid 812 is removed. Removal of the lid 812 can be suitable in various embodiments as long as the platform 808 is sufficiently exposed within the tray 810. The lid 812 can then be set aside.

[0042] 3B is a side view depicting an exemplary embodiment in which a user provides applicator device 150 for assembly. Applicator device 150 can be supplied in a sterile package sealed by cap 708. Preparing applicator device 150 can include separating housing 702 from cap 708 to expose sheath 704 (FIG. 3C). This separation can be accomplished by unscrewing (or otherwise detaching) cap 708 from housing 702. Cap 708 can 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 housing-orienting feature 1302 (or slot or recess) and tray-orienting feature 924 (abutment or detent) are aligned. Inserting sheath 704 into platform 808 temporarily unlocks sheath 704 from housing 702, and also temporarily unlocks platform 808 from tray 810. At this stage, removal of applicator device 150 from tray 810 will result in the same condition as before the initial insertion of applicator device 150 into tray 810 (i.e., the process can be reversed or interrupted at this point and then repeated without effect).

[0044] During distal advancement of housing 702, sheath 704 maintains its position relative to housing 702 within platform 808 and can mate with platform 808 to advance platform 808 distally relative to tray 810. This step unlocks and collapses platform 808 within tray 810. Sheath 704 contacts and severs a locking feature (not shown) within tray 810, thereby unlocking sheath 704 from housing 702 and preventing it from moving (relatively) while housing 702 distally advances platform 808. At the end of advancement of housing 702 and platform 808, sheath 704 is permanently unlocked from housing 702. At the end of distal advancement of housing 702, a sharp and sensor (not shown) within tray 810 can mate with an electronics housing (not shown) within housing 702. The operation and interaction of applicator device 150 and tray 810 is described in more detail 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. The user can advance housing 702 proximally relative to tray 810 or remove applicator 150 from tray 810 by some other movement that has the same end effect as decoupling applicator 150 and tray 810. Applicator device 150 is removed with sensor control device 102 (sharp, sensor, electronics) fully assembled therein and positioned for delivery.

[0046] 3E is a proximal perspective view depicting an exemplary embodiment in which a patient uses applicator device 150 to apply sensor control device 102 to a target area of skin, for example, on the abdomen or other suitable location. The sensor is applied to the target location by advancing housing 702, causing sheath 704 to collapse distally therein and an adhesive layer on the bottom surface of sensor control device 102 to adhere to the skin. The sharp tip automatically retracts when housing 702 is fully advanced, while the sensor (not shown) is left in place to measure the analyte level.

[0047] 3F is a proximal perspective view depicting an exemplary embodiment of a patient with the sensor control device 102 in the application position. The user can then remove the applicator 150 from the application site.

[0048] 3A-3F and further described elsewhere herein, system 100 can reduce or eliminate the possibility of accidental damage, permanent deformation, or incorrect 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 engaging through sheath 704, the relative tilt between sheath 704 and housing 702 does not result in damage or permanent deformation of arms or other components. The potential for relatively high forces during assembly (as with conventional devices) is reduced, thereby reducing the likelihood of user assembly failure.

[0049] Exemplary Sensor Applicator Device Figure 4A is a side view depicting an exemplary embodiment of applicator device 150 coupled to screw cap 708. This view is an example of how applicator 150 may be shipped and received by a user prior to assembly with a sensor by the user. Figure 4B is a side perspective view depicting applicator 150 and cap 708 after they have been separated. Figure 4C is a perspective view depicting an exemplary embodiment of the distal end of applicator device 150 with electronics housing 706 and adhesive patch 105 removed from the positions they would have maintained within sensor carrier 710 of sheath 704 when cap 708 was in place.

[0050] 4D-4G, by way of example and not limitation, the applicator device 20150 can be provided to a user as a single, integral assembly. FIGS. 4D and 4E provide perspective top and bottom views, respectively, of the applicator device 20150, while FIG. 4F provides an exploded view of the applicator device 20150 and FIG. 4G provides a side cutaway view. These perspective views illustrate how the applicator 20150 is shipped and received by a user. The exploded and cutaway views illustrate the components of the applicator device 20150. The applicator device 20150 can include a housing 20702, a gasket 20701, a sheath 20704, a sharpened body carrier 201102, a spring 205612, a sensor carrier 20710 (also referred to as the "puck carrier"), a sharpened body hub 205014, a sensor control device (also referred to as the "puck") 20102, an adhesive patch 20105, a desiccant 20502, a cap 20708, a serial label 20709, and a tamper-evident feature 20712. When a user receives the shipment, only the housing 20702, the cap 20708, the tamper-evident feature 20712, and the label 20709 are visible. The tamper-evident feature 20712 may be, for example, a sticker coupled to each of the housing 20702 and the cap 20708, and may be, for example, irreparably damaged by separating the housing 20702 and the cap 20708, thereby indicating to a user that the housing 20702 and the cap 20708 have previously been separated. These features are described in more detail below.

[0051] Exemplary Tray and Sensor Module Assembly FIG. 5 shows an exemplary embodiment of a tray 810 having a removably coupled sterilization lid 812, and is a proximal perspective view that may represent how the package is shipped to a user and received by the user prior to assembly.

[0052] 6A is a proximal perspective cutaway view depicting the sensor delivery components within a tray 810. A platform 808 is slidably coupled within the tray 810. A desiccant 502 is fixed relative to the tray 810. A sensor module 504 is mounted within the tray 810.

[0053] 6B is a proximal perspective view depicting sensor module 504 in greater detail. Here, retention arm extension 1834 of platform 808 releasably secures sensor module 504 in place. Module 2200 is coupled with connector 2300, sharp body module 2500, and sensor (not shown), allowing them to be removed as sensor module 504 during assembly.

[0054] Exemplary Applicator Housing and Cap 7A is a side view depicting an exemplary embodiment of an applicator housing 702 that can include an internal cavity with support structure for applicator functionality. A user can push the housing 702 distally to initiate the applicator assembly process, which can then also result in delivery of the sensor control device 102, after which the cavity in the housing 702 can act as a receptacle for a sharp object. In this exemplary embodiment, various features are shown, including a housing orientation feature 1302 for orienting the device during assembly and use. The tear ring groove 1304 can be a recess positioned around the circumference of the housing 702 distal to the tear ring protector 1314 and proximal to the tear ring retainer 1306. The tear ring groove 1304 can retain a tear ring, thus allowing a user to identify whether the device has been tampered with or otherwise used. The housing threads 1310 can be secured to the complementary cap threads on the cap 708 by aligning the housing 702 with these complementary threads ( FIGS. 4A and 4B ) and rotating the housing 702 in a clockwise or counterclockwise direction. Side gripping zones 1316 on the housing 702 can provide an exterior location where a user can grip the housing 702 to use it. The gripping overhangs 1318 are slightly raised ridges relative to the side gripping zones 1316 that can contribute to easier removal of the housing 702 from the cap 708. The shark teeth 1320 have flat sides positioned on the clockwise edge and can be raised zones that shear a tear ring (not shown) and hold the tear ring in place after the user unscrews the cap 708 and housing 702. In this exemplary embodiment, four shark teeth 1320 are used, although more or fewer shark teeth 1320 may be used as desired.

[0055] FIG. 7B is a perspective view depicting the distal end of the housing 702. Here, three housing guide structures (or “guide ribs”) 1321 are positioned at a 120-degree angle relative to each other and a 60-degree angle relative to the locking structures (or “locking ribs”) 1340, three of which are also positioned at 120-degree angles relative to each other. Other angular orientations, whether symmetrical or asymmetrical, can be used, with any number of structures 1321 and 1340, one or more. Here, each structure 1321 and 1340 is configured as a planar rib, although other shapes can be used. Each guide rib 1321 includes a guide edge (also referred to as a “sheath guide rail”) 1326 that can track the surface of the sheath 704 (e.g., guide rail 1418 described with respect to FIG. 8A). The hard-to-insert stop 1322 may be a flat, distally facing surface of the housing guide rib 1321 positioned near the proximal end of the housing guide rib 1321. The hard-to-insert stop 1322 provides a surface for the sensor carrier movement limiting surface 1420 of the sheath 704 (FIG. 8B) to abut against during use, preventing further movement in the proximal direction. 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 a rounded, distally facing surface of the housing guide rib 1321 that interfaces with the sensor carrier 710.

[0056] FIG. 7C is a side cross-sectional view depicting an exemplary embodiment of a housing. In this exemplary embodiment, the side cross-sectional profiles of the housing guide rib 1321 and the locking rib 1340 are shown. The locking rib 1340 includes sheath snap lead-in features 1330 near its distal end that flare outward distally from the central axis 1346 of the housing 702. Each sheath snap lead-in feature 1330 bends the detent snap rounded portion 1404 of the sheath 704, shown in FIG. 8C , inward toward the central axis 1346 as the sheath 704 moves toward the proximal end of the housing 702. Once the sheath 704 detent snap 1402 passes the distal point of the sheath snap lead-in feature 1330, it is locked into place within the locking groove 1332. Thus, detent snap 1402 cannot be easily moved distally due to the plane that is generally perpendicular to central axis 1346, shown as detent snap flat 1406 in FIG. 8C.

[0057] As the housing 702 moves further distally toward the skin surface and the sheath 704 advances toward the proximal end of the housing 702, the detent snap 1402 slips into the unlocking groove 1334, and the applicator 150 is ready for use in the "armed" position. If the user applies further force to the proximal end of the housing 702 while the sheath 704 is pressed against the skin, the detent snap 1402 passes over the firing detent 1344. This passage results in a firing sequence due to the release of energy stored in the deflected detent snap 1402 (e.g., as described with respect to FIGS. 12A-12D ), and the detent snap 1402 advances proximally toward 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 by detent snap 1402 after unlock groove 1334 is final lockout groove 1336, which detent snap 1402 enters at the end of a stroke or depression sequence performed by the user. Final lockout recess 1336 is perpendicular to central axis 1346 and may be a proximally facing surface that engages detent snap flat 1406 after detent snap 1402 has threaded, firmly holding sheath 704 in place relative to housing 702, thereby preventing reuse of the device. Insertion difficulty stop 1322 on housing guide rib 1321 prevents sheath 704 from advancing proximally relative to housing 702 by engaging sensor carrier travel limiting surface 1420.

[0058] 7D and 7E are enlarged side views of an exemplary embodiment of the locking rib 1340 of the applicator housing 702 as the detent snap 1402 of the sheath 704 moves toward the proximal end of the housing 702. FIG. 7D illustrates the sheath 704 in a “locked” state in which the detent rounded portion 1404 of the detent snap 1402 has already passed over the sheath snap lead-in feature 1330 and is therefore positioned in the locking groove 1332 of the locking rib 1340. When a force is applied to the proximal end of the housing 702, the detent rounded portion 1404 is advanced proximally into the unlocking groove 1334, placing the applicator 150 in an “armed” position. When further force is applied to the proximal end of the housing 702, the detent rounded portion 1404 is advanced proximally from the unlocking groove 1334 and passes over the firing detent 1344, the applicator 150 is “fired.” Thereafter, the sheath 704 is further advanced proximally such that the detent rounded portion 1404 slidably advances over the firing face 1337, as shown in FIG. 7E. In this embodiment, the firing face 1337 is substantially parallel to the central axis 1346. As the sheath 704 continues to advance proximally, the detent rounded portion 1404 reaches a sheath stop ramp 1338, which slows the movement of the sheath 704. When the detent rounded portion 1404 reaches the final lockout recess 1336, the detent snap flats 1406 (not shown) engage and securely hold the sheath 704 in place relative to the housing 702.

[0059] 7F and 7G are enlarged side views of an alternative embodiment of a locking rib 2340 designed to increase the firing rate of the sharpened tip from the sensor applicator. Here, the locking rib 2340 includes an inward detent ramp 2335 that reduces friction between the sheath 704 and the housing 2702 during firing. The locking rib 2340 further includes a sheath stop ramp 2338 at the proximal end of the firing face 2337. In FIG. 7F, the sheath 704 is initially shown in a "locked" state, with the detent rounded portion 1404 of the detent snap 1402 already passing over the sheath snap lead-in feature 2330 and positioned in the locking groove 2332. When a force is applied to the proximal end of the housing 2702, the detent rounded portion 1404 advances into the unlocking groove 2334, placing the applicator 150 in the "armed" position. As further force is applied to the proximal end of the housing 2702, the detent rounded portion 1404 passes over the firing detent 2344 and the applicator 150 "fires."

[0060] As shown in FIG. 7G , detent rounded portion 1404 then advances toward the proximal end of housing 2702 in a “free flight” state passing over inward detent ramp 2335. During proximal advancement in the “free flight” state, detent rounded portion 1404 may be discontinuous with or not contact inward detent ramp 2335 and firing face 2337. In this regard, little to no friction exists between detent rounded portion 1404 and inward detent ramp 2335 and firing face 2337, allowing detent rounded portion 1404 to be easily and quickly advanced, thereby improving the ejection rate of the sharp point from the applicator. Furthermore, as compared to the embodiment shown in FIGS. 7D and 7E , sheath stop ramp 2338, positioned proximally along locking rib 2340, provides a lip for frictionally engaging detent rounded portion 1404 to slow the movement of sheath 704. The sheath stop ramp 2338 has a sloped shape and can allow for strong frictional contact as the detent rounded portion 1404 advances proximally. Finally, when the detent rounded portion 1404 reaches the final lockout recess 2336, the detent snap flats 1406 (not shown) engage and firmly hold the sheath 704 to the housing 2702. The lockout recess 2336 prevents reverse or distal movement of the detent rounded portion 1404 and sheath 704. This embodiment reflects a higher firing rate compared to the embodiment shown in FIGS. 7D and 7E and also helps prevent premature withdrawal of the sharp.

[0061] 7H is an enlarged side view of an alternative embodiment 6340 of a locking rib 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 shown in a “locked” state, with the detent rounded portion 6404 of the detent snap 6402 positioned in the locking groove 6332. When force is applied to the proximal end of the housing 6702, the detent rounded portion 6404 is advanced proximally 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,” and the detent rounded portion 6404 advances over the angled firing surface 6338 toward the proximal end of the housing 6702. The angled firing surface 6338 can be angled toward the central axis 1346 to increase the downward force on the sheath 6704 obtained when the detent rounded portion 6404 is advanced proximally. In the illustrated embodiment, the detent rounded portion 6404 is in continuous contact with the angled firing surface 6338. The lockout recess 6336 prevents reverse or distal movement of the detent rounded portion 6404 and sheath 6704. This embodiment reflects a lower firing rate compared to the previously described embodiments and can be used, for example, with the motion-activated tip retraction process described with respect to FIGS. 14A-14C and 15A-15B.

[0062] FIG. 71 is an enlarged side view of yet another alternative embodiment 7340 of a locking rib designed to similarly 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 shown in a “fired” state with the detent rounded portion 6404 of the detent snap 6402 positioned in the bidirectional lockout recess 7336. Advancement of the detent rounded portion 6404 into the bidirectional lockout recess 7336 can prevent further movement of the sheath 6704 in either the proximal or distal direction. This can prevent undesired movement of the sheath 6704 during the sensor insertion process. Furthermore, in some embodiments, the bidirectional lockout recess 7336 can allow for immobilization of the sheath 6704 during a motion-activated tip retraction process, as described with respect to FIGS. 14A-14C and 15A-15B. As can be seen in FIG. 71 , the angled firing surface 7338 can be angled toward the central axis 1346 to increase the downward force on the sheath 6704 as the detent rounded portion 6404 advances proximally. In the illustrated embodiment, the detent rounded portion 6404 is in continuous contact with the angled firing surface 7338. This embodiment reflects a lower firing rate and can be used, for example, with the motion-activated tip retraction process described with respect to FIGS. 14A-14C and 15A-15B.

[0063] For purposes of illustration and not limitation, and with reference to Figures 7J-7L, a housing 20702 in accordance with the subject matter of the present disclosure is shown. The housing 20702 can be made of a cyclic olefin copolymer or other suitable material, such as polycarbonate or high-density polyethylene (HDPE). The housing 20702 can include one or more of the features described herein with respect to the housings, and similar features can operate as described herein. For example, the housing 20702 can include a gripping overhang 20702A, which can enable a user to securely grip the housing 20702. The housing 20702 can have additional gripping overhangs 20702A, such as two gripping overhangs 20702A on opposite sides of the housing 20702. The housing 20702 can include side gripping zones 20702B positioned below the gripping overhang 20702A. The side gripping zones 20702B can provide a texture suitable for improved grip by the user. The housing 20702 can have additional side gripping zones 20702B, for example, two side gripping zones 20702B on either side of the housing 20702, each positioned below the gripping overhang 20702A.

[0064] The housing 20702 can include a housing skirt 20702C, which can provide a surface for the tamper-evident feature 20712. The housing skirt 20702C can be supported by a plurality of skirt reinforcing ribs 20702D. The skirt reinforcing ribs 20702D can provide support for the housing skirt 20702C and can further help protect the applicator device 20150 during an impact event, such as a drop. Additionally, the skirt reinforcing ribs 20702D can be used to support the housing 20702 during manufacturing. The housing skirt 20702C and the skirt reinforcing ribs 20702D can provide stiffness to counteract forces resulting from gasket compression and can further help maintain compression of the gasket 20701 throughout the shelf life. The housing 20702 can include a gasket retaining ring 20702E and a plurality of gasket retaining pockets 20702F, which can retain the gasket 20701 relative to the housing 20702. For example, the gasket retaining ring 20702E can prevent lateral movement of the gasket 20701, and the gasket retaining pocket 20702E can prevent rotation of the gasket 20701. The housing 20702 can include multiple gasket retaining pockets, for example, 14 gasket retaining pockets 20702E. A gasket sealing surface 20702N can seal against the gasket 20701. The housing 20702 can additionally or alternatively include an applicator cap sealing lip 20702U that can interface with a cap 20708, as described in more detail below. The housing 20702 can have an inner surface 20702T that can receive the sheath 20704.

[0065] The housing 20702 can include threads 20702G configured to engage threads 20708D positioned on the cap 20708. These threads can include radial limiting features 20702H that can limit radial deformation of the cap 20702G during an impact event, such as a drop. The housing 20702 can include multiple radial limiting features 20702H, for example, six radial limiting features 20702H. The radial limiting features 20702H can be protrusions from the housing and can close a gap with the threads 20708D positioned on the cap 20708. This can limit elliptical deformation of the cap 20702H during an impact event, such as a drop. Preventing oval deformation of the cap 20702H can further ensure that the locking arm 20704J of the sheath 20704 remains locked between the cap 20702 and the sensor carrier 20710, limiting movement of the sheath 20704 prior to removal of the cap 20702H. The housing 20702 can further include a clearance notch 20702I for passage of the sheath during firing.

[0066] The interior of the housing 20702 can include a plurality of sensor carrier mounting features for receiving, aligning, and limiting movement of the sensor carrier 20710. For example, the housing 20702 can include a sheath guide rail 20702J that can assist in aligning and guiding the sheath 20704 as it moves relative to the housing 20702. The housing 20702 can include a sensor carrier mounting slot 20702K that can engage and retain the sensor carrier 20710, and a sensor carrier hard stop 20702L that can limit axial movement of the sensor carrier 20710 relative to the housing 20702. The housing 20702 can include a sensor carrier biasing feature 20702M that can eliminate cant 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 radially aligned relative to the housing 20702. The flat horizontal surfaces between the sensor carrier mounting slots 20702K and the sensor carrier radial limiting features 20702O can be used to stop the sheath 20704 at the end of a stroke. Corresponding features on the sheath 20704 can interact with these surfaces. The sensor carrier biasing features 20702M can further limit rotation of the sensor carrier 20710 relative to the housing 20702. The housing 20702 can include one or more of each of the sheath guide rails 20702J, sensor carrier mounting slots 20702K, sensor carrier hard-stops 20702L, sensor carrier radial limiting features 20702O, and sensor carrier biasing features 20702M, for example, three of each.

[0067] The interior of the housing 20702 can further include a plurality of sheath ribs 20702S for engaging the sheath 20704 for insertion as described herein. The housing 20702 can include one or more, for example, three, sheath ribs 20702S. Each sheath rib 20702S can include a sheath snap introduction feature 20702P configured to initially introduce the detent snap 20704A of the sheath 20704 into the correct location. The housing 20702 can include a firing detent 20702Q. After the detent snap 20704A of the sheath 20704 passes through the firing detent 20702Q, the firing sequence can begin and the sheath 20704 can advance toward the sheath stop ramp 20702R. The sheath stop ramp 20702 can slow the sheath 20704 at the end of firing.

[0068] For illustrative purposes, referring to Figures 7M-7Q and 7S-X, an exemplary cap 20708 is shown. The cap 20708 can include one or more of the features described herein with respect to the caps, and similar features can operate as described herein. The cap 20708 can be made of high-density polyethylene (HDPE) or any other suitable material, such as polypropylene or low-density polyethylene (LDPE). The cap 20708 can include a label surface 20708A configured to receive a label 20709. The cap 20708 can include ribs 20708B that can provide strength and also provide an improved gripping surface for the user. The cap 20708 can include a tear-off label ring 20708C that can receive a tamper-evident feature 20712. The cap 20708 can include a gasket sealing surface 20708G configured to engage the gasket 20701.

[0069] The cap 20708 can include threads 20708D therein that can engage threads 20702G positioned on the housing 20702. The cap 20708 can include a sealing interface 20708E that can be configured to receive the applicator cap sealing lip 20702U to create a seal between the housing 20702 and the cap 20708.

[0070] 7S-V illustrate enlarged cross-sectional side views of the interface between the housing 20702 and the cap 20708. As shown, the applicator cap sealing lip 20702U of the housing 20702 includes a first axial extension 2002a, and the sealing interface 20708E of the cap 20708 provides a cavity 2002d that is mateable with the first axial extension 2002a. In the illustrated embodiment, the diameter of the cavity 2002d formed from 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. 7U, the axial extension 2002a can have a thickness D1 at a height H1 measured from its distal edge. Similarly, the second axial extension 2002c can have a thickness D5 at a height H3 measured from the proximal edge of the cap 20708, and the cavity 2002d can have thicknesses D2, D3, and D4 at heights H2, H3, and H4, respectively, measured from the proximal edge of the cap 20708. In certain embodiments, D1 can be a thickness of 1 mm with a tolerance of ±0.03 mm, D2, D3, and D4 can have any suitable dimensions, H1 can be a height of 1.66 mm with a tolerance of ±0.1 mm, H2 can be a height of 8.25 mm with a tolerance of ±0.1 mm, H3 can be a height of 9.25 mm with a tolerance of ±0.1 mm, and H4 can be a height of 9.75 mm with a tolerance of ±0.1 mm. However, in other embodiments, permutations in which the diameter of the first axial extension 2002a can be sized to accommodate the diameter of the second axial extension 2002b can be employed without departing from the scope of the present disclosure.

[0071] In each embodiment, two radial seals 2004, 2006 may be defined or otherwise provided at the interface between the first axial extension 2002 a and the second axial extension 2002 b, and the radial seals 2004 and 2006 may help prevent fluid or contamination migration across both axes of the interface. Additionally, the dual radial seals described herein may accommodate a combination of tolerances and thermal variations and stress relief through redundant sealing techniques. In the illustrated embodiment, the dual radial seals 2004, 2006 utilize a "wedge" effect for effective sealing between the first axial extension 2002 a and the second axial extension 2002 b.

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

[0073] In accordance with the subject matter of the present disclosure, the cap 20708 can include one or more desiccant retaining clips 20708H to retain the desiccant 20502 within the cap 20708 and limit rotation of the desiccant 20502 (see, e.g., FIG. 7P). The cap 20708 can include any number of desiccant retaining clips 20708H. For example, the cap 20708 can include 1, 2, 3, 4, 5, 6, or more than 7 desiccant retaining clips 20708H. As can be seen in FIG. 7O, the cap 20708 can include three pairs, each consisting of two desiccant retaining clips 20708H. Each pair of desiccant retaining clips 20708H can correspond to a desiccant retaining snap 20502A (see, e.g., FIG. 7R) on the desiccant 20502 (see, e.g., FIG. 7P). As can be seen in FIG. 7P, the desiccant 20502 can include multiple desiccant retention snaps 20502A, each capable of snapping downward into a pair of desiccant retention clips 20708H. For example, the desiccant retention snaps 20502A can include ramps 20502Aa that radially expand the clips 20708H when the desiccant is pressed down onto the cap until the desiccant retention snaps 20502A lock into place within the desiccant retention clips 20708H. The desiccant retention clips 20708H can retain the desiccant 20502 within the cap 20708 and limit distal and rotational movement of the desiccant 20502. As can be seen in FIG. 7Q, the desiccant 20502 can include catch pockets (not shown) for angularly positioning the desiccant 20502 relative to the desiccant retention clips 20708H. In some embodiments, as can be seen in Figure 7Q, the desiccant 20502 can be cylindrical in shape.

[0074] In accordance with the subject matter of the present disclosure, the cap 20708 can include a ratchet 20708I that engages and removes the sensor cap when the cap 20708 is removed from the housing 20702, as described in more detail below. The cap 20708 can include a plurality of ribs 20708J for strength. Thus, as can be seen in FIGS. 4G and 7Q-7R, the internal bore 20502B of the desiccant 20502 can be sized and dimensioned to allow sufficient clearance for the sensor cap to pass through and engage the ratchet 20708I of the cap 20708, and the desiccant 20502 can include a plurality of rib pockets 20502C to provide clearance for the plurality of ribs 20708J of the cap 20708.

[0075] 7W-7X, for purposes of illustration and not limitation, in accordance with the presently disclosed subject matter, the cap 20708 can include one or more surfaces that engage other elements within the applicator device 20150 to provide support or limit movement in the event of an impact event, such as a drop. For example, the cap can include a sheath support surface 20708K configured to support the sheath 20704 during an impact event. The sheath support surface 20708K can limit distal movement of the sheath 20704 during an impact event. This can cause only weak stresses on the sensor carrier 20710 and the sensor control device 20102, reducing the risk of the sensor control device 20102 becoming detached from the sensor carrier 20710. Additionally or alternatively, the cap 20708 can include a raised ridge 20708L. The raised ridge 20708L can interface with a plug such as an elastomeric plug 9130A (which in some embodiments can be coupled to the desiccant cap 9130, and in other embodiments, can be coupled to the sensor cap 9120, as can be seen in FIG. 7Z ). In some embodiments, the elastomeric plug can comprise liquid silicone rubber. The raised ridge 20708L can interface with a plug such as an elastomeric plug 9130A (which can be coupled to the desiccant cap 9130). This allows the raised ridge 20708L to support the sharp body carrier 201102, the sensor carrier 20710, and the sensor control device 20102, thus preventing detachment of the sensor control device 20102 from the sensor carrier 20710 during an impact event. Furthermore, the additional support for the elastomeric plug 9130A and other features can increase stress on the various seals within the applicator device 20150, thereby improving sealing prior to removing the cap 20708 from the housing. For example, as can be seen in Figure 7Y, the elastomeric plug 9130A can include a stop surface 9130Aa, a sealing bead 9130Ab, an intermediate surface 9130Ac, and an upper surface 9130Ad. As can be seen in Figure 7Y, the upper surface 9130Ad can include a triangular surface having square or rectangular corners rather than a pointed apex.As can be seen in Figure 7Z, the sealing bead 9130Ab can be inserted into the sensor cap 9120 until the stop surface 9130Aa (shown in cross section in Figure 33) fits against the bottom of the surface of the sensor cap 9120. The sealing bead 9130Ab can be generally barrel-shaped (i.e., cylindrical with a thicker middle section that tapers to the top and bottom of the sealing bead 9130Ab) and configured to create an interference fit 9130Abb between the sealing bead 9130Ab and the inner diameter of the sensor cap 9120, thereby creating a sterility barrier to seal the inner chamber 9124.

[0076] Exemplary Applicator Sheath 8A and 8B are side and perspective views, respectively, depicting an exemplary embodiment of a sheath 704. In this exemplary embodiment, the sheath 704 can position the sensor control device 102 above the user's skin surface prior to application. The sheath 704 can include features that help hold the sharp in the proper position for proper application of the sensor, determine the force required for sensor application, and guide the sheath 704 relative to the housing 702 during application. A detent snap 1402 is located near the proximal end of the sheath 704, as described in more detail below with respect to FIG. 8C. The sheath 704 can have a generally cylindrical cross-section with a first radius in the proximal zone (near the top of the figure) that is shorter than a second radius in the distal zone (near the bottom of the figure). Also shown are a plurality of detent gaps 1410, three in this exemplary embodiment. The sheath 704 can include one or more detent gaps 1410, each of which can be a notch with room for the sheath snap-in feature 1330 to enter distally until the distal surface of the locking rib 1340 contacts the proximal surface of the detent gap 1410.

[0077] The guide rails 1418 are positioned between a sensor carrier movement limiting surface 1420 at the proximal end of the sheath 704 and a notch around the locking arm 1412. Each guide rail 1418 can be a channel between two ridges, through which a guide edge 1326 of a housing guide rib 1321 can slide distally relative to the sheath 704.

[0078] The locking arms 1412 are positioned near the distal end of the sheath 704 and can include an attached distal end and a free proximal end that can include a locking arm interface 1416. The locking arms 1412 can lock the sensor carrier 710 to the sheath 704 when the locking arm interface 1416 engages the locking interface 1502 of the sensor carrier 710. A locking arm strengthening rib 1414 can be positioned at a central location of each locking arm 1412 and can act as a strengthening point against an otherwise weak point of each locking arm 1412 to prevent the locking arms 1412 from bending excessively or breaking.

[0079] The detent snap reinforcement feature 1422 can be positioned along a distal section of the detent snap 1402 and can provide reinforcement to the detent snap 1402. The alignment notch 1424 can be a notch near the distal end of the sheath 704 and provides an opening for user alignment with the sheath-directing feature of the platform 808. The reinforcement rib 1426 can include a triangular buttress in this case that provides support for the detent base 1436. The housing guide rail gap 1428 can be a notch for the distal face of the housing guide rib 1321 to slide against during use.

[0080] 8C is an enlarged perspective view depicting an exemplary embodiment of the detent snap 1402 of the sheath 704. The detent snap 1402 can include a detent snap bridge 1408 positioned at or near its proximal end. The detent snap 1402 can further include a detent snap flat 1406 on the distal side of the detent snap bridge 1408. The outer surface of the detent snap bridge 1408 can include a detent snap round 1404, which is a rounded surface that allows for easier movement of the detent snap bridge 1408 over an inner surface of the housing 702, such as, for example, the locking rib 1340.

[0081] 8D is a side view depicting an exemplary embodiment of sheath 704. Here, alignment notch 1424 can be relatively close to detent gap 1410. Detent gap 1410 is at a relatively proximal location on the distal portion of sheath 704.

[0082] 8E is an end view depicting an exemplary embodiment of the proximal end of the sheath 704. Here, the back wall 1446 for the guide rail can provide a channel for slidably mating with the housing guide rib 1321 of the housing 702. The sheath rotation limiter 1448 can be a notch that reduces or prevents rotation of the sheath 704.

[0083] 8F-8H are perspective views of an alternative exemplary embodiment of a sheath 6704 at various stages of assembly with other components of the applicator. As shown in FIG. 8F, the sheath 6704 can have many of the same features as the sheath 704 described above with respect to FIGS. 8A-8C. The sheath 6704 can include, for example, one or more detent snaps 6402 having one or more detent rounded portions 6404 attached thereto. However, the sheath 6704 can have a reduced overall length compared to the sheath 704. Additionally, the sheath 6704 can include one or more inner sheath ribs 6425 positioned on its inner surface and projecting inwardly toward the central axis of the sheath 6704.

[0084] 8G, a perspective view shows the sheath 6704 in the process of assembly with the applicator housing 6702 and sensor carrier 6710. One or more internal sheath ribs 6425 of the sheath 6704 can interface with one or more corresponding rib notches 6519 in the sensor carrier 6710. The mating interface between the corresponding ribs 6425 and notches 6519 can help maintain axial alignment of the sheath 6704 and sensor carrier 6710 during the sensor insertion process. Furthermore, the interface between the ribs 6425 and notches 6519 can reduce lateral and rotational movement between the applicator components, thereby reducing the possibility of incorrect sensor insertion.

[0085] 8H, a perspective view shows the sheath 6704 in assembly with the applicator housing 6702 and the sensor electronics housing 706 inserted into the sensor carrier 6710. The inner sheath ribs 6425 are also shown.

[0086] It should be noted that while six inner sheath ribs 6425 and six corresponding rib notches 6519 are shown, any number of ribs and notches is fully within the present disclosure. Furthermore, while the ribs 6425 are shown having rounded surface edges, in other embodiments the ribs 6425 can have a rectangular or triangular shape and the rib notches 6519 can have a corresponding receiving shape for interfacing with the ribs 6425. Furthermore, while the ribs 6425 are shown positioned on the outer circumferential inner surface of the sheath 6704, the ribs 6425 can be positioned on any other surface or portion thereof that comes into contact with the sensor carrier 6710.

[0087] For purposes of illustration and not limitation, and with reference to FIGS. 8I-8O, a sheath 20704 in accordance with the subject matter of the present disclosure is shown. The sheath 20704 can be made of Delrin or other suitable materials, such as other low-friction polymers. The sheath 20704 can include one or more of the features described herein with respect to the sheaths, and similar features can operate as described herein. For example, the sheath 20704 can include a detent snap 20704A having a free proximal end configured to engage the sheath rib 20702S during firing. FIG. 8J illustrates a close-up view of the free proximal end of the detent snap 20704A. The detent snap 20704A can include a rounded portion 20704B for engagement with the sheath rib 20702S and a flat portion 20704C for final lockout of the housing 20704 after use. The rounded portion 20704B can include a parting line misalignment 20704D, which can prevent force spikes during firing. The detent snap 20704A can be coupled to the sheath 20704 at the enlarged distal portion 20704E, which can provide support thereto. The sheath 20704 can include multiple detent snaps 20704A, e.g., three. The sheath 20704 can include one or more housing clearances 20704F, e.g., three, which can allow it to pass through the housing 20702 at the end of firing. In accordance with the subject matter of the present disclosure, the sheath 20704 can further include multiple (e.g., six) reinforcing ribs 20704P, which can strengthen the sheath 20704.

[0088] The sheath 20704 can include a plurality of guides 20704G for engaging with the sheath guide rails 20702J of the housing 20702. The sheath 20704 can further include a slot 20704H including a stop 20704I at its distal end configured to engage the sheath guide rails 20702J to limit further proximal movement of the sheath 20704 relative to the housing 20702 at the end of firing. The sheath 20704 can include a clearance 20704T for clearing a sensor carrier biasing feature 20702I positioned on the sheath guide rails 20702J of the housing 20702.

[0089] In accordance with the subject matter of the present disclosure, the sheath 20704 can include a locking arm 20704J. The locking arm 20704J can be configured to engage the sensor carrier 20710 to limit movement of the sensor carrier 20710 or the sheath 20704 prior to firing. The locking arm 20704J can include a free proximal end 20704K and an attached distal end 20704L. The free proximal end 20704K can include a locking arm interface 20704M positioned on an inner surface of the locking arm 20704J. The locking arm interface 20704M can engage a locking ledge 20710N on the sensor carrier 20710. For example, when the cap 20708 is coupled 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 wedged between the cap 20708 and the sensor carrier 20710. Thus, the locking arm 20704J can limit proximal movement of the sheath 20704 when the cap 20708 is coupled to the housing 20702. Such engagement can limit movement of the sheath 20704 during an impact event, such as a drop. The locking arm interface 20704M can have a triangular shape when viewed in a side view (e.g., FIG. 8N) and a "U" shape when viewed in a top view (e.g., FIG. 8K). The shape of the locking arm interface 20704M can achieve advantages during manufacturing. For example, the shape of the locking arm interface 20704M can allow the sheath 20704 to be forcibly ejected from a mold during manufacturing of the sheath 20704. Forcing the sheath 20704 can allow for an easier manufacturing process using, for example, a one-piece mold and can eliminate parting lines that occur from two-piece molds. The parting lines may result in uneven surfaces that may catch on the sensor carrier 20710 during firing, resulting in potential spikes in firing force.Therefore, the use of forced ejection and a one-piece mold can produce a smoother locking arm interface 20704M, preventing potential spikes in firing force due to parting lines.

[0090] The proximal free end of the locking arm 20704J can further include a sharp edge 20704N on its outer surface. The sharp edge 20704N can be configured to engage a crush rib 20708F positioned on the cap 20708 during an impact event. The sharp edge 20704N can penetrate and permanently deform the crush rib 20708F, thereby absorbing energy during an impact event and preventing the sheath 20704 from collapsing. The shape of the locking arm interface 20704M can be advantageous for drop protection. The ramp can force the locking arm 20704J to move radially when the sheath 20704 collapses during a drop. This movement can force the sharp edge 20704N into the crush rib 20708F and help stop the sheath 20704 from collapsing. The sheath 20704 can include multiple locking arms 20704J, for example, two locking arms 20704J.

[0091] Additionally or alternatively, the sheath 20704 may include ribs 20704U configured to engage with locking interfaces 20710F on the sensor holding arms 20710B on the sensor carrier 20710. The ribs 20704U may, for example, prevent the sensor holding arms 20710B from bending outward during an impact event, and thus may prevent movement of the sensor control device 20102 during an impact event. The ribs 20704U may have a height (i.e., longitudinal) selected such that the ribs 20704U remain engaged with the locking interfaces 20710F on the sensor holding arms 20710B on the sensor carrier 20710, preventing the sensor control device 20102 from detaching from the sensor carrier 20710, even when the sheath 20704 moves proximally or distally during an impact event.

[0092] The sheath 20704 can include a noise damper 20704O. The noise damper 20704O can be configured to engage the sharp body carrier 201102 to slow the movement of the sharp body carrier 201102 when the sharp body carrier 201102 is retracted, thereby reducing noise caused by the sharp body carrier 201102 engaging the sheath 20704. In an exemplary embodiment, the noise damper 20704O includes an angled ramp extending from an inner surface of the sheath 20704, although other suitable configurations can be used.

[0093] In accordance with the subject matter of the present disclosure, the sheath 20704 can include a slot 20704Q configured (as described in more detail below) to receive a sharp body carrier retention feature 20710L positioned on the sensor carrier 20710, thereby allowing partial retraction of the sharp body carrier 201102 during deployment. The sheath 20704 can include a cap introducer 20704R, an alignment notch 20704S, and a skin interface 20704T.

[0094] Exemplary Sensor Carriers FIG. 9A is a proximal perspective view depicting an exemplary embodiment of a sensor carrier 710 capable of holding sensor electronics within the applicator 150. The sensor carrier 710 can hold a sharps carrier 1102 having a sharps module 2500. In this exemplary embodiment, the sensor carrier 710 has a generally hollow, flat, round cylindrical shape and can include one or more (e.g., three) deflectable sharps carrier locking arms 1524 extending proximally from a proximal face surrounding a centrally positioned spring alignment ridge 1516 to maintain alignment of the spring 1104. Each locking arm 1524 has a detent or retention feature 1526 positioned at its proximal end. An impact lock 1534 can be an outwardly extending tab positioned on the outer periphery of the sensor carrier 710 and can lock the sensor carrier 710 for further safety prior to firing. The rotation limiter 1506 may be a relatively short protrusion extending proximally on the proximal face of the sensor carrier 710, limiting rotation of the carrier 710. The sharp body carrier locking arm 1524 may interface with the sharp body carrier 1102 as described below with reference to Figures 10A-10E.

[0095] 9B is a distal perspective view of sensor carrier 710, where one or more (e.g., three) sensor electronics retention spring arms 1518 are biased orthogonally toward the position shown and include detents 1519 that can pass over the distal face of electronics housing 706 of device 102 when retracted into recess or cavity 1521. In certain embodiments, after sensor control device 102 is adhered to the skin with applicator 150, the user pulls applicator 150 proximally, i.e., away from the skin. This adhesive force holds sensor control device 102 on the skin and overcomes the lateral force applied by spring arms 1518. As a result, spring arms 1518 deflect radially outward, disconnecting detents 1519 from sensor control device 102, thereby releasing sensor control device 102 from applicator 150.

[0096] Figure 9C is a perspective view of an alternative exemplary embodiment of a sensor carrier 6710. As shown in Figure 9C, the sensor carrier 6710 can have many of the same features as the sensor carrier 710 described above with respect to Figures 9A-9B. In addition, the sensor carrier 6710 further includes one or more notch ribs 6519 positioned along its outer circumferential surface. As can be seen most clearly in Figures 8F-8H, the notch ribs 6519 are configured to interface with the inner sheath ribs 6425 to maintain axial alignment between the sheath and the sensor carrier and to reduce lateral and rotational movement between the applicator components during the sensor insertion process.

[0097] 9D and 9E, an exemplary sensor carrier 20710 is shown. The sensor carrier 20710 can include one or more of the features described herein with respect to multiple sensor carriers, and similar features can operate as described herein. For example, the sensor carrier 20710 can include a base 20710A and first and second retaining arms 20710B. Each retaining arm 20710B can include a first end portion 20710C coupled to the base 20710A and a free end portion 20710D. For example, each retaining arm 20710B can be coupled to the base 20710A at a first half of the base 20710A, and the free end portion 20710D can extend toward the second half of the base 20710A. Each retaining arm 20710B can include a sensor retaining feature 20710E positioned on an inner surface thereof. A sensor retaining feature 20710E can be positioned on the free end portion 20710D. The sensor retaining feature 20710E can be configured to retain the sensor control device 20102 within the housing 20702. The retaining feature 20710E can include a conical surface and an angled parting line, which can enable release of the sensor control device 20102 during delivery. Each retaining arm 20710B can include a locking interface 20710F positioned on its outer surface. The locking interface 20710F can engage with a rib 20704U on the sheath 20704. As described above, the rib 20704U can prevent the sensor retaining arm 20710B from bending outward, for example, during an impact event, thus keeping the retaining feature 20710E engaged with the sensor control device 20102, thereby preventing movement of the sensor control device 20102 during an impact event.

[0098] The sensor carrier 20710 may include multiple housing attachment features 20710F, for example, three housing attachment features 20710F. The housing attachment features 20710F may be evenly spaced on the sensor carrier 20710 and may extend upward from the top surface of the sensor carrier 20710. Each sensor housing attachment feature 20710F may include a housing snap 20710G, a housing positioning feature 20710H, a biasing feature 20710I, and a housing stop 20710J. The housing positioning feature 20710H may determine the location of the sensor carrier 20710 relative to the housing 20702 when the two are coupled together. The housing snap 20710G may engage a sensor carrier attachment slot 20702K on the housing 20702 to couple the sensor carrier 20710 to the housing 20702. The biasing feature 20710I can engage with a sensor carrier biasing feature 20702M on the housing 20702 configured to eliminate tilt between the sensor carrier 20710 and the housing 20702. The housing stop 20710J can engage with a sensor carrier hard stop 20702L on a sheath guide rail 20702J on the housing 20702 to axially position the sensor carrier 20710 relative to the housing 20702.

[0099] The sensor carrier 20710 can further include a plurality of sharp body carrier locking arms 20710K, for example, three sharp body carrier locking arms 20710K. The sharp body carrier locking arms 20710K can be evenly spaced on the sensor carrier 20710 and can extend upward from the top surface of the sensor carrier 20710. Each sharp body carrier locking arm 20710K can include a sharp body carrier retention feature 20710L and a rib 20710M. The rib 20710M can engage the inner surface of the sheath 20704, thereby biasing the sharp body carrier locking arm 20710K inward to cause the sharp body carrier retention feature 20710L to retain the sharp body carrier 201102, as described in more detail below. The carrier retention feature 20710L can have a triangular shape when viewed from a side view and a "U" shape when viewed from a top view.

[0100] In accordance with the subject matter of the present disclosure, the sensor carrier 20710 can include a plurality of locking ledges 20710N configured to engage the locking arm interfaces 20704M of the sheath 20704, as described above. For example, the sensor carrier 20710 can include two locking ledges 20710N. The sensor carrier 20710 can include a recess 20710O positioned proximal to each locking ledge 20710N and configured to receive the locking arm interface 20704M during firing and prevent the locking arm 20704J from engaging the housing 20702 during firing. The sensor carrier 20710 can include a hole 20710P extending through the center of the base 20710A. The hole 20710P can guide and limit the movement of the sharp hub 205014 during insertion. Additionally or alternatively, the sensor carrier 20710 can include a spring locator 20710Q.

[0101] The bottom surface of the sensor carrier 20710 can include reinforcing ribs 20710R and sensor locator ribs 20710S that can limit in-plane movement of the sensor control device 20102 relative to the sensor carrier 20710. The bottom surface of the sensor carrier 20710 can include a sensor support surface 20710T configured to support the sensor control device 20102.

[0102] Exemplary Sharp Body Carriers 10A and 10B are proximal perspective and side cross-sectional views, respectively, depicting an exemplary embodiment of a sharp body carrier 1102. The sharp body carrier 1102 can grip and hold the sharp body module 2500 within the applicator 150. The sharp body module 2500 can automatically retract as a result of one or more springs changing from a preloaded compressed state to an expanded state during the insertion process, as described with respect to FIGS. 40A-40F. Near the distal end of the sharp body carrier 1102, there can be an anti-rotation slot 1608 that prevents the sharp body carrier 1102 from rotating when positioned within the central region of the sharp body carrier locking arm 1524 (shown in FIG. 9A). The anti-rotation slot 1608 can be positioned between sections of the sharp body carrier base chamfer 1610 and can ensure complete retraction of the sharp body carrier 1102 through the sheath 704 upon retraction of the sharp body carrier 1102 at the end of the deployment procedure.

[0103] 10B, the sharps retaining arms 1618 can be positioned about a central axis within the sharps carrier 1102 and can include a sharps retaining clip 1620 at the distal end of each arm 1618. The sharps retaining clips 1620 can be approximately perpendicular to the central axis and can have a proximal face that can abut a distal-facing face of the sharps hub 2516 (FIG. 17A).

[0104] 10C and 10D, an exemplary sharps carrier 201102 is shown. The sharps carrier 201102 can include one or more of the features described herein with respect to the multiple sharps carriers, and similar features can operate as described herein. For example, the sharps carrier 201102 can include a series of features for engaging with the three sharps carrier locking arms 20710K of the sensor carrier 20710. These features can include a pre-partial retraction support surface 201102A and a post-partial retraction support surface 201102B. The pre-partial retraction support surface 201102A can engage with the sharps carrier support feature 20710L before partial retraction, e.g., during transport and storage. The post-partial retraction support surface 201102B can engage with the sharps carrier support feature 20710L after partial retraction. For example, when the sheath 20704 initially moves proximally relative to the sensor carrier 20710, the rib 20710M of the retention arm 20710L can engage with the slot 20704Q of the sheath 20704, thereby allowing the retention arm 20710L to move radially outward and further allowing the sharp body carrier retention feature 20710L to engage the post-partial retraction retention surface 201102B through the pre-partial retraction retention surface 201102A. The height between the end of the pre-partial retraction front surface 201102A and the beginning of the post-partial retraction surface 201102B can be the partial retraction distance. A running surface 201102C can be positioned below the post-partial retraction retention surface 201102B, and the running surface 201102C can slide against the retention arm 20710L as the sharp body carrier 201102 is retracted. An alignment wall 201102D can help keep the sharp body carrier 201102 in alignment with the sensor carrier 20710 during partial retraction. The sharp body carrier 201102 can include a chamfered surface 201102F that can include an anti-rotation slot 201102E that engages with a retention arm 20710L on the sensor carrier 20710.

[0105] The sharp body carrier 201102 can include a sharp body retention arm 201102G that includes an internal lead-in surface 201102I and a sharp body hub contact surface 201102H. The retention arm 201102G can receive and retain the sharp body hub 205014. The spring stop 201102J can engage the retraction spring 205612.

[0106] The spring 205612 can include any type of spring known in the art, such as a helical spring. For example, in certain embodiments, the spring 205612 can include a helical spring constructed of stainless steel. The spring 205612 can include any suitable range of spring constants, any suitable dimensions of wire diameter, inner diameter, outer diameter, and maximum solid strength. For example, the spring constant can be approximately 0.12, the wire diameter can be approximately 0.65 millimeters, the inner diameter can be approximately 9.6 millimeters, the outer diameter can be approximately 11.1 millimeters, and the maximum solid strength can be 11 millimeters.

[0107] Exemplary Sensor Module 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 functions to be rigidly coupled to the electronics housing 706. One or more deflectable arms or module snaps 2202 can snap into corresponding features 2010 of the housing 706. The sharpened body slot 2208 can provide a passage for the sharpened body tip 2502 and a temporary location for the sharpened body shaft 2504. The sensor ledge 2212 can define the sensor position in the horizontal plane, prevent the sensor from disengaging the connector 2300 from the post, and maintain the sensor 104 parallel to the plane of the connector seal. Additionally, the sensor ledge 2212 can define the sensor's bending shape and bend radius. The sensor ledge 2212 can limit the vertical movement of the sensor, prevent the tower from protruding above the electronics housing, and define the sensor tail length below the patch plane. The sensor wall 2216 can constrain the sensor and define the bending shape and minimum bending radius of the sensor.

[0108] 12A and 12B are perspective views depicting an exemplary embodiment of a connector 2300 in an open and closed state, respectively. The connector 2300 can be made of silicone rubber encapsulating a flexible carbon-impregnated polymer module that acts as a conductive contact 2302 between the sensor 104 and the electrical circuit contacts for the electronics within the housing 706. The connector can act as a moisture barrier for the sensor 104 when assembled in a compressed state after transfer from the container to the applicator and after 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 2208 can connect the two distal and proximal portions of the connector 2300.

[0109] FIG. 13 is a perspective view depicting an exemplary embodiment of the sensor 104. The neck 2406 can be a zone that allows for bending the sensor, for example, 90 degrees. A membrane on the tail 2408 can cover the active analyte sensing element of the sensor 104. The tail 2408 can be the portion of the sensor 104 that resides under the user's skin after insertion. The flag 2404 can include contacts and a sealing surface. The bias tower 2412 can be a tab that biases the tail 2408 into the pointed body slot 2208. The bias fulcrum 2414 can be a branch of the bias tower 2412 that contacts the inner surface of the needle to bias the tail into the slot. The bias adjuster 2416 can reduce local bending of the tail connection and prevent damage to the sensor trace. The contact 2418 can electrically connect the active portion of the sensor to the connector 2300. The feed loop 2420 can turn the electrical path 90 degrees from vertical and engage the sensor ledge 2212 (FIG. 11B).

[0110] 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 above-described embodiment, during or after insertion, the sensor 104 may be subjected to an axial force, as shown by force F1 in FIG. 14A , that pushes the sensor 104 proximally and up into the sensor module 504. According to some embodiments, this axial force may result in a detrimental force F2 being applied to the neck 2406 of the sensor 104, which in turn may result in a detrimental force F3 being transferred to the feed loop 2420 of the sensor 104. In some embodiments, for example, the axial force F1 may arise as a result of a sensor insertion mechanism designed to force the sensor through tissue, a tip retraction mechanism during insertion, or due to a physiological response effected by the tissue surrounding the sensor 104 (e.g., after insertion).

[0111] 15A and 15B are enlarged partial views of example embodiments of a sensor module assembly having certain axial strengthening features. In a general sense, the embodiments described herein relate to reducing the effects of axial forces on a sensor resulting from insertion and / or retraction mechanisms or from physiological responses to the sensor within the body. As can be seen in FIGS. 15A and 15B , according to one aspect of these embodiments, the sensor 3104 includes a proximal portion having a hook feature 3106 configured to engage a catch feature 3506 of the sensor module 3504. In some embodiments, the sensor module 3504 can further include a gap area 3508 to allow a distal portion of the sensor 3104 to recoil during assembly to allow assembly of the hook feature 3106 of the sensor 3104 over and into the catch feature 3506 of the sensor module 3504.

[0112] In accordance with another aspect of the above-described embodiment, the hook and catch features 3106, 3506 operate in the following manner. The sensor 3104 includes a proximal sensor portion that is coupled to the sensor module 3504 as described above, and a distal sensor portion that is positioned below the skin surface in contact with bodily fluids. As can be seen in FIGS. 15A and 15B , the proximal sensor portion includes a hook feature 3106 adjacent to a catch feature 3506 of the sensor module 3504. During or after sensor insertion, 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, preventing proximal displacement of the sensor 3104 along the longitudinal axis.

[0113] In accordance with another aspect of the above-described embodiment, the sensor 3104 can be assembled with the sensor module 3504 in the following manner: The sensor 3104 is mounted into the sensor module 3504 by laterally displacing the proximal sensor portion to bring the hook feature 3106 closer to the catch feature 3506 of the sensor module 3504. More specifically, laterally displacing the proximal sensor portion moves the proximal sensor portion into the gap area 3508 of the sensor module 3504.

[0114] 15A and 15B show 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 recognize that the hook feature 3106 could instead be part of the sensor module 3504, and similarly, the catch feature 3506 could instead be part of the sensor 3106. Likewise, those skilled in the art will recognize that other mechanisms (such as detents, latches, fasteners, screws, etc.) implemented on the sensor 3104 and sensor module 3504 to prevent axial displacement of the sensor 3104 are possible and within the present disclosure.

[0115] 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 for detecting a particular analyte concentration. 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 agent, and in some embodiments, a membrane may cover the chemical agent. During use, the tail 11902 is transdermally received under a user's skin, and the chemical agent contained on the tail 11902 helps facilitate analyte monitoring in the presence of bodily fluids.

[0116] The tail 11902 can be received within a hollow or recessed portion of a pointed body (not shown) that at least partially surrounds the tail 11902 of the sensor 11900. As shown, the tail 11902 can extend at an angle Q offset from the horizontal. In some embodiments, the angle Q can be approximately 85°. Thus, in contrast to other sensor tails, the tail 11902 does not extend perpendicularly from the flag 11904, but instead can extend at an angle offset from the vertical. This angular offset can prove advantageous by helping to maintain the tail 11902 within the recessed portion of the pointed body.

[0117] The tail 11902 includes a first or bottom end 11908a and an opposing top end 11908b. A tower 11910 can be provided at or near the top end 11908b and can extend vertically from where the neck 11906 interconnects the tail 11902 to the flag 11904. If the sharp moves laterally during operation, the tower 11910 can help pivot the tail 11902 toward the sharp and otherwise remain within the recessed portion of the sharp. Additionally, in some embodiments, the tower 11910 can provide or otherwise define a protrusion 11912 extending laterally therefrom. When the sensor 11900 is mated with the sharp and the tail 11902 extends into the recessed portion of the sharp, the protrusion 11912 can engage an inner surface of the recessed portion. When actuated, the protrusion 11912 can help keep the tail 11902 within the recessed portion.

[0118] The flag 11904 can include a generally planar surface positioned thereon with one or more sensor contacts 11914. The sensor contacts 11914 can be configured to align with a corresponding number of flexible carbon-impregnated polymer modules enclosed within the connector.

[0119] In some embodiments, as shown, the neck 11906 may provide or otherwise define a recess or bend 11916 that extends between the flag 11904 and the tail 11902. The bend 11916 may prove advantageous by adding flexibility to the sensor 11900 and helping to prevent bending of the neck 11906.

[0120] In some embodiments, a notch 11918 (shown in dashed lines) can optionally be defined in the flag near the neck 11906. The notch 11918 can add flexibility and tolerance to the sensor 11900 when the sensor 11900 is mounted in a mount. More specifically, the notch 11918 can help absorb interference forces that may occur when the sensor 11900 is mounted in a mount.

[0121] In some embodiments, as shown in FIGS. 15D-15G, the neck can include or otherwise define a nonlinear configuration, such as recesses or bends 11920a-11920d having multiple turns, e.g., 11921a, 11921b, extending between the flag 11904 and the tail 11902. The bends 11920a-11920d can be advantageous by reducing the in-place stiffness of the sensor 11900 by adding flexibility to the sensor 11900 in both vertical and horizontal orientations. The added flexibility can provide a multi-directional spring-like structure within the sensor 11900 that helps limit deformation of the neck 11906 while ensuring that the tail 11902 and flag 11904 can remain in their expected or fixed positions. The spring-like structure also increases the flexibility of the sensor 11900 while reducing stress on the overall structure.

[0122] In general, the sensor may be understood to include a tail, a flag, and a neck aligned along a plane having a vertical axis and a horizontal axis. The spring-like structure may be created by variously oriented turns at the bend of the neck of the sensor. Between the tail and the flag, the neck may include at least two turns about the vertical axis to provide the spring-like structure. The at least two turns may provide an overlapping layer of the neck structure about the axis of the planar surface shared by the tail, flag, and neck, where the neck itself remains intact. These overlapping turns comprise the spring-like structure. In some embodiments, the overlapping layer of the neck is oriented vertically. In some embodiments, the overlapping layer of the neck is oriented horizontally.

[0123] 15D shows an embodiment of a sensor 11900 including a neck having a bend 11920a including turns 11921a and 11921b between the flag 11904 and the tail 11902. In the illustrated embodiment, at least one turn 11921a abuts the top of the tail or possibly the tower 11910 of the sensor 11900. This orientation can be advantageous by reducing the overall footprint of the sensor, even considering the additional material used to create the bend 11920a. This arrangement can provide multiple overlapping horizontal layers that are vertically aligned between the turns.

[0124] 15E shows another embodiment of a sensor 11900 including a neck with a bend 11920b that generally forms a spiral pattern including at least turns 11923a, 11923b, and 11923c between the flag 11904 and the tail 11902. In this embodiment, the turns again abut the top of the tail or tower 11910 of the sensor 11900. In addition to maintaining the overall footprint of the sensor, this orientation can allow for additional balancing of horizontally and vertically directed stresses. The overlapping layers in this turn arrangement are substantially balanced along both the horizontal and vertical axes.

[0125] 15F shows another embodiment of a sensor 11900 including a neck with a bend 11920c including turns 11925a, 11925b, and 11925c between the flag 11904 and the tail 11902. In the illustrated embodiment, the turn 11925c connects a region or tower 11910 of the sensor's tail 11902 near its top end to the remainder of the bend 11920c. In addition to reducing the overall footprint of the sensor, this orientation is believed to provide additional flexibility in the horizontally oriented axis. This arrangement can provide multiple overlapping vertical layers with horizontal alignment between the turns.

[0126] FIG. 15G shows another embodiment of a sensor 11900 including a neck having a bend 11920d including turns 11927a, 11927b, and 11927c between the flag 11904 and the tail 11902. In the illustrated embodiment, the bend 11920d occurs primarily within the tail 11902 of the sensor, connecting the tail 11902 to the tower 11910, whereas the extension of the sensor between the tower 11910 and the flag 11904 is generally continuous. Turn 11927a connects the tower 11910 entirely to the remainder of the bend 11920d, and turn 11927c connects the tail 11902 to the remainder of the bend 11920d. This orientation is believed to provide additional flexibility in the vertically oriented axis. This arrangement can provide multiple overlapping vertical layers with horizontal alignment between the turns.

[0127] The turn in the neck can be created by folding the neck of the sensor from a larger neck structure, laser cutting the sensor from a sheet of material that contains the sensor, printing the sensor with a configuration that has a turn, stamping the sensor from a sheet of material that the sensor is made of, or other manufacturing process suitable for providing a precise bend in the neck.

[0128] 16A and 16B are isometric and partially exploded isometric views of an exemplary connector assembly 12000 according to one or more embodiments. As shown, the connector assembly 12000 can include a connector 12002, and FIG. 17C is an isometric bottom view of the connector 12002. The connector 12002 can include an injection molded portion used to help secure one or more flexible carbon-impregnated polymer modules 12004 (four are shown in FIG. 16B ) to the mount 12006. More specifically, the connector 12002 can help secure the module 12004 in place adjacent the sensor 11900 and in contact with sensor contacts 11914 ( FIG. 15C ) provided on the 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) provided in the mount 12006 .

[0129] As can be seen most clearly in FIG. 16C , the connector 12002 can define a pocket 12008 sized to receive the module 12004. Moreover, in some embodiments, the connector 12002 can further define one or more recesses 12010 configured to mate with one or more corresponding flanges 12012 ( FIG. 16B ) on the mount 12006. Mating the recesses 12010 with the flanges 12012 can secure the connector 12002 to the mount 12006, such as by an interference fit. In other embodiments, the connector 12002 can be secured to the mount 12006 with an adhesive or by sonic welding.

[0130] 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 can include an injection molded portion that is used to help keep one or more flexible metal contacts 12104 (four are shown in FIG. 16E ) secured in place against the sensor 11900 on the mount 12106. More specifically, the connector 12102 can help secure the contacts 12104 in place adjacent the sensor 11900 and in contact with the sensor contacts 11914 ( FIG. 15C ) provided on the flag 11904. The contacts 12104 may be made from a stamped conductive material that provides conductive communication between the sensor 11900 and corresponding circuit contacts (not shown) provided in the mount 12106. In some embodiments, for example, the contacts 12104 may be soldered to a PCB (not shown) disposed within the mount 12106.

[0131] As can be seen most clearly in FIG. 16F , the connector 12102 can define a pocket 12108 sized to receive the contact 12104. Moreover, in some embodiments, the connector 12102 can further define one or more recesses 12110 configured to mate with one or more corresponding flanges 12112 ( FIG. 120B ) on the mount 12106. Mating the recesses 12110 with the flanges 12112 can help secure the connector 12102 to the mount 12106, such as by an interference fit. In other embodiments, the connector 12102 can be secured to the mount 12106 with an adhesive or by sonic welding.

[0132] Exemplary Sharp Body Module FIG. 17A is a perspective view depicting an exemplary embodiment of a sharps module 2500 prior to assembly into the sensor module 504 (FIG. 6B). The sharps 2502 can include a distal tip 2506 capable of penetrating the skin while carrying the sensor within a hollow or recessed portion of the sharps shaft 2504 to place the active surface of the sensor tail in contact with bodily fluids. The hub pressing cylinder 2508 can provide a surface for the sharps carrier to press against during insertion. The hub small cylinder 2512 can provide space for extension of the sharps hub contact surface 1622 (FIG. 10B). The hub snap claw positioning cylinder 2514 can provide a distally facing surface of the hub snap claw 2516 for the sharps hub contact surface 1622 to abut against. The hub snap claw 2516 can include a conical surface that opens the clip 1620 during installation of the sharps module 2500.

[0133] 17B through 17H illustrate exemplary embodiments of a sharpened body module suitable for use during insertion of a skin analyte sensor at various assembly stages. According to one aspect of these embodiments, angling the sensor and / or insertion sharpened body relative to a reference point can enable co-localization of the tip of the insertion needle with the tip of the sensor and can create a single point of contact at the surface of the skin. Accordingly, the sharpened body can create a leading edge at the surface of the skin to form an insertion path for the sensor into the dermal layer when the sensor is inserted into a subject. In some embodiments, the sharpened body and / or skin sensor can be angled relative to a reference point (e.g., relative to each other, the surface of the skin, or the base of the applicator) to accommodate insertion where the angle of the sharpened body is different from the angle of the sensor. For example, the reference point can be the surface of the skin to be cleaved for skin insertion, or it can be a reference or component of the sensor applicator set. In some embodiments, the sharpened body can be positioned at an angle relative to the sensor. For example, when the sharpened body is designed to be angled relative to the sensor, the needle creates a leading edge for the sensor during actuation of the applicator set. Furthermore, the needle design itself and the positioning of the needle relative to the sensor can be implemented in any desired configuration, including all of the configurations disclosed in U.S. Patent Application Publication No. 2014 / 0171771, the entire contents of which are incorporated herein by reference for all purposes.

[0134] Additionally, although many of the exemplary embodiments described with respect to Figures 17B through 17J are described with respect to skin analyte sensors and skin insertion, one skilled in the art will understand that any of these embodiments can be sized and configured for use with analyte sensors that can be positioned beyond the skin space, such as into (or even 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).

[0135] 17B is a perspective view depicting an exemplary embodiment of a sharp body module 2550 that can be used for insertion of a skin sensor. This figure shows the sharp body module 2550 prior to assembly with the sensor module 504 (FIG. 6B), and the sharp body module 2550 can include similar components to the embodiment described with respect to FIG. 17A, including a sharp body 2552, a sharp body shaft 2554, a sharp body distal tip 2556, a hub press cylinder 2558, a hub small cylinder 2562, a hub snap pawl 2566, and a hub snap pawl positioning cylinder 2564. The sharp body 2552 can be positioned within the sharp body module 2550 at an eccentric location relative to a longitudinal axis 2545 that extends through the centers of the hub snap pawl 2566, the hub small cylinder 2562, and the hub press cylinder 2558. Additionally, the sharpened body module 2550 can include a sharpened body spacer 2568 parallel to and adjacent to a portion of the sharpened body 2552. The sharpened body spacer 2568 can be positioned between the sensor 104 (not shown) and the sharpened body 2552 along a proximal portion of the sharpened body 2552 to ensure that the sensor 104 and the sharpened body 2552 remain spaced apart at the proximal portion of the sharpened body 2552. The sharpened body 2552 can be positioned in an eccentric location during the molding process with the hub components 2558, 2562, 2566, which can each comprise a rigid plastic material.

[0136] 17C and 17D are two side views depicting the sharp body module 2550 prior to assembly with the sensor module 504 (FIG. 6B), including the sharp body 2552, spacer 2568, hub pressure cylinder 2558, hub small cylinder 2562, and hub snap pawl 2566. In some embodiments, the relative distance between the sharp body 2552 and the hub components can be positioned as follows: For example, the distance S between the sharp body 2552 and the radial center of the hub can range from 0.50 mm to within 1 mm (e.g., 0.89 mm). The height S2 of the sharp body spacer 2568 can range from 3 mm to within 5 mm (e.g., 3.26 mm). The height S2 of the sharp body spacer 2568 can range from 3 mm to within 5 mm (e.g., 3.26 mm). The length S4 of the tip 2552 can range from 1.5 mm to 25 mm (eg, 8.55 mm) and can be based on the location of the insertion site on the subject.

[0137] FIG. 17E depicts a cross-sectional side view of the sharp body module 2550, including the sharp body 2552, sharp body spacer 2568, and hub components (hub snap tab 2566, hub small cylinder 2562, and hub press cylinder 2558), assembled with the sensor module 504. As can be seen in FIG. 17E, the sharp body 2552 is disposed within the sharp body slot 2208 of the sensor module 504, which includes a curved inner surface 2250 positioned at its distal end. The curved inner surface 2250 of the sensor module 504 can come into contact with a portion of the sharp body 2552, achieving a deflection such that the sharp body distal tip 2556 points toward the central longitudinal axis 2545. As can be seen most clearly in FIG. 17H, the sharp body 2552 has an acute angle S between its distal portion and the central longitudinal axis 2545, which can span between 5° and 20°. θ In some embodiments, for example, S θ may range from 5° to 17°, 7° to 15°, or 9° to 13°, for example, 9°, 10°, 11°, 12°, or 13°.

[0138] Continuing with reference to FIG. 17E , near the distal end of the sensor module 504 is a protrusion 2251 that can promote perfusion of bodily fluids between the skin and the fluid space. While shown as a curved surface in FIG. 17E , the protrusion 2251 can be shaped in any desired manner. Furthermore, in some embodiments, multiple protrusions can be present. U.S. Patent Application Publication No. 2014 / 0275907, the entire contents of which are incorporated herein by reference for all purposes, describes sensor devices with various protrusion configurations, each of which can be implemented in the embodiments described herein. While many of the embodiments described herein show a needle exiting the protrusion, in other embodiments, the needle can retract from the base of the sensor device adjacent the protrusion and extend from this position above the tip of the sensor 104.

[0139] 17E and 17F , the sensor 104 may be a skin sensor and may include a sensor tail 2408 positioned at a distal end of the sensor 104 and oriented substantially parallel to the central longitudinal axis 2545. The distal end of the sensor tail 2408 may reside proximal to the distal tip 2556 in a static spaced relationship either within or abutting a portion of the tip shaft 2554. As further shown in FIG. 17E , a tip spacer 2568 provides a spaced relationship between the proximal portion of the tip 2552 and the sensor 104 so that the proximal portion of the tip 2552 and the sensor 104 are not in contact. The sensor module 504 may further include a sensor connector 2300 for storing the proximal portion of the sensor 104 relatively perpendicular to the distal end of the sensor 104.

[0140] 17F is a top cross-sectional view of the sensor module 504. The sensor module 504 may include one or more sensor module snaps 2202 for mating with a housing (not shown) of the sensor control device 102. The sensor module 504 may further include a sensor connector 2300, which may have sensor contacts 2302 for mating with a proximal portion of the sensor 104. The sensor connector 2300 may be made of silicone rubber encapsulating a flexible carbon-impregnated polymer module that acts as a conductive contact 2302 between the sensor 104 and electrical circuit contacts for the electronics within the sensor control device 102. The connector may act as a moisture barrier for the sensor 104 when assembled in a compressed state after transfer from the container to the applicator and after application to the user's skin. While three contacts 2302 are shown, it is 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 couple to the sensor module 504 by two connector posts 2206 positioned through a similar number of openings therein. Although two connector posts 2206 are shown, it is understood that any number of connector posts 2206 may be used to couple the connector 2300 to the sensor module 504.

[0141] 17G and 17H are perspective and side views, respectively, of another exemplary embodiment 2600 of a sharp body module that can be used to insert a skin sensor. This figure shows the sharp body module 2600 prior to assembly with the sensor module 504 (FIG. 6B), and the sharp body module 2600 can include similar components to the embodiment described with respect to FIGS. 17A and 17B, including a sharp body 2602, a sharp body shaft 2604, a sharp body distal tip 2606, a hub push cylinder 2608, a hub small cylinder 2612, a hub snap pawl 2616, and a hub snap pawl positioning cylinder 2614. In some embodiments, the sharp body 2602 can be a "pre-bent" needle that includes a proximal portion 2603 that proceeds from a point external to the sharp body module 2600 and intersects at an angle with the center point of the hub (e.g., through the hub push cylinder 2608). The sharp 2602 can further include a distal portion 2605 that extends distally at an angle from a point near the distal portion of the hub toward the insertion point on the user's skin. As shown in FIG. 17H , the sharp 2602 can include an angled portion 2607 that is positioned outside of the hub press cylinder 2608 and can have a substantially 90° angle between the proximal portion 2603 and the distal portion 2605 of the sharp 2602. The sharp module 2600 can further include a bent fin guide 2620 to maintain the "pre-bent" sharp 2602 in a defined position during assembly and / or use and can prevent lateral or rotational movement of the sharp 2602 relative to the hub components. The proximal portion 2603 of the sharp 2602 can be "trimmed" from the hub after the molding process is complete and prior to assembly of the sharp module 2600 with the sensor module 504.

[0142] 17I and 17J are side cross-sectional and side views, respectively, of the sharp body module 2600 (including the hub snap claws 2616, the hub small cylinder 2612, and the hub push cylinder 2608) assembled with the sensor module 504. As can be seen in FIG. 17I, the sensor module 504 includes a sharp body slot 2208 that allows the sharp body 2602 to extend through an oblique distal direction. As described above, the proximal portion of the sharp body 2602 passes through a bent fin guide 2620 coupled to the distal portion of the sensor module 504. The sensor module 504 may further include a sensor 104, which may be a skin sensor. As shown in FIG. 17I, the sharp body 2602 and the sensor tail 2408 are aligned at an acute angle S at the point where their respective longitudinal axes converge. θ The angle S can be formed. θ can range between 5° and 20°. In some embodiments, for example, S θ can range from 5° to 17°, 7° to 15°, or 9° to 13°, e.g., 9°, 10°, 11°, 12°, or 13°. In some embodiments, the distal sharp tip 2606 is positioned at a distance S6 proximal to the end of the sensor tail 2408. Distance S6 can range from 0.02 mm to 0.10 mm, e.g., 0.05 mm, 0.06 mm, or 0.07 mm.

[0143] 17I and 17J, the sensor module 504 may further include a sensor connector 2300 for storing a proximal portion of the sensor 104 relatively perpendicular to the distal end of the sensor 104. The sensor module 504 may include one or more sensor module snaps 2202 for coupling with a housing (not shown) of the sensor control device 102. The sensor connector 2300 may include the same structure as described with respect to FIG.

[0144] In the above-described embodiments, the sharpened body is fabricated from stainless steel or a similar flexible material (e.g., the material used to make acupuncture needles), and the applicator can be sized to allow insertion of at least a portion of the skin sensor into, but not through, the dermal layer of the skin. According to certain embodiments, the sharpened body has a cross-sectional diameter (width) of 0.1 mm to 0.5 mm. For example, the sharpened body can have a diameter of 0.1 mm to 0.3 mm, such as 0.15 mm to 0.25 mm, e.g., 0.16 mm to 0.22 mm. A given sharpened body can have a constant or uniform width along its entire length, or can have a varying or changing width along at least a portion of its length, e.g., the distal end portion used to pierce the surface of the skin. For example, for the embodiment shown in FIG. 17I, the width of the sharpened body 2602 can decrease along the distal portion between the curved fin guide 1620 and the distal sharpened body tip 2606.

[0145] The tip can have a length that allows the skin sensor to be inserted slightly into the dermal layer but not further. The insertion depth can be controlled by the length of the tip, the configuration of the base and / or other applicator components that limit the insertion depth. The tip can have a length between 1.5 mm and 25 mm. For example, the tip can have a length of 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, 23 mm to 25 mm, or a length greater than 25 mm. While the tip can have a length up to 25 mm, it will be understood that in certain embodiments, the tip will extend beyond the skin space and therefore the entire length of the tip will not be inserted into the subject. The non-insertion tip length can allow for handling and manipulation of the tip with the applicator set. Thus, while the sharpened tip can have a length of up to 25 mm, the insertion depth of the sharpened tip into the skin on a subject in certain embodiments described above will be limited to the dermal layer, for example, approximately 1.5 mm to 4 mm depending on the location of the skin, as described in more detail below. However, in all of the embodiments disclosed herein, the sharpened tip can be configured to extend beyond the skin space, such as into the subcutaneous tissue (e.g., 3 mm to 10 mm below the skin surface depending on the location of the skin on the body). Furthermore, in some exemplary embodiments, the sharpened tip described herein can include a hollow or partially hollow insertion needle having an internal space or lumen. However, in other embodiments, the sharpened tip described herein can include a solid insertion needle without an internal space or lumen. Furthermore, the sharpened tip of the subject applicator set can be bladed or non-bladed.

[0146] Similarly, in the above-described embodiments, the skin sensor is sized so that at least a portion thereof is positioned at the dermal layer but not beyond, and in transcutaneously positioned embodiments, a portion extends outside the skin, i.e., the skin sensor is dimensioned such that when it is fully or substantially fully inserted into the dermal layer, a distal-most portion (insertion portion or insertion length) of the sensor is located within the dermis of the subject, and no portion of the sensor is inserted beyond the dermal layer of the subject when the sensor is operably positioned on the skin.

[0147] Because the depth and thickness of the epidermis and dermis vary somewhat depending on the location on the skin, the dimensions (e.g., length) of the sensor can be selected according to the location on the subject's body where the sensor will be inserted. For example, the epidermis is only about 0.05 mm thick on the eyelid, but about 1.5 mm thick on the palms of the hands and soles of the feet. The dermis is the thickest of the three layers of skin, ranging from about 1.5 mm to 4 mm thick depending on the location on the skin. For implantation of the distal end of the sensor into, but not penetrating, the subject's dermal layer, the length of the insertion portion of the skin sensor should be longer than the thickness of the epidermis, but not exceed the combined thickness of the epidermis and dermis. The method includes determining an insertion site on the user's body, determining the depth of the dermal layer at the site, and selecting an applicator of an appropriate size for the site.

[0148] In certain aspects, the sensor is an elongated sensor having a longest dimension (or "length") of 0.25 mm to 4 mm. The inserted sensor length ranges from 0.5 mm to 3 mm, such as 1 mm to 2 mm, e.g., 1.5 mm, in embodiments where only a portion of the sensor is inserted into the skin. The sensor dimensions can be expressed in terms of the sensor's 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 can be from about 25:1 to about 10:1, including 20:1 and 15:1. The inserted portion of the skin sensor contains the sensing chemistry.

[0149] However, all of the embodiments disclosed herein are configured so that at least a portion of the sensor is positioned beyond the dermal layer, e.g., in (or through) the subcutaneous tissue (or fat). For example, the sensor can be sized so that when it is fully or substantially fully inserted into the body, the distal-most portion (insertion portion or insertion length) of the sensor is positioned in the subcutaneous tissue (beyond the dermis of the subject), and no portion of the sensor is inserted beyond the subcutaneous tissue of the subject when the sensor is operably positioned. As noted above, the subcutaneous tissue is typically located in the region of 3 mm to 10 mm below the outer skin, depending on the location of the skin on the body.

[0150] Exemplary applicator and sensor control device suitable for one-piece architecture 1 and 3A-3G, in a two-piece architecture system, the sensor tray 202 and the sensor applicator 102 are provided to the user in separate packages, thus requiring the user to unpack each package and ultimately assemble the system. In some applications, these separate, sealed packages allow the sensor tray 202 and the sensor applicator 102 to be sterilized in separate sterilization processes that are specific to the contents of each package and cannot be shared with the contents of others. More specifically, the sensor tray 202, including the plug assembly 207, including the sensor 110 and the sharpened body 220, can be sterilized using radiation sterilization, such as electron beam (or "e-beam") irradiation. However, radiation sterilization can damage electrical components located within the electronics housing of the sensor control device 102. As a result, if the sensor applicator 102, including the electronics housing of the sensor control device 102, needs to be sterilized, it can be sterilized by another method, such as gas chemical sterilization using ethylene oxide, for example. However, gas-chemical sterilization can destroy enzymes or other chemical and biological agents contained on sensors 110. Due to this sterilization incompatibility, sensor tray 202 and sensor applicator 102 are typically sterilized in separate sterilization processes and then packaged separately, thereby requiring the user to ultimately assemble the components for use.

[0151] In accordance with embodiments of the present disclosure, the sensor control device 102 can be modified to provide a one-piece architecture that allows for the addition of sterilization techniques specifically designed for the one-piece architecture sensor control device. The one-piece architecture allows the sensor applicator 150 and sensor control device 102 to be shipped to a user in a single sealed package that does not require any final user assembly steps. In other words, the user need only unpack one package and then deliver the sensor control device 102 to the target monitoring location. The one-piece system architecture described herein can prove advantageous by eliminating component parts, various manufacturing process steps, and user assembly steps. This results in reduced packaging and waste, and mitigates user error or system contamination.

[0152] 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 most clearly understood with reference thereto. 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 location on a user's skin.

[0153] However, unlike the sensor control device 102 of FIG. 1, the sensor control device 5002 may include a one-piece system architecture that does not require the user to unpack multiple packages and perform final assembly of the sensor control device 5002 prior to application. In other words, upon receipt by the user, the sensor control device 5002 is already fully assembled and properly positioned within the sensor applicator 150 (FIG. 1). To use the sensor control device 5002, the user need only open a single barrier (e.g., applicator cap 708 of FIG. 3B) before delivering the sensor control device 5002 to a target monitoring location for immediate use.

[0154] As shown, the sensor control device 5002 includes an electronics housing 5004 that may optionally be generally disc-shaped and have a circular cross-section. However, in other embodiments, the electronics housing 5004 may exhibit other cross-sectional shapes, such as oval or polygonal, without departing from the scope of this disclosure. The electronics housing 5004 may be configured to house or otherwise contain various electrical components used to operate the sensor control device 5002. In at least one embodiment, an adhesive patch (not shown) may be positioned on the bottom of the electronics housing 5004. The adhesive patch may be similar to adhesive patch 105 of FIG. 1 and, therefore, may aid in adhering the sensor control device 5002 to a user's skin for use.

[0155] As shown, the sensor control device 5002 includes an electronics housing 5004 that includes a shell 5006 and a mateable mount 5008. The shell 5006 can be secured to the mount 5008 by a variety of techniques, such as a snap-fit engagement, an interference fit, sonic welding, one or more mechanical fasteners (e.g., screws), a gasket, an adhesive, or any combination thereof. In some cases, the shell 5006 can be secured to the mount 5008 such that a sealed interface occurs between the shell 5006 and the mount 5008.

[0156] The sensor control device 5002 may further include a sensor 5010 (partially visible) and a sharp 5012 (partially visible) used to aid in transcutaneous delivery of the sensor 5010 beneath the user's skin during application of the sensor control device 5002. As shown, corresponding portions of the sensor 5010 and sharp 5012 extend distally from a bottom of the electronics housing 5004 (e.g., mount 5008). The sharp 5012 may include a sharp hub 5014 configured to securely support the sharp 5012. As seen most clearly in FIG. 18B , the sharp hub 5014 may include or otherwise define a mating member 5016. To couple the sharpened body 5012 to the sensor control device 5002, the sharpened body 5012 can be advanced axially through the electronics housing 5004 until the sharpened body hub 5014 engages the top surface of the shell 5006 and the mating member 5016 extends distally from the bottom of the mount 5008. Once the sharpened body 5012 penetrates the electronics housing 5004, the exposed portion of the sensor 5010 can be received within the hollow or recessed (arcuate) portion of the sharpened body 5012. The remainder of the sensor 5010 is positioned within the electronics housing 5004.

[0157] The sensor control device 5002 may further include a sensor cap 5018, which is shown disassembled or detached from the electronics housing 5004 in FIGS. 18A-18B. The sensor cap 5018 may be removably coupled to the sensor control device 5002 (e.g., the electronics housing 5004) at or near the bottom of the mount 5008. The sensor cap 5018 may help provide a hermetic barrier surrounding the exposed portions of the sensor 5010 and sharp 5012 to protect them from gas chemical sterilization. As shown, the sensor cap 5018 may include a generally cylindrical body having a first end 5020a and an opposing second end 5020b. The first end 5020a may be open to provide access into an interior chamber 5022 defined within the body. In contrast, the second end 5020b may be closed and may be provided with or otherwise define an engagement feature 5024. As described herein, the engagement feature 5024 can assist in mating the sensor cap 5018 to a cap (e.g., applicator cap 708 of FIG. 3B) of a sensor applicator (e.g., sensor applicator 150 of FIGS. 1 and 3A-3G) and can assist in removing the sensor cap 5018 from the sensor control device 5002 when the cap is removed from the sensor applicator.

[0158] The sensor cap 5018 can be removably coupled to the electronics housing 5004 at or near the bottom of the mount 5008. More specifically, the sensor cap 5018 can be removably coupled to a mating member 5016 that extends distally from the bottom of the mount 5008. In at least one embodiment, for example, the mating member 5016 can define a set of male threads 5026a ( FIG. 18B ) that can mate with a set of female threads 5026b ( FIG. 18A ) defined by the sensor cap 5018. In some embodiments, the male and female threads 5026a, 5026b can include a square thread design (e.g., lacking a helical curvature), which can prove advantageous for molding these parts. Alternatively, the male and female threads 5026a, 5026b can include a helical threaded engagement. Thus, the sensor cap 5018 can be threadably coupled to the sensor control device 5002 at the mating member 5016 of the sharp hub 5014. In other embodiments, the sensor cap 5018 can be removably coupled to the mating member 5016 by other types of engagement, including, but not limited to, an interference fit or a friction fit, or a frangible member or material that can be broken with a small separation force (e.g., axial or rotational force).

[0159] In some embodiments, the sensor cap 5018 may include a monolithic (single) structure extending between the first end 5020a and the second end 5020b. However, in other embodiments, the sensor cap 5018 may include two or more component parts. In the illustrated embodiment, for example, the sensor cap 5018 may include a sealing ring 5028 positioned at the first end 5020a and a desiccant cap 5030 positioned at the second end 5020b. The sealing ring 5028 may help seal the inner chamber 5022, as described in more detail below. In at least one embodiment, the sealing ring 5028 may include an elastomeric O-ring. The desiccant cap 5030 may store or include a desiccant that helps maintain a preferred humidity level within the inner chamber 5022. Additionally, the desiccant cap 5030 may define or otherwise provide an engagement feature 5024 for the sensor cap 5018.

[0160] 19A and 19B are exploded isometric top and bottom views, respectively, of a sensor control device 5002 according to one or more embodiments. The shell 5006 and mount 5008 act as opposing clamshell halves that enclose or otherwise substantially enclose various electronic components of the sensor control device 5002. More specifically, the electronic components may include, but are not limited to, a printed circuit board (PCB), one or more resistors, transistors, capacitors, inductors, diodes, and switches. A data processing unit and a battery may be mounted on or otherwise interact with the PCB. The data processing unit may include, for example, an application specific integrated circuit (ASIC) configured to perform one or more functions or routines related to the operation of the sensor control device 5002. More specifically, the data processing unit may be configured to perform data processing functions, where such functions may include, but are not limited to, filtering and encoding multiple data signals, each corresponding to a user's collected analyte levels. The data processing unit may further include or otherwise communicate with an antenna for communicating with the reader device 120 (FIG. 1). A battery may power the sensor control device 5002, and more specifically, the electronic components of the PCB. For example, the battery may be any battery known to those skilled in the art, such as a coin cell battery or a button battery, as shown in FIG. 19C. In certain embodiments, the battery 1900 may include a silver oxide battery. The battery 1900 may be laser welded to the PCB and positioned to ensure that the outer diameter of the battery remains within the perimeter of the PCB. In some embodiments, the battery 1900 may be connected to the PCB using a negative battery tab 1900a and a positive battery tab 1900b.For example, the negative battery tab 1900a of the battery 1900 can be substantially planar and lie in the same plane as the negative terminal of the battery 1900, while the positive battery tab 1900b can include one or more bends such that one end of the positive terminal 1900b contacts and lies in the same plane as the positive battery terminal, while a second end configured to couple to the PCB lies in the same plane as the negative battery tab 1900a. Further, the battery 1900 can be positioned in a battery opening on the PCB to eliminate electrical interference between the negative battery tab 1900a and the PCB. Although not shown, the sensor control device 5002 can also further include an adhesive patch that can be attached to the bottom 5102 ( FIG. 19B ) of the mount 5008 and can help adhere the sensor control device 5002 to a user's skin for use.

[0161] The sensor control device 5002 may provide or otherwise include a sealed subassembly including, among other component parts, a shell 5006, a sensor 5010, a sharp 5012, and a sensor cap 5018. The sealed subassembly of the sensor control device 5002 may help isolate the sensor 5010 and sharp 5012 within an inner chamber 5022 (FIG. 19A) of the sensor cap 5018 during gas-chemical sterilization processes that may otherwise adversely affect chemical agents disposed on the sensor 5010.

[0162] The sensor 5010 may include a tail 5104 extending from an opening 5106 ( FIG. 19B ) defined in the mount 5008 for transcutaneous reception beneath the user's skin. The tail 5104 may have an enzyme or other chemical agent included thereon to help facilitate analyte monitoring. The sharp 5012 may include a sharp tip 5108 extendable through an opening 5110 ( FIG. 19A ) defined by the shell 5006, which may be coaxially aligned with the opening 5106 in the mount 5008. As the sharp tip 5108 penetrates the electronics housing 5004, the tail 5104 of the sensor 5010 may be received within a hollow or recessed portion of the sharp tip 5108. The sharp tip 5108 may be configured to penetrate the skin while carrying the tail 5104, bringing the active chemical agent in the tail 5104 into contact with bodily fluids.

[0163] The sharp tip 5108 can be advanced through the electronics housing 5004 until the sharp hub 5014 engages the top surface of the shell 5006 and the mating member 5016 extends from the opening 5106 in the bottom 5102 of the mount 5008. In some embodiments, a sealing member (not shown), such as an O-ring or seal ring, can be sandwiched between the sharp hub 5014 and the top surface of the shell 5006 to help seal the interface between these two components. In some embodiments, the sealing member can comprise a separate component part, or alternatively, can form an integral part of the shell 5006, such as a co-molded or overmolded component part.

[0164] The sealing subassembly may further include a collar 5112 disposed within the electronics housing 5004 and extending at least partially into the opening 5106. The collar 5112 may be a generally annular structure defining or otherwise providing an annular ridge 5114 on an upper surface thereof. In some embodiments, as shown, a groove 5116 may be defined within the annular ridge 5114, which may be configured to receive or otherwise accommodate a portion of the sensor 5010 that extends laterally within the electronics housing 5004.

[0165] When assembling the sealing subassembly, the bottom 5118 of the collar 5112 can be exposed at the opening 5106 and can sealingly engage the first end 5020a of the sensor cap 5018, more specifically the seal ring 5028. In contrast, the annular ridge 5114 on the top of the collar 5112 can sealingly engage the inner surface (not shown) of the shell 5006. In at least one embodiment, a seal member (not shown) can be sandwiched between the annular ridge 5114 and the inner surface of the shell 5006 to form a sealing interface. In such an embodiment, the seal member can extend (flow) into a groove 5116 defined in the annular ridge 5114, thereby sealing around the sensor 5010 extending laterally within the electronics housing 5004. The seal member can include, for example, an adhesive, a gasket, or an ultrasonic weld and can help isolate enzymes and other chemical agents contained on the tail 5104.

[0166] 20 is a cross-sectional side view of an assembled seal subassembly according to one or more embodiments. The seal subassembly 5200 may form part of the sensor control device 5002 of FIGS. 18A-18B and 19A-20B and may include a portion of the shell 5006, the sensor 5010, the sharp 5012, the sensor cap 5018, and the collar 5112. The seal subassembly 5200 may be assembled in a variety of ways. In one assembly process, the sharp 5012 may be coupled to the sensor control device 5002 by extending the sharp tip 5108 through an opening 5110 defined in the top of the shell 5006 and advancing the sharp 5012 through the shell 5006 until the sharp 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) can be sandwiched between the sharp hub 5014 and the top surface of the shell 5006 to help seal the interface between these two components.

[0167] The collar 5112 can then be received over the mating member 5016 and advanced toward the inner surface 5204 of the shell 5006 to allow the annular ridge 5114 to engage the inner surface 5204. A seal member 5206 can be sandwiched between the annular ridge 5114 and the inner surface 5204, thereby forming a sealed interface. The seal member 5206 can extend (flow) into a groove 5116 ( FIGS. 19A-20B ) defined in the annular ridge 5114, thereby sealing around the sensor 5010 extending laterally within the electronics housing 5004 ( FIGS. 19A-20B ). However, in other embodiments, the collar 5112 can first be sealed to the inner surface 5204 of the shell 5006, followed by extending the sharp 5012 and sharp hub 5014 through the opening 5110 as described above.

[0168] The internal threads 5026b of the sensor cap 5018 threadably mate with the external threads 5026a of the fitting 5016, thereby removably coupling the sensor cap 5018 to the sensor control device 5002. Tightening (rotating) the fitting engagement between the sensor cap 5018 and the fitting 5016 can urge the first end 5020a of the sensor cap 5018 into sealing engagement with the bottom 5118 of the collar 5112. Furthermore, tightening the fitting engagement between the sensor cap 5018 and the fitting 5016 can enhance the sealing interface between the sharp hub 5014 and the top of the shell 5006, and between the annular ridge 5114 and the inner surface 5204 of the shell 5006.

[0169] The inner chamber 5022 may be sized and otherwise configured to receive the tail 5104 and sharpened tip 5108. Additionally, the inner chamber 5022 may be sealed to isolate the tail 5104 and sharpened tip 5108 from substances that may adversely interact with the chemical agent in the tail 5104. In some embodiments, a desiccant 5208 (shown in dashed lines) may be present in the inner chamber 5022 to maintain the proper humidity level.

[0170] Once properly assembled, the sealing subassembly 5200 can be subjected to any of the radiation sterilization processes mentioned herein to properly sterilize the sensor 5010 and sharps 5012. This sterilization step can be performed on the remainder of the sensor control device (FIGS. 18A-18B and 19A-20B) to prevent damage to sensitive electrical components. The sealing subassembly 5200 can be subjected to radiation sterilization before or after coupling the sensor cap 5018 to the sharps hub 5014. If the sensor cap 5018 is sterilized after being coupled to the sharps hub 5014, the sensor cap 5018 can be of a material that allows radiation to propagate through it. In some embodiments, the sensor cap 5018 can be transparent or translucent, but can otherwise be opaque without departing from the scope of this disclosure.

[0171] 21A-21C are staged cross-sectional side views illustrating the assembly of a sensor applicator 102 and a sensor control device 5002 according to one or more embodiments. Once the sensor control device 5002 is fully assembled, it can be installed into the sensor applicator 102. Referring to FIG. 21A, the sharp hub 5014 can include or otherwise define hub snap tabs 5302 configured to assist in coupling the sensor control device 5002 to the sensor applicator 102. More specifically, the sensor control device 5002 can be advanced into the sensor applicator 102, and the hub snap tabs 5302 can be received by corresponding arms 5304 of a sharp carrier 5306 disposed within the sensor applicator 102.

[0172] 21B shows the sensor control device 5002 received by the sharp body carrier 5306, and thus secured within the sensor applicator 102. Once the sensor control device 5002 is installed within the sensor applicator 102, the applicator cap 210 can be coupled to the sensor applicator 102. In some embodiments, the applicator cap 210 and the housing 208 can have a set of intermateable threads 5308 that allow the applicator cap 210 to be twisted onto the housing 208 in a clockwise (or counterclockwise) direction, thereby securing the applicator cap 210 to the sensor applicator 102.

[0173] As shown, a sheath 212 is further positioned within the sensor applicator 102, and the sensor applicator 102 can include a sheath locking mechanism 5310 configured to ensure that the sheath 212 does not prematurely collapse during an impact event. In the illustrated embodiment, the sheath locking mechanism 5310 can include a threaded engagement between the applicator cap 210 and the sheath 212. More specifically, one or more internal threads 5312a can be defined or otherwise provided on an inner surface of the applicator cap 210, and one or more external threads 5312b can be defined or otherwise provided on the sheath 212. The internal threads 5312a and external threads 5312b can be configured to threadably mate when the applicator cap 210 is threaded onto the sensor applicator 102 via the threads 5308. The female and male threads 5312 a , 5312 b can have the same thread pitch as the threads 5308 that allow the applicator cap 210 to be twisted onto the housing 208 .

[0174] 21C shows the applicator cap 210 fully threaded (coupled) to the housing 208. As shown, the applicator cap 210 may further provide or otherwise define a cap post 5314 centrally positioned therein and extending proximally from the bottom of the applicator cap 210. The cap post 5314 may be configured to receive at least a portion of the sensor cap 5018 when the applicator cap 210 is twisted onto the housing 208.

[0175] With the sensor control device 5002 installed in the sensor applicator 102 and the applicator cap 210 properly secured, the sensor control device 5002 can then be subjected to a gas chemical sterilization process configured to sterilize the electronics housing 5004 and any other exposed portions of the sensor control device 5002. Because the sensor 5010 and the distal portion of the sharp 5012 are sealed within the sensor cap 5018, the chemicals used during the gas chemical sterilization process cannot interact with the enzymes, chemical and biological agents provided on the tail 5104, as well as other sensor components, such as the membrane coating that regulates analyte inflow.

[0176] 22A and 22B are perspective and top views of a cap post 5314 according to one or more additional embodiments. In the illustrated views, a portion of a sensor cap 5018 is received within the cap post 5314, and more specifically, the desiccant cap 5030 of the sensor cap 5018 is disposed within the cap post 5314.

[0177] As shown, the cap post 5314 can define a receiver feature 5402 configured to receive the engagement feature 5024 of the sensor cap 5018 when the applicator cap 210 ( FIG. 21C ) is coupled (e.g., threaded) to the sensor applicator 102 ( FIGS. 21A-21C ). However, when the applicator cap 210 is removed from the sensor applicator 102, the receiver feature 5402 can prevent the engagement feature 5024 from reversing direction, thereby preventing the sensor cap 5018 from separating from the cap post 5314. Conversely to this separation, removing the applicator cap 210 from the sensor applicator 102 simultaneously separates the sensor cap 5018 from the sensor control device 5002 (Figures 18A-18B and 21A-21C), thereby exposing the sensor 5010 (Figures 21A-21C) and the distal portion of the tip 5012 (Figures 21A-21C).

[0178] Many design variations of the receiver feature 5402 can be employed without departing from the scope of this disclosure. In the illustrated embodiment, the receiver feature 5402 includes one or more flexible members 5404 (two shown) that are expandable or flexible to receive an engagement feature 5024 ( FIGS. 18A-18B ). The engagement feature 5024 can include, for example, an enlarged head, and the flexible member 5404 can include a collet-type device including a plurality of flexible fingers configured to flex radially outward to receive the enlarged head.

[0179] The flexible member 5404 may further provide or otherwise define a corresponding raised surface 5406 configured to interact with one or more opposing cam engagement surfaces 5408 provided on the outer wall of the engagement feature 5024. The configuration and alignment of the raised surface 5406 and the opposing cam engagement surface 5408 are such that the applicator cap 210 can rotate in a first direction A (e.g., clockwise) relative to the sensor cap 5018, but the cap post 5314 binds against the sensor cap 5018 when the applicator cap 210 is rotated in a second direction B (e.g., counterclockwise). More specifically, when the applicator cap 210 (and thus the cap post 5314) rotates in the first direction A, the cam engagement surface 5408 engages the raised surface 5406, and this engagement urges the flexible member 5404 to curve radially outward or otherwise deflect, creating a ratchet effect. However, by rotating the applicator cap 210 (and thus the cap post 5314) in the second direction B, the inclined surface 5410 of the cam engagement surface 5408 is driven to collide with the opposing inclined surface 5412 of the raised surface 5406, thereby binding the sensor cap 5018 to the flexible member 5404.

[0180] 23 is a cross-sectional side view of a sensor control device 5002 disposed within an applicator cap 210 in accordance with one or more embodiments. As shown, the opening to the receiver 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 remaining outer diameter of the sensor cap 5018. When the sensor cap 5018 is extended into the cap post 5314, the flexible member 5404 of the receiver feature 5402 can bend (expand) radially outward to accommodate the engagement feature 5024. In some embodiments, as shown, the engagement feature 5024 can provide or otherwise define a sloped or frusto-conical outer surface that helps bias the flexible member 5404 radially outward. Once the engagement feature 5024 advances beyond the receiver feature 5402, the flexible member 5404 can bend back to (or towards) its natural state, thereby locking the sensor cap 5018 into the cap post 5314.

[0181] As the applicator cap 210 is threaded (twisted onto) the housing 208 ( FIGS. 21A-21C ) in a first direction A, the cap post 5314 is correspondingly rotated in the same direction, gradually introducing the sensor cap 5018 into the cap post 5314. As the cap post 5314 rotates, the raised surface 5406 of the flexible member 5404 ratchets against the opposing cam engagement surface 5408 of the sensor cap 5018. This action continues until the applicator cap 210 is fully threaded (twisted onto) the housing 208. In some embodiments, the ratcheting action can occur over two complete revolutions of the applicator cap 210 before the applicator cap 210 reaches its final position.

[0182] 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 engagement surface 5408 (i.e., the angled surface 5410 in FIGS. 22A-22B ) to engage the raised surface 5406 (i.e., the angled surface 5412 in FIGS. 22A-22B ). As a result, continued rotation of the applicator cap 210 in the second direction B correspondingly rotates the sensor cap 5018 in the same direction, thereby unscrewing it from the fitting 5016 and allowing the sensor cap 5018 to detach from the sensor control device 5002. Detaching the sensor cap 5018 from the sensor control device 5002 exposes the sensor 5010 and a distal portion of the sharp 5012, thereby positioning the sensor control device 5002 for firing (use).

[0183] 24A and 24B are cross-sectional side views of a sensor applicator 102 waiting to deploy a sensor control device 5002 at a target monitoring location in accordance with one or more embodiments. More specifically, FIG. 24A shows the sensor applicator 102 waiting to deploy (fire) the sensor control device 5002, and FIG. 24B depicts the sensor applicator 102 in the process of deploying (showing) the sensor control device 5002. As shown, the applicator cap 210 (FIGS. 21A-21C and 23) has been removed, and correspondingly, the sensor cap 5018 (FIGS. 21A-21C and 23) has been detached (removed), thereby exposing the tail 5104 of the sensor 5010 and the sharp tip 5108 of the sharp 5012, as described above. With respect to the sheath 212 and sharp body carrier 5306, the sensor applicator 102 further includes a sensor carrier 5602 (alternatively referred to as a "puck" carrier) that helps position and secure the sensor control device 5002 within the sensor applicator 102.

[0184] 24A , as shown, the sheath 212 includes one or more sheath arms 5604 (one shown) configured to interact with one or more corresponding detents 5606 (one shown) defined within the housing 208. Alternatively, the detents 5606 are referred to as “firing” detents. When the sensor control device 5002 is initially installed within the sensor applicator 102, the sheath arms 5604 can be 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 of the sensor control device 5002. As discussed below, the process of firing the sensor applicator 102 retracts the engaging member 5016 so that it does not contact the user's skin.

[0185] The sensor carrier 5602 can further include one or more carrier arms 5608 (one shown) configured to interact with one or more corresponding grooves 5610 (one shown) defined on the sharp body carrier 5306. A spring 5612 can be positioned within a cavity defined by the sharp body carrier 5306, and the spring 5612 can passively bias the sharp body carrier 5306 upward within the housing 208. However, when the carrier arm 5608 is properly received within the groove 5610, the sharp body carrier 5306 is maintained in a defined position and prevented from moving upward. The carrier arm 5608 can be sized to be sandwiched between the sheath 212 and the sharp body carrier 5306, maintaining a radial shoulder 5614 defined on the sheath 212 with the carrier arm 5608 engaged within the groove 5610, thereby maintaining the sharp body carrier 5306 in a defined position.

[0186] In Figure 24B, the sensor applicator 102 is in the process of being fired. As discussed herein with reference to Figures 3F-3G, this firing can be achieved by advancing the sensor applicator 102 toward a target monitoring location until the sheath 212 engages the user's skin. Continued pressure on the sensor applicator 102 against the skin can cause the sheath arms 5604 to disengage from the corresponding detents 5606, thereby allowing the sheath 212 to collapse into the housing 208. As the sheath 212 begins to collapse, the radial shoulders 5614 eventually disengage from their radial engagement with the carrier arms 5608, thereby allowing the carrier arms 5608 to disconnect from the grooves 5610. The passive spring force of the spring 5612 then pushes the sharp body carrier 5306 freely upward, thereby forcing the carrier arm 5608 out of engagement with the groove 5610, thereby allowing the sharp body carrier 5306 to move slightly upward within the housing 208. In some embodiments, a portion of the coil can be incorporated into the design of the spring 5612 to increase the spring force required to overcome the engagement between the carrier arm 5608 and the groove 5610. In at least one embodiment, one or both of the carrier arm 5608 and the groove 5610 can be angled to help facilitate cutting.

[0187] As the sharps carrier 5306 moves upward within the housing 208, the sharps hub 5014 can move correspondingly in the same direction, thereby achieving partial retraction of the engaging member 5016 so that the engaging member 5016 is flush, substantially flush, or near-flush with the bottom of the sensor control device 5002. As will be appreciated, such flushness ensures that the engaging member 5016 does not come into contact with the user's skin, which could otherwise adversely affect sensor insertion, cause undue pain, or prevent an adhesive patch (not shown) positioned on the bottom of the sensor control device 5002 from properly adhering to the skin.

[0188] 25A-25C are step-by-step cross-sectional side views illustrating assembly and disassembly of an alternative embodiment of a sensor applicator 102 and a sensor control device 5002 according to one or more additional embodiments. The fully assembled sensor control device 5002 can be mounted into the sensor applicator 102 by coupling the hub snap tabs 5302 into the arms 5304 of a sharp body carrier 5306 disposed within the sensor applicator 102, substantially as described above.

[0189] In the illustrated embodiment, the sheath arm 5604 of the sheath 212 can be configured to interact with a first detent 5702a and a second detent 5702b defined within the housing 208. The first detent 5702a may alternatively be referred to as the “lock” detent, and the second detent 5702b may alternatively be referred to as the “fire” detent. When the sensor control device 5002 is initially installed within the sensor applicator 102, the sheath arm 5604 can be received within the first detent 5702a. As described below, the sheath 212 can be actuated to move the sheath arm 5604 to the second detent 5702b, thereby placing the sensor applicator 102 in the fired position.

[0190] 25B , applicator cap 210 is aligned with and advanced toward housing 208 so that sheath 212 is received within applicator cap 210. Instead of rotating applicator cap 210 relative to housing 208 to couple applicator cap 210 to housing 208, the threads of applicator cap 210 can be snapped onto corresponding threads of housing 208. Axial cuts or slots 5703 (one shown) defined in applicator cap 210 can allow a portion of applicator cap 210 proximal to its threads to flex outward and snap into engagement with the threads of housing 208. When applicator cap 210 is snapped onto housing 208, sensor cap 5018 can be snapped into cap post 5314 accordingly.

[0191] 21A-21C , the sensor applicator 102 can include a sheath locking mechanism configured to ensure that the sheath 212 does not prematurely collapse during an impact event. In the illustrated embodiment, the sheath locking mechanism includes one or more ribs 5704 (one shown) defined near the base of the sheath 212 and configured to interact with one or more ribs 5706 (two shown) and a shoulder 5708 defined near the base of the applicator cap 210. The rib 5704 can be configured to engage between the rib 5706 and the shoulder 5708 while attaching the applicator cap 210 to the housing 208. More specifically, once applicator cap 210 is snapped onto housing 208, applicator cap 210 can be rotated (e.g., clockwise) such that rib 5704 of sheath 212 is positioned between rib 5706 and shoulder 5708 of applicator cap 210, which "locks" applicator cap 210 in place until a user counter-rotates applicator cap 210 to remove it for use. The engagement of rib 5704 between rib 5706 and shoulder 5708 of applicator cap 210 can prevent sheath 212 from prematurely collapsing.

[0192] In Figure 25C, the applicator cap 210 has been removed from the housing 208. As with the embodiment of Figures 21A-21C, the applicator cap 210 can be removed by counter-rotating it, which correspondingly rotates the cap post 5314 in the same direction, unscrewing the sensor cap 5018 from the fitting 5016, substantially as described above. Further, disconnecting the sensor cap 5018 from the sensor control device 5002 exposes the sensor 5010 and a distal portion of the sharp 5012.

[0193] When applicator cap 210 is unscrewed from housing 208, rib 5704 defined on sheath 212 can slide into engagement with an upper portion of rib 5706 defined on applicator cap 210. The upper portion of rib 5706 can effect an upward displacement of sheath 212 when applicator cap 210 is rotated, moving sheath 212 upward and bending sheath arm 5604 out of engagement with first detent 5702a and providing a corresponding raised surface for receipt into second detent 5702b. When sheath 212 moves into second detent 5702b, radial shoulder 5614 disengages from radial engagement with carrier arm 5608, thereby allowing the passive spring force of spring 5612 to push sharp body carrier 5306 upward, forcing carrier arm 5608 out of engagement with groove 5610. As the sharp body carrier 5306 moves upward within the housing 208, the engaging member 5016 may correspondingly retract until it is flush, substantially flush, or near-flush with the bottom of the sensor control device 5002. At this point, the sensor applicator 102 is in the fired position. Thus, in this embodiment, removing the applicator cap 210 correspondingly retracts the engaging member 5016.

[0194] 26A is an isometric bottom view of the housing 208 according to one or more embodiments. As shown, one or more longitudinal ribs 5802 (four shown) may be defined within the housing 208. The ribs 5802 may be spaced equally or unequal distances from one another and may extend substantially parallel to the centerline of the housing 208. First and second detents 5702a, 5702b may be defined on one or more of the longitudinal ribs 5802.

[0195] 27A is an isometric bottom view of housing 208 having sheath 212 and other components at least partially positioned therein. As shown, sheath 212 can provide or otherwise define one or more longitudinal slots 5804 configured to mate with longitudinal ribs 5802 of housing 208. When sheath 212 collapses into housing 208, generally as described above, ribs 5802 can be received within slots 5804 to help maintain sheath 212 aligned with the housing during its movement. As will be appreciated, this reception can achieve tighter circumferential and radial alignment within the same dimensional and tolerance constraints as housing 208.

[0196] In the illustrated embodiment, the sensor carrier 5602 can be configured to hold the sensor control device 5002 in place axially (e.g., after the sensor cap 5018 is removed) and circumferentially therewith. To provide this retention, the sensor carrier 5602 can include or otherwise define one or more support ribs 5806 and one or more flexible arms 5808. The support ribs 5806 extend radially inward to provide radial support to the sensor control device 5002. The flexible arms 5808 extend partially around the circumference of the sensor control device 5002, with ends of the flexible arms 5808 being receivable in corresponding grooves 5810 defined in the sides of the sensor control device 5002. Thus, the flexible arms 5808 have the potential to provide both axial and radial support to the sensor control device 5002. In at least one embodiment, the end of the flexible arm 5808 can be biased into a groove 5810 in the sensor control device 5002 and otherwise locked into place with a corresponding sheath locking rib 5812 provided by the sheath 212.

[0197] 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 coupled to the housing 208 by a snap-fit engagement without departing from the scope of the present disclosure. This coupling may help to hold the sensor control device 5002 in place during transport and firing.

[0198] 28 is an enlarged cross-sectional side view of a sensor applicator 102 having a sensor control device 5002 installed therein according to one or more embodiments. As discussed above, the sensor carrier 5602 can include one or more carrier arms 5608 (two shown) engageable with the sharp body carrier 5306 at corresponding grooves 5610. In at least one embodiment, the grooves 5610 can be defined by pairs of protrusions 5902 defined on the sharp body carrier 5306. Receiving the carrier arms 5608 within the grooves 5610 can help stabilize the sharp body carrier 5306 from undesired tilting during the entire retraction (firing) process.

[0199] In the illustrated embodiment, the arms 5304 of the sharp body carrier 5306 can be sufficiently rigid to provide greater control over the radial and biaxial movement of the sharp body hub 5014. In some embodiments, relative control of the height of the sharp body hub 5014 may be more critical to the design, for example, so the clearance between the sharp body hub 5014 and the arms 5304 can be more tightly constrained in both axial directions.

[0200] In the illustrated embodiment, the sensor carrier 5602 defines or otherwise provides a central ridge 5904 sized to receive the sharp hub 5014. In some embodiments, as shown, the sharp hub 5014 can be provided with one or more radial ribs 5906 (two shown). In at least one embodiment, the inner diameter of the central ridge 5904 helps provide radial and tilting support to the sharp hub 5014 during the life of the sensor applicator 102 and throughout all phases of operation and assembly. Additionally, the inclusion of multiple radial ribs 5906 increases the length-to-width ratio of the sharp hub 5014, thereby further improving support against tilting.

[0201] 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 shown separating the upper portion of applicator cap 210 near its threads. As discussed above, slots 5703 can help applicator cap 210 flex outward so that it snaps into engagement with housing 208 (FIG. 25B). In contrast, applicator cap 210 can be twisted (screwed) off of housing 208 by an end user.

[0202] FIG. 29A further depicts ribs 5706 (one visible) defined by applicator cap 210. By interlocking with ribs 5704 ( FIG. 25C ) defined on sheath 212, ribs 5706 can help lock sheath 212 in all directions to prevent premature collapse during an impact or drop event. Sheath 212 can be unlocked when a user unscrews applicator cap 210 from the housing, generally as described above. As described herein, the top of each rib 5706 can provide a corresponding raised surface 6002 that slides and engages with rib 5704 defined on sheath 212 as applicator cap 210 is rotated away from housing 208, resulting in upward displacement of sheath 212 into housing 208.

[0203] In some embodiments, additional features may be provided within applicator cap 210 to hold a desiccant component that maintains proper humidity levels over the shelf life. Such additional features may be snaps, posts suitable for press-fitting, heat staking, ultrasonic welding, etc.

[0204] 29B is an enlarged cross-sectional view of the engagement between applicator cap 210 and housing 208 in accordance with one or more embodiments. As shown, applicator cap 210 can define a set of internal threads 6004, and housing 208 can define a set of external threads 6006 that are engagable with the internal threads 6004. As described herein, applicator cap 210 can be snapped onto housing 208, which can be achieved by advancing internal threads 6004 axially past external threads 6006 in the direction indicated by the arrows, thereby bending applicator cap 210 outward. As shown, corresponding surfaces 6008 of internal and external threads 6004, 6006 can be curved, beveled, or chamfered to help facilitate this displacement. Corresponding flats 6010 can be provided on each thread 6004, 6006 and configured to matingly engage when applicator cap 210 is properly snapped into place on housing 208. These flats 6010 can slide into engagement with one another when a user unscrews applicator cap 210 from housing 208.

[0205] The threaded engagement between the applicator cap 210 and the housing 208 provides a sealed engagement that protects the internal components from moisture, dust, etc. In some embodiments, the housing 208 may define or otherwise provide a stabilizing feature 6012 configured to be received within a corresponding groove 1914 defined on the applicator cap 210. The stabilizing feature 6012 may help to stabilize and strengthen the applicator cap 210 when it is snapped onto the housing 208. The stabilizing feature 6012 may prove advantageous by providing additional drop robustness to the sensor applicator 102. Furthermore, the stabilizing feature 6012 may help to increase the removal torque of the applicator cap 210.

[0206] 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 may include an injection molded portion. This may prove advantageous by molding the internal threads 5026a defined within the inner chamber 5022, as opposed to attaching a threaded core or threading the inner chamber 5022. In some embodiments, one or more stop ribs 6102 (one visible) may be defined within the inner chamber 5022 to prevent overtravel of the point hub 5014 (FIGS. 18A-18B) relative to the mating member 5016.

[0207] 30A and 30B, in some embodiments, one or more protrusions 6104 (two shown) may be defined on the first end 5020a of the sensor cap 5018 and may be configured to mate with one or more corresponding recesses 6106 (two shown) defined on the collar 5112. However, in other embodiments, the protrusions 6104 may instead be defined on the collar 5112 and the recesses 6106 may instead be defined on the sensor cap 5018 without departing from the scope of this disclosure.

[0208] The matable protrusions 6104 and recesses 6106 may prove advantageous in rotationally locking the sensor cap 5018 to prevent unintentional 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 throughout all phases of operation / assembly. In some embodiments, as shown, the recesses 6106 may be formed or otherwise defined in a generally kidney bean shape. This shape may prove advantageous in allowing over-rotation of a portion of the sensor cap 5018 relative to the collar 5112. Alternatively, the same advantage may be achieved by a flat-end threaded engagement between the two portions.

[0209] Embodiments disclosed herein include the following.

[0210] A. A sensor control device including: an electronics housing; a sensor disposed within the electronics housing, the sensor having a tail extending from a bottom of the electronics housing; a sharp extending through the electronics housing, the sharp having a sharp tip extending from the bottom of the electronics housing; and a sensor cap removably coupled to the bottom of the electronics housing, the sensor cap defining a sealed inner chamber for receiving the tail and the sharp.

[0211] B. An analyte monitoring system including a sensor applicator and a sensor control device disposed within the sensor applicator, the sensor control device including an electronics housing, a sensor disposed within the electronics housing, the sensor having a tail extending from a bottom of the electronics housing, a sharp extending through the electronics housing, the sharp having a sharp tip extending from the bottom of the electronics housing, and a sensor cap removably coupled to the bottom of the electronics housing, the sensor cap defining an engagement feature and a sealed inner chamber that receives the tail and the sharp. The analyte monitoring system may further include a cap coupled to the sensor applicator, the cap providing a cap post defining a receiver feature that receives the engagement feature when the cap is coupled to the sensor applicator, wherein removing the cap from the sensor applicator separates the sensor cap from the electronics housing, thereby exposing the tail and the sharp tip.

[0212] C. A method of providing an analyte monitoring system, comprising: mounting a sensor control device into a sensor applicator, the sensor control device including: an electronics housing; a sensor disposed within the electronics housing, the sensor having a tail extending from a bottom of the electronics housing; a sharp extending through the electronics housing, the sharp having a sharp tip extending from the bottom of the electronics housing; and a sensor cap removably coupled to the bottom of the electronics housing, the sensor cap defining a sealed inner chamber for receiving the tail and the sharp. The method further includes securing the cap to the sensor applicator, sterilizing the sensor control device by gas chemical sterilization while the sensor control device is disposed within the sensor applicator, and isolating the tail and the sharp tip from the gas chemical sterilization within the inner chamber.

[0213] Each of embodiments A, B, and C can have one or more of the following additional elements, in any combination: Element 1: The sensor cap includes a cylindrical body having a first end open to access the inner chamber and a second end opposite the first end providing an engagement feature engageable with the cap of the sensor applicator, wherein removing the cap from the sensor applicator correspondingly removes the sensor cap from the electronics housing, thereby exposing the tail and sharp tip; Element 2: The electronics housing includes a shell mateable with the mount, wherein the sensor control device further includes a sharp and a sensor locator defined on an inner surface of the shell and a collar received around the sharp and the sensor locator, wherein the sensor cap is removably coupled to the collar; Element 3: The sensor cap is removably coupled to the collar by one or more of an interference fit, a threaded engagement, a frangible member, and a frangible material. Element 4: The annular ridge surrounding the sharpened body and the sensor locator and collar provides a cylinder and an annular shoulder extending radially outward from the cylinder, with the seal member sandwiched between the annular shoulder and the annular ridge to form a sealing interface. Element 5: The annular ridge defines a groove, with a portion of the sensor seated in the groove and the seal member extending into the groove to seal around this portion of the sensor. Element 6: The seal member is a first seal member, and the sensor control device further includes a second seal member sandwiched between the annular shoulder and a portion of the mount to form a sealing interface. Element 7: The electronics housing includes a shell matable with the mount, with the sensor control device further including a sharpened body hub carrying the sharpened body and engageable with a top surface of the shell, and a mating member defined by the sharpened body hub and extending from a bottom of the electronics housing, with the sensor cap removably coupled to the mating member. Element 8: Further including a collar at least partially receivable within an opening defined in the mount and sealingly engaging the sensor cap with an inner surface of the shell. Element 9: The seal member is sandwiched 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 seats in the groove, and the seal member extends into the groove to seal around this portion of the sensor.

[0214] Element 11: The receiver feature includes one or more flexible members that curve to receive the engagement feature, the one or more flexible members preventing the engagement feature from slipping off the cap post when the cap is removed from the sensor applicator. Element 12: The receiver feature further includes a raised surface defined on at least one of the one or more flexible members and one or more cam engagement surfaces provided by the engagement feature and engageable with the raised surface, the raised surface and the one or more cam engagement 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 housing includes a shell mateable with the mount, the sensor control device further includes a sharpened body hub carrying a sharpened body and engageable with a top surface of the shell, and a mating member defined by the sharpened body hub and extending from a bottom of the electronics housing, the sensor cap is removably coupled to the mating member, and the sensor cap is separated from the mating member by rotating the cap in a second direction. Element 14: The electronics housing includes a shell mateable with the mount, the sensor control device further includes a sharpened body and a sensor locator defined on an inner surface of the shell, and a collar received around the sharpened body and the sensor locator, and the sensor cap is removably coupled to the collar.

[0215] Element 15: The cap provides a cap post that defines a receiver feature, and the sensor cap defines an engagement feature, the method further including receiving the engagement feature by the receiver feature 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 engagement feature on the receiver feature when the cap is removed, thereby separating the sensor cap from the electronics housing and exposing the tail and sharp tip. Element 17: The step of mounting the sensor control device in the sensor applicator is preceded by the steps of sterilizing the tail and sharp tip by radiation sterilization and sealing the tail and sharp tip in the internal chamber.

[0216] As non-limiting examples, exemplary combinations applicable to A, B, and C include elements 2 and 3, elements 2 and 4, elements 4 and 5, elements 4 and 6, elements 7 and 8, elements 8 and 9, elements 9 and 10, elements 11 and 12, and elements 15 and 16.

[0217] Exemplary Embodiments of Seal Arrangements 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 may therefore be most clearly understood with reference thereto. Furthermore, the sensor control device 9102 may replace the sensor control device 102 of FIG. 1 and thus may be used in conjunction with the sensor applicator 102 of FIG. 1, which may deliver the sensor control device 9102 to a target monitoring location on a user's skin.

[0218] As shown, the sensor control device 9102 includes an electronics housing 9104, which may optionally be generally disc-shaped and have a circular cross-section. However, in other embodiments, the electronics housing 9104 may exhibit other cross-sectional shapes, such as oval, elliptical, or polygonal, without departing from the scope of this disclosure. The electronics housing 9104 includes a shell 9106 and a mount 9108 matable with the shell 9106 to form an interior space. The shell 9106 may be secured to the mount 9108 by various techniques, such as a snap-fit engagement, an interference fit, sonic welding, laser welding, one or more mechanical fasteners (e.g., screws), a gasket, an adhesive, or any combination thereof. In some cases, the shell 9106 may be secured to the mount 9108 such that a sealed interface occurs between the shell 9106 and the mount 9108. An adhesive patch 9110 may be positioned on the underside of the mount 9108 and attached thereto. Similar to adhesive patch 108 of FIG. 1, adhesive patch 9110 can be configured to secure and maintain sensor control device 9102 in a fixed position on a user's skin during operation.

[0219] The sensor control device 9102 may further include a sensor 9112 and a sharp 9114 that is used to aid in transcutaneous delivery of the sensor 9112 beneath the user's skin during application of the sensor control device 9102. Corresponding portions of the sensor 9112 and sharp 9114 extend distally from a bottom of the electronics housing 9104 (e.g., mount 9108). A sharp hub 9116 may be overmolded onto the sharp 9114 and configured to securely carry the sharp 9114. As can be seen most clearly in FIG. 31A , the sharp hub 9116 may include or otherwise define a mating member 9118. To assemble the sharpened body 9114 into the sensor control device 9102, the sharpened body 9114 can be advanced axially through the electronics housing 9104 until the sharpened body hub 9116 engages the top surface of the electronics housing 9104 or an internal component of the electronics housing 9104 and the mating member 9118 extends distally from the bottom of the mount 9108. As described below, in at least one embodiment, the sharpened body hub 9116 can sealingly engage an upper portion of a sealing overmold onto the mount 9108. As the sharpened body 9114 penetrates the electronics housing 9104, the exposed portion of the sensor 9112 can be received within the hollow or recessed (arcuate) portion of the sharpened body 9114. The remainder of the sensor 9112 is positioned within the electronics housing 9104.

[0220] The sensor control device 9102 may further include a sensor cap 9120, which is shown separated from the electronics housing 9104 in FIGS. 31A-31B. The sensor cap 9120 may help provide a sealed barrier that surrounds and protects the exposed portions of the sensor 9112 and sharp 9114. As shown, the sensor cap 9120 may include a generally cylindrical body having a first end 9122a and an opposing second end 9122b. The first end 9122a may be open to provide access into an interior chamber 9124 defined within the body. In contrast, the second end 9122b may be closed, and an engagement feature 9126 may be provided or otherwise defined thereon. 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 when the sensor cap is removed from the sensor applicator.

[0221] The sensor cap 9120 can be removably coupled to the electronics housing 9104 at or near the bottom of the mount 9108. More specifically, the sensor cap 9120 can be removably coupled to a mating member 9118 extending distally from the bottom of the mount 9108. In at least one embodiment, for example, the mating member 9118 can define a set of external threads 9128a ( FIG. 31A ) that can mate with a set of internal threads 9128b ( FIG. 31B ) defined in the inner chamber 9124 of the sensor cap 9120. In some embodiments, the external and internal threads 9128a, 9128b can include a square thread design (e.g., lacking a helical curvature), but can alternatively include a helical threaded engagement. Thus, in at least one embodiment, the sensor cap 9120 can be threadably coupled to the sensor control device 9102 at the mating member 9118 of the prong hub 9116. In other embodiments, the sensor cap 9120 may be removably coupled to the mating member 9118 by other types of engagement, including, but not limited to, an interference fit or friction fit, or a frangible member or substance (e.g., wax, adhesive, etc.) that can be broken by a slight separation force (e.g., axial or rotational force).

[0222] In some embodiments, the sensor cap 9120 may include a monolithic (single) structure extending between the first end 9122a and the second end 9122b. However, in other embodiments, the sensor cap 9120 may include two or more component parts. In the illustrated embodiment, for example, the body of the sensor cap 9120 may include a desiccant cap 9130 positioned at the second end 9122b. The desiccant cap 9130 may store or include a desiccant that helps maintain a preferred humidity level within the inner chamber 9124. Additionally, the desiccant cap 9130 may define or otherwise provide an engagement feature 9126 for the sensor cap 9120. In at least one embodiment, the desiccant cap 9130 may include an elastomeric plug inserted into the bottom end of the sensor cap 9120.

[0223] 32A and 32B are exploded isometric top and bottom views, respectively, of a sensor control device 9102 according to one or more embodiments. The shell 9106 and mount 9108 act as opposing clamshell halves that enclose or otherwise substantially enclose various electronic components (not shown) of the sensor control device 9102. Exemplary electronic components that may be positioned between the shell 9106 and the mount 9108 include, but are not limited to, batteries, resistors, transistors, capacitors, inductors, diodes, and switches.

[0224] The shell 9106 can define a first opening 9202a, and the mount 9108 can define a second opening 9202b, where the openings 9202a, b can align when the shell 9106 is properly attached to the mount 9108. As can be seen most clearly in FIG. 32A , the mount 9108 can provide or otherwise define a seat 9204 that protrudes from an inner surface of the mount 9108 at the second opening 9202b. The seat 9204 can define at least a portion of the second opening 9202b. Additionally, a channel 9206 can be defined on the inner surface of the mount 9108, where the channel 9206 can surround the seat 9202b. In the illustrated embodiment, the channel 9206 is circular in shape, although it is contemplated that the channel 9206 could alternatively be another shape, such as oval, elliptical, or polygonal.

[0225] The mount 9108 can include a molded portion made of a rigid material such as plastic or metal. In some embodiments, the seal 9208 can be overmolded onto the mount 9108, and the seal 9208 can be made of an elastomer, rubber, polymer, or another easily moldable material suitable for facilitating a sealing interface. In embodiments in which the mount 9108 is made of plastic, the mount 9108 can be molded in a first "shot" of injection molding, and the seal 9208 can be overmolded onto the mount 9108 in a second "shot" of injection molding. Thus, the mount 9108 can be referred to or otherwise characterized as a "two-shot mount."

[0226] In the illustrated embodiment, the seal 9208 is overmolded onto the mount 9108 at the base 9204 and may also be overmolded onto the bottom of the mount 9108. More specifically, the seal 9208 may define or otherwise provide a first seal element 9210a overmolded onto the base 9204 and a second seal element 9210b ( FIG. 32B ) interconnected therewith and overmolded onto the mount 9108 at the bottom of the mount 9108. In some embodiments, one or both of the seal elements 9210a, 9210b may help form a corresponding section of the second opening 9202b. While the seal 9208 is described herein as being overmolded onto the mount 9108, it is contemplated that one or both of the seal elements 9210a, 9210b may include an elastomeric component part separate from the mount 9208, such as an O-ring or gasket.

[0227] The sensor control device 9102 may further include a collar 9212, which may be a generally annular structure disposed between the shell 9106 and the mount 9208 and defining a central opening 9214. The central opening 9214 may be sized to receive the first seal element 9210a and may align with the first and second openings 9202a, 9202b when the sensor control device 9102 is properly assembled. The shape of the central opening 9214 may generally match the shape of the second opening 9202b and the first seal element 9210a.

[0228] In some embodiments, the collar 9212 may define or otherwise be provided with an annular lip 9216 on its bottom surface. The annular lip 9216 may be sized or otherwise configured to fit within or be received within a channel 9206 defined on the inner surface of the mount 9108. In some embodiments, a groove 9218 may be defined on the annular lip 9216 and may be configured to receive or otherwise receive a portion of the sensor 9112 that extends laterally within the mount 9108. In some embodiments, the collar 9212 may further define or otherwise be provided with a collar channel 9220 ( FIG. 32A ) on its upper surface that is sized to receive and otherwise fit within an annular ridge 9222 ( FIG. 32B ) defined on the inner surface of the shell 9106 when the sensor control device 9102 is properly assembled. In some embodiments, the collar 9212 may further include a plurality of tabs 9212 a ( FIG. 32C ) on its outer periphery. The tabs 9212a can be positioned flush with the top surface of the collar 9212, creating a shelf for the circuit board. In some embodiments, the circuit board can be a foldable and / or flexible PCB, as described in U.S. Provisional Patent Application No. 63 / 081,223, filed September 21, 2020, the entire contents of which are incorporated herein by reference. For example, the PCB 4000 can be mounted on the multiple tabs 9212a within the electronics housing. As can be seen in FIG. 32D , after the PCB 4000 is loaded onto the sensor mount 9108, the first portion 4000a of the PCB can be positioned under the tabs 9212a (not shown in FIG. 32D ) and can rest on the sensor mount 9108. Thereafter, the second portion 4000b of the PCB 4000 can be folded over the first portion 4000a and mounted on the multiple tabs 9212a. In some embodiments, the tabs 9212a may be of the same size or different sizes and may be evenly spaced around the circumference of the collar 9212. In some embodiments, the tabs 9212a may extend from the top surface of the collar 9212, from the bottom surface of the collar 9212, or from an intermediate location between the top and bottom surfaces of the collar 9212.32C, the collar 9212 can include three tabs 9212a, which can be of different sizes, for example, two of the tabs being the same size as one another and longer than the third tab (i.e., as measured along the circumference of the collar 9212). In addition, the tabs 9212a can be of the same width or different widths (i.e., as measured as the distance extending radially outward). In some embodiments, as can be seen in FIG. 32E, the PCB 4000 can include one or more tabs 4000c that correspond to the tabs 9212a and can mate with and secure to the tabs 9212a.

[0229] The sensor 9112 may include a tail 9224 that extends through a second opening 9202b defined in the mount 9108 and is transcutaneously received under the user's skin. The tail 9224 may have an enzyme or other chemical agent included thereon to help facilitate analyte monitoring. The sharp 9114 may include a sharp tip 9226 extendable through the first opening 9202a defined by the shell 9106. The tail 9224 of the sensor 9112 may be received within a hollow or recessed portion of the sharp tip 9226 as the sharp tip 9226 penetrates the electronics housing 9104. The sharp tip 9226 may be configured to pierce the skin while carrying the tail 9224 to bring the active chemical agent of the tail 9224 into contact with bodily fluids.

[0230] The sensor control device 9102 can provide a seal subassembly that includes, among other component parts, the shell 9106, the sensor 9112, the sharp 9114, the seal 9208, the collar 9212, and a portion of the sensor cap 9120. The seal subassembly can help isolate the sensor 9112 and the sharp 9114 within an inner chamber 9124 (FIG. 32A) of the sensor cap 9120. In assembling the seal subassembly, the sharp tip 9226 is advanced through the electronics housing 9104 until the sharp hub 9116 engages the seal 9208, and more specifically, the first seal element 9210a. A fitting 9118 on the bottom of the sharp hub 9116 can extend out of the second opening 9202b in the bottom of the mount 9108, and the sensor cap 9120 can be coupled to the sharp hub 9116 at the fitting 9118. By coupling the sensor cap 9120 to the sharp hub 9116 at the fitting 9118, the first end 9122a of the sensor cap 9120 can be biased into sealing engagement with the seal 9208, and more specifically, with the second seal element 9210b on the bottom of the mount 9108. In some embodiments, when the sensor cap 9120 is coupled to the sharp body hub 9116, a portion of the first end 9122a of the sensor cap 9120 can abut (engage) against the bottom of the mount 9108, and the sealing engagement between the sharp body hub 9116 and the first seal element 9210a may be able to absorb any tolerance variations between the features.

[0231] 33 shows a cross-sectional side view of a sensor control device 9102 according to one or more embodiments. As noted above, the sensor control device 9102 can include or otherwise incorporate a sealing subassembly 9302, which can be advantageous for isolating the sensor 9112 and sharpened body 9114 within the inner chamber 9124 of the sensor cap 9120. To assemble the sealing subassembly 9302, the sensor 9112 can be positioned within the mount 9108 such that the tail 9224 extends through the second opening 9202b at the bottom of the mount 9108. In at least one embodiment, a positioning feature 9304 can be defined on an inner surface of the mount 9108, and the sensor 9112 can define a groove 9306 that can mate with the positioning feature 9304 to properly position the sensor 9112 within the mount 9108.

[0232] With the sensor 9112 properly positioned, the collar 9212 can be installed on the mount 9108. More specifically, the collar 9212 can be positioned such that a first seal element 9210a of the seal 9208 is received in a central opening 9214 defined by the collar 9212, with the first seal element 9210a creating a radial seal against the collar 9212 at the central opening 9214. Furthermore, an annular lip 9216 defined on the collar 9212 can be received in a channel 9206 defined on the mount 9108, and a groove 9218 defined through the annular lip 9216 can be aligned to receive a portion of the sensor 9112 that traverses the channel 9206 within the mount 9108. In some embodiments, an adhesive can be injected into the channel 9206 to secure the collar 9212 to the mount 9108. The adhesive can facilitate a sealed interface between these two components and create a seal around the sensor 9112 at the location of the groove 9218, thereby isolating the tail 9224 from the interior of the electronics housing 9104.

[0233] The shell 9106 may then be mated or otherwise coupled to the mount 9108. In some embodiments, as shown, the shell 9106 may be mated to the mount 9108 through a tongue-and-groove engagement 9308 around the outer periphery of the electronics housing 9104. An adhesive may be injected (applied) into the groove portion of the engagement 9308 to secure the shell 9106 to the mount 9108 and further create a sealed mating interface. Mating the shell 9106 to the mount 9108 allows an annular ridge 9222 defined on the inner surface of the shell 9106 to be received within a collar channel 9220 defined on the top surface of the collar 9212. In some embodiments, an adhesive may be injected into the collar channel 9220 to secure the shell 9106 to the collar 9212 and further facilitate a sealed interface between the two components at this location. When the shell 9106 is mated to the mount 9108 , the first seal element 9210 a can extend at least partially through (into) a first opening 9202 a defined in the shell 9106 .

[0234] The sharp 9114 can then be coupled to the sensor control device 9102 by extending the sharp tip 9226 through aligned first and second openings 9202 a, 9202 b defined in the shell 9106 and the mount 9108, respectively. The sharp 9114 can be advanced until the sharp hub 9116 engages the seal 9208, more specifically the first seal element 9210 a. The mating member 9118 can extend (protrude) out of the second opening 9202 b at the bottom of the mount 9108 when the sharp hub 9116 engages the first seal element 9210 a.

[0235] The sensor cap 9120 can then be removably coupled to the sensor control device 9102 by threadably mating 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 sharpened tip 9226 extending from the bottom of the mount 9108. Additionally, the internal chamber 9124 can be sealed to isolate the tail 9224 and sharpened tip 9226 from substances that could adversely interact with the chemical agent in the tail 9224. In some embodiments, a desiccant (not shown) can be present in the internal chamber 9124 to maintain an appropriate humidity level.

[0236] 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 axial (e.g., along the centerline of the openings 9202a, 9202b) sealing engagement with the second seal element 9210b, further strengthening the axial sealing interface between the sharp body hub 9116 and the first seal element 9210a. Furthermore, tightening the mating engagement between the sensor cap 9120 and the fitting member 9118 can compress the first seal element 9210a, thereby achieving a strong radial sealing engagement between the first seal element 9210a and the collar 9212 at the central opening 9214. Thus, in at least one embodiment, the first seal element 9210a can help facilitate axial and radial sealing engagement.

[0237] As described above, the first and second seal elements 9210a, 9210b can be overmolded onto the mount 9108 and physically connected or otherwise interconnected. Thus, a single injection molding shot can flow through the second opening 9202b of the mount 9108 to create both ends of the seal 9208. This can prove advantageous in that multiple sealing interfaces can be generated with only a single injection molding shot. An additional benefit of the two-shot molding design is that, as opposed to using separate elastomeric components (e.g., O-rings, gaskets, etc.), the interface between the first and second shots is a more reliable bond than a mechanical seal. Thus, the effective number of mechanical sealing barriers is essentially halved. Furthermore, two-shot components with a single elastomeric shot also have the implication of minimizing the number of two-shot components required to achieve all necessary sterility barriers. Once properly assembled, the sealing subassembly 9302 can be subjected to a radiation sterilization process to sterilize the sensor 9112 and sharps 9114. The sealing subassembly 9302 can be subjected to radiation sterilization before or after coupling the sensor cap 9120 to the sharps hub 9116. If the sensor cap 9120 is sterilized after being coupled to the sharps 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, although it can otherwise be opaque without departing from the scope of this disclosure.

[0238] FIG. 33A shows an exploded isometric view of a portion of another embodiment of the sensor control device 9102 of FIGS. 31A-31B and 32A-32B. The embodiments included above described the mount 9108 and seal 9208 being manufactured via a two-shot injection molding process. However, in other embodiments, as briefly indicated above, one or both of the seal elements 9210a, 9210b of the seal 9208 can include elastomeric component parts separate from the mount 9208. In the illustrated embodiment, for example, the first seal element 9210a can be overmolded onto the collar 9212, and the second seal element 9210b can be overmolded onto the sensor cap 9120. Alternatively, the first and second seal elements 9210a, 9210b can include separate component parts, such as a gasket or O-ring 9210a, positioned on the top surface of the collar 9212 ( FIGS. 32C and 33A ) and the sensor cap 9120, respectively. Tightening (rotating) the mating engagement between the sensor cap 9120 and the mating member 9118 can urge the second seal element 9210b into axial sealing engagement with the bottom of the mount 9108, enhancing the sealing interface between the sharp hub 9116 and the first seal element 9210a in the axial direction. In some embodiments, as shown in FIG. 33B , the sharp hub 9116 can include a raised mating surface 9116a (e.g., a ledge) configured to mate with the seal element 9210a. Thus, tightening (rotating) the mating engagement between the sensor cap 9120 and the mating member 9118 can enhance the sealing interface between the axial mating surface 9116a and the first seal element 9210a.

[0239] FIG. 34A shows an isometric bottom view of a mount 9108 according to one or more embodiments, and FIG. 34B shows an isometric top view of a sensor cap 9120 according to one or more embodiments. As shown in FIG. 34A, the mount 9108 can provide or otherwise define one or more recesses or pockets 9402 at or near the opening to the second opening 9202b. As shown in FIG. 34B, the sensor cap 9120 can provide or otherwise define one or more protrusions 9404 at or near its first end 9122a. The protrusions 9404 can be received in the pockets 9402 when the sensor cap 9120 is coupled to the point hub 9116 (FIGS. 32A-32B and 93). More specifically, as described above, when the sensor cap 9120 is coupled to the mating member 9118 ( FIGS. 32A-32B and 93 ) of the sharp hub 9116, the first end 9122 a of the sensor cap 9120 is brought into sealing engagement with the second seal element 9210 b. In this process, the protrusion 9404 can be received within the pocket 9402, which can help prevent premature unscrewing of the sensor cap 9120 from the sharp hub 9116.

[0240] 35A and 35B are side and cross-sectional side views, respectively, of an exemplary sensor applicator 9502 according to one or more embodiments. The sensor applicator 9502 may be similar in some respects to the sensor applicator 102 of FIG. 1 and, as such, may be designed to deliver (fire) a sensor control device such as the sensor control device 9102. FIG. 35A illustrates how the sensor applicator 9502 may be shipped to and received by a user, and FIG. 35B depicts the sensor control device 9102 positioned within the sensor applicator 9502.

[0241] 35A , the sensor applicator 9502 includes a housing 9504 and an applicator cap 9506 removably coupled thereto. In some embodiments, the applicator cap 9506 can be threaded onto the housing 9504 and can include an opening ring 9508. When the applicator cap 9506 is rotated (e.g., twisted off) relative to the housing 9504, the opening ring 9508 threads off, thereby allowing the applicator cap 9506 to be released from the sensor applicator 9502.

[0242] 35B, the sensor control device 9102 is positioned within the sensor applicator 9502. Once the sensor control device 9102 is fully assembled, it can then be installed into the sensor applicator 9502, and an applicator cap 9506 can be coupled to the sensor applicator 9502. In some embodiments, the applicator cap 9506 and housing 9504 can have opposing matable thread sets that allow the applicator cap 9506 to be twisted onto the housing 9504 in a clockwise (or counterclockwise) direction, thereby securing the applicator cap 9506 to the sensor applicator 9502.

[0243] By securing the applicator cap 9506 to the housing 9504, the second end 9122b of the sensor cap 9120 can be received in a cap post 9510 positioned within the applicator cap 9506 and extending proximally from a bottom of the applicator cap 9506. The cap post 9510 can be configured to receive at least a portion of the sensor cap 9120 when the applicator cap 9506 is coupled to the housing 9504.

[0244] 36A and 36B are perspective and top views, respectively, of a cap post 9510 in accordance with one or more additional embodiments. In the depicted depiction, a portion of a sensor cap 9120 is received within the cap post 9510, and more specifically, the desiccant cap 9130 of the sensor cap 9120 is disposed within the cap post 9510. The cap post 9510 can define a receiver feature 9602 configured to receive the engagement feature 9126 of the sensor cap 9120 when the applicator cap 9506 ( FIG. 35B ) is coupled (e.g., threaded) to the sensor applicator 9502 ( FIGS. 35A-35B ). However, when the applicator cap 9506 is removed from the sensor applicator 9502, the receiver feature 9602 can prevent the engagement feature 9126 from reversing direction, thereby preventing the sensor cap 9120 from separating from the cap post 9510. Instead, removing the applicator cap 9506 from the sensor applicator 9502 simultaneously detaches the sensor cap 9120 from the sensor control device 9102 (Figures 31A-32B and 32A-32B), thereby exposing the sensor 9112 (Figures 32A-32B) and the distal portion of the tip 9114 (Figures 32A-32B).

[0245] Many design variations of the receiver feature 9602 can be employed without departing from the scope of this disclosure. In the illustrated embodiment, the receiver feature 9602 includes one or more flexible members 9604 (two shown) that are stretchable or flexible to receive the engagement feature 9126. The engagement feature 9126 can include, for example, an enlarged head, and the flexible member 9604 can include a collet-type device including a plurality of flexible fingers configured to bend radially outward to receive the enlarged head.

[0246] The flexible member 9604 may further provide or otherwise define corresponding raised surfaces 9606 configured to interact with one or more opposing cam engagement surfaces 9608 provided on an outer wall of the engagement feature 9126. The configuration and alignment of the raised surfaces 9606 and the opposing cam engagement surfaces 9608 are such that the applicator cap 9506 can rotate 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 post 9510 binds against the sensor cap 9120. More specifically, when the applicator cap 9506 (and thus the cap post 9510) is rotated in the first direction A, the cam engagement surfaces 9608 engage the raised surfaces 9606, thereby urging the flexible member 9604 to bend or otherwise deflect radially outward, creating a ratchet effect. However, by rotating the applicator cap 9506 (and therefore the cap post 9510) in the second direction B, the inclined surface 9610 of the cam engagement surface 9608 is driven to collide with the opposite inclined surface 9612 of the raised surface 9606, thereby causing the sensor cap 9120 to bind to the flexible member 9604.

[0247] 37 is a cross-sectional side 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 receiver feature 9602 defines a first diameter D3, while the engagement feature 9126 of the sensor cap 9120 defines 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. When the sensor cap 9120 is extended into the cap post 9510, the flexible member 9604 of the receiver feature 9602 can bend (expand) radially outward to accommodate the engagement feature 9126. In some embodiments, as shown, the engagement feature 9126 can provide or otherwise define a sloped outer surface that helps bias the flexible member 9604 radially outward. Once the engagement feature 9126 advances beyond the receiver feature 9602, the flexible member 9604 can bend back to (or towards) its natural state, thereby locking the sensor cap 9120 into the cap post 9510.

[0248] As the applicator cap 9506 is threaded (twisted onto) the housing 9504 ( FIGS. 35A-35B ) in a first direction A, the cap post 9510 is correspondingly rotated in the same direction, gradually introducing the sensor cap 9120 into the cap post 9510. As the cap post 9510 rotates, the raised surface 9606 of the flexible member 9604 ratches against the opposing cam engagement surface 9608 of the sensor cap 9120. This action continues until the applicator cap 9506 is fully threaded (twisted onto) the housing 9504. In some embodiments, the ratcheting action can occur over two complete revolutions of the applicator cap 9506 until the applicator cap 9506 reaches its final position.

[0249] 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 engagement surface 9608 (i.e., the angled surface 9610 in FIGS. 36A-36B ) to engage the raised surface 9606 (i.e., the angled surface 9612 in FIGS. 36A-36B ). Accordingly, continued rotation of the applicator cap 9506 in the second direction B 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 detach from the sensor control device 9102. Detaching the sensor cap 9120 from the sensor control device 9102 exposes the sensor 9112 and a distal portion of the sharp 9114, thereby positioning the sensor control device 9102 for firing (use).

[0250] FIG. 38A is a cross-sectional view of a sensor control device 9800 illustrating an exemplary interaction between the sensor and the sharp. After assembly of the sharp, the sensor must be seated within the channel defined by the sharp. While the sensor control device in FIG. 9 does not show the sensor biased inward and otherwise fully aligned with the sharp, such bias and alignment may be the case upon full assembly, where the sensor may experience some biasing force at the location indicated by the two arrows A. Biasing the sensor against the sharp can have the advantage that any relative movement between the sensor and sharp during subcutaneous insertion does not expose the sensor tip (i.e., tail) outside the sharp channel, which could potentially result in insertion failure.

[0251] 38B-38D illustrate a sharp hub 205014 and sharp 209114 configured to unbias the sensor 11900 prior to delivery, e.g., during shipping and storage (FIG. 15B), and to bias the sensor 11900 during sensor delivery (FIG. 38C). By storing and transporting the sensor in an unbiased (relaxed or unstressed) position, the sensor may have a longer shelf life and / or a lower overall stress. Furthermore, storing and transporting the sensor in an unbiased position may reduce stress relaxation over the shelf life, thereby limiting loss of bias due to stress relaxation. Therefore, the bias during sensor delivery may be more predictable and consistent with the design. The sharp 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, and the protrusion 11912 can extend through the window 209114. In such a configuration, the bottom end 11908a is not biased toward the tip, thus allowing the sensor 11900 to be in a relaxed state. During firing, the needle carrier 201102 can be partially retracted, thereby retracting the tip 209114 to a partially retracted position. Partial retraction can occur when the sheath 20704 initially moves proximally relative to the sensor carrier 20710 during firing. Each sharp body carrier locking arm 20710K (see FIG. 9D) of the sensor carrier 20710 can extend radially outward when the rib 20710M of the retention arm 20710L engages a respective slot 20704Q (see FIG. 8M) in the sheath 20704, thereby allowing the sharp body carrier retention feature 20710L to engage the post-partially retracted retention surface 201102B (see FIG. 10C) of the sharp body carrier 201102 through the pre-partially retracted retention surface 201102A. In the partially retracted position, the window 209114A no longer receives the protrusion 11912 and the sharp body 209114 engages the protrusion 11912, which biases the bottom end 11908a towards the sharp body 209114 into the correct position for delivery as described above.

[0252] Embodiments disclosed herein include the following.

[0253] D. A sensor control device including: an electronic housing including a shell defining a first opening; a mount defining a second opening alignable with the first opening when the shell is coupled to the mount; a seal overmolded on the mount at the second opening, the seal including a first seal element overmolded on a pedestal protruding from an inner surface of the mount and a second seal element interconnected with the first seal element and overmolded on a bottom of the mount; a sensor disposed within the electronic housing, the sensor having a tail extending through the second opening and past the bottom of the mount; and a pointed body extending through the first and second openings and past the bottom of the electronic housing.

[0254] E. An assembly including: a sensor applicator, a sensor control device disposed within the sensor applicator, the sensor control device including a shell defining a first opening, a mount defining a second opening alignable with the first opening when the shell is mated to the mount, a seal overmolded on the mount at the second opening, the seal including a first seal element overmolded on a pedestal protruding from an inner surface of the mount and a second seal element interconnected with the first seal element and overmolded on a bottom of the mount, a sensor disposed within the electronics housing, the sensor having a tail extending through the second opening and past the bottom of the mount, and a sharp extending through the first and second openings and past the bottom of the electronics housing, The assembly further includes a sensor cap removably coupled to the sensor control device at the bottom of the mount, the sensor cap defining a sealed inner chamber that receives the tail and the sharp, and an applicator cap coupled to the sensor applicator.

[0255] Each of embodiments D and E can have one or more of the following additional elements, in any combination: Element 1: The mount includes a first injection-molded part formed in a first shot, and the seal includes a second injection-molded part overmolded onto the first injection-molded part in a second shot. Element 2: Further including a sharpened hub carrying a sharpened point and sealingly engaging the first seal element, and a sensor cap removably coupled to the sharpened hub at a bottom of the mount and sealingly engaging the second seal element, the sensor cap defining an inner chamber for receiving the tail and the sharpened point. Element 3: The sharpened point hub provides a fitting member extending past the bottom of the mount, the sensor cap being removably coupled to the fitting member. Element 4: Further including one or more pockets defined on the bottom of the mount at a second opening, and one or more protrusions defined on an end of the sensor cap receivable in the one or more pockets when the sensor cap is coupled to the sharpened hub. Element 5: A collar disposed within the electronics housing, the collar defining a central opening for radially receiving and sealingly engaging the first seal element. Element 6: A channel defined on an inner surface of the mount and surrounding the seat, an annular lip defined on an underside of the collar mateable with the channel, and adhesive disposed within the channel to secure and seal the collar to the mount at the location of the channel. Element 7: A groove defined through the annular lip for receiving a portion of the sensor extending laterally within the mount, the adhesive sealing around the sensor at the location of the groove. Element 8: A collar channel defined on an upper surface of the collar, an annular ridge defined on an inner surface of the shell mateable with the collar channel, and adhesive disposed within the collar channel to secure and seal the shell to the collar. Element 9: One or both of the first and second seal elements define at least a portion of the second opening. Element 10: The first seal element extends at least partially through the first opening when the shell is coupled to the mount.

[0256] Element 11: The sensor control device further includes a sharps hub that carries the sharps and sealingly engages the first seal element, and the sensor cap is removably coupled to the sharps hub at the bottom of the mount and sealingly engages the second seal element. Element 12: The sensor control device further includes one or more pockets defined on the bottom of the mount at the second opening and one or more protrusions defined on an end of the sensor cap that are receivable in the one or more pockets when the sensor cap is coupled to the sharps hub. Element 13: The sensor control device further includes a collar disposed within the electronics housing, the collar defining a central opening that radially receives and sealingly engages the first seal element. Element 14: The sensor control device further includes a channel defined on an inner surface of the mount and surrounding the seat, an annular lip defined on an underside of the collar that is mateable with the channel, and adhesive disposed within the channel to secure and seal the collar to the mount at the location of the channel. Element 15: Further includes a groove defined through the annular lip for receiving a portion of the sensor extending laterally within the mount, with adhesive sealing around the sensor at the location of the groove. Element 16: Further includes a collar channel defined on the upper surface of the collar, an annular ridge defined on the inner surface of the shell and mateable with the collar channel, and adhesive disposed within the collar channel for securing and sealing the shell to the collar. Element 17: One or both of the first and second sealing elements defines at least a portion of the second opening. Element 18: The first sealing element extends at least partially through the first opening.

[0257] As non-limiting examples, exemplary combinations applicable to D and E include elements 2 and 3, elements 2 and 4, elements 5 and 6, elements 6 and 7, elements 5 and 8, elements 11 and 12, elements 13 and 14, elements 14 and 15, and elements 13 and 16.

[0258] Exemplary Firing Mechanisms for One-Piece and Two-Piece Applicators 39A-39F illustrate exemplary details of an embodiment of the internal device configuration for "firing" the applicator 216 to apply the sensor control device 222 to a user, including safely retracting the sharpened body 1030 back into the used applicator 216. These figures, taken together, depict an exemplary sequence of driving the sharpened body 1030 (carrying a sensor coupled to the sensor control device 222) into the user's skin, withdrawing the sharpened body while leaving the sensor in operable contact with the user's interstitial fluid, and adhesively adhering the sensor control device to the user's skin. With reference to these figures, one skilled in the art will be able to understand modifications of such operations for use with alternative applicator assembly embodiments and components. Furthermore, the applicator 216 can be a sensor applicator having a one-piece or two-piece architecture as disclosed herein.

[0259] 39A , the sensor 1102 is supported within the tip 1030 slightly above the user's skin 1104. Rails 1106 (optionally three rails 1106) in the upper guidance zone 1108 can be provided to control movement of the applicator 216 relative to the sheath 318. The sheath 318 is held within the applicator 216 by detent features 1110 such that an appropriate downward force along the longitudinal axis of the applicator 216 will overcome the resistance provided by the detent features 1110, allowing the tip 1030 and sensor control device 222 to translate along the longitudinal axis into (and onto) the user's skin 1104. Additionally, a catch arm 1112 on the sensor carrier 1022 engages the tip retraction assembly 1024 to maintain the tip 1030 in position relative to the sensor control device 222.

[0260] 39B, a user force is applied to overcome and disable the detent feature 1110, causing the sheath 318 to collapse into the housing 314 and drive the sensor control device 222 (together with the attached portions) to translate downward along the longitudinal axis as shown by arrow L. The inner diameter of the upper guide zone 1108 of the sheath 318 constrains the position of the carrier arm 1112 throughout the entire stroke of the sensor / sharp insertion process. The retention of the stop surface 1114 of the carrier arm 1112 against the complementary surface 1116 of the sharp retraction assembly 1024 maintains the position of these members with the return spring 1118 fully biased.

[0261] In Figure 39C, the sensor 1102 and tip 1030 reach maximum insertion depth. In doing so, the carrier arm 1112 passes through the inner diameter of the upper guide zone 1108. The compressive force of the coil return spring 1118 then drives the angled stop surface 1114 radially outward, exerting a force that drives the tip carrier 1102 of the tip retraction assembly 1024 to pull the (slotted or otherwise configured) tip 1030 out of the user and away from the sensor 1102, as shown by arrow R in Figure 39D.

[0262] With the sharpened tip 1030 fully retracted, as shown in Figure 39E, the final locking feature 1120 engages with the upper guidance zone 1108 of the sheath 318. As shown in Figure 39F, the used applicator assembly 216 is removed from the insertion site, leaving the sensor control device 222 behind and with the sharpened tip 1030 safely secured inside the applicator assembly 216. At this point, the used applicator assembly 216 is ready to be discarded.

[0263] Actuation of the applicator 216 when attaching the sensor control device 222 is designed to give the user the sensation that both insertion and retraction of the tip 1030 are performed automatically by the internal mechanisms of the applicator 216. In other words, the present invention avoids the user from experiencing the sensation of forcing the tip 1030 into their skin. Thus, after the user applies enough force to overcome the resistance from the detent features of the applicator 216, the resulting behavior of the applicator 216 is perceived as an automatic response to the applicator being “triggered.” Even though all of the driving force to insert the tip 1030 is provided by the user and no additional biasing / driving means are used, the user does not perceive that they are providing additional force to drive the tip 1030 to penetrate the skin. As detailed above in FIG. 39C , retraction of the tip 1030 is automated by the coil return spring 1118 of the applicator 216.

[0264] For any of the applicator embodiments described herein, and for any of the components of the applicator embodiments, including embodiments of the sharpened body, sharpened body module, and sensor module, those skilled in the art will understand that these embodiments can be sized and configured to be suitable for use with a sensor configured to sense an analyte level in a bodily fluid within the epidermis, dermis, or subcutaneous tissue of a subject. In some embodiments, for example, the sharpened body and the distal portion of the analyte sensor disclosed herein can both be sized and configured to be positioned at a particular distal depth (i.e., the deepest point of penetration into a tissue or layer of a subject's body, e.g., the epidermis, dermis, or subcutaneous tissue). For some applicator embodiments, those skilled in the art will understand that certain embodiments of the sharpened body can be sized and configured to be positioned within a subject's body at a distal depth that is different from the final distal depth of the analyte sensor. In some embodiments, for example, the sharpened body can be positioned at a first distal depth within the subject's epidermis prior to retraction, while the distal portion of the analyte sensor can be positioned at a second distal depth within the subject's dermis. In other embodiments, the tip may be positioned at a first distal depth within the dermis of the subject prior to retraction, while the distal portion of the analyte sensor may be positioned at a second distal depth within the subcutaneous tissue of the subject. In yet other embodiments, the tip may be positioned at a first distal depth prior to retraction, and the analyte sensor may be positioned at a second distal depth, where the first and second distal depths are both within the same layer or tissue of the subject's body.

[0265] Additionally, with respect to any of the applicators described herein, one skilled in the art will understand that the analyte sensor and one or more structured components coupled to the analyte sensor, including but not limited to one or more spring mechanisms, can be positioned within the applicator in an off-center location relative to one or more axes thereof. In some applicator embodiments, for example, the analyte sensor and spring mechanism can be positioned off-center on a first side of the applicator relative to the applicator axis, and the sensor electronics can be positioned off-center on a second side of the applicator relative to the applicator axis. In other applicator embodiments, the analyte sensor, spring mechanism, and sensor electronics can be positioned off-center on the same side of the applicator axis. One skilled in the art will understand that other permutations and configurations in which any or all of the analyte sensor, spring mechanism, sensor electronics, and other applicator components are positioned in central or off-center locations relative to one or more axes of the applicator are possible and fully within the present disclosure.

[0266] Several deflectable structures are described herein, including, but not limited to, deflectable detent snap 1402, deflectable locking arm 1412, sharp body carrier locking arm 1524, sharp body retention arm 1618, and module snap 2202. These deflectable structures comprise a resilient material, such as plastic or metal (or other), and operate in a manner known to those skilled in the art. Each deflectable structure has a resting state or position that biases the resilient material toward it. When a force is applied to deflect or move the structure from this resting state or position, this bias of the resilient material returns the structure to this resting state or position upon removal (or weakening) of the force. In many instances, these structures are configured as arms with detents or snaps, although other structures or configurations possessing the same characteristics of deflectability and ability to return to a resting position can be used, including, but not limited to, legs, clips, catches, abutments, and the like on the deflectable member.

[0267] Body-worn device configuration details Certain elements of body-worn device fabrication may be applicable to any or all of the electrical connection configurations described above. FIGS. 40A-40D provide top ( FIG. 40A ) and bottom ( FIG. 40B-40D ) schematic views of an exemplary body-worn device subassembly. A socket 4802 or mount, along with other associated components including a processor 4004 (e.g., an ASIC including communications functions), a thermistor / thermocouple 4006, a battery mount 4008, etc., are attached through vias in a printed circuit board 4000. With these components loaded onto the circuit board 4800 as shown in FIG. 40C , the socket 4002 is adhered (e.g., using heat staking) to the circuit board 4000. With the battery 4010 in place, the circuit board 4000 is ready for assembly into the body-worn device.

[0268] The circuit board 4000 is awaiting an overmolding process or other encapsulation method. As shown in Figures 41A-41D, the circuit board 4000 is first placed into a two-piece mold 4102, 4104. Once the mold slide 4106 is inserted, the molds 4102, 4104 are closed, as shown in Figure 41B. As shown in Figure 41C, a thermoplastic material is injected into the molds 4102, 4104, encapsulating the circuit board 4000. As shown in Figure 41D, the molds 4102, 4104 are opened, ejecting the near-finished part.

[0269] Alternatively, the enclosure of the electronics assembly of the body-worn device 4212 can include elements snapped together (or welded / glued) as shown in the assembly diagram of FIG. 42A , the assembled state diagram of FIG. 42B , and the cross-sectional perspective view of FIG. 42C . The enclosure including the shell 4202 and the mount 4204 can be used to hermetically enclose and protect the circuit board 4000. The enclosure formed by coupling the shell 4202 and the mount 4204 together may be referred to herein as the interior space of the electronics housing. The circuit board 4000 can be formed according to any process and is not limited to the fabrication methods and combinations of components discussed above. In the case of snap-fitting, various interference-fit or snap-fit elements (e.g., annular rim 4206) can be provided, such as around the entire periphery of the housing, or as separate snap-fit connectors (not shown). Notably, such an approach can benefit from a supplemental O-ring sealing element to prevent fluid intrusion. Alternatively or additionally, a cured adhesive can be used at the snap joint to ensure a good seal, particularly with respect to the continuous annular snap feature 4206. As can be seen in FIG. 42C , a recess 4208 or other feature can be provided to ensure that any adhesive 4210 that may be extruded during assembly is not forced into an area where it could interfere with the operation and assembly of the body worn device 4212. In some embodiments, when the shell 4202 and mount 4204 are mated together with the bead of adhesive 4210 in place as shown, the recess 4208 not only provides space to capture the extruded adhesive 4210, but also provides additional surface area for a thicker layer of adhesive 4210 to seal the joint.

[0270] 43A , by way of example and not limitation, an electronics housing for a body worn device or sensor control device can include a shell 4302 and a mount 4304 that can be ultrasonically welded together to hermetically enclose and protect a circuit board 4306. The shell 4302 can be configured to have a shell inner perimeter 4310 a and a shell outer perimeter 4308 a, and the mount 4304 can be configured to have a mount inner perimeter 4310 b and a mount outer perimeter 4308 b. When connecting the shell and mount by ultrasonic welding means, ultrasonic welding can be applied along the inner perimeters 4310 a, 4310 b and outer perimeters 4308 a, 4308 b of the shell and mount, respectively. The respective inner perimeters 4310 a, 4310 b and outer perimeters 4308 a, 4308 b can be ultrasonically welded at a joining interface that includes an energy director that concentrates ultrasonic welding energy and abruptly initiates connection of the shell 4302 and the mount 4304 by fusing them around their respective perimeters. The energy director can be located on either or both of the shell 4302 and the mount 4304. As shown in FIG. 43C , the mating interface can be a butt joint, a shoulder joint, a tongue and groove joint, a combination of these joints, or any other type of joint. In accordance with the presently disclosed subject matter, a circuit board 4306 can be located between the shell 4302 and the mount 4304. The mount 4304 can have a connector 4314 on the circuit board 4306 that connects to the analyte sensor assembly. The analyte sensor assembly can have any of the analyte sensor features described above, including a distal portion and a proximal portion. The proximal portion of the analyte sensor can extend into the interior space of the electronics housing such that one or more sensor contacts thereof are electrically coupled to the connector 4314 on the circuit board 4306. The distal portion can extend from the bottom of the electronics housing.

[0271] In some embodiments, ultrasonic welding can be applied along only either the respective inner perimeters 4310a, 4310b or the outer perimeters 4308a, 4308b. In this manner, the respective outer perimeters 4308a, 4308b can be ultrasonically welded, while the respective inner perimeters 4310a, 4310b can be secured by other means, such as, but not limited to, adhesives. Alternatively, the respective inner perimeters 4310a, 4310b can be ultrasonically welded, while the respective outer perimeters 4308a, 4308b can be secured by other means, such as, but not limited to, adhesives. The enclosure (the interior space of the electronics housing) can be configured such that only the unbroken outer perimeters 4308a, 4308b are present, and the inner perimeters 4310a, 4310b are absent. For example, the enclosure can be shaped like a "C." In another embodiment, the mount 4304 can have an inner perimeter 4310b, but the shell 4302 does not have an inner perimeter 4310a; in this embodiment, only the respective outer perimeters 4308a, 4308b can be ultrasonically welded.

[0272] The mount 4304 may include an opening 4312 that can expose a connector 4314 on the circuit board 4306. A seal 4316 may be disposed around the periphery of the opening 4312 and between the shell 4302 and the mount 4304, and the seal 4316 may be configured to prevent ingress of contaminants into the enclosure. In some embodiments, the seal 4316 may be disposed in the interior space of the electronics housing so as to be disposed around either or both of the first opening 4312, 4606, and the second opening 4608. The seal 4316 may be configured to provide a seal around at least a portion of the proximal portion of the analyte sensor 9112 that extends into the interior of the electronics housing to protect the interior space from contaminants (such as, but not limited to, sweat and other abrasives). Thus, the seal is configured to prevent ingress of contaminants into the interior space of the electronics housing or the enclosure. The seal 4316 may be configured to seal the conductive portion or sensor contacts of the sensor 9112 within the electronics housing. In other words, the seal 4316 can be disposed around a non-conductive portion of the sensor 9112. The seal 4316 can be made from an elastomer, such as silicone rubber, a thermoplastic elastomer, or any other material. According to embodiments disclosed herein, the seal can be non-conductive. According to the subject matter of the present disclosure, the seal 4316 can be disposed between the circuit board 4306 and the mount 4304, with the circuit board 4306 itself being between the shell 4302 and the mount 4304. The seal 4316 can be compressed to improve the seal created around the periphery of the opening 4312. Furthermore, the height of the uncompressed seal 4316 can be greater than the height of the internal gap 4320 between the shell 4302 and the mount 4304. When the seal is disposed between the circuit board 4306 and the mount 4304, the maximum height of the uncompressed seal 4316 can be greater than the height of the internal gap 4322 between the circuit board 4306 and the mount 4304 at the location of this maximum height. In accordance with the presently disclosed subject matter, the seal 4316 can have an irregular cross-section, for example, as shown in FIG. 43A.The internal gap 4322 between the circuit board 4306 and the mount 4304 can vary along the cross section of the seal 4316, so that the seal 4316 is compressed at its maximum height and at other locations along the cross-sectional height of the seal 4316 shown in FIG. 43A. The mount can include a conduit 4318 for properly seating the seal 4316. The conduit 4318 can aid in the construction of the enclosure.

[0273] Due to the height difference between the gap 4320 in the enclosure and the height of the seal 4316, it may be advantageous to clamp the enclosure and internal electronics assembly with a clamping force to sufficiently compress the seal 4316 while ultrasonically welding the inner perimeters 4310a, 4310b and outer perimeters 4308a, 4308b of the shell 4302 and mount 4304, respectively. Such clamping may be achieved using a vice, nest, jig, fixture, or other method known to those skilled in the art. Furthermore, to achieve ultrasonic welding, an ultrasonic horn may apply pressure to the shell 4302 with a pneumatically or electronically driven press, thereby stiffening the enclosure against the clamping means. By vibrating the ultrasonic horn at a high frequency, the vibrations are transmitted through the shell 4302 toward the mount 4304. These vibrations generate heat within the shell 4302 and mount 4304, causing the shell 4302 and mount 4304 to melt and fuse together at their joining interface. The clamping force can be applied for a predetermined time sufficient to fuse the shell 4302 and the mount 4304 together. After the shell 4302 and the mount 4304 have been fused together, the clamping force can be removed and the ultrasonic horn can be retracted. The enclosure can then be removed as an assembly from the fastening means.

[0274] Although ultrasonic welding has been described for the purpose of attaching the shell 4302 and the mount 4304, it is contemplated that ultrasonic welding may be used to join two or more portions of any body worn device, insertion device, or other element of an analyte monitor system.

[0275] FIG. 43B illustrates an exemplary method 4300 of constructing a body-worn device in accordance with the presently disclosed subject matter. The method may begin at step 4324, where the method may include assembling an enclosure. The enclosure may include a shell having an outer upper shell perimeter and an inner upper shell perimeter, a mount having an opening with a perimeter, an outer mounting base perimeter, and an inner mounting base perimeter, a circuit board disposed between the shell and the mount, and a seal disposed between the shell and the mount. In step 4326, the method may include mounting the shell and the mount within a support such that the seal is held in compression between the shell and the mount. In step 4328, the method may include ultrasonically welding the outer upper shell perimeter to the outer mounting base perimeter. In step 4330, the method may include ultrasonically welding the inner upper shell perimeter to the inner mounting base perimeter. In accordance with the presently disclosed subject matter, the method may repeat one or more steps of the method of FIG. 43B as appropriate. Although the present disclosure describes and illustrates certain steps of the method of Figure 43B as being performed in a particular order, the present disclosure contemplates any suitable steps of the method of Figure 43B being performed in any suitable order. Further, while the present disclosure describes and illustrates example methods of configuring a body-worn device that include certain steps of the method of Figure 43B, the present disclosure contemplates any suitable method of configuring a body-worn device that includes any suitable steps, which may include all, some, or none of the steps of the method of Figure 43B. Further, while the present disclosure describes and illustrates certain components, devices, or systems performing certain steps of the method of Figure 43B, the present disclosure contemplates any suitable combination of any suitable components, devices, or systems performing any suitable steps of the method of Figure 43B.

[0276] 45A and 45B , by way of example and not limitation, a seal 4516 may be disposed around the portion of the sensor 9112 that extends laterally within the interior space 4514 of the electronics housing to prevent ingress of contaminants into the interior space 4514. Additionally, the use of the seal 4516 may reduce any movement of the analyte sensor 9112 relative to the electronics housing, as well as any stress applied to the analyte sensor 9112. Reducing movement of the analyte sensor 9112 may beneficially reduce irritation to a user's skin during use. Similarly, reducing stress on the sensor 9112 may extend the shelf life of the analyte sensor 9112. As described above, the sensor control device may include an electronics housing having a shell 4502 and a mount 4504. The mount 4504 may be secured to the shell 4502 to define the interior space 4514. In some embodiments, as a result of the assembly process, the shell 4502 and the mount 4504 can be sealed around the location where the sensor 9112 passes from the interior space 4514 to the outside of the electronics housing. In other words, as described above, while the shell 4502 and the mount 4504 can be sealably connected by adhesive, ultrasonic welding, or any other suitable means around their respective perimeters 4308a-4308ab, 4310a-4310b, in some embodiments, the electronics housing can include an otherwise unsealed opening through which the sensor 9112 passes. Thus, the seal 4516 can seal this opening through which the sensor 9112 passes. As can be seen in FIGS. 45A and 45B , the shell 4502 and the mount 4504 can have inner surfaces 4506, 4508, respectively. The inner surfaces 4506, 4508 can define a conduit 4518 within the shell 4502 and the mount 4504, respectively. In some embodiments, as can be seen in Figures 45A-45D, when mount 4504 is secured to shell 4502 to define interior space 4514, channel 4510 can align with channel 4512 to form conduit 4518.45A-45D, the seal 4516 can be disposed within the channels 4510, 4512. As disclosed herein, the electronics housing can include a shell 4502 that mates with a mount 4504 to form an interior space 4514; however, one skilled in the art can appreciate that the same or substantially similar electronics housing and body worn device can be achieved by forming the electronics housing from an integral, monolithic component.

[0277] As shown in FIGS. 45A-45D, the seal 4516 can be compressed between the shell 4502 and the mount 4504. For example, without limitation, the seal 4516 can be positioned within the conduit 4518. In particular, the cross-sectional profile of the seal 4516 can approximately match the cross-sectional profile of the conduit 4518 formed by the alignment of the channels 4510, 4512. According to embodiments, as shown in FIGS. 45E and 45F, the cross-sectional profile of the seal 4516 can be substantially the same shape as the cross-sectional profile of the conduit 4518, but slightly larger in size, thereby allowing the seal 4516 to be compressed. As a result, the seal 4516 can be configured to protect the interior space 4514 from contaminants. Alternatively or additionally, one or more ribs or other raised surfaces 4522 can be positioned on any or all of the inner surfaces 4506, 4508 of the shell 4502 and mount 4504, respectively, to further compress the seal 4516 within the conduit 4518. For example, and without limitation, as shown in FIG. 45D where the cross-sectional profile of the seal 4516 is substantially the same shape as the conduit 4518, the ribs 4522 on the inner surface 4506 can press against the seal 4516, thereby placing it in compression and improving sealing quality. The ribs 4522 can alternatively or additionally be positioned on other surfaces of either the inner surface 4508 or the conduit 4518. Furthermore, the ribs 4522 can be any shape and can be repeated in any pattern. Alternatively or additionally, the ribs or other raised surfaces can be positioned on any of the outer surfaces of the seal 4516. For example, and without limitation, as shown in FIG. 45C where the cross-sectional profile of the seal 4516 is substantially the same shape as the conduit 4518, ribs 4522 on the seal 4516 can press against the inner surface 4506, thereby placing the seal 4516 in compression and improving sealing quality. Alternatively or additionally, ribs 4522 can be positioned on the seal 4156 such that they can press against the sensor 9112. Furthermore, the ribs 4522 can be any shape and can be repeated in any pattern on the face of the seal 4516.

[0278] In some embodiments, the sensor can be sealed using other techniques. For example, as shown in FIGS. 45G-45I, the sensor can be sealed within the body-worn unit using a curable, dispense-in-place elastomer that is placed around the sensor to seal it from foreign objects. By using a curable elastomer as described herein, a proper seal 4516 can be achieved by dispensing the elastomer in place, placing it around the sensor, and then curing the elastomer in place. This step can be achieved by at least partially filling the conduit 4518 with the curable elastomer 4516. In some embodiments, this step can be achieved by filling only the first channel 4510 with the curable elastomer, while in other embodiments, both the first channel 4510 and the second channel 4512 can be filled to adequately seal the sensor 9112. The curable dispense-in-place elastomeric seal 4516 may include at least one of ultraviolet curable silicone, room temperature vulcanizing silicone, ultraviolet curable urethane, or any other suitable curable elastomer known in the art.

[0279] As discussed above, the shell 4502 and mount 4504 can be joined using welding techniques such as ultrasonic welding or laser welding. As also discussed above, welding can be performed at weld joints 4524 located on either or both the interior or exterior perimeter of the electronics housing. In doing so, the welding process can additionally have the secondary purpose of curing the curable elastomeric seal 4516 in place. Alternatively, if the welding process is not intended to cure the elastomer (e.g., a UV-curable elastomer), the fusion temperature of the curable silicone can be elevated relative to the shell 4502 and mount 4504. Thus, to avoid damaging the elastomer, by way of example and not limitation, a filler material such as mica can be added to the elastomer to increase the fusion temperature of the elastomer.

[0280] 46A-46D , the shell 4602 can define a first opening 4606, and the mount 4604 can define a second opening 4608, where the first opening 4606 and the second opening 4608 can be positioned to align when the shell 4602 and the base 4608 are assembled. The body-worn device can further include a collar 4610 positioned within an interior space 4612 formed by assembly of the shell 4602 and the base 4604 and configured to align with each of the first and second openings 4606, 4608. In such a body-worn device configuration, an elastomeric seal 4614 can be positioned between the collar 4610 and the mount 4604. The seal 4614 can have a central opening 4632 axially aligned with the first opening 4606, the second opening 4608, and the collar 4610. Additionally or alternatively, the seal 4614 can be positioned around at least a portion of the circumference defined by either or both of the openings 4606, 4608. Thus, the elastomeric seal 4614 can be configured to allow a proximal portion of the analyte sensor 4616 to pass through the elastomeric seal 4614, i.e., the seal 4614 prevents the ingress of foreign objects into the body worn unit, while allowing a distal portion of the analyte sensor 4616 to extend from the body worn unit to measure the user's analyte level. In particular, the seal 4614 can be configured to prevent foreign objects that may pass through the openings 4606, 4608 from entering the interior space of the electronics housing.

[0281] 46B, to accomplish this, the elastomeric seal 4614 can take one of several physical configurations. For example, the seal 4614 can include one, two, three, or four seals, or any other number of seals. For example, the elastomeric seal 4614 can have a one-piece configuration, in which case the elastomeric seal 4614 includes a slit 4618 that extends partially the height of the elastomeric seal 4614 to allow the proximal portion of the analyte sensor 4616 to pass through. Alternatively, the seal 4614 can have a two-piece configuration, in which a first seal 4622 and a second seal 4620 define a full slit 4618 in each of the two seal components 4620, 4622 for the proximal portion of the sensor to pass through. Alternatively, the second seal 4620 can include a partial slit 4618a to accommodate the proximal portion, and the first seal 4622 can also include a partial slit 4618b that aligns with the partial slit 4618a of the second seal 4620 to define a full slit 4618 through which the proximal portion of the analyte sensor 4616 can pass while the seal 4614 prevents entry of foreign objects into the body worn unit. Alternatively, the slit 4618 can be defined in only one of the first seal 4622 or the second seal 4620. The second seal 4620 and the first seal 4622 can each have a sealing surface 4624 a, 4624 b, where the sealing surface 4624 a of the second seal is opposite the sealing surface 4624 b of the first seal such that the two sealing surfaces are disposed in contact with one another when the first seal 4624 a is mated with the second seal 4624 b during assembly. As another example, and by way of illustration and not limitation, the seals 464 can have a two-piece configuration in which the first seal 4622 is mounted in a channel 4606 positioned in the shell 4602 around the first opening 4606, and the second seal 4620 is mounted in a channel 4608 positioned in the mount 4604 around the second opening 4608.The channels 4634 and 4636 can be defined circumferentially around the first opening 4606 and the second opening 4608, respectively. The seal 4614 can share any of the other features of the independent two-piece configuration. In accordance with the presently disclosed subject matter, including any of the two-piece configurations described above, the first seal 4622 can have a first seal opening 4632b and the second seal 4620 can have a second seal opening 4632a, both of which can be axially aligned with the first opening 4622 and the second opening 4620, respectively, of the shell 4602 and the mount 4604.

[0282] Whether the seal has a one-piece, two-piece, or integrated configuration, the body-mounted unit can be compressed during assembly, thereby further compressing the seal. In a one-piece configuration, this compression means that the sides of the slit 4618 can be pressed together, thereby sealing the slit 4618. In two-piece and two-piece independent configurations, this compression means that the sides of the partial slits 4618a, 4618b can be pressed together, thereby sealing the full slit 4618, and that the sealing surfaces 4624a, 4624b of the second and first seals can also be pressed together, sealing the two halves 4620, 4622 of the seal as if they were one piece. Alternatively, if a collar 4610 is provided, the collar 4610 can fit onto the mount 4604, thereby placing the seal assembly 4614 in compression between the collar 4610 and the mount 4604. In this manner, a subassembly for sterilizing the sensor assembly can be assembled without requiring the shell 4602 to compress the seal assembly 4614.

[0283] Additionally, in any of the two-piece configurations described above, one or both of the components may include at least one rib to facilitate sealing during compression. For example, the sealing surface 4624a of the second seal 4620 may have ribs 4628a, while the sealing surface 4624b of the first seal 4622 may have no ribs. Alternatively, the sealing surface 4624b of the first seal may have ribs 4628b that face and contact the ribs 4628a of the sealing surface 4624a of the bottom half. Still alternatively, the sealing surface 4624b of the first seal may have channels 4630 sized and shaped to receive the ribs 4628a of the bottom half, thereby sealing the interface between the channels 4630 and the ribs 4628a under compression. Alternatively, the reverse configuration is possible.

[0284] The seal 4614 can be made from any suitable material, including, but not limited to, a self-healing silicone or a self-healing polymer. Such self-healing materials can be cut and then repaired by a heat-activated reversible bond when exposed to heat at the cut location. For example, for assembly of the seal 4614 and the analyte sensor 4616, a slit 4618 may be cut to allow a proximal portion of the analyte sensor 4616 to pass through. As described above, the slit 4618 may not be sealed except by compression alone. However, additionally or alternatively, if the seal is made from a self-healing material, the two sides of the slit 4618 can be reconnected, thereby repairing the slit 4618, by exposing the slit to a suitable heat source. One example of a suitable heat source is a laser, although other suitable heat sources will be known to those skilled in the art. Furthermore, in alternative embodiments, any suitable non-healing elastomer or polymer can be used to create the seal. The seal can be of a high durometer, a low durometer, or any other suitable durometer. For example, in some embodiments, the durometer can be between about 20A and 40A.

[0285] 47 , the seal can take on many form factors. For example, without limitation, the cross-sectional profile of the conduit 4518 and seal 4516 can be circular, polygonal (e.g., but not limited to, square, rectangular, hexagonal, or octagonal), or any other shape. In accordance with the presently disclosed subject matter, the seal 4516 can have a notch 4702 for passage of at least a portion of the distal portion of the analyte sensor and a slit 4704 for insertion of at least a portion of the analyte sensor into position within the notch 4702. Both the notch 4702 and the slit 4704 are sized and dimensioned such that a seal around the distal portion of the analyte sensor is maintained during compression. For example, the notch 4702 and the slit 4704 can be shaped such that the cross-sectional profile of the seal 4516, which is substantially the same shape as the conduit 4518, is not substantially affected. Slit 4704 can be either centered or decentered relative to notch 4702, as shown in Figures 47A and 47C, respectively. Additionally, slit 4702 can be straight to form a butt joint, as shown in configurations 47a and 47c, for example and by no means limitation, or slit 4702 can form an interlocking interface, such as a tongue and groove joint, as shown in configuration 47d, for example and by no means limitation. Alternatively, any other type of joint can be formed by the slit 4702 interface. In another embodiment, the seal can be composed of two or more separate parts, as shown in configuration 47b.

[0286] However configured, final assembly of the body-worn device 4212 can involve adhesive patch placement. An exemplary approach is shown in FIGS. 44A-44C. First, the inner liner 4402 is removed from the double-sided adhesive patch 4404. This exposed adhesive cures across the body-worn device body 5106 (with the temperature sensor 4006 folded over to seat in a complementary pocket) with the first window 4408 aligned for temperature sensing and the second window 4410 aligned for receiving the sensor assembly. Thus, upon removal of the outer release liner, the body-worn device is ready for placement into an applicator assembly, or alternatively, for placement into a container with or without the outer liner in place, depending on the presence or absence of any liner tension features provided thereon.

[0287] 48A-48D , the sensor applicator 4800 can also include a seal for sealing itself during the sterilization process. For example, the sensor applicator 4800 can include a housing 4802 that couples to a cap 4804. The sensor applicator 4800 can further include a sheath 4806, a sharpened body carrier 4808, a sensor carrier 4810, a sensor 4830, a sharpened body 4812, and a sharpened body hub 4814, with a body-worn unit 4816 also positioned within the sensor applicator 4800. In accordance with the presently disclosed subject matter, the sensor applicator 4800 can be delivered to a user pre-assembled such that the housing 4800 is mated with the cap 4804. Furthermore, as described above, the sensor applicator 4800 can be sterilized using a variety of sterilization techniques, including, but not limited to, electron beam (e.g., focused electron beam, low electron beam, etc.) sterilization. Thus, to facilitate effective sterilization of the sensor 4830 and sharpened body 4812, the cap 4804 can include a collimator 4818 that can be axially aligned with one or both of the sharpened body 4812 and the opening 4820 in the mount 4822. During sterilization, the electron beam need only be directed generally toward the body-worn unit, and the collimator 4818 can function to precisely direct the electron beam toward the body-worn unit 4816 while simultaneously preventing damage to sensitive electrical components within the body-worn unit. To accomplish this, the collimator 4818 can be conical or frusto-conical in shape. As another example, the collimator 4818 can be provided with a polygonal cross-sectional shape, such as a cube, rectangle (including, e.g., a parallelogram), or pyramid, without departing from the scope of this disclosure. Furthermore, the collimator 4818 can have either a symmetrical or asymmetrical cross-section. As described herein above, the cap 4804 can further include a desiccant 4836 to maintain a preferred humidity level. The desiccant 4836 can be substantially concentric with the collimator 4818 and can have a cross section that is substantially parallel to the collimator 4818 .For example, the desiccant 4834 can be provided with a polygonal cross-sectional shape, such as a cube, a parallelogram (including, e.g., a rectangle), or a pyramid, without departing from the scope of the present disclosure. Furthermore, the desiccant 4836 can have either a symmetrical or asymmetrical cross-section. In accordance with the subject matter of the present disclosure, the proximal end of the collimator can have an opening 4824 covered with a label that allows the electron beam to pass through the opening 4824 without allowing foreign matter to enter. The label can be made from Tyvek. The interface between the distal end of the collimator 4818 and the body-worn unit 4816 can be sealed to further seal a sterile zone formed within the collimator and extending into the openings 4820, 4822 of the body-worn unit 4816. 48A and 48D , by way of example and not limitation, a seal 4826 made of elastomer or any other suitable material can be disposed between the collimator and the mount of the body-mounted unit, and a proximal portion of the seal 4826 can be either tapered or flat. Further, some embodiments can include a sharpened body hub 4814 and a collar 4838 having a seal 4838 a disposed about an opening in the collar 4838 so as to seal the interface between the sharpened body hub 4814 and the collar 4838 to prevent the ingress of foreign matter. In some embodiments, the collar 4838 can be substantially similar to the collar 9216 and its associated components described above.

[0288] Various other modifications and alterations in the structure and method of operation of the disclosed embodiments of the present invention will be apparent to those skilled in the art without departing from the scope and spirit of the present disclosure. Although the present disclosure has been described in terms of certain embodiments, it should be understood that the claimed disclosure should not be unduly limited to such embodiments. It is intended that the following claims define the scope of the present disclosure and that structures and methods within the scope of the claims and their equivalents be covered thereby.

[0289] Additional details of suitable devices, systems, methods, components, and their operation, along with associated features, are described in International Publication Nos. WO 2018 / 136898 to Rao et al., WO 2019 / 236850 to Thomas et al., WO 2019 / 236859 to Thomas et al., WO 2019 / 236876 to Thomas et al., and U.S. Patent Application Publication No. 2020 / 0196919, filed June 6, 2019, the entire contents of each of which are incorporated herein by reference. Additional details regarding embodiments of the applicator, its components, and variations thereof are described in U.S. Patent Application Publication Nos. 2013 / 0150691, 2016 / 0331283, and 2018 / 0235520, the entire contents of all of which are incorporated herein by reference for all purposes. Additional details regarding embodiments of the sharpened body module, sharpened body, components thereof, and variations thereof are described in U.S. Patent Application Publication No. 2014 / 0171771, the entire contents of which are incorporated herein by reference for all purposes.

[0290] It should be noted that all features, elements, components, functions, and steps described with respect to any embodiment provided herein are intended to be freely combinable and interchangeable with any other embodiment. Even if a certain feature, element, component, function, or step is described only with respect to one embodiment, it should be understood that such feature, element, component, function, or step can be used in the case of all other embodiments described herein, unless expressly stated otherwise. Therefore, this paragraph serves in each case as a rationale and written support prior to the introduction of claims for combining features, elements, components, functions, and steps from various embodiments, or substituting features, elements, components, functions, and steps from one embodiment for another, even if the following description does not explicitly state that such combinations or substitutions are possible in a particular instance. Accordingly, the foregoing descriptions of specific embodiments of the disclosed subject matter have been presented for purposes of illustration and description. It should be expressly recognized that an explicit enumeration of all possible combinations and permutations would be unduly burdensome, particularly considering that the permissible scope of each and every such combination and permutation would be readily recognized by one of ordinary skill in the art.

[0291] While the above-described embodiments are susceptible to various modifications and alternative forms, specific examples thereof have been shown in the drawings and are described in detail herein. It will be apparent to those skilled in the art that various modifications and variations can be made to the methods and systems of the disclosed subject matter without departing from the spirit or scope of the disclosed subject matter. Accordingly, the disclosed subject matter is intended to include modifications and variations that come within the scope of the appended claims and their equivalents. Furthermore, negative limitations that define claims of the invention by any feature, function, step, or element of the above-described embodiments, as well as features, functions, steps, or elements not within the invention, may be recited in or added to the claims.

[0292] The present invention can also be described by the following numbered clauses: Clause 1. A specimen monitoring system comprising: a sensor control device; The sensor control device a shell having a first opening; and a mount coupled to the shell to define an interior space, the mount having a second opening axially aligned with the first opening; an electronics housing including: a circuit board disposed within the interior space of the electronic device housing; an analyte sensor having a proximal portion extending into an interior space of the electronics housing with one or more sensor contacts electrically coupled to the circuit board, and a distal portion extending from a bottom of the electronics housing configured to measure glucose levels in the bodily fluid; at least one seal disposed within the interior volume of the electronics housing proximate the first opening and the second opening, the seal configured to provide a seal around at least a portion of the proximal portion of the analyte sensor that extends into the interior of the electronics housing, and further configured to seal the at least one sensor contact within the interior of the electronics housing; Including, system. Clause 2. The system of clause 1, further including a collar disposed within the interior space between the shell and the at least one seal and axially aligned with each of the first opening and the second opening. Clause 3. The system of any preceding clause, wherein at least one seal is axially aligned with the first opening and the second opening. Clause 4. A system of any preceding clause in which at least one seal is compressed between the shell and the mount. Clause 5. The system of any preceding clause, wherein the at least one seal defines a slit, and wherein at least a portion of the proximal portion of the analyte sensor extends through the slit. Clause 6. The system of clause 5, wherein the at least one seal further comprises a first seal and a second seal mateable therewith. Clause 7. The system of clause 6, wherein a slit is defined in at least one of the first seal and the second seal. Clause 8. The system of clause 6, wherein a slit is defined at the interface between the first seal and the second seal. Clause 9. The system of any one of clauses 6 to 8, wherein the shell includes a first interface extending into the interior space, the first interface defining a first channel circumferentially positioned about the first opening, the mount includes a second interface extending into the interior space, the second interface defining a second channel circumferentially positioned about the second opening, the first seal integrated into the first channel, and the second seal integrated into the second channel. Clause 10. The system of clause 9, wherein the first interface is configured to mate with the second interface. Clause 11. The system of clause 9 or clause 10, wherein the first interface is configured to be welded to the second interface. Clause 12. The system of any one of clauses 6 to 11, wherein the first seal includes a first sealing surface and the second seal includes a second sealing surface, and the first sealing surface and the second sealing surface are configured to contact each other to isolate the interior space from foreign matter. Clause 13. The system of clause 12, wherein the seal is formed by compressing the first sealing surface against the second sealing surface. Clause 14. The system of clause 12 or clause 13, wherein the first sealing surface includes a first rib. Clause 15. The system of any one of clauses 12 to 14, wherein the second sealing surface defines at least one channel configured to receive the first rib and / or a second rib configured to contact the first rib. Clause 16. The system of clause 12 or clause 13, wherein the second sealing surface includes a first rib. Clause 17. The system of clause 16, wherein the first sealing surface defines at least one channel configured to receive the first rib and / or a second rib configured to contact the first rib. Clause 18. The system of any preceding clause, wherein at least one seal comprises at least one of an elastomeric material, a rubber material, and a polymeric material. Clause 19. The system of any preceding clause, wherein the seal comprises at least one of ultraviolet curable silicone, room temperature vulcanizing silicone, and ultraviolet curable urethane. Clause 20. The system of any preceding clause, wherein the seal at least partially isolates the electronics housing from movement of the analyte sensor. Clause 21. The system of any preceding clause, wherein the seal is configured to at least one of reduce stress on the analyte sensor and provide a moisture barrier to seal a distal portion of the glucose sensor extending from the bottom of the electronics housing. Clause 22. The system of any preceding clause, wherein at least one seal includes a self-healing material configured to self-bond upo...

Claims

1. 1. A specimen monitor system comprising: Sensor control devices, Including, The sensor control device a shell having a first opening; and a mount coupled to the shell to define an interior space, the mount having a second opening axially aligned with the first opening; an electronics housing including: a circuit board disposed within the interior space of the electronic device housing; an analyte sensor having a proximal portion and a distal portion, the proximal portion extending into the interior space and having one or more sensor contacts electrically coupled to the circuit board, the distal portion configured to measure glucose levels in bodily fluids and extending from a bottom of the electronics housing; at least one seal disposed in the interior space of the electronics housing proximate the first opening and the second opening, the seal configured to provide a seal around at least a portion of the proximal portion of the analyte sensor extending into the interior space of the electronics housing and configured to seal at least one sensor contact within the interior space of the electronics housing; Including, system.

2. The system of claim 1 , further comprising a collar disposed in the interior space between the shell and the at least one seal and axially aligned with each of the first opening and the second opening.

3. The system of claim 1 , wherein the at least one seal is axially aligned with the first opening and the second opening.

4. The system of claim 1 , wherein the at least one seal is compressed between the shell and the mount.

5. 10. The system of claim 1, wherein the at least one seal defines a slit, and wherein at least a portion of the proximal portion of the analyte sensor extends through the slit.

6. The system of claim 5 , wherein the at least one seal further comprises a first seal and a second seal mateable with the first seal.

7. The system of claim 6 , wherein the slit is defined in at least one of the first seal and the second seal.

8. The system of claim 6 , wherein the slit is defined at an interface between the first seal and the second seal.

9. the shell includes a first interface extending into the interior space; the first interface defines a first channel circumferentially positioned about the first opening, and the mount includes a second interface extending into the interior space; the second interface defines a second channel positioned circumferentially around the second opening; the first seal is integrated into the first channel and the second seal is integrated into the second channel; The system of claim 6.

10. The system of claim 9 , wherein the first interface is configured to mate with the second interface.

11. The system of claim 10 , wherein the first interface is configured to be welded to the second interface.

12. the first seal includes a first sealing surface and the second seal includes a second sealing surface; the first and second sealing surfaces are configured to contact one another and isolate the interior space from foreign matter; The system of claim 6.

13. 13. The system of claim 12, wherein the seal is formed by compressing the first sealing surface against the second sealing surface.

14. The system of claim 13 , wherein the first sealing surface includes a first rib.

15. The second sealing surface comprises: at least one channel configured to receive the first rib; and a second rib in contact with the first rib; Determine the following: The system of claim 14.

16. The system of claim 13 , wherein the second sealing surface includes a first rib.

17. The first sealing surface comprises: at least one channel configured to receive the first rib; and a second rib in contact with the first rib; Determine 17. The system of claim 16.

18. The system of claim 1 , wherein the at least one seal comprises at least one of an elastomer, a rubber, and a polymer material.

19. The system of claim 1 , wherein the seal comprises at least one of a UV-curable silicone, a room temperature vulcanizing silicone, and a UV-curable urethane.

20. 10. The system of claim 1, wherein the seal at least partially isolates the electronics housing from movement of the analyte sensor.

21. 10. The system of claim 1, wherein the seal is configured to at least one of reduce stress on the analyte sensor and provide a moisture barrier to seal the distal portion of the glucose sensor that extends from a bottom of the electronics housing.

22. The system of claim 1 , wherein the at least one seal comprises a self-healing material configured to self-bond upon heat activation.

23. 7. The system of claim 6, wherein the first seal has a first seal opening and the second seal has a second seal opening, and the first seal opening and the second seal opening are both axially aligned with the first opening and the second opening, respectively.

24. The system of claim 1 , further comprising an adhesive patch attached to a bottom of the mount and configured to secure the electronics housing on a user's skin.

25. 2. The system of claim 1, wherein the shell includes a first inner surface defining a first channel, the mount includes a second inner surface defining a second channel aligned with the first channel, and the at least one seal is disposed in at least one of the first channel and the second channel.

26. the seal includes a first surface adjacent to the first channel and a second surface adjacent to the second channel; the seal further includes at least one rib on the first surface and at least one rib on the second surface.

26. The system of claim 25.

27. 26. The system of claim 25, wherein the first inner surface is adjacent to a first sealing surface of the at least one seal and the second inner surface is adjacent to a second sealing surface of the at least one seal, and wherein the first inner surface and the second inner surface each include at least one rib configured to contact the first sealing surface and the second sealing surface, respectively.

28. the shell includes a first inner surface and the mount includes a second inner surface; the first inner surface and the second inner surface are separated by a first height, and the seal has a second height greater than the first height. The system of claim 1 .

29. The system of claim 1 , wherein the seal comprises a one-piece construction.

30. 30. The system of claim 29, wherein the seal defines a centering slit for receiving the proximal portion of the analyte sensor.

31. 30. The system of claim 29, wherein the seal includes a decentering slit for receiving the proximal portion of the analyte sensor.

32. The system of claim 1 , wherein the seal comprises a two-piece construction.

33. 33. The system of claim 32, wherein the seal includes a slit for receiving the proximal portion of the analyte sensor, the slit having a mating interface.

34. further comprising an applicator for delivery of the analyte sensor; an applicator housing including a sensor carrier configured to secure the sensor control device within an interior of the applicator; an applicator cap removably coupled to the applicator housing to seal the interior of the applicator, the applicator cap further including a collimator having a distal end and a proximal end, the distal end positioned adjacent the mount such that an interface between the distal end and the mount is sealed, the proximal end having an opening; The system of claim 1 , comprising:

35. 35. The system of claim 34, wherein the collimator comprises a cross-sectional shape selected from the group consisting of a cone, a truncated cone, a pyramid, a circle, a cube, a rectangle, and any combination thereof.

36. 35. The system of claim 34, wherein the opening in the collimator includes a seal configured to prevent moisture from passing through the collimator without preventing electron beam radiation from passing through the collimator.

37. 35. The system of claim 34, wherein the collimator is axially aligned with at least one of the analyte sensor and the second opening.

38. 1. A method of assembling an analyte monitor system, comprising: a shell having a first opening; and a mount coupled to the shell to define an interior space, the mount having a second opening axially aligned with the first opening; providing an electronics housing comprising: providing a circuit board disposed within the interior space of the electronics housing; providing an analyte sensor having a proximal portion and a distal portion, at least a portion of the proximal portion extending into the interior space of the electronics housing and having one or more sensor contacts electrically coupled to the circuit board, the distal portion configured to measure glucose levels in bodily fluids and extending from a bottom of the electronics housing; disposing at least one seal in the interior volume of the electronics housing proximate the first opening and the second opening, the at least one seal configured to provide a seal around at least a portion of the proximal portion of the analyte sensor extending into the interior volume of the electronics housing and configured to seal the one or more sensor contacts within the interior volume of the electronics housing; attaching an adhesive patch to a lower surface of the mount, the adhesive patch configured to secure the electronics housing on a user's skin; assembling a sensor control device including the electronics housing, a circuit board, an analyte sensor, and an adhesive patch; A method comprising:

39. 39. The method of claim 38, wherein the at least one seal is axially aligned with the first opening and the second opening.

40. 39. The method of claim 38, further comprising placing the proximal portion of the analyte sensor through a slit in the at least one seal.

41. 39. The method of claim 38, wherein the at least one seal comprises a first seal and a second seal mateable with the first seal, and wherein assembling the analyte sensor comprises disposing the first seal and the second seal around the proximal portion of the analyte sensor.

42. 42. The method of claim 41, further comprising integrating the first seal into a channel in the shell adjacent to the first opening and the second seal into a channel in the mount adjacent to the second opening.

43. 42. The method of claim 41, further comprising compressing a first sealing surface of the first seal against a second sealing surface of the second seal.

44. 41. The method of claim 40, further comprising repairing the slit using a heat-activated reversible bond when the seal comprises a self-healing material.

45. 41. The method of claim 40, wherein the mount includes a first inner surface defining a first channel and the shell includes a second inner surface defining a second channel, and wherein providing the at least one seal includes dispensing a curable elastomer into at least the first channel and around the proximal portion of the analyte sensor.

46. the curable elastomer comprises one of an ultraviolet curable silicone, a room temperature vulcanizing silicone, and an ultraviolet curable urethane; the method further comprising curing the curable elastomer; 46. The method of claim 45.

47. 39. The method of claim 38, further comprising coupling the mount to the shell using one of ultrasonic welding and laser welding.

48. further comprising ultrasonically or laser welding the mount to the shell along at least a first weld joint; the first and second channels coincide with the first weld joint; 48. The method of claim 47.

49. 48. The method of claim 47, further comprising melting at least one of the shell and the mount without melting the seal.

50. 1. A method of assembling an analyte monitor system, comprising: assembling a sensor control device; Including, Assembling the sensor control device includes: a shell having a first opening; and a mount disposed opposite the shell and defining an interior space, the mount having a second opening aligned with the first opening; providing an electronics housing comprising: providing a circuit board disposed within the interior space of the electronics housing and including a plurality of electronics modules; providing an analyte sensor including: a tail portion extending from a bottom of the electronics housing through the second opening and configured to measure an analyte level in a bodily fluid; a flag portion extending into the interior space of the electronics housing and including a plurality of sensor contacts coupled to the circuit board; and a neck portion interconnecting the tail portion and the flag portion; providing a sharpened hub engageable with an upper outer surface of the shell and including a sharpened hub and a mating member configured to extend distally from a lower surface of the mount through the first and second openings; an applicator for delivery of the analyte sensor, comprising: a housing including a sensor carrier configured to secure the sensor control device within an interior of the applicator; and an applicator cap removably coupled to the housing to seal the interior of the applicator, the applicator cap further including a collimator having a distal end and a proximal end, the distal end positioned adjacent the mount such that an interface between the distal end and the mount is sealed, the proximal end having an opening; providing the applicator comprising: Including, method.

51. 51. The method of claim 50, further comprising providing a label adjacent to the opening of the collimator, such that an electron beam is configured to pass through the opening and such that foreign matter cannot pass through the opening.

52. 52. The method of claim 51, wherein the label comprises Tyvek.

53. 53. The method of claim 52, further comprising axially aligning the collimator with at least one of the analyte sensor and the second opening.

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