SYSTEMS, DEVICES AND METHODS FOR ANALYTE SENSORS - Patent application

Abstract

The system for measuring an analyte level includes an analyte sensor having an in vivo portion in contact with a user's interstitial fluid and an in vitro portion. The sensor further includes at least one working electrode and a reference electrode positioned on the in vivo portion, and a first substrate. The at least one working electrode and the reference electrode sense a signal associated with a measured analyte level in the user's interstitial fluid. Additionally, the in vitro portion includes a plurality of electronic components mounted thereon, at least one of the electronic components configured to receive a generated signal associated with the measured analyte level. The electronic components are mounted to the in vitro portion using photonic soldering.

Description

[Technical field]

[0001] Related Applications This application claims priority to U.S. Provisional Patent Application No. 63 / 306,872, entitled "Systems, Devices, and Methods For an Analyte Sensor," filed February 4, 2022, the disclosure of which is incorporated herein by reference for all purposes.

[0002] The subject matter described herein generally relates to systems, devices, and methods for analyte sensors. For example, methods of assembling a sensor subassembly, a body-worn pack assembly, and an applicator assembly are disclosed. Also disclosed are sensors including an in vivo portion, an in vivo portion, and a neck interconnecting the in vivo and in vitro portions, and methods of constructing the sensors. Also disclosed are sensors having electronic components mounted directly thereon. [Background technology]

[0003] Detection and / or monitoring of analyte levels, such as glucose, ketones, lactate, oxygen, or hemoglobin A1C, can be of great importance 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 that information to determine when they require and / or need insulin to reduce glucose levels in the body, or when they require additional glucose to increase glucose levels in the body.

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

[0005] To increase patient adherence to a frequent glucose monitoring regimen, an in vivo analyte monitoring system can be utilized in which a sensor control device can be worn on the body of an individual requiring analyte monitoring. To increase comfort and convenience for the individual, the sensor control 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 dermal sensor that senses a user's analyte level in bodily fluids located in the dermis layer of the human body, using an applicator or insertion mechanism so that the sensor is in contact with the bodily fluid. The sensor control device can also be configured to transmit the analyte data to another device from which the individual or her health care provider ("HCP") can review the data and make treatment decisions.

[0006] While existing sensors can be convenient for users, they can be made more comfortable, convenient, and portable by further reducing the size of the body-worn unit. Furthermore, by reducing the size of the body-worn unit and / or by reducing the number of internal components, the manufacturing cost of the body-worn unit can be reduced. Because the body-worn unit can be a disposable, one-time use unit that requires periodic replacement, lower manufacturing costs can be one means of reducing replacement costs to the patient. One limitation to such miniaturization is the need for a sensor substrate to position electrodes for sensing analyte concentrations and a separate substrate to position electronic components for providing power, processing sensor data, and transmitting sensor data to a remote device. However, previous manufacturing techniques prevent such components from being directly attached to the sensor substrate. [Prior art documents] [Patent documents]

[0007] [Patent Document 1] US Patent Application Publication No. 2014 / 0171771 [Patent Document 2] U.S. Patent Application Publication No. 2014 / 0275907 [Patent Document 3] US Patent Application Publication No. 2021 / 0161437 [Patent Document 4] International Publication No. 2018 / 136898 [Patent Document 5] International Publication No. 2019 / 236850 [Patent Document 6] International Publication No. 2019 / 236859 [Patent Document 7] International Publication No. 2019 / 236876 [Patent Document 8] U.S. Patent Application Serial No. 16 / 433,931 [Patent Document 9] U.S. Patent Application Serial No. 17 / 661,531 [Patent Document 10] US Patent Application Publication No. 2022 / 0079475 [Patent Document 11] US Patent Application Publication No. 2020 / 0196919 [Patent Document 12] US Patent Application Publication No. 2013 / 0150691 [Patent Document 13] US Patent Application Publication No. 2016 / 0331283 [Patent Document 14] US Patent Application Publication No. 2018 / 0235520 [Non-patent literature]

[0008] [Non-Patent Document 1] G. Arutinov, R. Hendriks, and J. Van Den Brand, "Photonic Flash Soldering on Flex Foils for Flexible Electronic Systems," 2016 IEEE 66th Electronic Components and Technology Conference (ECTC), 2016, pp. 95-100, doi:10.1109 / ECTC.2016.179. [Non-Patent Document 2] Electra's technical data sheet for Carapace EMP110W-LED imageable solder mask for the LED EMP110 W-LED(cool-white / extra-cool-white / warm-white)_rev5, https: / / electrapolymers.com / wp-content / uploads / sds_files / EMP110%20W-LED.pdf [Non-Patent Document 3] "Kestser Alloy Temperature Chart" Summary of the Invention [Problem to be solved by the invention]

[0009] Thus, a need exists for a continuous analyte monitoring system that has a reduced size and is economical to manufacture. [Means for solving the problem]

[0010] 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 will 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 in the appended drawings.

[0011] To achieve these and other advantages and in accordance with the purposes of the presently disclosed subject matter, as embodied and broadly described, the presently disclosed subject matter relates to a system for measuring an analyte level including an analyte sensor having an in vivo portion configured to be positioned in contact with interstitial fluid of a user and an in vivo portion. The analyte sensor can include a first substrate, at least one working electrode, and a reference electrode. The at least one working electrode can be positioned on the in vivo portion and can sense a signal associated with an analyte level in the interstitial fluid of the user. The in vitro portion can include a plurality of electronic components mounted thereon, at least one of the plurality of electronic components can be configured to receive a generated signal associated with the analyte level.

[0012] As embodied herein, the electronic components can be electrically coupled to at least one of the working electrode and the reference electrode. The electronic components can be further configured to transmit a signal associated with the analyte level to a remote device having a display screen. As embodied herein, the electronic components can be attached to the ex vivo portion using photonic soldering.

[0013] As embodied herein, the first substrate can be a flexible monolithic unit. The first substrate can be polyamide or polyethylene terephthalate. The electronic components can include one or more processors and one or more batteries. As embodied herein, the electronic components can include a Wi-Fi antenna, an NFC antenna, a Bluetooth antenna, a BTLE antenna, or a GPS antenna. As embodied herein, the one or more batteries can be printed batteries. As embodied herein, the analyte sensor can further include a second substrate having at least one antenna.

[0014] As embodied herein, the remote device can be a display device, a mobile phone, or a wrist-worn device.As embodied herein, the analyte sensor can be configured to sense at least one of lactate, glucose, or ketones.

[0015] As embodied herein, the in vitro portion can include a first layer. The first layer can include a gradient mixture of materials, and the mixture of materials can include fiberglass. As embodied herein, the first layer can be about 10% fiberglass, and the in vivo portion can include PET. As embodied herein, the in vitro portion can include at least a second layer. In some embodiments, each of the first layer and at least the second layer can include a gradient mixture of materials.

[0016] As embodied herein, the system may include a sensor control device for housing the analyte sensor and an applicator for delivering the analyte sensor, the applicator may include a housing having a sensor carrier configured to secure the sensor control device within the applicator, and an applicator cap removably coupled to the housing to seal the interior of the applicator.

[0017] The presently disclosed subject matter also relates to a method of assembling a system for measuring an analyte level comprising providing an analyte sensor having an in vivo portion configured to be positioned in contact with interstitial fluid of a user and an in vivo portion. The analyte sensor can include a first substrate, at least one working electrode, and a reference electrode. The at least one working electrode and the reference electrode can be positioned on the in vivo portion and can further generate a signal associated with the analyte level. Electronic components can be mounted on the in vivo portion, and at least one of the electronic components can be configured to receive the generated signal associated with the analyte level.

[0018] As embodied herein, the first substrate may be flexible. At least one working electrode and a reference electrode may be printed on the substrate. According to some embodiments, the method may include printing a working electrode on a first side of the analyte sensor and printing a reference electrode on a second side of the analyte sensor.

[0019] As embodied herein, the method may include connecting electronics to a first side of the analyte sensor using photonic soldering. As embodied herein, the method may include attaching an electronic component to the first side by photonic soldering. As embodied herein, the method may include masking a portion of the first substrate prior to photonic soldering. As embodied herein, the method may include coating the first substrate with a reflective coating prior to performing photonic soldering. As embodied herein, during the photonic soldering process, the method may include using a vacuum to prevent the first substrate from warping.

[0020] As embodied herein, the method may include sterilizing the analyte sensor. The analyte sensor may be sterilized using radiation sterilization, heat treatment, electron beam sterilization, gamma sterilization, X-ray sterilization, ethylene oxide sterilization, autoclave steam sterilization, chlorine dioxide gas sterilization, or hydrogen peroxide sterilization. Additionally, as embodied herein, the analyte sensor may be sterilized prior to mounting the electronic components to the ex vivo portion. As embodied herein, the analyte sensor may be sterilized after mounting the electronic components to the ex vivo portion.

[0021] Details of the inventive subject matter recited 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 within the figures are not necessarily to scale, with emphasis instead being placed upon illustrating the principles of the inventive subject matter. Moreover, all illustrations are intended to convey concepts, and relative sizes, shapes, and other detailed attributes may be illustrated generally, rather than literally or precisely. [Brief description of the drawings]

[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. 2 is a block diagram illustrating an exemplary embodiment of a sensor control device. [Figure 2C] FIG. 2 is a block diagram illustrating an exemplary embodiment of a sensor control device. [Figure 3A] FIG. 13 is a proximal perspective view depicting an exemplary embodiment in which a user prepares a tray for assembly. [Figure 3B] 11 is a side view depicting an exemplary embodiment of a user preparing the applicator device for assembly. [Figure 3C] FIG. 13 is a proximal perspective view depicting an exemplary embodiment in which a user inserts an applicator device into a tray during assembly. [Figure 3D] 13A is a proximal perspective view depicting an exemplary embodiment in which a user removes the applicator device from a tray during assembly. FIG. [Figure 3E] FIG. 1 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 a sensor applied and an applicator device used. [Figure 4A] 1 is a side view depicting an exemplary embodiment of an applicator device coupled with a cap. [Figure 4B] FIG. 2 is a side perspective view depicting an exemplary embodiment with the applicator device and cap separated. [Figure 4C] 1 is a perspective view depicting an exemplary embodiment of a distal end of an applicator device and an electronics housing. [Diagram 5] FIG. 1 is a proximal perspective view depicting an exemplary embodiment of a tray with a sterilization lid attached. [Figure 6A] FIG. 13 is a proximal perspective cutaway view depicting an exemplary embodiment of a tray having a sensor delivery component. [Figure 6B] FIG. 13 is a proximal perspective view depicting a sensor delivery component. [Figure 7A]FIG. 2 is a top perspective view illustrating an exemplary embodiment of a sensor module. [Figure 7B] FIG. 2 is a bottom perspective view illustrating an exemplary embodiment of a sensor module. [Figure 8A] FIG. 1 is a perspective view depicting an exemplary embodiment of a sensor connector. [Figure 8B] FIG. 2 is a condensed view illustrating an exemplary embodiment of a sensor connector. [Figure 9A] FIG. 1 is a perspective view illustrating an exemplary embodiment of a sensor. [Figure 9B] FIG. 1 is a perspective view illustrating an exemplary embodiment of a sensor. [Figure 10A] FIG. 2 illustrates a bottom perspective view of an exemplary embodiment of a sensor module assembly. [Figure 10B] FIG. 2 illustrates a top perspective view of an exemplary embodiment of a sensor module assembly. [Figure 11A] FIG. 2 is an enlarged partial view of an exemplary embodiment of a sensor module assembly. [Figure 11B] FIG. 2 is an enlarged partial view of an exemplary embodiment of a sensor module assembly. [Figure 11C] FIG. 1 is a side view of an exemplary sensor according to one or more embodiments of the present disclosure. [Figure 11D] FIG. 1 is a side view of an exemplary sensor according to one or more embodiments of the present disclosure. [Figure 11E] FIG. 1 is a side view of an exemplary sensor according to one or more embodiments of the present disclosure. [Figure 11F] FIG. 1 is a side view of an exemplary sensor according to one or more embodiments of the present disclosure. [Figure 11G] FIG. 1 is a side view of an exemplary sensor according to one or more embodiments of the present disclosure. [Figure 11H] FIG. 1 is a side view of an exemplary sensor according to one or more embodiments of the present disclosure. [Figure 12A] FIG. 1 is an isometric view of an exemplary connector assembly according to one or more embodiments. [Figure 12B] FIG. 1 is a partially exploded isometric view of an exemplary connector assembly according to one or more embodiments. [Figure 12C] FIG. 14 is an isometric bottom view of the connector of FIGS. 12A-12B. [Figure 12D] FIG. 1 is an isometric view of another exemplary connector assembly according to one or more embodiments. [Figure 12E] FIG. 1 is a partially exploded isometric view of another exemplary connector assembly according to one or more embodiments. [Figure 12F] FIG. 12C is an isometric bottom view of the connector of FIGS. 12D-12E. [Figure 13A] FIG. 2 is a perspective view illustrating an exemplary embodiment of a Sharp module. [Figure 13B] FIG. 13 is a perspective view of another exemplary embodiment of a sharp module. [Figure 13C] FIG. 13C is a schematic diagram illustrating the Sharp module of FIG. 13B. [Figure 13D] FIG. 13C is a schematic diagram illustrating the Sharp module of FIG. 13B. [Figure 13E] FIG. 13C is a schematic side view of the Sharp module of FIG. 13B when assembled with a sensor module. [Figure 13F] FIG. 13C is a top-down schematic diagram of the Sharp module of FIG. 13B when assembled with a sensor module. [Figure 13G] FIG. 13 is a perspective view of another exemplary embodiment of a sharp module. [Figure 13H] FIG. 13H is a side schematic diagram illustrating the Sharp module of FIG. 13G. [Figure 13I] FIG. 13H is a side cross-sectional view of the Sharp module of FIG. 13G when assembled with a sensor module. [Figure 13J] FIG. 13H is a side view of the Sharp module of FIG. 13G when assembled with a sensor module. [Figure 14A] FIG. 2 is an isometric view of another exemplary sensor control device. [Figure 14B] FIG. 2 is a side view of another exemplary sensor control device. [Figure 15A] FIG. 14C is an exploded isometric top view of the sensor control device of FIGS. 14A-14B. [Figure 15B] FIG. 14C is an exploded isometric bottom view of the sensor control device of FIGS. 14A-14B. [Figure 16] FIG. 2 is a cross-sectional side view of an assembled seal subassembly according to one or more embodiments. [Figure 17A] 14A-14B , in cross-sectional side views illustrating the assembly of a sensor applicator with the sensor control device of FIG. [Figure 17B] 14A-14B , in cross-sectional side views illustrating the assembly of a sensor applicator with the sensor control device of FIG. [Figure 17C] 14A-14B , in cross-sectional side views illustrating the assembly of a sensor applicator with the sensor control device of FIG. [Figure 18A] FIG. 17D is a perspective view of the cap post of FIG. 17C in accordance with one or more additional embodiments. [Figure 18B] FIG. 17D is a top view of the cap post of FIG. 17C in accordance with one or more additional embodiments. [Figure 19] FIG. 14C is a cross-sectional side view of the sensor control device of FIGS. 14A and 14B. [Figure 20A] FIG. 13 is a cross-sectional side view of a sensor applicator waiting to deploy a sensor control device at a target monitor location. [Figure 20B] FIG. 13 is a cross-sectional side view of a sensor applicator waiting to deploy a sensor control device at a target monitor location. [Figure 21A] 14A-14B , depicting cross-sectional side views of an exemplary embodiment of a sensor applicator, and a step-by-step assembly and disassembly of the sensor control device of FIG. 14A-B . [Figure 21B] 14A-14B , depicting cross-sectional side views of an exemplary embodiment of a sensor applicator, and a step-by-step assembly and disassembly of the sensor control device of FIG. 14A-B . [Figure 21C] 14A-14B , depicting cross-sectional side views of an exemplary embodiment of a sensor applicator, and a step-by-step assembly and disassembly of the sensor control device of FIG. 14A-B . [Figure 22A] FIG. 2 is an isometric bottom view of a housing according to one or more embodiments. [Figure 23A] FIG. 2 is an isometric bottom view of a housing having a sheath and other components at least partially positioned therein. [Figure 24] FIG. 2 is an enlarged cross-sectional side view of a sensor applicator having a sensor control device disposed therein according to one or more embodiments. [Figure 25A] FIG. 2 is an isometric top view of a cap according to one or more embodiments. [Figure 25B] 11 is an enlarged cross-sectional view of the engagement between the cap and the housing according to one or more embodiments. [Figure 26A] FIG. 2 is an isometric view of a sensor cap according to one or more embodiments. [Figure 26B] FIG. 1 is an isometric view of a collar according to one or more embodiments. [Figure 27A] FIG. 1 is a side view of an exemplary sensor control device in accordance with one or more embodiments of the present disclosure. [Figure 27B] FIG. 1 is an isometric view of an exemplary sensor control device in accordance with one or more embodiments of the present disclosure. [Figure 28A] FIG. 3 is an exploded isometric top view of the sensor control device of FIG. 2 according to one or more embodiments. [Figure 28B] FIG. 3 is an exploded isometric bottom view of the sensor control device of FIG. 2 in accordance with one or more embodiments. [Figure 29] 27A-27B and 28A-28B according to one or more embodiments. FIG. [Figure 29A] FIG. 27C is an exploded isometric view of a portion of another embodiment of the sensor control device of FIGS. 27A-27B and 28A-28B. [Figure 30A] FIG. 27A is an isometric bottom view of the mount of FIGS. 27A-27B and 28A-28B. [Figure 30B] FIG. 27B is an isometric top view of the sensor cap of FIGS. 27A-27B and 28A-28B. [Figure 31A] FIG. 2 is a side view of an exemplary sensor applicator according to one or more embodiments. [Figure 31B] FIG. 1 is a cross-sectional side view of an exemplary sensor applicator according to one or more embodiments. [Figure 32A] FIG. 31C is a perspective view of the cap post of FIG. 31B according to one or more embodiments. [Figure 32B] FIG. 31C is a top view of the cap post of FIG. 31B according to one or more embodiments. [Diagram 33] FIG. 1 is a cross-sectional side view of a sensor control device positioned within an applicator cap in accordance with one or more embodiments. [Diagram 34] 1 is a cross-sectional view of a sensor control device illustrating an exemplary interaction between a sensor and a sharp. [Figure 35A] 1A-1C are cross-sectional views depicting an exemplary embodiment of an applicator during a deployment stage. [Figure 35B] 1A-1C are cross-sectional views depicting an exemplary embodiment of an applicator during a deployment stage. [Figure 35C] 1A-1C are cross-sectional views depicting an exemplary embodiment of an applicator during a deployment stage. [Figure 35D] 1A-1C are cross-sectional views depicting an exemplary embodiment of an applicator during a deployment stage. [Figure 35E] 1A-1C are cross-sectional views depicting an exemplary embodiment of an applicator during a deployment stage. [Fig. 35F] 1A-1C are cross-sectional views depicting an exemplary embodiment of an applicator during a deployment stage. [Figure 36A] 1A-1C illustrate steps in a process for assembling a sensor subassembly. [Figure 36B] 1A-1C illustrate steps in a process for assembling a sensor subassembly. [Figure 36C] 1A-1C illustrate steps in a process for assembling a sensor subassembly. [Figure 36D] 1A-1C illustrate steps in a process for assembling a sensor subassembly. [Figure 36E] 1A-1C illustrate steps in a process for assembling a sensor subassembly. [Figure 36F]1A-1C illustrate steps in a process for assembling a sensor subassembly. [Figure 36G] 1A-1C illustrate steps in a process for assembling a sensor subassembly. [Fig. 36H] 1A-1C illustrate steps in a process for assembling a sensor subassembly. [Figure 37A] 1A-1C show process steps for assembling a sensor control device. [Figure 37B] 1A-1C show process steps for assembling a sensor control device. [Figure 37C] 1A-1C show process steps for assembling a sensor control device. [Figure 37D] 1A-1C show process steps for assembling a sensor control device. [Figure 37E] 1A-1C show process steps for assembling a sensor control device. [Figure 37F] 1A-1C show process steps for assembling a sensor control device. [Figure 37G] 1A-1C show process steps for assembling a sensor control device. [Fig. 37H-1] 1A-1C show process steps for assembling a sensor control device. [Fig. 37H-2] 1A-1C show process steps for assembling a sensor control device. [Fig. 37I] 1A-1C show process steps for assembling a sensor control device. [Figure 37J] 1A-1C show process steps for assembling a sensor control device. [Figure 38A] 1A-1D illustrate steps in a process for assembling the applicator. [Figure 38B] 1A-1D illustrate steps in a process for assembling the applicator. [Figure 38C] 1A-1D illustrate steps in a process for assembling the applicator. [Figure 38D] 1A-1D illustrate steps in a process for assembling the applicator. [Figure 38E] 1A-1D illustrate steps in a process for assembling the applicator. [Figure 38F] 1A-1D illustrate steps in a process for assembling the applicator. [Figure 38G] 1A-1D illustrate steps in a process for assembling the applicator. [Fig. 38H] 1A-1D illustrate steps in a process for assembling the applicator. [Fig. 38I] 1A-1D illustrate steps in a process for assembling the applicator. [Figure 38J] 1A-1D illustrate steps in a process for assembling the applicator. [Figure 38K] 1A-1D illustrate steps in a process for assembling the applicator. [Figure 39] FIG. 10B is a cross-sectional view of the sensor applicator and external sterilization assembly of FIG. 10A. [Diagram 40] FIG. 2 is an exploded view of an exemplary sensor control device having a monolithically integrated sensor and PCB in accordance with one or more embodiments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

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

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

[0025] The 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 documents 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] In general, embodiments of the present disclosure include systems, devices, and methods for the 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 with an electronics housing of a sensor control device enclosed therein. According to some embodiments, a structure separate from the applicator, such as a container, can also be provided to a user as a sterile package with a sensor module and a sharps module enclosed therein. A user can couple the sensor module to the electronics housing and 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 or damaged or inducing an adverse physiological response. Other improvements and advantages are also provided. Various configurations of these devices are described in detail using embodiments that are merely examples.

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

[0028] Additionally, for each and every embodiment of the methods disclosed herein, systems and devices having the functionality to perform each of these embodiments are encompassed in the present disclosure. For example, sensor control device embodiments are disclosed, which may have 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 may perform or facilitate the performance of any and all method steps. These sensor control device embodiments may be used and may have the functionality to perform steps performed by the sensor control device from any and all of the methods described herein.

[0029] As mentioned above, certain embodiments of systems, devices, and methods are described herein to enable improved assembly and use of dermal sensor insertion devices for use with in vivo analyte monitor systems. In particular, certain embodiments of the present disclosure are designed to improve sensor insertion methods for in vivo analyte monitor systems, and in particular to prevent premature retraction of the insertion sharp during the sensor insertion process. For example, certain embodiments include a dermal sensor insertion mechanism with a high 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 possibility of prematurely extracting the insertion sharp during the sensor insertion process, reduce the possibility of incorrect sensor insertion, and reduce the possibility of damaging the sensor during the sensor insertion process, to name a few advantages. Certain embodiments of the present disclosure also enable improved insertion sharps modules that account for the small scale of dermal sensors and the relatively shallow insertion path present in the dermal layer of a subject. Additionally, certain embodiments of the present disclosure are designed to prevent undesired axial and / or rotational movement of applicator components during sensor insertion. These embodiments may thus reduce the likelihood of capillary disruption resulting in instability of the positioned dermal sensor, rash at the insertion site, damage to surrounding tissue, and contamination of the dermal fluid 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 the embodiments described herein.

[0031] There are various types of in vivo analyte monitor systems. For example, a "continuous analyte monitor" system (or a "continuous glucose monitor" system) may transmit data continuously, e.g., automatically according to a schedule, from the sensor control device to the reader device without requiring acknowledgement. As another example, a "flash analyte monitor" system (or a "flash glucose monitor" system or simply a "flash" system) may communicate data from the sensor control device using a near field communication (NFC) protocol or a radio frequency identification (RFID) protocol, or the like, upon scanning or data need by the reader device. In vivo analyte monitor systems may operate without the need for finger stick calibration.

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

[0033] An in-vivo analyte monitor system may include a sensor that contacts a user's bodily fluid while positioned in the body and senses the level of an analyte contained 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," "body-worn electronics" devices or units, "body-worn" devices or units, or "sensor data communication" devices or units, to name a few.

[0034] An in-vivo analyte 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 types. 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 or incorporated into in-vivo or in-vivo monitoring systems.

[0035] Exemplary Embodiments of an In-Vivo Analyte Monitor System FIG. 1 is a conceptual diagram illustrating an exemplary embodiment of an analyte monitor system 100 including a sensor applicator 150, a sensor control device 102, and a reader device 120. In this case, 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 is described in more detail in FIG. 2B and FIG. 2C, and can communicate with the reader device 120 through a communication path 140 using wired or wireless technology. Exemplary wireless protocols include Bluetooth, Bluetooth low energy (such as BLE, BTLE, 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 set forth below in connection with FIG. 2A. The reader device 120 can communicate with a local computer system 170 through 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, smartphone, 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 through 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 through the communication path 142. The network 190 can be any of several networks, such as private and public networks, local area networks, wide area networks, and the like.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 embodiments of a reader device 2A is a block diagram illustrating an exemplary embodiment of a reader device configured as a smartphone. In this case, the reader device 120 may include a display 122, an input component 121, and a processing core 206 including a communication processor 222 coupled to a memory 223 and an application processor 224 coupled to a memory 225. Similarly, a separate memory 230, an RF transceiver 228 having an antenna 229, and a power source 226 having a power management module 238 may be included. Additionally, a multi-function transceiver 232 capable of communicating through Wi-Fi, NFC, Bluetooth, BTLE, and GPS using one or more antennas 234 may be included. As will be appreciated by those skilled in the art, these components are electrically and communicatively coupled to create a functional device.

[0037] Exemplary embodiments of a 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 (including analyte monitor circuitry) that may have most of the processing functionality for rendering final result data 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 communication circuit 168 (which may be implemented as a transmitter, receiver, transceiver, passive circuitry, or otherwise according to a communication protocol). In this embodiment, both the AFE 162 and the processor 166 are used as the analyte monitor circuitry, although in other embodiments, either circuitry may perform the analyte monitor function. The processor 166 may include one or more processors, microprocessors, controllers, and / or microcontrollers, each of which may be a separate chip or distributed among (and be part of) several different chips.

[0038] Also included within the ASIC 161 is a memory 163, which may be shared by the various functional units present within the ASIC 161 or may be distributed among two or more of these functional units. The memory 163 may be a separate chip. The memory 163 may be a volatile and / or non-volatile memory. In this embodiment, the ASIC 161 is coupled to a power source 170, which may be a coin cell battery or the like. The AFE 162 interfaces with the in-vivo analyte sensor 104 to accept measurement data therefrom and output these data in digital type to a processor 166, which further processes these data to provide final result glucose individual values ​​and glucose trend values ​​and the like. These data may then be provided to a communication circuit 168 for transmission through one or more antennas 171, for example, to a 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 may be packaged together or separately. In this case, 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, which includes memory 165, which may be isolated or distributed within chip 174. 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 embodiments of an assembly process for a 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 prior to 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 prior to combining the components to provide a 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 applying the sensor control device 102 to the 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 an 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-adhered portion of the lid 812 from the tray 810 such that the adhered 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 presents applicator device 150 for assembly. Applicator device 150 may be provided in a sterile package sealed by cap 708. Preparing applicator device 150 may include disconnecting housing 702 from cap 708 to expose sheath 704 (FIG. 3C). This disconnection may be accomplished by twisting (or otherwise detaching) cap 708 from housing 702. Cap 708 may then be set aside.

[0043] 3C is a proximal perspective view depicting an exemplary embodiment in which a user inserts applicator device 150 into tray 810 during assembly. First, a user can insert sheath 704 into platform 808 inside tray 810 after aligning housing orientation feature 1302 (or slot or recess) with tray orientation feature 924 (abutment or detent). Inserting sheath 704 into platform 808 temporarily unlocks sheath 704 from housing 702, and also temporarily unlocks platform 808 from tray 810. In this process, removal of applicator device 150 from tray 810 will result in the same condition as it was prior to 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 the housing 702, the sheath 704 maintains its position relative to the housing 702 within the platform 808 and can mate with the platform 808 to advance the platform 808 distally relative to the tray 810. This step unlocks and collapses the platform 808 within the tray 810. The sheath 704 contacts and disengages a locking feature (not shown) within the tray 810, thereby unlocking the sheath 704 from the housing 702 and preventing it from moving (relatively) while the housing 702 advances the platform 808 distally. At the end of advancement of the housing 702 and platform 808, the sheath 704 is permanently unlocked from the housing 702. At the end of distal advancement of the housing 702, the sharps and sensor (not shown) within the tray 810 can mate with the electronics housing (not shown) within the housing 702. The operation and interaction of applicator device 150 with tray 810 is described in further 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. A user can remove applicator 150 from tray 810 by advancing housing 702 proximally relative to tray 810 or 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) (not shown) 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. Distal advancement of housing 702 collapses sheath 704 therein, applying the sensor to the target location such that an adhesive layer on the bottom surface of sensor control device 102 adheres to the skin. The sharps automatically retract 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 application position. The user can then remove the applicator 150 from the application site.

[0048] 3A-3F and further described elsewhere herein, system 100 may result in a reduction or elimination of the possibility of accidental destruction, permanent deformation, or incorrect assembly of applicator components as compared to prior art systems. Because applicator housing 702 directly engages platform 808 while sheath 704 is unlocked, rather than indirect engagement through sheath 704, the relative angle between sheath 704 and housing 702 will not result in destruction or permanent deformation of arms or other components. The possibility of relatively high forces during assembly (as in conventional devices) will be reduced, thereby reducing the possibility of user assembly failure.

[0049] Exemplary embodiments of a sensor applicator device FIG 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 is shipped and received by a user prior to assembly with a sensor by the user. FIG 4B is a side perspective view depicting applicator 150 and cap 708 after they have been separated. FIG 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 position they would have been maintained in sensor electronics carrier 710 of sheath 704 when cap 708 was in place.

[0050] Exemplary embodiments of the tray and sensor module assembly FIG. 5 shows an exemplary embodiment of a tray 810 with a sterilization lid 812 removably coupled thereto, in a proximal perspective view that may represent how the package is shipped to a user and received by the user prior to assembly.

[0051] 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.

[0052] 6B is a proximal perspective view depicting the sensor module 504 in greater detail. In this case, the retention arm extension 1834 of the platform 808 releasably secures the sensor module 504 in place. The module 2200 is coupled with the connector 2300, the sharps module 2500, and the sensor (not shown) so that they can be removed together as the sensor module 504 during assembly.

[0053] Exemplary embodiments of the sensor module 7A and 7B 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. 8A and 8B) and a sensor 104 (FIG. 9A). The module 504 features a rigid coupling with an electronics housing 706. One or more deflectable arms or module snaps 2202 can snap into corresponding features 2010 of the housing 706. The sharp slot 2208 can provide a place for the sharp tip 2502 to pass through and for the sharp shaft 2504 to temporarily reside. The sensor ledge 2212 can define the sensor position in the horizontal plane, prevent the sensor from lifting the connector 2300 off the post, and keep the sensor 104 parallel to the plane of the connector seal. Additionally, the sensor ledge 2212 can define the curved shape and minimum radius of curvature of the sensor. The sensor ledge 2212 can limit the vertical movement of the sensor, prevent the tower from protruding above the plane of the electronics housing, and define the length of the in vivo portion below the plane of the patch. The sensor wall 2216 can constrain the sensor and define the curved shape and minimum radius of curvature of the sensor.

[0054] 8A and 8B 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 in 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 water-tight seal for the electrical and sensor contacts. One or more hinges 2208 can connect the two distal and proximal portions of the connector 2300.

[0055] FIG. 9A 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 in vivo portion 2408 can cover the active analyte sensing element of the sensor 104. The in vivo portion 2408 can be the portion of the sensor 104 that resides under the user's skin after insertion. The extra-vitro portion 2404 can include contacts and a sealing surface. The bias tower 2412 can be a tab that biases the in vivo portion 2408 into the sharp 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 in vivo portion into the slot. The bias adjuster 2416 can reduce local curvature of the in vivo portion connection and prevent damage to the sensor traces. The contacts 2418 can electrically couple 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. 7B).

[0056] 9A, the sensor 104 can be configured with a neck 2406 that interconnects the in vitro portion 2404 and the in vivo portion 2408 and allows bending of the sensor 104 between these portions. In one example, the neck 2406 can be curved approximately 90 degrees to facilitate contact of the contact 2418 of the in vivo portion 2404 with the sensor ledge 2212 (FIG. 7B). However, the sensor 104 can be manufactured and, in some embodiments, shipped or stored in a relatively flat configuration in which the neck 2406 is substantially free of bending, and thus the in vivo portion 2404, the neck 2406, and the in vivo portion 2408 can form a substantially flat surface. In order to configure the sensor 104 into the illustrated embodiment, the neck 2406 must be curved. However, bending the neck 2406 subjects the sensor 104 in general, and the neck 2404 in particular, to stresses that may weaken or damage the sensor 104, result in microfractures, or otherwise reduce the efficiency and effectiveness of the sensor 104. The techniques described below can ensure that the neck 2404 can be bent to a desired angle while reducing damage to the sensor 104 and its components.

[0057] One exemplary technique for reducing damage caused by bending the neck 2406 of the sensor 104 is to apply a sufficient amount of heat for a sufficient amount of time in close temporal proximity to the time that will bend the neck 2406. These factors of the degree of heating, the length of exposure time, and the proximity of the heat application to the time that bending occurs can be determined based on the type of material that comprises the sensor 104 in general, and the neck 2406 in particular, with suitable examples of these materials provided below. For example, care must be taken to avoid damaging the contacts 2418 and the membrane covering the in vivo portion 2408.

[0058] The application of heat can be controlled by the manufacturing components used to bend the neck 2406. In one embodiment, the neck 2406 of the sensor 104 can be bent or folded by heating a portion of the neck 2406 to a predetermined temperature and bending the neck 2406 itself to form an angle between the in vivo portion 2408 of the sensor 104 and the extra vivo portion 2404 of the sensor. As described above, the predetermined temperature and length of heating can be determined based on the characteristics of one or more of the materials that make up the neck 2406 of the sensor 104. The temperature and length of heating can be selected based on being sufficient to improve the malleability of the neck 2406 of the sensor 104 without damaging the remainder of the sensor. Heating the neck 2406 of the sensor 104 can include heating only a region of the neck 2406 of the sensor 104, heating substantially all of the neck 2406, or heating one or more other components of the sensor 104.

[0059] The heating and bending steps can be performed by one or more heating and bending devices. For example, the sensor 104 can be inserted into a heating-bending device in a first configuration that includes separate dedicated components for heating the neck 2406 and bending the neck 2406. The step of configuring the sensor 104 then includes heating the neck 2406 with a first component for heating the neck 2406 and then passing the sensor 104 to a second component for bending the neck 2406 to a desired angle. The step of heating the neck 2406 can be performed by a heating element of the heating device. The heating element can be brought up to a desired temperature and can be placed in contact with or in close proximity to a designated portion of the neck 2406 for a set period of time to increase the temperature of the neck 2406. Additionally, the neck 2406 can be indirectly heated by increasing the local temperature around the sensor 104 without the neck 2406 being in direct contact with the heating element.

[0060] Additionally, the heating and bending steps can be performed by an integrated heating-bending device in which the components necessary to heat the neck 2406 are integrated into the components for bending the neck 2406. Thus, heat can be applied before or after the bending process is completed as well as during bending. By ensuring that the temperature of the heating element remains substantially unchanged and that the distance between the heating element and the neck 2406 remains substantially unchanged, the degree of heating, e.g., the temperature being applied to the neck 2406, can remain unchanged during the heating and / or heating-bending steps. Alternatively, the temperature of the neck 2406 can be varied during the bending process. For example, the temperature of the neck can be increased to a set threshold temperature, decreased to a set threshold before the bending is added, and increased again after the bending process (e.g., to avoid micro-fractures). In case the heating element is integrated into the bending device, the process can include increasing or decreasing the temperature of the neck 2406 while it is being bent.

[0061] Additionally, after bending the neck 2406 to form a desired angle, steps in manufacturing or operating the sensor 104 can include verifying the integrity of the sensor 104 after bending by inspecting the neck 2406 for microfractures. If the number and severity of microfractures exceeds a predetermined threshold, the sensor can be discarded. Other integrity checks can include inspecting the sensing components of the sensor 104 to ensure that they remain in a configuration consistent with their intended function and that the bending process did not introduce defects.

[0062] 9B, the sensor 104A can include each of the features of the sensor 104, including the neck 2406A, the bias tower 2412A, the bias adjuster 2416A, the bias fulcrum 2414A, and the power feed loop 2420A. Additionally, the sensor 104A can include an in vivo portion 2404A and an in vivo portion 2408A. The sensor 104A can further include an electronic component 2418A attached directly to the in vivo portion 2404A, for example, by using photonic soldering, as described in more detail below. Thus, the need for contacts 2418 is eliminated in the sensor 104A.

[0063] 10A and 10B 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 that pushes the sensor 104 proximally up into the sensor module 105, as shown by force F1 in FIG. 10A. 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 occur as a result of a sensor insertion mechanism designed to force itself through tissue, a sharp retraction mechanism during insertion, or due to a physiological response effected by the tissue surrounding the sensor 104 (e.g., after insertion).

[0064] 11A and 11B are enlarged partial views of an exemplary embodiment of a sensor module assembly having certain axial stiffening features. In a general sense, the embodiments described herein relate to mitigating the effects of axial forces on a sensor as a result of an insertion mechanism and / or a retraction mechanism or from a physiological response to the sensor within the body. As can be seen in FIG. 11A and 11B, 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 clearance 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.

[0065] 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 sensor proximal portion that is coupled to the sensor module 3504 as described above, and a sensor distal portion that is positioned below the skin surface in contact with bodily fluids. As can be seen in FIGS. 11A and 11B, the sensor proximal 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 exerted 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 and prevents proximal displacement of the sensor 3104 along the longitudinal axis.

[0066] In accordance with another aspect of the above embodiment, the sensor 3104 can be assembled with the sensor module 3504 in the following manner: The sensor 3104 is mounted within the sensor module 3504 by laterally displacing the sensor proximal portion to bring the hook feature 3106 closer to the catch feature 3506 of the sensor module 3504. More specifically, laterally displacing the sensor proximal portion moves the sensor proximal portion into the clearance area 3508 of the sensor module 3504.

[0067] 11A and 11B show the hook feature 3106 as part of the sensor 3104 and the catch feature 3506 as part of the sensor module 3504, one of ordinary skill in the art will recognize that the hook feature 3106 can instead be part of the sensor module 3504 and similarly the catch feature 3506 can instead be part of the sensor 3106. Similarly, one of ordinary skill in the art will recognize that other mechanisms implemented on the sensor 3104 and the sensor module 3504 to prevent axial displacement of the sensor 3104 (such as, for example, detents, latches, fasteners, screws, etc.) are possible and within the disclosure of the present invention.

[0068] 11C 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 may thus be used to detect a particular analyte concentration in an analyte monitoring system. As shown, the sensor 11900 includes an in vivo portion 11902, an extra-vivo portion 11904, and a neck 11906 interconnecting these portions. The in vivo portion 11902 includes an enzyme or other chemical or biological agent, and in some embodiments, a membrane may cover the chemical agent. During use, the in vivo portion 11902 is transdermally received under the skin of a user, and the chemical agent included on the in vivo portion 11902 helps facilitate analyte monitoring in the presence of bodily fluids.

[0069] The in vivo portion 11902 of the sensor 11900 can be received within a hollow or recessed portion of a sharp (not shown) to at least partially surround it. As shown, the in vivo portion 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 in vivo portions, the in vivo portion 11902 does not extend perpendicularly from the extra-vivo portion 11904, but instead can extend at an angular offset from the vertical. This angular offset can prove advantageous in helping to maintain the in vivo portion 11902 within the recessed portion of the sharp.

[0070] The in vivo portion 11902 includes a first or bottom end 11908a and an opposite second or 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 in vivo portion 11902 to the extra vivo portion 11904. The tower 11910 can help pivot the in vivo portion 11902 towards the sharp if the sharp moves laterally during actuation 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 in vivo portion 11902 extends into the recessed portion of the sharp, the protrusion 11912 can engage an inner surface of the recessed portion. When actuated, the protrusions 11912 can help keep the in vivo portion 11902 within the recessed portion.

[0071] The extracorporeal portion 11904 can include a generally flat surface having disposed thereon 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 encapsulated within a connector.

[0072] In some embodiments, as shown, the neck 11906 may provide or otherwise define a recess or bend 11916 that extends between the in vivo portion 11904 and the in vivo portion 11902. The bend 11916 may prove advantageous in adding flexibility to the sensor 11900 and helping to prevent bending of the neck 11906.

[0073] In some embodiments, a notch 11918 (shown in dashed lines) can be optionally defined in the ex vivo portion near the neck 11906. The notch 11918 can provide additional 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.

[0074] In some embodiments, as shown in Figures 11D-11G, the neck can include or otherwise define a non-linear configuration, such as a recess or bend 11920a-11920d having multiple turns, e.g., 11921a, 11921b, extending between the in vivo portion 11904 and the in vivo portion 11902. The bends 11920a-11920d can be advantageous by reducing the positional 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 in vivo portion 11902 and the in vivo portion 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.

[0075] In general, the sensor can be configured to include an in vivo part, an in vivo part, and a neck aligned along a flat surface having a vertical axis and a horizontal axis. A spring-like structure can be formed by various orientations of turns at the bend of the neck of the sensor. The neck can include at least two turns that provide a spring-like structure with respect to the vertical axis between the in vivo part and the in vivo part. The at least two turns can provide an overlapping layer of structure of the neck with respect to the axis of the flat surface shared by the in vivo part, the in vivo part, and the neck, where the neck itself remains intact. These overlapping turns constitute 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.

[0076] 11D shows an embodiment of a sensor 11900 including a neck having a bend 11920a including turns 11921a and 11921b between the in vivo portion 11904 and the in vivo portion 11902. In the illustrated embodiment, at least one turn 11921a abuts the top end of the in vivo portion or potentially the tower 11910 of the sensor 11900. This orientation can be advantageous in reducing the overall footprint of the sensor even taking into account the additional material used to generate the bend 11920a. This arrangement can provide multiple overlapping horizontal layers that are vertically aligned between the turns.

[0077] 11E shows another embodiment of a sensor 11900 including a neck with a bend 11920b that generally forms a swirling pattern including at least turns 11923a, 11923b, and 11923c between the in vivo portion 11904 and the in vivo portion 11902. In this embodiment, the turns again abut the top of the in vivo portion 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 oriented stresses. The overlapping layers in this winding arrangement are substantially balanced along both the horizontal and vertical axes.

[0078] 11F shows another embodiment of a sensor 11900 including a neck having a bend 11920c including turns 11925a, 11925b, and 11925c between the in vivo portion 11904 and the in vivo portion 11902. In the illustrated embodiment, the turn 11925c connects a region or tower 11910 of the sensor near its top end to the remainder of the bend 11920c. In addition to reducing the overall footprint of the sensor, this orientation can provide additional flexibility in the horizontally oriented axis. This arrangement can provide multiple overlapping vertical layers that are horizontally aligned between the turns.

[0079] 11G shows another embodiment of the sensor 11900 including a neck having a bend 11920d including turns 11927a, 11927b, and 11927c between the in vivo portion 11904 and the in vivo portion 11902. In the illustrated embodiment, the bend 11920d occurs primarily within the in vivo portion 11902 of the sensor and connects the in vivo portion 11902 and the tower 11910, whereas the run of the sensor between the tower 11910 and the in vivo portion 11904 is substantially continuous. Turn 11927a connects the tower 11910 generally to the remainder of the bend 11920d, whereas turn 11927c connects the in vivo portion 11902 to the remainder of the bend 11920d. This orientation can provide additional flexibility in the vertically oriented axis. This arrangement can provide multiple overlapping vertical layers with horizontal alignment between the turns.

[0080] The neck turns can be formed by folding or curving the neck of the sensor from a larger neck structure, the sensor can be laser cut from the sheet or layer of material in which the sensor is constructed, the sensor having a configuration with turns can be printed from the sheet or layer of material in which the sensor is included, the sensor can be stamped from the sheet or layer of material in which the sensor is constructed, or by other manufacturing process suitable for providing a precision bend in the neck.

[0081] 11H, the sensor 11900A can include each of the features of the sensor 11900, including the neck 11906A, the bottom end 11908c, the top end 11908d, the tower 11910A, the protrusion 11912A, the recess or bend 11916A (or alternatively, a recess or bend similar to 11920a-11920d shown in FIGS. 11D-11G), and the notch 11918A. Additionally, the sensor 11900A can include an in vitro portion 11904A and an in vivo portion 11902A. The sensor 11900A can include an electronic component 11914A attached directly to the in vivo portion 2404A, for example, by using photonic soldering, as described in more detail below. Thus, the sensor 11900A can eliminate the need for sensor contacts 11914.

[0082] 12A and 12B 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. 13C is an isometric bottom view of the connector 12002. The connector 12002 can include an injection molded part that is used to help secure one or more flexible carbon-impregnated polymer modules 12004 (four shown in FIG. 12B) to the mount 12006. More specifically, the connector 12002 can contact and help secure the module 12004 in a fixed position adjacent the sensor 11900 with a sensor contact 11914 (FIG. 11C) provided on the ex vivo portion 11904 (FIG. 11C). The module 12004 can be fabricated from a conductive material to provide conductive communication between the sensor 11900 and corresponding circuit contacts (not shown) provided in the mount 12006.

[0083] As can be seen most clearly in FIG. 12C, the connector 12002 can define a pocket 12008 sized to receive the module 12004. Additionally, 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. 12B ) 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 using an adhesive or by sonic welding.

[0084] 12D and 12E 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. 12F is an isometric bottom view of the connector 12102. The connector 12102 can include an injection molded part that is used to help keep one or more flexible metal contacts 12104 (four shown in FIG. 12E) fixed relative to the sensor 11900 on the mount 12106. More specifically, the connector 12102 can contact and help secure the sensor contacts 11914 (FIG. 11C) provided on the ex vivo portion 11904 in a fixed position adjacent the sensor 11900. The contacts 12104 can be made of 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) positioned within the mount 12106 .

[0085] As can be seen most clearly in FIG. 12F, the connector 12102 can define a pocket 12108 sized to receive the contact 12104. Additionally, 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. 80B ) 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 using an adhesive or by sonic welding.

[0086] Exemplary embodiments of the Sharp module FIG. 13A is a perspective view depicting an exemplary embodiment of a sharps module 2500 prior to assembly into a sensor module 504 (FIG. 6B). The sharps 2502 can include a distal tip 2506 that can penetrate the skin while carrying the sensor in vivo portion within a hollow or recess in the sharps shaft 2504 to place the active surface of the sensor in vivo portion 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 the stretching of the sharps hub contact surface 1622 (FIG. 14B). The hub snap claw positioning cylinder 2514 can provide a distal 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.

[0087] 13B-13H illustrate exemplary embodiments of a sharps module at various assembly steps for use during insertion of a dermal analyte sensor. According to one aspect of these embodiments, angling of the sensor and / or insertion sharps relative to a reference point can enable co-localization of the tip of the insertion needle with the tip of the sensor, and can also create a single contact point at the surface of the skin. Thus, the sharps 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 the subject's body. In some embodiments, for example, the sharps and / or dermal sensor can be angled relative to a reference point (e.g., each other, the surface of the skin, or the base of the applicator) for insertion, where the angle of the sharps is different from the angle of the sensor. For example, the reference point can be the surface of the skin to be cleaved for dermal insertion, or can be a reference or component of the sensor applicator set. In some embodiments, the sharps can be positioned at an angle relative to the sensor. For example, when the sharps are 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 Publication No. 2014 / 0171771, the entire contents of which are incorporated by reference into this specification for all purposes.

[0088] Additionally, although many of the exemplary embodiments described with respect to Figures 13B through 13J are described with respect to dermal analyte sensors and dermal insertion, one of ordinary skill in the art will appreciate that any of these embodiments can be sized and configured for use with analyte sensors that can be positioned beyond the dermal 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).

[0089] 13B is a perspective view depicting an exemplary embodiment of a sharps module 2550 that can be used for insertion of a dermal sensor. This view shows the sharps module 2550 prior to assembly with the sensor module 504 (FIG. 6B), and the sharps module 2550 can include similar components to the embodiment described with respect to FIG. 13A, including a sharp 2552, a sharps shaft 2554, a sharps distal tip 2556, a hub pressing cylinder 2558, a hub minor cylinder 2562, a hub snap pawl 2566, and a hub snap pawl positioning cylinder 2564. The sharps 2552 can be positioned in the sharps module 2550 at an eccentric location relative to a longitudinal axis 2545 that extends through the center of the hub snap pawl 2566, the hub minor cylinder 2562, and the hub pressing cylinder 2558. Additionally, the sharps module 2550 can include a sharps spacer 2568 parallel to and adjacent to a portion of the sharps 2552. A sharp spacer 2568 can be positioned between the sensor 104 (not shown) and the sharp 2552 along a proximal portion of the sharp 2552 to ensure that the sensor 104 and the sharp 2552 remain spaced apart at the proximal portion of the sharp 2552. The sharp 2552 can be positioned in an eccentric location during the molding process with hub components 2558, 2562, 2566, each of which can include a hard plastic material.

[0090] 13C and 13D are two side views depicting the sharp module 2550 prior to assembly with the sensor module 504 (FIG. 6B) and including the sharp 2552, the spacer 2568, the hub pressing cylinder 2558, the hub small cylinder 2562, and the hub snap claw 2566. In some embodiments, the relative distance between the sharp 2552 and the hub components can be positioned as follows. For example, the distance Si between the sharp 2552 and the radial center of the hub can be a distance of 0.50 mm to 1 mm (e.g., 0.89 mm). The height S2 of the sharp spacer 2568 can range from 3 mm to 5 mm (e.g., 3.26 mm). The height S3 of the hub can range from 5 mm to 10 mm (e.g., 6.77 mm). The length S4 of the sharp 2552 can range from 1.5 mm to 25 mm (e.g., 8.55 mm) and can be based on the location of the insertion site on the subject.

[0091] FIG. 13E depicts a cross-sectional side view of the sharps module 2550 including the sharps 2552, the sharps spacer 2568, and the hub components (hub snap claws 2566, hub small cylinder 2562, and hub pressing cylinder 2558) assembled with the sensor module 504. As can be seen in FIG. 13E, the sharps 2552 are positioned within the sharps slot 2208 of the sensor module 504 including the curved inner surface 2250 located at the distal end. The curved inner surface 2250 of the sensor module 504 can be in contact with a portion of the sharps 2552, causing the sharps distal tip 2556 to deflect toward the central longitudinal axis 2545. As can be seen most clearly in FIG. 13H, the sharps 2552 can be positioned such that the distal portion and the central longitudinal axis 2545 form an acute angle So that can range between 5° and 20°. In some embodiments, for example, So can be in the range of 5° to 17°, 7° to 15°, or 9° to 13°, e.g., 9°, 10°, 11°, 12°, or 13°.

[0092] Continuing to refer to FIG. 13E, near the distal end of the sensor module 504 is a protrusion 2251 that can facilitate perfusion of bodily fluids, such as dermal fluid. Although shown as curved in FIG. 13E, the protrusion 2251 can be shaped in any desired manner. Additionally, in some embodiments, there can be multiple protrusions. U.S. Patent Publication No. 2014 / 0275907, the entire contents of which are incorporated herein by reference for all purposes, describes sensor devices having 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 exit the base of the sensor device adjacent the protrusion and extend from this location above the tip of the sensor 104.

[0093] 13E and 13F, the sensor 104 may be a dermal sensor and may include an in vivo portion 2408 located at a distal end of the sensor 104 and oriented substantially parallel to the central longitudinal axis 2545. The distal end of the sensor in vivo portion 2408 may be in spaced relation to, or nested within, or abutting a portion of the sharp shaft 2554 proximal to the distal sharp tip 2556. As further shown in FIG. 13E, a sharp spacer 2568 provides a spaced relation between a proximal portion of the sharp 2552 and the sensor 104 such that the proximal portion of the sharp 2552 and the sensor 104 are not in contact. The sensor module 504 may further include a sensor connector 2300 for accommodating a proximal portion of the sensor 104 that is relatively perpendicular to the distal end of the sensor 104.

[0094] 13F 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 coupling with a housing (not shown) of the sensor control device 102. The sensor module 504 may further include a sensor connector 2300 that may have sensor contacts 2302 for coupling with a proximal portion of the sensor 104. The sensor connector 2300 may be fabricated from 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 in 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. Although 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 be coupled to the sensor module 504 by two connector posts 2206 positioned through a like 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.

[0095] 13G and 13H are perspective and side views, respectively, of another exemplary embodiment 2600 of a sharps module that can be used for insertion of a dermal sensor. This figure shows the sharps module 2600 prior to assembly with the sensor module 504 (FIG. 6B), and the sharps module 2600 can include similar components to the embodiment described with respect to FIGS. 13A and 13B, including a sharp 2602, a sharp shaft 2604, a sharp distal tip 2606, a hub pressing 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 2602 can be a "pre-curved" needle that includes a proximal portion 2603 that proceeds from a point on the exterior of the sharps module 2600 and intersects at an angle with the center point of the hub (e.g., through the hub pressing cylinder 2608). The sharp 2602 may further include a distal portion 2605 that extends distally at an angle from a point near the distal portion of the hub toward an insertion point on the user's skin. As shown in FIG. 13H, the sharp 2602 may include a bent portion 2607 that may be positioned outside of the hub pressing cylinder 2608 and have a substantially 90° angle between the proximal portion 2603 and the distal portion 2605 of the sharp 2602. The sharp module 2600 may further include a bent fin guide 2620 to maintain the "pre-curved" sharp 2602 in a defined position during assembly and / or use and may prevent lateral or rotational movement of the sharp 2602 relative to the hub components. The proximal portion 2603 of the sharp 2602 may be "trimmed" from the hub after the molding process is completed and prior to assembly of the sharp module 2600 with the sensor module 504.

[0096] 13I and 13J are side cross-sectional and side views, respectively, of the sharps module 2600 (including the hub snap claws 2616, the hub small cylinder 2612, and the hub pressing cylinder 2608) assembled with the sensor module 504. As can be seen in FIG. 13I, the sensor module 504 includes a sharps slot 2208 that allows the sharps 2602 to extend through in an oblique and distal direction. As described above, the proximal portion of the sharps 2602 passes through a bent fin guide 2620 coupled to the distal portion of the sensor module 504. The sensor module 504 can further include a sensor 104, which can be a dermal sensor. As shown in FIG. 13I, the sharps 2602 and the sensor in vivo portion 2408 can form an acute angle So at the point where their respective longitudinal axes converge. The angle So can range between 5° and 20°. In some embodiments, for example, So 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 proximal to the end of the sensor in vivo portion 2408 at a distance S6. Distance S6 can range between 0.02 mm and 0.10 mm, e.g., 0.05 mm, 0.06 mm, or 0.07 mm.

[0097] 13I and 13J, the sensor module 504 can further include a sensor connector 2300 for receiving a proximal portion of the sensor 104 that is relatively perpendicular to the distal end of the sensor 104. The sensor module 504 can include one or more sensor module snaps 2202 for mating with a housing (not shown) of the sensor control device 102. The sensor connector 2300 can include the same structure as described with respect to FIG.

[0098] In the above-described embodiments, the sharp may be made of stainless steel or a similar flexible material (e.g., a material used to make acupuncture needles) and may be sized to allow insertion of at least a portion of the dermal sensor into, but not through, the dermal layer of the skin by the applicator. According to certain embodiments, the sharp has a cross-sectional diameter (width) of 0.1 mm to 0.5 mm. For example, the sharp may 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 sharp may have a constant or uniform width along its entire length, or may have a varying or changing width along at least a portion of its length, e.g., the tip portion used to pierce the surface of the skin. For example, with respect to the embodiment illustrated in FIG. 13I, the width of the sharp 2602 may be reduced along a distal portion between the bent fin guide 1620 and the distal sharp tip 2606.

[0099] The sharp can have a length that allows the dermal sensor to be inserted precisely into the dermal layer and not further. The insertion depth can be controlled by the length of the sharp, the configuration of the base and / or other applicator components that limit the insertion depth. The sharp can have a length between 1.5mm and 25mm. For example, the sharp can have a length of 1mm to 3mm, 3mm to 5mm, 5mm to 7mm, 7mm to 9mm, 9mm to 11mm, 11mm to 13mm, 13mm to 15mm, 15mm to 17mm, 17mm to 19mm, 19mm to 21mm, 21mm to 23mm, 23mm to 25mm, or a length greater than 25mm. The sharp can have a length up to 25mm, but it will be appreciated that in certain embodiments the entire length of the sharp will not be inserted into the subject as it would extend beyond the dermal space. The non-inserted sharp length can allow for handling and manipulation of the sharp with the applicator set. Thus, although the sharps can have a length of up to 25 mm, the insertion depth of the sharps in the subject's skin in certain embodiments described above will be limited to the dermis layer, e.g., about 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 sharps can be configured to extend beyond the dermis space, e.g., 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). In addition to this, in some exemplary embodiments, the sharps described herein can include hollow or partially hollow insertion needles with an internal space or lumen. However, in other embodiments, the sharps described herein can include solid insertion needles without an internal space or lumen. Furthermore, the sharps of the subject applicator set can be bladed or non-bladed.

[0100] Similarly, in the above-described embodiments, the dermal sensor is also sized such that at least a portion of it is positioned at the dermal layer and not beyond, with a portion extending outside the skin in percutaneous positioning embodiments, i.e., the dermal sensor is sized 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 positioned within the dermis of the subject, and when the sensor is operably positioned in the dermis, no portion of the sensor is inserted beyond the dermis layer of the subject.

[0101] Since the depth and thickness of the epidermis and dermis vary to some extent depending on the location of the skin, the dimensions (e.g., length) of the sensor can be selected according to the part of the subject's body where the sensor is to be inserted. For example, the epidermis is only about 0.05 mm thick on the eyelid, but about 1.5 mm thick on the palm and sole. The dermis is the thickest of the three layers of skin, and ranges from about 1.5 mm to 4 mm thick depending on the location of the skin. For implantation of the distal end of the sensor into, but not penetrating, the dermis layer of the subject, the length of the insertion portion of the dermal 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 dermis layer at the site, and selecting an applicator set of an appropriate size for the site.

[0102] In certain aspects, the sensor is an elongated sensor having a longest dimension (or "length") of 0.25 mm to 4 mm. The insertion length of the sensor 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 dermis. The dimensions of the sensor can be expressed using the aspect ratio of the sensor. In certain embodiments, the dermal sensor has a length to width (diameter) aspect ratio of about 30:1 to about 6:1. For example, the aspect ratio can be about 25:1 to about 10:1, including 20:1 and 15:1. The insertion portion of the dermal sensor contains the sensing chemical agent.

[0103] However, all of the embodiments disclosed herein can be configured such that at least a portion of the sensor is positioned beyond the dermis layer, for example, in (or through) the subcutaneous tissue (or fat). For example, the sensor can be dimensioned such that when it is fully or substantially fully inserted into the body, the most distal portion (insertion portion or insertion length) of the sensor is positioned in the subcutaneous tissue (beyond the dermis of the subject), and when the sensor is operatively positioned, no portion of the sensor is inserted beyond the subcutaneous tissue of the subject. As mentioned above, typically, the subcutaneous tissue is in the region of 3 mm to 10 mm below the outer skin surface, depending on the location of the skin on the body.

[0104] Exemplary embodiments of an applicator and sensor control device for a one-piece architecture Briefly referring back to FIG. 1 and FIG. 3A-3G, for a two-piece architecture system, the sensor tray 202 and the sensor applicator 102 are provided to the user as 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 steps that are unique to the contents of each package and cannot be shared with the contents of the other. More specifically, the sensor tray 202, including the plug assembly 207, including the sensor 110 and the sharps 220, can be sterilized using radiation sterilization, such as electron beam (or "e-beam") irradiation. However, radiation sterilization may damage electrical components positioned 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, for example, using ethylene oxide. However, gas chemical sterilization may damage enzymes or other chemical and biological agents contained on the sensors 110. Due to this sterilization incompatibility, the sensor tray 202 and the sensor applicator 102 are typically sterilized in separate sterilization processes and then packaged separately, thereby requiring the user to ultimately assemble the components for use.

[0105] According to the disclosed embodiments of the present invention, the sensor control device 102 can be modified to provide a one-piece architecture that can apply sterilization techniques specifically designed for the one-piece architecture sensor control device. The one-piece architecture allows the sensor applicator 150 and the sensor control device 102 to be shipped to the user in a single sealed package that does not require any final user assembly steps. In other words, the user only needs to 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 processing steps, and user assembly steps. This results in less packaging and waste, and less potential for user error or contamination of the system.

[0106] 14A and 14B are isometric and side views, respectively, of another exemplary sensor control device 5002 in accordance with one or more embodiments of the present disclosure. The sensor control device 5002 may be similar in some respects to the sensor control device 102 of FIG 1 and therefore may be best understood with reference thereto. Moreover, 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 monitor location on the user's skin.

[0107] 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 a user to unpack multiple packages and final assemble 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 one barrier (e.g., applicator cap 708 of FIG. 3B) before dispatching the sensor control device 5002 to a target monitoring location ready for use.

[0108] As illustrated, the sensor control device 5002 includes an electronics housing 5004 that can be generally disk-shaped and have a circular cross-section. However, in other embodiments, the electronics housing 2004 can exhibit other cross-sectional shapes, such as oval or polygonal, without departing from the scope of the present disclosure. The electronics housing 5004 can be configured to house or otherwise enclose various electrical components used to operate the sensor control device 5002. In at least one embodiment, an adhesive patch (not shown) can be positioned on the bottom of the electronics housing 5004. The adhesive patch can be similar to the adhesive patch 105 of FIG. 1 and can thus aid in adhering the sensor control device 5002 to a user's skin for use.

[0109] As illustrated, the sensor control device 5002 includes an electronics housing 5004 including 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 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 therebetween.

[0110] The sensor control device 5002 may further include a sensor 5010 (partially visible) and a sharp 5012 (partially visible) that is used to aid in transdermal delivery of the sensor 5010 beneath the skin of a user during application of the sensor control device 5002. As shown, corresponding portions of the sensor 5010 and sharp 5012 extend distally from a bottom (e.g., mount 5008) of the electronics housing 5004. The sharp 5012 may include a sharp hub 5014 configured to securely carry it. As can be seen most clearly in FIG. 14B, the sharp hub 5014 may include or otherwise define a mating member 5016. To couple the sharp 5012 to the sensor control device 5002, the sharp 5012 may be advanced axially through the electronics housing 5004 until the sharp hub 5014 engages an upper surface of the shell 5006 and the mating member 5016 extends distally from the bottom of the mount 5008. When the sharp 5012 penetrates the electronics housing 5004, the exposed portion of the sensor 5010 can be received within a hollow or recessed (arcuate) portion of the sharp 5012. The remainder of the sensor 5010 is positioned within the electronics housing 5004.

[0111] The sensor control device 5002 may further include a sensor cap 5018, which is shown in FIGS. 14A-14B disassembled or separated from the electronics housing 5004. The sensor cap 5016 may be removably coupled to the sensor control device 5002 (e.g., electronics housing 5004) at or near the bottom of the mount 5008. The sensor cap 5018 may help provide a sealing barrier surrounding exposed portions of the sensor 5010 and the sharps 5012 to protect against 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 defined by an engagement feature 5024. As described herein, the engagement features 5024 can aid 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 aid in removing the sensor cap 5018 from the sensor control device 5002 when the cap is removed from the sensor applicator.

[0112] 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. 14B) that can mate with a set of female threads 5026b (FIG. 14A) defined by the sensor cap 5018. In some embodiments, the male and female threads 5026a, 5026b can include a flat 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 form a helical threaded engagement. Thus, the sensor cap 5018 can be threadably coupled to the sensor control device 5002 with 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 or friction fit, or a frangible member or material that can be broken with a small separation force (e.g., axial or rotational force).

[0113] 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 seal ring 5028 positioned at the first end 5020a and a desiccant cap 5030 positioned at the second end 5020b. The seal ring 5028 may be configured to help seal the inner chamber 5022, as described in more detail below. In at least one embodiment, the seal ring 5028 may include an elastomeric O-ring. The desiccant cap 5030 may contain 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.

[0114] 15A and 15B are exploded isometric top and bottom views, respectively, of a sensor control device 5002 according to one or more embodiments. The shell 5006 and the mount 5008 act as opposing clamshell halves that encapsulate or otherwise substantially encapsulate 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 one or more batteries 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 3702. 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 a plurality of data signals each corresponding to a sampled analyte level of a user. The data processing unit may further include or otherwise communicate with one or more antennas for communicating with the reader device 120 (FIG. 1). One or more batteries may provide power to the sensor control device 5002, and more specifically, to the electronic components of the PCB. Although not shown, the sensor control device 5002 may further include an adhesive patch that may be applied to the bottom 5102 (FIG. 15B) of the mount 5008 and may help adhere the sensor control device 5002 to the user's skin for use.

[0115] The sensor control device 5002 may provide or otherwise include a sealed subassembly that includes, among other component parts, a shell 5006, a sensor 5010, sharps 5012, and a sensor cap 5018. The sealed subassembly of the sensor control device 5002 may help isolate the sensor 5010 and sharps 5012 within an inner chamber 5022 (FIG. 15A) of the sensor cap 5018 during a gas chemical sterilization process that could otherwise adversely affect chemical agents provided on the sensor 5010.

[0116] The sensor 5010 can include an in vivo portion 5104 that extends from an opening 5106 (FIG. 15B) defined in the mount 5008 to be transdermally received beneath the skin of the user. The in vivo portion 5104 can have an enzyme or other chemical agent included thereon to help facilitate analyte monitoring. The sharp 5012 can include a sharp tip 5108 extendable through an opening 5110 (FIG. 19A) defined by the shell 5006, which opening 5110 can be coaxially aligned with the opening 5106 of the mount 5008. When the sharp tip 5108 penetrates the electronics housing 5004, the in vivo portion 5104 of the sensor 5010 can be received within a hollow or recessed portion of the sharp tip 5108. The sharp tip 5108 can be configured to penetrate the skin while carrying the in vivo portion 5104, bringing the active chemical agent of the in vivo portion 5104 into contact with bodily fluids.

[0117] 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 include a separate component part, or alternatively, can form an integral part of the shell 5006, such as a co-molded or overmolded component part.

[0118] The sealing subassembly may further include a collar 5112 positioned 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 house or otherwise receive a portion of the sensor 5010 that extends laterally within the electronics housing 5004.

[0119] When assembling the sealing subassembly, the bottom 5118 of the collar 5112 can be exposed at the opening 5106, and the bottom 5118 can sealingly engage the first end 5020a of the sensor cap 5018, and 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 in vivo portion 5104.

[0120] 16 is a cross-sectional side view of an assembled seal subassembly according to one or more embodiments. The seal subassembly 5200 can form a portion of the sensor control device 5002 of FIGS. 14A-14B and 15A-16B and can include portions of the shell 5006, the sensor 5010, the sharp 5012, the sensor cap 5018, and the collar 5112. The seal subassembly 5200 can be assembled in a variety of ways. In one assembly process, the sharp 5012 can be coupled to the sensor control device 5002 by extending the sharp tip 5108 through an opening 5110 defined in a top portion of the shell 5006 and advancing the sharp 5012 through the shell 5006 until the sharp hub 5014 engages the top portion of the shell 5006 and the mating member 196 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.

[0121] The collar 5112 may then be received over (and around) 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. The seal member 5206 may be sandwiched between the annular ridge 5114 and the inner surface 5204, thereby forming a sealed interface. The seal member 5206 may extend (flow) into a groove 5116 (FIGS. 15A-16B) defined in the annular ridge 5114, thereby sealing around the sensor 5010 extending laterally within the electronics housing 5004 (FIGS. 15A-16B). However, in other embodiments, the collar 5112 may first be sealed to the inner surface 5204 of the shell 5006, followed by the extension of the sharps 5012 and sharps hub 5014 through the opening 5110 as described above.

[0122] The female threads 5026b of the sensor cap 5018 may be threadably engaged with the male threads 5026a of the fitting 5016, thereby removably coupling the sensor cap 5018 to the sensor control device 5002. Tightening (rotating) the mating engagement between the sensor cap 5018 and the fitting 5016 may urge the first end 5020a of the sensor cap 5018 into sealing engagement with the bottom 5118 of the collar 5112. Additionally, tightening the mating engagement between the sensor cap 5018 and the fitting 5016 may improve the sealing joint 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.

[0123] The inner chamber 5022 can be sized or otherwise configured to receive the in vivo portion 5104 and the sharp tip 5108. Additionally, the inner chamber 5022 can be sealed to isolate the in vivo portion 5104 and the sharp tip 5108 from substances that may adversely interact with the chemical agents of the in vivo portion 5104. In some embodiments, a desiccant 5208 (shown in dashed lines) can be present in the inner chamber 5022 to maintain the proper humidity level.

[0124] 36A-36H illustrate stages in a manufacturing process for producing a sensor subassembly, also referred to as a sealed subassembly, such as sealed subassembly 5200 (FIG. 36H, see FIG. 20). In a particular embodiment, assembled sensor subassembly 5200 can include a sensor 5010, a sensor mount 5008, a collar 5112, a sharps 5012, and a sensor cap 5018. As described herein, the sensor 5012 can include a temperature sensor, a blood pressure sensor, a pulse or heart rate sensor, a glucose level sensor, an analyte sensor, or a physical activity sensor. Various sensors can be configured and made compatible with the sealed subassembly manufacturing techniques described herein based on the electrical or chemical procedures applied to or used for the selected sensor.

[0125] 36A, a sensor 5010 is mounted within a sensor mount 5008. Based on the configuration of the sensor 5010, the sensor mount can include components to interface with and stabilize the sensor 5010, such as flanges 4020, 12112 (see FIG. 12E), 12104, etc., as described herein.

[0126] 36B, the manufacturing process can include dispensing adhesive into the mount channel 4025 of the sensor mount 5008. The adhesive can be dispensed manually or using a suitable automated tool. For example, a specially configured tool having a dispensing valve for dispensing a predetermined amount of adhesive into the mount channel 4025 can be used.

[0127] As shown in FIG. 36C, the manufacturing process can include loading the collar 5112 onto the sensor mount 5008. In particular, the collar 5112 is loaded to fit into the mount channel 4025 of the sensor 5008. The collar can be loaded manually or using a suitable manufacturing tool including a manually actuated or robotic loading arm, a vacuum or suction gripping arm, a magnetic gripping arm, an adaptive gripping arm or attachment, or other suitable tool. The collar 5112 can then be clamped to the sensor mount 4025 to ensure that the collar 5112 is properly seated within the sensor mount 4025 and to distribute adhesive through the sensor mount 4025 and the collar 5112. The collar 5112 can be clamped to the sensor mount 4025 using a suitable clamping tool including a manual clamp, a ratcheting clamp, an electric slide, a pneumatic slide, a linear slide including a ball-screw linear adapter, or the like.

[0128] The adhesive is then cured to secure the collar 5112 to the sensor mount 5008, as shown in FIG. 36D. The adhesive can include a variety of curable adhesives for use with high throughput manufacturing environments. The adhesive used can be selected based on the curing method and cure time. For example, the adhesive can be selected to reduce the cure time while also limiting exposure of the chemical agents or electronics of the sensor 5010 to excessive heat, chemicals, etc., radiation, or excessive infrared or ultraviolet (UV) light that may destroy the effectiveness of the sensor. As an example, the adhesive can be a chemically curable adhesive. In this case, curing the adhesive may include exposing the adhesive to one or more chemical bonding catalysts. As another example, the adhesive can be an aerobically curable adhesive. In this case, curing the adhesive may include exposing the adhesive to a sufficient amount of air before the collar 5112 is attached or before proceeding to the next step. As another example, the adhesive can be a heat curable adhesive. In this case, curing the adhesive may include exposing the adhesive to ambient heat or a heating element for a predetermined amount of time. As another example, the adhesive may be a UV curable adhesive. In this case, curing the adhesive may include using one or more UV light sources. The UV light source may include, for example, a UV light emitting diode (LED) positioned to cure the adhesive using a light guide and multiple angled spot LEDs. FIG. 36D illustrates where multiple curing agent sources 4010 are used to cure the adhesive from above and below the sensor mount 5008.

[0129] In certain embodiments, while the adhesive is curing, the collar 5112 and the sensor mount 5008 can function to protect the sensor 5010 from exposure to a curing agent that could otherwise damage the sensor 5010 or other components of the sealed subassembly 5200. Additionally, other temporary components can be used to further protect the sensor 5010. As an example, the collar 5112 can block exposure to chemicals, heat, or UV light sources while the adhesive is curing. Additionally, depending on the adhesive and curing method, the materials that make up the sensor mount 5008 or collar 5112 can be selected to selectively allow the curing agent to pass partially through to the adhesive.

[0130] As shown in FIG. 36E, the manufacturing process can include fitting the sharpener hub 5014 to the sensor mount 5008 to cover and mate with the sensor 5010. Fitting the sharpener hub 5014 to the sensor mount 5008 can include passing a portion or all of the sharpener 5012 through an opening 5110 and a collar 5112 in the sensor mount 5008. In some embodiments, the manufacturing process can further include inspecting the sharpener 5012 for defects. Inspection can be performed before or after inserting the sharpener hub 5014 into the sensor mount 5008. Inspection can be performed manually, for example, by loading the sharpener into a microscope or other magnifying vision device and allowing a human operator to verify the condition of the sharpener. Alternatively, inspection can be performed automatically, for example, by imaging the sharpener using a high resolution camera or x-ray imaging. Once the sharpeners 5012 have been imaged, a computer vision system can compare these images to acceptable sharpeners or apply machine learning models to the images to verify the condition of the sharpener. If a sharp is deemed defective, it may be discarded.

[0131] 36F, the manufacturing process can include attaching a sensor cap 5018 to a sensor mount 5008 to cover the sensor 5010 and the sharps 5012 to provide a sealed sensor subassembly 5200. In certain embodiments, the sensor cap 5018 can include a unitary structure. In other embodiments, the sensor cap 5018 can include multiple component parts. For example, as discussed herein, the sensor cap 5018 can include a desiccant cap 5030 or desiccant plug that contains a desiccant to control moisture exposure of the sensor 5010 and the sharps 5012. The manufacturing process can include assembling the sensor cap 5018 by inserting a desiccant into the desiccant cap 5030 and attaching the desiccant cap 5030 to the sensor cap 5018.

[0132] Attaching the sensor cap 5018 to the sensor mount 5008 can be performed by force-fitting the sensor cap 5018 to the sensor mount 5008. For example, the sensor mount 5008 or the Sharp hub 5104 can define a male thread set that can mate with a female thread set defined by the sensor cap 5018. The male and female threads can include a flat thread design (e.g., lacking a helical curvature) that can prove advantageous for molding these parts. The sensor cap 5018 can be removably coupled to the sensor mount 5018 by an interference or friction fit or other type of engagement including, but not limited to, a frangible member or material that can be broken with a small separation force (e.g., axial or rotational force). The sensor cap 5018 can be manually locked into a defined position or can be locked using a mechanical tool such as a pneumatic actuator to force-fit the sensor cap 5018 with the sensor mount 5008.

[0133] As shown in FIG. 36G, attaching the sensor cap 5018 to the sensor mount 5008 can include twisting the sensor cap into position. The male and female threads can include a helical threaded engagement. Thus, the sensor cap 5018 can be threadably coupled to the sensor mount 5008 or with a mating member of the sharp hub 5014. FIG. 36G shows the completed sensor subassembly 5200.

[0134] The manufacturing process can include dispensing adhesive onto one or more surfaces of the Sharp hub 5014. For example, the manufacturing process can include dispensing adhesive onto the top surface of the Sharp hub 5014 while looking at the sensor subassembly 5200 with the Sharp cap 5018 facing down. The manufacturing process can include dispensing adhesive onto the area of ​​the Sharp hub 5014 that interfaces with the sensor mount 5008. The process can further include curing the adhesive. Curing the adhesive can secure the Sharp hub 5014 to the sensor mount 5008. Curing the adhesive can seal the Sharp hub to reduce leakage between the Sharp hub 5014 and the Sharp. The adhesive can be dispensed and cured in a manner similar to the manner in which adhesive is dispensed into the mount channel 4025 and then cured. The adhesive can be used to secure the Sharp hub 5014 to the sensor mount 5008. The adhesive, when cured, can further improve sealing of the sensor subassembly 5200.

[0135] The manufacturing process may further include testing the sealed sensor subassembly 5200 for leaks. The testing may be performed using a pressure decay leak test, a vacuum decay leak test, a tracer gas leak test, a trace analysis test, or a leak flow rate test. In certain embodiments, the leak test may be automated using a specialized machine tool to facilitate testing of individual sealed sensor subassemblies 5200 or simultaneous testing of multiple sealed sensor subassemblies. If the sealed sensor subassembly fails the leak test, it may be discarded.

[0136] Once properly assembled, the sealed subassembly 5200 can be subjected to a sterilization process, such as any of the radiation sterilization processes mentioned herein, to properly sterilize the sensor 5010 and the sharps 5012. The sterilization process can further include thermal procedures, electron beam sterilization, gamma sterilization, x-ray sterilization, ethylene oxide sterilization, autoclave steam sterilization, chlorine dioxide gas sterilization, and hydrogen peroxide sterilization. In particular, the sterilization process can be configured using appropriate mechanical tools to facilitate simultaneous sterilization of multiple sealed subassemblies 5200. For example, multiple sealed subassemblies 5200 can be loaded into a tray for subsequent sterilization.

[0137] This sterilization step can be performed without the remainder of the sensor control device (FIGS. 14A-14B and 15A-16B) to prevent damage to sensitive electrical components. Sterilization can be applied to the sealed subassembly 5200 before or after coupling the sensor cap 5018 to the Sharp hub 5014. If the sensor cap 5018 is sterilized after being coupled to the Sharp hub 5014, the sensor cap 5018 can be made of a material that allows for the through propagation of a sterilizing element. 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.

[0138] 39 is a cross-sectional side view of the sensor applicator 102 and external sterilization assembly 1414 in accordance with one or more additional embodiments. As shown, the sensor control device 1302 is received within the sensor applicator 102, and an applicator cap 1404 is coupled to the housing 1402 within which the sensor control device 1302 is secured.

[0139] In the illustrated embodiment, the applicator cap 1404 may again be inverted and may define or otherwise provide a cap post 1602 sized to receive the distal ends of the sensor 1316 and sharps 1318 extending from the bottom of the electronics housing 1304. Additionally, a radiation shield 1416 may be positioned on the exterior of the sensor applicator 102 and may extend into the inverted portion of the applicator cap 1404. More specifically, the radiation shield 1416 may extend into the inverted portion of the applicator cap 1404 to the bottom of the cap post 1602, which may be open ended. As embodied herein, a cap seal 1604 may be disposed at the interface between the cap post 1602 and the radiation shield 1416 to completely seal the open end of the cap post 1602.

[0140] As embodied herein, a cap filler 1606 can be positioned within the applicator cap 1404. In one or more embodiments, the cap filler 1606 can include an integral part or an extension of the applicator cap 1404, for example, molded with or overmolded onto the applicator cap 1404. In other embodiments, the cap filler 1606 can include a separate structure mated to or otherwise attached to the applicator cap 1404 without departing from the scope of the present disclosure. The cap filler 1606 can provide or otherwise define an internal collimator 1608 that can help focus the radiation 1412 toward the components to be sterilized. In at least one embodiment, the cap post 1602 can be received within the internal collimator 1608, as shown.

[0141] The outer collimator 1418 and the inner collimator 1608 may cooperate to define a sterilization zone 1610 that focuses the radiation 1412 toward the sensor 1316 and the sharps 1318. The transmitted radiation 1412 may pass through the sterilization zone 1610 and impinge upon and sterilize the sensor 1316 and the sharps 1318. However, each of the cap fill 1606 and the radiation shield 1416 may be made of any of the materials mentioned herein that substantially prevent the radiation 1412 from penetrating the inner walls of the sterilization zone 1610 and thereby damaging the radiation sensitive components 1408 within the housing 1304. In at least one embodiment, the cap fill 1606 may be made of machined or 3D printed polypropylene and the radiation shield 1416 may be made of stainless steel. Further, in some sensor embodiments, such as those shown in FIGS. 9B and 11H, the cap filling 1606 and radiation shield 1416 can prevent electronic components (e.g., electronic component 2418A, electronic component 11914A) mounted on the in vitro portion (e.g., in vivo portion 2404A, in vivo portion 11904A) from being damaged by radiation 1412.

[0142] The outer and inner collimators 1418, 1608 may exhibit any suitable cross-sectional shape necessary to properly focus the radiation 1412 toward the sensors 1316 and 1318 for sterilization. In the illustrated embodiment, for example, the outer collimator 1418 exhibits a circular cross-section and the inner collimator 1608 is substantially cylindrical with substantially parallel inner walls. However, in other embodiments, the outer and inner collimators 1418, 1608 may exhibit other cross-sectional shapes without departing from the scope of this disclosure.

[0143] In the illustrated embodiment, the external collimator 1418 defines a first opening 1612a that allows the radiation 1412 to enter the sterilization zone 1610 and a second opening 1612b positioned at or near the bottom opening to the cap post 1602 for focusing the radiation 1412 onto the sensor 1316 and sharp 1318 positioned within the cap post 1602.

[0144] The cap seal 1604 may be disposed at an interface between the radiation shield 1416 and the cap post 1602 and / or the cap filler 1606. The cap seal 1604 may help form part of a sealing area 1430 configured to completely seal a portion of the sterile zone 1610 to isolate the sensor 1316 and the sharps 1318 from external contamination. The sealing area 1430 may include (encompass) selected portions of the interior of the electronics housing 1304 and the sterile zone 1610. In the illustrated embodiment, the sealing area 1430 may be defined or otherwise formed by the cap post 1602 and the top and bottom seals 1432a, 1432b, thereby providing a barrier corresponding to its respective sealing location. The bottom seal 1432b may be disposed to seal the interface between the applicator cap 1404 and the bottom of the electronics housing 1304.

[0145] Additional details regarding applicator embodiments, their components, methods of sterilizing such embodiments, and variations thereof are described in U.S. Patent Publication No. 2021 / 0161437, the entire contents of which are incorporated by reference into this specification for all purposes.

[0146] 37A-37J show stages of an exemplary process for manufacturing a sensor control device 5002. In particular, FIGS. 37A-37J show stages for manufacturing an electronics housing 5004. The sensor control device 5002 may be optionally referred to as a body-worn sensor pack assembly since the sensor control device 5002 may be attached to a user's skin for use utilizing an adhesive patch (e.g., adhesive patch 105) while housing a sensor 5010. The electronics housing 5004 shown in FIGS. 37A-37J includes a printed circuit board (PCB) 4100, a shell cap 5006, a sensor subassembly 5200 including a sensor 5010, a sensor mount 5008 matable with the shell cap 5006, a collar 5112, and a sensor cap 5018.

[0147] 37A-37B illustrate an example PCB 4100 that can be used in the electronics housing 5004 of the body worn sensor pack assembly. The PCB 4100 can include components such as an ASIC 4101, one or more batteries 4103, and one or more antennas 4105. As shown, the PCB 4100 can be a foldable or flexible PCB, although non-foldable PCBs can also be used. In a foldable PCB embodiment, the manufacturing process can include folding the PCB 4100 at fold points 4110 to fit into the footprint of the mount 5008 and shell cap 5006 that define the overall footprint of the electronics housing 5004. FIG. 37B shows the PCB 4100 during the folding process. Folding the PCB 4100 can connect the components of the PCB 4100, for example, connecting one or more batteries 4103 to appropriate battery terminals. As shown in FIG. 37C, the manufacturing process can include dispensing a first adhesive 4120 onto a sensor mount 5008 of a sensor subassembly 5200. As an example, the adhesive can be dispensed into locations corresponding to components of the PCB 4100, such as folding points, battery locations, or PCB connectors. The adhesive can be dispensed manually or using a suitable automated tool. For example, a specially configured tool can be used that has a dispensing valve to dispense a predetermined amount of adhesive into designated locations on the sensor mount 5008. As described herein, the dispensing valve can be used in combination with other components to manipulate the sensor mount 5008 before, during, and after dispensing as needed. For example, the sensor mount 5008 can be rotated by a rotary motor to facilitate even distribution of the adhesive.

[0148] As shown in Figure 37D, the manufacturing process can include loading the PCB 4100 onto a sensor mount 5008 of the sensor subassembly 5200 after the PCB 4100 is aligned with the sensor 5010 and the sensor subassembly 5200. For example, the PCB 4100 can include one or more openings 4102 sized to fit over the sharp hub 5014 of the sealed sensor sharp assembly 5200. Figure 37E shows the PCB 4110 disposed on the sealed subassembly 5200.

[0149] As shown in Fig. 37F, the manufacturing process can include curing a first adhesive to secure the PCB to the sensor mount. The adhesive and curing process can include any of the features described above herein. Fig. 37G shows the PCB 4100 in a folded state secured to the sensor mount 5008.

[0150] As shown in FIG. 37H, the manufacturing process can include dispensing a second adhesive 4135 onto the outer diameter 4130 of the sensor mount 5008 (e.g., channel 9206 shown in FIG. 29) and onto the inner diameter 4131 of the sensor mount 5008 or collar 5112 of the sensor subassembly 5200 (e.g., collar channel 9220 shown in FIG. 29). The adhesive can be dispensed manually or using a suitable automated tool. For example, a specially configured tool having a dispense valve for dispensing a predetermined amount of adhesive onto the outer diameter 4130 and the inner diameter 4131 can be used. As discussed herein, the dispense valve can be used in combination with other components to manipulate the sensor mount 5008 before, during, and after dispensing as needed.

[0151] As shown in FIG. 37H-1 for purposes of illustration and not limitation, dispensing the second adhesive 4135 onto the outer diameter 4130 of the sensor mount 5008 and onto the inner diameter 4131 of the sensor mount 5008 or onto the collar 5112 of the sensor subassembly 5200 may include tilting the sensor mount 5200 along the axis 4140 to a predetermined angle 4145 before dispensing the second adhesive 4145 onto the inner diameter 4131 of the sensor mount 5008 or onto the collar 5112 of the sensor subassembly 5200. This tilting step may be used with any of the adhesive dispensing steps described herein. As shown in FIG. 37H-2, tilting the sensor mount 5008 along the axis 4140 returns the sensor mount 5008 and the sensor subassembly 5200 to a substantially horizontal position before dispensing the second adhesive 4135 onto the outer diameter 4130 of the sensor mount 5008.

[0152] 37I, the manufacturing process includes attaching a shell cap 5006 to the sensor subassembly 5200 through a sensor mount 5008. An opening 4150 in the shell cap 5006 is aligned with the sharp hub 5014 before the shell cap 5006 is lowered onto the mount 5008. The shell cap 5006 can be manually attached to the sensor subassembly 5200 or can be attached using a suitable gripping or clamping tool, including but not limited to a manually actuated or robotic loading arm, a vacuum or suction gripping arm, a magnetic gripping arm, an adaptive gripping arm or attachment, or other suitable tool.

[0153] As shown in FIG. 37J, the manufacturing process includes curing the second adhesive to form the body-worn sensor pack assembly. The first adhesive 4130 or the second adhesive 4135 can include a variety of curable adhesives for use with a high-throughput manufacturing environment. The adhesive used can be selected based on the curing method and curing time. For example, an adhesive can be selected to reduce the curing time while also limiting exposure of the chemical agents or electronics or PCB 4100 of the sensor subassembly 5200 to excessive heat, chemicals, radiation, or excessive infrared or UV light. As an example, the adhesive selected as the first adhesive 4130 or the second adhesive 4135 can be a chemically curable adhesive. In this case, curing the adhesive would include exposing the first adhesive 4130 or the second adhesive 4135 to one or more chemical bonding catalysts. As another example, the adhesive can be an aerobically curable adhesive. In this case, curing the first adhesive 4130 or the second adhesive 4135 may include, for example, exposing the adhesive to air for a sufficient amount of time before the shell cap 5006 is lowered to the mount 5008 or before proceeding to the next step in the manufacturing process. As another example, the adhesive selected may be a heat curable adhesive. In this case, curing the first adhesive 4130 or the second adhesive 4135 may include exposing the adhesive to ambient heat or a heating element for a predetermined amount of time sufficient to cure the adhesive. As another example, the adhesive selected may be a UV curable adhesive. In this case, curing the first adhesive 4130 or the second adhesive 4135 may include exposing the adhesive to UV light by one or more UV light sources. The UV light source may include, for example, a UV light emitting diode (LED) positioned to cure the adhesive using a light guide and a plurality of angled spot LEDs. 37F and 37J show where in one embodiment a curing agent source 4155 is used to cure the first adhesive 4130 and the second adhesive 4135 from above and below the sensor mount 5008.

[0154] In certain embodiments, the sensor mount 5008 and shell cap 5006 comprise a material that partially allows the curing agent to selectively pass through to the first adhesive 4130 and the second adhesive 4135. The sensor mount 5008 and shell cap 5006 can function to protect the sensor 5010, PCB 4100, and other components of the electronics housing 5004 from exposure to the curing agent that could otherwise damage components of the electronics housing 5004 and the sealed subassembly 5200. Additionally, other temporary components can be used to further protect these components.

[0155] In some embodiments, the PCB 4100 includes a wireless communication component and the manufacturing process further includes writing data to the wireless communication component of the PCB 4100. For example, data to be written to the wireless communication component of the PCB 4100 can be read from the sensor subassembly 5200, the PCB 4100, the shell cap 5004, the mount 5006, or other components associated with the electronics housing 5004. These data can then be written to the wireless communication component of the PCB 4100.

[0156] In some embodiments, the manufacturing process can further include testing the electronics housing 5004 (e.g., the body worn sensor pack assembly) for leaks. The testing can include using a pressure decay leak test, a vacuum decay leak test, a tracer gas leak test, a trace analysis test, or a leak flow rate test. If the body worn sensor pack assembly fails the leak test, it can be discarded.

[0157] 17A-17C are step-by-step 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 loaded into the sensor applicator 102. With reference to FIG. 17A, the sharps 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 sharps carrier 5306 positioned within the sensor applicator 102.

[0158] 17B shows the sensor control device 5002 received by the sharps carrier 5306, and thus secured within the sensor applicator 102. With the sensor control device 5002 loaded into the sensor applicator 102, the applicator cap 210 can be coupled to the sensor applicator 102. In some embodiments, the applicator cap 210 and housing 208 can have a set of opposing matable threads 5308 that allow the applicator cap 210 to be threaded onto the housing 208 in a clockwise (or counterclockwise) direction, thereby securing the applicator cap 210 to the sensor applicator 102.

[0159] As illustrated, a sheath 212 is further positioned within the sensor applicator 102, which 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 provide a threaded engagement between the applicator cap 210 and the sheath 212. More specifically, one or more female threads 5312a can be defined or otherwise provided on an inner surface of the applicator cap 210, and one or more male threads 5312b can be defined or otherwise provided on the sheath 212. The female threads 5312a and male threads 5312b can be configured to threadably mate when the applicator cap 210 is threadedly engaged with the sensor applicator 102 via 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 screwed onto the housing 208 .

[0160] 17C shows the applicator cap 210 fully threadedly coupled to the housing 208. As shown, the applicator cap 210 may further provide or otherwise define a cap post 5314 centrally located therein and extending proximally from a bottom thereof. The cap post 5314 may be configured to receive at least a portion of the sensor cap 5018 when the applicator cap 210 is threaded onto the housing 208.

[0161] With the sensor control device 5002 loaded into the sensor applicator 102 and the applicator cap 210 properly secured, the sensor control device 5002 can then be subjected to a gas chemical sterilization configured to sterilize its electronics housing 5004 and any other exposed portions. Because the sensor 5010 and distal portion of the sharps 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 in vivo portion 5104, as well as other sensor components, such as membrane coatings that regulate analyte inflow.

[0162] 18A and 18B are perspective and top views of a cap post 5314 in accordance with one or more additional embodiments. In the depicted depiction, a portion of a sensor cap 5018 is received within the cap post 5314, and more specifically, a desiccant cap 5030 of the sensor cap 5018 is disposed within the cap post 5314.

[0163] As illustrated, 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. 17C ) is coupled (e.g., threaded) to the sensor applicator 102 ( FIGS. 17A-17C ). However, when the applicator cap 210 is removed from the sensor applicator 102, the receiver feature 5402 can prevent the engagement feature 914 from reversing direction, thereby preventing the sensor cap 5018 from separating from the cap post 5314. Conversely, removing the applicator cap 210 from the sensor applicator 102 simultaneously detaches the sensor cap 5018 from the sensor control device 5002 (Figures 14A-14B and 17A-17C), thereby exposing the sensor 5010 (Figures 17A-17C) and distal portions of the sharps 5012 (Figures 17A-17C).

[0164] Many design variations of the receiver feature 5402 can be used 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. 14A-14B). The engagement feature 5024 can include, for example, an enlarged head, and the flexible member 5404 can include a collet-type device that includes a plurality of flexible fingers configured to flex radially outward to receive the enlarged head.

[0165] The flexible member 5404 may further provide or otherwise define a corresponding ramp surface 5406 configured to interact with one or more opposing cam surfaces 5408 provided on an outer wall of the engagement feature 5024. The configuration and alignment of the ramp surface 5406 and the opposing cam surface 5408 is such that the applicator cap 210 can rotate in a first direction A (e.g., clockwise) relative to the sensor cap 5018, but when the applicator cap 210 is rotated in a second direction B (e.g., counterclockwise), the cap post 5314 locks against the sensor cap 5018. More specifically, when the applicator cap 210 (and thus the cap post 5314) rotates in the first direction A, the cam surface 5408 engages the ramp surface 5406, which engagement urges the flexible member 5404 to bend radially outward or otherwise deflect, providing a ratcheting effect. However, rotating the applicator cap 210 (and thus the cap post 5314) in the second direction B drives the inclined surface 5410 of the cam surface 5408 into the opposing inclined surface 5412 of the ramp surface 5406, thereby causing the sensor cap 5018 to adhere to the flexible member 5404.

[0166] 19 is a cross-sectional side view of a sensor control device 5002 positioned within an applicator cap 210 according to one or more embodiments. As shown, the opening to the receiver feature 5402 exhibits a first diameter D3, whereas the engagement feature 5024 of the sensor cap 5018 provides a second diameter D4 that is larger than the first diameter D3 and larger than the outer diameter of the remainder of the sensor cap 5018. When the sensor cap 5018 extends into the cap post 5314, the flexible member 5404 of the 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 within the cap post 5314 .

[0167] As the applicator cap 210 is threaded onto the housing 208 (FIGS. 17A-17C) in a first direction A, the cap post 5314 rotates correspondingly in the same direction, gradually introducing the sensor cap 5018 into the cap post 5314. As the cap post 5314 rotates, the ramp surface 5406 of the flexible member 5404 ratchets against the opposing cam surface 5408 of the sensor cap 5018. This continues until the applicator cap 210 is fully threaded onto the housing 208. In some embodiments, the ratcheting may occur for two full rotations of the applicator cap 210 before the applicator cap 210 reaches its final position.

[0168] To remove the applicator cap 210, the applicator cap 210 is rotated in the second direction B, causing a corresponding rotation of the cap post 5314 in the same direction, such that the cam surface 5408 (i.e., the inclined surface 5410 in FIGS. 18A-18B ) locks against the ramp surface 5406 (i.e., the inclined surface 5412 in FIGS. 18A-18B ). As a result, continued rotation of the applicator cap 210 in the second direction B causes the sensor cap 5018 to correspondingly rotate in the same direction, thereby unscrewing from the mating member 5016 and allowing the sensor cap 5018 to detach from the sensor control device 5002. Decoupling the sensor cap 5018 from the sensor control device 5002 exposes the distal portions of the sensor 5010 and the sharps 5012, thereby placing the sensor control device 5002 in a defined position for firing (use).

[0169] 20A and 20B are cross-sectional side views of a sensor applicator 102 waiting to deploy a sensor control device 5002 at a target monitoring location according to one or more embodiments. More specifically, FIG. 20A shows the sensor applicator 102 waiting to deploy (fire) the sensor control device 5002, and FIG. 20B depicts the sensor applicator 102 in the process of deploying (firing) the sensor control device 5002. As shown, the applicator cap 210 (FIGS. 17A-17C and 55) is removed and correspondingly the sensor cap 5018 (FIGS. 17A-17C and 55) is detached (removed), thereby exposing the in vivo portion 5104 of the sensor 5010 and the sharp tip 5108 of the sharp 5012, as described above. With respect to the sheath 212 and the sharps 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 .

[0170] 20A , 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 may be received within the detents 5606, thereby placing the sensor applicator 102 in a fired position. In the fired position, the engagement 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 engagement member 5016 from contacting the user's skin.

[0171] The sensor carrier 5602 may further include one or more carrier arms 5608 (one shown) configured to interact with a corresponding one or more grooves 5610 (one shown) defined on the sharps carrier 5306. A spring 5612 may be positioned within a cavity defined by the sharps carrier 5306, and the spring 5612 may passively bias the sharps carrier 5306 upwardly within the housing 208. However, when the carrier arm 5608 is properly received within the groove 5610, the sharps carrier 5306 is maintained in a defined position and prevented from moving upwardly. The carrier arm 5608 is sandwiched between the sheath 212 and the sharps carrier 5306, and a radial shoulder 5614 defined on the sheath 212 may be sized to maintain the carrier arm 5608 engaged within the groove 5610, thereby maintaining the sharps carrier 5306 in a defined position.

[0172] In FIG. 20B, the sensor applicator 102 is in the process of being fired. As discussed herein with reference to FIGS. 3F-3G, this firing can be accomplished 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 radial engagement with the carrier arms 5608, thereby allowing the carrier arms 5608 to disengage from the grooves 5610. The passive spring force of the spring 5612 is then free to push the sharps carrier 5306 upward, thereby forcing the carrier arm 5608 out of engagement with the groove 5610, thereby allowing the sharps carrier 5306 to move slightly upward within the housing 208. In some embodiments, fewer coils may be incorporated into the design of the spring 5612 in increasing 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 may be angled to help facilitate disengagement.

[0173] As the sharps carrier 5306 moves upward within the housing 208, the sharps hub 5014 can move correspondingly in the same direction, which can result in a partial retraction of the mating member 5016 such that the mating 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 mating member 5016 does not come into contact with the user's skin, which could otherwise adversely affect sensor insertion, or 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.

[0174] 21A-21C 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 in accordance with one or more additional embodiments. As generally described above, the fully assembled sensor control device 5002 can be loaded into the sensor applicator 102 by coupling the hub snap prongs 5302 into the arms 5304 of a sharps carrier 5306 positioned within the sensor applicator 102.

[0175] 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 a "locking" detent and the second detent 5702b may alternatively be referred to as a "firing" detent. When the sensor control device 5002 is initially installed within the sensor applicator 102, the sheath arm 5604 may be received within the first detent 5702a. As described below, the sheath 212 may be actuated to move the sheath arm 5604 to the second detent 5702b, thereby placing the sensor applicator 102 in a fired position.

[0176] 21B, applicator cap 210 is aligned with and advanced toward housing 208 such 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, threads of applicator cap 210 can be snapped onto corresponding threads of housing 208. Axial breaks or slots 5703 (one shown) defined in applicator cap 210 can allow a portion of applicator cap 210 proximate its threads to flex outwardly and be snapped into threaded engagement with housing 208. As applicator cap 210 is snapped onto housing 208, sensor cap 5018 can correspondingly be snapped into cap post 5314.

[0177] 17A-17C, 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 5706 (two shown) defined near a base of the sheath 212 and near a base of the applicator cap 210, and one or more ribs 5704 (one shown) configured to interact with a shoulder 5708. 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. Engagement of rib 5704 between rib 5706 and shoulder 5708 of applicator cap 210 can prevent sheath 212 from prematurely collapsing.

[0178] In Figure 21C, the applicator cap 210 has been removed from the housing 208. As with the embodiment of Figures 17A-17C, 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 mating member 5016, as generally described above. Additionally, disconnecting the sensor cap 5018 from the sensor control device 5002 exposes the distal portions of the sensor 5010 and sharps 5012.

[0179] When the applicator cap 210 is twisted off of the housing 208, a rib 5704 defined on the sheath 212 can slidingly engage an upper portion of a rib 5706 defined on the applicator cap 210. The upper portion of the rib 5706 can provide a corresponding ramp surface that causes an upward displacement of the sheath 212 when the applicator cap 210 is rotated, this upward movement of the sheath 212 bending the sheath arm 5604 out of engagement with the first detent 5702a and into receipt in the second detent 5702b. As the sheath 212 moves to the second detent 5702b, the radial shoulder 5614 disengages from radial engagement with the carrier arm 5608, thereby allowing the passive spring force of the spring 5612 to push the sharp carrier 5306 upward, forcing the carrier arm 5608 out of engagement with the groove 5610. As the sharps carrier 5306 moves upward within the housing 208, the engaging member 5016 can 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.

[0180] 22A 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 equidistantly or unequally spaced from one another and may extend substantially parallel to a centerline of the housing 208. First and second detents 5702a, 5702b may be defined on one or more of the longitudinal ribs 5802.

[0181] 23A is an isometric bottom view of the housing 208 having the sheath 212 and other components at least partially disposed therein. As shown, the sheath 212 can provide or otherwise define one or more longitudinal slots 5804 configured to mate with longitudinal ribs 5802 of the housing 208. As generally described above, when the sheath 212 collapses into the housing 208, the ribs 5802 can be received within the slots 5804 to help maintain the sheath 212 aligned with the housing during movement of the sheath 212. As will be appreciated, this reception can result in tighter circumferential and radial alignment within the same dimensional and tolerance constraints as the housing 208.

[0182] 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 has been removed) and circumferentially therewith. To achieve 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 can extend partially around the circumference of the sensor control device 5002 and receive ends of the flexible arms 5808 within corresponding grooves 5810 defined in the sides of the sensor control device 5002. Thus, the flexible arms 5808 may be able 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 is biased into a groove 5810 in the sensor control device 5002 and can be locked into place by a corresponding sheath locking rib 5812 otherwise provided by the sheath 212.

[0183] 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 may help hold the sensor control device 5002 in place during transport and firing.

[0184] 24 is an enlarged cross-sectional side view of a sensor applicator 102 having a sensor control device 5002 mounted thereon 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 sharps carrier 5306 in corresponding grooves 5610. In at least one embodiment, the grooves 5610 can be defined by a pair of protrusions 5902 defined on the sharps carrier 5306. Receiving the carrier arms 5608 within the grooves 5610 can help stabilize the sharps carrier 5306 from undesired tilting during all stages of retraction (firing).

[0185] In the illustrated embodiment, the arms 5304 of the Sharp carrier 5306 can be made stiff enough to provide greater control over the radial and biaxial motion of the Sharp hub 5014. In some embodiments, relative control of the height of the Sharp hub 5014 may be more critical to the design, for example, so that the clearance between the Sharp hub 5014 and the arms 5304 can be more tightly constrained in both axial directions.

[0186] In the illustrated embodiment, the sensor carrier 5602 defines or otherwise provides a central boss 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 boss 5904 helps provide radial and tilt support to the Sharp hub 5014 during the life of the sensor applicator 102 and through all phases of operation and assembly. Additionally, having multiple radial ribs 5906 increases the length to width ratio of the Sharp hub 5014, thereby further improving support against tilt.

[0187] 25A 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 an upper portion of applicator cap 210 near its threads. As discussed above, slots 5703 can aid in applicator cap 210 flexing outward to snap into engagement with housing 208 (FIG. 21B). In contrast, applicator cap 210 can be twisted off (unscrewed) from housing 208 by an end user.

[0188] FIG. 25A further illustrates ribs 5706 (one visible) defined by applicator cap 210. By interlocking with ribs 5704 (FIG. 21C) defined on sheath 212 (FIG. 21C), 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 twists applicator cap 210 off of the housing, as generally described above. As described herein, the top of each rib 5706 can provide a corresponding ramp surface 6002 that slideably engages with rib 5704 defined on sheath 212 as applicator cap 210 is rotated off of housing 208, resulting in upward displacement of sheath 212 into housing 208.

[0189] In some embodiments, additional features may be provided within applicator cap 210 to hold a desiccant component that maintains proper moisture levels over its useful shelf life. Such additional features may be snaps, posts for press fitting, heat staking, ultrasonic welding, or the like.

[0190] 25B 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 female threads 6004, and housing 208 can define a set of male threads 6006 engageable with female threads 6004. As described herein, applicator cap 210 can be snapped onto housing 208, which can be accomplished by advancing female threads 6004 axially past male threads 6006 in the direction shown by the arrow, thereby bending applicator cap 210 outward. To help facilitate this displacement, the corresponding surfaces 6008 of female and male threads 6004, 6006 can be curved, beveled, or angled, as shown. Corresponding flat surfaces 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 flat surfaces 6010 can slidingly engage one another when a user unscrews applicator cap 210 from housing 208.

[0191] The threaded engagement between the applicator cap 210 and the housing 208 provides a sealed engagement that protects the internal components from moisture, dust, and the like. In some embodiments, the housing 208 may define or otherwise provide a stabilizing feature 6012 configured to be received into a corresponding groove 1914 defined on the applicator cap 210. The stabilizing feature 6012 may help stabilize and stiffen 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. Additionally, the stabilizing feature 6012 may also help increase the removal torque of the applicator cap 210.

[0192] 26A and 26B are isometric views of a sensor cap 5018 and a collar 5112, respectively, according to one or more embodiments. Referring to FIG. 26A, in some embodiments, the sensor cap 5018 can include an injection molded part. This can prove advantageous to mold the internal threads 5026a defined within the inner chamber 5022, as opposed to installing a threaded core or threading the inner chamber 5022. In some embodiments, one or more stop ribs 6102 (one visible) can be defined within the inner chamber 5022 to prevent overtravel of the sharp hub 5014 (FIGS. 14A-14B) relative to the mating member 5016.

[0193] 26A and 26B, 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 the present disclosure.

[0194] The matable projections 6104 and recesses 6106 may prove advantageous in rotationally locking the sensor cap 5018 to prevent accidental twisting of the sensor cap 5018 from the collar 5112 (and thus 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 an approximately kidney bean shape. This shape may prove advantageous in allowing some over-rotation of the sensor cap 5018 relative to the collar 5112. Alternatively, the same benefit may be achieved by a flat-ended threaded engagement between the two parts.

[0195] Embodiments disclosed herein include the following:

[0196] A. A sensor control device including an electronics housing, a sensor positioned within the electronics housing, the sensor having an in vivo portion 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 in vivo portion and the sharp.

[0197] B. An analyte monitoring system including a sensor applicator and a sensor control device positioned within the sensor applicator, the sensor control device including an electronics housing, a sensor positioned within the electronics housing, the sensor having an in vivo portion 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 in vivo portion and the sharp. The analyte monitoring system may further include a cap coupled to the sensor applicator, the cap providing a cap post that defines 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 in vivo portion and the sharp tip.

[0198] C. A method of preparing an analyte monitor system comprising loading into a sensor applicator a sensor control device including an electronics housing, a sensor positioned within the electronics housing, the sensor having an in-vivo portion 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 in-vivo portion and the sharp, the method further including securing the cap to the sensor applicator, sterilizing the sensor control device by gas chemical sterilization while the sensor control device is positioned within the sensor applicator, and isolating the in-vivo portion and the sharp tip from the gas chemical sterilization in the inner chamber.

[0199] Each of embodiments A, B, and C may 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 a cap of a sensor applicator, whereby removal of the cap from the sensor applicator correspondingly removes the sensor cap from the electronics housing, thereby exposing the in vivo portion and the sharp tip. Element 2: the electronics housing includes a shell matable with the mount, the sensor control device further includes a sharp and sensor locator defined on an inner surface of the shell and a collar received thereabout, the sensor cap removably coupled to the collar. Element 3: the sensor cap 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 sharp and the sensor locator and collar provides a column and an annular shoulder extending radially outward therefrom, 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 the 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, the sensor control device further includes a sharp hub carrying the sharp and engageable with a top surface of the shell, and a mating member defined by the sharp hub and extending from a bottom of the electronics housing, and the sensor cap is removably coupled to the mating member. Element 8: Further includes 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: A 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 the portion of the sensor.

[0200] Element 11: the receiver feature includes one or more flexible members that flex to receive the engagement feature, the one or more flexible members preventing the engagement feature from slipping out of the cap post when the cap is removed from the sensor applicator. Element 12: further including a ramp surface defined on at least one of the one or more flexible members and one or more cam surfaces provided by the engagement feature and engageable with the ramp surface, the ramp surface and the one or more cam surfaces allowing the cap and cap post to rotate in a first direction relative to the sensor cap but preventing the cap and cap post from rotating in a second direction opposite the first direction relative to the sensor cap. Element 13: the electronics housing includes a shell matable with the mount, the sensor control device further includes a sharps hub carrying a sharp and engageable with a top surface of the shell, and a mating member defined by the sharps 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 disengaged from the mating member by rotating the cap in the second direction. Element 14: The electronics housing includes a shell that is mateable with the mount, and the sensor control device further includes a sharp and sensor locator defined on an inner surface of the shell and a collar received therearound, and the sensor cap is removably coupled to the collar.

[0201] Element 15: the cap provides a cap post defining a receiver feature, the sensor cap defining an engagement feature, the method further comprising receiving the engagement feature by the receiver feature when the cap is secured to the sensor applicator. Element 16: the cap is removed from the sensor applicator and engaging the engagement feature on the receiver feature when the cap is removed, thereby decoupling the sensor cap from the electronics housing and exposing the in vivo portion and the sharp tip. Element 17: the steps of sterilizing the in vivo portion and the sharp tip by radiation sterilization and sealing the in vivo portion and the sharp tip in the inner chamber precede the steps of loading the sensor control device into the sensor applicator.

[0202] 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.

[0203] Exemplary Embodiments of Seal Arrangements for Analyte Monitoring Systems 27A and 27B are side and isometric views, respectively, of an exemplary sensor control device 9102 in accordance with one or more embodiments of the present disclosure. The sensor control device 9102 may be similar in some respects to the sensor control device 102 of FIG. 1 and therefore may be best understood with reference thereto. Moreover, the sensor control device 9102 may replace the sensor control device 102 of FIG. 1 and therefore may be used in conjunction with the sensor applicator 102 of FIG. 1, which may deliver the sensor control device 9102 to a target monitor location on the user's skin.

[0204] As illustrated, the sensor control device 9102 includes an electronics housing 9104 that may be generally disk-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 the present disclosure. The electronics housing 9104 includes a shell 9106 and a mount 9108 matable therewith. The shell 9106 may be secured to the mount 9108 by a variety of techniques, such as a snap 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 certain embodiments, 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 or otherwise attached to the underside of the mount 9108. Similar to the adhesive patch 105 of FIG. 1, the adhesive patch 9110 can be configured to secure and maintain the sensor control device 9102 in a defined position on the user's skin during operation.

[0205] The sensor control device 9102 may further include a sensor 9112 and a sharp 9114 that is used to aid in transdermal delivery of the sensor 9112 beneath the skin of a user during application of the sensor control device 9102. Corresponding portions of the sensor 9112 and sharp 9114 extend distally from a bottom (e.g., mount 9108) of the electronics housing 9104. 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. 27A , the sharp hub 9116 may include or otherwise define a mating member 9118. In assembling the sharp 9114 to the sensor control device 9102, the sharp 9114 can be advanced axially through the electronics housing 9104 until the sharp hub 9116 engages the top surface of the electronics housing 9104 or an internal component 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 sharp hub 9116 can sealingly engage an upper portion of a seal overmolded onto the mount 9108. As the sharp 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 sharp 9114. The remainder of the sensor 9112 is disposed within the electronics housing 9104.

[0206] The sensor control device 9102 may further include a sensor cap 9120, shown in FIGS. 27A-B separated from the electronics housing 9104. The sensor cap 9120 may help provide a sealing barrier that surrounds and protects exposed portions of the sensor 9112 and the sharps 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 may provide or otherwise define an engagement feature 9126. As described in more detail below, the engagement features 9126 can assist in fitting the sensor cap 9120 to an applicator cap of a sensor applicator (e.g., the 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.

[0207] 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 male threads 9128a (FIG. 27A) that can mate with a set of female threads 9128b (FIG. 27B) defined within the inner chamber 9124 of the sensor cap 9120. In some embodiments, the male and female threads 9128a, 9128b can include a flat thread design (e.g., lacking a helical curvature) or can alternatively comprise a helical threaded engagement. Thus, in at least one embodiment, the sensor cap 9120 can be threadably coupled to the sensor control device 9102 with the mating member 9118 of the sharp hub 9116. In other embodiments, the sensor cap 9120 can be removably coupled to the mating member 9118 by other types of engagement, including but not limited to an interference or friction fit, or a frangible member or substance (e.g., wax, adhesive, etc.) that can be broken by a slight separation force (e.g., axial or rotational force).

[0208] 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 disposed at the second end 9122b. The desiccant cap 9130 may contain 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 that is inserted into a bottom end of the sensor cap 9120.

[0209] 28A and 28B 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, one or more batteries, resistors, transistors, capacitors, inductors, diodes, and switches.

[0210] The shell 9106 can define a first opening 9202a and the mount 9108 can define a second opening 9202b, where the openings 9202a, 9202b can align when the shell 9106 is properly mounted to the mount 9108. As can be seen most clearly in FIG. 28A , the mount 9108 can provide or otherwise define a pedestal 9204 that protrudes from an inner surface of the mount 9108 at the second opening 9202b. The pedestal 9204 can define at least a portion of the second opening 9202b. Additionally, a channel 9206 can be defined on an inner surface of the mount 9108, where the channel 9206 can surround the pedestal 9202. In the illustrated embodiment, the channel 9206 is circular in shape, but it is contemplated that the channel 9206 could alternatively be another shape, such as elliptical, oval, or polygonal.

[0211] The mount 9108 may include a molded part made of a rigid material such as plastic or metal. In some embodiments, the seal 9208 may be overmolded onto the mount 9108, and the seal 9208 may be made of an elastomer, rubber, polymer, or another flexible material suitable for facilitating a hermetic bond. In embodiments in which the mount 9108 is made of plastic, the mount 9108 may be molded in a first "shot" of injection molding, and the seal 9208 may be overmolded onto the mount 9108 in a second "shot" of injection molding. Thus, the mount 9108 may be referred to or otherwise characterized as a "two-shot mount."

[0212] In the illustrated embodiment, the seal 9208 is overmolded onto the mount 9108 at the pedestal 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 pedestal 9204 and a second seal element 9210b (FIG. 28B) 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. Although the seal 9208 is described herein as being overmolded onto the mount 9108, it is also 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.

[0213] The sensor control device 9102 may further include a collar 9212, which may be a generally annular structure that defines 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.

[0214] In some embodiments, the collar 9212 can define or otherwise be provided with an annular lip 9216 on a bottom surface thereof. The annular lip 9216 can be sized or otherwise configured to fit or be received within a channel 9206 defined on an inner surface of the mount 9108. In some embodiments, a groove 9218 can be defined on the annular lip 9216 and can 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 can further define or otherwise be provided with a collar channel 9220 ( FIG. 28A ) on an upper surface thereof that is sized to receive or otherwise fit within an annular ridge 9222 ( FIG. 28B ) defined on an inner surface of the shell 9106 when the sensor control device 9102 is properly assembled.

[0215] The sensor 9112 can include an in vivo portion 9224 that extends through a second opening 9202b defined in the mount 9108 to be transcutaneously received under the skin of the user. The in vivo portion 9224 can have an enzyme or other chemical agent included thereon to help facilitate analyte monitoring. The sharp 9114 can include a sharp tip 9226 extendable through a first opening 9202a defined by the shell 9106. The in vivo portion 9224 of the sensor 9112 can 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 can be configured to penetrate the skin while carrying the in vivo portion 9224 to place the active chemical agent of the in vivo portion 9224 in contact with bodily fluids.

[0216] The sensor control device 9102 can provide a sealing subassembly including, 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 sealing subassembly can help isolate the sensor 9112 and the sharp 9114 in the inner chamber 9124 (FIG. 28A) of the sensor cap 9120. In assembling the sealing subassembly, the sharp tip 9226 is advanced through the electronics housing 9104 until the sharp hub 9116 engages the seal 9208, more specifically the first seal element 9210a. The mating member 9118 provided at 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 with the mating member 9118. Coupling the sensor cap 9120 to the Sharp hub 9116 with the mating member 9118 can bias the first end 9122a of the sensor cap 9120 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 hub 9116, a portion of the first end 9122a of the sensor cap 9120 can abut (engage) with the bottom of the mount 9108, and the sealing engagement between the Sharp hub 9116 and the first seal element 9210a may be able to accommodate any tolerance variations between features.

[0217] 29 illustrates 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 that can be advantageous for isolating the sensor 9112 and the sharps 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 in vivo portion 9224 extends through a 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 it within the mount 9108.

[0218] With the sensor 9112 properly positioned, the collar 9212 can be placed 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 within a central opening 9214 defined by the collar 9212, with the first seal element 9210a generating a radial seal against the collar 9212 at the central opening 9214. Additionally, an annular lip 9216 defined on the collar 9212 can be received within 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 in 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 hermetic bond between these two components and create a seal around the sensor 9112 in the groove 9218 , thereby isolating the in vivo portion 9224 from the interior of the electronics housing 9104 .

[0219] 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 at 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 engagement interface. By mating the shell 9106 to the mount 9108, an annular ridge 9222 defined on an inner surface of the shell 9106 may be received within a collar channel 9220 defined on an upper 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 bond between the two components at this location. When the shell 9106 is mated to the mount 9108, the first seal element 9210a can extend at least partially through (into) a first opening 9202a defined in the shell 9106.

[0220] 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 9202a, 9202b 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, and more specifically, the first seal element 9210a. The mating member 9118 can extend (protrude) out of the second opening 9202b at the bottom of the mount 9108 when the sharp hub 9116 engages the first seal element 9210a.

[0221] The sensor cap 9120 can then be removably coupled to the sensor control device 9102 by threadably mating the female threads 9128b of the sensor cap 9120 with the male threads 9128a of the fitting 9118. The inner chamber 9124 can be sized or otherwise configured to receive the in vivo portion 9224 and the sharp tip 9226 extending from the bottom of the mount 9108. Additionally, the inner chamber 9124 can be sealed to isolate the in vivo portion 9224 and the sharp tip 9226 from substances that may adversely interact with the chemical agents of the in vivo portion 9224. In some embodiments, a desiccant (not shown) can be present in the inner chamber 9124 to maintain the proper humidity level.

[0222] Tightening (rotating) the mating engagement between the sensor cap 9120 and the mating 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 enhancing the axial sealing bond between the sharp hub 9116 and the first seal element 9210a. Furthermore, tightening the mating engagement between the sensor cap 9120 and the mating member 9118 can compress the first seal element 9210a, thereby providing 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.

[0223] As mentioned 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 generate 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 the bond between the first and second shots is a more reliable adhesive than a mechanical seal, as opposed to using separate elastomeric components (e.g., O-rings, gaskets, etc.). Thus, the effective number of mechanical sealing barriers is essentially halved. Additionally, the two-shot components with a single elastomeric shot also have the implication of minimizing the number of two-shot components required to achieve all the necessary sterility barriers. Once properly assembled, a radiation sterilization process can be applied to the sealing subassembly 9302 to sterilize the sensor 9112 and the sharps 9114. The sealed subassembly 9302 may be subjected to radiation sterilization before or after coupling the sensor cap 9120 to the Sharp hub 9116. If the sensor cap 9120 is sterilized after being coupled to the Sharp hub 9116, the sensor cap 9120 may be made of a material that allows the transmission of radiation therethrough. In some embodiments, the sensor cap 9120 may be transparent or translucent, but may otherwise be opaque without departing from the scope of this disclosure.

[0224] FIG. 29A shows an exploded isometric view of a portion of another embodiment of the sensor control device 9102 of FIGS. 27A-27B and 28A-28B. The embodiments included above described the mount 9108 and the seal 9208 being manufactured by 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 that are 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 gaskets or O-rings, positioned on the collar 9212 and the sensor cap 9120, respectively. By tightening (rotating) the mating engagement between the sensor cap 9120 and the mating member 9118, the second seal element 9210b can be urged into axial sealing engagement with the bottom of the mount 9108, strengthening the axial sealing joint between the sharp hub 9116 and the first seal element 9210a.

[0225] FIG. 30A illustrates an isometric bottom view of a mount 9108 according to one or more embodiments, and FIG. 30B illustrates an isometric top view of a sensor cap 9120 according to one or more embodiments. As shown in FIG. 30A, the mount 9108 can provide or otherwise define one or more recesses or pockets 9402 at or near the opening to the second aperture 9202b. As shown in FIG. 30B, 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 within the pockets 9402 when the sensor cap 9120 is coupled to the Sharp hub 9116 (FIGS. 28A-28B and 93). More specifically, as described above, when the sensor cap 9120 is coupled to the mating member 9118 (FIGS. 28A-28B and 93) of the Sharp hub 9116, the first end 9122a of the sensor cap 9120 is brought into sealing engagement with the second seal element 9210b. 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.

[0226] 31A and 31B are side and cross-sectional side views, respectively, of an exemplary sensor applicator 9502 according to one or more embodiments. The sensor applicator 9502 can be similar in some respects to the sensor applicator 102 of FIG. 1 and, therefore, can be designed to deliver (fire) a sensor control device, such as the sensor control device 9102. FIG. 31A illustrates how the sensor applicator 9502 may be shipped to and received by a user, and FIG. 31B depicts the sensor control device 9102 disposed within the sensor applicator 9502.

[0227] 31A , 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 threadedly engaged with the housing 9504 and can include an unsealing ring 9508. When the applicator cap 9506 is rotated (e.g., twisted off) relative to the housing 9504, the unsealing ring 9508 can be twisted off, thereby releasing the applicator cap 9506 from the sensor applicator 9502.

[0228] 31B, 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 loaded 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.

[0229] By securing the applicator cap 9506 to the housing 9504, the second end 9122b of the sensor cap 9120 can be received within 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.

[0230] 32A and 32B 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, a desiccant cap 9130 of the sensor cap 9120 is positioned within the cap post 9510. The cap post 9510 can define a receiver feature 9602 configured to receive an engagement feature 9126 of the sensor cap 9120 when the applicator cap 9506 (FIG. 31B) is coupled (e.g., threaded) to the sensor applicator 9502 (FIGS. 31A-31B). 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 27A-27B and 28A-28B), thereby exposing the sensor 9112 (Figures 28A-28B) and distal portions of the sharps 9114 (Figures 28A-28B).

[0231] Many design variations of the receiver feature 9602 can be used 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 members 9604 can include a collet-type device that includes a plurality of flexible fingers configured to flex radially outward to receive the enlarged head.

[0232] The flexible member 9604 may further provide or otherwise define a corresponding ramp surface 9606 configured to interact with one or more opposing cam surfaces 9608 provided on an outer wall of the engagement feature 9126. The configuration and alignment of the ramp surface 9606 and the opposing cam surface 9608 is 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 locks against the sensor cap 9120. More specifically, as the applicator cap 9506 (and thus the cap post 9510) rotates in the first direction A, the cam surface 9608 engages the ramp surface 9606, thereby urging the flexible member 9604 to bend or otherwise deflect radially outward, creating a ratcheting effect. However, by rotating the applicator cap 9506 (and thus the cap post 9510) in the second direction B, the inclined surface 9610 of the cam surface 9608 is driven to collide with the opposing inclined surface 9612 of the ramp surface 9606, resulting in the sensor cap 9120 becoming attached to the flexible member 9604.

[0233] 33 is a cross-sectional side view of the sensor control device 9102 positioned within the applicator cap 9506 according to one or more embodiments. As shown, the opening to the receiver feature 9602 exhibits a first diameter D3, whereas the engagement feature 9126 of the sensor cap 9120 exhibits a second diameter D4 that is larger than the first diameter D3 and larger than the outer diameter of the remainder of the sensor cap 9120. When the sensor cap 9120 extends 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 within the cap post 9510 .

[0234] As the applicator cap 9506 is threaded onto the housing 9504 (FIGS. 31A-31B) in a first direction A, the cap post 9510 rotates correspondingly in the same direction, gradually introducing the sensor cap 9120 into the cap post 9510. As the cap post 9510 rotates, the ramp surface 9606 of the flexible member 9604 ratchets against the opposing cam surface 9608 of the sensor cap 9120. This continues until the applicator cap 9506 is fully threaded onto the housing 9504. In some embodiments, the ratcheting action can occur for two full revolutions of the applicator cap 9506 before the applicator cap 9506 reaches its final position.

[0235] To remove the applicator cap 9506, the applicator cap 9506 is rotated in a second direction B, which correspondingly rotates the cap post 9510 in the same direction, such that the cam surface 9608 (i.e., the ramp surface 9610 in FIGS. 32A-32B) locks against the ramp surface 9606 (i.e., the ramp surface 9612 in FIGS. 32A-32B). As a result, 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. Decoupling the sensor cap 9120 from the sensor control device 9102 exposes the sensor 9112 and distal portions of the sharps 9114, thereby placing the sensor control device 9102 in a defined position for firing (use).

[0236] FIG. 34 is a cross-sectional view of a sensor control device 9800 showing an example interaction between the sensor and the sharp. After assembly of the sharp, the sensor should be seated in the channel defined by the sharp. Although the sensor control device in FIG. 9 does not show the sensor deflected inward and otherwise perfectly aligned with the sharp, such deflection and alignment may be the case upon full assembly where the sensor may receive some biasing force at the location shown by the two arrows A. Biasing the sensor against the sharp may have the advantage that any relative movement between the sensor and the sharp during subcutaneous insertion does not result in exposure of the sensor tip (i.e., the in vivo portion) outside the sharp channel which could potentially result in failure of insertion.

[0237] 38A-38K illustrate stages of an exemplary process for manufacturing an applicator assembly (e.g., applicator device 150). The applicator assembly includes an inserter 4200, a body-worn sensor pack assembly (e.g., sensor control device 5002) coupled to a pack carrier 710 (e.g., sensor electronics carrier 710 of FIG. 4A or sensor carrier 5602 of FIGS. 17A-17C), a sheath 704, an applicator housing 702, and a cap 708.

[0238] As shown in FIGS. 38A-B, the manufacturing process includes assembling the inserter 4200 by loading the spring 5612 into the sharps carrier 704 and lowering the puck carrier 710 to the sharps carrier 704 to compress the spring 5612 until it is seated in the sharps carrier 704. The spring 5612 can be compressed manually or using a suitable compression tool, including but not limited to a manually actuated or robotic loading arm, a vacuum or suction gripping arm, a magnetic gripping arm, an adaptive gripping arm or attachment, a pneumatic guided or servo actuator, or other suitable tool. After the spring 5612 is compressed, the process includes locking one or more retention features 4205 of the puck carrier 710 with the sharps carrier 704 to hold the compression of the spring. The locking can be performed while clamping the puck carrier 710 to the sharps carrier 704 using any suitable clamping mechanism.

[0239] As shown in FIG. 38C, the manufacturing process can include coupling the body-worn sensor pack assembly 5002 to the puck carrier 710. For example, the mount retention features can be aligned with the arms of the puck carrier 710, and the puck assembly 5002 can be advanced until it snaps into place. As shown in FIG. 38D, the manufacturing process can include applying an adhesive patch 105 (or adhesive patch 9110) to the body-worn sensor pack assembly or the puck carrier. The adhesive patch can be applied manually or using a gripping or applicator mechanical tool, a vacuum or suction gripping arm, a magnetic gripping arm, an adaptive gripping arm or attachment, a pneumatic guided or servo actuator, or other suitable tool. Prior to applying the adhesive patch, the body-worn sensor pack assembly (including the puck carrier) and the adhesive patch can be loaded into a suitable holding tool. The adhesive patch can be configured to fit the contours and components of the body-worn sensor pack assembly, for example, the adhesive patch can include a hold to receive a sharps cap. The adhesive patch can be aligned (e.g., manually, using a light guided alignment arm, a spring-loaded alignment tool, etc.) to the body worn sensor pack assembly and lowered onto the body worn sensor pack assembly manually or using a suitable mechanical tool as discussed herein. Once the adhesive patch 105 has been applied to the body worn sensor pack assembly 5002 or pack carrier 710, the manufacturing process can include removing tabs 4210a and 4210b of the adhesive patch 105, for example, by capturing exposed corners of the liner and peeling them away from the patch manually or using automated equipment, to expose a face 4220 of the adhesive patch 150 that will be attached to the wearer's body, as shown in Figures 38E and 38F.

[0240] As shown in FIG. 38G, the manufacturing process can include attaching the sheath 704 to the puck carrier 710. Attaching the sheath to the puck carrier can include loading the sheath into a fixture nest (not illustrated) and lowering the puck carrier 710 with a compression spring into the sheath 704. The manufacturing process can further include attaching the sheath 704 to an applicator housing 708. Attaching the sheath 704 to the applicator housing 708 can include loading the applicator housing 708 into a fixture nest (not illustrated) and engaging alignment ribs of the applicator housing 708 into notches in the fixture nest. The sheath 704 is then lowered onto the applicator housing 708 until it engages the alignment ribs of the applicator housing 708. The sheath 704 and puck carrier 710 can be manipulated manually or using a suitable mechanical tool, e.g., a pneumatically guided actuator, to forcefully attach the components as discussed herein.

[0241] 38H, the manufacturing process can include loading a desiccant 502 into the cap 702. The desiccant 502 can be used to control moisture exposure of the body-worn sensor pack assembly 5002 and the adhesive patch 105. The desiccant can be loaded manually or using a suitable tool, such as a manually actuated or robotic loading arm, a vacuum or suction gripping arm, a magnetic gripping arm, an adaptive gripping arm or attachment, a pneumatic guided actuator, or other suitable tool.

[0242] As shown in FIGURE 38I, the manufacturing process can include coupling the cap 702 to the applicator housing 708. Coupling the cap 702 to the applicator housing 708 can include lowering the cap 702 onto the applicator housing 708. As shown in FIGURE 38J, coupling the cap 702 to the applicator housing 708 can include lowering the cap 702 onto the applicator housing 708 and threading the cap 702 onto the applicator housing 708 until a predetermined torque is reached. The cap 702 can be threaded onto the applicator housing 708 manually or using a suitable automated tool, for example, a servo rotation actuator can be used to rotate the cap 702 until a suitable motor torque is reached.

[0243] In certain embodiments, a tamper evident sticker or other method of detecting that applicator housing 702 has been opened can be applied to the interior or exterior of applicator housing 708. As shown in FIGURE 38K, the manufacturing process can include applying a label 4220 to the exterior of the assembled applicator housing 708.

[0244] Embodiments disclosed herein include the following:

[0245] D. An electronic housing including a shell defining a first opening, and 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, and a sensor positioned within the electronics housing, the sensor having an in vivo portion 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.

[0246] E. An assembly including a sensor applicator, a sensor control device positioned within the sensor applicator, an electronics housing 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 projecting 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 positioned within the electronics housing, the sensor control device including a sensor having an in vivo portion 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 including a sensor cap removably coupled to the sensor control device at the bottom of the mount, the sensor cap defining a sealed inner chamber for receiving the in vivo portion and the sharp, and an applicator cap coupled to the sensor applicator.

[0247] Each of embodiments D and E may have one or more of the following additional elements in any combination: Element 1: the mount includes a first injection molded part molded in a first shot and the seal includes a second injection molded part overmolded on the first injection molded part in a second shot. Element 2: a sharps hub carrying a sharp and sealingly engaging the first seal element, and a sensor cap removably coupled to the sharps hub at a bottom of the mount and sealingly engaging the second seal element, the sensor cap further including an inner chamber for receiving the in vivo part and the sharps. Element 3: the sharps hub provides a mating member extending past the bottom of the mount, the sensor cap removably coupled to the mating member. Element 4: 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 receivable in the one or more pockets when the sensor cap is coupled to the sharps hub. Element 5: further comprising a collar positioned within the electronics housing, the collar defining a central opening for radially receiving and sealingly engaging the first seal element. Element 6: further comprising a channel defined on an inner surface of the mount surrounding the pedestal, an annular lip defined on an underside of the collar matable with the channel, and an adhesive provided within the channel for securing and sealing the collar to the mount at the channel. Element 7: further comprising 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 groove. Element 8: further comprising a collar channel defined on an upper surface of the collar, an annular ridge defined on an inner surface of the shell matable with the collar channel, and an adhesive provided within the collar channel for securing and sealing the shell to the collar. Element 9: one or both of the first and second seal elements defining at least a portion of the second opening. Element 10: the first seal element extending at least partially through the first opening when the shell is coupled to the mount.

[0248] Element 11: The sensor control device further includes a Sharps hub carrying a Sharps and sealingly engaging the first seal element, and the sensor cap is removably coupled to the Sharps hub at a bottom of the mount and sealingly engaging 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 receivable into 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 positioned within the electronics housing, the collar defining a central opening for radially receiving and sealingly engaging 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 pedestal, an annular lip defined on an underside of the collar and mateable with the channel, and an adhesive provided in the channel to secure and seal the collar to the mount at the channel. Element 15: further including 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 in the groove. Element 16: further including a collar channel defined on a top surface of the collar, an annular ridge defined on an inner surface of the shell matable with the collar channel, and adhesive provided within the collar channel to secure and seal the shell to the collar. Element 17: one or both of the first and second sealing elements defines at least a portion of a second opening. Element 18: the first sealing element extends at least partially through the first opening.

[0249] 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.

[0250] Additional details of suitable devices, systems, methods, components, and their operation and related features are provided in International Publication No. WO 2018 / 136898 to Rao et al., International Publication No. WO 2019 / 236850 to Thomas et al., International Publication No. WO 2019 / 236859 to Thomas et al., International Publication No. WO 2019 / 236876 to Thomas et al., and U.S. Patent Application No. 16 / 433,931, filed June 6, 2019, each of which is incorporated by reference in its entirety.

[0251] Exemplary embodiments of sensor structures and associated manufacturing processes Next, an exemplary embodiment of the sensor structure and associated manufacturing process shown in Figures 9B and 11H will be described below. In accordance with the subject matter of the present disclosure, a system for analyte level measurement is provided that includes an analyte sensor (e.g., sensor 104A, sensor 11900A) having an in vivo portion 4002 and an in vitro portion 4004. The in vivo portion 4002 can have a first side and a second side, and can be configured to be positioned in contact with a user's interstitial fluid to generate a signal associated with a measured analyte level. The in vivo portion 4004 can include a number of electronic components (2418A, 11914A) mounted thereon. In this manner, an integral monolithic sensor can be formed having an in vivo portion including a substrate having one or more electrodes printed thereon, and an in vivo portion having a substrate having electronic components mounted thereon, as shown in Figure 40. The integral monolithic sensors described herein can be advantageous by reducing the number of components required, thereby reducing the overall size of the sensor control device, reducing manufacturing complexity and costs, and potentially increasing user access to these devices. Reducing size can increase comfort and convenience for the user. For example, prior embodiments disclose analyte sensors having an in vitro portion 2404, 11904 configured to electrically couple to a circuit board using an electrical connector, as shown in FIG. 9A and FIG. 35A. The disclosed embodiments eliminate the need for connectors by mounting electronic components on the board of the analyte sensor at the in vivo portion 4004 to form a single component, thereby allowing for a reduction in the size of the sensor control device 102 and increasing the reliability of the connection between the electronic components and the circuit board. Eliminating the need for connectors and reducing the size of the overall sensor control device 102 can reduce manufacturing and purchasing costs. In practice, one working electrode for each analyte is required to measure multiple analytes. As a result, a sensor configured to measure multiple analytes includes a corresponding number of multiple working electrodes. The greater the number of electrodes in the sensor, the larger the connector must be, a problem exacerbated for multiple analyte sensors.The smaller size and associated lower manufacturing costs are advantageous because the sensor control device 102 is a single-use device having only a limited life span, thereby requiring frequent replacement.

[0252] Since the body-worn unit can be worn on the patient's body, increasing the flexibility of the substrate and then the extra-vital portion can increase the resistance of the body-worn unit to forces resulting from patient movement. To achieve the desired flexibility, the substrate can be made from polyamide or polyethylene terephthalate (PET). In some embodiments, the PET substrate can have the following material properties:

[0253] [Table 1] Table 1: Material properties of PET

[0254] In addition, the substrate can be made of one or more layers. The one or more layers can include various materials including polyamide or PET, copper, fiberglass, and / or a gradient mixture of materials including any of the materials mentioned above. For example, the gradient mixture of materials can include about 10% fiberglass. As another example, the gradient mixture of materials can include fiberglass and / or another material including a material having a melting temperature of 5°F, 10°F, 15°F, 20°F, or any other temperature higher than the melting temperature of fiberglass and / or PET. The intravivo portion 4002 can also include one or more layers, each of which optionally also has a gradient mixture of materials. In one non-limiting example, a layer of the intravivo portion can include PET and a layer of the extravivo portion can include about 10% fiberglass. Due to the flexibility of the substrate and the fact that the electronic components are mounted directly on the substrate without the need for connectors, the substrate can be folded in half, thus further reducing the size of the body worn unit. Further, to reduce height, one or more batteries can be positioned such that the solder contacts are soldered to the substrate, but the batteries themselves are offset from the substrate. As can be seen in FIG. 9B and FIG. 40, the in vivo portion 4004 can be any suitable shape, including but not limited to a circle (e.g., as shown in FIG. 40), a cloverleaf (e.g., as shown in FIG. 9B), a semicircle, a square, a triangle, or a diamond. Furthermore, the in vivo portion 2408A, 4002A can extend from an edge of the in vivo portion 2408A (e.g., as shown in FIG. 9B), can be positioned at the center of the in vivo portion 4004 (as shown in FIG. 40), or can be positioned in any other suitable location. In the latter case, the in vivo portion 4002 can extend through an opening in the in vivo portion 4004. Furthermore, as also recognized in the art, the in vivo portion 4002 can be positioned offset from the center of the in vivo portion 4004. The electronic components 2418 may be positioned in any suitable location on the in vitro portion 4004 and on either or both sides of the in vivo portion 4004 .For example, in one embodiment, the battery can be positioned on a first side of the in vivo portion 4004 and the antenna can be positioned on a second side of the extra vivo portion 4004. As shown in FIG. 40, the body worn unit can include a shell 4006 and a mount 4008, either of which can include an opening for the in vivo portion 4002.

[0255] According to embodiments, as described above, the sensor of the presently disclosed subject matter can include an in vivo portion having a substrate and at least one working electrode and a reference electrode configured to be printed thereon. Exemplary embodiments and methods of printed analyte sensors having one or more electrodes are disclosed in U.S. Patent Application No. 17 / 661,531, the entire contents of which are incorporated herein by reference. According to embodiments disclosed herein, the at least one electrode can include one or more working electrodes. For example, the at least one or more working electrodes can include two, three, four, five or more working electrodes. Each working electrode, which can be configured to measure an analyte of interest (such as, but not limited to, glucose, ketones, lactate, etc.), can be printed on a first side of the in vivo portion 4002, and the reference electrode can be printed on a second side of the in vivo portion 4002. More specifically, in some embodiments, the working electrodes can all be printed on a first side of the in vivo portion 4002 and the reference electrode can be printed on a second side of the in vivo portion 4002; alternatively, in some embodiments, one working electrode can be printed on a first side of the in vivo portion 4002 and a second working electrode can be printed on a second side of the in vivo portion 4002. In additional embodiments, a third working electrode can be printed on the first or second side of the in vivo portion 4002 along with the first or second electrode, respectively. According to embodiments, the in vivo portion 4002 can include four, five, six or more electrodes. According to embodiments, the analyte sensor (including the in vivo portion 4002 and the extra vivo portion 4004) can include a wire sensor (such as, but not limited to, a platinum sensor, i.e., an analyte sensor having a platinum core as a working electrode).

[0256] According to an embodiment, as can be seen in FIG. 40, the in vitro portion 4004 of the sensor 104a can include a number of electronic components (2418A, 11914A). The number of electronic components (2418A, 11914A) can be communicatively coupled to at least one working electrode and a reference electrode and can be configured to receive signals associated with measured analyte levels generated by the electrodes. In some embodiments, all of the electronic components (e.g., electronic component 2418A, electronic component 11914A) can be mounted on the in vivo portion 4004 of the sensor. As a result, a separate printed circuit board is not required to mount the electrical components 2418A, 11914A. The in vivo portion 4004 can include an electronic component 2418A mounted on the in vivo portion 4004 to receive analyte measurement signals generated by a sensor in the in vivo portion 4002. These electronic components 2418A can include one or more processors, one or more batteries, one or more antennas, resistors, transistors, capacitors, inductors, diodes, and / or switches. The electronic components can be mounted on a substrate of the in vivo part. For example, as can be seen in FIG. 40, the electronic components 2418A can include at least a battery and an antenna. The substrate of the in vivo part can include any or all of the electronic components of the present disclosure as well. Additionally or alternatively, the antenna or antennas do not have to be mounted directly on the substrate, but can be mounted on an additional second substrate. Additionally or alternatively, the antenna can be a raised antenna as described in US20220079475A1, the entire contents of which are incorporated herein by reference. The antenna or antennas can be powered by one or more batteries. The battery can be mounted on the first substrate, or alternatively or additionally on a second substrate together with the antenna or antennas.Alternatively or additionally, one or more batteries may be mounted or positioned within the sensor control device 102 and these batteries may provide power to one or more antennas and / or other electronic components mounted on the in vivo portion 4004. The one or more batteries may include, for example, but are not limited to, a coin battery, a powered battery, a printed battery, or any other type of battery. According to an embodiment, the one or more processors may be one or more ASICs. As embodied herein, the electronic components may be configured to transmit sensor data using one or more antennas over Wi-Fi, NFC, Bluetooth, BTLE, or GPS, which may be received by a remote device having a display screen, such as a handheld analyte monitor device, a mobile phone, a wrist-worn device, or any other computing device. The remote device may be further configured to display the received sensor data on the display screen. Additionally, as described herein, the analyte sensor may be sterilized to prevent contamination, and as embodied herein, this sterilization may occur before or after the electronic components are mounted on the in vivo portion 4004.

[0257] According to the subject matter of the present disclosure, electronic components can be mounted on a substrate using photonic soldering. Photonic soldering can allow electronic components to be mounted during the mounting process without damage to the substrate that can occur due to heat exposure in a reflow oven, as described in more detail herein. More specifically, light can heat and reflow the solder without heating the substrate due to the different material properties of the solder and the substrate. In contrast, conventional reflow ovens expose the substrate to higher temperature levels that can cause the substrate to melt or otherwise be damaged. The use of photonic soldering can enable mass automated assembly. Additionally, photonic soldering can be used to mount wire sensors on a substrate. For example, wire sensors can include, but are not limited to, platinum sensors, i.e., sensors having a platinum working electrode as a core, and the like.

[0258] Photonic soldering uses a flash of light to reflow the solder paste in a molten state, thereby creating a permanent connection between the substrate and the electronic component. In particular, this can occur when the substrate is lighter in color than the electronic component and / or solder paste, thereby allowing the darker components to absorb more light, i.e., reach the heat required for soldering without affecting the lighter components. For example, but not limited to, the substrate can be transparent or white to allow light to be transmitted or reflected, thereby improving the performance of the photonic soldering process. The amount of light and energy delivered to the substrate and the electrical components can be well controlled by controlling the power of the lamp used, the wavelength of the light generated, the duration and frequency of the pulse generated, and the area exposed to the light. The rapid heating and cooling process by the flash of light allows the solder to reflow without damage to the polymer substrate. Although photonic soldering can be performed using a laser focused on the solder tabs of individual components, a flash lamp provides a larger exposed area, allowing multiple components to be soldered simultaneously, facilitating mass production. In contrast, during conventional reflow soldering, a solder paste is used to temporarily attach an electronic component to a board and is then melted in a reflow oven, thereby providing a permanent connection between the electronic component and the board. Certain flexible board materials, such as polyamide or PET, can be damaged during reflow soldering by the heat of the reflow oven.

[0259] As embodied herein, the photonic soldering process can use light pulses (e.g., but not limited to, xenon light) to reflow the solder paste. This light can be delivered to the target component using multiple repeated light pulses to controllably increase the solder paste temperature. As embodied herein, the user can modify the photonic soldering process by controlling the input power, pulse duration, number of pulses, and / or flash rate of the pulses. As embodied herein, the electronic components can be placed on the substrate by hand or machine. Furthermore, the components can be soldered either individually or simultaneously. The components can be mounted on the first side of the sensor, which can be done after printing the electrodes, as embodied herein.

[0260] Further information regarding photonic flash soldering and its uses is described in "Photonic Flash Soldering on Flex Foils for Flexible Electronic Systems" by Arutinov et al. (G. Arutinov, R. Hendriks, and J. Van Den Brand, "Photonic Flash Soldering on Flex Foils for Flexible Electronic Systems," 2016 IEEE 66th Electronic Components and Technology Conference (ECTC), 2016, pp. 95-100, doi:10.1109 / ECTC.2016.179.), which is incorporated herein by reference in its entirety.

[0261] In some embodiments, photonic soldering can be applied to multiple substrates simultaneously. For example, a sheet of substrate material can have a 2X2, 3X3, 4X4, 5X5 array, or any other substrate blank arrangement. The substrate can then be etched to form the outline of the contacts to print the carbon traces prior to photonic soldering, and the contacts can then be masked to prevent light absorption as discussed herein. In some embodiments, electrodes can be printed onto the substrate using carbon ink as described above, and the electrodes can include contacts (e.g., contacts 2418 shown in FIG. 9A) on the in vivo portion for electrically coupling the active portion of the sensor to electronic components positioned on the in vivo portion of the sensor. Alternatively, the traces can be copper. To further protect the substrate during the photonic soldering process according to embodiments disclosed herein, the substrate can be masked to prevent light pulses from contacting the substrate except at the location of the components or leads to be soldered. The mask can include a titanium dioxide material that can reflect light to minimize light absorption. By way of example and not limitation, a suitable mask can have the material properties in the table below.

[0262] [Table 2] Table 2: Exemplary solder mask material properties Source: Electra's technical data sheet for Carapace EMP110W-LED photoimageable solder mask for the LED named EMP110 W-LED (cool-white / extra-cool-white / warm-white)_rev5, accessible at https: / / electrapolymers.com / wp-content / uploads / sds_files / EMP110%20W-LED.pdf. In some embodiments, the mask can be applied using a silk screen. Additionally or alternatively, the substrate can be coated with a reflective coating prior to photonic soldering to prevent light from penetrating the substrate material, and / or the light source can be used with a UV light filter. Printed traces may also be exposed to the risk of thermal damage from light exposure caused by photonic soldering. Melt reflow from heated solder may also pose a risk of shorting the carbon traces. Thus, a metal-based removable mask can be applied over the circuit board traces to prevent light absorption in the traces and to prevent solder reflow from shorting the traces. After masking the traces, the solder material can be dispensed onto the substrate and the electronic components can be positioned over the solder, either manually or automatically. In some embodiments, one or more batteries can be manually soldered to the substrate as the battery solder tabs are non-coplanar, i.e., they can heat at different rates. The photonic soldering process described above can then be applied to the substrate and electronic components. After the soldering process is complete, the substrate that constitutes the final product can be cut from the sheet and the in vivo portion 4002 of the sensor can be dipped into a membrane material to form the membrane.

[0263] According to the embodiments disclosed herein, the substrate can be secured to a work bench or other work surface using a vice, clips, or any clamping means to prevent movement of the substrate due to potential distortion during the photonic soldering process. The substrate can be secured to the work surface using a vacuum. The photonic soldering process can be performed using any type of known commercially available solder. However, in some embodiments, a solder having a relatively low melting point can be used for the photonic soldering process. For example, a PET panel has a melting point of about 260° C., and a standard solder having a tin-copper-silver alloy has a melting point of about 220° C. Although the PET panel has a higher melting point than the standard solder, there is a risk that heating the standard solder to its melting point will result in damage to the PET panel. In contrast, a low temperature solder, for example a solder having a bismuth-tin-silver alloy with a melting point of about 140° C., requires a lower temperature to melt, thus reducing the possibility of damaging the PET panel. For example and not by way of limitation, additional solder types having the alloys and properties listed below may also be used with substrates having an appropriate high melting range.

[0264] [Table 3] Table 3: Exemplary solder alloys and properties Further details regarding solder alloys can be found in the Kestser Alloy Temperature Chart, which is incorporated herein by reference in its entirety for all purposes.

[0265] Exemplary embodiments of the firing mechanism for one-piece and two-piece applicators 35A-35F illustrate exemplary details of an embodiment of an internal device mechanism for "firing" the applicator 216, including safely retracting the sharpener 1030 back into the applicator 216 used to apply the sensor control device 222 to the user. These figures, taken together, depict an exemplary sequence of driving the sharpener 1030 (carrying a sensor coupled to the sensor control device 222) into the user's skin, withdrawing the sharpener while leaving the sensor in operative contact with the user's interstitial fluid, and adhering the sensor control device to the user's skin using an adhesive. With reference to these figures, one skilled in the art will be able to recognize modifications of such actions for use with alternative applicator assembly embodiments and components. Additionally, the applicator 216 can be a sensor applicator having a one-piece or two-piece architecture as disclosed herein.

[0266] 35A, the sensor 1102 is supported within the sharp 1030 slightly above the user's skin 1104. Rails 1106 (optionally three rails 1106) on the upper guide section 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 such that the sharp 1030 and sensor control device 222 can be translated along the longitudinal axis into (and onto) the user's skin 1104. Additionally, the catch arm 1112 of the sensor carrier 1022 engages the sharp retraction assembly 1024 to maintain the sharp 1030 in position relative to the sensor control device 222.

[0267] 35B, a user force is applied to overcome or disable the detent feature 1110, and the sheath 318 collapses into the housing 314, driving the sensor control device 222 (along with the attached portions) to translate downward along the longitudinal axis as shown by arrow L. The inner diameter of the upper guide section 1108 of the sheath 318 constrains the position of the carrier arm 1112 throughout the 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.

[0268] In Figure 35C, the sensor 1102 and sharp 1030 reach maximum insertion depth. In doing so, the carrier arm 1112 passes through the inner diameter of the upper guide section 1108. The compression force of the coil return spring 1118 then releases a force that drives the angled stop surface 1114 radially outward, driving the sharp carrier 1102 of the sharp retraction assembly 1024 to pull the sharp 1030 (slotted or otherwise configured) out of the user and away from the sensor 1102, as shown by arrow R in Figure 35D.

[0269] With the sharp 1030 fully retracted, as shown in Figure 35E, the upper guide section 1108 of the sheath 318 is set with the final locking feature 1120. As shown in Figure 35F, the used applicator assembly 216 is removed from the insertion site leaving the sensor control device 222 behind and with the sharp 1030 safely secured inside the applicator assembly 216. At this point, the used applicator assembly 216 can be discarded.

[0270] The actuation of the applicator 216 when applying the sensor control device 222 is designed to give the user the sensation that both the insertion and retraction of the sharpener 1030 are performed automatically by the internal mechanism of the applicator 216. In other words, the present invention avoids the user from experiencing the sensation of forcing the sharpener 1030 into his / her skin. Thus, after the user applies enough force to overcome the resistance from the detent feature of the applicator 216, the resulting action of the applicator 216 is perceived as an automatic response to the applicator being "triggered". Even though all the driving force to insert the sharpener 1030 is provided by the user and no additional biasing / driving means are used, the user does not perceive that he / she is providing additional force to drive the sharpener 1030 to penetrate the skin. As shown above in FIG. 35C, the retraction of the sharpener 1030 is automated by the coil return spring 1118 of the applicator 216.

[0271] With respect to any of the applicator embodiments described herein, as well as any of the components of the applicator embodiments, including but not limited to the sharps, sharps module, and sensor module embodiments, those skilled in the art will appreciate that these embodiments can be sized and configured for use with a sensor configured to sense an analyte level in a bodily fluid in the epidermis, dermis, or subcutaneous tissue of a subject. In some embodiments, for example, the sharps and distal portions of the analyte sensor disclosed herein can be sized and configured to be positioned at a particular distal depth (i.e., the deepest penetration point into a tissue or layer of the subject's body, e.g., the epidermis, dermis, or subcutaneous tissue). With respect to some applicator embodiments, those skilled in the art will appreciate that certain embodiments of the sharps can be sized and configured to be positioned at a different distal depth within the subject's body as compared to the final distal depth of the analyte sensor. In some embodiments, for example, the sharps can be positioned at a first distal depth within the epidermis of the subject prior to retraction, whereas the distal portion of the analyte sensor can be positioned at a second distal depth within the dermis of the subject. In other embodiments, the sharp may be positioned at a first distal depth within the dermis of the subject prior to retraction, while a distal portion of the analyte sensor may be positioned at a second distal depth within subcutaneous tissue of the subject. In yet other embodiments, the sharp may be positioned at a first distal depth prior to retraction, and the analyte sensor may be positioned at a second distal depth, both of which are within the same layer or tissue of the subject's body.

[0272] In addition, one of ordinary skill in the art will appreciate that for any of the applicators described herein, the analyte sensor and one or more structured components coupled to the analyte sensor, including but not limited to one or more spring mechanisms, may be positioned within the applicator at an eccentric location relative to one or more axes thereof. In some applicator embodiments, for example, the analyte sensor and spring mechanism may be positioned at an eccentric location on a first side of the applicator relative to the applicator axis, and the sensor electronics may be positioned at an eccentric location on a second side of the applicator relative to the applicator axis. In other applicator embodiments, the analyte sensor, spring mechanism, and sensor electronics may be positioned at eccentric locations on the same side of the applicator axis. One of ordinary skill in the art will appreciate that other permutations and configurations in which any or all of the analyte sensor, spring mechanism, sensor electronics, and other components of the applicator are positioned in central or eccentric locations relative to one or more axes of the applicator are possible and fully within the disclosure of the present invention.

[0273] Several deflectable structures have been described herein, including but not limited to deflectable detent snap 1402, deflectable locking arm 1412, sharp carrier locking arm 1524, sharp retaining arm 1618, and module snap 2202. These deflectable structures include resilient materials such as plastic or metal (or other) and operate in a manner known to those skilled in the art. Each of the deflectable structures has a rest state or position toward which the resilient material is biased. If a force is applied to deflect or move the structure from this rest state or position, when the force is removed (or weakened), this bias of the resilient material will return the structure to this rest state or position. In many instances, these structures are configured as arms with detents or snaps, although other structures or configurations that possess the same characteristics of deflectability and ability to return to a rest position can be used, including but not limited to legs, clips, catches, and supports on the deflectable members.

[0274] In summary, a system for measuring an analyte level has been described that includes an analyte sensor having an in vivo portion in contact with a user's interstitial fluid and an in vitro portion. The sensor further includes at least one working electrode and a reference electrode positioned on the in vivo portion and a first substrate. The at least one working electrode and the reference electrode generate a signal associated with the measured analyte level. Additionally, the in vitro portion includes a plurality of electronic components mounted thereon, at least one of the electronic components configured to receive the generated signal associated with the measured analyte level. The electronic components are mounted to the in vitro portion using photonic soldering.

[0275] Additional details of suitable devices, systems, methods, components, and their operation, along with associated features, are described in International Publication No. WO 2018 / 136898 to Rao et al., International Publication No. WO 2019 / 236850 to Thomas et al., International Publication No. WO 2019 / 236859 to Thomas et al., International Publication No. WO 2019 / 236876 to Thomas et al., and U.S. Patent Publication No. 2020 / 0196919, filed June 6, 2019, the entire contents of each of which are incorporated herein by reference. Further details regarding the applicator, embodiments of its components, and variations thereof are described in U.S. Patent Publication Nos. 2013 / 0150691, 2016 / 0331283, and 2018 / 0235520, the entire contents of all of which are incorporated herein by reference for all purposes. Further details regarding the Sharp Module, embodiments of the Sharp, its components, and variations thereof are described in U.S. Patent Publication No. 2014 / 0171771, the entire contents of which are incorporated herein by reference for all purposes.

[0276] 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 is understood that such feature, element, component, function, or step can be used in all other embodiments described herein, unless otherwise expressly stated. Thus, this paragraph serves as a reason and written support prior to the introduction of the appended claims for combining features, elements, components, functions, and steps from various embodiments, or substituting features, elements, components, functions, and steps from one embodiment with another, in each case, even if the following description does not expressly state that such combinations or substitutions are possible in a particular case. That is, the above description of specific embodiments of the subject matter of the present disclosure is presented for the purpose of illustration and description. It is expressly recognized that an explicit enumeration of all possible combinations and permutations would be unduly burdensome, especially considering that the permissibility of each and every such combination and permutation would be readily recognized by those skilled in the art.

[0277] While the embodiments are susceptible to various modifications and alternative forms, specific examples thereof have been shown in the drawings and described in detail herein. It will be apparent to those skilled in the art that various modifications and variations can be made in the methods and systems of the presently disclosed subject matter without departing from the spirit or scope of the presently disclosed subject matter. That is, the presently disclosed subject matter is intended to include modifications and variations that are within the scope of the appended claims and their equivalents. Furthermore, any feature, function, step, or element of the above-described embodiments, as well as any feature, function, step, or element not present in the present invention, may be recited in or added to the scope of the appended claims. [Explanation of symbols]

[0278] 100 Sample Monitor System 102 Sensor Control Device 104 In vivo analyte sensors 120 Reader Device 150 Sensor Applicator

Claims

1. 1. A system for measuring an analyte level, comprising:

1. An analyte sensor having an in vivo portion configured to be positioned in contact with interstitial fluid of a user and an in vivo portion, A first substrate; at least one working electrode positioned on the biological portion; a reference electrode positioned on the in vivo portion; a plurality of electronic components mounted on said in vivo portion; the analyte sensor comprising: Including, the at least one working electrode is configured to sense an analyte level in the interstitial fluid of the user, and at least one of the plurality of electronic components is configured to receive a generated signal associated with the analyte level. system.

2. 10. The system of claim 1, wherein the plurality of electronic components are further configured to transmit the signal associated with the analyte level to a remote device having a display screen.

3. The system of claim 2 , wherein the remote device comprises a display device, a mobile phone, or a wrist-worn device.

4. The sensor of claim 1 , wherein the electronic components are attached to the ex-vivo portion using photonic soldering.

5. The system of claim 1 , wherein the first substrate is a flexible monolithic unit.

6. The system of claim 1 , wherein the plurality of electronic components includes one or more processors and a battery.

7. The system of claim 6 , wherein the battery comprises a printed battery.

8. 8. The system of claim 1, wherein the at least one working electrode is configured to sense at least one of lactate, glucose, and ketones.

9. The system of claim 1 , wherein the analyte sensor further comprises a second substrate having at least one antenna.

10. The system of any one of claims 1 to 9, wherein the plurality of electronic components includes at least a Wi-Fi antenna, an NFC antenna, a Bluetooth antenna, a BTLE antenna, or a GPS antenna.

11. The system of claim 1 , wherein the first substrate is one of polyamide or polyethylene terephthalate.

12. a sensor control device housing the analyte sensor; 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 comprising: The system of any one of claims 1 to 11, further comprising:

13. 13. The system of claim 1, wherein the plurality of electronic devices are electrically coupled to the at least one working electrode and to the reference electrode.

14. The system of claim 1 , wherein the ex vivo portion comprises a first layer.

15. The system of claim 14 , wherein the first layer comprises a gradient mixture of materials.

16. The system of claim 15 , wherein the gradient mixture of material includes fiberglass.

17. 16. The system of claim 15, wherein the gradient mixture of material includes about 10% fiberglass and the in vivo portion includes PET.

18. The system of claim 14 , wherein the ex vivo portion includes a second layer.

19. 20. The system of claim 18, wherein the first layer and the second layer each comprise a gradient mixture of materials.

20. 1. A method of assembling a system for measuring an analyte level, comprising: providing an analyte sensor having an in vivo portion configured to be positioned in contact with interstitial fluid of a user and an in vitro portion, the analyte sensor comprising: A first substrate; at least one working electrode positioned on the biological portion; a reference electrode positioned on the in vivo portion; having the at least one working electrode is configured to sense an analyte level in the interstitial fluid of the user. the providing step; attaching a plurality of electronic components to the ex vivo portion, at least one of the plurality of electronic components configured to receive a generated signal associated with the analyte level; The method includes:

21. 21. The method of claim 20, wherein providing the analyte sensor comprises printing the at least one working electrode and the reference electrode onto the substrate.

22. 22. The method of claim 20 or claim 21, wherein the plurality of electronic components are further configured to transmit the signal associated with the analyte level to a remote device having a display screen.

23. 21. The method of claim 20, wherein the remote device is at least one of a handheld analyte monitor device, a mobile phone, or a wrist-worn device.

24. 24. The method of any one of claims 20 to 23, further comprising the step of attaching the electronic component to the ex-vivo part using photonic soldering.

25. 25. The method of claim 24, further comprising masking a portion of the first substrate prior to photonic soldering.

26. 26. The method of claim 24 or claim 25, further comprising coating the first substrate with a reflective coating prior to photonic soldering.

27. 27. The method of any one of claims 24 to 26, further comprising applying a vacuum to prevent the first substrate from bowing during the photonic soldering process.

28. 28. The method of any one of claims 20 to 27, wherein the first substrate is a flexible monolithic unit.

29. 28. The method of any one of claims 20 to 27, wherein the plurality of electronic components comprises one or more processors and a battery.

30. 30. The method of claim 29, wherein the plurality of electronic components further comprises at least one antenna.

31. 31. The method of claim 29 or claim 30, further comprising a second substrate having at least one antenna.

32. 32. The method of claim 31, wherein the at least one antenna comprises a Wi-Fi antenna, an NFC antenna, a Bluetooth antenna, a BTLE antenna, or a GPS antenna.

33. 33. The method of any one of claims 29 to 32, wherein the battery comprises a printed battery.

34. 34. The method of any one of claims 20 to 33, wherein the first substrate is one of polyamide or polyethylene terephthalate.

35. 35. The method of any one of claims 20 to 34, further comprising printing the at least one working electrode on a first side of the analyte sensor and printing the reference electrode on a second side of the analyte sensor.

36. 36. The method of claim 35, wherein the electronic component is attached to the first surface using photonic soldering.

37. 37. The method of claim 36, wherein the plurality of electronic components are mounted on the first surface prior to printing the at least one working electrode and the reference electrode.

38. 38. The method of any one of claims 20 to 37, further comprising sterilizing the analyte sensor.

39. 40. The method of claim 38, wherein sterilizing the analyte sensor comprises using radiation sterilization, heat treatment, electron beam sterilization, gamma sterilization, X-ray sterilization, ethylene oxide sterilization, autoclave steam sterilization, chlorine dioxide gas sterilization, or hydrogen peroxide sterilization.

40. 40. The method of claim 38 or claim 39, wherein the analyte sensor is sterilized prior to mounting the plurality of electronic components to the ex vivo part.

41. 41. The method of any one of claims 38 to 40, wherein the analyte sensor is sterilized after mounting the plurality of electronic components on the ex vivo portion.

42. The method of claim 20 , wherein the ex vivo portion comprises a first layer.

43. 43. The method of claim 42, wherein the first layer comprises a gradient mixture of materials.

44. 43. The method of claim 42, wherein the gradient mixture of material includes fiberglass.

45. 43. The method of claim 42, wherein the gradient mixture of material comprises about 10% fiberglass and the in vivo portion comprises PET.

46. 43. The method of claim 42, wherein the ex vivo portion comprises a second layer.

47. 47. The method of claim 46, wherein the first layer and the second layer each comprise a gradient mixture of materials.

48. 1. A system for measuring an analyte level, comprising:

1. An analyte sensor having an in vivo portion configured to be positioned in contact with interstitial fluid of a user and an in vivo portion, Flexible substrate, a membrane disposed on the in vivo portion and configured to regulate analyte inflow; at least one working electrode positioned on the biological portion; a reference electrode positioned on the in vivo portion; and a plurality of electronic components mounted on the ex vivo part using photonic soldering, the plurality of electronic components including a processor, a battery, and an antenna; the analyte sensor having a sensor control device housing the analyte sensor; 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 comprising: Including, the at least one working electrode is configured to sense an analyte level in the interstitial fluid of the user, and the antenna is further configured to receive a generated signal associated with the sensed analyte level. system.

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