Systems, devices, and methods for analyte monitoring

Abstract

An analyte monitoring system with a sensor control includes an electronics housing. The housing may include an outer shell disposed opposite the mount, each including an aperture axially aligned with another aperture. The inner surfaces are aligned, and a seal is disposed within the interior space. The shell further comprises a circuit board arranged in the internal space of the shell; and an analyte sensor having a proximal portion and a distal portion, the proximal portion coupled with the circuit board and the distal portion configured to measure a glucose level in the bodily fluid and extending from the bottom of the electronics housing.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 388,053, filed on July 11, 2022, and U.S. Provisional Patent Application No. 63 / 442,743, filed on February 1, 2023, which are incorporated herein by reference in their entireties. Technical Field

[0003] The subject matter described herein relates generally to systems, devices, and methods for in vivo analyte monitoring. Background Art

[0004] Detecting and / or monitoring analyte levels (such as glucose, ketones, lactate, oxygen, hemoglobin AIC, etc.) can be critical to the health of diabetic patients. Diabetic patients may experience complications including loss of consciousness, cardiovascular disease, retinopathy, neuropathy, and nephropathy. Diabetic patients often need to monitor their glucose levels to ensure that they are kept within a clinically safe range, and can also use this information to determine if and / or when insulin is needed to lower the glucose level in their body, or when additional glucose is needed to increase the glucose level in their body.

[0005] There is a growing body of clinical data demonstrating a strong correlation between glucose monitoring frequency and glycemic control. However, despite this correlation, many people diagnosed with diabetes 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.

[0006] In order to increase patient compliance with frequent glucose monitoring programs, an in vivo analyte monitoring system can be utilized in which a sensor control device can be worn on the body of an individual who needs analyte monitoring. In order to increase the comfort and convenience of the individual, the sensor control device can have a small form factor and can be assembled and applied by the individual with a sensor applicator. The application process includes inserting a sensor (such as a dermal sensor that senses the user's analyte level in a body fluid located in the dermis of the human body) using an applicator or insertion mechanism so that the sensor is in contact with the body fluid. The sensor control device can also be configured to transmit analyte data to another device, from which the individual or its health care provider ("HCP") can review the data and make treatment decisions.

[0007] Although galvanic sensors may be convenient for users, they may also be susceptible to causing discomfort to some users. For example, analyte monitoring devices that use adhesives to assemble the various mechanical components of the analyte monitoring system may cause discomfort because some adhesives may irritate the user's skin. Isobutyl acrylate ("IBOA") is a typical adhesive that may cause irritation to the user.

[0008] Additionally, the use of adhesives may be disadvantageous from a mechanical perspective. For example, the time required to cure the adhesive may increase manufacturing time and cost. Adhesives may be light sensitive and may have a relatively short shelf life, thereby affecting their ability to be stored and later used safely.

[0009] Therefore, there is a need for more reliable sensor insertion devices, systems and methods, particularly for use with dermal sensors, that are easy for patients to use and less likely to cause user discomfort. Additionally, there is a need for sensor insertion devices, systems and methods that provide humidity control and extended shelf stability. Summary of the invention

[0010] The objects and advantages of the disclosed subject matter will be set forth in the following description and will be apparent from the description, and will be understood by the practice of the disclosed subject matter. Additional advantages of the disclosed subject matter will be realized and obtained by the methods and systems particularly pointed out in the written description and its claims, and according to the accompanying drawings.

[0011] To achieve these and other advantages, and in accordance with the purposes of the disclosed subject matter, as specifically implemented and broadly described, the disclosed subject matter relates to an analyte monitoring system. The analyte monitoring system includes a sensor control device having an electronic device housing. The electronic device housing includes an internal space. When the support and the housing are arranged relative to each other, the internal space is defined between the support and the housing of the electronic device housing. The internal space can be between the inner surface of the support and the inner surface of the housing, wherein the inner surface of the support is opposite to the inner surface of the housing. The sensor control device also includes at least one seal at least partially disposed in the internal space. For example, the seal can be partially or completely contained in the internal space. When coupled together, the internal space can be defined between the outer periphery of the support and the outer periphery of the housing. The internal space can be optionally divided into one or more portions. The portion of the internal space containing at least one seal can be defined by one or more channels within the internal interface of the support and / or the housing. The portion of the internal space containing at least one seal can be fluidly coupled to the portion of the internal space containing a circuit board. The sensor control device can also include a circuit board and an analyte sensor. The circuit board can be disposed in the internal space of the electronic device housing. The circuit board can be completely contained in the internal space of the electronic device housing. The analyte sensor may be disposed in the interior space of the electronic device housing. The analyte sensor may be partially contained within the interior space of the electronic device housing. In addition, the analyte sensor may include a proximal portion and a distal portion, so that a portion of the proximal portion extends into the interior of the electronic device housing and has one or more sensor contacts electrically coupled to the circuit board, and the distal portion is configured to measure the glucose level in the body fluid and extends from the bottom of the electronic device housing. The sensor control device may also include at least one seal, which is disposed in the interior space of the electronic device housing, near the first opening and the second opening, and is configured to provide a seal around at least a portion of the proximal portion of the analyte sensor, the proximal portion extending into the interior of the electronic device housing, and is configured to seal one or more sensor contacts within the interior of the electronic device housing. The distal portion may be referred to as the tail of the sensor in this article. The adhesive patch is an optional feature of the sensor control device and may be attached to the bottom of the support, such as for permanent attachment to the bottom of the support. The "top" and "bottom" mentioned herein refer to the configuration of the system in use. As described herein, the top of the support is opposite to the bottom of the support and is coupled to the housing.

[0012] In some embodiments, the analyte monitoring system can further include a collar disposed in the interior space between the housing and the at least one seal such that the collar is axially aligned with each of the first aperture and the second aperture.

[0013] In some embodiments, the electronic device housing includes: a housing having a first opening; and a support fixed to the housing to define an internal space, the support having a second opening axially aligned with the first opening. The electronic device housing may also include at least one seal having a slit axially aligned with the first opening and the second opening. In addition, the proximal portion of the analyte sensor may extend through the slit of the at least one seal. In one embodiment, the circuit board may be positioned radially outward from the first opening and the second opening, for example, laterally spaced from the first opening and the second opening. In this embodiment, the analyte sensor may extend laterally from the circuit board to the first opening and the second opening, and then axially through the first opening and the second opening. The proximal portion of the analyte sensor may extend laterally from the circuit board, and the distal portion of the analyte sensor may extend axially through the first opening and the second opening. The proximal portion of the analyte sensor may be arranged in a plane intersecting with the plane of the distal portion of the analyte sensor, such as a vertical configuration.

[0014] In some embodiments, at least one seal may be compressed between the housing and the support. In another embodiment, at least one seal may include a first seal and a second seal, so that the first seal and the second seal are matable. In addition, in some embodiments, the slit may be defined in at least one of the first seal and the second seal. Alternatively, in some embodiments, the slit may be defined at the interface between the first seal and the second seal. In another embodiment, the housing may include a first interface extending into the interior space, wherein the first interface defines a first channel positioned circumferentially around the first opening, and the support includes a second interface extending into the interior space, wherein the second interface defines a second channel positioned circumferentially around the second opening, wherein the first seal is integrated into the first channel, and the second seal is integrated into the second channel. The first interface may be the inner surface of the housing, and the second interface may be the inner surface of the support, and the first interface may be opposite to the second interface. The first channel and the second channel may define a portion of the interior space containing at least one seal. In some embodiments, the first interface and the second interface may be configured to fit together. In another embodiment, the first interface may be welded to the second interface. In some embodiments disclosed herein, the first seal may include a first sealing surface, and the second seal may include a second sealing surface, and the first sealing surface and the second sealing surface may contact each other and may be configured to isolate the internal space from foreign matter. More specifically, the first sealing surface and the second sealing surface may be configured to isolate at least a portion of the internal space containing the circuit board from foreign matter. Therefore, according to the disclosed subject matter, a seal may be formed by pressing the first sealing surface against the second sealing surface. In one embodiment, the first sealing surface may include a first rib, and in another embodiment, the second sealing surface may include a second rib in contact with the first rib or a channel sized to receive the first rib. Alternatively, in some embodiments, the second sealing surface may include a first rib, and in another embodiment, the first sealing surface may include a second rib in contact with the first rib or a channel sized to receive the first rib. In some embodiments, at least one seal is elastically deformable. In some embodiments, at least one seal may be made of at least one of an elastomer, a rubber, a polymer, a UV-curable silicone, a room temperature vulcanized silicone, and a UV-curable polyurethane. In addition, at least one seal may be made of a self-healing material configured to bond to itself by heat activation. In some embodiments, the first seal may have a first sealing opening, the second seal may have a second sealing opening, and the first sealing opening and the second sealing opening may each be axially aligned with each of the first opening and the second opening.In yet another embodiment, at least one seal can be configured to provide a moisture barrier for sealing a distal portion of the glucose sensor extending from a bottom of the electronic device housing. More specifically, at least one seal can be configured to provide a moisture barrier for sealing the distal portion of the glucose sensor from an interior space of the electronic device housing containing a circuit board.

[0015] According to the disclosed subject matter, the seal can be compressed between the housing and the support. In another embodiment, the housing includes a first inner surface, the support includes a second inner surface, the distance between the first inner surface and the second inner surface defines a first height, and the seal has a second height greater than the first height. The first height can be the height of a portion of the internal space of the electronic device housing that contains at least one seal. In addition, in one embodiment, the seal has a first surface that can be adjacent to the first channel, a second surface that can be adjacent to the second channel, and at least one rib located on each of the first surface and the second surface. In yet another embodiment, the first inner surface of the housing can be adjacent to the first surface of the seal, the second inner surface of the support can be adjacent to the second surface of the seal, and each inner surface includes at least one rib that contacts the first surface and the second surface of the seal. In some embodiments, the seal can be disposed in at least one of the first channel and the second channel.

[0016] According to the disclosed subject matter, the seal can have a one-piece configuration. In one embodiment, the seal can also include a central slit for receiving the proximal portion of the analyte sensor. In another embodiment, the seal can include an eccentric slit for receiving the proximal portion of the analyte sensor. In addition, in one embodiment, the seal can have a two-piece configuration. In another embodiment, the slit can have an interlocking interface. In some embodiments, the seal can at least partially isolate the electronic device housing from the movement of the analyte sensor. For example, the seal can surround at least a portion of the analyte sensor so that the stress on the sensor is not transmitted to the circuit board. In some embodiments, the seal can reduce the stress on the analyte sensor. For example, the seal can be elastically deformed and can therefore be configured to absorb impact. The seal can also provide a moisture barrier for sealing the distal portion of the glucose sensor extending from the bottom of the electronic device housing.

[0017] In some embodiments, the support can be coupled to the housing using one of ultrasonic welding and laser welding. In other embodiments, this can be achieved by welding the support to the housing along at least one weld joint that coincides with the first channel and the second channel. In some embodiments, this can be achieved without melting the seal.

[0018] In some embodiments, the system may further include an applicator for delivering the analyte sensor. The applicator may include an applicator housing having a sensor carrier configured to secure the sensor control device within the interior of the applicator; and an applicator cap removably coupled to the applicator housing to seal the interior of the applicator. The applicator cap may also include a collimator having a distal end and a proximal end, the distal end being disposed proximate to the support so that an interface between the distal end and the support is sealed, and the proximal end having an opening.

[0019] In some embodiments, the collimator can have a cross-sectional shape selected from the group consisting of a cone, a truncated cone, a pyramid, a circle, a cube, a rectangle, and any combination thereof. In another embodiment, the opening of the collimator can include a label that prevents moisture from entering the collimator while still allowing electron beam radiation to enter the collimator. The label may be referred to as a barrier in this article. The barrier may cover the opening of the collimator. In some embodiments, the label may be made of Tyvek. In some embodiments, the collimator may be axially aligned with at least one of the analyte sensor and the second opening.

[0020] As further disclosed herein, the disclosed subject matter may relate to an analyte monitoring system, including a sensor control device having an electronic device housing. The electronic device housing includes: a housing having a first opening; and a support fixed to the housing to define an internal space, the support having a second opening axially aligned with the first opening. The electronic device housing may also include at least one seal having a slit axially aligned with the first opening and the second opening. The sensor control device may also include a circuit board and an analyte sensor, each of which is disposed within the internal space. In addition, the analyte sensor may include a proximal portion and a distal portion, such that a portion of the proximal portion extends through the slit of at least one seal and is electrically coupled to the circuit board, and the distal portion is configured to measure glucose levels in a bodily fluid and extends from the bottom of the electronic device housing. The sensor control device may also include an adhesive patch attached to the bottom of the support, the adhesive patch being configured to fix the electronic device housing to the user's skin. The system may also include a sharp hub that engages with the upper outer surface of the housing and includes a sharp object and a second mating member configured to extend within the first opening, and a first mating member of the electronic device housing that extends within the first opening to define a first sterile barrier. The system may also include an applicator for delivering an analyte sensor, the applicator including an applicator housing having a sensor carrier that is configured to fix the sensor control device to the interior of the applicator. The system may also include an applicator cap that is removably coupled to the applicator housing to seal the interior of the applicator.

[0021] Also disclosed herein are methods for producing an analyte sensor system according to the above disclosed embodiments. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] The details of the subject matter described herein (both with respect to its structure and operation) may be apparent from a careful reading of the accompanying drawings, in which like reference numerals refer to like parts. The components in the figures are not necessarily drawn to scale, emphasis instead being placed on illustrating the principles of the subject matter. In addition, all illustrations are intended to convey concepts, in which relative size, shape, and other detailed attributes may be illustrated schematically rather than literally or precisely.

[0023] Figure 1 It is a system overview of sensor applicators, reader devices, monitoring systems, networks and remote systems.

[0024] Figure 2A is a block diagram depicting an exemplary embodiment of a reader device.

[0025] Figure 2B and Figure 2C is a block diagram depicting an exemplary embodiment of a sensor control device.

[0026] Figure 3A is a proximal perspective view of an exemplary embodiment depicting a user preparing a tray for assembly.

[0027] Figure 3B is a side view of an exemplary embodiment depicting a user preparing an applicator assembly for assembly.

[0028] Figure 3C is a proximal perspective view of an exemplary embodiment depicting a user inserting an applicator assembly into a tray during assembly.

[0029] Figure 3D is a proximal perspective view of an exemplary embodiment depicting a user removing the applicator assembly from a tray during assembly.

[0030] Figure 3E is a proximal perspective view of an exemplary embodiment depicting a patient applying a sensor using an applicator assembly.

[0031] Figure 3F is a proximal perspective view of an exemplary embodiment depicting a patient with an applied sensor and an applicator device in use.

[0032] Figure 4A is a side view depicting an exemplary embodiment of an applicator assembly coupled to a cap.

[0033] Figure 4B is a side perspective view of an exemplary embodiment depicting a decoupled applicator assembly and cap.

[0034] Figure 4C is a perspective view depicting an exemplary embodiment of a distal end of an applicator assembly and an electronics housing.

[0035] Figure 4D is a top perspective view of an exemplary applicator assembly in accordance with the disclosed subject matter.

[0036] Figure 4E yes Figure 4D A bottom perspective view of an applicator device.

[0037] Figure 4F yes Figure 4D Exploded view of the applicator assembly.

[0038] Figure 4G yes Figure 4D Side cross-sectional view of an applicator device.

[0039] Figure 5 is a proximal perspective view depicting an exemplary embodiment of a tray with a coupled sterilization cover.

[0040] Fig. 6A is a proximal perspective cutaway view depicting an exemplary embodiment of a tray having a sensor delivery component.

[0041] Figure 6B is a proximal perspective view depicting a sensor delivery component.

[0042] Fig. 7A is a side view depicting an exemplary embodiment of a housing.

[0043] Figure 7B is a perspective view of an exemplary embodiment depicting a distal end of a housing.

[0044] Figure 7C is a cross-sectional side view depicting an exemplary embodiment of a housing.

[0045] Fig.7D and Fig. 7E is a cross-sectional side view of a locking rib portion of an exemplary embodiment depicting a portion of a housing and a sheath.

[0046] Figure 7F and Figure 7G is a cross-sectional side view of a locking rib portion of another exemplary embodiment depicting a portion of a housing and a sheath.

[0047] Figure 7H is a cross-sectional side view of a locking rib portion of another exemplary embodiment depicting a portion of a housing and a sheath.

[0048] Fig.7Iis a cross-sectional side view of a locking rib portion of another exemplary embodiment depicting a portion of a housing and a sheath.

[0049] Figure 7J is a side view of an exemplary housing in accordance with the disclosed subject matter.

[0050] Figure 7K yes Figure 7J A bottom perspective view of a housing.

[0051] Figure 7L yes Figure 7J A side sectional view of the housing.

[0052] Figure 7M is a top perspective view of a cap in accordance with the disclosed subject matter.

[0053] Figure 7N yes Figure 7M A side cross-sectional view of a cap.

[0054] Fig.7O yes Figure 7M Top view of the hat.

[0055] Figure 7P is a cross-sectional view of a desiccant in a cap in accordance with the disclosed subject matter.

[0056] Figure 7Q to Figure 7R are bottom and top perspective views of exemplary desiccants in accordance with the disclosed subject matter.

[0057] FIG. 7S to FIG. 7T is an enlarged cross-sectional side view of an interface between a housing and a cap in accordance with the disclosed subject matter.

[0058] Figure 7U to Figure 7V are enlarged cross-sectional side views of a housing and a cap, respectively, in accordance with the disclosed subject matter.

[0059] Figure 7W to Figure 7X yes Figure 7M A side cross-sectional view of a cap.

[0060] Figure 7Y is a top perspective view of an exemplary elastomeric plug according to one or more embodiments.

[0061] Figure 7Z is a partial cross-sectional perspective view of an exemplary sensor cap and elastomeric plug according to one or more embodiments.

[0062] Fig. 8A is a side view depicting an exemplary embodiment of a sheath.

[0063] Figure 8B is a perspective view of an exemplary embodiment depicting the proximal end of a sheath.

[0064] Figure 8C is a close-up perspective view of an exemplary embodiment depicting the distal side of a detent buckle of a sheath.

[0065] Fig.8D is a side view of an exemplary embodiment depicting features of a sheath.

[0066] Fig. 8E is an end view of an exemplary embodiment of the proximal end of the sheath.

[0067] FIG. 8F to FIG. 8H is a perspective view depicting another exemplary embodiment of a sheath in various stages of assembly with other applicator components.

[0068] Figure 8I is a side view of a sheath in accordance with the disclosed subject matter.

[0069] Figure 8J yes Figure 8I A close-up view of the detent buckle of the case.

[0070] Figure 8K yes Figure 8I Top view of the sheath.

[0071] Figure 8L yes Figure 8I A stereoscopic view of the sheath.

[0072] Figure 8M yes Figure 8I A side cross-sectional view of the sheath.

[0073] Figure 8N According to the disclosed subject Figure 8I A close up view of the locking arms of the sheath and the engagement of the locking arms with the cap and sensor carrier.

[0074] Fig.8O According to the disclosed subject Figure 8I A close-up view of the ribs of the sheath and the engagement of the ribs with the sensor carrier.

[0075] Fig. 9A is a proximal perspective view depicting an exemplary embodiment of a sensor carrier.

[0076] Fig. 9B is a distal perspective view depicting an exemplary embodiment of a sensor carrier.

[0077] Fig. 9C is a distal perspective view depicting another exemplary embodiment of a sensor carrier.

[0078] Fig.9D is a top perspective view of a sensor carrier in accordance with the disclosed subject matter.

[0079] Fig.9E yes Fig.9D Bottom view of the sensor carrier.

[0080] Fig. 10A is a perspective view of a sharps carrier in accordance with the disclosed subject matter.

[0081] Fig. 10B yes Fig. 10A A side cross-sectional view of a sharp object carrier.

[0082] Fig. 10C is a perspective view of a sharps carrier in accordance with the disclosed subject matter.

[0083] Fig. 10D yes Fig. 10C A side cross-sectional view of a sharp object carrier.

[0084] FIG. 11A to FIG. 11B 2 are top and bottom perspective views, respectively, depicting an exemplary embodiment of a sensor module.

[0085] Fig. 12A and Fig. 12B A perspective view and a compressed view, respectively, depict an exemplary embodiment of a sensor connector.

[0086] Fig.13 is a perspective view depicting an exemplary embodiment of a sensor.

[0087] Fig.14A and Fig. 14B are bottom and top perspective views, respectively, of an exemplary embodiment of a sensor module assembly.

[0088] Fig.15A and Fig. 15B is a close-up partial view of an exemplary embodiment of a sensor module assembly.

[0089] FIG. 15C to FIG. 15G is a side view of an exemplary sensor according to one or more embodiments of the present disclosure.

[0090] Fig.16A and Fig. 16B are isometric and partially exploded isometric views of an exemplary connector assembly according to one or more implementations.

[0091] Fig. 16C yes FIG. 16A to FIG. 16B Isometric bottom view of the connector.

[0092] Fig.16D and Fig.16E is an isometric view and a partially exploded isometric view of another exemplary connector assembly according to one or more embodiments.

[0093] Fig.16F yes FIG. 16D to FIG. 16E Isometric bottom view of the connector.

[0094] Fig.17A is a perspective view depicting an exemplary embodiment of a sharps module.

[0095] Fig. 17B is a perspective view of another exemplary embodiment of a sharps module.

[0096] Fig. 17C and Fig.17D It depicts Fig. 17B Schematic diagram of the sharp object module.

[0097] Fig.17E and Fig.17F They are Fig. 17B A side view schematic diagram and a top view schematic diagram of the sharp object module and the sensor module assembled together.

[0098] Figure 17G is a perspective view of another exemplary embodiment of a sharps module.

[0099] Fig.17H It depicts Figure 17G Schematic side view of the sharp object module.

[0100] Fig.17I and Fig.17J They are Figure 17G A cross-sectional side view and a side view of the sharp object module assembled with the sensor module.

[0101] Fig.18A and Fig.18B 2 are an isometric view and a side view, respectively, of another exemplary sensor control device.

[0102] Fig.19A and Fig.19B They are FIG. 18A to FIG. 18B Exploded isometric top and bottom views of the sensor control device.

[0103] Fig.19C is a top perspective view of a battery in accordance with the disclosed subject matter.

[0104] Fig. 20 is a cross-sectional side view of an assembled sealing subassembly according to one or more embodiments.

[0105] FIG. 21A to FIG. 21C It shows that FIG. 18A to FIG. 18B A progressive cross-sectional side view of the assembly of a sensor applicator of a sensor control device.

[0106] Fig.22A and Fig. 22B According to one or more additional embodiments Fig. 21C The three-dimensional view and top view of the cap column.

[0107] Fig.23 yes FIG. 18A to FIG. 18B Cross-sectional side view of a sensor control unit.

[0108] Fig.24A and Fig. 24B is a cross-sectional side view of a sensor applicator ready to deploy a sensor control device to a target monitoring location.

[0109] FIG. 25A to FIG. 25C It shows that FIG. 18A to FIG. 18B Progressive cross-sectional side views of the assembly and disassembly of an exemplary embodiment of a sensor applicator of a sensor control device.

[0110] Fig.26A is an isometric bottom view of a housing according to one or more embodiments.

[0111] Fig.27A is an isometric bottom view of the housing with the sheath and other components at least partially positioned within the housing.

[0112] Fig.28 is an enlarged cross-sectional side view of a sensor applicator with a sensor control device installed in the sensor applicator according to one or more embodiments.

[0113] Fig.29A is an isometric top view of a cap according to one or more embodiments.

[0114] Fig.29B is an enlarged cross-sectional view of the engagement between the cap and the housing according to one or more embodiments.

[0115] Fig. 30A and Fig. 30B are isometric views of a sensor cap and a collar, respectively, according to one or more embodiments.

[0116] Fig.31A and Fig.31B 1 and 2 are side and isometric views, respectively, of an exemplary sensor control device according to one or more embodiments of the present disclosure.

[0117] Fig.32A and Fig.32B 2 are exploded isometric top and bottom views, respectively, of the sensor control device of FIG. 2 according to one or more embodiments.

[0118] Fig.32C According to one or more embodiments FIG. 32A to FIG. 32B A top perspective view of the shaft collar.

[0119] FIG. 32D to FIG. 32E is an isometric top view of the sensor control device of FIG. 2 , according to one or more implementations.

[0120] Fig.33 According to one or more embodiments FIG. 31A to FIG. 31B and FIG. 32A to FIG. 32B Cross-sectional side view of a sensor control unit.

[0121] Fig.33A yes FIG. 31A to FIG. 31B and FIG. 32A to FIG. 32B An exploded isometric view of a portion of another embodiment of a sensor control device.

[0122] Fig.33B According to one or more embodiments Fig.33A Cross-sectional view of the sharp hub and support.

[0123] Fig.34A yes FIG. 31A to FIG. 31B and FIG. 32A to FIG. 32B Isometric bottom view of the support.

[0124] Fig.34B yes FIG. 31A to FIG. 31B and FIG. 32A to FIG. 32B Isometric top view of the sensor cap.

[0125] Fig.35A and Fig.35B 2 are a side view and a cross-sectional side view, respectively, of an exemplary sensor applicator according to one or more embodiments.

[0126] Fig.36A and Fig.36B According to one or more embodiments Fig.35B The three-dimensional view and top view of the cap column.

[0127] Fig.37 is a cross-sectional side view of a sensor control device positioned within an applicator cap according to one or more embodiments.

[0128] Fig.38A is a cross-sectional view of a sensor control device showing an exemplary interaction between a sensor and a sharp object.

[0129] Fig.38B is a cross-sectional side view of a sharp hub, sharp object, and sensor in accordance with the disclosed subject matter, with the sensor in an unbiased position.

[0130] Fig.38C is a cross-sectional side view of a sharp hub, sharp object, and sensor in accordance with the disclosed subject matter, with the sensor in a biased position.

[0131] Fig.38D is a close-up of a portion of a sharp object in accordance with the disclosed subject matter.

[0132] FIG. 39A to FIG. 39F A cross-sectional view depicting an exemplary embodiment of an applicator during a deployment phase is shown.

[0133] FIG. 40A to FIG. 40D It is a structural diagram of the close-fitting sub-assembly.

[0134] Fig.40E is a three-dimensional image of a complete body-worn electronic device subassembly.

[0135] FIG. 41A to FIG. 41D Shows the Fig.40E The components in the process of co-molding / overmolding.

[0136] FIG. 42A to FIG. 42C Is has Fig.40E Assembly and cross-sectional views of alternative snap-fit ​​methods for components in FIG.

[0137] Fig.43A Is has Fig.40E Cross-sectional view of an alternative ultrasonic welding method for an assembly in FIG.

[0138] Fig.43B is a flow chart of a method for constructing an analyte monitoring system using ultrasonic welding.

[0139] Fig.43C Shown are the types of joints that may be used to join the housing and the support at the joining interface.

[0140] FIG. 44A to FIG. 44B is a stereogram showing the production process Fig.44C The adhesive backing is applied when the final body-fitting device is ready for use as shown in the assembly diagram.

[0141] FIG. 45A to FIG. 45D is a cross-sectional view of a body-fitting component having an elastomeric seal compressed between an outer shell and a support of the body-fitting component.

[0142] Figures 45E to 45F is a cross-sectional view of a body-fitting component having an elastomeric seal compressed within a raceway formed by an outer shell and a seat of the body-fitting component.

[0143] Figure 45G to Figure 45I are assembly and cross-sectional views of an on-body assembly having an in-place dispensed elastomeric seal compressed around the sensor and between the housing and a mount of the on-body assembly.

[0144] Fig.46A and FIG. 46C to FIG. 46Dis a cross-sectional and exploded view of a body-fitting component having a resilient seal compressed within an interior space formed by an outer shell and a seat of the body-fitting component.

[0145] Fig.46B Depicted Fig.46A and FIG. 46C to FIG. 46D Different configurations of the elastic seal of the body-fitting component depicted in .

[0146] Fig.47 Exemplary perspective views of elastomeric seals in accordance with the disclosed subject matter are provided.

[0147] FIG. 48A to FIG. 48D is a cross-sectional view of an exemplary sensor cap assembly including a cap having a collimator configured to seal an on-body unit during sterilization. DETAILED DESCRIPTION

[0148] Before describing the present subject matter in detail, it should be understood that the present disclosure is not limited to the particular embodiments described, as such may of course vary. It should also be understood that the terminology used herein is only for the purpose of describing particular embodiments and is not intended to be limiting, as the scope of the present disclosure will be limited only by the appended claims.

[0149] As used herein and in the appended claims, the singular forms "a," "an," and "the" include plural references unless the context clearly dictates otherwise.

[0150] The publications discussed herein are only used to be disclosed before the filing date of the present application. Anything herein should not be construed as admitting that the present disclosure is not entitled to be published in advance by virtue of a previous disclosure. In addition, the publication date provided may be different from the actual publication date, which may require independent confirmation.

[0151] Generally, embodiments of the present disclosure include systems, devices and methods for inserting an analyte sensor for use with an in vivo analyte monitoring system into an applicator. The applicator can be provided to a user in a sterile package, wherein the electronic device housing of the sensor control device is included. According to some embodiments, a structure (such as a container) separated from the applicator can also be provided to the user as a sterile package, wherein the sensor module and the sharp object module are included. The user can couple the sensor module to the electronic device housing, and the sharp object can be coupled to the applicator through an assembly process, which involves inserting the applicator into the container in a particular manner. In other embodiments, the applicator, the sensor control device, the sensor module and the sharp object module can be arranged in a single package. The applicator can be used to position the sensor control device on the human body, wherein the sensor contacts the body fluids of the wearer. The embodiments provided herein are improvements for reducing the possibility of the sensor being improperly inserted or damaged or causing adverse physiological reactions. Other improvements and advantages are also provided. Various configurations of these devices are described in detail by embodiments that are merely examples.

[0152] In addition, many embodiments include an in vivo analyte sensor that is structurally configured such that at least a portion of the sensor is or can be positioned in the body of a user to obtain information about at least one analyte of the body. However, it should be noted that the embodiments disclosed herein can be used with in vivo analyte monitoring systems that incorporate in vitro capabilities as well as purely in vitro or ex vivo analyte monitoring systems (including completely non-invasive systems).

[0153] In addition, for each embodiment of the method disclosed herein, systems and devices capable of executing each of these embodiments are covered within the scope of the present disclosure. For example, embodiments of sensor control devices are disclosed, and these devices may have one or more sensors, analyte monitoring circuits (e.g., analog circuits), memories (e.g., for storing instructions), power supplies, communication circuits, transmitters, receivers, processors, and / or controllers (e.g., for executing instructions), which may perform any and all method steps or facilitate the execution of any and all method steps. These sensor control device embodiments may be used and can be used to implement those steps performed by the sensor control device according to any and all methods described herein.

[0154] As described above, multiple embodiments of systems, devices, and methods are described herein, which provide improved assembly and use of dermal sensor insertion devices for use with in vivo analyte monitoring systems. Specifically, several embodiments of the present disclosure are designed to improve sensor insertion methods for in vivo analyte monitoring systems, and specifically prevent premature retraction of inserted sharps during the sensor insertion process. For example, some embodiments include dermal sensor insertion mechanisms with increased firing speed and delayed sharp retraction. In other embodiments, the sharp retraction mechanism can be motion-actuated so that the sharp will not retract before the user pulls the applicator away from the skin. Therefore, these embodiments can reduce the possibility of premature withdrawal of inserted sharps during the sensor insertion process; reduce the possibility of improper sensor insertion; and reduce the possibility of damaging the sensor during the sensor insertion process, just to name a few advantages. Several embodiments of the present disclosure also provide improved insertion sharps modules to address the problem of small dermal sensors and relatively shallow insertion paths present in the dermis of a subject. In addition, several embodiments of the present disclosure are designed to prevent undesirable axial and / or rotational movement of applicator components during sensor insertion. Thus, these embodiments can reduce the likelihood of unstable positioned dermal sensors, irritation at the insertion site, damage to surrounding tissue, and capillary rupture leading to contamination of skin fluid with blood, to name a few advantages. Additionally, to mitigate inaccurate sensor readings that may be caused by trauma at the insertion site, several embodiments of the present disclosure can reduce the distal penetration depth of the needle relative to the sensor tip during insertion.

[0155] However, before describing these aspects of the embodiments in detail, it is first desirable to describe examples of devices that may be present, for example, within an in vivo analyte monitoring system, as well as examples of their operation, all of which may be used with the embodiments described herein.

[0156] There are various types of in vivo analyte monitoring systems. For example, a "continuous analyte monitoring" system (or "continuous glucose monitoring" system) can continuously transmit data from a sensor control device to a reader device without prompting (e.g., automatically according to a schedule). As another example, a "transient analyte monitoring" system (or "transient glucose monitoring" system or simply "transient" system) can respond to a scan or data request from a reader device, such as by near field communication (NFC) or radio frequency identification (RFID) protocol, to transmit data from a sensor control device. In vivo analyte monitoring systems can also operate without the need for fingertip calibration.

[0157] In vivo analyte monitoring systems can be distinguished from "in vitro" systems that contact a biological sample outside the body (or "ex vivo") and generally include a meter assembly having a port for receiving an analyte test strip carrying a user's bodily fluid, which can be analyzed to determine the user's blood glucose level.

[0158] The in-vivo monitoring system may include a sensor that contacts the user's bodily fluids when positioned in the body and senses the analyte level contained therein. The sensor may be part of a sensor control device located on the user's body and may include an electronic device and a power supply that enable and control analyte sensing. The sensor control device and its variants may also be referred to as a "sensor control unit," "on-body electronic device" device or unit, "on-body" device or unit, or "sensor data communication" device or unit, to name a few.

[0159] The in vivo monitoring system may also include a device that receives sensed analyte data from the sensor control device and processes and / or displays the sensed analyte data to the user in any number of forms. The device and its variants 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) have also been used with or incorporated into in vivo and in vitro monitoring systems.

[0160] Exemplary In Vivo Analyte Monitoring Systems

[0161] Figure 1 1 is a conceptual diagram depicting an exemplary embodiment of an analyte monitoring system 100, which includes a sensor applicator 150, a sensor control device 102, and a reader device 120. Here, the sensor applicator 150 can be used to deliver the sensor control device 102 to a monitoring location on the user's skin, where the sensor 104 is held in place for a period of time by an adhesive patch 105. Figure 2B and Figure 2C 1 and may communicate with the reader device 120 via a communication path 140 using wired or wireless technology. Exemplary wireless protocols include Bluetooth, Bluetooth Low Energy (BLE, BTLE, Bluetooth SMART, etc.), near field communication (NFC), etc. A user may use screen 122 and input 121 to monitor applications installed in memory on the reader device 120, and may use power port 123 to recharge the device battery. More details about the reader device 120 are provided below in connection with Figure 2A 141. The reader device 120 may communicate with the local computer system 170 via a communication path 141 using wired or wireless technology. The local computer system 170 may include one or more of a laptop, desktop, tablet computer, flat-panel TV, smart phone, set-top box, video game console, or other computing device, and the wireless communication may include any of a plurality of applicable wireless networking protocols including Bluetooth, Bluetooth Low Energy (BTLE), Wi-Fi, or others. The local computer system 170 may communicate with the network 190 via a communication path 143, similar to the manner in which the reader device 120 may communicate with the network 190 via a communication path 142 as previously described by wired or wireless technology. The network 190 may be any of many networks such as private and public networks, local area networks, or wide area networks. The trusted computer system 180 may include a server and may provide authentication services and secure data storage, and may communicate with the network 190 via a communication path 144 by wired or wireless technology.

[0162] Exemplary Reader Devices

[0163] Figure 2A 1 is a block diagram depicting an exemplary embodiment of a reader device configured as a smartphone. Here, the reader device 120 may include a display 122, an input component 121, and a processing core 206, which includes a communication processor 222 coupled to a memory 223 and an application processor 224 coupled to a memory 225. A separate memory 230, an RF transceiver 228 with an antenna 229, and a power supply 226 with a power management module 238 may also be included. A multi-function transceiver 232 may also be included, which may communicate with the antenna 234 via Wi-Fi, NFC, Bluetooth, BTLE, and GPS. As will be appreciated by those skilled in the art, these components are electrically and communicatively coupled in a manner to form a functional device.

[0164] Exemplary Sensor Control Device

[0165] Figure 2B and Figure 2C is a block diagram depicting an exemplary embodiment of a sensor control device 102 having an analyte sensor 104 and sensor electronics 160 (including analyte monitoring circuitry) which may have most of the processing capabilities for presenting final result data suitable for display to a user. Figure 2B, a single semiconductor chip 161 is depicted, which may be a customized application specific integrated circuit (ASIC). Shown within ASIC 161 are certain advanced functional units, 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, a receiver, a transceiver, a passive circuit, or otherwise implemented according to a communication protocol). In this embodiment, both AFE 162 and processor 166 are used as analyte monitoring circuits, but in other embodiments either circuit may perform analyte monitoring functions. Processor 166 may include one or more processors, microprocessors, controllers, and / or microcontrollers, each of which may be a discrete chip or distributed between multiple different chips (and portions thereof).

[0166] Memory 163 is also included in ASIC 161 and may be shared by various functional units present in ASIC 161, or may be distributed between two or more functional units therein. Memory 163 may also be a separate chip. Memory 163 may be volatile and / or non-volatile memory. In this embodiment, ASIC 161 is coupled to power supply 170, which may be a button cell battery, etc. AFE 162 interfaces with in vivo analyte sensor 104 and receives measurement data therefrom, and outputs the data in digital form to processor 166, which in turn processes the data to derive final results such as glucose discrete values ​​and trend values. The data may then be provided to communication circuit 168 for transmission to reader device 120 (not shown) via antenna 171, for example, where a resident software application requires minimal further processing to display the data in the data receiving device.

[0167] Figure 2C Similar to Figure 2B , but instead includes two discrete semiconductor chips 162 and 174, which can be packaged together or separately. Here, AFE 162 resides on ASIC 161. Processor 166 is integrated with power management circuit 164 and communication circuit 168 on chip 174. AFE 162 includes memory 163, and chip 174 includes memory 165, which can be isolated or distributed therein. In one exemplary embodiment, AFE 162 is combined with power management circuit 164 and processor 166 on one chip, while communication circuit 168 is on a separate chip. In another exemplary embodiment, both AFE 162 and communication circuit 168 are on one chip, and processor 166 and power management circuit 164 are on another chip. It should be noted that other chip combinations are also possible, including three or more chips, each chip assuming responsibility for the individual functions described, or sharing one or more functions to achieve fail-safe redundancy.

[0168] Exemplary Assembly Process for a Sensor Control Device

[0169] The components of the sensor control device 102 may be obtained by the user in a variety of packages that require final assembly by the user before delivery to the appropriate user location. FIG. 3A to FIG. 3D An exemplary embodiment of an assembly process for the sensor control device 102 performed by a user is depicted, including preparing the individual components prior to coupling the components in order to prepare the sensor for delivery. FIG. 3E to FIG. 3F An exemplary embodiment is depicted in which the sensor control device 102 is delivered to the appropriate user location by selecting an appropriate delivery location and applying the device 102 to that location.

[0170] Figure 3A 810 for the assembly process, the container is here configured as a tray (although other packaging can be used). The user can complete this preparation by removing the cover 812 from the tray 810 to expose the platform 808 (e.g., by peeling the unadhered portion of the cover 812 from the tray 810 so that the adhered portion of the cover 812 is removed). Removal of the cover 812 is appropriate in various embodiments as long as the platform 808 is fully exposed within the tray 810. The cover 812 can then be set aside.

[0171] Figure 3B 704. FIG. 705 is a side view of an exemplary embodiment depicting a user preparing the applicator device 150 for assembly. The applicator device 150 may be provided in a sterile package sealed by a cap 708. Preparation of the applicator device 150 may include decoupling the housing 702 from the cap 708 to expose the sheath 704 ( Figure 3C ). This can be accomplished by unscrewing (or otherwise decoupling) the cap 708 from the housing 702. The cap 708 can then be set aside.

[0172] Figure 3C 810 is a proximal perspective view of an exemplary embodiment depicting a user inserting the applicator device 150 into the tray 810 during assembly. Initially, after aligning the housing orientation feature 1302 (or slot or recess) and the tray orientation feature 924 (abutment or detent), the user can insert the sheath 704 into the platform 808 within the tray 810. Inserting the sheath 704 into the platform 808 temporarily unlocks the sheath 704 relative to the housing 702, and also temporarily unlocks the platform 808 relative to the tray 810. At this stage, removing the applicator device 150 from the tray 810 will result in the same state before the applicator device 150 was initially inserted into the tray 810 (i.e., the process can be reversed or aborted at this point and then repeated without consequence).

[0173] The sheath 704 can be held in position relative to the housing 702 within the platform 808 as the housing 702 is advanced distally, coupled to the platform 808 to push the platform 808 distally relative to the tray 810. This step unlocks the platform 808 within the tray 810 and collapses it. The sheath 704 can contact and disengage a locking feature (not shown) within the tray 810 that unlocks the sheath 704 relative to the housing 702 and prevents the sheath 704 from (relatively) moving as the housing 702 continues to advance the platform 808 distally. At the end of advancement of the housing 702 and the platform 808, the sheath 704 is permanently unlocked relative to the housing 702. The sharps and sensors (not shown) within the tray 810 can be coupled to the electronic device housing (not shown) within the housing 702 at the end of the distal advancement of the housing 702. The operation and interaction of the applicator device 150 and the tray 810 are further described below.

[0174] Figure 3D 810 is a proximal perspective view of an exemplary embodiment depicting a user removing the applicator assembly 150 from the tray 810 during assembly. The user may remove the applicator 150 from the tray 810 by advancing the housing 702 proximally relative to the tray 810 or other motion having the same effect as decoupling the ends of the applicator 150 and the tray 810. The applicator assembly 150 is removed with the sensor control assembly 102 (not shown) (sharp, sensor, electronics) fully assembled therein and positioned for delivery.

[0175] Figure 3E is a proximal perspective view of an exemplary embodiment depicting a patient applying the sensor control device 102 to a target area of ​​skin (e.g., on the abdomen or other appropriate location) using the applicator device 150. The housing 702 is advanced distally to collapse the sheath 704 within the housing 702 and apply the sensor to the target location such that the adhesive layer on the bottom side of the sensor control device 102 adheres to the skin. When the housing 702 is fully advanced, the sharps are automatically retracted while the sensor (not shown) remains in place to measure the analyte level.

[0176] Figure 3F is a proximal perspective view of an exemplary embodiment depicting a patient with the sensor control device 102 in an applied position. The user may then remove the applicator 150 from the application site.

[0177] Compared with the prior art systems, FIG. 3A to FIG. 3FThe system 100 described elsewhere herein can provide a method of reducing or eliminating the possibility of accidental breakage, permanent deformation, or improper assembly of applicator components. Since the applicator housing 702 directly engages the platform 808 when the sheath 704 is unlocked, rather than indirectly engaging via the sheath 704, the relative angle between the sheath 704 and the housing 702 will not cause breakage or permanent deformation of the arms or other components. The possibility of relatively high forces during assembly (such as in conventional devices) will be reduced, which in turn reduces the possibility of unsuccessful assembly by the user.

[0178] Exemplary Sensor Applicator Devices

[0179] Figure 4A is a side view depicting an exemplary embodiment of an applicator device 150 coupled with a screw-on cap 708. This is an example of how the applicator 150 may be shipped to and received by a user prior to the user assembling it with a sensor. Figure 4B is a side perspective view depicting the applicator 150 and cap 708 after decoupling. Figure 4C is a perspective view of an exemplary embodiment depicting the distal end of applicator device 150 with electronics housing 706 and adhesive patch 105 removed from their positions within sensor carrier 710 where they would be retained in sheath 704 when cap 708 is in place.

[0180] For purposes of illustration and not limitation, reference is made to Figures 4D to 4G , the applicator device 20150 can be provided to the user as a single integrated component. Figure 4D and Figure 4E A perspective top view and a bottom view of the applicator device 20150 are provided, respectively. Figure 4F An exploded view of the applicator assembly 20150 is provided, and Figure 4GA side cutaway view is provided. A perspective view shows how the applicator 20150 is delivered to and received by a user. The exploded view and cutaway view show the components of the applicator device 20150. The applicator device 20150 may include a housing 20702, a gasket 20701, a sheath 20704, a sharp object carrier 201102, a spring 205612, a sensor carrier 20710 (also referred to as a "disc carrier"), a sharp hub 205014, a sensor control device (also referred to as a "disc") 20102, an adhesive patch 20105, a desiccant 20502, a cap 20708, a serial label 20709, and an anti-tamper feature 20712. When received by a user, only the housing 20702, the cap 20708, the anti-tamper feature 20712, and the label 20709 are visible. The tamper-proof feature 20712 can be, for example, a sticker coupled to each of the housing 20702 and the cap 20708, and the tamper-proof feature 20712 can be irreparably damaged, for example, by uncoupling the housing 20702 from the cap 20708, thereby indicating to the user that the housing 20702 and the cap 20708 have been previously uncoupled. These features will be described in more detail below.

[0181] Exemplary Tray and Sensor Module Assemblies

[0182] Figure 5 8 is a proximal perspective view depicting an exemplary embodiment of a tray 810 with a sterilization cap 812 removably coupled to the tray, which may represent how a package may be shipped to and received by a user prior to assembly.

[0183] Fig. 6A 810 is a perspective cutaway view of a sensor delivery component depicting the sensor delivery component within the tray 810. The platform 808 is slidably coupled within the tray 810. The desiccant 502 is stationary relative to the tray 810. The sensor module 504 is mounted within the tray 810.

[0184] Figure 6B is a proximal perspective view depicting the sensor module 504 in greater detail. Here, the retaining 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 with the sensor module 504 during assembly.

[0185] Exemplary Applicator Housing and Cap

[0186] Fig. 7Ais a side view depicting an exemplary embodiment of an applicator housing 702, which may include an internal cavity having a support structure for the applicator function. The user can push the housing 702 in the distal direction to start the applicator assembly process, and then can also deliver the sensor control device 102, after which the cavity of the housing 702 can act as a receiver for sharp objects. In an exemplary embodiment, various features are shown, including a housing orientation feature 1302 for orienting the device during assembly and use. The tamper-proof ring groove 1304 can be a recess located around the periphery of the housing 702, distal to the tamper-proof ring protector 1314 and proximal to the tamper-proof ring retainer 1306. The tamper-proof ring groove 1304 can hold the tamper-proof ring so that the user can identify whether the device has been tampered with or otherwise used. By aligning with the complementary cap thread and rotating in a clockwise or counterclockwise direction, the housing thread 1310 can secure the housing 702 to the complementary thread on the cap 708 ( Figure 4A and Figure 4B ). The side gripping areas 1316 of the housing 702 can provide an outer surface location where a user can grip the housing 702 to use it. The gripping overhang 1318 is a slightly raised ridge relative to the side gripping areas 1316, which can help to easily remove the housing 702 from the cap 708. The shark teeth 1320 can be a raised section with a flat side located on the clockwise edge to shear off the tamper-proof ring (not shown) and hold the tamper-proof ring in place after the user unscrews the cap 708 and housing 702. In the exemplary embodiment, four shark teeth 1320 are used, but more or fewer can be used as needed.

[0187] Figure 7B is a perspective view depicting the distal end of the housing 702. Here, three housing guide structures (or "guide ribs") 1321 are at 120 degree angles to each other and at 60 degree angles to a locking structure (or "locking rib") 1340, three of which are also at 120 degree angles to each other. Other angular orientations, symmetrical or asymmetrical, and any number of one or more structures 1321 and 1340 may be used. Here, each structure 1321 and 1340 is configured as a planar rib, but other shapes may also be used. Each guide rib 1321 includes a guide edge (also called a "sheath guide") 1326 that can be extended along a surface of the sheath 704 (e.g., about Fig. 8A The insertion hard stop 1322 may be a flat, distally facing surface of the housing guide rib 1321 located near the proximal end of the housing guide rib 1321. The insertion hard stop 1322 is a guide rail 1418 as described above. Figure 8B) provides a surface for abutment during use to prevent further movement of the sensor carrier travel limiter surface 1420 in the proximal direction. During assembly, the carrier interface post 1327 passes through the opening 1510 ( Fig. 9A ). The sensor carrier interface 1328 can be a rounded, distally facing surface of the housing guide rib 1321 that interfaces with the sensor carrier 710.

[0188] Figure 7C 1 is a side cross-sectional view depicting an exemplary embodiment of the housing. In the exemplary embodiment, a side cross-sectional profile of the housing guide rib 1321 and the locking rib 1340 is shown. The locking rib 1340 includes a sheath snap-in feature 1330 near the distal end of the locking rib 1340 that flares outwardly from the central axis 1346 of the housing 702. Figure 8C As shown, when the sheath 704 moves toward the proximal end of the housing 702, each sheath buckle introduction feature 1330 causes the pawl buckle circle 1404 of the pawl buckle 1402 of the sheath 704 to bend inward toward the central axis 1346. Once passing the distal point of the sheath buckle introduction feature 1330, the pawl buckle 1402 of the sheath 704 is locked in place in the locking groove 1332. Therefore, due to the surface having a plane that is nearly perpendicular to the central axis 1346, the pawl buckle 1402 cannot easily move in the distal direction, as shown in FIG. Figure 8C As shown in the ratchet buckle plane 1406.

[0189] As the housing 702 moves further in the distal direction toward the skin surface, and as the sheath 704 is advanced toward the proximal end of the housing 702, the pawl catch 1402 moves into the unlocking groove 1334, and the applicator 150 is in the "armed" position, ready for use. As the user further applies force to the proximal end of the housing 702 while the sheath 704 is pressed against the skin, the pawl catch 1402 passes over the firing pawl 1344. This initiates the firing sequence (e.g., as described with respect to FIG. 1 ) due to the release of the energy stored in the deflected pawl catch 1402. FIG. 12A to FIG. 12D), the pawl buckle travels in the proximal direction relative to the skin surface toward the sheath stop ramp 1338, which is slightly flared relative to the central axis 1346 and slows the movement of the sheath 704 during the firing sequence. After unlocking the groove 1334, the next groove encountered by the pawl buckle 1402 is the final locking groove 1336, which the pawl buckle 1402 enters at the end of the stroke or push sequence performed by the user. The final locking recess 1336 can be a proximally facing surface perpendicular to the central axis 1346, which engages the pawl buckle flat surface 1406 after the pawl buckle 1402 passes and prevents reuse of the device by firmly holding the sheath 704 in the appropriate position relative to the housing 702. The insertion hard stop 1322 of the housing guide rib 1321 prevents the sheath 704 from being advanced proximally relative to the housing 702 by engaging the sensor carrier travel limiter surface 1420.

[0190] Fig.7D and Fig. 7E 702 is a close-up side view of an exemplary embodiment of locking rib 1340 of applicator housing 702 as detent catch 1402 of sheath 704 is moved toward the proximal end of housing 702 . Fig.7D The sheath 704 is shown in a "locked" state, wherein the pawl circle 1404 of the pawl buckle 1402 has passed the sheath buckle introduction feature 1330 and is located in the locking groove 1332 of the locking rib 1340. When force is applied to the proximal end of the housing 702, the pawl circle 1404 is pushed proximally into the unlocking groove 1334, placing the applicator 150 in the "armed" position. When force is further applied to the proximal end of the housing 702, the applicator 150 is "fired" because the pawl circle 1404 is pushed proximally from the unlocking groove 1334 and passes the firing pawl 1344. Thereafter, the sheath 704 is further pushed proximally, causing the pawl circle 1404 to slidably advance over the firing surface 1337, as shown in FIG. Fig. 7E In this embodiment, the firing surface 1337 is substantially parallel to the central axis 1346. As the sheath 704 continues to be advanced proximally, the detent circle 1404 reaches the sheath stop ramp 1338, which slows the movement of the sheath 704. When the detent circle 1404 reaches the final locking recess 1336, the detent snap flat surface 1406 (not shown) is engaged and securely holds the sheath 704 in place relative to the housing 702.

[0191] Figure 7F and Figure 7G23 is a close-up side view of an alternative embodiment of a locking rib 2340 designed to increase the firing speed of the sharp object of the sensor applicator. Here, the locking rib 2340 includes an inward detent ramp 2335 to reduce friction between the sheath 704 and the housing 2702 during firing. The locking rib 2340 also includes a sheath stop ramp 2338 located proximal to the firing surface 2337. Figure 7F , the sheath 704 is initially shown in a "locked" state, wherein the detent circle 1404 of the detent buckle 1402 has passed the sheath buckle introduction feature 2330 and is located in the locking groove 2332. When force is applied to the proximal end of the housing 2702, the detent circle 1404 advances into the unlocking groove 2334, placing the applicator 150 in the "armed" position. When force is further applied to the proximal end of the housing 2702, the applicator 150 is "fired" because the detent circle 1404 passes the firing detent 2344.

[0192] like Figure 7G As shown, the detent circle 1404 is then advanced toward the proximal end of the housing 2702 in a "free flight" state, wherein the detent circle 1404 passes over the inward detent ramp 2335. When advancing proximally in the "free flight" state, the detent circle 1404 may not continuously or not contact the inward detent ramp 2335 and the firing surface 2337. In this regard, the detent circle 1404 can be easily and quickly advanced because there is little friction between the detent circle 1404 and the inward detent ramp 2335 and the firing surface 2337, thereby increasing the firing speed of the sharp object from the applicator. Fig.7D and Fig. 7E In the illustrated embodiment, a sheath stop ramp 2338 positioned proximally along the locking rib 2340 provides an edge portion to frictionally engage the detent circle 1404 and slow the movement of the sheath 704. The sheath stop ramp 2338 can have an inclined shape and provide increased frictional contact as the detent circle 1404 is advanced in the proximal direction. Finally, when the detent circle 1404 reaches the final locking recess 2336, the detent snap flat surface 1406 (not shown) is engaged and the sheath 704 is securely held in place relative to the housing 2702. The locking recess 2336 prevents the detent circle 1404 and the sheath 704 from moving rearwardly or distally. Fig.7D and Fig. 7E This embodiment reflects a higher firing speed than the embodiment depicted in , which also helps prevent premature withdrawal of the sharp object.

[0193] Figure 7H6340, which is designed to maintain a downward force on the sheath 6704 during firing, which in turn can prevent unwanted movement of the sheath 6704 during the sensor insertion process. Here, the sheath 6704 is shown in a "locked" state, wherein the detent circle 6404 of the detent buckle 6402 is located in the locking groove 6332. When force is applied to the proximal end of the housing 6702, the detent circle 6404 advances into the unlocking groove 6334, placing the applicator in the "armed" position. When force is further applied to the proximal end of the housing 6702, the applicator is "fired" and the detent circle 6404 advances toward the proximal end of the housing 6702 over the inclined firing surface 6338. The inclined firing surface 6338 can be inclined toward the central axis 1346 so that as the detent circle 6404 advances in the proximal direction, the downward force generated on the sheath 6704 increases. In the depicted embodiment, the detent circle 6404 is in constant contact with the inclined firing surface 6338. The locking recess 6336 prevents the detent circle 6404 and the sheath 6704 from moving rearwardly or distally. This embodiment reflects a slower firing speed relative to the previously described embodiments and can be used in conjunction with, for example, FIG. 14A to FIG. 1 4C and FIG. 15A to FIG. 15B The described motion-actuated sharp object retraction process is used in conjunction with.

[0194] Fig.7I 7336, which is a close-up side view of yet another alternative embodiment of the locking rib 7340, which is also designed to maintain a downward force on the sheath 6704 during firing, which in turn can prevent undesired movement of the sheath 6704 during the sensor insertion process. Here, the sheath 6704 is shown in a "fired" state, wherein the detent circle 6404 of the detent buckle 6402 is located in the two-way locking recess 7336. When the detent circle 6404 is advanced into the two-way locking recess 7336, the sheath 6704 can be prevented from further movement in the proximal or distal direction. This can reduce undesired movement of the sheath 6704 during the sensor insertion process. Additionally, in some embodiments, such as with respect to FIG. 14A to FIG. 1 4C and FIG. 15A to FIG. 15B As described, the bi-directional locking recess 7336 can provide for securing the sheath 6704 during the motion-activated sharp object retraction process. Fig.7I As can be seen in the figure, the inclined firing surface 7338 is angled toward the central axis 1346 so that as the pawl circle 6404 is advanced in the proximal direction, the downward force generated on the sheath 6704 increases. In the depicted embodiment, the pawl circle 6404 is in constant contact with the inclined firing surface 7338. This embodiment reflects a slower firing speed and can be used in conjunction with, for example, FIG. 14A to FIG. 1 4C and FIG. 15A to FIG. 15B The described motion-actuated sharp object retraction process is used in conjunction with.

[0195] refer to Figures 7J to 7L , for purposes of illustration and not limitation, a housing 20702 according to the disclosed subject matter is provided. The housing 20702 may be made of cyclic olefin copolymer or other suitable material, such as polycarbonate or high-density polyethylene (HDPE). The housing 20702 may include one or more features described herein with respect to the housing, wherein similar features may operate as described herein. For example, the housing 20702 may include a grip overhang 20702A that enables a user to securely grip the housing 20702. The housing 20702 may have additional grip overhangs 20702A, for example, two grip overhangs 20702A located on opposite sides of the housing 20702. The housing 20702 may include a side grip area 20702B disposed below the grip overhang 20702A. The side grip area 20702B may be textured to improve the user's grip. The housing 20702 can have additional side grip areas 20702B, for example, two side grip areas 20702B on opposite sides of the housing 20702, each side grip area being disposed below the grip overhang 20702A.

[0196] The housing 20702 can include a housing skirt 20702C that can provide a surface for the tamper-proof feature 20712. The housing skirt 20702C can be supported by a plurality of skirt reinforcing ribs 20702D. The skirt reinforcing ribs 20702D can provide support for the housing skirt 20702C and can help protect the applicator device 20150 during an impact event, such as a drop. In addition, the skirt reinforcing ribs 20702D can be used to support the housing 20702 during manufacturing. The housing skirt 20702C and the skirt reinforcing ribs 20702D can provide rigidity against gasket compression forces and can help keep the gasket 20701 compressed during shelf life. The housing 20702 can include a gasket retaining ring 20702E and a plurality of gasket retaining pockets 20702F that can retain the gasket 20701 relative to the housing 20702. For example, the gasket retaining ring 20702E can prevent lateral movement of the gasket 20701, and the gasket retaining recess 20702E can prevent rotation of the gasket 20701. The housing 20702 can include a plurality of gasket retaining recesses, for example, 14 gasket retaining recesses 20702E. The gasket sealing surface 20702N can seal the gasket 20701. The housing 20702 can additionally or alternatively have an applicator cap sealing lip 20702U, which can interface with the cap 20708, as described in more detail below. The housing 20702 can have an inner surface 20702T that can receive the sheath 20704.

[0197] The housing 20702 may include threads 20702G configured to engage with threads 20708D disposed on the cap 20708. The threads may include radial restriction features 20702H that may limit radial deformation of the cap 20702G during an impact event, such as a drop. The housing 20702 may include a plurality of radial restriction features 20702H, for example, six radial restriction structures 20702H. The radial restriction features 20702H may be protrusions on the housing and may close a gap with threads 20708D disposed on the cap 20708. This may limit elliptical deformation of the cap 20702H during an impact event, such as a drop. Preventing the oval deformation of the cap 20702H can in turn ensure that the locking arms 20704J of the sheath 20704 remain locked between the cap 20702 and the sensor carrier 20710 to limit the movement of the sheath 20704 before the cap 20702H is removed (as described in more detail below). The housing 20702 can also include a clearance notch 20702I for providing clearance for the sheath arms during firing.

[0198] The interior of the housing 20702 may include a plurality of sensor carrier attachment features for receiving, aligning, and limiting the movement of the sensor carrier 20710. For example, the housing 20703 may include a sheath guide 20702J, which may help align and guide the sheath 20704 as it moves relative to the housing 20702. The housing 20702 may include a sensor carrier attachment slot 20702K that may engage and retain the sensor carrier 20710, and a sensor carrier hard stop 20702L that may limit the axial movement of the sensor carrier 20710 relative to the housing 20702. The housing 20702 may include a sensor carrier biasing feature 20702M that may remove a ramp between the sensor carrier 20710 and the housing 20702 after assembly, and a sensor carrier radial limiting feature 20702O that may maintain radial alignment of the sensor carrier relative to the housing 20702. The flat horizontal surface between the sensor carrier attachment slot 20702K and the sensor carrier radial limiting feature 20702O can be used to stop the sheath 20704 at the end of the stroke. Corresponding features on the sheath 20704 can interact with these surfaces. The sensor carrier biasing feature 20702M can further limit the rotation of the sensor carrier 20710 relative to the housing 20702. The housing 20702 can include one or more of the sheath guide rail 20702J, the sensor carrier attachment slot 20702K, the sensor carrier hard stop 20702L, the sensor carrier radial limiting feature 20702O, and the sensor carrier biasing feature 20702M, for example, three of each.

[0199] The interior of the housing 20702 may also include a plurality of sheath ribs 20702S for engaging the sheath 20704 for insertion, as described herein. The housing 20702 may include one or more, for example, three, of the sheath ribs 20702S. Each sheath rib 20702S may include a sheath buckle introduction feature 20702P that is configured to initially introduce the pawl buckle 20704A of the sheath 20704 into the correct position. The housing 20702 may include a firing pawl 20702Q. After the pawl buckle 20704A of the sheath 20704 passes through the firing pawl 20702Q, the firing sequence may be initiated, and the sheath 20704 may advance toward the sheath stop ramp 20702R. The sheath stop ramp 20702 may slow down the sheath 20704 at the end of firing.

[0200] For illustrative purposes, refer to Figure 7M to Figure 7Q and Figures 7S to 7X , an exemplary cap 20708 is provided. The cap 20708 may include one or more features described herein regarding the cap, wherein similar features may operate as described herein. The cap 20708 may be made of high-density polyethylene (HDPE) or any other suitable material, such as polypropylene or low-density polyethylene (LDPE). The cap 20708 may include a label surface 20708A configured to receive a label 20709. The cap 20708 may include a rib 20708B that may provide strength and provide an improved gripping surface for the user. The cap 20708 may include a tamper-proof label ring 20708C that may receive an anti-tamper feature 20712. The cap 20708 may also include a gasket sealing surface 20708G configured to engage the gasket 20701.

[0201] Internally, the cap 20708 can include threads 20708D that can engage threads 20702G disposed on the housing 20702. The cap 20708 can also include a sealing interface 20708E that can be configured to receive an applicator cap sealing lip 20702U to form a seal between the housing 20702 and the cap 20708.

[0202] Figure 7S to Figure 7VAn enlarged cross-sectional side view of the interface between the housing 20702 and the cap 20708 is shown. As shown, the applicator cap sealing lip 20702U of the housing 20702 includes a first axial extension 2002a, and the sealing interface 20708E of the cap 20708 provides a cavity 2002d that can mate with the first axial extension 2002a. In the illustrated embodiment, the diameter of the cavity 2002d formed by the second axial extension 2002b and the third axial extension 2002c of the cap 20708 is sized to receive the diameter of the first axial extension 2002a of the housing 20702 within the cavity 2002d. For example, as shown in FIG. Figure 7U As shown, the axial extension 2002a can have a thickness D1 at a height H1 as measured from the distal edge of the axial extension 2002a. Similarly, the second axial extension 2002c can have a thickness D5 at a height H3 as measured from the proximal edge of the cap 20708; the cavity 2002d can have thicknesses D2, D3, and D4 at heights H2, H3, and H4, respectively, as measured from the proximal edge of the cap 20708. In some embodiments, D1 can measure 1 mm with a tolerance of + / - 0.03 mm, D2, D3, and D4 can have any suitable dimensions, H1 can measure 1.66 mm with a tolerance of + / - 0.1 mm, H2 can measure 8.25 mm with a tolerance of + / - 0.1 mm, H3 can measure 9.25 mm with a tolerance of + / - 0.1 mm, and H4 can measure 9.75 mm with a tolerance of + / - 0.1 mm. However, in other embodiments, the opposite approach may be employed, wherein the diameter of the first axial extension 2002a may be sized to receive the diameter of the second axial extension 2002b without departing from the scope of the present disclosure.

[0203] In each embodiment, two radial seals 2004, 2006 may be defined or otherwise provided at the interface between the first axial extension 2002a and the second axial extension 2002b, and the radial seals 2004 and 2006 may help prevent fluid or contaminants from migrating across the interface in either axial direction. In addition, the dual radial seals described herein may accommodate tolerances and thermal variations and stress relaxation via redundant sealing strategies. In the illustrated embodiment, the dual radial seals 2004, 2006 utilize a "wedge" effect to effectively seal between the first axial extension 2002a and the second axial extension 2002b.

[0204] The cap 20708 may include one or more sets of extrusion ribs 20708F (see Figure 7N), such as two sets of crush ribs 20708F. The crush ribs 20708F can be configured to engage the sharp edge 20704N of the locking arm 20704J during an impact event (e.g., a drop), as described in more detail below (e.g., see Figure 8N ).

[0205] In accordance with the disclosed subject matter, the cap 20708 may include one or more desiccant retaining clips 20708H to retain the desiccant 20502 within the cap 20708 and to limit rotation of the desiccant 20502 (e.g., see Figure 7P ). The cap 20708 may include any number of desiccant retaining clips 20708H. For example, the cap 20708 may include one, two, three, four, five, six or more desiccant retaining clips 20708H. Fig.7O As can be seen in FIG. 20708 , the cap 20708 may include three pairs of two desiccant retaining clips 20708H. Each pair of desiccant retaining clips 20708H may correspond to the desiccant 20502 (e.g., see Figure 7P ) on the desiccant retaining clip 20502A (see, for example, Figure 7R ).like Figure 7P As can be seen in the figure, the desiccant 20502 can include a plurality of desiccant retaining clips 20502A, and each desiccant retaining clip 20502A can snap into a pair of desiccant retaining clips 20708H. For example, the desiccant retaining clips 20502A can include an inclined surface 20502Aa to radially expand the clips 20708H when the desiccant is pressed onto the cap until the desiccant retaining clips 20502A are locked into place within the desiccant retaining clips 20708H. The desiccant retaining clips 20708H can retain the desiccant 20502 within the cap 20708 to limit distal and rotational movement of the desiccant 20502. Figure 7Q As can be seen in the figure, the desiccant 20502 can include a locking recess (not shown) to position the desiccant 20502 at an angle relative to the desiccant retaining clip 20708H. In some embodiments, as shown in FIG. Figure 7Q As can be seen in the figure, the desiccant 20502 can be cylindrical.

[0206] In accordance with the disclosed subject matter, the cap 20708 can include a ratchet 20708I to engage and remove the sensor cap when the cap 20708 is removed from the housing 20702, as described in more detail below. The cap 20708 can include a plurality of ribs 20708J to provide strength. Figure 4G and Figure 7Q to Figure 7RAs can be seen, the size and dimensions of the inner hole 20502B of the desiccant 20502 can be designed to allow the sensor cap to have sufficient clearance to pass through and engage with the ratchet 20708I of the cap 20708; the desiccant 20502 may include a plurality of rib recesses 20502C to provide clearance for the plurality of ribs 20708J of the cap 20708.

[0207] For purposes of illustration and not limitation, reference is made to Figure 7W and Figure 7X In accordance with the disclosed subject matter, the cap 20708 can include one or more surfaces to engage other elements in the applicator device 20150 to provide support or limit movement in the event of an impact event (e.g., a drop). For example, the cap can include a sheath support surface 20708K that is configured to support the sheath 20704 during an impact event. The sheath support surface 20708K can limit distal movement of the sheath 20704 during an impact event. This can reduce stress on the sensor carrier 20710 and the sensor control device 20102, and can reduce the risk of the sensor control device 20102 falling off the sensor carrier 20710. Additionally or alternatively, the cap 20708 can include a raised ridge 20708L. The raised ridge 20708L can interface with a plug, such as an elastomeric plug 9130A (which in some embodiments can be coupled to the desiccant cap 9130, and in other embodiments, such as Figure 7Z 20102, the sensor carrier 20710, and the sensor control device 20102, thereby preventing the sensor control device 20102 from falling off the sensor carrier 20710 during an impact event. In addition, the additional support on the elastic plug 9130A and other features can increase the stress on various seals in the applicator device 20150, thereby improving the seal before removing the cap 20708 from the housing. For example, as shown in FIG. Figure 7Y As can be seen in FIG. 1 , the elastic plug 9130A may include a stop surface 9130Aa, a sealing bead 9130Ab, an intermediate surface 9130Ac, and a top surface 9130Ad. Figure 7Y As can be seen in FIG. 9130A , the top surface 9130Ad may include a triangular surface having square or rectangular corners rather than sharp vertices. Figure 7Z As can be seen in FIG. 1 , the sealing bead 9130Ab can be inserted into the sensor cap 9120 until the stop surface 9130Aa (eg, Fig.33The sealing bead 9130Ab may be generally barrel-shaped (i.e., cylindrical with a thicker middle portion that tapers toward the top and bottom of the sealing bead 9130Ab) and configured to form an interference fit 9130Abb between the sealing bead 9130Ab and the inner diameter of the sensor cap 9120, thereby forming a sterile barrier and sealing the inner chamber 9124.

[0208] Exemplary Applicator Sheath

[0209] Fig. 8A and Figure 8B 1 and 2 are side views and perspective views, respectively, depicting an exemplary embodiment of the sheath 704. In this exemplary embodiment, the sheath 704 can position the sensor control device 102 above the surface of the user's skin prior to application. The sheath 704 can also include features that help hold the sharp object in place for proper sensor application, determine the force required for sensor application, and guide the sheath 704 relative to the housing 702 during application. The detent buckle 1402 is located near the proximal end of the sheath 704, which will be discussed below. Figure 8C Further description. The sheath 704 can have a generally cylindrical cross-section, with a first radius of the proximal section (closer to the top of the figure) being shorter than a second radius of the distal section (closer to the bottom of the figure). A plurality of detent gaps 1410 are also shown, three in the exemplary embodiment. The sheath 704 can include one or more detent gaps 1410, each of which can be a cutout with space for the sheath snap lead-in feature 1330 to enter distally until the distal surface of the locking rib 1340 contacts the proximal surface of the detent gap 1410.

[0210] The guide rails 1418 are disposed between the sensor carrier travel frame limiter surface 1420 at the proximal end of the sheath 704 and the cutout around the locking arm 1412. Each guide rail 1418 may be a channel between two ridges where the guide edge 1326 of the housing guide rib 1321 may slide distally relative to the sheath 704.

[0211] The locking arms 1412 are disposed near the distal end of the sheath 704 and may include an attached distal end and a free proximal end, which may include a locking arm interface 1416. When the locking arm interface 1416 of the locking arms 1412 engages the locking interface 1502 of the sensor carrier 710, the locking arms 1412 may lock the sensor carrier 710 to the sheath 704. The locking arm reinforcement ribs 1414 may be disposed near the center of each locking arm 1412 and may act as a reinforcement point for the weak point of each locking arm 1412 to prevent the locking arms 1412 from excessive bending or breaking.

[0212] Detent buckle reinforcement feature 1422 may be located along a distal section of detent buckle 1402 and may provide reinforcement for detent buckle 1402. Alignment notch 1424 may be a cutout near the distal end of sheath 704 that provides an opening for a user to align with the sheath orientation feature of platform 808. Reinforcement rib 1426 may include a buttress, here triangular, that provides support for detent base 1436. Housing rail gap 1428 may be a cutout for the distal surface of housing guide rib 1321 to slide during use.

[0213] Figure 8C is a close-up perspective view of an exemplary embodiment of a detent buckle 1402 of the sheath 704. The detent buckle 1402 can include a detent buckle bridge 1408 located near or at its proximal end. The detent buckle 1402 can also include a detent buckle flat 1406 located on the distal side of the detent buckle bridge 1408. The outer surface of the detent buckle bridge 1408 can include a detent buckle circle 1404, which is a rounded surface that allows the detent buckle bridge 1408 to more easily pass through the inner surface of the housing 702, such as the locking rib 1340.

[0214] Fig.8D 704. is a side view depicting an exemplary embodiment of the sheath 704. Here, the alignment notch 1424 can be relatively close to the detent gap 1410. The detent gap 1410 is in a relatively proximal position on the distal portion of the sheath 704.

[0215] Fig. 8E 1444 is an end view of an exemplary embodiment depicting the proximal end of the sheath 704. Here, the rear wall of the guide rail 1446 can provide a channel that slidably couples with the housing guide ribs 1321 of the housing 702. The sheath rotation limiter 1448 can be a notch that reduces or prevents rotation of the sheath 704.

[0216] FIG. 8F to FIG. 8H 6704 is a perspective view of an alternative exemplary embodiment of a sheath 6704 at various stages of assembly with the other components of the applicator. Figure 8F As shown, the sheath 6704 can have many features similar to those previously described. FIG. 8A to FIG. 8C 6704. For example, sheath 6704 can include one or more detent buckles 6404 to which one or more detent circles 6402 are attached. However, the overall length of sheath 6704 can be shorter than that of sheath 702. Additionally, sheath 6704 can include one or more inner sheath ribs 6425 disposed on an inner surface of sheath 6704 and extending in an inward direction toward a central axis of sheath 6704.

[0217] Go to Figure 8G, the sheath 6704 is shown in a perspective view at a stage of assembly with the applicator housing 6702 and the sensor carrier 6710. One or more inner sheath ribs 6425 of the sheath 6704 can interface with one or more corresponding rib notches 6519 in the sensor carrier 6710. The mating interface between the corresponding ribs 6425 and notches 6519 can help maintain axial alignment of the sheath 6704 and the sensor carrier 6710 during sensor insertion. In addition, the interface between the ribs 6425 and notches 6519 can reduce lateral and rotational movement between the applicator components, which in turn can reduce the possibility of improper sensor insertion.

[0218] Go to Figure 8G , the sheath 6704 is shown in perspective view at a stage of assembly with the applicator housing 6702 and the sensor electronics housing 706 inserted into the sensor carrier 6710. The inner sheath ribs 6425 are also shown.

[0219] It should be noted that although six inner jacket ribs 6425 and six corresponding rib recesses 6519 are depicted, any number of ribs and recesses are well within the scope of the present disclosure. In addition, although the ribs 6425 are depicted as having rounded surface edges, in other embodiments, the ribs 6425 can have a rectangular or triangular shape, and the rib recesses 6519 can have a corresponding receiving shape for docking with the ribs 6425. In addition, although the ribs 6425 are depicted as being disposed on the inner circumference of the jacket 6704, the ribs 6425 can also be disposed on any other surface of the jacket 6704 or a portion thereof that contacts the sensor carrier 6710.

[0220] refer to FIG. 8I to FIG. 8O , for purposes of illustration and not limitation, a sheath 20704 in accordance with the disclosed subject matter is provided. The sheath 20704 can be made of Delrin or other suitable materials (e.g., other low friction polymers). The sheath 20704 can include one or more features described herein with respect to sheaths, wherein similar features can operate as described herein. For example, the sheath 20704 can include a detent catch 20704A having a free proximal end that is configured to engage the sheath rib 20702S during firing. Figure 8JA close-up of the free proximal end of the pawl buckle 20704A is shown. The pawl buckle 20704A may include a rounded portion 20704B for engaging with the sheath rib 20702S, and a flat portion 20704C for final locking on the housing 20704 after use. The rounded portion 20704B may include a parting line mismatch 20704D, which may prevent force spikes during firing. The pawl buckle 20704A may be coupled to the sheath 20704 at an enlarged distal portion 20704E, which may provide support to the pawl buckle 20704. The sheath 20704 may include a plurality of pawl buckles 20704A, for example three. The sheath 20704 may include one or more (e.g., three) housing gaps 20704F, which may allow the sheath 20704 to leave the housing 20702 at the end of firing. In accordance with the disclosed subject matter, the sheath 20704 can further comprise a plurality of reinforcing ribs 20704P (eg, six) which can reinforce the sheath 20704 .

[0221] The sheath 20704 may include a plurality of guides 20704G for engaging the sheath rails 20702J of the housing 20702. The sheath 20704 may also include a slot 20704H including a stop 20704I at a distal end thereof configured to engage the sheath rails 20702J of the sheath 20702 to limit further proximal movement of the sheath 20704 relative to the housing 20702 at the end of firing. The sheath 20704 may also include a gap 20704T for clearing a sensor carrier biasing feature 20702I disposed on the sheath rails 20702J of the housing 20702.

[0222] According to the disclosed subject matter, the sheath 20704 can include a locking arm 20704J. The locking arm 20704J can be configured to engage the sensor carrier 20710 and limit the movement of the sensor carrier 20710 or the sheath 20704 before firing. The locking arm 20704J can include a free proximal end 20704K and an attached distal end 20704L. The free proximal end 20704K can include a locking arm interface 20704M disposed on an inner surface of the locking arm 20704J. The locking arm interface 20704M can engage a locking flange 20710N on the sensor carrier 20710. For example, when the cap 20708 is coupled to the housing 20702, the cap 20708 can push the locking arm 20704J inwardly and can cause the locking arm interface 20704M to engage the sensor carrier 20710. That is, the locking arm 20704J can be wedged between the cap 20708 and the sensor carrier 20710. Thus, when the cap 20708 is coupled to the housing 20702, the locking arm 20704J can limit the proximal movement of the sheath 20704. Such engagement can limit the movement of the sheath 20704 during an impact event (such as a fall). When viewed from a side view (e.g., Figure 8N ), the locking arm interface 20704M can have a triangular shape and when viewed from a top view (e.g., Figure 8K ), may have a "U" shape. The shape of the locking arm interface 20704M may provide benefits during manufacturing. For example, the shape of the locking arm interface 20704M may allow the sheath 20704 to be forcibly ejected from the mold during manufacturing of the sheath 20704. Forcibly ejecting the sheath 20704 may allow for a more simplified manufacturing process, such as using a one-piece mold, and may eliminate parting lines created by a two-piece mold. Parting lines may result in an uneven surface that may get stuck on the sensor carrier 20710 during firing and may result in a potential peak in firing force. Therefore, using a forced ejection and a one-piece mold may form a smoother locking arm interface 20704M and prevent potential peaks in firing force due to parting lines.

[0223] The proximal free end of the locking arm 20704J may also include a sharp edge 20704N on the outer surface. The sharp edge 20704N may be configured to engage the extrusion rib 20708F provided on the cap 20708 during an impact event. The sharp edge 20704N may penetrate into the extrusion rib 20708F and permanently deform the extrusion rib 20708F, which may absorb energy during an impact event and prevent the sheath 20704 from collapsing. The shape locking arm interface 20704M is also beneficial for fall prevention. When the sheath 20704 collapses during a fall, the inclined surface may force the locking arm 20704J to move radially. This may force the sharp edge 20704N to penetrate into the extrusion rib 20708F and may help prevent the sheath 20704 from collapsing. The sheath 20704 may include a plurality of locking arms 20704J, for example, two locking arms 20704J.

[0224] Additionally or alternatively, the sheath 20704 can include ribs 20704U configured to engage a locking interface 20710F on a sensor retaining arm 20710B on the sensor carrier 20710. The ribs 20704U can prevent the sensor retaining arm 20710B from bending outwardly during, for example, an impact event, and thus can prevent movement of the sensor control device 20102 during an impact event. The ribs 20704U can have a selected height (i.e., in the longitudinal direction) such that even if the sheath 20704 moves proximally or distally during an impact event, the ribs 20704U will continue to engage the locking interface 20710F on the sensor retaining arm 20710B on the sensor carrier 20710 and prevent the sensor control device 20102 from falling off the sensor carrier 20710.

[0225] The sheath 20704 can include a noise dampener 20704O. The noise dampener 20704O can be configured to engage the sharps carrier 201102 when the sharps carrier 201102 is retracted to slow the movement of the sharps carrier 201102, thereby reducing the noise generated by the sharps carrier 201102 engaging the sheath 20704. In an exemplary embodiment, the noise dampener 20704O includes an angled ramp extending from an inner surface of the sheath 20704, but other suitable configurations can also be used.

[0226] In accordance with the disclosed subject matter, the sheath 20704 can include a slot 20704Q configured to receive a sharps carrier retention feature 20710L disposed on the sensor carrier 20710, thereby allowing the sharps carrier 201102 to be partially retracted during deployment (as described in more detail below). The sheath 20704 can also include a cap lead-in 20704R, an alignment notch 20704S, and a skin interface 20704T.

[0227] Exemplary sensor carrier

[0228] Fig. 9A is a proximal perspective view depicting an exemplary embodiment of a sensor carrier 710 that can hold the sensor electronics within the applicator 150. It can also hold the sharps carrier 1102 together with the sharps module 2500. In this exemplary embodiment, the sensor carrier 710 generally has a hollow circular flat cylindrical shape and can include one or more deflectable sharps carrier locking arms 1524 (e.g., three) that extend proximally from a proximal surface about a centrally positioned spring alignment ridge 1516 to maintain alignment of the spring 1104. Each locking arm 1524 has a detent or retaining feature 1526 located at or near its proximal end. The impact lock 1534 can be an outwardly extending tab located on the periphery of the sensor carrier 710 and can lock the sensor carrier 710 prior to firing for added safety. The rotation limiter 1506 can be a relatively short protrusion extending proximally on the proximal surface of the sensor carrier 710 that limits rotation of the carrier 710. As described below with reference to FIG. 10A to FIG. 1 As described in 0E, the sharps carrier locking arm 1524 can be docked with the sharps carrier 1102.

[0229] Fig. 9B 15 is a distal perspective view of the sensor carrier 710. Here, one or more sensor electronics retaining spring arms 1518 (e.g., three) are generally biased toward the position shown and include a detent 1519 that can pass over the distal surface of the electronics housing 706 of the device 102 when received in a recess or cavity 1521. In some embodiments, after the sensor control device 102 has been adhered to the skin with the applicator 150, the user pulls the applicator 150 in a proximal direction, i.e., away from the skin. The adhesive force holds the sensor control device 102 to the skin and overcomes the lateral force applied by the spring arms 1518. As a result, the spring arms 1518 deflect radially outward and disengage the detent 1519 from the sensor control device 102, thereby releasing the sensor control device 102 from the applicator 150.

[0230] Fig. 9C 67 is a perspective view of an alternative exemplary embodiment of the sensor carrier 6710. Fig. 9C As shown, the sensor carrier 6710 can have many features similar to those previously described. FIG. 9A to FIG. 9B The sensor carrier 6710 has the same features as described above. In addition, the sensor carrier 6710 also includes one or more notched ribs 6519 arranged along the outer peripheral surface. FIG. 8F to FIG. 8HAs best seen, the notched ribs 6519 are configured to interface with the inner sheath ribs 6425 to maintain axial alignment of the sheath and sensor carrier and to reduce lateral and rotational movement between the applicator components during the sensor insertion process.

[0231] refer to Fig.9D and Fig.9E , for purposes of illustration and not limitation, an exemplary sensor carrier 20710 is provided. The sensor carrier 20710 may include one or more features described herein with respect to the sensor carrier, wherein similar features may operate as described herein. For example, the sensor carrier 20710 may include a base 20710A and first and second retaining arms 20710B. Each retaining arm 20710B may include a first end portion 20710C coupled to the base 20710A and a free end portion 20710D. For example, each retaining arm 20710B may be coupled to the base 20710A at a first half of the base 20710A, and the free end portion 20710D may extend toward a second half of the base 20710A. Each retaining arm 20710B may include a sensor retaining feature 20710E disposed on an inner surface of the sensor retaining arm 20710B. The sensor retaining feature 20710E may be disposed on the free end portion 20710D. The sensor retention feature 20710E can be configured to retain the sensor control device 20102 within the housing 20702. The retention feature 20710E can include a tapered surface and an angled parting line, which can allow the sensor control device 20102 to be released upon delivery. Each retention arm 20710 can include a locking interface 20710F disposed on an outer surface of the retention arm 20710B. The locking interface 20710F can engage a rib 20704U on the sheath 20704. As described above, the rib 20704U can prevent the sensor retention arm 20710B from bending outward during, for example, an impact event, and thus can keep the retention feature 20710E engaged with the sensor control device 20102, thereby preventing movement of the sensor control device 20102 during an impact event.

[0232] The sensor carrier 20710 may include a plurality of housing attachment features 20710F, for example, three housing attachment features 20710F. The housing attachment features 20710F may be equally spaced on the sensor carrier 20710 and may extend upward from the top surface of the sensor carrier 20710. Each sensor housing attachment feature 20710F may include a housing snap 20710G, a housing locator feature 20710H, a biasing feature 20710I, and a housing stop 20710J. When the sensor carrier 20710 is coupled to the housing 20702, the housing locator feature 20710H may position the sensor carrier relative to the housing. The housing snap 20710G may engage the sensor carrier attachment slot 20702K on the housing 20702 to couple the sensor carrier 20710 to the housing 20702. The biasing feature 20710I can engage a sensor carrier biasing feature 20702M on the housing 20702 that is configured to remove a ramp between the sensor carrier 20710 and the housing 20702. The housing stop 20710J can engage a sensor carrier hard stop 20702L on a boot guide 20702J on the housing 20702 to axially position the sensor carrier 20710 relative to the housing 20702.

[0233] The sensor carrier 20710 may also include a plurality of sharp carrier locking arms 20710K, for example, three sharp carrier locking arms 20710K. The sharp carrier locking arms 20710K may be equally spaced on the sensor carrier 20710 and may extend upward from the top surface of the sensor carrier 20710. Each sharp carrier locking arm 20710K may include a sharp carrier retaining feature 20710L and a rib 20710M. The rib 20710M may engage the inner surface of the sheath 20704, which may push the sharp carrier locking arms 20710K inwardly and cause the sharp carrier retaining features 20710L to retain the sharp carrier 201102, as described in more detail below. The carrier retaining feature 20710L may have a triangular shape when viewed from a side view, and may have a "U" shape when viewed from a top view.

[0234] According to the disclosed subject matter, the sensor carrier 20710 can include a plurality of locking flanges 20710N configured to engage the locking arm interface 20704M of the sheath 20704, as described above. For example, the sensor carrier 20710 can include two locking flanges 20710N. The sensor carrier 20710 can include a recess 20710O disposed proximate to each locking flange 20710N and configured to receive the locking arm interface 20704M during firing to prevent the locking arm 20704J from engaging with the housing 20702 during firing. The sensor carrier 20710 can include a hole 20710P extending through a middle portion of the base 20710A. The hole 20710P can guide and limit the movement of the sharp hub 205014 during insertion. Additionally or alternatively, the sensor carrier 20710 can include a spring locator 20710Q.

[0235] The bottom surface of the sensor carrier 20710 may include reinforcing ribs 20710R and sensor locator ribs 20710S, which may limit planar movement of the sensor control device 20102 relative to the sensor carrier 20710. The bottom surface of the sensor carrier 20710 may include a sensor support surface 20710T configured to support the sensor control device 20102.

[0236] Exemplary sharps carrier

[0237] Fig. 10A and Fig. 10B 1 and 2 are proximal perspective views and cross-sectional side views, respectively, depicting an exemplary embodiment of a sharps carrier 1102. The sharps carrier 1102 can hold and retain the sharps module 2500 within the applicator 150. Fig.40A As described in FIG. 40F , during the insertion process, it may also automatically retract as one or more springs change from a preloaded compressed state to an expanded state. Near the distal end of the sharps carrier 1102 may be an anti-rotation groove 1608 that prevents the sharps carrier from rotating when the sharps carrier 1102 is within the central region of the sharps carrier locking arm 1524 (e.g., Fig. 9A 16). The anti-rotation slot 1608 can be located between sections of the sharps carrier base chamfer 1610, which can ensure that the sharps carrier 1102 is fully retracted through the sheath 704 when the sharps carrier 1102 is retracted at the end of the deployment process.

[0238] like Fig. 10BAs shown, the sharp retaining arms 1618 can be located inside the sharp carrier 1102 about the central axis and can include a sharp retaining clip 1620 at the distal end of each arm 1618. The sharp retaining clip 1620 can have a proximal surface that can be nearly perpendicular to the central axis and can abut the distally facing surface of the sharp hub 2516 ( Fig.17A ).

[0239] refer to Fig. 10C and Fig. 10D , an exemplary sharps carrier 201102 is provided for purposes of illustration and not limitation. The sharps carrier 201102 may include one or more features described herein with respect to sharps carriers, wherein similar features may operate as described herein. For example, the sharps carrier 201102 may include a series of features for engaging with three sharps carrier locking arms 20710K of the sensor carrier 20710. These features may include a partially retracted front retaining surface 201102A and a partially retracted rear retaining surface 201102B. The partially retracted front retaining surface 201102A may engage the sharps carrier retaining feature 20710L before partial retraction (e.g., during transport and storage). The partially retracted rear retaining surface 201102B may engage the sharps carrier retaining feature 20710L after partial retraction. For example, when the sheath 20704 initially moves proximally relative to the sensor carrier 20710, the ribs 20710M of the retaining arms 20710L can engage the grooves 20704Q of the sheath 20704, which can allow the retaining arms 20710L to move radially outward and allow the sharps carrier retaining feature 20710L to pass over the partially retracted front retaining surface 201102A and engage the partially retracted rear retaining surface 201102B. The height between the end of the partially retracted front face 201102A and the beginning of the partially retracted rear face 201102B can be the partially retracted distance. The running surface 201102C can be disposed below the partially retracted rear retaining surface 201102B and can slide against the retaining arms 20710L when the sharps carrier 201102 is retracted. The alignment wall 201102D can help maintain the sharps carrier 201102 aligned with the sensor carrier 20704 during partial retraction. The sharps carrier 201102 can include a chamfer 201102F that can include an anti-rotation groove 201102E to engage a retaining arm 20710L on the sensor carrier 20710.

[0240] Internally, the sharps carrier 201102 can include a sharps retaining arm 201102G including a lead-in surface 201102I and a sharp hub contact surface 201102H. The retaining arm 201102G can receive and retain the sharp hub 205014. The spring stop 201102J can engage the retraction spring 205612.

[0241] The spring 205612 can include any type of spring known in the art, such as a coil spring. For example, according to certain embodiments, the spring 205612 can include a coil spring constructed of stainless steel. The spring 205612 can include any suitable range of spring constants, as well as any suitable size of wire diameter, inner diameter, outer diameter, and maximum solid strength. For example, the spring constant can be about 0.12, the wire diameter can be about 0.65 mm, the inner diameter can be about 9.6 mm, the outer diameter can be about 11.1 mm, and the maximum solid strength can be 11 mm.

[0242] Exemplary Sensor Module

[0243] Fig.11A and Fig. 11B 23 and 24 are top and bottom perspective views, respectively, depicting an exemplary embodiment of a sensor module 504. The module 504 may hold a connector 2300 ( Fig. 12A and Fig. 12B ) and sensor 104 ( Fig.13 ). The module 504 can be securely coupled to the electronic device housing 706. One or more deflectable arms or module snaps 2202 can snap into corresponding features 2010 of the housing 706. The sharps slot 2208 can provide a location for the sharp tip 2502 to pass through and the sharp shaft 2504 to temporarily rest. The sensor flange 2212 can define the sensor position in the horizontal plane, prevent the sensor from lifting the connector 2300 from the column, and keep the sensor 104 parallel to the plane of the connector seal. It can also define the sensor bending geometry and minimum bend radius. It can limit the travel of the sensor in the vertical direction and prevent the tower from extending above the electronic device housing surface and limit the sensor tail length below the patch surface. The sensor wall 2216 can constrain the sensor and define the sensor bending geometry and minimum bend radius.

[0244] Fig. 12A and Fig. 12B2300 in an open state and a closed state, respectively. The connector 2300 can be made of silicone rubber that encapsulates a flexible carbon-impregnated polymer module that serves as a conductive contact 2302 between the sensor 104 and the circuit contacts of the electronic device within the housing 706. The connector can also serve as a moisture barrier for the sensor 104 when assembled in a compressed state after transfer from the container to the applicator and after application to the user's skin. Multiple sealing surfaces 2304 can provide a watertight seal for the electrical contacts and the sensor contacts. One or more hinges 2208 can connect the two distal and proximal portions of the connector 2300.

[0245] Fig.13 2408 can be a portion of the sensor 104 that is located beneath the user's skin after insertion. The marker 2404 can include contacts and sealing surfaces. The bias tower 2412 can be a tab that biases the tail 2408 into the sharps slot 2208. The bias fulcrum 2414 can be a branch of the bias tower 2412 that contacts the inner surface of the needle to bias the tail into the slot. The bias adjuster 2416 can reduce local bending of the tail connection and prevent damage to the sensor traces. The contacts 2418 can electrically couple the active portion of the sensor to the connector 2300. The service loop 2420 can translate the circuit path ninety degrees from the vertical direction and align with the sensor flange 2212 ( Fig. 11B ) join.

[0246] Fig.14A and Fig. 14B 2 and 3 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 embodiment, during or after insertion, the sensor 104 can be subjected to an axial force that pushes upwardly against the sensor 104 and into the sensor module 504 in a proximal direction, such as Fig.14A According to some embodiments, this may result in a reaction force F2 being applied to the neck 2406 of the sensor 104, thereby causing a reaction force F3 to be transmitted to the service loop 2420 of the sensor 104. In some embodiments, for example, the axial force F1 may be generated by a sensor insertion mechanism in which the sensor is designed to propel itself through the tissue, a sharp object retraction mechanism during insertion, or a physiological reaction generated by the tissue surrounding the sensor 104 (e.g., after insertion).

[0247] Fig.15A and Fig. 15B is a close-up partial view of an exemplary embodiment of a sensor module assembly having certain axial reinforcement features. In a general sense, the embodiments described herein are directed to mitigating the effects of axial forces on the sensor due to insertion and / or retraction mechanisms or the body's physiological response to the sensor. Fig.15A and Fig. 15B 3104, according to one aspect of the embodiments, the sensor 3104 includes a proximal portion having a hook feature 3106 configured to engage the snap feature 3506 of the sensor module 3504. In some embodiments, the sensor module 3504 may also include a clearance region 3508 to allow the distal portion of the sensor 3104 to swing back during assembly, thereby allowing the hook feature 3106 of the sensor 3104 to be assembled onto and into the snap feature 3506 of the sensor module 3504.

[0248] According to another aspect of the embodiment, the hook feature 3106 and the snap feature 3506 operate in the following manner. The sensor 3104 includes a proximal sensor portion coupled to the sensor module 3504 as described above and a distal sensor portion located below the skin surface and in contact with the body fluid. Fig.15A and Fig. 15B As shown, the proximal sensor portion includes a hook feature 3106 adjacent to a snap feature 3506 of the sensor module 3504. During or after sensor insertion, one or more forces are applied in a proximal direction along the longitudinal axis of the sensor 3104. In response to the one or more forces, the hook feature 3106 engages the snap feature 3506 to prevent displacement of the sensor 3104 in a proximal direction along the longitudinal axis.

[0249] According to another aspect of the embodiment, the sensor 3104 can be assembled with the sensor module 3504 in the following manner. The sensor 3104 is loaded into the sensor module 3504 by displacing the proximal sensor portion in the lateral direction so that the hook feature 3106 approaches the snap feature 3506 of the sensor module 3504. More specifically, the proximal sensor portion is displaced in the lateral direction so that the proximal sensor portion moves into the gap area 3508 of the sensor module 3504.

[0250] although Fig.15A and Fig. 15BThe hook feature 3106 is depicted as part of the sensor 3104, and the snap feature 3506 is depicted as part of the sensor module 3504, but those skilled in the art will appreciate that the hook feature 3106 may alternatively be part of the sensor module 3504, and likewise, the snap feature 3506 may alternatively be part of the sensor 3106. Similarly, those skilled in the art will also recognize that other mechanisms (e.g., detents, latches, fasteners, screws, etc.) implemented on the sensor 3104 and the sensor module 3504 to prevent axial displacement of the sensor 3104 are possible and within the scope of the present disclosure.

[0251] Fig. 15C 1 is a side view of an exemplary sensor 11900 according to one or more embodiments of the present disclosure. The sensor 11900 may be similar in some respects to any sensor described herein and may therefore be used in an analyte monitoring system to detect a specific analyte concentration. As shown, the sensor 11900 includes a tail 11902, a marker 11904, and a neck 11906 interconnecting the tail 11902 and the marker 11904. The tail 11902 includes an enzyme or other chemical or biological substance, and in some embodiments, the membrane may cover the chemical substance. In use, the tail 11902 is transcutaneously received under the skin of the user, and the chemical substance contained thereon facilitates analyte monitoring in the presence of body fluids.

[0252] The tail 11902 can be received within a hollow or recessed portion of a sharp object (not shown) to at least partially surround the tail 11902 of the sensor 11900. As shown, the tail 11902 can extend at an angle Q that deviates from horizontal. In some embodiments, the angle Q can be approximately 85 degrees. Therefore, compared to other sensor tails, the tail 11902 may not extend perpendicularly from the mark 11904, but rather extend at an angle that deviates from perpendicular. This may prove to be beneficial in retaining the tail 11902 within the recessed portion of the sharp object.

[0253] The tail 11902 includes a first or bottom end 11908a and a second or top end 11908b opposite the bottom end 11908b. The tower 11910 can be disposed at or near the top end 11908b and can extend vertically upward from the location where the neck 11906 interconnects the tail 11902 with the mark 11904. During operation, if the sharp object moves laterally, the tower 11910 will help the tail 11902 pivot toward the sharp object, otherwise it will remain in the recessed portion of the sharp object. In addition, in some embodiments, the tower 11910 can provide or otherwise define a protrusion 11912 extending laterally therefrom. When the sensor 11900 is engaged with the sharp object and the tail 11902 extends within the recessed portion of the sharp object, the protrusion 11912 can engage the inner surface of the recessed portion. In operation, the protrusion 11912 can help keep the tail 11902 in the recessed portion.

[0254] The flag 11904 may include a generally flat planar surface on which are disposed one or more sensor contacts 11914. The sensor contacts 11914 may be configured to align with a corresponding number of flexible carbon-impregnated polymer modules encapsulated within the connector.

[0255] In some embodiments, as shown, the neck 11906 can provide or otherwise define a recess or bend 11916 extending between the flag 11904 and the tail 11902. The bend 11916 can prove advantageous in increasing the flexibility of the sensor 11900 and helping to prevent the neck 11906 from bending.

[0256] In some embodiments, a notch 11918 (shown in phantom) can optionally be defined in the indicia proximate the neck 11906. The notch 11918 can add flexibility and tolerance to the sensor 11900 when the sensor 11900 is mounted to the mount. More specifically, the notch 11918 can help absorb disturbance forces that may occur when the sensor 11900 is mounted within the mount.

[0257] In some embodiments, FIG. 15D to FIG. 15GAs shown, the neck may include or otherwise define a non-linear configuration, such as a depression or bend 11920a-11920d having a plurality of turns (e.g., 11921a, 11921b) extending between the flag 11904 and the tail 11902. The bends 11920a-11920d may be advantageous in reducing the in-situ stiffness of the sensor 11900 by adding flexibility to the sensor 11900 in both vertical and horizontal orientations. The increased flexibility may provide a multi-directional spring-like structure in the sensor 11900, which helps limit deformation of the neck 11906 while ensuring that the tail 11902 and the flag 11904 may remain in their intended or fixed positions. The spring-like structure also increases the compliance of the sensor 11900 while reducing stress on the overall structure.

[0258] Generally, the sensor can be understood to include a tail, a mark and a neck aligned along a planar surface with a vertical axis and a horizontal axis. The spring-like structure can be formed by various turning orientations in the neck bend of the sensor. Between the tail and the mark, the neck can include at least two turns relative to the vertical axis, providing a spring-like structure. Relative to the axis of the planar surface shared by the tail, the mark and the neck, at least two turns can provide overlapping layers of the neck structure, wherein the neck itself remains intact. These overlapping turns constitute a spring-like structure. In some embodiments, the overlapping layers of the neck are vertically oriented. In some embodiments, the overlapping layers of the neck are horizontally oriented.

[0259] Fig.15D One embodiment of a sensor 11900 is shown, the sensor including a neck located between a flag 11904 and a tail 11902, the neck having a curved portion 11920a, the curved portion including turns 11921a and 11921b. In the illustrated embodiment, at least one turn 11921a abuts the tail tip of the sensor 11900 or possibly the tower 11910. This orientation can be advantageous because it reduces the overall footprint of the sensor, even taking into account the additional material used to create the bend 11920a. The arrangement can provide multiple overlapping, vertically aligned horizontal layers between the turns.

[0260] Fig.15EAnother embodiment of a sensor 11900 is shown, which includes a neck located between the flag 11904 and the tail 11902, the neck having a bend 11920a, which generally forms a vortex pattern, including at least turns 11923a, 11923b and 11923c. In this embodiment, the turns again abut the tail or top of the tower 11910 of the sensor 11900. In addition to maintaining the overall footprint of the sensor, this orientation can also provide additional balance of horizontal and vertical oriented stresses. The overlapping layers in this turn arrangement are substantially balanced along both the horizontal and vertical axes.

[0261] Fig.15F Another embodiment of a sensor 11900 is shown, which includes a neck located between a flag 11904 and a tail 11902, the neck having a bend 11920c, the bend including turns 11925a, 11925b, and 11925c. In the illustrated embodiment, the turn 11925c connects the area of ​​the tail 11902 near the tail tip or tower 11910 of the sensor to the remainder of the bend 11920c. In addition to reducing the overall footprint of the sensor, this orientation can also be considered to provide additional flexibility in a horizontally oriented axis. The arrangement can provide multiple overlapping, horizontally aligned vertical layers between the turns.

[0262] Figure 15G Another embodiment of a sensor 11900 is shown, the sensor including a neck located between a flag 11904 and a tail 11902, the neck having a bend 11920d, the bend including turns 11927a, 11927b, and 11927c. In the illustrated embodiment, the bend 11920d occurs primarily at the tail 11902 of the sensor, connecting the tail 11902 and the tower 11910, while the stretching of the sensor between the tower 11910 and the flag 11904 is generally uninterrupted. Turn 11927a generally connects the tower 11910 to the remainder of the bend 11920d, while turn 11927c connects the tail 11902 to the remainder of the bend 11920d. This orientation can be considered to provide additional flexibility in a vertically oriented axis. The arrangement can provide multiple overlapping, horizontally aligned vertical layers between the turns.

[0263] The bend in the neck can be formed by collapsing the neck of the sensor from the larger neck structure, laser cutting the sensor from a sheet of material including the sensor, printing the sensor with the bend configuration, stamping the sensor from a sheet of material forming the sensor, or other suitable manufacturing processes to provide a precise bend in the neck.

[0264] Fig.16A and Fig. 16B 1 is an isometric view and a partially exploded isometric view of an exemplary connector assembly 12000 according to one or more embodiments. As shown, the connector assembly 12000 may include a connector 12002, and Fig. 17C 12002 is an isometric bottom view of the connector 12002. The connector 12002 may include an injection molded component to facilitate attaching one or more flexible carbon impregnated polymer modules 12004 ( Fig. 16B More specifically, connector 12002 can help secure module 12004 in place near sensor 11900 and connect to a connector 11904 (four are shown in FIG. 11904 ). Fig. 15C ) on the sensor contact 11914 ( Fig. 15C ) contacts. Module 12004 can be made of a conductive material to provide conductive communication between sensor 11900 and corresponding circuit contacts (not shown) disposed within support 12006.

[0265] like Fig. 16C As best seen in FIG. 1 , the connector 12002 can define a recess 12008 sized to receive the module 12004. Additionally, in some embodiments, the connector 12002 can further define one or more recesses 12010 configured to engage with one or more corresponding flanges 12012 ( Fig. 16B ) Mating the recess 12010 with the flange 12012 can secure the connector 12002 to the support 12006 via an interference fit, etc. In other embodiments, the connector 12002 can be secured to the support 12006 using an adhesive or via sonic welding.

[0266] Fig.16D and Fig.16E 1 is an isometric view and a partially exploded isometric view of another exemplary connector assembly 12100 according to one or more embodiments. As shown, the connector assembly 12100 may include a connector 12102, and Fig.16F 12102 is an isometric bottom view of the connector 12102. The connector 12102 may include an injection molded component to help attach one or more flexible metal contacts 12104 ( Fig.16E More specifically, connector 12102 can help secure contact 12104 in place near sensor 11900 and connect to sensor contact 11914 (shown in Figure 11904) disposed on flag 11904. Fig. 15C) contact. Contacts 12104 can be made of stamped conductive material to provide conductive communication between sensor 11900 and corresponding circuit contacts (not shown) disposed within support 12106. In some embodiments, for example, contacts 12104 can be soldered to a PCB (not shown) disposed within support 12106.

[0267] like Fig.16F As best seen in FIG. 1 , the connector 12102 can define a recess 12108 sized to receive the contact 12104. Additionally, in some embodiments, the connector 12102 can further define one or more recesses 12110 configured to engage with one or more corresponding flanges 12112 ( Fig. 16B ). Mating the recess 12110 with the flange 12112 can help secure the connector 12102 to the support 12106 via an interference fit, etc. In other embodiments, the connector 12102 can be secured to the support 12106 using an adhesive or via sonic welding.

[0268] Exemplary Sharps Module

[0269] Fig.17A is depicted in the sensor module 504 ( Figure 6B ) is a perspective view of an exemplary embodiment of a sharp object module 2500 before assembly in a sharp object shaft 2504. The sharp object 2502 may include a distal tip 2506 that can penetrate the skin while carrying the sensor tail in the hollow or recessed portion of the sharp object shaft 2504 to contact the active surface of the sensor tail with the body fluid. The hub push cylinder 2508 can provide a pushing surface for the sharp object carrier during insertion. The hub cylinder 2512 can be a sharp hub contact surface 1622 ( Fig. 10B ) provides space for the extension of the sharp object module 2500. The hub snap claw positioning cylinder 2514 can provide a distally facing surface of the hub snap claw 2516 to abut the sharp hub contact surface 1622. The hub snap claw 2516 can include a tapered surface that opens the clip 1620 during installation of the sharp object module 2500.

[0270] FIG. 17B to FIG. 17HAn exemplary embodiment of a sharp object module in different assembly stages for inserting a skin analyte sensor is shown. According to one aspect of the embodiment, angling the sensor and / or the insertion sharp object relative to a reference point can co-locate the tip of the insertion needle and the tip of the sensor, and in addition, a single contact point can be generated at the skin surface. Therefore, when the sensor is inserted into the subject, the sharp object can form a leading edge at the skin surface, forming an insertion path for the sensor to enter the dermis. In some embodiments, for example, the sharp object and / or the dermal sensor can be angled relative to a reference point (e.g., each other, the skin surface, or the bottom of the applicator) for insertion, wherein the angle of the sharp object is different from the angle of the sensor. For example, the reference point can be the skin surface to be broken through when the skin is inserted, or it can be a reference or component of the sensor applicator group. In some embodiments, the sharp object can be set at a certain angle relative to the sensor. For example, when it is designed to make the sharp object angled relative to the sensor, the needle forms a leading edge for the sensor during the operation of the applicator group. Furthermore, the needle design itself, as well as the positioning of the needle relative to the sensor, may be implemented in any desired configuration, including all such configurations disclosed in U.S. Patent Publication No. 2014 / 0171771, which is incorporated herein by reference in its entirety for all purposes.

[0271] In addition, despite the FIG. 17B to FIG. 17J Many of the exemplary embodiments described relate to skin analyte sensors and skin insertion, but those skilled in the art will appreciate that any embodiment may be sized and configured for use with an analyte sensor that may be positioned outside of the skin space, such as into (or even completely through) subcutaneous tissue (e.g., 3 mm to 10 mm below the skin surface, depending on the location of the skin on the body).

[0272] Fig. 17B 25 is a perspective view of an exemplary embodiment of a sharp object module 2550 that can be used to insert a dermal sensor. Figure 6B ) before assembling the sharps module 2550, and may include Fig.17AComponents similar to those of the embodiments described above include a sharp 2552, a sharp shaft 2554, a sharp distal tip 2556, a hub push cylinder 2558, a hub small cylinder 2562, a hub snap claw 2566, and a hub snap claw positioning cylinder 2564. The sharp 2552 can be positioned in an eccentric position relative to the longitudinal axis 2545 within the sharp module 2550, and the longitudinal axis extends through the center of the hub snap claw 2566, the hub small cylinder 2562, and the hub push cylinder 2558. In addition, the sharp module 2550 can include a sharp spacer 2568 parallel to and adjacent to a portion of the sharp 2552. The sharp spacer 2568 can be positioned between the sensor 104 (not shown) and the sharp 2552 along the proximal portion of the sharp 2552, and can ensure that the sensor 104 and the sharp 2552 remain spaced apart at the proximal portion of the sharp 2552. The sharp point 2552 can be positioned in an off-center position during the molding process about the hub components 2558, 2562, 2566, each of which can be composed of a rigid plastic material.

[0273] Fig. 17C and Fig.17D is depicted in conjunction with sensor module 504 ( Figure 6B ) are two side views of the sharps module 2550 before assembly, and include a sharp 2552, a spacer 2568, a hub push cylinder 2558, a hub small cylinder 2562, and a hub snap claw 2566. In some embodiments, the relative distance between the sharp 2552 and the hub component can be positioned as follows. For example, the distance S1 between the sharp 2552 and the radial center of the hub can be in the range of 0.50 mm to 1 mm (e.g., 0.89 mm). The height S2 of the sharp spacer 2568 can be in the range of 3 mm to 5 mm (e.g., 3.26 mm). The height S3 of the hub can be in the range of 5 mm to 10 mm (e.g., 6.77 mm). The length S4 of the sharp 2552 can be in the range of 1.5 mm to 25 mm (e.g., 8.55 mm) and can depend on the location of the insertion site on the subject.

[0274] Fig.17E A cross-sectional side view of a sharps module 2550 assembled with a sensor module 504 is depicted, the sharps module including a sharp 2552, a sharps spacer 2568, and a hub component (hub snap claw 2566, hub cylinder 2562, and hub push cylinder 2558). Fig.17E As can be seen in FIG. 5 , the sharp object 2552 is located within the sharp object slot 2208 of the sensor module 504, which includes a curved inner surface 2250 located at the distal end. The curved inner surface 2250 of the sensor module 504 can contact a portion of the sharp object 2552 and cause deflection so that the distal tip 2556 of the sharp object is oriented toward the central longitudinal axis 2545. Fig.17H As best seen in FIG. 2 , the sharp tip 2552 can be positioned such that the distal portion and the central longitudinal axis 2545 form an acute angle S θ , the acute angle S θ The range of can be between 5 degrees and 20 degrees. In some embodiments, for example, S θ The range can be from 5 degrees to 17 degrees, or 7 degrees to 15 degrees, or 9 degrees to 13 degrees, for example, 9 degrees, 10 degrees, 11 degrees, 12 degrees or 13 degrees.

[0275] Still reference Fig.17E Near the distal end of the sensor module 504 is a protrusion 2251 that can enhance the perfusion of body fluids (such as skin fluid). Fig.17E 2251 is shown as a curved surface, but the protrusion 2251 can be shaped in any desired manner. In addition, in some embodiments, there can be multiple protrusions. U.S. Patent Publication No. 2014 / 0275907 describes a sensor device with different protrusion configurations, each of which can be implemented with the embodiments described herein, and the patent disclosure is incorporated herein by reference in its entirety for all purposes. Many of the embodiments described herein show the needle withdrawing from the protrusion, and in other embodiments, the needle can withdraw from the base of the sensor device adjacent to the protrusion and extend from that position to above the tip of the sensor 104.

[0276] Still reference Fig.17E and Fig.17F , the sensor 104 may be a dermal sensor and may include a sensor tail 2408 located at a distal end of the sensor 104 and may be positioned in an orientation substantially parallel to the central longitudinal axis 2545. The distal end of the sensor tail 2408 may be proximal to the distal sharp tip 2556, spaced apart from, stationary in, or resting against a portion of the sharp shaft 2554. Fig.17E As further depicted in FIG. 5 , the sharp object spacer 2568 provides a spaced relationship between the proximal portion of the sharp object 2552 and the sensor 104 so that the proximal portion of the sharp object 2552 and the sensor 104 do not contact. The sensor module 504 may also include a sensor connector 2300 for accommodating the proximal portion of the sensor 104, which is relatively perpendicular to the distal end of the sensor 104.

[0277] Fig.17F2 is a top cross-sectional view of the sensor module 504. The sensor module 504 may include one or more sensor module clips 2202 for coupling with a housing (not shown) of the sensor control device 102. The sensor module 504 may also include a sensor connector 2300, which may have sensor contacts 2302 for coupling with a proximal portion of the sensor 104. The sensor connector 2300 may be made of silicone rubber that encapsulates a flexible carbon impregnated polymer module that serves as a conductive contact 2302 between the sensor 104 and circuit contacts of the electronics within the sensor control device 102. The connector may also serve 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 depicted, it should be understood that the connector 2300 may have fewer contacts (e.g., two) or more contacts (e.g., four, five, six, etc.) depending on the particular type or configuration of the sensor 104. The sensor connector 2300 may also be coupled to the sensor module 504 via two connector posts 2206 positioned through the same number of openings in the connector 2300. Although two connector posts 2206 are depicted, it should be understood that any number of connector posts 2206 may be used to couple the connector 2300 to the sensor module 504.

[0278] Figure 17G and Fig.17H 2600, respectively, is a perspective view and a side view of another exemplary embodiment of a sharp object module 2600 that can be used to insert a dermal sensor. Figure 6B ) before assembly of the sharps module 2600, and may include Fig.17A and Fig. 17B Components similar to the described embodiments include a sharp 2602, a sharp shaft 2604, a sharp distal tip 2606, a hub push cylinder 2608, a hub small cylinder 2612, a hub snap claw 2616, and a hub snap claw positioning cylinder 2614. In some embodiments, the sharp 2602 can be a "pre-bent" needle that includes a proximal portion 2603 that originates from a point outside the sharp module 2600 and intersects with a center point of the hub at a certain angle (e.g., through the hub push cylinder 2608). The sharp 2602 can also include a distal portion 2605 that extends in a distal direction at a certain angle from a point near the distal portion of the hub to an insertion point into the user's skin. As shown in FIG. Fig.17HAs shown, the sharp 2602 may include an angled portion 2607 located outside the hub push cylinder 2608, which may have a substantially 90 degree angle between the proximal portion 2603 and the distal portion 2605 of the sharp 2602. The sharp module 2600 may also include a curved fin guide 2620 for holding the "pre-bent" sharp 2602 in place during assembly and / or use, and may prevent lateral or rotational movement of the sharp 2602 relative to the hub component. After the molding process is completed, and before the sharp module 2600 is assembled with the sensor module 504, the proximal portion 2603 of the sharp 2602 may be "trimmed" from the hub.

[0279] Fig.17I and Fig.17J A cross-sectional side view and a side view of the sharp object module 2600 (including the hub snap claw 2616, the hub small cylinder 2612 and the hub push cylinder 2608) assembled with the sensor module 504 are shown respectively. Fig.17I As can be seen in FIG. 5 , the sensor module 504 includes a sharps slot 2208 through which a sharp 2602 can extend in an angled and distal direction. As previously described, a proximal portion of the sharp 2602 passes through a curved fin guide 2620 that is coupled to a distal portion of the sensor module 504. The sensor module 504 can also include a sensor 104, which can be a dermal sensor. Fig.17I As can be seen in FIG. 2 , the sharp object 2602 and the sensor tail 2408 may form an acute angle S at the point where their respective longitudinal axes converge. θ . Angle S θ The range of can be between 5 degrees and 20 degrees. In some embodiments, for example, S O The range of can be from 5 degrees to 17 degrees, or 7 degrees to 15 degrees, or 9 degrees to 13 degrees, for example, 9 degrees, 10 degrees, 11 degrees, 12 degrees, or 13 degrees. In some embodiments, the distal sharp tip 2606 is located at a distance Se near the end of the sensor tail 2408. The distance S6 can range from 0.02 mm to 0.10 mm, for example, 0.05 mm, 0.06 mm, or 0.07 mm.

[0280] Still reference Fig.17I and Fig.17J The sensor module 504 may further include a sensor connector 2300 for accommodating a proximal portion of the sensor 104, the proximal portion being relatively perpendicular to the distal end of the sensor 104. The sensor module 504 may further include one or more sensor module buckles 2202 for coupling with a housing (not shown) of the sensor control device 102. The sensor connector 2300 may include Fig.17F Same structure as described.

[0281] In the above-described embodiments, the sharp object can be made of stainless steel or a similar flexible material (e.g., material used to make acupuncture needles) and sized so that the applicator inserts at least a portion of the dermal sensor into the dermis but does not penetrate the dermis of the skin. According to certain embodiments, the sharp object has a cross-sectional diameter (width) of 0.1 mm to 0.5 mm. For example, the sharp object can have a diameter of 0.1 mm to 0.3 mm (such as 0.15 mm to 0.25 mm, for example, 0.16 mm to 0.22 mm). A given sharp object can have a constant (i.e., uniform) width along its entire length, or can have a varying (i.e., changing) width along at least a portion of its length (such as a tip portion for piercing the skin surface). For example, with respect to Fig.17I In the embodiment shown in FIG. 2 , the width of the sharp 2602 may narrow along the distal portion between the curved fin guide 1620 and the distal sharp tip 2606 .

[0282] The length that the sharp object has can also just be used to insert the dermal sensor into the dermis layer, but can't go deeper. The insertion depth can be controlled by the length of the sharp object, the configuration of the base and / or other applicator parts that limit the insertion depth. The sharp object can have a length between 1.5mm and 25mm. For example, the length that the sharp object has can be 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 the length is greater than 25mm. It will be understood that although the length that the sharp object has can reach 25mm, in some embodiments, the full length of the sharp object will not be inserted into the subject's body because it will extend beyond the dermal space. The length of the sharp object that is not inserted can provide a sharp object for handling and manipulating the applicator group. Thus, although the sharp object has a length of up to 25 mm, in these certain embodiments, the insertion depth of the sharp object in the subject's skin will be limited to the dermis, for example, about 1.5 mm to 4 mm, depending on the skin location, as described in more detail below. However, in all embodiments disclosed herein, the sharp object can be configured to extend beyond the dermal space, such as into (or even completely through) 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, in some exemplary embodiments, the sharp objects described herein may include a hollow or partially hollow insertion needle having an internal space or lumen. However, in other embodiments, the sharp objects described herein may include a solid insertion needle without an internal space and / or lumen. In addition, the sharp object of the subject's applicator group may also be bladed or bladeless.

[0283] Likewise, in the above-described embodiments, the dermal sensor is sized such that at least a portion of the sensor is located in the dermal layer, but no deeper, and a portion extends outside the skin in transcutaneously positioned embodiments. That is, the dermal sensor is sized such that when the dermal sensor is fully or substantially fully inserted into the dermal layer, the most distal portion (insertion portion or insertion length) of the sensor is located within the dermal layer of the subject, and when the sensor is operably placed on the dermis, no portion of the sensor is inserted outside the dermal layer of the subject.

[0284] The size (e.g., length) of the sensor can be selected based on the body part of the subject into which the sensor is to be inserted, as the depth and thickness of the epidermis and dermis exhibit a certain degree of variability depending on the skin location. For example, the thickness of the epidermis on the eyelids is only about 0.05 mm, but the thickness of the epidermis on the palms and soles of the feet is about 1.5 mm. The dermis is the thickest of the three layers of skin and is approximately 1.5 mm to 4 mm thick, depending on the skin location. In order to implant the distal end of the sensor but not penetrate the dermis layer of the subject, the length of the inserted portion of the dermal sensor should be greater than the thickness of the epidermis, but should not exceed the combined thickness of the epidermis and dermis. The method may include: determining an insertion site on the user's body, and determining the depth of the dermis layer at that site, and selecting an appropriately sized applicator group for that site.

[0285] In some aspects, the sensor is an elongated sensor having a longest dimension (or "length") of 0.25 mm to 4 mm. In embodiments where only a portion of the sensor is inserted into the dermis, the length of the inserted sensor ranges from 0.5 mm to 3 mm, such as 1 mm to 2 mm, for example, 1.5 mm. The size of the sensor can also be expressed by its aspect ratio. In some embodiments, the aspect ratio of the length to the width (diameter) of the dermal sensor is 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 inserted portion of the dermal sensor has a sensing chemical.

[0286] However, all embodiments disclosed herein can be configured such that at least a portion of the sensor is located outside the dermis, such as into (or through) the subcutaneous tissue (or fat). For example, the sensor can be sized such that when the sensor is fully or substantially fully inserted into the body, the distal-most portion (insertion portion or insertion length) of the sensor is located within the subcutaneous tissue (beyond the dermis of the subject), and when the sensor is operably placed in position, no portion of the sensor is inserted outside the subcutaneous tissue of the subject. As described, the subcutaneous tissue typically exists in the region of 3 mm to 10 mm below the outer skin surface, depending on the location of the skin on the body.

[0287] Exemplary Applicator and Sensor Control for One-Piece Architecture

[0288] Again briefly reference Figure 1 and Figure 3A To FIG. 3G, for a two-piece architecture system, the sensor tray 202 and the sensor applicator 102 are provided to the user as separate packages, requiring the user to open each package and ultimately assemble the system. In some applications, the separate sealed packages allow the sensor tray 202 and the sensor applicator 102 to be sterilized in separate sterilization processes that are unique to the contents of each package and are otherwise incompatible with the contents of the other. More specifically, the sensor tray 202 including the plug assembly 207 (including the sensor 110 and the sharp object 220) can be sterilized using radiation sterilization (such as electron beam (or "e-beam") irradiation). However, radiation sterilization can damage electrical components arranged in the electronic device housing of the sensor control device 102. Therefore, if the sensor applicator 102 of the electronic device housing containing the sensor control device 102 needs to be sterilized, it can be sterilized via another method, such as gas chemical sterilization using, for example, ethylene oxide. However, gas chemical sterilization may damage enzymes or other chemicals and biological agents included on the sensor 110. Because of this sterilization incompatibility, the sensor tray 202 and sensor applicator 102 are typically sterilized in separate sterilization processes and then packaged separately, requiring the user to finally assemble the components for use.

[0289] According to embodiments of the present disclosure, the sensor control device 102 can be modified to provide a one-piece architecture that can withstand sterilization techniques specifically designed for one-piece architecture sensor control devices. 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 end-user assembly steps. Instead, the user only needs to open a package and then transport the sensor control device 102 to the target monitoring location. The one-piece system architecture described herein can prove to be advantageous in eliminating component parts, various manufacturing process steps, and user assembly steps. Therefore, packaging and waste are reduced, and the possibility of user error or contamination of the system is mitigated.

[0290] Fig.18A and Fig.18B 1 and 2 are isometric and side views of another exemplary sensor control device 5002 according to one or more embodiments of the present disclosure. The sensor control device 5002 may be similar in some aspects to Figure 1 The sensor control device 102 of FIG. 100 is thus best understood with reference to the sensor control device 102. In addition, the sensor control device 5002 may replace Figure 1The sensor control device 102 can therefore be used with Figure 1 The sensor applicator 102 can be used in conjunction with the sensor control device 5002, which can deliver the sensor control device 5002 to the target monitoring location on the user's skin.

[0291] However, with Figure 1 Unlike the sensor control device 102 of the present invention, the sensor control device 5002 may include a one-piece system architecture that does not require the user to open multiple packages and finally assemble the sensor control device 5002 before application. Instead, when received by the user, the sensor control device 5002 may already be fully assembled and properly positioned within the sensor applicator 150 ( Figure 1 To use the sensor control device 5002, the user only needs to open a barrier (e.g., Figure 3B The applicator cap 708 is then quickly transported to the target monitoring location for use.

[0292] As shown, the sensor control device 5002 includes an electronic device housing 5004, which is optionally generally disc-shaped and can have a circular cross-section. However, in other embodiments, the electronic device housing 5004 can have other cross-sectional shapes, such as oval or polygonal, without departing from the scope of the present disclosure. The electronic device housing 5004 can be configured to accommodate or otherwise contain various electrical components used to operate the sensor control device 5002. In at least one embodiment, an adhesive patch (not shown) can be arranged at the bottom of the electronic device housing 5004. The adhesive patch can be similar to Figure 1 The adhesive patch 105 can thus help adhere the sensor control device 5002 to the user's skin for use.

[0293] As shown, the sensor control device 5002 includes an electronic device housing 5004, which includes a housing 5006 and a support 5008 that can cooperate with the housing 5006. The housing 5006 can be fixed to the support 5008 via a variety of means, such as snap-fit ​​engagement, interference fit, sonic welding, one or more mechanical fasteners (e.g., screws), washers, adhesives, or any combination thereof. In some cases, the housing 5006 can be fixed to the support 5008 so that a sealing interface is generated therebetween.

[0294] The sensor control device 5002 may also include a sensor 5010 (partially visible) and a sharp object 5012 (partially visible) for facilitating transcutaneous 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 the sharp object 5012 extend distally from the bottom of the electronic device housing 5004 (e.g., the support 5008). The sharp object 5012 may include a sharp hub 5014 that is configured to secure and carry the sharp object 5012. As shown in Fig.18B 5014, the sharp hub 5014 may include or otherwise define a mating member 5016. To couple the sharp object 5012 to the sensor control device 5002, the sharp object 5012 may be advanced axially through the electronic device housing 5004 until the sharp hub 5014 engages the upper surface of the housing 5006 and the mating member 5016 extends distally from the bottom of the support 5008. When the sharp object 5012 penetrates the electronic device housing 5004, the exposed portion of the sensor 5010 may be received within the hollow or recessed (arcuate) portion of the sharp object 5012. The remainder of the sensor 5010 is disposed within the interior of the electronic device housing 5004.

[0295] The sensor control device 5002 may further include a sensor cap 5018. FIG. 18A to FIG. 18B 5004). The sensor cap 5016 can be removably coupled to the sensor control device 5002 (e.g., the electronic device housing 5004) at or near the bottom of the support 5008. The sensor cap 5018 can help provide a sealing barrier that surrounds and protects the exposed portions of the sensor 5010 and the sharp object 5012 from gas chemical sterilization. As shown, the sensor cap 5018 can include a generally cylindrical body having a first end 5020a and a second end 5020b opposite the first end 5020a. The first end 5020a can be open to provide access to an internal chamber 5022 defined within the body. In contrast, the second end 5020b can be closed and a mating feature 5024 can be provided or otherwise defined. As described herein, the mating feature 5024 can help mate the sensor cap 5018 to a sensor applicator (e.g., Figure 1 and Figure 3A to the sensor applicator 150 of FIG. 3G ) cap (e.g., Figure 3B applicator cap 708) and can help remove the sensor cap 5018 from the sensor control device 5002 when removing the cap from the sensor applicator.

[0296] The sensor cap 5018 can be removably coupled to the electronic device housing 5004 at or near the bottom of the support 5008. More specifically, the sensor cap 5018 can be removably coupled to a mating member 5016 that extends distally from the bottom of the support 5008. In at least one embodiment, for example, the mating member 5016 can define a set of external threads 5026a ( Fig.18B ), which can be connected to a set of internal threads 5026b (defined by the sensor cap 5018) Fig.18A ) engagement. In some embodiments, the external threads 5026a and the internal threads 5026b can include a flat thread design (e.g., without a helical curvature), which can prove advantageous when molding components. Alternatively, the external threads 5026a and the internal threads 5026b can include a helical thread engagement. Thus, the sensor cap 5018 can be threadedly coupled to the sensor control device 5002 at the mating member 5016 of the sharp hub 5014. In other embodiments, the sensor cap 5018 can be removably coupled to the mating member 5016 via other types of engagement, including but not limited to an interference fit or a friction fit, or a fragile member or substance that can be broken with minimal separation force (e.g., axial force or rotational force).

[0297] In some embodiments, the sensor cap 5018 may include an integral (single) structure extending between the first end 5020a and the second end 5020b. However, in other embodiments, the sensor cap 5018 may include two or more component parts. In the illustrated embodiment, for example, the sensor cap 5018 may include a sealing ring 5028 positioned at the first end 5020a and a desiccant cap 5030 arranged at the second end 5020b. The sealing ring 5028 may be configured to help seal the inner chamber 5022, as described in more detail below. In at least one embodiment, the sealing ring 5028 may include an elastic O-ring. The desiccant cap 5030 may contain or include a desiccant to help maintain a preferred humidity level within the inner chamber 5022. The desiccant cap 5030 may also define or otherwise provide a bonding feature 5024 of the sensor cap 5018.

[0298] Fig.19A and Fig.19B5002 , respectively, are exploded isometric top and bottom views of the sensor control device 5002 according to one or more embodiments. The housing 5006 and the support 5008 operate as relative flip-top halves that surround or otherwise substantially enclose various electronic components of the sensor control device 5002. More specifically, the electronic components may include, but are not limited to, a printed circuit board (PCB), one or more resistors, transistors, capacitors, inductors, diodes, and switches. The data processing unit and the battery may be mounted to the PCB or otherwise interact with the PCB. The data processing unit may include, for example, an application specific integrated circuit (ASIC), which is configured to implement one or more functions or routines associated with the operation of the sensor control device 5002. More specifically, the data processing unit may be configured to perform data processing functions, wherein such functions may include, but are not limited to, filtering and encoding of data signals, wherein each data signal corresponds to a sampled analyte level of a user. The data processing unit may also include a reader device 120 ( Figure 1 ) or otherwise communicate with the antenna. The battery can provide power to the sensor control device 5002, and more specifically, to the electronic components of the PCB. For example, the battery can be any battery known to those of ordinary skill in the art, such as a button cell battery or button cell battery, such as Fig.19C As shown. In some embodiments, the battery 1900 may include a silver oxide battery. The battery 1900 may be laser welded to the PCB and positioned to ensure that the outer diameter of the battery remains within the periphery of the PCB. In some embodiments, the battery 1900 may be connected to the PCB using a negative battery tab 1900a and a positive battery tab 1900b. For example, the negative battery tab 1900a of the battery 1900 may be substantially planar and located in the same plane as the negative terminal of the battery 1900; while the positive battery tab 1900b may include one or more bends so that one end of the positive terminal 1900b contacts the positive battery terminal and is located in the same plane, while the second end configured to be coupled to the PCB is located in the same plane as the negative battery tab 1900a. In addition, the battery 1900 may be positioned in a battery opening on the PCB to eliminate electrical interference between the negative battery tab 1900a and the PCB. Although not shown, the sensor control device 5002 may also include a bottom 5102 ( Fig.19B ) and can help adhere the sensor control device 5002 to the user's skin for use.

[0299] The sensor control device 5002 may provide or otherwise include a sealing subassembly that includes the housing 5006, the sensor 5010, the sharp object 5012, and the sensor cap 5018, among other component parts. The sealing subassembly of the sensor control device 5002 may help isolate the sensor 5010 and the sharp object 5012 within the inner chamber 5022 ( Fig.19A ) otherwise it may adversely affect the chemicals provided on the sensor 5010.

[0300] The sensor 5010 may include a tail portion 5104 extending out of an opening 5106 ( Fig.19B ) to be received transcutaneously beneath the user's skin. The tail 5104 may have an enzyme or other chemical included thereon to help facilitate analyte monitoring. The sharp object 5012 may include an opening 5110 ( Fig.19A ) and the opening 5110 can be coaxially aligned with the opening 5106 of the support 5008. When the sharp tip 5108 penetrates the electronic device housing 5004, the tail 5104 of the sensor 5010 can be received in the hollow or recessed portion of the sharp tip 5108. The sharp tip 5108 can be configured to penetrate the skin when the tail 5104 is carried so that the active chemical substance of the tail 5104 contacts the body fluid.

[0301] The sharp object tip 5108 can be advanced through the electronic device housing 5004 until the sharp hub 5014 engages the upper surface of the housing 5006 and the mating member 5016 extends out of the opening 5106 in the bottom 5102 of the support 5008. In some embodiments, a sealing member (not shown) (such as an O-ring or sealing ring) can be inserted into the sharp hub 5014 and the upper surface of the housing 5006 to help seal the interface between the two components. In some embodiments, the sealing member can include a separate component, but can also alternatively form an integral part of the housing 5006, such as a co-molded or overmolded component portion.

[0302] The sealing subassembly can also include a collar 5112 positioned within the electronic device housing 5004 and extending at least partially into the opening 5106. The collar 5112 can be a generally annular structure that defines or otherwise provides an annular ridge 5114 on a top surface thereof. In some embodiments, as shown, a groove 5116 can be defined in the annular ridge 5114 and can be configured to accommodate or otherwise receive a portion of the sensor 5010 that extends laterally within the electronic device housing 5004.

[0303] When the sealing subassembly is assembled, the bottom 5118 of the collar 5112 can be exposed at the opening 5106 and can sealingly engage the first end 5020a of the sensor cap 5018, and more specifically, the sealing ring 5028. In contrast, the annular ridge 5114 at the top of the collar 5112 can sealingly engage the inner surface (not shown) of the housing 5006. In at least one embodiment, a sealing member (not shown) can be inserted into the annular ridge 5114 and the inner surface of the housing 5006 to form a sealing interface. In such an embodiment, the sealing member can also extend (flow) into the groove 5116 defined in the annular ridge 5114, thereby sealing around the sensor 5010 extending laterally within the electronic device housing 5004. The sealing member can include, for example, an adhesive, a gasket, or an ultrasonic weld, and can help isolate enzymes and other chemicals included on the tail 5104.

[0304] Fig. 20 is a cross-sectional side view of an assembled sealing subassembly 5200 according to one or more embodiments. The sealing subassembly 5200 may be formed FIG. 18A to FIG. 18B and FIG. 19A to FIG. 20 The sensor control device 5002 of FIG. 5006 is a portion of the sensor control device 5002 of FIG. 5006, and can include a housing 5006, a sensor 5010, a sharp object 5012, a sensor cap 5018, and a portion of a collar 5112. The sealing subassembly 5200 can be assembled in various ways. In one assembly process, the sharp object 5012 can be coupled to the sensor control device 5002 by extending the sharp object tip 5108 through the opening 5110 defined in the top of the housing 5006 and pushing the sharp object 5012 through the housing 5006 until the sharp hub 5014 engages the top of the housing 5006 and the mating member 5016 extends distally from the housing 5006. In some embodiments, as described above, a sealing member 5202 (e.g., an O-ring or sealing ring) can be inserted into the upper surface of the sharp hub 5014 and the housing 5006 to help seal the interface between the two components.

[0305] The collar 5112 can then be received over (around) the mating member 5016 and advanced toward the inner surface 5204 of the housing 5006 so that the annular ridge 5114 can engage the inner surface 5204. The sealing member 5206 can be inserted into the annular ridge 5114 and the inner surface 5204 to form a sealing interface. The sealing member 5206 can also extend (flow) into the groove 5116 ( FIG. 19A to FIG. 20 B), thereby sealing around the sensor 5010 extending laterally within the electronic device housing 5004 ( FIG. 19A to FIG. 20B) However, in other embodiments, the collar 5112 may first be sealed to the inner surface 5204 of the housing 5006, and then the sharps 5012 and sharp hub 5014 may extend through the aperture 5110, as described above.

[0306] The sensor cap 5018 can be removably coupled to the sensor control device 5002 by threading the internal threads 5026b of the sensor cap 5018 with the external threads 5026a of the mating member 5016. Tightening (rotating) the mating engagement between the sensor cap 5018 and the mating member 5016 can cause the first end 5020a of the sensor cap 5018 to sealably engage with the bottom 5118 of the collar 5112. In addition, tightening the mating engagement between the sensor cap 5018 and the mating member 5016 can also enhance the sealing interface between the sharp hub 5014 and the top of the housing 5006 and between the annular ridge 5114 and the inner surface 5204 of the housing 5006.

[0307] The inner chamber 5022 can be sized and otherwise configured to receive the tail 5104 and the sharp tip 5108. In addition, the inner chamber 5022 can be sealed to isolate the tail 5104 and the sharp tip 5108 from substances that may interact adversely with the chemistry of the tail 5104. In some embodiments, a desiccant 5208 (shown in phantom) can be present within the inner chamber 5022 to maintain an appropriate humidity level.

[0308] Once properly assembled, the sealing subassembly 5200 can be subjected to any of the radiation sterilization processes described herein to properly sterilize the sensor 5010 and sharps 5012. This sterilization step can be performed separately from the rest of the sensor control device ( FIG. 18A to FIG. 18B and FIG. 19A to FIG. 20 B) to prevent damage to sensitive electrical components. The sealing subassembly 5200 can be subjected to radiation sterilization before or after the sensor cap 5018 is coupled to the sharp hub 5014. When sterilized after the sensor cap 5018 is coupled to the sharp hub 5014, the sensor cap 5018 can be made of a material that allows radiation to propagate through. In some embodiments, the sensor cap 5018 can be transparent or translucent, but can also be opaque without departing from the scope of the present disclosure.

[0309] FIG. 21A to FIG. 21C is a progressive cross-sectional side view showing the assembly of the sensor applicator 102 with the 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. Fig.21A, the sharp hub 5014 may include or otherwise define a hub snap claw 5302 that is configured to help couple the sensor control device 5002 to the sensor applicator 102. More specifically, the sensor control device 5002 may be advanced into the interior of the sensor applicator 102, and the hub snap claw 5302 may be received by a corresponding arm 5304 of a sharps carrier 5306 positioned within the sensor applicator 102.

[0310] exist Fig. 21B , the sensor control device 5002 is shown as being received by the sharps carrier 5306 and thus secured within the sensor applicator 102. Once the sensor control device 5002 is 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 the housing 208 can have opposing, matable sets of threads 5308 that enable the applicator cap 210 to be screwed onto the housing 208 in a clockwise (or counterclockwise) direction, thereby securing the applicator cap 210 to the sensor applicator 102.

[0311] As shown, the sheath 212 is also positioned within the sensor applicator 102, and the sensor applicator 102 may include a sheath locking mechanism 5310 configured to ensure that the sheath 212 does not collapse prematurely during an impact event. In the illustrated embodiment, the sheath locking mechanism 5310 may include a threaded engagement between the applicator cap 210 and the sheath 212. More specifically, one or more internal threads 5312a may be defined or otherwise disposed on the inner surface of the applicator cap 210, and one or more external threads 5312b may be defined or otherwise disposed on the sheath 212. The internal threads 5312a and the external threads 5312b may be configured to threadably engage when the applicator cap 210 is threadedly connected to the sensor applicator 102 at the threads 5308. The internal threads 5312a and the external threads 5312b may have the same pitch as the threads 5308, which enables the applicator cap 210 to be screwed onto the housing 208.

[0312] exist Fig. 21C , the applicator cap 210 is shown as being fully threaded (coupled) to the housing 208. As shown, the applicator cap 210 may also provide and otherwise define a cap post 5314 that is centrally located within the applicator cap 210 and extends proximally from the 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 screwed onto the housing 208.

[0313] With the sensor control assembly 5002 loaded within the sensor applicator 102 and the applicator cap 210 properly secured, the sensor control assembly 5002 can then be subjected to a gas chemical sterilization configured to sterilize the electronics housing 5004 and any other exposed portions of the sensor control assembly 5002. Because the distal portion of the sensor 5010 and sharp 5012 are sealed within the sensor cap 5018, the chemicals used during the gas chemical sterilization process cannot interact with the enzymes, chemicals, and biological agents provided on the tail 5104 and other sensor components such as the membrane coating that regulates the influx of the analyte.

[0314] Fig.22A and Fig. 22B 53 and 53, respectively, are a perspective view and a top view of the cap post 5314 according to one or more additional embodiments. In the illustration, a portion of the sensor cap 5018 is received within the cap post 5314, and more specifically, the desiccant cap 5030 of the sensor cap 5018 is disposed within the cap post 5314.

[0315] As shown, the cap post 5314 can define a receiver feature 5402 that is configured to receive the applicator cap 210 ( Fig. 21C ) is coupled (eg, threadedly connected) to the sensor applicator 102 ( FIG. 21A to FIG. 21C ) when receiving the engagement feature 5024 of the sensor cap 5018. However, when the applicator cap 210 is removed from the sensor applicator 102, the receiver feature 5402 can prevent the engagement feature 5024 from reversing direction, thereby preventing the sensor cap 5018 from separating from the cap post 5314. Conversely, removing the applicator cap 210 from the sensor applicator 102 will simultaneously cause the sensor cap 5018 to separate from the sensor control device 5002 ( FIG. 18A to FIG. 18B and FIG. 21A to FIG. 21C ) is separated, thereby exposing the sharp object 5012 ( FIG. 21A to FIG. 21C ) and the distal portion of the sensor 5010 ( FIG. 21A to FIG. 21C ).

[0316] Many design variations of the receiver feature 5402 may be employed without departing from the scope of the present disclosure. In the illustrated embodiment, the receiver feature 5402 includes one or more compliant members 5404 (two are shown) that are expandable or flexible to receive the engagement feature 5024 ( FIG. 18A to FIG. 18B ). Engagement feature 5024 may include, for example, an enlarged head, and compliant member 5404 may include a collet-type device including a plurality of compliant fingers configured to flex radially outward to receive the enlarged head.

[0317] The compliant member 5404 may also provide or otherwise define a corresponding inclined surface 5406 that is configured to interact with one or more opposing cam surfaces 5408 disposed on an outer wall of the engagement feature 5024. The configuration and alignment of the inclined surfaces 5406 and the opposing cam surfaces 5408 enable the applicator cap 210 to rotate relative to the sensor cap 5018 in a first direction A (e.g., clockwise), but when the applicator cap 210 is rotated in a second direction B (e.g., counterclockwise), the cap post 5314 abuts against the sensor cap 5018. More specifically, when the applicator cap 210 (and therefore the cap post 5314) is rotated in the first direction A, the cam surfaces 5408 engage the inclined surfaces 5406, which causes the compliant member 5404 to bend or otherwise deflect radially outward and produce a ratcheting effect. However, rotating the applicator cap 210 (and therefore the cap post 5314 ) in the second direction B will drive the angled surface 5410 of the cam surface 5408 into the opposing angled surface 5412 of the inclined surface 5406 , which causes the sensor cap 5018 to abut against the compliant member 5404 .

[0318] Fig.23 5002 is a cross-sectional side view of the sensor control device 5002 positioned within the applicator cap 210 according to one or more embodiments. As shown, the opening of the receiver feature 5402 has a first diameter D3, and the engagement feature 5024 of the sensor cap 5018 has a second diameter D4, which is greater than the first diameter D3 and greater than the outer diameter of the remainder of the sensor cap 5018. When the sensor cap 5018 extends into the cap post 5314, the compliant member 5404 of the receiver feature 5402 can bend (expand) radially outward to receive the engagement feature 5024. In some embodiments, as shown, the engagement feature 5024 can provide or otherwise define an angled or frustoconical outer surface that helps bias the compliant member 5404 radially outward. Once the engagement feature 5024 bypasses the receiver feature 5402, the compliant member 5404 can bend back (or toward) its natural state, thereby locking the sensor cap 5018 within the cap post 5314.

[0319] When the applicator cap 210 is threadedly connected to (screwed to) the housing 208 in a first direction A ( FIG. 21A to FIG. 21C), the cap post 5314 correspondingly rotates in the same direction and the sensor cap 5018 is gradually introduced into the cap post 5314. As the cap post 5314 rotates, the inclined surface 5406 of the compliant member 5404 ratchets against the opposing cam surface 5408 of the sensor cap 5018. This will continue until the applicator cap 210 is fully threaded (screwed onto) the housing 208. In some embodiments, the ratcheting action can occur during two complete rotations of the applicator cap 210 before the applicator cap 210 reaches its final position.

[0320] To remove the applicator cap 210, the applicator cap 210 is rotated in the second direction B, which correspondingly rotates the cap post 5314 in the same direction and causes the cam surface 5408 (ie, FIG. 22A to FIG. 22B The angled surface 5410) abuts against the inclined surface 5406 (ie, FIG. 22A to FIG. 22B 5412). Thus, 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 to allow the sensor cap 5018 to be separated from the sensor control device 5002. Separating the sensor cap 5018 from the sensor control device 5002 exposes the sharp 5012 and the distal portion of the sensor 5010, thereby placing the sensor control device 5002 in a fired (use) position.

[0321] Fig.24A and Fig. 24B is a cross-sectional side view of a sensor applicator 102 ready to deploy a sensor control device 5002 to a target monitoring location according to one or more embodiments. More specifically, Fig.24A The sensor applicator 102 is depicted ready to deploy (fire) the sensor control device 5002, and Fig. 24B The sensor applicator 102 is depicted during deployment (firing) of the sensor control device 5002. As shown, the applicator cap 210 ( FIG. 21A to FIG. 21C and Fig.23 ) has been removed, which correspondingly separates (removes) sensor cap 5018 ( FIG. 21A to FIG. 21C and Fig.23 ), thereby exposing the tail 5104 of the sensor 5010 and the sharp tip 5108 of the sharp object 5012, as described above. In conjunction with the sheath 212 and the sharp object carrier 5306, the sensor applicator 102 also includes a sensor carrier 5602 (alternatively referred to as a "disc" carrier), which helps to position and fix the sensor control device 5002 within the sensor applicator 102.

[0322] First reference Fig.24AAs shown, the sheath 212 includes one or more sheath arms 5604 (one shown) that are configured to interact with corresponding one or more detents 5606 (one shown) defined within the interior of the housing 208. The detents 5606 are alternatively referred to as "firing" detents. When the sensor control device 5002 is initially installed in the sensor applicator 102, the sheath arms 5604 can be received within the detents 5606, which places the sensor applicator 102 in a fired position. In the fired position, the mating member 5016 extends distally beyond the bottom of the sensor control device 5002. As discussed below, the process of firing the sensor applicator 102 causes the mating member 5016 to retract so that it does not contact the user's skin.

[0323] The sensor carrier 5602 may also include one or more carrier arms 5608 (one shown) configured to interact with corresponding one or more recesses 5610 (one shown) defined on the sharps carrier 5306. A spring 5612 may be disposed within a cavity defined by the sharps carrier 5306 and may passively bias the sharps carrier 5306 upward within the housing 208. However, when the carrier arms 5608 are properly received within the recesses 5610, the sharps carrier 5306 is held in place and prevented from moving upward. The carrier arms 5608 are inserted into the sheath 212 and the sharps carrier 5306, and the radial shoulders 5614 defined on the sheath 212 may be sized to hold the carrier arms 5608 engaged within the recesses 5610, thereby holding the sharps carrier 5306 in place.

[0324] exist Fig. 24B , the sensor applicator 102 is in the firing process. Figure 3F 3G , this can be accomplished by advancing the sensor applicator 102 toward the target monitoring location until the sheath 212 engages the user's skin. Continued pressure of the sensor applicator 102 against the skin may cause the sheath arms 5604 to disengage from the corresponding detents 5606, which allows 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, which allows the carrier arms 5608 to disengage from engagement with the grooves 5610. The passive spring force of the spring 5612 can then freely push the sharps carrier 5306 upward, thereby forcing the carrier arms 5608 to disengage from engagement with the grooves 5610, which allows 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 to increase the spring force required to overcome the engagement between the carrier arms 5608 and the grooves 5610. In at least one embodiment, one or both of the carrier arm 5608 and the groove 5610 can be angled to facilitate easy disengagement.

[0325] As the sharps carrier 5306 moves upward within the housing 208, the sharp hub 5014 can correspondingly move in the same direction, which can cause a portion of the mating member 5016 to retract so that it becomes flush, substantially flush, or sub-flush with the bottom of the sensor control device 5002. As will be appreciated, this ensures that the mating member 5016 does not contact the user's skin, which could otherwise adversely affect sensor insertion, cause undue pain, or prevent an adhesive patch (not shown) positioned on the bottom of the sensor control device 5002 from properly adhering to the skin.

[0326] FIG. 25A to FIG. 25C is a progressive cross-sectional side view illustrating the assembly and disassembly of an alternative embodiment of the sensor applicator 102 and the sensor control device 5002 according to one or more additional embodiments. The fully assembled sensor control device 5002 can be loaded into the sensor applicator 102 by coupling the hub snap claws 5302 into the arms 5304 of the sharps carrier 5306 positioned within the sensor applicator 102, as generally described above.

[0327] In the illustrated embodiment, the sheath arm 5604 of the sheath 212 can be configured to interact with a first pawl 5702a and a second pawl 5702b defined within the interior of the housing 208. The first pawl 5702a can alternatively be referred to as a "locking" pawl, and the second pawl 5702b can alternatively be referred to as a "firing" pawl. When the sensor control device 5002 is initially installed in the sensor applicator 102, the sheath arm 5604 can be received within the first pawl 5702a. As discussed below, the sheath 212 can be actuated to move the sheath arm 5604 to the second pawl 5702b, which places the sensor applicator 102 in the firing position.

[0328] exist Fig.25B , the applicator cap 210 is aligned with the housing 208 and advanced toward the housing 208 so that the sheath 212 is received within the applicator cap 210. Instead of rotating the applicator cap 210 relative to the housing 208, the threads 210 of the applicator cap can snap onto corresponding threads of the housing 208 to couple the applicator cap 210 to the housing 208. Axial cutouts or slots 5703 (one shown) defined in the applicator cap 210 can allow a portion of the applicator cap 210 proximate its threads to flex outwardly, thereby snapping into engagement with the threads of the housing 208. When the applicator cap 210 is snapped onto the housing 208, the sensor cap 5018 can correspondingly snap into the cap post 5314.

[0329] Similar to FIG. 21A to FIG. 21CIn an embodiment of the sensor applicator 102, the sheath locking mechanism is configured to ensure that the sheath 212 does not collapse prematurely during an impact event. In the illustrated embodiment, the sheath locking mechanism includes one or more ribs 5704 (one shown) defined near the base of the sheath 212 and configured to interact with one or more ribs 5706 (two shown) and a shoulder 5708 defined near the base of the applicator cap 210. The ribs 5704 can be configured to interlock between the ribs 5706 and the shoulders 5708 while the applicator cap 210 is attached to the housing 208. More specifically, once the applicator cap 210 is snapped onto the housing 208, the applicator cap 210 can be rotated (e.g., clockwise), which positions the rib 5704 of the sheath 212 between the rib 5706 and the shoulder 5708 of the applicator cap 210, thereby "locking" the applicator cap 210 in place until the user reverses the rotation of the applicator cap 210 to remove the applicator cap 210 for use. The engagement of the rib 5704 between the rib 5706 and the shoulder 5708 of the applicator cap 210 can also prevent the sheath 212 from collapsing prematurely.

[0330] exist Fig.25C , the applicator cap 210 is removed from the housing 208. FIG. 21A to FIG. 21C As in the embodiment of the present invention, the applicator cap 210 can be removed by rotating the applicator cap 210 in the opposite direction, which correspondingly rotates the cap column 5314 in the same direction and unscrews the sensor cap 5018 from the mating member 5016, as generally described above. In addition, separating the sensor cap 5018 from the sensor control device 5002 exposes the distal portion of the sensor 5010 and the sharp object 5012.

[0331] When the applicator cap 210 is unscrewed from the housing 208, the rib 5704 defined on the sheath 212 can slidably engage the top of the rib 5706 defined on the applicator cap 210. The top of the rib 5706 can provide a corresponding inclined surface that causes the sheath 212 to displace upward as the applicator cap 210 is rotated, and the upward movement of the sheath 212 causes the sheath arm 5604 to bend to disengage from the first pawl 5702a, thereby being received in the second pawl 5702b. When the sheath 212 moves to the second pawl 5702b, the radial shoulder 5614 moves out of radial engagement with the carrier arm 5608, which allows the passive spring force of the spring 5612 to push the sharps carrier 5306 upward and force the carrier arm 5608 to disengage from the groove 5610. As the sharps carrier 5306 moves upward within the housing 208, the mating member 5016 can correspondingly retract until it becomes flush, substantially flush, or sub-flush with the bottom of the sensor control device 5002. At this point, the sensor applicator 102 is in the firing position. Thus, in this embodiment, removing the applicator cap 210 correspondingly causes the mating member 5016 to retract.

[0332] Fig.26A 2 is an isometric bottom view of the housing 208 according to one or more embodiments. As shown, one or more longitudinal ribs 5802 (four are shown) can be defined within the interior of the housing 208. The ribs 5802 can be spaced equidistantly or unequally from each other and extend substantially parallel to the centerline of the housing 208. The first detent 5702a and the second detent 5702b can be defined on one or more of the longitudinal ribs 5802.

[0333] Fig.27A 5804 is an isometric bottom view of the housing 208 with the sheath 212 and other components at least partially positioned within the housing 208. As shown, the sheath 212 may provide or otherwise define one or more longitudinal slots 5804 that are configured to mate with longitudinal ribs 5802 of the housing 208. When the sheath 212 is collapsed into the housing 208, as generally described above, the ribs 5802 may be received within the slots 5804 to help maintain alignment of the sheath 212 with the housing during movement of the sheath 212. As will be appreciated, this may result in tighter circumferential and radial alignment within the same size and tolerance limits of the housing 208.

[0334] In the illustrated embodiment, the sensor carrier 5602 can be configured to hold the sensor control device 5002 axially (e.g., once the sensor cap 5018 is removed) and circumferentially in place. To achieve this, 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 for the sensor control device 5002. The flexible arms 5808 extend partially around the circumference of the sensor control device 5002, and the ends of the flexible arms 5808 can be received in corresponding grooves 5810 defined in the sides of the sensor control device 5002. Therefore, the flexible arms 5808 can be capable of providing both axial support and radial support for the sensor control device 5002. In at least one embodiment, the ends of the flexible arms 5808 can be biased into the grooves 5810 of the sensor control device 5002 and otherwise locked in place using corresponding sheath locking ribs 5812 provided by the sheath 212.

[0335] In some embodiments, the sensor carrier 5602 can be ultrasonically welded to the housing 208 at one or more points 5814. However, in other embodiments, the sensor carrier 5602 can alternatively be coupled to the housing 208 via a snap-fit ​​engagement without departing from the scope of the present disclosure. This can help keep the sensor-control device 5002 in place during transport and firing.

[0336] Fig.28 is an enlarged cross-sectional side view of a sensor applicator 102 according to one or more embodiments, wherein the sensor control device 5002 is installed in the sensor applicator. As discussed above, the sensor carrier 5602 can include one or more carrier arms 5608 (two are shown) that can engage with the sharps carrier 5306 at 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 undesirable tilting during all stages of retraction (firing).

[0337] In the illustrated embodiment, the arms 5304 of the sharp carrier 5306 may be sufficiently rigid to provide more finely controlled radial and biaxial movement of the sharp hub 5014. For example, in some embodiments, the clearance between the sharp hub 5014 and the arms 5304 may be more restrictive in both axial directions because relative control of the height of the sharp hub 5014 may be more critical to the design.

[0338] In the illustrated embodiment, the sensor carrier 5602 defines or otherwise provides a central boss 5904 that is sized to receive the sharp hub 5014. In some embodiments, as shown, the sharp hub 5014 can provide one or more radial ribs 5906 (two are shown). In at least one embodiment, the inner diameter of the central boss 5904 helps provide radial and tilt support for the sharp hub 5014 during the life of the sensor applicator 102 and at all stages of operation and assembly. In addition, having multiple radial ribs 5906 increases the aspect ratio of the sharp hub 5014, which also improves support for tilting.

[0339] Fig.29A 57 is an isometric top view of an applicator cap 210 according to one or more embodiments. In the illustrated embodiment, two axial grooves 5703 are depicted, which separate the upper portion of the applicator cap 210 near its threads. As described above, the grooves 5703 can help the applicator cap 210 bend outward to snap-fit ​​into engagement with the housing 208 ( Fig.25B ). In contrast, the applicator cap 210 can be unscrewed (unscrewed) from the housing 208 by the end user.

[0340] Fig.29A Also depicted are ribs 5706 (one visible) defined by the applicator cap 210. Fig.25C ) on the rib 5704 ( Fig.25C ) interlocked, the ribs 5706 can help lock the sheath 212 in all directions to prevent premature collapse during an impact or drop event. As generally described above, the sheath 212 can be unlocked when the user unscrews the applicator cap 210 from the housing. As described herein, the top of each rib 5706 can provide a corresponding inclined surface 6002, and when the applicator cap 210 is rotated to unscrew from the housing 208, the ribs 5704 defined on the sheath 212 can slidably engage the inclined surface 6002, which causes the sheath 212 to shift upward into the housing 208.

[0341] In some embodiments, additional features may be provided on the interior of the applicator cap 210 to retain a desiccant component that maintains an appropriate humidity level during shelf life. Such additional features may be snaps, press-fit posts, heat staking, ultrasonic welding, etc.

[0342] Fig.29B2 is an enlarged cross-sectional view of the engagement between the applicator cap 210 and the housing 208 according to one or more embodiments. As shown, the applicator cap 210 can define a set of internal threads 6004, and the housing 208 can define a set of external threads 6006 that can engage with the internal threads 6004. As described herein, the applicator cap 210 can be snapped onto the housing 208, which can be achieved by axially advancing the internal threads 6004 through the external threads 6006 in the direction indicated by the arrows, which causes the applicator cap 210 to bend outward. To help simplify this transition, as shown, the corresponding surfaces 6008 of the internal threads 6004 and the external threads 6006 can be curved, angled or chamfered. Corresponding flat surfaces 6010 can be provided on each thread 6004, 6006 and are configured to engage matingly once the applicator cap 210 is properly snapped into place on the housing 208. When the user unscrews the applicator cap 210 from the housing 208, the planar surfaces 6010 may slidingly engage one another.

[0343] The threaded engagement between the applicator cap 210 and the housing 208 results in a sealed engagement that protects the internal components from moisture, dust, etc. In some embodiments, the housing 208 can define or otherwise provide a stabilizing feature 6012 that is configured to be received within a corresponding groove 1914 defined on the applicator cap 210. Once the applicator cap 210 is snapped onto the housing 208, the stabilizing feature 6012 can help stabilize and strengthen the applicator cap 210. This can prove to be advantageous in providing additional drop robustness to the sensor applicator 102. This can also help increase the removal torque of the applicator cap 210.

[0344] Fig. 30A and Fig. 30B 5018 and the collar 5112, respectively, according to one or more embodiments. Fig. 30A In some embodiments, the sensor cap 5018 may include an injection molded component. This may prove advantageous when molding 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 (visible) may be defined within the inner chamber 5022 to prevent over-travel of the mating member 5016 relative to the sharpened hub 5014 ( FIG. 18A to FIG. 18B ).

[0345] refer to Fig. 30A and Fig. 30BBoth, in some embodiments, one or more protrusions 6104 (two are shown) can be defined on the first end 5020a of the sensor cap 5018 and are configured to cooperate with one or more corresponding indentations 6106 (two are shown) defined on the collar 5112. However, in other embodiments, the protrusions 6104 can instead be defined on the collar 5112 and the indentations 6106 can be defined on the sensor cap 5018 without departing from the scope of the present disclosure.

[0346] The matable protrusion 6104 and indentation 6106 may prove advantageous in rotationally locking the sensor cap 5018 to prevent accidental unscrewing of the sensor cap 5018 from the collar 5112 (and thus the sensor control device 5002) during the life of the sensor applicator 102 and at all stages of operation / assembly. In some embodiments, as shown, the indentation 6106 may be formed or otherwise defined in the general shape of a kidney bean. This 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 via a flat-end threaded engagement between the two components.

[0347] Embodiments disclosed herein include:

[0348] A. A sensor control device, comprising an electronic device housing, a sensor arranged in the electronic device housing and having a tail extending from the bottom of the electronic device housing, a sharp object extending through the electronic device housing and having a sharp object tip extending from the bottom of the electronic device housing, and a sensor cap removably coupled at the bottom of the electronic device housing and defining a sealed internal chamber for receiving the tail and the sharp object.

[0349] B. An analyte monitoring system comprising a sensor applicator, a sensor control device positioned within the sensor applicator and comprising an electronic device housing, a sensor disposed within the electronic device housing and having a tail extending from a bottom of the electronic device housing, a sharp extending through the electronic device housing and having a sharp tip extending from a bottom of the electronic device housing, and a sensor cap removably coupled at the bottom of the electronic device housing and defining an engagement feature and a sealed inner chamber for receiving the tail and the sharp. The analyte monitoring system may also include a cap coupled to the sensor applicator and providing a cap post defining a receiver feature that receives the engagement feature when the cap is coupled to the sensor applicator, wherein removal of the cap from the sensor applicator causes the sensor cap to separate from the electronic device housing, thereby exposing the tail and the sharp tip.

[0350] C. A method of preparing an analyte monitoring system, comprising: loading a sensor control device into a sensor applicator, the sensor control device comprising an electronic device housing, a sensor disposed within the electronic device housing and having a tail extending from a bottom of the electronic device housing, a sharp extending through the electronic device housing and having a sharp tip extending from the bottom of the electronic device housing, and a sensor cap removably coupled at the bottom of the electronic device housing and defining a sealed inner chamber receiving the tail and the sharp. The method further comprises: securing the cap to the sensor applicator, sterilizing the sensor control device with a gaseous chemical sterilization while the sensor control device is positioned within the sensor applicator, and isolating the tail and the sharp tip within the inner chamber from the gaseous chemical sterilization.

[0351] Each of embodiments A, B, and C may have one or more of the following additional elements in any combination: Element 1: wherein the sensor cap includes a cylindrical body having a first end and a second end, the first end being open to enter the internal chamber, the second end being opposite the first end and providing an engagement feature that can engage with the cap of the sensor applicator, wherein removing the cap from the sensor applicator correspondingly removes the sensor cap from the electronic device housing, thereby exposing the tail and the sharp tip. Element 2: wherein the electronic device housing includes a housing that can mate with the support, the sensor control device also includes a sharp object and a sensor locator defined on the inner surface of the housing, and a collar received around the sharp object and the sensor locator, wherein the sensor cap is removably coupled to the collar. Element 3: wherein the sensor cap is removably coupled to the collar by one or more of an interference fit, a threaded engagement, a frangible member, and a frangible substance. Element 4: wherein an annular ridge surrounds the sharp object and the sensor locator, and the collar provides a column and an annular shoulder extending radially outward from the column, and wherein a sealing member is inserted into the annular shoulder and the annular ridge to form a sealing interface. Element 5: wherein the annular ridge defines a groove, and a portion of the sensor is located in the groove, and wherein the sealing member extends into the groove to seal the portion of the sensor. Element 6: wherein the sealing member is a first sealing member, and the sensor control device further includes a second sealing member that is inserted into the annular shoulder and a portion of the support to form a sealing interface. Element 7: wherein the electronic device housing includes a shell that can be mated with the support, the sensor control device further includes a sharp hub that carries a sharp object and can engage with the top surface of the shell, and a mating member defined by the sharp hub and extending from the bottom of the electronic device housing, wherein the sensor cap is removably coupled to the mating member. Element 8: further includes a collar that is at least partially receivable in an opening defined in the support and sealingly engages the sensor cap and the inner surface of the shell. Element 9: wherein the sealing member is inserted into the collar and the inner surface of the shell to form a sealing interface. Element 10: wherein the annular ridge defines a groove, and a portion of the sensor is located in the groove, and wherein the sealing member extends into the groove to seal the portion of the sensor.

[0352] Element 11: wherein the receiver feature includes one or more flexible members that bend to receive the engagement feature, and wherein the one or more flexible members prevent the engagement feature from leaving the cap post when the cap is removed from the sensor applicator. Element 12: also includes an inclined 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 inclined surface, wherein the inclined surface and the one or more cam surfaces allow the cap and the cap post to rotate relative to the sensor cap in a first direction, but prevent the cap and the cap post from rotating relative to the sensor cap in a second direction opposite to the first direction. Element 13: wherein the electronic device housing includes a shell that can be mated with the support, the sensor control device also includes a sharp hub that carries a sharp object and can engage with the top surface of the shell, and a mating member defined by the sharp hub and extending from the bottom of the electronic device housing, wherein the sensor cap is removably coupled to the mating member, and rotating the cap in the second direction separates the sensor cap from the mating component. Element 14: wherein the electronic device housing includes a shell that can cooperate with the support, and the sensor control device also includes a sharp object and a sensor locator defined on an inner surface of the shell, and an axle ring received around the sharp object and the sensor locator, wherein the sensor cap is removably coupled to the axle ring.

[0353] Element 15: wherein the cap provides a cap post defining a receiver feature, and the sensor cap defines an engagement feature, the method further comprising: receiving the engagement feature with the receiver feature when the cap is secured to the sensor applicator. Element 16: further comprising: removing the cap from the sensor applicator, and engaging the engagement feature to the receiver feature when the cap is removed, thereby separating the sensor cap from the electronic device housing and exposing the tail and sharp tip. Element 17: wherein the tail and sharp tip are sterilized using radiation sterilization and the tail and sharp tip are sealed within the internal chamber prior to loading the sensor control device into the sensor applicator.

[0354] As non-limiting examples, exemplary combinations suitable for A, B, and C include: element 2 and element 3; element 2 and element 4; element 4 and element 5; element 4 and element 6; element 7 and element 8; element 8 and element 9; element 9 and element 10; element 11 and element 12; and element 15 and element 16.

[0355] Exemplary embodiments of sealing arrangements for analyte monitoring systems

[0356] Fig.31A and Fig.31B 9102 are side views and isometric views, respectively, of an exemplary sensor control device 9102 according to one or more embodiments of the present disclosure. The sensor control device 9102 may be similar in some aspects to Figure 1The sensor control device 102 of FIG. 104 may be replaced by the sensor control device 102 of FIG. 104 and may therefore be best understood with reference to the sensor control device 102. Figure 1 The sensor control device 102 can therefore be used with Figure 1 The sensor applicator 102 can be used in conjunction with the sensor control device 9102, which can deliver the sensor control device 9102 to the target monitoring location on the user's skin.

[0357] As shown, the sensor control device 9102 includes an electronic device housing 9104, which can optionally be generally disc-shaped and can have a circular cross-section. However, in other embodiments, the electronic device housing 9104 can present other cross-sectional shapes, such as oval, elliptical, or polygonal, without departing from the scope of the present disclosure. The electronic device housing 9104 includes a housing 9106 and a support 9108 that can cooperate with the housing 9106 to define an interior space. The housing 9106 can be secured to the support 9108 via a variety of means, such as a snap fit, an interference fit, sonic welding, laser welding, one or more mechanical fasteners (e.g., screws), washers, adhesives, or any combination thereof. In some cases, the housing 9106 can be secured to the support 9108 so that a sealed interface is generated therebetween. The adhesive patch 9110 can be positioned on the bottom side of the support 9108 and otherwise attached to the bottom side of the support. Similar to Figure 1 Adhesive patch 108, adhesive patch 9110 can be configured to secure and maintain the sensor control device 9102 in an appropriate position on the user's skin during operation.

[0358] The sensor control device 9102 may also include a sensor 9112 and a sharp object 9114 for assisting in transcutaneous 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 the sharp object 9114 extend distally from the bottom of the electronic device housing 9104 (e.g., the support 9108). The sharp hub 9116 may be overmolded onto the sharp object 9114 and configured to secure and carry the sharp object 9114. As shown in Fig.31A9104, the sharp hub 9116 may include or otherwise define a mating member 9118. When the sharp object 9114 is assembled to the sensor control device 9102, the sharp object 9114 can be axially advanced through the electronic device housing 9104 until the sharp hub 9116 engages the upper surface of the electronic device housing 9104 or an internal component thereof, and the mating member 9118 extends distally from the bottom of the support 9108. As described below herein, in at least one embodiment, the sharp hub 9116 can sealingly engage an upper portion of a seal overmolded onto the support 9108. When the sharp object 9114 penetrates the electronic device housing 9104, the exposed portion of the sensor 9112 can be received within the hollow or recessed (arcuate) portion of the sharp object 9114. The remainder of the sensor 9112 is disposed within the interior of the electronic device housing 9104.

[0359] The sensor control device 9102 may also include a sensor cap 9120. FIG. 31A to FIG. 31B 9104 as being separated from the electronic device housing 9104. The sensor cap 9120 can help provide a sealing barrier that surrounds and protects exposed portions of the sensor 9112 and the sharp object 9114. As shown, the sensor cap 9120 can include a generally cylindrical body having a first end 9122a and a second end 9122b opposite the first end 9122a. The first end 9122a can be open to provide access to an internal chamber 9124 defined within the body. In contrast, the second end 9122b can be closed and can provide or otherwise define an engagement feature 9126. As described in more detail below, the engagement feature 9126 can help mate the sensor cap 9120 to a sensor applicator (e.g., Figure 1 and an applicator cap for a sensor applicator 102), and can assist in removing the sensor cap 9120 from the sensor control device 9102 when removing the sensor cap from the sensor applicator.

[0360] The sensor cap 9120 can be removably coupled to the electronic device housing 9104 at or near the bottom of the support 9108. More specifically, the sensor cap 9120 can be removably coupled to a mating member 9118 that extends distally from the bottom of the support 9108. In at least one embodiment, for example, the mating member 9118 can define a set of external threads 9128a ( Fig.31A ), the set of external threads can be connected with a set of internal threads 9128b (defined in the inner chamber 9124 of the sensor cap 9120) Fig.31B) engagement. In some embodiments, the external threads 9128a and the internal threads 9128b may include a flat thread design (e.g., without a helical curvature), but may alternatively include a helical thread engagement. Thus, in at least one embodiment, the sensor cap 9120 may be threadably coupled to the sensor control device 9102 at the mating member 9118 of the sharpened hub 9116. In other embodiments, the sensor cap 9120 may be removably coupled to the mating member 9118 via other types of engagement, including but not limited to an interference fit or a friction fit, or a frangible member or substance (e.g., wax, adhesive, etc.) that can be broken with minimal separation force (e.g., axial force or rotational force).

[0361] In some embodiments, the sensor cap 9120 may include an integral (single) structure extending between a first end 9122a and a second end 9122b. However, in other embodiments, the sensor cap 9120 may include two or more component parts. For example, in the illustrated embodiment, the body of the sensor cap 9120 may include a desiccant cap 9130 disposed at the second end 9122b. The desiccant cap 9130 may contain or include a desiccant to help maintain a preferred humidity level within the inner chamber 9124. In addition, the desiccant cap 9130 may also define or otherwise provide an engagement feature 9126 of the sensor cap 9120. In at least one embodiment, the desiccant cap 9130 may include an elastic plug inserted into the bottom end of the sensor cap 9120.

[0362] Fig.32A and Fig.32B 9102 according to one or more embodiments. The housing 9106 and the support 9108 operate as opposing clamshell halves that surround or otherwise substantially enclose various electronic components (not shown) of the sensor control device 9102. Exemplary electronic components that may be disposed between the housing 9106 and the support 9108 include, but are not limited to, batteries, resistors, transistors, capacitors, inductors, diodes, and switches.

[0363] The housing 9106 can define a first opening 9202a, and the support 9108 can define a second opening 9202b, and when the housing 9106 is properly mounted to the support 9108, the openings 9202a, 9202b can be aligned. Fig.32AAs best seen, the support 9108 may provide or otherwise define a base 9204 that extends from an inner surface of the support 9108 at the second opening 9202b. The base 9204 may define at least a portion of the second opening 9202b. Additionally, a channel 9206 may be defined on the inner surface of the support 9108 and may surround the base 9202. In the illustrated embodiment, the channel 9206 is circular in shape, but may alternatively be other shapes, such as elliptical, oval, or polygonal.

[0364] The support 9108 can include a molded portion made of a rigid material, such as plastic or metal. In some embodiments, the seal 9208 can be overmolded onto the support 9108 and can be made of an elastomer, rubber, polymer, or another pliable material suitable for facilitating a sealing interface. In embodiments where the support 9108 is made of plastic, the support 9108 can be molded in a first injection molding "shot" and the seal 9208 can be overmolded onto the support 9108 in a second injection molding "shot." Thus, the support 9108 can be referred to or otherwise characterized as a "two-shot support."

[0365] In the illustrated embodiment, the seal 9208 can be overmolded onto the support 9108 at the base 9204 and can also be overmolded onto the bottom of the support 9108. More specifically, the seal 9208 can define or otherwise provide a first sealing element 9210a and a second sealing element 9210b ( Fig.32B ), the first sealing element is overmolded onto the base 9204, and the second sealing element is interconnected with the first sealing element 9210a and overmolded onto the support 9108 at the bottom of the support 9108. In some embodiments, one or both of the sealing elements 9210a, 9210b can help form a corresponding portion (segment) of the second opening 9202b. Although the seal 9208 is described herein as being overmolded onto the support 9108, it is also contemplated herein that one or both of the sealing elements 9210a, 9210b can include a resilient component portion independent of the support 9208, such as an O-ring or a gasket.

[0366] The sensor control device 9102 may also include a collar 9212 disposed between the housing 9106 and the support 9208 and may be a generally annular structure defining a central opening 9214. The central opening 9214 may be sized to receive the first sealing element 9210a and may be aligned with the first opening 9202a and the second opening 9202b when the sensor control device 9102 is properly assembled. The shape of the central opening 9214 may generally match the shape of the second opening 9202b and the first sealing element 9210a.

[0367] In some embodiments, the collar 9212 may define or otherwise provide an annular lip 9216 on its bottom surface. The annular lip 9216 may be sized and otherwise configured to mate with or be received in a channel 9206 defined on an inner surface of the support 9108. In some embodiments, a groove 9218 may be defined in the annular lip 9216 and may be configured to accommodate or otherwise receive a portion of the sensor 9112 extending laterally within the support 9108. In some embodiments, the collar 9212 may also define or otherwise provide a collar channel 9220 ( Fig.32A ) which is sized to receive and otherwise engage with an annular ridge 9222 ( Fig.32B ) in cooperation. In some embodiments, the collar 9212 may also include a plurality of protrusions 9212a ( Fig.32C ). Tabs 9212a can be located on the same plane as the top surface of collar 9212 and form a shelf for the circuit board. In some embodiments, the circuit board can be a foldable and / or flexible PCB, as described in U.S. Provisional Application No. 63 / 081,223 filed on September 21, 2020, which is incorporated herein by reference in its entirety. For example, PCB 4000 can be mounted in an electronic device housing on multiple tabs 9212a. Fig.32D As can be seen in FIG. 4 , after the PCB 4000 has been loaded onto the sensor holder 9108, the first portion 4000a of the PCB can be located on the protrusion 9212a ( Fig.32D 9212a). Fig.32C As shown, the collar 9212 may include three tabs 9212a, and the tabs 9212a may have different sizes, for example, two of which are the same size as each other and are longer than the third tab (i.e., as measured along the circumference of the collar 9212). In addition, the tabs 9212a may have the same or different widths (i.e., as measured by the distance extending radially outward). In some embodiments, as Fig.32EAs can be seen in FIG. 4 , PCB 4000 may include one or more tabs 4000c that correspond to tab 9212a and that cooperate with and are fixed to tab 9212a.

[0368] The sensor 9112 may include a tail 9224 that extends through a second opening 9202b defined in the holder 9108 to be received transcutaneously beneath the user's skin. The tail 9224 may have an enzyme or other chemical included thereon to help facilitate analyte monitoring. The sharp object 9114 may include a sharp object tip 9226 that can extend through the first opening 9202a defined by the housing 9106. When the sharp object tip 9226 penetrates the electronic device housing 9104, the tail 9224 of the sensor 9112 may be received in a hollow or recessed portion of the sharp object tip 9226. The sharp object tip 9226 may be configured to penetrate the skin when the tail 9224 is carried so that the active chemical of the tail 9224 contacts the body fluid.

[0369] The sensor control device 9102 can provide a sealing subassembly that includes the housing 9106, the sensor 9112, the sharp object 9114, the seal 9208, the collar 9212 and portions of the sensor cap 9120, and other component portions. The sealing subassembly can help isolate the sensor 9112 and the sharp object 9114 in the inner chamber 9124 ( Fig.32A ). When assembling the sealing subassembly, the sharp object tip 9226 is advanced through the electronic device housing 9104 until the sharp hub 9116 engages the seal 9208, and more specifically, the first sealing element 9210a. The mating member 9118 disposed at the bottom of the sharp hub 9116 can extend out of the second opening 9202b of the bottom of the support 9108, and the sensor cap 9120 can be coupled to the sharp hub 9116 at the mating member 9118. Coupling the sensor cap 9120 to the sharp hub 9116 at the mating member 9118 can cause the first end 9122a of the sensor cap 9120 to be sealingly engaged with the seal 9208, and more specifically, the second sealing element 9210b of the bottom of the support 9108. In some embodiments, when the sensor cap 9120 is coupled to the sharpened hub 9116, a portion of the first end 9122a of the sensor cap 9120 can extend (engage) against the bottom of the support 9108, and the sealing engagement between the sensor hub 9116 and the first sealing element 9210a can be able to present any tolerance variations between the features.

[0370] Fig.339102 according to one or more embodiments. As described above, the sensor control device 9102 may include or otherwise incorporate a sealing subassembly 9302 that may be used to isolate the sensor 9112 and the sharp object 9114 within the inner chamber 9124 of the sensor cap 9120. To assemble the sealing subassembly 9302, the sensor 9112 may be positioned within the support 9108 such that the tail 9224 extends through the second opening 9202b at the bottom of the support 9108. In at least one embodiment, a locating feature 9304 may be defined on an inner surface of the support 9108, and the sensor 9112 may define a groove 9306 that may cooperate with the locating feature 9304 to properly position the sensor 9112 within the support 9108.

[0371] Once the sensor 9112 is properly positioned, the collar 9212 can be installed on the support 9108. More specifically, the collar 9212 can be positioned so that the first sealing element 9210a of the seal 9208 is received within the central opening 9214 defined by the collar 9212, and the first sealing element 9210a creates a radial seal against the collar 9212 at the central opening 9214. In addition, the annular lip 9216 defined on the collar 9212 can be received within the channel 9206 defined on the support 9108, and the groove 9218 defined through the annular lip 9216 can be aligned to receive the portion of the sensor 9112 that passes transversely through the channel 9206 within the support 9108. In some embodiments, an adhesive can be injected into the channel 9206 to secure the collar 9212 to the support 9108. The adhesive can also facilitate a sealed interface between the two components and create a seal around the sensor 9112 at the groove 9218 , which can isolate the tail 9224 from the interior of the electronic device housing 9104 .

[0372] The housing 9106 can then be mated with or otherwise coupled to the mount 9108. In some embodiments, as shown, the housing 9106 can be mated with the mount 9108 via a tongue and groove joint 9308 at the periphery of the electronic device housing 9104. An adhesive can be injected (applied) into the groove portion of the joint 9308 to secure the housing 9106 to the mount 9108 and also to form a sealed engagement interface. Mating the housing 9106 to the mount 9108 can also allow the annular ridge 9222 defined on the inner surface of the housing 9106 to be received within the collar channel 9220 defined on the upper surface of the collar 9212. In some embodiments, an adhesive can be injected into the collar channel 9220 to secure the housing 9106 to the collar 9212 and also to facilitate a sealed interface between the two components at that location. When the housing 9106 is mated with the support 9108 , the first sealing element 9210 a can at least partially extend through (into) the first opening 9202 a defined in the housing 9106 .

[0373] The sharp object 9114 can then be coupled to the sensor control device 9102 by extending the sharp object tip 9226 through the aligned first opening 9202a and second opening 9202b defined in the housing 9106 and the support 9108, respectively. The sharp object 9114 can be advanced until the sharp hub 9116 engages the seal 9208, and more specifically, the first sealing element 9210a. When the sharp hub 9116 engages the first sealing element 9210a, the mating member 9118 can extend (extend) out of the second opening 9202b at the bottom of the support 9108.

[0374] The sensor cap 9120 can be removably coupled to the sensor control device 9102 by threading the internal threads 9128b of the sensor cap 9120 with the external threads 9128a of the mating member 9118. The inner chamber 9124 can be sized and otherwise configured to receive the tail 9224 and the sharp tip 9226 extending from the bottom of the support 9108. In addition, the inner chamber 9124 can be sealed to isolate the tail 9224 and the sharp tip 9226 from substances that may interact adversely with the chemicals in the tail 9224. In some embodiments, a desiccant (not shown) can be present in the inner chamber 9124 to maintain an appropriate humidity level.

[0375] Tightening (rotating) the mating engagement between the sensor cap 9120 and the mating member 9118 can promote the first end 9122a of the sensor cap 9120 to seal and engage with the second sealing element 9210b in the axial direction (e.g., along the centerline of the openings 9202a, 9202b), and can further enhance the sealing interface between the sharp hub 9116 and the first sealing element 9210a in the axial direction. In addition, tightening the mating engagement between the sensor cap 9120 and the mating member 9118 can compress the first sealing element 9210a, which can cause the radial sealing engagement between the first sealing element 9210a and the shaft ring 9212 at the central opening 9214 to be enhanced. Therefore, in at least one embodiment, the first sealing element 9210a can help promote axial and radial sealing engagement.

[0376] As described above, the first sealing element 9210a and the second sealing element 9210b can be overmolded onto the support 9108 and can be physically linked or otherwise interconnected. Therefore, a single injection molding injection can flow through the second opening 9202b of the support 9108 to form both ends of the seal 9208. This may prove to be advantageous because multiple sealing interfaces can be generated with only a single injection molding injection. An additional advantage of the two-shot molding design is that the interface between the first shot and the second shot is a reliable combination, rather than a mechanical seal, compared to using a separate elastic component (e.g., O-ring, gasket, etc.). Therefore, the effective number of mechanical seal barriers is effectively reduced by half. In addition, the two-shot components with a single elastic injection also help to minimize the number of two-shot components required to achieve all necessary sterile barriers. Once properly assembled, the sealing subassembly 9302 can be subjected to radiation sterilization to sterilize the sensor 9112 and the sharp object 9114. The sealing subassembly 9302 can be subjected to radiation sterilization before or after the sensor cap 9120 is coupled to the sharp hub 9116. When sterilized after the sensor cap 9120 is coupled to the sharp hub 9116, the sensor cap 9120 can be made of a material that allows radiation to propagate through it. In some embodiments, the sensor cap 9120 can be transparent or translucent, but can also be opaque without departing from the scope of the present disclosure.

[0377] Fig.33A yes FIG. 31A to FIG. 31B and FIG. 32A to FIG. 32BExploded isometric view of a portion of another embodiment of a sensor control device 9102 of FIG. The embodiments included above describe a support 9108 and a seal 9208 manufactured via a two-shot injection molding process. However, in other embodiments, as briefly described above, one or both of the sealing elements 9210a, 9210b of the seal 9208 may include an elastic component portion that is independent of the support 9208. For example, in the illustrated embodiment, the first sealing element 9210a can be overmolded onto the collar 9212, and the second sealing element 9210b can be overmolded onto the sensor cap 9120. Alternatively, the first sealing element 9210a and the second sealing element 9210b can include separate component portions, such as respectively positioned on the collar 9212 ( Fig.32C and Fig.33A ) and a gasket or O-ring 9210a on the upper surface of the sensor cap 9120. Tightening (rotating) the mating engagement between the sensor cap 9120 and the mating member 9118 can cause the second sealing element 9210b to seal with the bottom of the support 9108 in the axial direction, and can enhance the sealing interface between the sharp hub 9116 and the first sealing element 9210a in the axial direction. In some embodiments, as Fig.33B As shown, the sharp hub 9116 may include a raised mating surface 9116a (e.g., a flange) configured to mate with the sealing element 9210a. Therefore, tightening (rotating) the mating engagement between the sensor cap 9120 and the mating member 9118 may enhance the sealing interface between the mating surface 9116a and the first sealing element 9210a in the axial direction.

[0378] Fig.34A is an isometric bottom view of support 9108 according to one or more embodiments, and Fig.34B is an isometric top view of the sensor cap 9120. Fig.34A As shown, the support 9108 can provide or otherwise define one or more indentations or recesses 9402 at or near the opening of the second opening 9202b. Fig.34B As shown, the sensor cap 9120 can provide or otherwise define one or more protrusions 9404 at or near the first end 9122a of the sensor cap 9120. When the sensor cap 9120 is coupled to the sharp hub 9116 ( FIG. 32A to FIG. 32B 93), the protrusion 9404 can be received in the recess 9402. More specifically, as described above, when the sensor cap 9120 is coupled to the mating member 9118 ( FIG. 32A to FIG. 32B93), the first end 9122a of the sensor cap 9120 is sealed and engaged with the second sealing element 9210b. In this process, the protrusion 9404 can also be received in the recess 9402, which can help prevent the sensor cap 9120 from being screwed off from the sharp hub 9116 too early.

[0379] Fig.35A and Fig.35B 9502 are side views and cross-sectional side views, respectively, of an exemplary sensor applicator 9502 according to one or more embodiments. The sensor applicator 9502 may be similar in some respects to Figure 1 The sensor applicator 102 can therefore be designed to deliver (fire) a sensor control device, such as sensor control device 9102. Fig.35A depicts how the sensor applicator 9502 may be delivered to and received by a user, and Fig.35B A sensor control device 9102 is depicted as being arranged within the interior of the sensor applicator 9502.

[0380] like Fig.35A As shown, the sensor applicator 9502 includes a housing 9504 and an applicator cap 9506 removably coupled to the housing 9504. In some embodiments, the applicator cap 9506 can be threadedly connected to the housing 9504 and include an anti-tamper ring 9508. When the applicator cap 9506 is rotated (e.g., unscrewed) relative to the housing 9504, the anti-tamper ring 9508 can shear to release the applicator cap 9506 from the sensor applicator 9502.

[0381] exist Fig.35B , the sensor control device 9102 is positioned within the sensor applicator 9502. Once the sensor control device 9102 is fully assembled, it can be loaded into the sensor applicator 9502, and the applicator cap 9506 can be coupled to the sensor applicator 9502. In some embodiments, the applicator cap 9506 and the housing 9504 can have opposing, matable sets of threads that enable the applicator cap 9506 to be screwed onto the housing 9504 in a clockwise (or counterclockwise) direction, thereby securing the applicator cap 9506 to the sensor applicator 9502.

[0382] Securing the applicator cap 9506 to the housing 9504 can also allow the second end 9122b of the sensor cap 9120 to be received within a cap post 9510 that is located within the interior of the applicator cap 9506 and extends proximally from the bottom thereof. The cap post 9510 can be configured to receive at least a portion of the sensor cap 9120 when the applicator cap 9506 is coupled to the housing 9504.

[0383] Fig.36A and Fig.36B9506 ( FIG. 10A ) and 10B , respectively, are a perspective view and a top view of a cap post 9510 according to one or more additional embodiments. In the illustration, a portion of the sensor cap 9120 is received within the cap post 9510, and more specifically, the desiccant cap 9130 of the sensor cap 9120 is disposed within the cap post 9510. The cap post 9510 may define a receiver feature 9602 that is configured to be received within the applicator cap 9506 ( Fig.35B ) is coupled (e.g., threadedly connected) to the sensor applicator 9502 ( FIG. 35A to FIG. 35B ). However, when the applicator cap 9506 is removed from the sensor applicator 9502, the receiver feature 9602 can prevent the engagement feature 9126 from reversing direction, thereby preventing the sensor cap 9120 from separating from the cap post 9510. Conversely, removing the applicator cap 9506 from the sensor applicator 9502 will simultaneously cause the sensor cap 9120 to separate from the sensor control device 9102 ( FIG. 31A to FIG. 31B and FIG. 32A to FIG. 32B ) is separated, thereby exposing sensor 9112 ( FIG. 32A to FIG. 32B ) and sharp objects 9114( FIG. 32A to FIG. 32B ) distal portion.

[0384] Many design variations of the receiver feature 9602 may be employed without departing from the scope of the present disclosure. In the illustrated embodiment, the receiver feature 9602 includes one or more compliant members 9604 (two are shown) that are expandable or flexible to receive the engagement feature 9126. The engagement feature 9126 may include, for example, an enlarged head, and the compliant member 9604 may include a collet-type device including a plurality of compliant fingers configured to flex radially outward to receive the enlarged head.

[0385] The compliant member 9604 may also provide or otherwise define a corresponding inclined surface 9606 that is configured to interact with one or more opposing cam surfaces 9608 disposed on an outer wall of the engagement feature 9126. The configuration and alignment of the inclined surfaces 9606 and the opposing cam surfaces 9608 enable the applicator cap 9506 to rotate relative to the sensor cap 9120 in a first direction A (e.g., clockwise), but when the applicator cap 9506 is rotated in a second direction B (e.g., counterclockwise), the cap post 9510 abuts against the sensor cap 9120. More specifically, when the applicator cap 9506 (and therefore the cap post 9510) is rotated in the first direction A, the cam surfaces 9608 engage with the inclined surfaces 9606, which causes the compliant member 9604 to bend or otherwise deflect radially outward and produce a ratcheting effect. However, rotating the applicator cap 9506 (and therefore the cap post 9510 ) in the second direction B will drive the angled surface 9610 of the cam surface 9608 into the opposing angled surface 9612 of the inclined surface 9606 , which causes the sensor cap 9120 to abut against the compliant member 9604 .

[0386] Fig.37 9106 is a cross-sectional side view of a sensor control device 9102 positioned within an applicator cap 9506 according to one or more embodiments. As shown, the opening of the receiver feature 9602 has a first diameter D3, while the engagement feature 9126 of the sensor cap 9120 has a second diameter D4 that is greater than the first diameter D3 and greater than the outer diameter of the remainder of the sensor cap 9120. When the sensor cap 9120 extends into the cap post 9510, the compliant member 9604 of the receiver feature 9602 can bend (expand) radially outward to receive the engagement feature 9126. In some embodiments, as shown, the engagement feature 9126 can provide or otherwise define an angled outer surface that helps bias the compliant member 9604 radially outward. Once the engagement feature 9126 bypasses the receiver feature 9602, the compliant member 9604 can bend back (or toward) its natural state, thereby locking the sensor cap 9120 within the cap post 9510.

[0387] When the applicator cap 9506 is threadedly connected to (screwed onto) the housing 9504 in a first direction A ( FIG. 35A to FIG. 35B), the cap post 9510 correspondingly rotates in the same direction and the sensor cap 9120 is gradually introduced into the cap post 9510. As the cap post 9510 rotates, the inclined surface 9606 of the compliant member 9604 ratchets against the opposing cam surface 9608 of the sensor cap 9120. This will continue until the applicator cap 9506 is fully threaded (screwed onto) the housing 9504. In some embodiments, the ratcheting action may occur during two complete rotations of the applicator cap 9506 before the applicator cap 9506 reaches its final position.

[0388] To remove the applicator cap 9506, the applicator cap 9506 is rotated in the second direction B, which correspondingly rotates the cap post 9510 in the same direction and causes the cam surface 9608 (ie, FIG. 36A to FIG. 36B The angled surface 9610) abuts against the inclined surface 9606 (ie, FIG. 36A to FIG. 36B 14. The angled surface 9612 of the applicator cap 9506 is formed on the applicator cap 9506. Thus, continued rotation of the applicator cap 9506 in the second direction B causes the sensor cap 9120 to correspondingly rotate in the same direction, thereby unscrewing from the mating member 9118 to allow the sensor cap 9120 to be separated from the sensor control device 9102. Separating the sensor cap 9120 from the sensor control device 9102 exposes the distal portion of the sensor 9112 and the sharp object 9114, thereby placing the sensor control device 9102 in a fired (use) position.

[0389] Fig.38A 9 is a cross-sectional view of a sensor control assembly 9800 illustrating an exemplary interaction between a sensor and a sharp. After the sharp is assembled, the sensor should be placed in the channel defined by the sharp. The sensor control assembly in FIG. 9 does not show the sensor deflected inwardly and otherwise fully aligned with the sharp, but this may be the case when fully assembled because the sensor may be subject to a slight biasing force at the position indicated by the two arrows A. It may be advantageous to bias the sensor against the sharp so that any relative movement between the sensor and the sharp during subcutaneous insertion does not expose the sensor tip (i.e., tail) outside of the sharp channel, which could result in insertion failure.

[0390] FIG. 38B to FIG. 38D An exemplary sharp hub 205014 and sharp object 209114 are shown, which are configured to unbias the sensor 11900 ( Fig. 15B ), and biasing the sensor 11900 during transport of the sensor ( Fig.38C). By storing and transporting the sensor in an unbiased (relaxed or stress-free) position, the sensor can have an extended shelf life and reduced overall stress. In addition, by storing and transporting the sensor in an unbiased position, stress relaxation during the shelf life can be reduced, thereby limiting the loss of bias force due to stress relaxation. Therefore, the bias force during sensor delivery can be more predictable, and the bias during delivery can be performed as designed. The sharp object 209114 may include a window 209114A. Prior to use, the window 209114A can be aligned with the protrusion 11912 on the top end 11908b of the sensor 11900, and the protrusion 11912 can extend through the window 209114. In this configuration, the bottom end 11908a is not biased toward the sharp object, and therefore, the sensor 11900 can be in a relaxed state. During firing, the needle carrier 201102 can be partially retracted, thereby pulling the sharp object 209114 into a partially retracted position. During firing, as the sheath 20704 initially moves proximally relative to the sensor carrier 20710, partial retraction may occur. Each sharp carrier locking arm 20710K (see FIG. 20704 ) of the sensor carrier 20710 is engaged by the ribs 20710M of the retaining arms 20710L when they engage the corresponding grooves 20704Q of the sheath 20704. Fig.9D ) may extend radially outward (see Figure 8M ), which can allow the sharps carrier retention feature 20710L to pass over the partially retracted front retention surface 201102A of the sharps carrier 201102 and engage the partially retracted rear retention surface 201102B of the sharps carrier (see Fig. 10C ). In the partially retracted position, window 209114A no longer receives protrusion 11912, and sharp object 209114 engages protrusion 11912, thereby biasing bottom end 11908a toward sharp object 209114 and into the appropriate position for delivery, as described above.

[0391] Embodiments disclosed herein include:

[0392] D. A sensor control device, comprising an electronic device housing, the electronic device housing comprising: a shell defining a first opening and a support defining a second opening, the second opening being able to align with the first opening when the shell is coupled to the support; a seal, overmolded onto the support at the second opening, and comprising a first sealing element overmolded onto a base extending from an inner surface of the support, and a second sealing element interconnected with the first sealing element and overmolded onto a bottom of the support; a sensor, arranged in the electronic device housing and having a tail extending through the second opening and through the bottom of the support; and a sharp object, extending through the first opening and the second opening and through the bottom of the electronic device housing.

[0393] E. An assembly comprising a sensor applicator, a sensor control device positioned within the sensor applicator and comprising an electronic device housing, the electronic device housing comprising: a housing defining a first opening and a support defining a second opening, the second opening being alignable with the first opening when the housing is mated to the support; a seal overmolded onto the support at the second opening and comprising a first sealing element overmolded onto a base extending from an inner surface of the support, and a second sealing element interconnected with the first sealing element and overmolded onto a bottom of the support; a sensor disposed within the electronic device housing and having a tail extending through the second opening and through the bottom of the support; and a sharp object extending through the first opening and the second opening and through the bottom of the electronic device housing. The assembly also comprises: a sensor cap removably coupled to the sensor control device at the bottom of the support and defining a sealed internal chamber for receiving the tail and the sharp object; and an applicator cap coupled to the sensor applicator.

[0394] Each of embodiments D and E may have one or more of the following additional elements in any combination: Element 1: wherein the support includes a first injection molded part molded in a first shot, and the seal includes a second injection molded part overmolded onto the first injection molded part in a second shot. Element 2: also includes a sharp hub carrying a sharp object and sealingly engaging the first sealing element, and a sensor cap removably coupled to the sharp hub at the bottom of the support and sealingly engaging the second sealing element, wherein the sensor cover defines an internal chamber that receives the tail and the sharp object. Element 3: wherein the sharp hub provides a mating member extending through the bottom of the support, and the sensor cap is removably coupled to the mating member. Element 4: also includes one or more recesses defined on the bottom of the support at the second opening, and one or more protrusions defined on one end of the sensor cap and can be received in the one or more recesses when the sensor cap is coupled to the sharp hub. Element 5: also includes a collar positioned within the electronic device housing and defining a central opening that receives and sealingly engages the first sealing element in a radial direction. Element 6: Also includes a channel defined on the inner surface of the support and surrounding the base, an annular lip defined on the bottom side of the collar and capable of cooperating with the channel, and an adhesive disposed in the channel to secure and seal the collar to the support at the channel. Element 7: Also includes a groove defined through the annular lip to accommodate a portion of the sensor extending laterally within the support, wherein the adhesive seals around the sensor at the groove. Element 8: Also includes a collar channel defined on the upper surface of the collar, an annular ridge defined on the inner surface of the housing and capable of cooperating with the collar channel, and an adhesive disposed in the collar channel to secure and seal the housing to the collar. Element 9: Wherein, one or both of the first sealing element and the second sealing element define at least a portion of the second opening. Element 10: Wherein, when the housing is coupled to the support, the first sealing element extends at least partially through the first opening.

[0395] Element 11: wherein the sensor control device also includes a sharp hub that carries a sharp object and sealingly engages the first sealing element, and wherein the sensor cap is removably coupled to the sharp hub at the bottom of the support and sealingly engages the second sealing element. Element 12: wherein the sensor control device also includes one or more recesses defined on the bottom of the support at the second opening, and one or more protrusions defined on one end of the sensor cap and can be received in the one or more recesses when the sensor cap is coupled to the sharp hub. Element 13: wherein the sensor control device also includes a collar positioned in the electronic device housing and defining a central opening, the central opening receiving and sealingly engaging the first sealing element in a radial direction. Element 14: wherein the sensor control device also includes a channel defined on the inner surface of the support and surrounding the base, an annular lip defined on the bottom side of the collar and capable of mating with the channel, and an adhesive disposed in the channel to secure and seal the collar to the support at the channel. Element 15: wherein the sensor control device also includes a groove defined through the annular lip to accommodate a portion of the sensor extending laterally within the support, and wherein the adhesive seals around the sensor at the groove. Element 16: wherein the sensor control device further comprises a collar channel defined on an upper surface of the collar, an annular ridge defined on an inner surface of the housing and capable of cooperating with the collar channel, and an adhesive disposed in the collar channel to secure and seal the housing to the collar. Element 17: wherein one or both of the first sealing element and the second sealing element define at least a portion of the second opening. Element 18: wherein the first sealing element at least partially extends through the first opening.

[0396] As non-limiting examples, exemplary combinations suitable for D and E include: element 2 and element 3; element 2 and element 4; element 5 and element 6; element 6 and element 7; element 5 and element 8; element 11 and element 12; element 13 and element 14; element 14 and element 15; and element 13 and element 16.

[0397] Exemplary Firing Mechanisms for One-Piece and Two-Piece Applicators

[0398] FIG. 39A to FIG. 39FExemplary details of an embodiment of an internal device mechanism that "fires" the applicator 216 to apply the sensor control device 222 to the user, and includes safely retracting the sharp object 1030 into the used applicator 216. In summary, these figures represent an exemplary sequence of driving the sharp object 1030 (supporting a sensor coupled to the sensor control device 222) into the user's skin, withdrawing the sharp object while leaving the sensor behind in operative contact with the user's interstitial fluid, and adhering the sensor control device to the user's skin with an adhesive. Those skilled in the art can refer to understand the modification of such activities for use with alternative applicator assembly embodiments and components. In addition, the applicator 216 can be a sensor applicator having a one-piece architecture or a two-piece architecture as disclosed herein.

[0399] Now go to Fig.39A , the sensor 1102 is supported within the sharp 1030, just above the user's skin 1104. Tracks 1106 (optionally, three of them) of the upper guide section 1108 may be provided to control the movement of the applicator 216 relative to the sheath 318. The sheath 318 is retained by a detent feature 1110 within the applicator 216, such that an appropriate downward force along the longitudinal axis of the applicator 216 will cause the resistance provided by the detent feature 1110 to be overcome, so that the sharp 1030 and the sensor control device 222 can be translated along the longitudinal axis into (and onto) the user's skin 1104. In addition, the latch 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.

[0400] exist Fig.39B 1024, a user force is applied to overcome or override the detent feature 1110, and the sheath 318 collapses into the housing 314, thereby driving the sensor control 222 (along with associated components) to translate downwardly along the longitudinal axis as indicated 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 travel of the sensor / sharp insertion process. The stop surface 1114 of the carrier arm 1112 abuts against the complementary surface 1116 of the sharp retraction assembly 1024 to retain the member in position with the return spring 1118 fully energized.

[0401] exist Fig.39C, the sensor 1102 and sharp 1030 have reached full insertion depth. In doing so, the carrier arm 1112 clears the inner diameter of the upper guide section 1108. The compressive force of the helical return spring 1118 then drives the angled stop surface 1114 radially outward, releasing the force to drive the sharps carrier 1102 of the sharps retraction assembly 1024, thereby pulling the (slotted or otherwise configured) sharp 1030 out of the user and away from the sensor 1102, as shown. Fig.39D As shown by the arrow R in .

[0402] like Fig.39E As shown, with the sharp object 1030 fully retracted, the upper guide section 1108 of the sheath 318 is provided with a final locking feature 1120. Fig.39F As shown, the spent applicator assembly 216 is removed from the insertion site, leaving the sensor control device 222 behind, and with the sharp 1030 securely secured within the applicator assembly 216. The spent applicator assembly 216 is now ready for disposal.

[0403] The operation of the applicator 216 when the sensor control device 222 is applied is designed to provide the user with a sense that the insertion and retraction of the sharp object 1030 are both automatically performed by the internal mechanism of the applicator 216. In other words, the present invention avoids the user experiencing the feeling that he is manually driving the sharp object 1030 into his skin. Therefore, once the user applies sufficient force to overcome the resistance from the pawl feature of the applicator 216, the resulting action of the applicator 216 is considered to be an automatic response to the applicator being "triggered." Although all of the driving force is provided by the user and no additional biasing / driving device is used to insert the sharp object 1030, the user is unaware that he is providing additional force to drive the sharp object 1030 to pierce his skin. As described above in Fig.39C As described in detail in , retraction of the sharp object 1030 is automatically performed by the helical return spring 1118 of the applicator 216.

[0404] With respect to any applicator embodiment described herein and any component thereof (including but not limited to sharps, sharps module and sensor module embodiments), it will be understood by those skilled in the art that the embodiment can be sized and configured for use with a sensor configured to sense the analyte level in the body fluid of the epidermis, dermis or subcutaneous tissue of a subject. In some embodiments, for example, the sharps and distal portions of the analyte sensors disclosed herein can be sized and configured to be positioned at a specific terminal depth (i.e., in a tissue or layer of the subject's body, for example, the furthest penetration point in the epidermis, dermis or subcutaneous tissue). With respect to some applicator embodiments, it will be understood by those skilled in the art that certain embodiments of the sharps can be sized and configured to be positioned at different terminal depths in the subject's body relative to the final terminal depth of the analyte sensor. In some embodiments, for example, before retraction, the sharps can be positioned at a first terminal depth in the epidermis of the subject, and the distal portion of the analyte sensor can be positioned at a second terminal depth in the dermis of the subject. In other embodiments, the sharp object can be positioned at a first end depth in the dermis of the subject before retraction, and the distal portion of the analyte sensor can be positioned at a second end depth in the subcutaneous tissue of the subject. In yet other embodiments, the sharp object can be positioned at a first end depth before retraction, and the analyte sensor can be positioned at a second end depth, wherein the first end depth and the second end depth are both in the same layer or tissue of the subject's body.

[0405] In addition, with respect to any applicator embodiment described herein, it will be appreciated by those skilled in the art that the analyte sensor and one or more structural components coupled thereto (including but not limited to one or more spring mechanisms) can be disposed in the applicator in an eccentric position relative to one or more axes of the applicator. In some applicator embodiments, for example, the analyte sensor and the spring mechanism can be disposed at a first eccentric position relative to the axis of the applicator on a first side of the applicator, and the sensor electronics can be disposed at a second eccentric position about the axis of the applicator on a second side of the applicator. In other applicator embodiments, the analyte sensor, the spring mechanism, and the sensor electronics can be disposed at an eccentric position on the same side relative to the axis of the applicator. It will be appreciated by those skilled in the art that other arrangements and configurations in which any or all of the analyte sensor, the spring mechanism, the sensor electronics, and the other components of the applicator are disposed in a centered or eccentric position relative to one or more axes of the applicator are possible and are fully within the scope of the present disclosure.

[0406] Many deflectable structures are described herein, including but not limited to deflectable pawl buckle 1402, deflectable locking arm 1412, sharp object carrier locking arm 1524, sharp object retaining arm 1618 and module buckle 2202. These deflectable structures are composed of elastic materials such as plastic or metal (or other) and operate in a manner familiar to those of ordinary skill in the art. Each deflectable structure has a static state or position toward which the elastic material is biased. If a force is applied to cause the structure to deflect or move from the static state or position, the bias of the elastic material will cause the structure to return to the static state or position once the force is removed (or reduced). In many cases, these structures are configured as arms with pawls or buckles, but other structures or configurations (including but not limited to legs, clips, locks, abutments on deflectable members, etc.) can also be used to maintain the same deflectable characteristics and the ability to return to a static position.

[0407] Detailed diagram of the structure of the personal device

[0408] Certain components of the on-body device fabrication may be utilized with any or all of the electrical connection configurations described above. FIG. 40A to FIG. 40D The top of an exemplary body-fitting device subassembly is provided ( Fig.40A ) and bottom ( FIG. 40B to FIG. 40D ) construction diagram. The socket 4802 or support passes through a through hole in the printed circuit board 4000 along with other associated components including the processor 4004 (e.g., an ASIC including communication facilities), thermistor / thermocouple 4006, battery support 4008, etc. Fig.40C As shown, once the circuit board 4800 is populated with these components, the socket 4002 is adhered to the circuit board 4000 (eg, using a hot melt stake). Once the battery 4010 is in place, the circuit board 4000 is ready to be incorporated into a body-fitting device.

[0409] The circuit board 4000 is ready for an overmolding process or other sealing method. FIG. 41A to FIG. 41D As shown, the circuit board 4000 is first placed in the two-piece mold 4102, 4104. The mold slide 4106 is inserted and the molds 4102, 4104 are closed, as shown in FIG. Fig.41B As shown. Fig.41C As shown, thermoplastic material is injected into molds 4102, 4104 to wrap circuit board 4000. Molds 4102, 4104 are opened and the nearly final component is ejected, such as Fig.41D shown.

[0410] Alternatively, if Fig.42A Assembly diagram, Fig.42B Assembly diagram and Fig.42CAs shown in the cross-sectional stereoscopic view of , the housing of the electronic device assembly of the body-fitting device 4212 may include elements that snap-fit ​​(or welded / adhered) together. The housing including the housing 4202 and the support 4204 can be used to seal and protect the circuit board 4000. The housing formed by coupling the housing 4202 and the support 4204 together may be referred to herein as the interior space of the electronic device housing. The circuit board 4000 may be formed according to any process and is not limited to the combination of manufacturing methods and components discussed above. When snap-fitting, various interference or snap-fit ​​elements (e.g., annular edge 4206) may be provided around the entire periphery of the housing, or as separate snap-fit ​​connectors (not shown). It should be noted that this approach may benefit from additional O-ring sealing elements to avoid fluid intrusion. Alternatively or additionally, an adhesive provided at the snap-fit ​​joint may be used to ensure a good seal, particularly when connected to a continuous annular snap-fit ​​feature 4206. As Fig.42C As can be seen, grooves 4208 or other features can be provided to ensure that adhesive 4210 that may be squeezed out during assembly is not forced into areas that may interfere with the operation or assembly of the body-fitting device 4212. In some embodiments, when the housing 4202 and the support 4204 are assembled together with the bead of adhesive 4210 as shown, the grooves 4208 not only provide space to capture the squeezed-out adhesive 4210, but also provide additional surface area for a thicker layer of adhesive 4210 to seal the joint.

[0411] refer to Fig.43A For purposes of illustration and not limitation, the electronic device housing of the body-attaching device or sensor control device may include a housing 4302 and a support 4304, which may be ultrasonically welded together to seal and protect a circuit board 4306. The housing 4302 may be configured to have a housing inner periphery 4310a and a housing outer periphery 4308a, and the support 4304 may be configured to have a support inner periphery 4310b and a support outer periphery 4308b. When the housing and the support are connected by an ultrasonic welding device, ultrasonic welding may be performed along their respective inner peripheries 4310a, 4310b and outer peripheries 4308a, 4308b. The respective inner peripheries 4310a, 4310b and outer peripheries 4308a, 4308b may be ultrasonically welded at the joining interface, which includes an energy director to concentrate the ultrasonic welding energy and quickly initiate the joining of the periphery by melting the housing 4302 and the support 4304 at the respective peripheries. The energy director may be disposed on either or both of the housing 4302 and the support 4304. Fig.43CAs shown, the connection interface can be a butt joint, a step joint or a tongue-and-groove joint, a combination of these joints, or any other type of joint. According to the disclosed subject matter, a circuit board 4306 can be disposed between the housing 4302 and the support 4304. The support 4304 can have a connector 4314 on the circuit board 4306 that is connected to the analyte sensor assembly. The analyte sensor assembly can have any of the features of the above-mentioned analyte sensor, including a distal portion and a proximal portion. The proximal portion can extend into the interior space of the electronic device housing so that one or more sensor contacts of the proximal portion of the analyte sensor are electrically coupled to the connector 4314 on the circuit board 4306. The distal portion can extend from the bottom of the electronic device housing.

[0412] In some embodiments, ultrasonic welding can be applied only along one of the corresponding inner peripheries 4310a, 4310b or outer peripheries 4308a, 4308b. In this way, the corresponding outer peripheries 4308a, 4308b can be ultrasonically welded, and the corresponding inner peripheries 4310a, 4310b can be fixed by other means (such as but not limited to adhesives). Alternatively, the corresponding inner peripheries 4310a, 4310b can be ultrasonically welded, and the corresponding outer peripheries 4308a, 4308b can be fixed by other means (such as but not limited to adhesives). The cover (the internal space of the electronic device housing) can also be configured so that there are only continuous outer peripheries 4308a, 4308b, and there are no inner peripheries 4310a, 4310b. For example, the cover can be formed into a "C" shape. In another embodiment, the support 4304 may have an inner periphery 4310b, but the housing 4302 does not have an inner periphery 4310a; in this embodiment, only the corresponding outer peripheries 4308a, 4308b may be ultrasonically welded.

[0413] The support 4304 may also have an aperture 4312, which may expose the connector 4314 on the circuit board 4306. A seal 4316 may be provided around the periphery of the aperture 4312 and between the housing 4302 and the support 4304, and may be configured to prevent contaminants from entering the housing. In some embodiments, the seal 4316 may be provided in the internal space of the electronic device housing, so that the seal 4316 is provided near any one or both of the first aperture 4312, 4606 and the second aperture 4608. The seal 4316 may be configured to provide a seal around at least a portion of the proximal portion of the analyte sensor 9112, which extends into the interior of the electronic device housing to protect the interior space from contaminants (such as, but not limited to, sweat and other debris). Therefore, the seal is configured to prevent contaminants from entering the internal space or housing of the electronic device housing. The seal 4316 may also be configured to seal the conductive portion or sensor contacts of the sensor 9112 in the interior of the electronic device housing. In other words, seal 4316 can be disposed around the non-conductive portion of sensor 9112. Seal 4316 can be made of an elastomer (such as silicone rubber or thermoplastic elastomer) or any other material. According to the embodiments disclosed herein, the seal can be non-conductive. According to the disclosed subject matter, seal 4316 can be disposed between circuit board 4306 and support 4304, and circuit board 4306 itself is located between housing 4302 and support 4304. Seal 4316 can be compressed to improve the seal formed around the periphery of opening 4312. In addition, the height of uncompressed seal 4316 can be greater than the height of internal gap 4320 between housing 4302 and support 4304. When the seal is disposed between circuit board 4306 and support 4304, the maximum height of uncompressed seal 4316 can be greater than the height of internal gap 4322 between circuit board 4306 and support 4304 at the maximum height position. In accordance with the disclosed subject matter, seal 4316 can have an irregular cross-section, e.g. Fig.43A The internal gap 4322 between the circuit board 4306 and the support 4304 can vary along the cross-section of the seal 4316, so that the seal 4316 is compressed at its maximum height and at other locations along the cross-sectional height of the seal 4316, such as Fig.43A The mount may include a raceway 4318 to properly seat the seal 4316. The raceway 4318 may aid in the construction of the housing.

[0414] Due to the height difference between the gap 4320 in the housing and the height of the seal 4316, it may be advantageous to clamp the housing and the internal electronic device components with a clamping force to fully compress the seal 4316 while ultrasonically welding the corresponding inner peripheries 4310a, 4310b and outer peripheries 4308a, 4308b of the housing 4302 and the support 4304. Such a clamping device can be implemented with a vise, a sleeve, a fixture, a fixture, or other methods known to those skilled in the art. In addition, in order to achieve ultrasonic welding, the ultrasonic horn can apply pressure to the housing 4302 via a pneumatic or electronically driven press, which can support the housing on the clamping device. By vibrating the ultrasonic horn at a high frequency, the vibration is transmitted through the housing 4302 toward the support 4304. The vibration can generate heat in the housing 4302 and the support 4304, causing them to melt and fuse together at the joint interface. The clamping force can be applied for a predetermined time sufficient to fuse the housing 4302 and the support 4304 together. After the housing 4302 and the support 4304 are fused together, the clamping force can be removed and the ultrasonic horn can be retracted. The housing can then be removed from the clamping device as an assembly.

[0415] Although ultrasonic welding is described as being used to attach housing 4302 and support 4304, ultrasonic welding may be used to couple any two or more parts to couple an adhesible device, an insert, or other element of an analyte monitoring system.

[0416] Fig.43B An exemplary method 4300 for constructing a body-hugging device according to the disclosed subject matter is shown. The method may begin at step 4324, where the method may include assembling a cover. The cover may include a shell having a top shell periphery and a top shell inner periphery, a support having an opening with a periphery, a mounting base periphery and a mounting base inner periphery, a circuit board disposed between the shell and the support, and a seal disposed between the shell and the support. At step 4326, the method may include: installing the shell and the support in a support member so that the seal remains in a compressed state between the shell and the support. At step 4328, the method may include: ultrasonically welding the top shell periphery to the mounting base periphery. At step 4330, the method may include: ultrasonically welding the top shell inner periphery to the mounting base inner periphery. According to the disclosed subject matter, the method may be repeated as appropriate. Fig.43B Although the present disclosure will Fig.43B The specific steps of the method are described and shown as occurring in a particular order, but the present disclosure contemplates Fig.43B Any suitable steps of the method may occur in any suitable order. In addition, although the present disclosure describes and illustrates an exemplary method for constructing a body-fitting device, including Fig.43BHowever, the present disclosure contemplates any suitable method for constructing a body-fitting device, including any suitable steps, which may include, where appropriate, Fig.43B In addition, although the present disclosure describes and illustrates the implementation of Fig.43B specific components, devices or systems for specific steps of the method, but the present disclosure contemplates performing Fig.43B Any suitable combination of any suitable components, devices or systems of any suitable steps of the method.

[0417] refer to Fig.45A and Fig.45B For purposes of illustration and not limitation, a seal 4516 may be disposed around a portion of the sensor 9112 that extends laterally within the interior space 4514 of the electronic device housing to prevent contaminants from entering the interior space 4514. In addition, the use of the seal 4516 may reduce any movement of the analyte sensor 9112 relative to the electronic device housing, as well as any stress applied to the analyte sensor 9112. Reducing the movement of the analyte sensor 9112 may beneficially reduce irritation to the user's skin during use. Similarly, reducing stress on the sensor 9112 may increase the life of the analyte sensor 9112. As described above, the sensor control device may include an electronic device housing having a housing 4502 and a support 4504. The support 4504 may be fixed to the housing 4502 to define the interior space 4514. In some embodiments, and as a result of the assembly process, the housing 4502 and the support 4504 may be sealed and pass around the sensor 9112 from the interior space 4514 to a position outside the electronic device housing. In other words, and as explained above, the housing 4502 and the support 4504 can be sealably joined around their respective peripheries 4308a-4308b, 4310a-4310b via adhesive, ultrasonic welding, or any other suitable means; however, in some embodiments, the electronic device housing can include an otherwise unsealed opening for the sensor 9112 to pass through. Thus, the seal 4516 can seal the opening through which the sensor 9112 passes. Fig.45A and Fig.45B As can be seen in FIG. 4 , the housing 4502 and the support 4504 can have inner surfaces 4506, 4508, respectively. The inner surfaces 4506, 4508 can in turn define a raceway 4518 in the housing 4502 and the support 4504, respectively. In an embodiment, and as FIG. 45A to FIG. 45D As can be seen in FIG. 45, when the support 4504 is secured to the housing 4502 to define the interior space 4514, the channel 4510 can be aligned with the channel 4512 to form the raceway 4518. In an embodiment, and as FIG. 45A to FIG. 45DAs further shown, seals 4516 can be disposed within channels 4510, 4512. As disclosed herein, an electronic device housing can include a housing 4502 that cooperates with a support 4504 to form an interior space 4514; however, those skilled in the art will appreciate that the same or substantially similar electronic device housings and body-fitting devices can be achieved by forming the electronic device housing from an integral, single-piece component.

[0418] like FIG. 45A to FIG. 45D As shown, seal 4516 can be compressed between housing 4502 and support 4504. For example, but not limited to, seal 4516 can be positioned within raceway 4518. Specifically, the cross-sectional profile of seal 4516 can generally match the cross-sectional profile of raceway 4518 formed by aligning channels 4510, 4512. According to an embodiment, and as shown in FIG. Fig.45E and Fig.45F As shown, the cross-sectional profile of the seal 4516 can be substantially the same as the cross-sectional profile of the raceway 4518, but slightly larger in size than the raceway, thereby compressing the seal 4516. Thus, the seal 4516 can be configured to protect the interior space 4514 from contamination. Alternatively or additionally, one or more ribs or other raised surfaces 4522 can be located on any or all of the interior surfaces 4506, 4508 of the housing 4502 and the support 4504, respectively, to further compress the seal 4516 within the raceway 4518. For example, but not limited to, and as Fig.45D As shown, in the case where the cross-sectional profile of the seal 4516 is substantially the same as the shape of the raceway 4518, the ribs 4522 on the inner surface 4506 can be pressed against the seal 4516, thereby placing it in a compressed state and improving the sealing quality. The ribs 4522 can alternatively or additionally be located on any other surface of the inner surface 4508 or the raceway 4518. In addition, the ribs 4522 can be of any shape and can be repeated in any pattern. Alternatively or additionally, the ribs or other raised surfaces can be located on any outer surface of the seal 4516. For example, but not limited to, and as Fig.45C As shown, in the case where the cross-sectional profile of the seal 4516 is substantially the same shape as the raceway 4518, the ribs 4522 on the seal 4516 can be pressed against the inner surface 4506, thereby placing the seal 4516 in a compressed state and improving the sealing quality. The ribs 4522 can alternatively or additionally be located on the seal 4156 so that it can be pressed against the sensor 9112. In addition, the ribs 4522 can be of any shape and can be repeated in any pattern on the surface of the seal 4516.

[0419] In some embodiments, the sensor may be sealed using other techniques. Figure 45G to Figure 45IAs shown, the sensor can be sealed within the body-fitting unit using a curable, dispensed-in-place elastomer that is disposed around the sensor to seal the sensor from foreign matter. By using a curable elastomer as described herein, a suitable seal 4516 can be achieved by dispensing the elastomer in place and placing it around the sensor, and then curing the elastomer in place. This can be achieved by at least partially filling the raceway 4518 with the curable elastomer 4516. In some embodiments, this can be achieved by filling only the first channel 4510 with the curable elastomer; however, in other embodiments, both the first channel 4510 and the second channel 4512 can be filled to fully seal the sensor 9112. The curable elastic seal 4516 dispensed in place can include at least one of a UV-curable silicone, a room temperature vulcanized silicone, a UV-curable polyurethane, or any other suitable curable elastomer known in the art.

[0420] As explained above, the housing 4502 and the support 4504 can be connected using welding techniques (such as ultrasonic welding or laser welding). As described above, welding can be performed at the weld joint 4524 located at one or both of the inner periphery and the outer periphery of the electronic device housing. By doing so, the welding process can also have the secondary purpose of curing the curable elastic seal 4516 in situ. Alternatively, in the case where the welding process is not intended to cure the elastomer (e.g., UV curable elastomer), the melting temperature of the curable silicone can be increased relative to the melting temperature of the housing 4502 and the support 4504. Therefore, for the purpose of example and not limitation, fillers such as mica can be added to the elastomer to increase its melting temperature to avoid damaging the elastomer.

[0421] refer to FIG. 46A to FIG. 46D, the housing 4602 may define a first opening 4606, and the support 4604 may define a second opening 4608; the first opening 4606 and the second opening 4608 may be arranged to align with the housing 4602 and the base 4608 is assembled. In addition, the body-fitting device may include a collar 4610, which is disposed within an interior space 4612 formed by the assembly of the housing 4602 and the base 4604, and is configured to align with each of the first opening 4606 and the second opening 4608. In such a body-fitting device configuration, an elastic seal 4614 may be disposed between the collar 4610 and the support 4604. The seal 4614 may also have a central opening 4632, which is axially aligned with the first opening 4606, the second opening 4608, and the collar 4610. Additionally or alternatively, seal 4614 can be disposed around at least a portion of a circumference defined by either or both of openings 4606, 4608. Thus, resilient seal 4614 can be configured to allow a proximal portion of analyte sensor 4616 to pass through resilient seal 4614; thus, seal 4614 enables a distal portion of analyte sensor 4616 to extend from the body-fitting unit to measure the user's analyte level while also preventing foreign matter from entering the body-fitting unit. Specifically, seal 4614 can be configured to prevent foreign matter from entering the interior space of the electronic device housing that may pass through openings 4606, 4608.

[0422] like Fig.46BAs shown, to achieve this, the elastic seal 4614 can adopt one of several physical configurations. For example, the seal 4614 can include one, two, three or four seals, or any other number of seals. For example, the elastic seal 4614 can have a one-piece configuration, wherein the elastic seal 4614 includes a slit 4618 that partially passes through the height of the elastic seal 4614 so that the proximal portion of the analyte sensor 4616 can pass through the slit 4618. Alternatively, the seal 4614 can have a two-piece configuration including a first seal 4622 and a second seal 4620, wherein a complete slit 4618 is defined in each of the two seals 4620, 4622 for the proximal portion of the sensor to pass through. Alternatively, the second seal 4620 may include a partial slit 4618a in which the proximal portion may be placed, and the first seal 4622 may also include a partial slit 4618b that is aligned with the partial slit 4618a of the second seal 4620 to define a complete slit 4618 so that the proximal portion of the analyte sensor 4616 can pass through the complete slit 4618 while the seal 4614 also prevents foreign matter from entering the body-fitting unit. Alternatively, the slit 4618 may be defined only in one of the first seal 4622 or the second seal 4620. The second seal 4620 and the first seal 4622 may also each have a sealing surface 4624a, 4624b, wherein the sealing surface of the second seal 4624a is opposite to the sealing surface of the first seal 4624b, so that during assembly, when the first seal 4624a is mated with the second seal 4624b, the two sealing surfaces contact each other. As another example, for purposes of illustration and not limitation, seal 464 can have a two-piece configuration in which a first seal 4622 is integrated into a channel 4606 located in housing 4602 proximate first opening 4606, and a second seal 4620 is integrated into a channel 4608 located in support 4604 proximate second opening 4608. Channels 4634 and 4636 can be defined circumferentially around first opening 4606 and second opening 4608, respectively. Seal 4614 can share any other features of the stand-alone two-piece configuration. In accordance with the disclosed subject matter (which includes any of the two-piece configurations), the first seal 4622 can have a first sealing opening 4632b, the second seal 4620 can have a second sealing opening 4632a, and the first sealing opening 4632a and the second sealing opening 4632b can each be axially aligned with each of the first opening 4622 and the second opening 4620 of the housing 4602 and the support 4604, respectively.

[0423] Whether the seal is a one-piece configuration, an independent two-piece configuration, an integrated two-piece configuration, or any other configuration, during assembly, the body-hugging unit can be compressed so that the seal is compressed in turn. In a one-piece configuration, this means that either side of the slit 4618 can be compressed together so that the slit 4618 is sealed. In a two-piece independent configuration and a two-piece integrated configuration, this means that the sides of the partial slits 4618a, 4618b can be compressed together so that the entire slit 4618 is sealed, and the sealing surfaces of the second seal 4624a and the first seal 4624b can also be compressed together so that the two halves of the seals 4620, 4622 are sealed like one piece. Alternatively, when a collar 4610 is provided, the collar 4610 can cooperate with the support 4604 so that the sealing assembly 4614 is compressed between the collar 4610 and the support 4604. In this way, a subassembly for sterilizing a sensor assembly can be assembled that does not require housing 4602 to compress seal assembly 4614.

[0424] In addition, in any one of the two-piece configurations, one or both pieces may include at least one rib to facilitate sealing during compression. For example, the sealing surface 4624a of the second seal 4620 may have a rib 4628a, and the sealing surface 4624b of the first seal 4622 may not have a rib. Alternatively, the sealing surface of the first seal 4624b may have a rib 4628b opposite to the rib 4628a of the sealing surface 4624a of the lower half that contacts the rib 4628a of the lower half. Also alternatively, the sealing surface of the first seal 4624b may have a channel 4630, the size and shape of the channel being designed to receive the rib 4628a of the lower half, so that the interface between the channel 4630 and the rib 4628a can be sealed under compression. Alternatively, a configuration vice versa is also possible.

[0425] Seal 4614 can be made of any suitable material, including but not limited to self-healing silicon or self-healing polymer. Such self-healing materials can be repaired when cut and then exposed to heat at the cut position via heat-activated reversible bonding. For example, in order to assemble seal 4614 and analyte sensor 4616, slit 4618 can be cut so that the proximal portion of analyte sensor 4616 can pass through slit 4618. As explained above, slit 4618 can be sealed only by compression. However, in addition or alternatively, if the seal is made of self-healing material, the two sides of slit 4618 can be reconnected, thereby repairing slit 4618 by subjecting the slit to a suitable heat source. An example of a suitable heat source is a laser, but other suitable heat sources are also known to those skilled in the art. In addition, in another embodiment, any suitable non-healing elastomer or polymer can be used to make the seal. The seal can also be a high durometer, a low durometer, or any other suitable durometer. For example, in some embodiments, the durometer can be between about 20A and 40A.

[0426] According to the disclosed subject matter, and as Fig.47 As shown, the seal can take a variety of shapes. For example, but not limited to, the cross-sectional profile of the raceway 4518 and the seal 4516 can be circular, polygonal (for example, but not limited to square, rectangular, hexagonal, or octagonal), or any other shape. In accordance with the disclosed subject matter, the seal 4516 can have a cutout 4702 for at least a portion of the distal portion of the analyte sensor to pass through and a slit 4704 for inserting at least a portion of the analyte sensor into position within the cutout 4702. The size and dimensions of both the cutout 4702 and the slit 4704 are designed so that the seal around the distal portion of the analyte sensor is maintained during compression. For example, the shape of the cutout 4702 and the slit 4704 can be such that the cross-sectional profile of the seal 4516 (which has substantially the same shape as the raceway 4518) is not substantially affected. The slit 4704 can be centered or eccentric relative to the cutout 4702, as shown in FIG. Fig.47 A and Fig.47 C. In addition, the slits 4602 can be straight lines to form, for example, but not limited to, butt joints, as shown in configurations 47a and 47c, or the slits 4702 can form an interlocking interface, such as, but not limited to, a tongue and groove joint, as shown in configuration 47d. Alternatively, any other type of joint can be formed by the interface of the slits 4702. In another embodiment, the seal can include two or more separate pieces, as shown in configuration 47b.

[0427] Regardless of the configuration, final assembly of the electronic device components of the body-attaching device 4212 may involve adhesive patch installation. FIG. 44A to FIG. 44CAn exemplary method is shown in . First, the double-sided adhesive patch 4404 removes the inner liner 4402. The exposed adhesive is placed on the body-fitting device body 5106 (the temperature sensor 4006 is folded into a complementary pocket) and adhered to the first window 4408 aligned for temperature sensing and the second window 4410 for sensor assembly reception. Thus, when the outer release liner is removed, it can be placed in the applicator assembly, or alternatively can be placed in a container with or without an outer liner, depending on whether any liner puller feature is provided therein.

[0428] According to the disclosed subject matter, and as FIG. 48A to FIG. 48DAs shown, the sensor applicator 4800 can also include a seal to seal the sensor applicator 4800 during the sterilization process. For example, the sensor applicator 4800 can include a housing 4802 coupled to a cap 4804. The sensor applicator 4800 can also include a sheath 4806, a sharp carrier 4808, a sensor carrier 4810, a sensor 4830, a sharp 4812, and a sharp hub 4814; a snug unit 4816 is also located within the sensor applicator 4800. In accordance with the disclosed subject matter, the sensor applicator 4800 can be delivered to the user pre-assembled such that the housing 4800 is mated with the cap 4804. In addition, as described above, the sensor applicator 4800 can be sterilized using various sterilization techniques, including but not limited to electron beam sterilization (e.g., but not limited to focused electron beam, low electron beam, etc.). Therefore, in order to promote the effective disinfection of sensor 4830 and sharp object 4812, cap 4804 can include collimator 4818, which can be aligned axially with one or both of the opening 4820 of sharp object 4812 and support 4822. During disinfection, the electron beam can usually be directed toward the close-fitting unit, and collimator 4818 can accurately guide the electron beam to close-fitting unit 4816, and simultaneously prevent damage to the sensitive electrical components in the close-fitting unit. To achieve this, the shape of collimator 4818 can be conical or truncated conical. As another example, without departing from the scope of the present disclosure, collimator 4818 can present a polygonal cross-sectional shape, such as a cube, a rectangle (for example, including a parallelogram) or a pyramid. In addition, collimator 4818 can have a symmetrical or asymmetrical cross-section. As described above, cap 4804 can also include desiccant 4836 to maintain a preferred humidity level. The desiccant 4836 can be substantially concentric with the collimator 4818 and have a cross-section that is substantially parallel to the collimator 4818. For example, without departing from the scope of the present disclosure, the desiccant 4834 can have a polygonal cross-sectional shape, such as a cube, a parallelogram (e.g., including a rectangle), or a pyramid. In addition, the desiccant 4836 can have a symmetrical or asymmetrical cross-section. In accordance with the disclosed subject matter, the proximal end of the collimator can have an opening covered with a label 4824 that allows the electron beam to pass through the opening 4824 without allowing foreign matter to enter. The label can be made of Tyvek. In order to further seal the sterilization zone formed in the collimator and extending into the openings 4820, 4822 of the body-hugging unit 4816, the interface between the distal end of the collimator 4818 and the body-hugging unit 4816 can be sealed. Reference Fig.48A and Fig.48DFor purposes of illustration and not limitation, a seal 4826 made of an elastomer or any other suitable material may be disposed between the collimator and the mount of the body-fitting unit; the proximal portion of the seal 4826 may be tapered or flat. In addition, some embodiments may include a sharp hub 4814 and a collar 4838 having a seal 4838a disposed about an opening in the collar 4838 such that the seal 4838a is configured to seal the interface between the sharp hub 4814 and the collar 4838 to prevent the ingress of foreign matter. In some embodiments, the collar 4838 may be substantially similar to the collar 9216 and its associated components described above.

[0429] Various other modifications and changes to the structures and methods of operation of the embodiments of the present disclosure will be apparent to those skilled in the art without departing from the scope and spirit of the present disclosure. Although the present disclosure has been described in conjunction with certain embodiments, it should be understood that the disclosure claimed should not be overly limited to these embodiments. It is intended that the following claims define the scope of the present disclosure, and that structures and methods within the scope of these claims and their equivalents are encompassed therein.

[0430] Additional details of suitable devices, systems, methods, components and operations thereof, and related features are described in International Publication No. WO2018 / 136898 of Rao et al., International Publication No. WO2019 / 236850 of Thomas et al., International Publication No. WO2019 / 236859 of Thomas et al., International Publication No. WO2019 / 236876 of Thomas et al., and U.S. Patent Publication No. 2020 / 0196919, each of which is incorporated herein by reference in its entirety. Further details regarding embodiments of the applicator, its components and variations thereof are described in U.S. Patent Publication Nos. 2013 / 0150691, 2016 / 0331283 and 2018 / 0235520, all of which are incorporated herein by reference in their entirety and for all purposes. Additional details regarding embodiments of sharp modules, sharps, components thereof, and variations thereof are described in U.S. Patent Publication No. 2014 / 0171771, which is incorporated herein by reference in its entirety and for all purposes.

[0431] 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 combined and replaced with those from any other embodiment. If a feature, element, component, function or step is described only for one embodiment, it should be understood that the feature, element, component, function or step can be used with each other embodiment described herein unless otherwise explicitly stated. Therefore, this paragraph serves as a pre-condition and written support for the introduction of claims at any time, which combine the features, elements, components, functions and steps of different embodiments, or replace those of one embodiment with the features, elements, components, functions and steps of another embodiment, even if the following description does not explicitly state, but in certain circumstances, such a combination or replacement is possible. Therefore, for the purpose of illustration and description, the foregoing description of specific embodiments of the disclosed subject matter has been presented. It is explicitly acknowledged that the expression of each possible combination and replacement is too cumbersome, especially considering that the permissibility of each such combination and replacement will be easily recognized by a person of ordinary skill in the art.

[0432] Although 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 may be made to the methods and systems of the disclosed subject matter without departing from the spirit or scope of the disclosed subject matter. Therefore, the disclosed subject matter is intended to include modifications and variations within the scope of the appended claims and their equivalents. In addition, any features, functions, steps, or elements of the embodiments may be listed in or added to the claims, as well as negative limitations on the scope of the invention of the claims by limiting the features, functions, steps, or elements not within the scope.

[0433] The invention may also be described in terms of the following numbered clauses.

[0434] Clause 1. An analyte monitoring system comprising:

[0435] Sensor control device, comprising:

[0436] Electronic equipment housing, comprising:

[0437] A housing having a first opening;

[0438] a support coupled to the housing to define an interior space, the support having a second opening axially aligned with the first opening;

[0439] A circuit board is arranged in the inner space of the electronic device housing;

[0440] an analyte sensor having a proximal portion extending into the interior space of the electronic device housing and having one or more sensor contacts electrically coupled to the circuit board, and a distal portion configured to measure a glucose level in a bodily fluid and extending from a bottom of the electronic device housing;

[0441] At least one seal is disposed in the interior space of the electronic device housing, proximate the first opening and the second opening, and is configured to provide a seal around at least a portion of a proximal portion of the analyte sensor, the proximal portion extending into the interior of the electronic device housing, and is configured to seal at least one sensor contact within the interior of the electronic device housing.

[0442] Clause 2. The system of Clause 1, further comprising a collar disposed in the interior space between the housing and the at least one seal, the collar axially aligned with each of the first aperture and the second aperture.

[0443] Clause 3. The system of any preceding clause, wherein at least one seal is axially aligned with the first opening and the second opening.

[0444] Clause 4. The system of any preceding clause, wherein at least one seal is compressed between the housing and the support.

[0445] Clause 5. The system of any preceding clause, wherein at least one seal defines a slit, and at least a portion of the proximal portion of the analyte sensor extends through the slit.

[0446] Clause 6. The system of clause 5, wherein the at least one seal further comprises a first seal and a second seal, wherein the second seal is matable with the first seal.

[0447] Clause 7. The system of Clause 6, wherein the slit is defined in at least one of the first seal and the second seal.

[0448] Clause 8. The system of Clause 6, wherein the slit is defined at an interface between the first seal and the second seal.

[0449] Clause 9. A system according to any of clauses 6 to 8, wherein the housing includes a first interface extending into the interior space, wherein the first interface defines a first channel positioned circumferentially around the first opening, and the support includes a second interface extending into the interior space, wherein the second interface defines a second channel positioned circumferentially around the second opening, wherein the first seal is integrated into the first channel and the second seal is integrated into the second channel.

[0450] Clause 10. The system of clause 9, wherein the first interface is configured to mate with the second interface.

[0451] Clause 11. The system of clause 9 or clause 10, wherein the first interface is configured to be welded to the second interface.

[0452] Clause 12. The system of any of clauses 6 to 11, wherein the first seal comprises a first sealing surface and the second seal comprises a second sealing surface, wherein the first sealing surface and the second sealing surface contact each other and are configured to isolate the interior space from foreign matter.

[0453] Clause 13. The system of clause 12, wherein the seal is formed by pressing the first sealing surface against the second sealing surface.

[0454] Clause 14. The system of clause 12 or clause 13, wherein the first sealing surface comprises a first rib.

[0455] Clause 15. The system of any of clauses 12 to 14, wherein the second sealing surface defines: at least one channel configured to receive the first rib; and / or a second rib configured to contact the first rib.

[0456] Clause 16. The system of clause 12 or clause 13, wherein the second sealing surface comprises a first rib.

[0457] Clause 17. The system of clause 16, wherein the first sealing surface defines: at least one channel configured to receive the first rib; and / or a second rib configured to contact the first rib.

[0458] Clause 18. The system of any preceding clause, wherein at least one seal comprises at least one of an elastomeric, rubber, and polymeric material.

[0459] Clause 19. The system of any preceding clause, wherein the seal comprises at least one of a UV curable silicone, a room temperature vulcanized silicone, and a UV curable polyurethane.

[0460] Clause 20. The system of any preceding clause, wherein the seal at least partially isolates the electronics housing from movement of the analyte sensor.

[0461] Clause 21. The system of any preceding clause, wherein the seal is configured to at least one of: reduce stress on the analyte sensor, and provide a moisture barrier to seal a distal portion of the glucose sensor extending from a bottom of the electronic device housing.

[0462] Clause 22. The system of any preceding clause, wherein at least one seal comprises a self-healing material configured to bond to itself via thermal activation.

[0463] Clause 23. A system according to any one of clauses 6 to 17 or 18 to 22, in a system dependent upon clauses 6 to 17, wherein the first seal has a first sealing opening, the second seal has a second sealing opening, and the first sealing opening and the second sealing opening are each axially aligned with each of the first opening and the second opening.

[0464] Clause 24. The system of any preceding clause, further comprising an adhesive patch attached to the bottom of the mount and configured to secure the electronic device housing to the user's skin.

[0465] Clause 25. The system of any preceding clause, wherein the housing includes a first inner surface defining a first channel, the support includes a second inner surface defining a second channel aligned with the first channel, and at least one seal is disposed in at least one of the first channel and the second channel.

[0466] Clause 26. The system of clause 25, wherein the seal comprises a first surface adjacent to the first channel and a second surface adjacent to the second channel, and wherein the seal further comprises at least one rib on the first surface and at least one rib on the second surface.

[0467] Clause 27. A system according to clause 26, wherein the first inner surface is adjacent to a first sealing surface of at least one seal, the second inner surface is adjacent to a second sealing surface of at least one seal, and the first inner surface and the second inner surface each include at least one rib configured to contact the first sealing surface and the second sealing surface, respectively.

[0468] Clause 28. The system of any preceding clause, wherein the housing comprises a first inner surface and the support comprises a second inner surface, wherein the first inner surface and the second inner surface are separated by a first height, and the seal has a second height greater than the first height.

[0469] Clause 29. The system of any of clauses 1 to 5 or clauses 18 to 22 or 24 to 28, wherein the seal comprises a one-piece configuration.

[0470] Clause 30. The system of Clause 29, wherein the seal defines a central slot for receiving a proximal portion of the analyte sensor.

[0471] Clause 31. The system of Clause 29, wherein the seal comprises an off-center slit for receiving a proximal portion of the analyte sensor.

[0472] Clause 32. The system of any of Clauses 1 to 28, wherein the seal comprises a two-piece configuration.

[0473] Clause 33. The sy...

Claims

1. An analyte monitoring system comprising: Sensor control device, comprising: Electronic equipment housing, comprising: A housing having a first opening; a support coupled to the housing to define an interior space, the support having a second opening axially aligned with the first opening; A circuit board is arranged in the internal space of the electronic device housing; an analyte sensor having a proximal portion extending into the interior space and having one or more sensor contacts electrically coupled to the circuit board and a distal portion configured to measure a glucose level in a bodily fluid and extending from a bottom of the electronic device housing; At least one seal is disposed in the interior space of the electronic device housing proximate the first opening and the second opening, and the seal is configured to provide a seal around at least a portion of the proximal portion of the analyte sensor extending into the interior space of the electronic device housing, and the seal is configured to seal at least one sensor contact within the interior space of the electronic device housing.

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

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

4. The system according to claim 1, wherein: The at least one seal is compressed between the housing and the support.

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

6. The system according to claim 5, wherein: The at least one seal also includes a first seal and a second seal that can cooperate with the first seal.

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

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

9. The system according to claim 6, wherein: The housing includes a first interface extending into the interior space, wherein the first interface defines a first channel positioned circumferentially around the first opening, and the support includes a second interface extending into the interior space, wherein the second interface defines a second channel positioned circumferentially around the second opening, wherein the first seal is integrated into the first channel, and the second seal is integrated into the second channel.

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

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

12. The system according to claim 6, wherein: The first seal includes a first sealing surface and the second seal includes a second sealing surface, wherein the first sealing surface and the second sealing surface contact each other and are configured to isolate the interior space from foreign matter.

13. The system according to claim 12, wherein: The seal is formed by pressing the first sealing surface against the second sealing surface.

14. The system according to claim 13, wherein: The first sealing surface includes a first rib.

15. The system of claim 14, wherein: The second sealing surface defines at least one channel configured to receive the first rib; and The second rib is in contact with the first rib.

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

17. The system of claim 16, wherein: The first sealing surface defines at least one channel configured to receive the first rib; and The second rib is in contact with the first rib.

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

19. The system of claim 1, wherein: The sealing member includes at least one of UV-curable silicone, room temperature vulcanized silicone, and UV-curable polyurethane.

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

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

22. The system of claim 1, wherein: The at least one seal includes a self-healing material configured to bond to itself via thermal activation.

23. The system of claim 6, wherein: The first seal has a first sealing opening, the second seal has a second sealing opening, and the first sealing opening and the second sealing opening are each axially aligned with each of the first opening and the second opening.

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

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

26. The system of claim 25, wherein: The seal includes a first surface adjacent to the first channel and a second surface adjacent to the second channel, and wherein the seal further includes at least one rib on the first surface and at least one rib on the second surface.

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

28. The system of claim 1, wherein: The housing includes a first inner surface and the support includes a second inner surface, wherein the first inner surface and the second inner surface are separated by a first height and the seal has a second height greater than the first height.

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

30. The system of claim 29, wherein: The seal defines a central slot for receiving the proximal portion of the analyte sensor.

31. The system of claim 29, wherein: The seal includes an off-center slit for receiving the proximal portion of the analyte sensor.

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

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

34. The system of claim 1, further comprising an applicator for delivering the analyte sensor, the applicator comprising: an applicator housing including a sensor carrier configured to secure the sensor control device within an interior of the applicator; as well as An applicator cap is removably coupled to the applicator housing to seal the interior of the applicator, wherein the applicator cap also includes a collimator having a distal end and a proximal end, the distal end is arranged to be adjacent to the support so that the interface between the distal end and the support is sealed, and the proximal end has an opening.

35. The system of claim 34, wherein: The collimator comprises a cross-sectional shape selected from the group consisting of conical, frustoconical, pyramidal, circular, cubic, rectangular, and any combination thereof.

36. The system of claim 34, wherein: The aperture of the collimator includes a seal configured to prevent moisture from entering the collimator but not to prevent electron beam radiation from entering the collimator.

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

38. A method for assembling an analyte monitoring system, comprising: An electronic device housing is provided, the electronic device housing comprising: A housing having a first opening; a support coupled to the housing to define an interior space, the support having a second opening axially aligned with the first opening; Providing a circuit board, wherein the circuit board is arranged in the internal space of the electronic device housing; providing an analyte sensor having a proximal portion and a distal portion, at least a portion of the proximal portion extending into the interior space of the electronic device housing and the proximal portion having one or more sensor contacts electrically coupled to the circuit board, and the distal portion being configured to measure a glucose level in a bodily fluid and extending from a bottom of the electronic device housing; disposing at least one seal in the interior space of the electronic device housing proximate the first opening and the second opening, the at least one seal being configured to provide a seal around at least a portion of the proximal portion of the analyte sensor extending into the interior space of the electronic device housing, and the at least one seal being configured to seal the one or more sensor contacts within the interior space of the electronic device housing; attaching an adhesive patch to an underside of the mount, and the adhesive patch is configured to secure the electronic device housing to the skin of a user; and Assembling a sensor control device, the sensor control device including the electronic device housing, circuit board, analyte sensor and adhesive patch.

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

40. The method of claim 38, further comprising: The proximal portion of the analyte sensor is disposed through the slit of the at least one seal.

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

42. The method of claim 41 further comprising: The first seal is integrated into a channel in the housing proximate the first opening, and the second seal is integrated into a channel in the support proximate the second opening.

43. The method of claim 41, further comprising: The first sealing surface of the first seal is pressed against the second sealing surface of the second seal.

44. The method of claim 40, further comprising: The slit is repaired using heat-activated reversible bonding, wherein the seal comprises a self-healing material.

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

46. ​​The method of claim 45, wherein: The curable elastomer includes one of UV curable silicone, room temperature vulcanized silicone and UV curable polyurethane, and wherein the method further comprises: curing the curable elastomer.

47. The method of claim 38, further comprising: The support is coupled to the housing by one of ultrasonic welding and laser welding.

48. The method of claim 47, further comprising: The support is ultrasonically or laser welded to the housing along at least a first weld joint, wherein the first channel and the second channel coincide with the first weld joint.

49. The method of claim 47, further comprising: At least one of the housing and the support is melted without melting the seal.

50. A method for assembling an analyte monitoring system, comprising: Assemble the sensor control unit, including: An electronic device housing is provided, the electronic device housing comprising: a housing having a first opening; and a support, disposed opposite to the housing to define an internal space, the support having a second opening aligned with the first opening; Providing a circuit board, the circuit board is arranged in the internal space of the electronic device housing, and the circuit board includes a plurality of electronic device modules; An analyte sensor is provided, the analyte sensor comprising: a tail portion extending from the bottom of the electronic device housing and passing through the second opening, and the tail portion is configured to measure the analyte level in a body fluid; a flag portion extending into the interior space of the electronic device housing and comprising a plurality of sensor contacts coupled to the circuit board; and a neck portion interconnecting the tail portion and the flag portion; providing a sharpened hub engageable with an upper outer surface of the housing and comprising a sharp point and a mating member configured to extend through the first and second openings and to extend distally from a bottom side of the mount; and An applicator for delivering the analyte sensor is provided, the applicator comprising: a housing including a sensor carrier configured to secure the sensor control device within the applicator; and An applicator cap is removably coupled to the housing to seal the interior of the applicator, wherein the applicator cap also includes a collimator having a distal end and a proximal end, the distal end is arranged to be adjacent to the support so that the interface between the distal end and the support is sealed, and the proximal end has an opening.

51. The method of claim 50, further comprising: A label is disposed near the opening of the collimator so that the electron beam is configured to pass through the opening and foreign matter cannot pass through the opening.

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

53. The method of claim 52, further comprising: The collimator is axially aligned with at least one of the analyte sensor and the second aperture.

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