Systems, devices and methods for analyte monitors

Abstract

An analyte measurement device comprising: an analyte sensor configured to measure an analyte level, the analyte sensor including a tail portion for subcutaneous placement and having an analyte responsive enzyme disposed thereon, an applicator for delivering the analyte sensor having a housing defining an airtight sealed chamber, the tail portion being disposed in the chamber prior to subcutaneous placement, and a capture material disposed in the chamber, the capture material including at least one of activated charcoal, molecular sieves, and silica gel, and configured to adsorb at least one substance in the chamber. Methods of packaging the analyte sensor are also disclosed.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Patent Application No. 63 / 320,451, filed March 16, 2022, the contents of which are hereby incorporated by reference in their entirety.

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

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

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

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

[0006] While current sensors can be convenient for users, they are also prone to malfunctions due to incorrect insertion. These malfunctions can be caused by user error, lack of proper training, inadequate user adjustment, overly complicated procedures, and other issues. This can be particularly true for analyte monitoring systems with dermal sensors that are typically smaller in scale compared to sensors used to measure analyte levels in interstitial fluid ("ISF") and inserted with sharps (also known as "introducers" or "needles") that are shorter than those used for ISF sensors. Some prior art systems may, for example, rely too heavily on the precise assembly and deployment of the sensor control device and applicator by the individual user. Other prior art systems may utilize sharps insertion and retraction mechanisms that are prone to premature withdrawal before the sensor can be properly implanted. In addition, with respect to skin sensors, some prior art systems may utilize sharps that are not optimally configured to create an insertion path within the dermal layer without causing trauma to the surrounding tissue. These issues and others described herein can lead to incorrectly inserted or damaged sensors and consequent failure to properly monitor a patient's analyte levels. [Prior art documents] [Patent documents]

[0007] [Patent Document 1] U.S. Patent No. 6,174,952 [Patent Document 2] U.S. Patent No. 6,316,520 [Patent Document 3] US Patent Publication No. 2014 / 0171771 [Patent Document 4] US Patent Publication No. 2014 / 0275907 [Patent Document 5] U.S. Provisional Patent Application No. 63 / 081,223 [Patent Document 6] International Publication No. WO2018 / 136898 [Patent Document 7] International Publication No. WO2019 / 236850 [Patent Document 8] International Publication No. WO2019 / 236859 [Patent Document 9] International Publication No. WO2019 / 236876 [Patent Document 10] US Patent Publication No. 2020 / 0196919 [Patent Document 11] US Patent Publication No. 2013 / 0150691 [Patent Document 12] US Patent Publication No. 2016 / 0331283 [Patent Document 13] US Patent Publication No. 2018 / 0235520 Summary of the Invention [Problem to be solved by the invention]

[0008] Thus, there is a need for more reliable insertion devices, systems, and methods that are easier for patients to use and less prone to error, especially for use with skin sensors. Additionally, there is a need for sensor insertion devices, systems, and methods that provide sensor stability and extended shelf life. [Means for solving the problem]

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

[0010] To achieve these and other advantages and in accordance with the purposes of the presently disclosed subject matter, as embodied and broadly described, the presently disclosed subject matter relates to an analyte measuring device. The analyte measuring device includes an analyte sensor configured to measure an analyte level. The analyte sensor includes a tail portion for subcutaneous placement, the tail portion having an analyte responsive enzyme disposed thereon. The analyte measuring device further includes an applicator for analyte sensor delivery having a housing defining an airtight sealed chamber. The housing can be configured to at least partially define the airtight sealed chamber. The airtight sealed chamber can be formed / defined prior to subcutaneous placement of the tail portion. In some embodiments, the airtight sealed chamber exists only prior to subcutaneous placement of the tail portion, i.e., in a pre-subcutaneous configuration. The housing can be formed of a gas impermeable material. The tail portion is disposed within the airtight sealed chamber prior to subcutaneous placement, i.e., in a pre-subcutaneous configuration. In other words, the airtight sealed chamber is configured to receive the tail portion prior to subcutaneous placement of the tail portion. In summary, the analyte measuring device has a pre-subcutaneous placement configuration (a configuration used prior to subcutaneous placement of the tail portion) in which an airtight sealed chamber exists to receive the tail portion.

[0011] The analyte measurement device further includes a capture material disposed within the hermetically sealed chamber, the capture material including at least one of activated carbon, molecular sieves, and silica gel, and configured to adsorb at least one substance within the hermetically sealed chamber. The at least one substance may include at least one volatile organic compound. The capture material may form part of a compound that contains additional materials, e.g., a compound that also contains a polymeric material. The capture material is within the hermetically sealed chamber, e.g., the capture material may be used to form a housing that at least partially defines the hermetically sealed chamber or to form a component within the hermetically sealed chamber, or the capture material may be a coating on at least an inner surface of the housing or on a component within the hermetically sealed chamber, or the capture material may be positioned in any suitable location within the hermetically sealed chamber. The capture material may take the form of, for example, a coating, a stick, a powder, a patch, or a pouch.

[0012] Optionally, the applicator may include an applicator cap. The applicator cap and the housing may mutually define an airtight sealed chamber. The airtight sealed chamber may be formed between the applicator cap and the housing prior to subcutaneous placement of at least the tail portion, i.e., in a pre-subcutaneous placement configuration. The applicator cap may include, be coupled to, or otherwise contain the capture material such that the capture material is within the airtight sealed chamber. The applicator cap may be formed of a gas-impermeable material. In one example, the applicator cap and the housing are formed of gas-impermeable materials, which may be the same or different, and a seal, which may also be gas-impermeable, may be formed between the housing and the applicator cap.

[0013] The capture material can surround the tail portion. Specifically, the capture material can be configured to surround the tail portion when the tail portion is in the hermetically sealed chamber, i.e., prior to subcutaneous placement of the tail portion (when the device, specifically the tail portion of the device, is in a pre-subcutaneous configuration). Additionally or alternatively, the tail portion can have a length and the capture material can surround the tail portion along this length. Specifically, the capture material can be configured to surround the tail portion along this length when the tail portion is in the hermetically sealed chamber, i.e., prior to subcutaneous placement of the tail portion (when the device, specifically the tail portion of the device, is in a pre-subcutaneous configuration). Additionally or alternatively, the tail portion can be received within a hollow or recessed portion of the sharp of the analyte measurement device and the capture material can be immediately adjacent to the tail portion and the sharp within the chamber, specifically the hermetically sealed chamber. In other words, the hollow or recessed portion of the sharp can be configured to receive at least a portion of the tail portion. The hollow or recessed portion can be configured to at least partially circumscribe the tail. The capture material can be immediately adjacent to the tail portion and the sharp when the tail portion and the sharp are in the hermetically sealed chamber, i.e., in a pre-subcutaneous configuration (prior to subcutaneous placement of the tail portion). The sharp may be referred to as an introducer or needle. Additionally or alternatively, a sensor sleeve of the analyte measurement device can at least partially surround the tail portion in a chamber, particularly in the hermetically sealed chamber, and the sensor sleeve includes the capture material. The capture material can form a coating over the sensor sleeve. The sensor sleeve may include the capture material, optionally in combination with at least one polymeric material. Specifically, the sensor sleeve can be configured to receive at least a portion of the tail portion when the tail portion is in the hermetically sealed chamber, i.e., when the tail portion is in a pre-subcutaneous configuration.

[0014] Additionally or alternatively, the analyte measuring device may include a sensor cap that at least partially defines a sensor cap chamber. The sensor cap chamber may be entirely enclosed (at least partially) within a hermetically sealed chamber defined by the housing. The sensor cap chamber may only exist prior to subcutaneous placement of the tail portion, i.e., in a pre-subcutaneous configuration. The sensor cap chamber may optionally be hermetically sealed. If the analyte measuring device includes a sensor sleeve as described above, optionally the sensor sleeve may be disposed within the sensor cap chamber, and the tail portion may be received within the sensor sleeve and the sensor cap chamber prior to subcutaneous placement (i.e., in a pre-subcutaneous configuration). Optionally, the sensor cap may be formed of a gas impermeable material.

[0015] The analyte measurement device may include an electronics housing disposed within the applicator, and the housing may be configured to be worn on the patient's skin. The analyte sensor may include a first portion and a tail portion. The first portion may be within the electronics housing, and the tail portion may extend through an opening in the electronics housing. The collar may be positioned within the electronics housing and may include a capture material.

[0016] As discussed above, the analyte measuring device may include a sensor cap. The sensor cap may have a first end and a sensor cap chamber. When the analyte measuring device includes both a sensor cap and an electronics housing, optionally, the first end of the sensor cap may be removably coupled to the electronics housing, and the tail portion of the sensor may be received in the sensor cap chamber prior to subcutaneous placement. The sensor cap chamber may be defined in part by the electronics housing. The sensor cap chamber may be formed between the electronics housing and the sensor cap. The sensor cap chamber may only exist prior to subcutaneous placement of the tail portion, i.e., in a pre-subcutaneous placement configuration. In one example, the sensor cap and the electronics housing may be formed of gas impermeable materials, which may be the same or different, and a seal, which may also be gas impermeable, may be formed between the sensor cap and the electronics housing.

[0017] The analyte measuring device can include a sensor sleeve disposed in the sensor cap, the sensor sleeve including a capture material and at least partially surrounding the tail portion.

[0018] The capture material can be coupled to the applicator, disposed within the electronics housing, or disposed within the sensor cap chamber. Additionally or alternatively, at least one of the electronics housing, the sensor cap, the applicator, and the sensor sleeve can include a capture material.

[0019] The scavenging material can be a selective scavenging material, ie, a scavenging material configured to adsorb specific volatile organic compounds.

[0020] In accordance with the subject matter of the present disclosure, there is provided a method of packaging an analyte sensor. The method includes providing an analyte sensor configured to measure an analyte level. The analyte sensor includes a tail portion for subcutaneous placement, the tail portion having an analyte responsive enzyme disposed thereon. The method further includes providing an applicator for delivery of the analyte sensor. The applicator includes a housing defining an airtight sealed chamber. The tail portion is disposed within the chamber prior to subcutaneous placement. The method further includes disposing a capture material within the chamber, the capture material including at least one of activated carbon, molecular sieves, and silica gel, and configured to adsorb at least one substance within the chamber.

[0021] The method may include providing an electronics housing disposed within an applicator, the electronics housing configured to be attached to the skin of a patient, and the analyte sensor including a first portion within the electronics housing and a tail portion extending through an opening in the electronics housing.

[0022] The method may optionally include providing a sensor cap having a first end and a sensor cap chamber, the first end optionally removably coupled to the electronics housing, and a tail portion received within the sensor cap chamber prior to subcutaneous placement.

[0023] The method can include providing a sensor sleeve, the sensor sleeve including a capture material and at least partially surrounding the tail portion.

[0024] The applicator may further include an applicator cap. Optionally, the method may include coupling the applicator cap to a housing of the applicator to form an airtight sealed chamber therebetween. The tail portion of the analyte sensor may be disposed within the applicator cap or housing prior to coupling the applicator cap to the housing. Similarly, the capture material may be disposed inside the housing or applicator cap prior to coupling the applicator cap to the housing, either as a coating on the housing or applicator cap or if not used to form the housing or applicator cap.

[0025] Disposing the capture material in the chamber may include combining the capture material with an applicator, disposing the capture material in an electronics housing, or disposing the capture material in a sensor cap chamber.

[0026] The method may further include coupling the sensor cap to the electronics housing to form a sensor cap chamber. The sensor cap chamber may be entirely enclosed within a hermetically sealed chamber.

[0027] The features and corresponding descriptions presented throughout this specification with respect to the analyte measurement device apply equally to the method of packaging an analyte sensor. The method of packaging an analyte sensor is performed prior to subcutaneous placement of the tail portion of the sensor. During the method of packaging an analyte sensor, the analyte sensor and applicator may be placed in a pre-subcutaneous placement configuration.

[0028] The capture material can be a selective capture material.

[0029] Details of the inventive subject matter recited herein, both as to its structure and operation, will be apparent from consideration of the accompanying drawings, in which like reference numerals refer to like parts. The components within the figures are not necessarily to scale, with emphasis instead being placed upon illustrating the principles of the inventive subject matter. Moreover, all illustrations are intended to convey concepts, and relative sizes, shapes, and other detailed attributes may be illustrated generally, rather than literally or precisely. [Brief description of the drawings]

[0030] [Figure 1] 1 is a system schematic diagram of a sensor applicator, a reader device, a monitor system, a network, and a remote system. [Figure 2A] FIG. 2 is a block diagram illustrating an exemplary embodiment of a reader device. [Figure 2B] FIG. 2 is a block diagram illustrating an exemplary embodiment of a sensor control device. [Figure 2C] FIG. 2 is a block diagram illustrating an exemplary embodiment of a sensor control device. [Figure 3A] FIG. 13 is a proximal perspective view depicting an exemplary embodiment in which a user prepares a tray for assembly. [Figure 3B] 11 is a side view depicting an exemplary embodiment of a user preparing the applicator device for assembly. [Figure 3C] FIG. 13 is a proximal perspective view depicting an exemplary embodiment in which a user inserts an applicator device into a tray during assembly. [Figure 3D] 13A is a proximal perspective view depicting an exemplary embodiment in which a user removes the applicator device from a tray during assembly. FIG. [Figure 3E] FIG. 1 is a proximal perspective view depicting an exemplary embodiment in which a patient applies a sensor using an applicator device. [Figure 3F] FIG. 1 is a proximal perspective view depicting an exemplary embodiment of a patient with a sensor applied and an applicator device used. [Figure 4A]1 is a side view depicting an exemplary embodiment of an applicator device coupled with a cap. [Figure 4B] FIG. 2 is a side perspective view depicting an exemplary embodiment with the applicator device and cap separated. [Figure 4C] 1 is a perspective view depicting an exemplary embodiment of a distal end of an applicator device and an electronics housing. [Figure 4D] 1 is a top perspective view of an exemplary applicator device in accordance with the presently disclosed subject matter. [Figure 4E] FIG. 4E is a bottom perspective view of the applicator device of FIG. 4D. [Figure 4F] FIG. 4E is an exploded view of the applicator device of FIG. 4D. [Figure 4G] FIG. 4E is a side cutaway view of the applicator device of FIG. 4D. [Diagram 5] FIG. 1 is a proximal perspective view depicting an exemplary embodiment of a tray with a sterilization lid attached. [Figure 6A] FIG. 13 is a proximal perspective cutaway view depicting an exemplary embodiment of a tray having a sensor delivery component. [Figure 6B] FIG. 13 is a proximal perspective view depicting a sensor delivery component. [Figure 7A] FIG. 2 is a side view depicting an exemplary embodiment of a housing. [Figure 7B] 1 is a perspective view depicting an exemplary embodiment of a distal end of a housing. [Figure 7C] 1 is a side cross-sectional view depicting an exemplary embodiment of a housing. [Figure 7D] FIG. 13 is a side cross-sectional view depicting a locking rib portion of an exemplary embodiment of a housing along with a portion of a sheath. [Figure 7E] FIG. 13 is a side cross-sectional view depicting a locking rib portion of an exemplary embodiment of a housing along with a portion of a sheath. [Figure 7F] FIG. 13 is a side cross-sectional view depicting a locking rib portion of another exemplary embodiment of a housing and a portion of a sheath. [Figure 7G] FIG. 13 is a side cross-sectional view depicting a locking rib portion of another exemplary embodiment of a housing and a portion of a sheath. [Figure 7H] FIG. 13 is a side cross-sectional view depicting a locking rib portion of another exemplary embodiment of a housing and a portion of a sheath. [Figure 7I] FIG. 13 is a side cross-sectional view depicting a locking rib portion of another exemplary embodiment of a housing and a portion of a sheath. [Figure 7J] FIG. 2 is a side view of an exemplary housing according to the presently disclosed subject matter. [Figure 7K] FIG. 7J is a bottom perspective view of the housing of FIG. 7J. [Figure 7L] FIG. 7C is a side cutaway view of the housing of FIG. 7J. [Figure 7M] FIG. 2 is a bottom perspective view of a cap in accordance with the subject matter of the present disclosure. [Figure 7N(i)] FIG. 7B is a side cutaway view of the cap of FIG. 7M. [Figure 7N(ii)] FIG. 7M is a side cutaway view of the cap of FIG. 7M depicting a capture material in accordance with the presently disclosed subject matter. [Figure 7O] FIG. 7B is a top view of the cap of FIG. 7M. [Figure 7P] FIG. 2 is a cutaway view of a desiccant in a cap in accordance with the presently disclosed subject matter. [Figure 7Q] FIG. 2 is a bottom perspective view of an exemplary desiccant according to the presently disclosed subject matter. [Figure 7R] FIG. 2 is a top perspective view of an exemplary desiccant according to the presently disclosed subject matter. [Figure 7S] 1 is an enlarged cross-sectional side view of an interface between a housing and a cap in accordance with the subject matter of the present disclosure. [Figure 7T] 1 is an enlarged cross-sectional side view of an interface between a housing and a cap in accordance with the subject matter of the present disclosure. [Figure 7U] FIG. 2 is an enlarged cross-sectional side view of a housing in accordance with the subject matter of the present disclosure. [Figure 7V] FIG. 2 is an enlarged cross-sectional side view of a cap in accordance with the subject matter of the present disclosure. [Figure 7W] FIG. 7B is a side cutaway view of the cap of FIG. 7M. [Figure 7X] FIG. 7B is a side cutaway view of the cap of FIG. 7M. [Figure 7Y] FIG. 2 illustrates a top perspective view of an exemplary elastomeric plug according to one or more embodiments. [Figure 7Z(i)] FIG. 2 is a partial cross-sectional perspective view of an exemplary sensor cap and elastomeric plug according to one or more embodiments. [Figure 7Z(ii)] FIG. 2 is a cross-sectional perspective view of an exemplary elastomeric plug according to one or more embodiments. [Figure 7Z(iii)] FIG. 2 is a cross-sectional perspective view of an exemplary elastomeric plug according to one or more embodiments. [Figure 8A] 1 is a side view depicting an exemplary embodiment of a sheath. [Figure 8B] 1 is a perspective view depicting an exemplary embodiment of a proximal end of a sheath. [Figure 8C] FIG. 13 is an enlarged perspective view depicting an exemplary embodiment of the distal side of a detent snap of a sheath. [Figure 8D] 1A-1C are side views depicting exemplary embodiments of features of a sheath. [Figure 8E] FIG. 13 is an end view of an exemplary embodiment of a proximal end of a sheath. [Figure 8F] 11A-11C are perspective views depicting another exemplary embodiment of a sheath at various stages of assembly with other applicator components. [Figure 8G] 11A-11C are perspective views depicting another exemplary embodiment of a sheath at various stages of assembly with other applicator components. [Figure 8H] 11A-11C are perspective views depicting another exemplary embodiment of a sheath at various stages of assembly with other applicator components. [Figure 8I] FIG. 2 is a side view of a sheath in accordance with the presently disclosed subject matter. [Figure 8J] FIG. 8I is a close-up view of the detent snap of the sheath of FIG. [Figure 8K] FIG. 8I is a top view of the sheath of FIG. [Figure 8L] FIG. 8I is a perspective view of the sheath of FIG. [Figure 8M] FIG. 8I is a side cutaway view of the sheath of FIG. [Figure 8N]FIG. 8I is an enlarged view of the locking arm of the sheath of FIG. 8I and its engagement with the cap and sensor carrier in accordance with the subject matter of the present disclosure. [Figure 8O] FIG. 8I is a close-up view of the ribs of the sheath of FIG. 8I and their engagement with the sensor carrier in accordance with the subject matter of the present disclosure. [Figure 9A] FIG. 2 is a proximal perspective view depicting an exemplary embodiment of a sensor carrier. [Figure 9B] FIG. 2 is a distal perspective view depicting an exemplary embodiment of a sensor carrier. [Figure 9C] FIG. 13 is a distal perspective view depicting another exemplary embodiment of a sensor carrier. [Figure 9D] FIG. 2 is a top perspective view of a sensor carrier according to the subject matter of the present disclosure. [Figure 9E] FIG. 9E is a bottom view of the sensor carrier of FIG. 9D. [Figure 10A] FIG. 2 is a perspective view of a sharps carrier in accordance with the subject matter of the present disclosure. [Figure 10B] FIG. 10B is a side cutaway view of the sharps carrier of FIG. 10A. [Figure 10C] FIG. 2 is a perspective view of a sharps carrier in accordance with the subject matter of the present disclosure. [Figure 10D] FIG. 10D is a side cutaway view of the sharps carrier of FIG. 10C. [Figure 11A] FIG. 2 is a top perspective view illustrating an exemplary embodiment of a sensor module. [Figure 11B] FIG. 2 is a bottom perspective view illustrating an exemplary embodiment of a sensor module. [Figure 12A] FIG. 1 is a perspective view depicting an exemplary embodiment of a sensor connector. [Figure 12B] FIG. 2 is a condensed view illustrating an exemplary embodiment of a sensor connector. [Figure 13] FIG. 1 is a perspective view illustrating an exemplary embodiment of a sensor. [Figure 14A] FIG. 2 illustrates a bottom perspective view of an exemplary embodiment of a sensor module assembly. [Figure 14B] FIG. 2 illustrates a top perspective view of an exemplary embodiment of a sensor module assembly. [Figure 15A]FIG. 2 is an enlarged partial view of an exemplary embodiment of a sensor module assembly. [Figure 15B] FIG. 2 is an enlarged partial view of an exemplary embodiment of a sensor module assembly. [Figure 15C] FIG. 1 is a side view of an exemplary sensor according to one or more embodiments of the present disclosure. [Figure 15D] FIG. 1 is a side view of an exemplary sensor according to one or more embodiments of the present disclosure. [Figure 15E] FIG. 1 is a side view of an exemplary sensor according to one or more embodiments of the present disclosure. [Figure 15F] FIG. 1 is a side view of an exemplary sensor according to one or more embodiments of the present disclosure. [Figure 15G] FIG. 1 is a side view of an exemplary sensor according to one or more embodiments of the present disclosure. [Figure 16A] FIG. 1 is an isometric view of an exemplary connector assembly according to one or more embodiments. [Figure 16B] FIG. 1 is a partially exploded isometric view of an exemplary connector assembly according to one or more embodiments. [Figure 16C] FIG. 15 is an isometric bottom view of the connector of FIGS. 16A-16B. [Figure 16D] FIG. 1 is an isometric view of another exemplary connector assembly according to one or more embodiments. [Figure 16E] FIG. 1 is a partially exploded isometric view of another exemplary connector assembly according to one or more embodiments. [Figure 16F] FIG. 16C is an isometric bottom view of the connector of FIGS. 16D-16E. [Figure 17A] FIG. 2 is a perspective view illustrating an exemplary embodiment of a Sharp module. [Figure 17B] FIG. 13 is a perspective view of another exemplary embodiment of a sharp module. [Figure 17C] FIG. 17C is a schematic diagram illustrating the Sharp module of FIG. 17B. [Figure 17D] FIG. 17C is a schematic diagram illustrating the Sharp module of FIG. 17B. [Figure 17E]FIG. 17C is a schematic side view of the Sharp module of FIG. 17B when assembled with a sensor module. [Figure 17F] FIG. 17C is a top schematic view of the Sharp module of FIG. 17B when assembled with a sensor module. [Figure 17G] FIG. 13 is a perspective view of another exemplary embodiment of a sharp module. [Figure 17H] FIG. 17F is a side schematic diagram illustrating the Sharp module of FIG. 17G. [Figure 17I] FIG. 17F is a side cross-sectional view of the Sharp module of FIG. 17G when assembled with a sensor module. [Figure 17J] FIG. 17H is a side view of the Sharp module of FIG. 17G when assembled with a sensor module. [Figure 18A] FIG. 2 is an isometric view of another exemplary sensor control device. [Figure 18B] FIG. 2 is a side view of another exemplary sensor control device. [Figure 19A] FIG. 18C is an exploded isometric top view of the sensor control device of FIGS. 18A-18B. [Figure 19B(i)] FIG. 18C is an exploded isometric bottom view of the sensor control device of FIGS. 18A-18B. [Figure 19B(ii)] FIG. 1 is an exploded isometric view of a sensor control device according to one or more embodiments. [Figure 19B(iii)] FIG. 1 is a perspective view of a cap according to one or more embodiments. [Figure 19B(iv)] FIG. 1 is a perspective view of a collar according to one or more embodiments. [Figure 19C] FIG. 2 is a top perspective view of a cell battery in accordance with the subject matter of the present disclosure. [Figure 20A] FIG. 2 is a cross-sectional side view of an assembled seal subassembly according to one or more embodiments. [Figure 20B] 1 is a cross-sectional side view of an assembled sealing subassembly depicting a capture material according to one or more embodiments in accordance with the presently disclosed subject matter. [Figure 20C]1 is a cross-sectional side view of an assembled sealing subassembly depicting a capture material according to one or more embodiments in accordance with the presently disclosed subject matter. [Figure 21A] 18A-18B , depicting a cross-sectional side view of a sensor applicator assembly with the sensor control device of FIG. 18A. [Figure 21B] 18A-18B , depicting a cross-sectional side view of a sensor applicator assembly with the sensor control device of FIG. 18A. [Figure 21C] 18A-18B , depicting a cross-sectional side view of a sensor applicator assembly with the sensor control device of FIG. 18A. [Figure 22A] FIG. 21D is a perspective view of the cap post of FIG. 21C in accordance with one or more additional embodiments. [Figure 22B] FIG. 21D is a top view of the cap post of FIG. 21C in accordance with one or more additional embodiments. [Figure 23] FIG. 18C is a cross-sectional side view of the sensor control device of FIGS. 18A-18B. [Figure 24A] FIG. 13 is a cross-sectional side view of a sensor applicator ready to deploy a sensor control device at a target monitor location. [Figure 24B] FIG. 13 is a cross-sectional side view of a sensor applicator ready to deploy a sensor control device at a target monitor location. [Figure 25A] 18A-18B , depicting cross-sectional side views in stages illustrating the assembly and disassembly of an exemplary embodiment of a sensor applicator and the sensor control device of FIGS. 18A-18B . [Figure 25B] 18A-18B , depicting cross-sectional side views in stages illustrating the assembly and disassembly of an exemplary embodiment of a sensor applicator and the sensor control device of FIGS. 18A-18B . [Figure 25C] 18A-18B , depicting cross-sectional side views in stages illustrating the assembly and disassembly of an exemplary embodiment of a sensor applicator and the sensor control device of FIGS. 18A-18B . [Figure 26A] FIG. 2 is an isometric bottom view of a housing according to one or more embodiments. [Figure 27A]FIG. 2 is an isometric bottom view of a housing having a sheath and other components at least partially positioned therein. [Figure 28] FIG. 2 is an enlarged cross-sectional side view of a sensor applicator having a sensor control device disposed therein according to one or more embodiments. [Figure 29A] FIG. 2 is an isometric top view of a cap according to one or more embodiments. [Figure 29B] 11 is an enlarged cross-sectional view of the engagement between the cap and housing according to one or more embodiments. [Figure 30A] FIG. 2 is an isometric view of a sensor cap according to one or more embodiments. [Figure 30B] FIG. 1 is an isometric view of a collar according to one or more embodiments. [Figure 31A] FIG. 1 is a side view of an exemplary sensor control device in accordance with one or more embodiments of the present disclosure. [Figure 31B] FIG. 1 is an isometric view of an exemplary sensor control device in accordance with one or more embodiments of the present disclosure. [Figure 32A] FIG. 3 is an exploded isometric top view of the sensor control device of FIG. 2 according to one or more embodiments. [Figure 32B] FIG. 3 is an exploded isometric bottom view of the sensor control device of FIG. 2 in accordance with one or more embodiments. [Figure 32C] FIG. 32C is a top perspective view of the collar of FIGS. 32A-B according to one or more embodiments. [Fig. 32D] FIG. 3 is an isometric top view of the sensor control device of FIG. 2 according to one or more embodiments. [Figure 32E] FIG. 3 is an isometric top view of the sensor control device of FIG. 2 according to one or more embodiments. [Diagram 33] 31A-31B and 32A-32B according to one or more embodiments. FIG. [Figure 33A] FIG. 32C is an exploded isometric view of a portion of another embodiment of the sensor control device of FIGS. 31A-31B and 32A-32B. [Figure 33B] FIG. 33B is a cross-sectional view of the Sharp hub and mount of FIG. 33A according to one or more embodiments. [Figure 34A] FIG. 32A is an isometric bottom view of the mount of FIGS. 31A-31B and 32A-32B. [Figure 34B] FIG. 32A is an isometric top view of the sensor cap of FIGS. 31A-31B and 32A-32B. [Figure 35A] FIG. 2 is a side view of an exemplary sensor applicator according to one or more embodiments. [Figure 35B] FIG. 1 is a cross-sectional side view of an exemplary sensor applicator according to one or more embodiments. [Figure 36A] FIG. 35C is a perspective view of the cap post of FIG. 35B according to one or more embodiments. [Figure 36B] FIG. 35C is a top view of the cap post of FIG. 35B according to one or more embodiments. [Figure 37] FIG. 1 is a cross-sectional side view of a sensor control device positioned within an applicator cap in accordance with one or more embodiments. [Figure 38A] 1 is a cross-sectional view of a sensor control device illustrating an exemplary interaction between a sensor and a sharp. [Figure 38B] FIG. 1 is a side cross-sectional view of a Sharps hub, a Sharp, and a sensor, with the sensor in an unenergized position in accordance with the subject matter of the present disclosure. [Figure 38C] FIG. 13 is a side cross-sectional view of a Sharps hub, a Sharp, and a sensor with the sensor in an energized position in accordance with the subject matter of the present disclosure. [Figure 38D] 1 is an enlarged view of a portion of a sharp in accordance with the subject matter of the present disclosure. [Figure 39A] 1A-1C are cross-sectional views depicting an exemplary embodiment of an applicator during stages of deployment. [Figure 39B] 1A-1C are cross-sectional views depicting an exemplary embodiment of an applicator during stages of deployment. [Figure 39C] 1A-1C are cross-sectional views depicting an exemplary embodiment of an applicator during stages of deployment. [Figure 39D]1A-1C are cross-sectional views depicting an exemplary embodiment of an applicator during stages of deployment. [Figure 39E] 1A-1C are cross-sectional views depicting an exemplary embodiment of an applicator during stages of deployment. [Figure 39F] 1A-1C are cross-sectional views depicting an exemplary embodiment of an applicator during stages of deployment. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0031] Before describing the subject matter of the present invention in detail, it is to be understood that the disclosure is not limited to particular embodiments described, which can, of course, vary. The scope of the disclosure is not limited, except as by the appended claims, and it is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting.

[0032] As used in this specification and the appended claims, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise.

[0033] The documents discussed herein are provided solely for their disclosure prior to the filing date of this application. Nothing herein should be construed as an admission that the present disclosure is not entitled to antedate such documents by virtue of prior disclosure. Further, the dates of the documents provided may be different from the actual publication dates, which may need to be independently confirmed.

[0034] In general, embodiments of the present disclosure include systems, devices, and methods for the use of an analyte sensor insertion applicator for use with an in vivo analyte monitor system. The applicator can be provided to a user in a sterile package with an electronics housing of a sensor control device enclosed therein. According to some embodiments, a structure separate from the applicator, such as a container, can also be provided to a user as a sterile package with a sensor module and a sharps module enclosed therein. A user can couple the sensor module to the electronics housing and couple the sharps to the applicator through an assembly process that involves inserting the applicator into the container in a specified manner. In other embodiments, the applicator, sensor control device, sensor module, and sharps module can be provided in a single package. The applicator can be used to position the sensor control device on the human body with the sensor in contact with the wearer's bodily fluids. The embodiments provided herein are improvements that reduce the likelihood of the sensor being improperly inserted or damaged or inducing an adverse physiological response. Other improvements and advantages are also provided. Various configurations of these devices are described in detail using embodiments that are merely examples.

[0035] Additionally, many embodiments include an in vivo analyte sensor that is structurally configured such that at least a portion of the sensor can be positioned on the body of a user to obtain information regarding at least one analyte in the body of the user. However, it should be noted that the embodiments disclosed herein may be used in in vivo analyte monitoring systems that incorporate extracorporeal functionality, as well as purely ex vivo or ex vivo analyte monitoring systems, including completely non-invasive systems.

[0036] Additionally, for each and every embodiment of the methods disclosed herein, systems and devices having the functionality to perform each of these embodiments are encompassed in the present disclosure. For example, sensor control device embodiments are disclosed, which may have one or more sensors, analyte monitor circuitry (e.g., analog circuitry), memory (e.g., for storing instructions), power sources, communication circuitry, transmitters, receivers, processors, and / or controllers (e.g., for executing instructions) that may perform or facilitate the performance of any and all method steps. These sensor control device embodiments may be used and may have the functionality to perform steps performed by the sensor control device from any and all of the methods described herein.

[0037] As mentioned above, certain embodiments of systems, devices, and methods are described herein to enable improved assembly and use of dermal sensor insertion devices for use with in vivo analyte monitor systems. In particular, certain embodiments of the present disclosure are designed to improve sensor insertion methods for in vivo analyte monitor systems, and in particular to prevent premature retraction of the insertion sharp during the sensor insertion process. For example, certain embodiments include a dermal sensor insertion mechanism with a high firing rate and delayed sharp retraction. In other embodiments, the sharp retraction mechanism can be motion-activated such that the sharp does not retract until the user pulls the applicator away from the skin. As a result, these embodiments can reduce the possibility of prematurely extracting the insertion sharp during the sensor insertion process, reduce the possibility of incorrect sensor insertion, and reduce the possibility of damaging the sensor during the sensor insertion process, to name a few advantages. Certain embodiments of the present disclosure also enable improved insertion sharps modules that account for the small scale of dermal sensors and the relatively shallow insertion path present in the dermal layer of a subject. Additionally, certain embodiments of the present disclosure are designed to prevent undesired axial and / or rotational movement of applicator components during sensor insertion. These embodiments may thus reduce the likelihood of capillary disruption resulting in instability of the positioned dermal sensor, rash at the insertion site, damage to surrounding tissue, and contamination of the dermal fluid with blood, to name a few advantages. Additionally, to mitigate inaccurate sensor readings that may be caused by trauma at the insertion site, some embodiments of the present disclosure may shorten the distal depth penetration of the needle relative to the sensor tip during insertion.

[0038] However, before describing the above aspects of the embodiments in detail, it is desirable to first describe examples of devices and their operation that may be present, for example, in an in vivo analyte monitor system, all of which may be used in the embodiments described herein.

[0039] There are various types of in vivo analyte monitor systems. For example, a "continuous analyte monitor" system (or a "continuous glucose monitor" system) may transmit data continuously, e.g., automatically according to a schedule, from the sensor control device to the reader device without requiring acknowledgement. As another example, a "flash analyte monitor" system (or a "flash glucose monitor" system or simply a "flash" system) may communicate data from the sensor control device using a near field communication (NFC) protocol or a radio frequency identification (RFID) protocol, or the like, upon scanning or data need by the reader device. In vivo analyte monitor systems may operate without the need for finger stick calibration.

[0040] In vivo analyte monitor systems can be distinguished from "ex vivo" systems, which generally include a measurement device that contacts a biological sample outside the body (or "ex vivo") and has a port for accepting an analyte test strip carrying a user's bodily fluid that can be analyzed to determine the user's blood glucose level.

[0041] An in-vivo analyte monitor system may include a sensor that contacts a user's bodily fluid while positioned in the body and senses the level of an analyte contained therein. The sensor may be part of a sensor control device that resides on the user's body, the sensor control device including the electronics and power source that enable and control the analyte sensing. Sensor control devices and variations thereof may be referred to as "sensor control units," "body-worn electronics" devices or units, "body-worn" devices or units, or "sensor data communication" devices or units, to name a few.

[0042] An in-vivo analyte monitoring system may include a device that receives sensed analyte data from the sensor control device and processes and / or displays it to a user in any number of types. This device and variations thereof may be referred to as a "handheld reader device," "reader device" (or simply "reader"), "handheld electronic device" (or simply "handheld"), "portable data processing" device or unit, "data receiver," "receiver" device or unit (or simply "receiver"), or "remote" device or unit, to name a few. Other devices, such as personal computers, may also be used or incorporated into in-vivo or in-vivo monitoring systems.

[0043] Exemplary In-Vivo Analyte Monitor System FIG. 1 is a conceptual diagram illustrating an exemplary embodiment of an analyte monitor system 100 including a sensor applicator 150, a sensor control device 102, and a reader device 120. In this case, the sensor applicator 150 can be used to deliver the sensor control device 102 to a monitoring location on a user's skin where the sensor 104 is held stationary for a period of time by an adhesive patch 105. The sensor control device 102 is described in more detail in FIG. 2B and FIG. 2C, and can communicate with the reader device 120 through a communication path 140 using wired or wireless technology. Exemplary wireless protocols include Bluetooth, Bluetooth low energy (such as BLE, BTLE, Bluetooth Smart), Near Field Communication (NFC), and others. A user can monitor applications installed in memory on the reader device 120 using a screen 122 and input 121, and the device's battery can be recharged using a power port 123. Further details regarding the reader device 120 are set forth below in connection with FIG. 2A. The reader device 120 can communicate with a local computer system 170 through a communication path 141 using wired or wireless technology. The local computer system 170 can include one or more of a laptop, desktop, tablet, phablet, smartphone, set-top box, video game console, or other computing device, and the wireless communication can include any of several applicable wireless network connection protocols including Bluetooth, Bluetooth Low Energy (BTLE), Wi-Fi, or others. The local computer system 170 can communicate with the network 190 through a communication path 143 using wired or wireless technology as described above in a manner similar to the manner in which the reader device 120 can communicate with the network 190 through the communication path 142. The network 190 can be any of several networks, such as private and public networks, local area networks, wide area networks, and the like.The trusted computer system 180 may include a server, may provide authentication services and secure data storage, and may communicate with the network 190 through a communications path 144 using wired or wireless technology.

[0044] Exemplary Reader Device 2A is a block diagram illustrating an exemplary embodiment of a reader device configured as a smartphone. In this case, the reader device 120 may include a display 122, an input component 121, and a processing core 206 including a communication processor 222 coupled to a memory 223 and an application processor 224 coupled to a memory 225. Also included may be a separate memory 230, an RF transceiver 228 having an antenna 229, and a power source 226 having a power management module 238. Additionally, a multi-function transceiver 232 capable of communicating through Wi-Fi, NFC, Bluetooth, BTLE, and GPS using an antenna 234 may be included. As will be appreciated by those skilled in the art, these components are electrically and communicatively coupled to create a functional device.

[0045] Exemplary Sensor Control Device 2B and 2C are block diagrams illustrating an exemplary embodiment of a sensor control device 102 having an analyte sensor 104 and sensor electronics 160 (including analyte monitor circuitry) that may have most of the processing functionality for rendering final result data for display to a user. FIG. 2B shows a single semiconductor chip 161, which may be a custom application specific integrated circuit (ASIC). Within the ASIC 161, certain high level functional units are shown including an analog front end (AFE) 162, a power management (or control) circuit 164, a processor 166, and a communication circuit 168 (which may be implemented as a transmitter, receiver, transceiver, passive circuitry, or otherwise according to a communication protocol). In this embodiment, both the AFE 162 and the processor 166 are used as the analyte monitor circuitry, although in other embodiments, either circuitry may perform the analyte monitor function. The processor 166 may include one or more processors, microprocessors, controllers, and / or microcontrollers, each of which may be a separate chip or distributed among (and be part of) several different chips.

[0046] Also included within the ASIC 161 is a memory 163, which may be shared by the various functional units present within the ASIC 161 or may be distributed among two or more of these functional units. The memory 163 may be a separate chip. The memory 163 may be a volatile and / or non-volatile memory. In this embodiment, the ASIC 161 is coupled to a power source 170, which may be a coin cell battery or the like. The AFE 162 interfaces with the in-vivo analyte sensor 104 to receive measurement data therefrom and outputs these data in digital type to a processor 166, which further processes these data to provide final result glucose individual values ​​and glucose trend values, etc. These data may then be provided to a communication circuit 168 for transmission through an antenna 171, for example, to a reader device 120 (not shown), where little further processing is required by a resident software application to display the data.

[0047] FIG. 2C is similar to FIG. 2B, but includes two separate semiconductor chips 162 and 174, which may be packaged together or separately. In this case, AFE 162 resides on ASIC 161. Processor 166 is integrated with power management circuitry 164 and communication circuitry 168 on chip 174. AFE 162 includes memory 163, which includes memory 165, which may be isolated or distributed within chip 174. In one exemplary embodiment, AFE 162 is combined with power management circuitry 164 and processor 166 on one chip, while communication circuitry 168 is on a separate chip. In another exemplary embodiment, both AFE 162 and communication circuitry 168 are on one chip, while processor 166 and power management circuitry 164 are on another chip. It should be noted that other chip combinations are possible, including three or more chips, each performing separate functions as described, or sharing one or more functions to achieve fail-safe redundancy.

[0048] Exemplary Assembly Process for a Sensor Control Device The components of the sensor control device 102 are available to the user in multiple packages that require final assembly by the user prior to delivery to the appropriate user location. Figures 3A-3D depict an exemplary embodiment of a user assembly process for the sensor control device 102 including preparation of the individual components prior to combining the components to provide a sensor for delivery. Figures 3E-3F depict an exemplary embodiment of delivery of the device 102 to the appropriate user location by selecting the appropriate delivery location and applying the sensor control device 102 to the location.

[0049] 3A is a proximal perspective view depicting an exemplary embodiment in which a user provides a container 810, in this case configured as a tray for an assembly process (although other packaging can be used). The user can accomplish this preparation by removing the lid 812 from the tray 810 to expose the platform 808, for example, by peeling the non-adhered portion of the lid 812 from the tray 810 such that the adhered portion of the lid 812 is removed. Removal of the lid 812 can be suitable in various embodiments as long as the platform 808 is sufficiently exposed within the tray 810. The lid 812 can then be set aside.

[0050] 3B is a side view depicting an exemplary embodiment in which a user presents applicator device 150 for assembly. Applicator device 150 may be provided in a sterile package sealed by cap 708. Preparing applicator device 150 may include disconnecting housing 702 from cap 708 to expose sheath 704 (FIG. 3C). This disconnection may be accomplished by twisting (or otherwise detaching) cap 708 from housing 702. Cap 708 may then be set aside.

[0051] 3C is a proximal perspective view depicting an exemplary embodiment in which a user inserts applicator device 150 into tray 810 during assembly. First, a user can insert sheath 704 into platform 808 inside tray 810 after aligning housing orientation feature 1302 (or slot or recess) with tray orientation feature 924 (abutment or detent). Inserting sheath 704 into platform 808 temporarily unlocks sheath 704 from housing 702, and also temporarily unlocks platform 808 from tray 810. In this process, removal of applicator device 150 from tray 810 will result in the same condition as it was prior to the initial insertion of applicator device 150 into tray 810 (i.e., the process can be reversed or interrupted at this point and then repeated without effect).

[0052] During distal advancement of the housing 702, the sheath 704 maintains its position relative to the housing 702 within the platform 808 and can mate with the platform 808 to advance the platform 808 distally relative to the tray 810. This step unlocks and crushes the platform 808 within the tray 810. The sheath 704 contacts and disengages a locking feature (not shown) within the tray 810, thereby unlocking the sheath 704 from the housing 702 and preventing it from moving (relatively) while the housing 702 advances the platform 808 distally. At the end of advancement of the housing 702 and platform 808, the sheath 704 is permanently unlocked from the housing 702. At the end of distal advancement of the housing 702, the sharps and sensor (not shown) within the tray 810 can mate with the electronics housing (not shown) within the housing 702. The operation and interaction of applicator device 150 with tray 810 is described in further detail below.

[0053] 3D is a proximal perspective view depicting an exemplary embodiment in which a user removes applicator device 150 from tray 810 during assembly. A user can remove applicator 150 from tray 810 by advancing housing 702 proximally relative to tray 810 or other movement that has the same end effect as decoupling applicator 150 and tray 810. Applicator device 150 is removed with sensor control device 102 (Sharp, sensor, electronics) (not shown) fully assembled therein and positioned for delivery.

[0054] 3E is a proximal perspective view depicting an exemplary embodiment in which a patient uses applicator device 150 to apply sensor control device 102 to a target area of ​​skin, for example on the abdomen or other suitable location. Distal advancement of housing 702 collapses sheath 704 therein, applying the sensor to the target location such that an adhesive layer on the bottom surface of sensor control device 102 adheres to the skin. The sharps automatically retract when housing 702 is fully advanced, while the sensor (not shown) is left in place to measure the analyte level.

[0055] 3F is a proximal perspective view depicting an exemplary embodiment of a patient with the sensor control device 102 in application position. The user can then remove the applicator 150 from the application site.

[0056] 3A-3F and further described elsewhere herein, system 100 may result in a reduction or elimination of the possibility of accidental destruction, permanent deformation, or incorrect assembly of applicator components as compared to prior art systems. Because applicator housing 702 directly engages platform 808 while sheath 704 is unlocked, rather than indirect engagement through sheath 704, the relative angle between sheath 704 and housing 702 will not result in destruction or permanent deformation of arms or other components. The possibility of relatively high forces during assembly (as in conventional devices) will be reduced, thereby reducing the possibility of user assembly failure.

[0057] Exemplary Sensor Applicator Device FIG 4A is a side view depicting an exemplary embodiment of applicator device 150 coupled to a screw cap 708. This view is an example of how applicator 150 is shipped and received by a user prior to assembly with a sensor by the user. FIG 4B is a side perspective view depicting applicator 150 and cap 708 after they have been separated. FIG 4C is a perspective view depicting an exemplary embodiment of the distal end of applicator device 150 with electronics housing 706 and adhesive patch 105 removed from the positions they would have been maintained within sensor carrier 710 of sheath 704 when cap 708 was in place.

[0058] 4D-4G, for purposes of illustration and not limitation, the applicator device 20150 can be provided to a user as a single, integral assembly. Figures 4D and 4E provide perspective top and bottom views, respectively, of the applicator device 20150, Figure 4F provides an exploded view of the applicator device 20150, and Figure 4G provides a side cutaway view. The perspective view illustrates how the applicator 20150 is shipped and received by a user. The exploded and cutaway views illustrate the components of the applicator device 20150. The applicator device 20150 may include one or more of a housing 20702, a gasket 20701, a sheath 20704, a sharps carrier 201102, a spring 205612, a sensor carrier (also referred to as a "puck carrier") 20710, a sharps hub 205014, a sensor control device (also referred to as a "puck") 20102, an adhesive patch 20105, a desiccant 20502, a cap 20708, a serial number label 20709, and a tamper evident feature 20712. The applicator device 20150 may further include a sensor, as described in more detail herein. Upon receipt by a user, only the housing 20702, the cap 20708, the tamper evident feature 20712, and the label 20709 are visible. As specifically shown herein, the housing 20702 may define an airtight sealed chamber within which a capture material may be disposed, as described in more detail herein. In certain embodiments, the cap 20708 can be coupled to the housing 20702 to form a chamber. The tamper evident feature 20712 can be, for example, a sticker coupled to each of the housing 20702 and the cap 20708, and can be, for example, irreparably damaged by separating the housing 20702 and the cap 20708, thereby indicating to a user that the housing 20702 and the cap 20708 have been separated. These features are described in more detail below.

[0059] Exemplary Tray and Sensor Module Assembly FIG. 5 shows an exemplary embodiment of a tray 810 with a sterilization lid 812 removably coupled thereto, in a proximal perspective view that may represent how the package is shipped to a user and received by the user prior to assembly.

[0060] 6A is a close-up perspective cutaway view depicting the sensor delivery components within a tray 810. A platform 808 is slidably coupled within the tray 810. A desiccant 502 is fixed relative to the tray 810. As described in more detail herein, the tray may additionally or alternatively include a capture material. A sensor module 504 is mounted within the tray 810.

[0061] 6B is a proximal perspective view depicting the sensor module 504 in greater detail. In this case, the retention arm extension 1834 of the platform 808 releasably secures the sensor module 504 in place. The module 2200 is coupled with the connector 2300, the sharps module 2500, and the sensor (not shown) so that they can be removed together as the sensor module 504 during assembly.

[0062] Exemplary Applicator Housing and Cap FIG. 7A is a side view depicting an exemplary embodiment of an applicator housing 702 that may include an internal cavity with a support structure suitable for the applicator's function. The applicator housing 702 may be made of high density polyethylene (HDPE) or any other suitable material, such as polypropylene, polycarbonate, or low density polyethylene (LDPE). Additionally or alternatively, the housing may be made of a capture material as described in more detail herein. A user may push the housing 702 distally to initiate the applicator assembly process, which may then also cause the sensor control device 102 to be delivered, after which the cavity in the housing 702 may act as a receptacle for a sharp. In this exemplary embodiment, various features are shown, including a housing orientation feature 1302 for orienting the device during assembly and use. The unopened ring groove 1304 may be a recess located around the circumference of the housing 702 distal to the unopened ring protector 1314 and proximal to the unopened ring retainer 1306. The tamper-evident ring groove 1304 can hold an tamper-evident ring so that the user can identify if the device has been tampered with or otherwise used. The housing threads 1310 can align with complementary threads on the cap 708 (FIGS. 4A and 4B) and secure the housing 702 to those complementary cap threads by rotating in a clockwise or counterclockwise direction. The side gripping zone 1316 of the housing 702 can provide an exterior location where the user can grip the housing 702 to use it. The gripping ledge 1318 is a slightly raised ridge relative to the side gripping zone 1316 that can contribute to ease of removal of the housing 702 from the cap 708. The shark tooth 1320 can be a raised zone with flat sides positioned on the clockwise edge to thread off the tamper-evident ring (not shown) and hold the tamper-evident ring securely in place after the user unscrews the cap 708 and housing 702.In this exemplary embodiment, four shark teeth 1320 are used, although more or fewer shark teeth 1320 may be used as desired.

[0063] FIG. 7B is a perspective view depicting the distal end of the housing 702. In this case, the optional three housing guide structures (or "guide ribs") 1321 are optionally positioned at 120 degrees relative to each other and at 60 degrees relative to the locking structures (or "locking ribs") 1340, of which there are three, also at 120 degrees relative to each other. Other angular orientations can be used with any number of one or more structures 1321 and 1340, whether symmetrical or asymmetrical. In this case, each structure 1321 and 1340 is configured as a planar rib, although other shapes can be used. Each guide rib 1321 includes a guide edge (also referred to as a "sheath guide rail") 1326 that can track the surface of the sheath 704 (e.g., guide rail 1418 described with respect to FIG. 8A). The insertion stiffening 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 stiffening stop 1322 may provide a surface against which the sensor carrier movement limiting surface 1420 (FIG. 8B) of the sheath 704 abuts during use to prevent it from moving further in the proximal direction. The carrier interface post 1327 may pass through an opening 1510 (FIG. 9A) in the sensor carrier 710 during assembly. The sensor carrier interface 1328 may be a rounded distally facing surface of the housing guide rib 1321 that interfaces with the sensor carrier 710.

[0064] 7C is a side cross-sectional view depicting an exemplary embodiment of the housing. In this exemplary embodiment, the side cross-sectional profile of the housing guide rib 1321 and the locking rib 1340 are shown. The locking rib 1340 can include a sheath snap lead-in feature 1330 near its distal end that can flare outwardly distally from the central axis 1346 of the housing 702. Each sheath snap lead-in feature 1330 causes the detent snap heads 1404 of the detent snaps 1402 of the sheath 704, shown in FIG. 8C, to bend inwardly toward the central axis 1346 as the sheath 704 moves toward the proximal end of the housing 702. Once the detent snaps 1402 of the sheath 704 pass the distal points of the sheath snap lead-in features 1330, they are locked into place within the locking grooves 1332. Thus, detent snap 1402 cannot be easily moved distally due to a surface having a plane generally perpendicular to central axis 1346, shown in FIG. 8C as detent snap flat 1406.

[0065] As the housing 702 moves further distally toward the skin surface and the sheath 704 advances toward the proximal end of the housing 702, the detent snap 1402 shifts into the unlocking groove 1334 and the applicator 150 is in the "armed" position. As the user applies more force to the proximal end of the housing 702 while the sheath 704 is pressed against the skin, the detent snap 1402 passes over the firing detent 1344. This passage results in a firing sequence due to the release of energy stored in the deflected detent snap 1402 (e.g., as described with respect to FIGS. 12A-12D ) and the detent snap 1402 advances proximally relative to the skin surface toward the sheath stop ramp 1338 which flares outward slightly relative to the central axis 1346 and slows the movement of the sheath 704 during the firing sequence. The next groove encountered by the detent snap 1402 after the unlock groove 1334 is a final lockout recess 1336 into which the detent snap 1402 enters at the end of a stroke or push sequence performed by the user. The final lockout recess 1336 may be a proximally facing surface that is perpendicular to the central axis 1346 and engages the detent snap flats 1406 after the detent snap 1402 has cleared and prevents reuse of the device by positively holding the sheath 704 in place relative to the housing 702. The insertion stiffening stop 1322 of the housing guide rib 1321 prevents the sheath 704 from advancing proximally relative to the housing 702 by engaging the sensor carrier travel limiting surface 1420.

[0066] 7D and 7E are close-up side views of an exemplary embodiment of the locking rib 1340 of the applicator housing 702 as the detent snap 1402 of the sheath 704 moves towards the proximal end of the housing 702. FIG. 7D illustrates the sheath 704 in a "locked" state where the detent head 1404 of the detent snap 1402 has already passed over the sheath snap lead-in feature 1330 and is disposed in the locking groove 1332 of the locking rib 1340. When a force is applied to the proximal end of the housing 702, the detent head 1404 is advanced proximally into the unlocking groove 1334 placing the applicator 150 in an "armed" position. When further force is applied to the proximal end of the housing 702, the detent head 1404 is advanced proximally out of the unlocking groove 1334 and passes over the firing detent 1344, causing the applicator 150 to be "fired." Thereafter, the sheath 704 is further advanced proximally such that the detent head 1404 slidably advances over the firing face 1337, as shown in FIG. 7E. In this embodiment, the firing face 1337 may be substantially parallel to the central axis 1346. As the sheath 704 continues to advance proximally, the detent head 1404 reaches a sheath stop ramp 1338 which slows the movement of the sheath 704. When the detent head 1404 reaches the final lockout recess 1336, the detent snap flats 1406 (not shown) engage to securely hold the sheath 704 in place relative to the housing 702.

[0067] 7F and 7G are close-up side views of an alternative embodiment of a locking rib 2340 designed to improve the firing rate of the sharp from the sensor applicator. In this case, the locking rib 2340 can include an inward detent ramp 2335 that reduces friction between the sheath 704 and the housing 2702 during firing. The locking rib 2340 can further include a sheath stop ramp 2338 at the proximal end of the firing face 2337. First, FIG. 7F shows the sheath 704 in a "locked" state with the detent head 1404 of the detent snap 1402 already passing over the sheath snap lead-in feature 2330 and positioned in the locking groove 2332. When a force is applied to the proximal end of the housing 2702, the detent head 1404 advances into the unlocking groove 2334 to place the applicator 150 in the "armed" position. Further application of force to the proximal end of the housing 2702 causes the applicator 150 to be “fired” when the detent head 1404 passes over the firing detent 2344 .

[0068] As shown in FIG. 7G, the detent head 1404 then advances toward the proximal end of the housing 2702 in a "free flight" state passing over the inward detent ramp 2335. During proximal advancement in the "free flight" state, the detent head 1404 may be discontinuous or not in contact with the inward detent ramp 2335 and the launch face 2337. In this regard, since there is little or no friction between the detent head 1404 and the inward detent ramp 2335 and the launch face 2337, the detent head 1404 may be advanced easily and quickly, thereby improving the firing rate of the sharp from the applicator. The sheath stop ramp 2338, located further proximally along the locking rib 2340 compared to the embodiment shown in FIG. 7D and FIG. 7E, provides an edge portion for frictionally engaging the detent head 1404 to slow down the movement of the sheath 704. The sheath stop ramp 2338 has an inclined shape and can allow for strong frictional contact as the detent head 1404 advances proximally. Finally, when the detent head 1404 reaches the final lockout recess 2336, the detent snap flats 1406 (not shown) engage to securely hold the sheath 704 against the housing 2702. The lockout recess 2336 prevents reverse or distal movement of the detent head 1404 and sheath 704. This embodiment reflects a higher firing rate compared to the embodiment depicted in Figures 7D and 7E and also helps prevent premature withdrawal of the sharp.

[0069] 7H is a close-up side view of an alternative embodiment 6340 of a locking rib designed to maintain a downward force on the sheath 6704 during firing, thereby preventing undesired movement of the sheath 6704 during the sensor insertion process. In this case, the sheath 6704 is shown in a "locked" state with the detent head 6404 of the detent snap 6402 disposed in the locking groove 6332. When force is applied to the proximal end of the housing 6702, the detent head 6404 is advanced into the unlocking groove 6334 placing the applicator in an "armed" position. When further force is applied to the proximal end of the housing 6702, the applicator is "fired" and the detent head 6404 advances over the angled firing surface 6338 toward the proximal end of the housing 6702. The angled firing surface 6338 can be angled toward the central axis 1346 to increase the downward force against the sheath 6704 obtained as the detent head 6404 advances proximally. In the depicted embodiment, the detent head 6404 is in continuous contact with the angled firing surface 6338. The lockout recess 6336 prevents reverse or distal movement of the detent head 6404 and sheath 6704. This embodiment reflects a lower firing rate compared to the embodiments described above and can be used, for example, for a motion-actuated sharp retraction stroke as described with respect to FIGS. 14A-14C and 15A-15B.

[0070] FIG. 7I is a close-up side view of yet another alternative embodiment 7340 of a locking rib designed to similarly maintain a downward force on the sheath 6704 during firing, thereby preventing undesired movement of the sheath 6704 during the sensor insertion process. In this case, the sheath 6704 is shown in a "fired" state with the detent head 6404 of the detent snap 6402 disposed in the bidirectional lockout recess 7336. Once the detent head 6404 enters the bidirectional lockout recess 7336, further movement of the sheath 6704 in either the proximal or distal direction can be prevented. This can prevent undesired movement of the sheath 6704 during the sensor insertion process. Additionally, in some embodiments, the bidirectional lockout recess 7336 can allow for immobilization of the sheath 6704 during a motion-activated sharp retraction process, as described with respect to FIGS. 14A-14C and 15A-15B. As can be seen in FIG 7I, the angled firing surface 7338 can be angled toward the central axis 1346 to increase the downward force against the sheath 6704 obtained as the detent nodule 6404 advances proximally. In the depicted embodiment, the detent nodule 6404 is in continuous contact with the angled firing surface 7338. This embodiment reflects a lower firing rate and can be used, for example, for the motion actuated sharp retraction stroke described with respect to FIGS. 14A-14C and 15A-15B.

[0071] 7J-7L, for purposes of illustration and not limitation, a housing 20702 according to the presently disclosed subject matter is shown. The housing 20702 can be made of a cyclic olefin copolymer or other suitable material, such as polycarbonate or high density polyethylene (HDPE). The housing 20702 can include one or more of the features described herein with respect to the housings, and similar features can be actuated as described herein. For example, the housing 20702 can include a gripping ledge 20702A that can enable a user to securely grip the housing 20702. The housing 20702 can have additional gripping ledges 20702A, for example, two gripping ledges 20702A on opposing sides of the housing 20702. The housing 20702 can include a side gripping zone 20702B disposed below the gripping ledge 20702A. The side gripping zones 20702B can provide a texture suitable for improved grip by a user. The housing 20702 can have additional side gripping zones 20702B, for example, two side gripping zones 20702B on opposite sides of the housing 20702, each located below the gripping ledge 20702A.

[0072] The housing 20702 can include a housing skirt 20702C that can provide a surface for the tamper evident feature 20712. The housing skirt 20702C can be supported by a plurality of skirt stiffening ribs 20702D. The skirt stiffening ribs 20702D can provide support for the housing skirt 20702C and can further help protect the applicator device 20150 during an impact event such as a drop. Additionally, the skirt stiffening ribs 20702D can be used to support the housing 20702 during manufacturing. The housing skirt 20702C and the skirt stiffening ribs 20702D can provide stiffness against forces due to gasket compression and can further help maintain compression of the gasket 20701 throughout the shelf life. The housing 20702 can include a gasket retaining ring 20702E and a number of gasket retaining pockets 20702F that can secure the gasket 20701 to the housing 20702. For example, the gasket retaining ring 20702E can prevent lateral movement of the gasket 20701, and the gasket retaining pockets 20702E can prevent rotation of the gasket 20701. The housing 20702 can include a number of gasket retaining pockets, for example, 14 gasket retaining pockets 20702E. A gasket sealing surface 20702N can seal against the gasket 20701. The housing 20702 can additionally or alternatively include an applicator cap sealing lip 20702U that can interface with a cap 20708, as described in more detail below. The housing 20702 can have an inner surface 20702T that can receive the sheath 20704.

[0073] The housing 20702 can include threads 20702G configured to engage threads 20708D disposed on the cap 20708. The threads can include radial limiting features 20702H that can limit radial deformation of the cap 20702G during an impact event, such as a drop. The housing 20702 can include multiple radial limiting features 20702H, for example, six radial limiting features 20702H. The radial limiting features 20702H can be protrusions from the housing and can close a gap with the threads 20708D disposed on the cap 20708. This can limit elliptical deformation of the cap 20702H during an impact event, such as a drop. Preventing oval deformation of the cap 20702H can further ensure that the locking arm 20704J of the sheath 20704 remains locked between the cap 20702 and the sensor carrier 20710 to limit movement of the sheath 20704 prior to removal of the cap 20702H (as described in more detail below). The housing 20702 can further include a clearance notch 20702I for passage of the sheath during firing.

[0074] The interior of the housing 20702 can include a number of sensor carrier attachment features for receiving, aligning, and limiting movement of the sensor carrier 20710. For example, the housing 20703 can include a sheath guide rail 20702J that can help align and guide the sheath 20704 as it moves relative to the housing 20702. The housing 20702 can include a sensor carrier attachment slot 20702K that can engage and secure the sensor carrier 20710, and a sensor carrier firm stop 20702L that can limit axial movement of the sensor carrier 20710 relative to the housing 20702. The housing 20702 can include a sensor carrier biasing feature 20702M that can eliminate rocking between the sensor carrier 20710 and the housing 20702 after assembly, and a sensor carrier radial limiting feature 20702O that can keep the sensor carrier radially aligned relative to the housing 20702. A flat horizontal surface between the sensor carrier mounting slot 20702K and the sensor carrier radial limiting feature 20702O can be used to stop the sheath 20704 at the end of the stroke. Corresponding features on the sheath 20704 can interact with these surfaces. The sensor carrier biasing feature 20702M can further limit rotation of the sensor carrier 20710 relative to the housing 20702. The housing 20702 can include one or more of each of the sheath guide rails 20702J, the sensor carrier mounting slots 20702K, the sensor carrier stiffening stops 20702L, the sensor carrier radial limiting feature 20702O, and the sensor carrier biasing feature 20702M, for example, three of each.

[0075] The interior of the housing 20702 can further include a number of sheath ribs 20702S for engaging the sheath 20704 for insertion, as described herein. The housing 20702 can include one or more, for example, three, sheath ribs 20702S. Each sheath rib 20702S can include a sheath snap introduction feature 20702P configured to initially introduce the detent snap 20704A of the sheath 20704 into the correct location. The housing 20702 can include a firing detent 20702Q. After the detent snap 20704A of the sheath 20704 passes the firing detent 20702Q, a firing sequence can begin and the sheath 20704 can progress toward the sheath stop ramp 20702R. The sheath stop ramp 20702 can decelerate the sheath 20704 at the end of firing.

[0076] 7M-7Q, for illustrative purposes, an exemplary cap 20708 is shown. The cap 20708 can include one or more of the features described herein with respect to the caps, and similar features can operate as described herein. The cap 20708 can be made of high density polyethylene (HDPE) or any other suitable material, such as polypropylene, polycarbonate, or low density polyethylene (LDPE). Additionally or alternatively, the cap 20708 can be made of an acquisition material, as described in more detail herein. The cap 20708 can include a label surface 20708A configured to receive a label 20709. The cap 20708 can include ribs 20708B that can provide strength and provide an improved gripping surface for a user. The cap 20708 can include an unopened label ring 20708C that can receive an unopened evidence feature 20712. The cap 20708 can include a gasket sealing surface 20708G configured to engage the gasket 20701.

[0077] Internally, the cap 20708 can include threads 20708D that can engage threads 20702G disposed on the housing 20702. The cap 20708 can include a sealing interface 20708E that can be configured to receive an applicator cap sealing lip 20702U to create a seal between the housing 20702 and the cap 20708. As specifically shown herein, the cap 20708 can be removably coupled to the housing 20702 to define an airtight sealed chamber. For example, the housing 20702 and the cap 20708 can be formed of a gas impermeable material such that a gas impermeable seal is formed therebetween. For example, the hermetically sealed chamber may have a mean water vapor transmission rate (MVTR) of no more than about 2 mg / day when exposed to an environment of 30° C.±2° C. and 65%±5% relative humidity, which are long-term storage conditions recommended in FDA Guidance Document Q1A(R2) “Stability Testing of New Drug Substances and Products” and ICH Guidance Document Q1F “Stability Data Package for Registration Applications in Climatic Zones III and IV.” Additionally or alternatively, as embodied herein, the hermetically sealed chamber may have a mean water vapor transmission rate (MVTR) of no more than about 1 mg / day when exposed to an environment of 30° C.±2° C. and 65%±5% relative humidity.

[0078] 7S-7V illustrate enlarged cross-sectional side views of the interface between the housing 20702 and the cap 20708. As shown, the applicator cap sealing lip 20702U of the housing 20702 includes a first axial extension 2002a, and the sealing interface 20708E of the cap 20708 provides a cavity 2002d matable with the first axial extension 2002a. In the illustrated embodiment, the diameter of the cavity 2002d formed from the second axial extension 2002b and the third axial extension 2002c of the cap 20708 is sized to receive the diameter of the first axial extension 2002a of the housing 20702 therein. 7U, the axial extension 2002a can have a thickness D1 at a height H1 measured from its distal edge. Similarly, the second axial extension 2002c can have a thickness D5 at a height H3 measured from the proximal edge of the cap 20708, and the cavity 2002d can have thicknesses D2, D3, and D4 at heights H2, H3, and H4, respectively, measured from the proximal edge of the cap 20708. In certain embodiments, D1 may have a dimension of 1 mm with a tolerance of ±0.03 mm, D2, D3, D4 may have any suitable dimensions, H1 may have a dimension of 1.66 mm with a tolerance of ±0.1 mm, H2 may have a dimension of 8.25 mm with a tolerance of ±0.1 mm, H3 may have a dimension of 9.25 mm with a tolerance of ±0.1 mm, and H4 may have a dimension of 9.75 mm with a tolerance of ±0.1 mm. However, in other embodiments, an inverse configuration may be used in which the diameter of the first axial extension 2002a may be sized to accommodate the diameter of the second axial extension 2002b without departing from the scope of the present disclosure.

[0079] 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, which may help prevent fluid or contamination migration across both axes of this interface. Additionally, the dual radial seals described herein may address tolerances and a combination of thermal changes and stress relief with a redundant sealing approach. In the illustrated embodiment, the dual radial seals 2004, 2006 utilize a "wedge" effect for effective sealing between the first axial extension 2002a and the second axial extension 2002b.

[0080] The cap 20708 can include one or more sets of crush ribs 20708F (see FIG. 7N(i)), for example, two sets of crush ribs 20708F. The crush ribs 20708F can be configured to engage edges 20704N, which can be sharp edges of the locking arm 20704J, during an impact event, for example, a drop, as described in more detail below (see, for example, FIG. 8N).

[0081] In accordance with the subject matter of the present disclosure, the cap 20708 can include one or more desiccant retaining clips 20708H for retaining the desiccant 20502 within the cap 20708 and limiting rotation of the desiccant 20502 (see, e.g., FIG. 7P). The cap 20708 can include any number of desiccant retaining clips 20708H. For example, the cap 20708 can include one, two, three, four, five, six, or more than six desiccant retaining clips 20708H. As can be seen in FIG. 7O, the cap 20708 can include three pairs, each consisting of two desiccant retaining clips 20708H. Each pair of desiccant retaining clips 20708H can correspond to a desiccant retaining snap 20502A (see, e.g., FIG. 7R) on the desiccant 20502 (see, e.g., FIG. 7P). As can be seen in FIG. 7P, the desiccant 20502 can include a plurality of desiccant retaining snaps 20502A, each of which can snap downwardly into a pair of desiccant retaining clips 20708H. For example, the desiccant retaining snaps 20502A can include an angled surface 20502Aa for radially expanding the clips 20708H until the desiccant retaining snaps 20502A are locked into place within the desiccant retaining clips 20708H when the desiccant is pressed onto the cap. The desiccant retaining clips 20708H can secure the desiccant 20502 within the cap 20708 to limit distal and rotational movement of the desiccant 20502. As can be seen in FIG. 7Q, the desiccant 20502 can include a catch pocket (not shown) for positioning the desiccant 20502 at an angle relative to the desiccant retaining clips 20708H. In some embodiments, as can be seen in FIGURE 7Q, the desiccant 20502 can be cylindrical in shape. In addition to or as an alternative to the desiccant 20502, one or more capture materials can be disposed within the cap 20708 in a chamber defined by the housing 20702 and the cap 20708. For example, the capture material can be disposed in the cap 20708 using clips 20708H as described above.

[0082] In accordance with the subject matter of the present disclosure, the cap 20708 can include a ratchet 20708I for engaging the sensor cap and removing the sensor cap when the cap 20708 is removed from the housing 20702, as described in more detail below. The cap 20708 can include a plurality of ribs 20708J for providing strength. Correspondingly, as can be seen in FIGS. 4G and 7Q-7R, the inner bore 20502B of the desiccant 20502 can be sized and dimensioned to provide sufficient clearance for the sensor cap to pass and engage the ratchet 20708I of the cap 20708, and the desiccant 20502 can include a plurality of rib pockets 20502C for providing clearance for the plurality of ribs 20708J of the cap 20708.

[0083] 7W-7X, for purposes of illustration and not limitation, in accordance with the subject matter of the present disclosure, the cap 20708 can include one or more surfaces that engage other elements within the applicator device 20150 to provide support or limit movement in the event of an impact event, such as a drop. For example, the cap can include a sheath support surface 20708K configured to support the sheath 20704 during an impact event. The sheath support surface 20708K can limit distal movement of the sheath 20704 during an impact event. This can cause less stress on the sensor carrier 20710 and the sensor control device 20102, which can reduce the risk of the sensor control device 20102 becoming detached from the sensor carrier 20710. Additionally or alternatively, the cap 20708 can include a higher ridge 20708L. The higher ridge 20708L can interface with a plug such as an elastomeric plug 9130A (which can be coupled to the desiccant cap 9130 or, in other embodiments, to the sensor cap 9120 as can be seen in FIG. 7Z(i)). In some embodiments, the elastomeric plug can include rubber, silicone, liquid silicone rubber, silicone-polyurethane hybrid, polyurethane, polysulfide, latex, styrene-butadiene, and / or flexible plastic. Additionally or alternatively, the elastomeric plug can include a material having a durometer hardness of about 5 Shore A to about 80 Shore A. Additionally or alternatively, the elastomeric plug can include a capture material as described in more detail herein. For example, the elastomeric plug can be formed by molding a combination of a capture material and an elastomeric material such as, for example, silicone or rubber. This allows the higher ridge 20708L to support the sharps carrier 201102, the sensor carrier 20710, and the sensor control device 20102, thus preventing detachment of the sensor control device 20102 from the sensor carrier 20710 during an impact event.Additionally, the additional support for the elastomeric plug 9130A and other features can increase external pressure against various seals within the applicator device 20150, thereby improving the seal before removing the cap 20708 from the housing. For example, as can be seen in FIG. 7Y, the elastomeric plug 9130A can include a stop surface 9130Aa, a sealing bead 9130Ab, an intermediate surface 9130Ac, and an upper surface 9130Ad. As can be seen in FIG. 7Y, the upper surface 9130Ad can include a triangular surface with square or rectangular corners rather than a pointed apex. As can be seen in FIG. 7Z(i), the sealing bead 9130Ab can be inserted into the sensor cap 9120 until the stop surface 9130Aa (shown in cross section in FIG. 33) engages with the bottom surface of the sensor cap 9120. The sealing bead 9130Ab can be approximately 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 create an interference fit 9130Abb that creates a sterile barrier between the sealing bead 9130Ab and the inner diameter of the sensor cap 9120 to seal the inner chamber 9124.

[0084] As described above, the elastomeric plug 9130A can include a capture material configured to adsorb at least one substance. For example, the elastomeric plug 9130A can be formed of silicone, rubber, or other elastomeric material combined with a capture material such as activated carbon or silica gel. Additionally or alternatively, as embodied herein, the elastomeric plug 9130A can include an elastomeric component 9130Af and a capture material component 9130Ae. With reference to FIG. 7Z(ii), the elastomeric component 9130Af and the capture material component 9130Ae can be separate components that are assembled together to form the elastomeric plug 9130A. For example, the elastomeric component 9130Af and the capture material component 9130Ae can each be molded and then assembled. As specifically shown herein, the elastomeric component 9130Af can include tabs 9130Aff that can engage grooves 9130Aee in the acquisition material component 9130Ae to secure the acquisition material component 9130Ae.

[0085] Additionally or alternatively, the elastomeric plug 9130A can be manufactured using a two-shot injection molding process. For example, referring to FIG. 7Z(iii), a first molding step can form the acquisition material component 9130Ae, and a second injection molding step can form the elastomeric component 9130Af on top of the acquisition material component 9130Ae. The elastomeric component 9130Af can be manufactured from any suitable material. By way of example and not limitation, the elastomeric component 9130Af can be manufactured from a thermoplastic elastomer or liquid silicone rubber. The acquisition material component 9130Ae can be manufactured from activated carbon, silica gel, and / or one or more molecular sieves, as described in more detail herein. Additionally or alternatively, the acquisition material component 9130Ae can be manufactured from a thermoplastic combined with one or more of activated carbon, silica gel, and / or one or more molecular sieves.

[0086] Exemplary Applicator Sheath 8A and 8B are side and perspective views, respectively, depicting an exemplary embodiment of a sheath 704. In this exemplary embodiment, the sheath 704 can stage the sensor control device 102 above the user's skin surface prior to application. The sheath 704 can include features that help hold the sharp in the proper position for proper application of the sensor, determine the force required for sensor application, and guide the sheath 704 relative to the housing 702 during application. A detent snap 1402 is near the proximal end of the sheath 704, which is described in more detail below with respect to FIG. 8C. The sheath 704 can have a generally cylindrical cross-section having a first radius at the proximal section (near the top of the figure) that is shorter than a second radius at the distal section (near the bottom of the figure). Also shown are a number of detent clearances 1410, three in this exemplary embodiment. The sheath 704 can include one or more detent clearances 1410, each of which can be a notch having room for the sheath snap-in feature 1330 to advance distally until the distal surface of the locking rib 1340 contacts the proximal surface of the detent clearance 1410.

[0087] Guide rails 1418 can be disposed between a sensor carrier movement limiting surface 1420 at the proximal end of the sheath 704 and a notch around the locking arm 1412. Each guide rail 1418 can be a channel between two ridges, through which a guide edge 1326 of a housing guide rib 1321 can slide distally relative to the sheath 704.

[0088] The locking arms 1412 can be disposed near the distal end of the sheath 704 and can include an attached distal end and a free proximal end that can include a locking arm interface 1416. The locking arms 1412 can lock the sensor carrier 710 to the sheath 704 when the locking arm interface 1416 engages the locking interface 1502 of the sensor carrier 710. A locking arm strengthening rib 1414 can be disposed at a central location of each locking arm 1412 and can act as a strengthening point for an otherwise weak point of each locking arm 1412 to prevent the locking arms 1412 from bending excessively or breaking.

[0089] A detent snap stiffening feature 1422 can be positioned along a distal section of the detent snap 1402 and can provide reinforcement to the detent snap 1402. The alignment notch 1424 can be a notch near the distal end of the sheath 704 and provides an opening for user alignment with the sheath orientation feature of the platform 808. The stiffening rib 1426 can include a buttress, in this case triangular shaped, that provides support against the detent base 1436. The housing guide rail clearance 1428 can be a notch for the distal face of the housing guide rib 1321 to slide against during use.

[0090] 8C is a close-up perspective view depicting an exemplary embodiment of a detent snap 1402 of the sheath 704. The detent snap 1402 can include a detent snap bridge 1408 positioned at or near its proximal end. The detent snap 1402 can further include a detent snap flat 1406 distal to the detent snap bridge 1408. The outer surface of the detent snap bridge 1408 can include a detent snap bob 1404, which is a rounded surface that allows for easier movement of the detent snap bridge 1408 over an inner surface of the housing 702, such as, for example, the locking rib 1340.

[0091] 8D is a side view depicting an exemplary embodiment of the sheath 704. In this case, the alignment notch 1424 can be relatively close to the detent clearance 1410. The detent clearance 1410 is at a relatively proximal location on the distal portion of the sheath 704.

[0092] 8E is an end view depicting an exemplary embodiment of the proximal end of the sheath 704. In this case, the back wall 1446 for the guide rail can provide a channel for slidably mating with the housing guide rib 1321 of the housing 702. The sheath rotation limiter 1448 can be a notch that reduces or prevents rotation of the sheath 704.

[0093] 8F-8H are perspective views of an alternative exemplary embodiment of a sheath 6704 at various stages of assembly with other components of the applicator. As shown in FIG. 8F, the sheath 6704 can have many of the same features as the sheath 704 described above with respect to FIGS. 8A-8C. The sheath 6704 can include, for example, one or more detent snaps 6402 having one or more detent heads 6404 attached thereto. However, the sheath 6704 can have a shorter overall length as compared to the sheath 704. Additionally, the sheath 6704 can include one or more inner sheath ribs 6425 disposed on an inner surface thereof and projecting inwardly toward a central axis of the sheath.

[0094] 8G, a perspective view of the sheath 6704 is shown at a stage of assembly with the applicator housing 6702 and sensor carrier 6710. One or more inner sheath ribs 6425 of the sheath 6704 may 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 may help maintain axial alignment of the sheath 6704 and sensor carrier 6710 during the sensor insertion process. Additionally, the interface between the ribs 6425 and notches 6519 may reduce lateral and rotational movement between the applicator components, thereby reducing the possibility of incorrect sensor insertion.

[0095] 8H, the sheath 6704 is shown at the assembly stage with the sensor electronics housing 706 inserted into the applicator housing 6702 and sensor carrier 6710. The inner sheath ribs 6425 are also shown.

[0096] It should be noted that while six inner sheath ribs 6425 and six corresponding rib notches 6519 are shown, any number of ribs and notches are fully within the present disclosure. Additionally, while the ribs 6425 are shown having rounded edges, in other embodiments the ribs 6425 can have a rectangular or triangular shape and the rib notches 6519 can have a corresponding receiving shape for interfacing with the ribs 6425. Additionally, while the ribs 6425 are shown disposed on the outer circumferential inner surface of the sheath 6704, the ribs 6425 can be disposed on any other surface or portion of the sheath 6704 that comes into contact with the sensor carrier 6710.

[0097] 8I-8O, for purposes of illustration and not limitation, a sheath 20704 is shown in accordance with the subject matter of the present disclosure. The sheath 20704 can be made of Delrin or other suitable materials, such as other low friction polymers. The sheath 20704 can include one or more of the features described herein with respect to the sheaths, and similar features can operate as described herein. For example, the sheath 20704 can include a detent snap 20704A having a free proximal end configured to engage the sheath rib 20702S during firing. FIG. 8J illustrates a close-up view of the free proximal end of the detent snap 20704A. The detent snap 20704A can include a rounded portion 20704B for engagement with the sheath rib 20702S and a flat portion 20704C for final lockout to the housing 20704 after use. The rounded portion 20704B can include a parting line misalignment 20704D that can prevent force spikes during firing. The detent snap 20704A can be coupled to the sheath 20704 at the enlarged distal portion 20704E that can provide support thereto. The sheath 20704 can include multiple, e.g., three, detent snaps 20704A. The sheath 20704 can include one or more, e.g., three, housing clearances 20704F that can allow it to pass through the housing 20702 at the end of firing. In accordance with the subject matter of the present disclosure, the sheath 20704 can further include multiple (e.g., six) stiffening ribs 20704P that can stiffen it.

[0098] The sheath 20704 can include a plurality of guides 20704G for engaging with the sheath guide rails 20702J of the housing 20702. The sheath 20704 can further include a slot 20704H including a stop 20704I at its distal end configured to engage the sheath guide rails 20702J to limit further proximal movement of the sheath 20704 relative to the housing 20702 at the end of firing. The sheath 20704 can further include a clearance 20704T for passing a sensor carrier biasing feature 20702I disposed on the sheath guide rails 20702J of the housing 20702.

[0099] In accordance with the subject matter of the present disclosure, the sheath 20704 can include a locking arm 20704J. The locking arm 20704J can be configured to engage the sensor carrier 20710 to limit movement of the sensor carrier 20710 or the sheath 20704 prior to firing. The locking arm 20704J can include a free proximal end 20704K and an attached distal end 20704L. The free proximal end 20704K can include a locking arm interface 20704M disposed on an inner surface of the locking arm 20704J. The locking arm interface 20704M can engage a locking ledge 20710N on the sensor carrier 20710. For example, when the cap 20708 is coupled to the housing 20702, the cap 20708 can bias the locking arm 20704J inwardly, causing 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, the locking arm 20704J can limit the proximal movement of the sheath 20704 when the cap 20708 is coupled to the housing 20702. Such engagement can limit the movement of the sheath 20704 during an impact event, such as a drop. The locking arm interface 20704M can have a triangular shape when viewed in a side view (e.g., FIG. 8N) and a "U" shape when viewed in a top view (e.g., FIG. 8K). This shape of the locking arm interface 20704M can provide advantages during manufacturing. For example, this shape of the locking arm interface 20704M can allow the sheath 20704 to be forcibly ejected from a mold during manufacturing of the sheath 20704. Forcing the sheath 20704 to be forcibly ejected can allow for an easier manufacturing process, for example, using a one-piece mold, eliminating parting lines that occur from a two-piece mold. The parting lines may result in uneven surfaces that may catch on the sensor carrier 20710 during firing, resulting in potential spikes in firing forces.Therefore, the use of forced extrusion and a one-piece mold can produce a smoother locking arm interface 20704M, preventing potential spikes in firing force due to parting lines.

[0100] The proximal free end of the locking arm 20704J may further include a sharp edge 20704N on an outer surface, which may optionally be a sharp edge. The sharp edge 20704N may be configured to engage a crush rib 20708F disposed on the cap 20708 during an impact event. The sharp edge 20704N may penetrate into the crush rib 20708F and permanently deform it, thereby absorbing energy during an impact event to prevent the sheath 20704 from collapsing. This shape of the locking arm interface 20704M may be advantageous for drop protection. The ramp may force the locking arm 20704J to move radially as the sheath 20704 collapses during a drop. This movement may force the sharp edge 20704N into the crush rib 20708F and help stop the sheath 20704 from collapsing. The sheath 20704 can include multiple locking arms 20704J, for example, two locking arms 20704J.

[0101] Additionally or alternatively, the sheath 20704 may include a rib 20704U configured to engage a locking interface 20710F on the sensor holding arm 20710B on the sensor carrier 20710. The rib 20704U may, for example, prevent the sensor holding arm 20710B from bending outward during an impact event, and thus may prevent movement of the sensor control device 20102 during an impact event. The rib 20704U may have a height (i.e., longitudinal) selected such that the rib 20704U remains engaged with the locking interface 20710F on the sensor holding arm 20710B on the sensor carrier 20710 to prevent the sensor control device 20102 from detaching from the sensor carrier 20710, even if the sheath 20704 moves proximally or distally during an impact event.

[0102] The sheath 20704 can optionally include an attenuator 20704O, which can be a noise attenuator configured to reduce noise. The noise attenuator 20704O can be configured to engage the sharps carrier 201102 to slow down the movement of the sharps carrier 201102 when the sharps carrier 201102 is retracted, thereby reducing noise caused by the sharps carrier 201102 engaging the sheath 20704. In an exemplary embodiment, the noise attenuator 20704O includes an inclined ramp extending from an inner surface of the sheath 20704, although other suitable configurations can be used.

[0103] In accordance with the subject matter of the present disclosure, 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 partial retraction of the sharps carrier 201102 during deployment (as described in more detail below). The sheath 20704 can further include a cap introducer 20704R, an alignment notch 20704S, and a skin interface 20704T.

[0104] Exemplary Sensor Carriers 9A is a proximal perspective view depicting an exemplary embodiment of a sensor carrier 710 capable of holding sensor electronics within the applicator 150. The sensor carrier 710 can hold a sharps carrier 1102 having a sharps module 2500. In this exemplary embodiment, the sensor carrier 710 has a generally hollow flat round cylindrical shape and can include one or more (e.g., three) deflectable sharps carrier locking arms 1524 extending proximally from a proximal face surrounding a centrally located spring alignment ridge 1516 to maintain alignment of the spring 1104. Each locking arm 1524 has a detent or retention feature 1526 located at its proximal end. The impact lock 1534 can be an outwardly extending tab located on the outer periphery of the sensor carrier 710 and can lock the sensor carrier 710 for added safety prior to firing. The rotation limiter 1506 can be a relatively short protruding portion extending proximally on the proximal face of the sensor carrier 710 to limit rotation of the carrier 710. The sharps carrier locking arm 1524 can interface with the sharps carrier 1102 as described below with reference to Figures 10A-10E.

[0105] 9B is a distal perspective view of the sensor carrier 710. In this case, one or more (e.g., three) sensor electronics retaining spring arms 1518 are optionally biased at right angles toward the position shown and include detents 1519 that can pass over a distal face of the electronics housing 706 of the device 102 when stored in the recess or cavity 1521. In certain embodiments, after the sensor control device 102 is adhered to the skin with the applicator 150, the user pulls the applicator 150 in a proximal direction, i.e., away from the skin. This adhesive force holds the sensor control device 102 on the skin and overcomes the lateral force applied by the spring arms 1518. As a result, the spring arms 1518 deflect radially outward, disconnecting the detents 1519 from the sensor control device 102, thereby releasing the sensor control device 102 from the applicator 150.

[0106] FIG 9C is a perspective view of an alternative exemplary embodiment of a sensor carrier 6710. As shown in FIG 9C, the sensor carrier 6710 can have many of the same features as the sensor carrier 710 described above with respect to FIG 9A-9B. Additionally, the sensor carrier 6710 further includes one or more notch ribs 6519 disposed along the circumferential outer surface. As can be seen most clearly in FIG 8F-8H, the notch ribs 6519 are configured to interface with the inner sheath ribs 6425 to maintain axial alignment of the sheath and the sensor carrier and reduce lateral and rotational movement between the applicator components during the sensor insertion process.

[0107] 9D and 9E, for purposes of illustration and not limitation, an exemplary sensor carrier 20710 is shown. The sensor carrier 20710 can include one or more of the features described herein with respect to a plurality of sensor carriers, and similar features can operate as described herein. For example, the sensor carrier 20710 can include a base 20710A and first and second retaining arms 20710B. Each retaining arm 20710B can include a first end portion 20710C coupled to the base 20710A and a free end portion 20710D. For example, each retaining arm 20710B can be coupled to the base 20710A at a first half of the base 20710A, and the free end portion 20710D can extend toward a second half of the base 20710A. Each retaining arm 20710B can include a sensor retaining feature 20710E disposed on an inner surface thereof. The sensor retention feature 20710E can 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 conical surface and an angular parting line that can enable release of the sensor control device 20102 upon delivery. Each retention arm 20710B can include a locking interface 20710F disposed on its outer surface. The locking interface 20710F can engage with a rib 20704U on the sheath 20704. As described above, the rib 20704U can prevent the sensor retention arm 20710B from bending outward during, for example, an impact event, thus keeping the retention feature 20710E in engagement with the sensor control device 20102, thereby preventing movement of the sensor control device 20102 during an impact event.

[0108] The sensor carrier 20710 may include multiple housing attachment features 20710F, for example, three housing attachment features 20710F. The housing attachment features 20710F may be evenly spaced on the sensor carrier 20710 and may extend upward from a top surface of the sensor carrier 20710. Each sensor housing attachment feature 20710F may include one or more of a housing snap 20710G, a housing positioning feature 20710H, a biasing feature 20710I, and a housing stop 20710J. The housing positioning feature 20710H may determine the location of the sensor carrier 20710 relative to the housing 20702 when the two are to be coupled together. The housing snap 20710G may engage a sensor carrier attachment slot 20702K on the housing 20702 to couple the sensor carrier 20710 to the housing 20702. The biasing feature 20710I can engage a sensor carrier biasing feature 20702M on the housing 20702 configured to eliminate rocking between the sensor carrier 20710 and the housing 20702. The housing stop 20710J can engage a sensor carrier stiffening stop 20702L on a sheath guide rail 20702J on the housing 20702 to axially position the sensor carrier 20710 relative to the housing 20702.

[0109] The sensor carrier 20710 can further include a plurality of sharps carrier locking arms 20710K, for example, three sharps carrier locking arms 20710K. The sharps carrier locking arms 20710K can be evenly spaced on the sensor carrier 20710 and can extend upward from a top surface of the sensor carrier 20710. Each sharps carrier locking arm 20710K can include a sharps carrier retention feature 20710L and a rib 20710M. The rib 20710M can engage an inner surface of the sheath 20704, thereby biasing the sharps carrier locking arms 20710K inwardly to retain the sharps carrier 201102 in the sharps carrier retention feature 20710L, as described in more detail below. The carrier retention feature 20710L can have a triangular shape when viewed in a side view and a "U" shape when viewed in a top view.

[0110] In accordance with the subject matter of the present disclosure, the sensor carrier 20710 can include a plurality of locking ledges 20710N configured to engage the locking arm interface 20704M of the sheath 20704 as described above. For example, the sensor carrier 20710 can include two locking ledges 20710N. The sensor carrier 20710 can include recesses 20710O disposed near each locking ledge 20710N and configured to receive the locking arm interface 20704M during firing and prevent the locking arm 20704J from engaging the housing 20702 during firing. The sensor carrier 20710 can include a hole 20710P extending through the center of the base 20710A. The hole 20710P can guide and limit the movement of the sharp hub 205014 during insertion. Additionally or alternatively, the sensor carrier 20710 can include a spring locator 20710Q.

[0111] The bottom surface of the sensor carrier 20710 can include stiffening ribs 20710R and sensor locator ribs 20710S that can limit in-plane movement of the sensor control device 20102 relative to the sensor carrier 20710. The bottom surface of the sensor carrier 20710 can include a sensor support surface 20710T configured to support the sensor control device 20102.

[0112] Exemplary Sharp Carriers 10A and 10B are proximal perspective and side cross-sectional views, respectively, depicting an exemplary embodiment 1102 of a sharps carrier. The sharps carrier 1102 can grip and hold the sharps module 2500 within the applicator 150. The sharps carrier 1102 can automatically retract as a result of one or more springs changing from a preloaded compressed state to an expanded state during the insertion process, as described with respect to FIGS. 40A-40F. There can be an anti-rotation slot 1608 near the distal end of the sharps carrier 1102 that prevents the sharps carrier 1102 from rotating when positioned within the central region of the sharps carrier locking arm 1524 (shown in FIG. 9A). The anti-rotation slot 1608 can be positioned between sections of the sharps carrier base chamfer 1610, which can ensure complete retraction of the sharps carrier 1102 through the sheath 704 upon retraction of the sharps carrier 1102 at the end of the deployment procedure.

[0113] 10B, sharps retaining arms 1618 can be positioned within the sharps carrier 1102 about a central axis and can include a sharps retaining clip 1620 at each distal end thereof. The sharps retaining clips 1620 can be approximately perpendicular to the central axis and can have a proximal surface that can abut a distally facing surface of the sharps hub 2516 (FIG. 17A).

[0114] 10C and 10D, for purposes of illustration and not limitation, an exemplary sharps carrier 201102 is shown. The sharps carrier 201102 can include one or more of the features described herein with respect to the sharps carriers, and similar features can operate as described herein. For example, the sharps carrier 201102 can include a series of features for engaging with the three sharps carrier locking arms 20710K of the sensor carrier 20710. These features can include a pre-partial retraction retaining surface 201102A and a post-partial retraction retaining surface 201102B. The pre-partial retraction retaining surface 201102A can engage the sharps carrier retaining feature 20710L prior to partial retraction, for example, during transport and storage. The post-partial retraction retaining surface 201102B can 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 rib 20710M of the retention arm 20710L can engage the slot 20704Q of the sheath 20704, thereby allowing the retention arm 20710L to move radially outward and the sharps carrier retention feature 20710L to engage the partially retracted post-retraction retention surface 201102B through the partially retracted pre-retraction retention surface 201102A. The height between the end of the partially retracted front surface 201102A and the start of the partially retracted post-retraction surface 201102B can be the partially retracted distance. A running surface 201102C can be located below the partially retracted post-retraction retention surface 201102B, which can slide relative to the retention arm 20710L as the sharps carrier 201102 retracts. The alignment wall 201102D can help keep the sharps carrier 201102 in alignment with the sensor carrier 20704 during partial retraction. The sharps carrier 201102 can include a chamfered surface 201102F, which can include an anti-rotation slot 201102E that engages with the retention arm 20710L on the sensor carrier 20710.

[0115] Internally, the sharps carrier 201102 can include a sharps retention arm 201102G that includes a lead-in surface 201102I and a sharps hub contact surface 201102H. The retention arm 201102G can receive and secure the sharps hub 205014. The spring stop 201102J can engage the retraction spring 205612.

[0116] The spring 205612 may include any type of spring known in the art, such as a helical spring. For example, according to certain embodiments, the spring 205612 may include a helical spring made of stainless steel. The spring 205612 may include any suitable range of spring constants and may include any suitable dimensions of wire diameter, inner diameter, outer diameter, and maximum solid strength. For example, the spring constant may be about 0.12, the wire diameter may be about 0.65 millimeters, the inner diameter may be about 9.6 millimeters, the outer diameter may be about 11.1 millimeters, and the maximum solid strength may be 11 millimeters.

[0117] Exemplary Sensor Module 11A and 11B are top and bottom perspective views, respectively, depicting an exemplary embodiment of a sensor module 504. The module 504 can secure a connector 2300 (FIGS. 12A and 12B) and a sensor 104 (FIG. 13). The module 504 has the ability to be rigidly coupled to an electronics housing 706. One or more deflectable arms or module snaps 2202 can snap into corresponding features 2010 of the housing 706. A sharp slot 2208 can provide a place for the sharp tip 2502 to pass through and for the sharp shaft 2504 to temporarily reside. The sensor ledge 2212 can define the sensor position in the horizontal plane, prevent the sensor from lifting the connector 2300 off the post, and keep the sensor 104 parallel to the plane of the connector seal. Additionally, the sensor ledge 2212 can define the curved shape and minimum radius of curvature of the sensor. The sensor ledge 2212 can limit the vertical movement of the sensor, prevent the tower from protruding above the electronics housing, and define the sensor tail length below the patch plane. The sensor wall 2216 can constrain the sensor and define the curved shape and minimum radius of curvature of the sensor.

[0118] 12A and 12B are perspective views depicting an exemplary embodiment of a connector 2300 in an open and closed state, respectively. The connector 2300 can be made of silicone rubber encapsulating a flexible carbon impregnated polymer module that acts as a conductive contact 2302 between the sensor 104 and the electrical circuit contacts for the electronics in the housing 706. The connector can act as a moisture barrier for the sensor 104 when assembled in a compressed state after transfer from the container to the applicator and after application to the user's skin. Multiple sealing surfaces 2304 can provide a watertight seal for the electrical and sensor contacts. One or more hinges 2208 can connect the two distal and proximal portions of the connector 2300.

[0119] FIG. 13 is a perspective view depicting an exemplary embodiment of the sensor 104. The neck 2406 can be a zone that allows for, for example, a 90 degree bend of the sensor. The membrane on the tail 2408 can cover the active analyte sensing element of the sensor 104. The tail 2408 can be the portion of the sensor 104 that resides under the user's skin after insertion. The flag 2404 can include a contact and a sealing surface. The bias tower 2412 can be a tab that biases the tail 2408 into the sharp slot 2208. The bias fulcrum 2414 can be a branch of the bias tower 2412 that contacts the inner surface of the needle to bias the tail into the slot. The bias adjuster 2416 can reduce local bending of the tail connection and prevent breakage of the sensor trace. The contact 2418 can electrically connect the active portion of the sensor to the connector 2300. The power feed loop 2420 can turn the electrical path 90 degrees from vertical and engage the sensor ledge 2212 (FIG. 11B).

[0120] 14A and 14B are bottom and top perspective views, respectively, depicting an exemplary embodiment of a sensor module assembly including a sensor module 504, a connector 2300, and a sensor 104. According to one aspect of the above-described embodiment, during or after insertion, the sensor 104 may be subjected to an axial force that pushes the sensor 104 proximally up into the sensor module 504, as shown by force F1 in FIG. 14A. According to some embodiments, this axial force may result in a detrimental force F2 being applied to the neck 2406 of the sensor 104, which in turn may result in a detrimental force F3 being transferred to the power feed loop 2420 of the sensor 104. In some embodiments, for example, the axial force F1 may occur as a result of a sensor insertion mechanism designed to force itself through tissue, a sharp retraction mechanism during insertion, or due to a physiological response effected by the tissue surrounding the sensor 104 (e.g., after insertion).

[0121] 15A and 15B are enlarged partial views of an exemplary embodiment of a sensor module assembly having certain axial stiffening features. In a general sense, the embodiments described herein relate to mitigating the effects of axial forces on a sensor as a result of an insertion mechanism and / or a retraction mechanism or from a physiological response to the sensor within the body. As can be seen in FIG. 15A and 15B, according to one aspect of these embodiments, the sensor 3104 includes a proximal portion having a hook feature 3106 configured to engage a catch feature 3506 of the sensor module 3504. In some embodiments, the sensor module 3504 can further include a clearance area 3508 to allow a distal portion of the sensor 3104 to recoil during assembly to allow assembly of the hook feature 3106 of the sensor 3104 over and into its catch feature 3506.

[0122] In accordance with another aspect of the above-described embodiment, the hook and catch features 3106, 3506 operate in the following manner: The sensor 3104 includes a proximal sensor portion that is coupled to the sensor module 3504 as described above, and a distal sensor portion that is positioned below the skin surface in contact with bodily fluids. As can be seen in FIGS. 15A and 15B, the proximal sensor portion includes a hook feature 3106 adjacent to a catch feature 3506 of the sensor module 3504. During or after sensor insertion, one or more forces are exerted 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 catch feature 3506 and prevents proximal displacement of the sensor 3104 along the longitudinal axis.

[0123] In accordance with another aspect of the above embodiment, the sensor 3104 can be assembled with the sensor module 3504 in the following manner: The sensor 3104 is mounted within the sensor module 3504 by laterally displacing the proximal sensor portion to bring the hook feature 3106 closer to the catch feature 3506 of the sensor module 3504. More specifically, laterally displacing the proximal sensor portion moves the proximal sensor portion into the clearance area 3508 of the sensor module 3504.

[0124] 15A and 15B show the hook feature 3106 as part of the sensor 3104 and the catch feature 3506 as part of the sensor module 3504, one of ordinary skill in the art will recognize that the hook feature 3106 can instead be part of the sensor module 3504 and similarly the catch feature 3506 can instead be part of the sensor 3106. Similarly, one of ordinary skill in the art will recognize that other mechanisms implemented on the sensor 3104 and sensor module 3504 (such as, for example, detents, latches, fasteners, screws, etc.) to prevent axial displacement of the sensor 3104 are possible and within the present disclosure.

[0125] 15C is a side view of an exemplary sensor 11900 in accordance with one or more embodiments of the present disclosure. The sensor 11900 may be similar in some respects to any of the sensors described herein and may thus be used to detect a particular analyte concentration in an analyte monitoring system. As shown, the sensor 11900 includes a tail 11902, a flag 11904, and a neck 11906 interconnecting the tail 11902 and the flag 11904. The tail 11902 includes an enzyme or other chemical or biological agent, and in some embodiments, a membrane may cover the chemical agent. During use, the tail 11902 is transdermally received under the skin of a user, and the chemical agent included on the tail 11902 helps facilitate analyte monitoring in the presence of bodily fluids. Additionally or alternatively, the enzyme and / or other chemical agent may be disposed on an electrode defined on the tail 11902. For example, electrodes can be deposited on the tail 11902 using one or more materials including, for example, conductive carbon inks and dielectric material layers. Additional materials can be used in the construction of the sensor tail, such as, for example, fluorinated polymers, polyethylene terephthalate, polyurethane, polyimide, or other non-conductive polymers, to form an insulating layer, for example. As described in more detail herein, the materials used to construct the sensor tail, electrodes, and / or enzymes or other chemical agents may outgas volatile organic compounds, such as, for example, formaldehyde and / or benzaldehyde. As specifically illustrated herein, capture materials can be used to adsorb volatile organic compounds, as described in more detail herein.

[0126] The tail 11902 may be received within a hollow or recessed portion of a sharp (not shown) to at least partially surround the tail 11902 of the sensor 11900. As shown, the tail 11902 may extend at an angle Q offset from the horizontal. In some embodiments, the angle Q may be approximately 85°. Thus, in contrast to other sensor tails, the tail 11902 may not extend perpendicularly from the flag 11904, but instead may extend at an angle offset from the vertical. This may prove advantageous in helping to maintain the tail 11902 within the recessed portion of the sharp.

[0127] The tail 11902 includes a first or bottom end 11908a and an opposing top end 11908b. A tower 11910 can be provided at or near the top end 11908b and can extend vertically upward from where the neck 11906 interconnects the tail 11902 to the flag 11904. When the sharp moves laterally during actuation, the tower 11910 will help pivot the tail 11902 towards the sharp and otherwise remain within the recessed portion of the sharp. Additionally, in some embodiments, the tower 11910 can provide or otherwise define a protrusion 11912 extending laterally therefrom. When the sensor 11900 is mated with the sharp and the tail 11902 extends into the recessed portion of the sharp, the protrusion 11912 can engage an inner surface of the recessed portion. When actuated, the protrusion 11912 can help keep the tail 11902 within the recessed portion.

[0128] The flag 11904 can include a generally planar surface having disposed thereon one or more sensor contacts 11914. The sensor contacts 11914 can be configured to align with a corresponding number of flexible carbon-impregnated polymer modules encapsulated within a connector.

[0129] In some embodiments, as shown, the neck 11906 may provide or otherwise define a recess or bend 11916 that extends between the flag 11904 and the tail 11902. The bend 11916 may prove advantageous in adding flexibility to the sensor 11900 and helping to prevent bending of the neck 11906.

[0130] In some embodiments, a notch 11918 (shown in dashed lines) can optionally be defined in the flag near the neck 11906. The notch 11918 can provide additional flexibility and tolerance to the sensor 11900 when the sensor 11900 is mounted in a mount. More specifically, the notch 11918 can help absorb interference forces that may occur when the sensor 11900 is mounted in a mount.

[0131] In some embodiments, as shown in Figures 15D-15G, the neck can include or otherwise define a non-linear configuration, such as a recess or bend 11920a-d having multiple turns, e.g., 11921a, 11921b, extending between the flag 11904 and the tail 11902. The bends 11920a-d can be advantageous by reducing the positional stiffness of the sensor 11900 by adding flexibility to the sensor 11900 in both vertical and horizontal orientations. The added flexibility can provide a multi-directional spring-like structure within the sensor 11900 that helps limit deformation of the neck 11906 while ensuring that the tail 11902 and flag 11904 can remain in their expected or fixed positions. The spring-like structure also increases the flexibility of the sensor 11900 while reducing stress on the overall structure.

[0132] In general, the sensor may be understood to include a tail, a flag, and a neck aligned along a planar surface having a vertical axis and a horizontal axis. The spring-like structure may be created by variously oriented windings at the bend of the neck of the sensor. Between the tail and the flag, the neck may include at least two windings about the vertical axis to provide a spring-like structure. The at least two windings may provide a superimposed layer of the neck structure about the axis of the planar surface shared by the tail, the flag, and the neck, in which case the neck itself remains intact. These superimposed windings constitute the spring-like structure. In some embodiments, the superimposed layer of the neck may be oriented vertically. In some embodiments, the superimposed layer of the neck may be oriented horizontally.

[0133] 15D shows an embodiment of the sensor 11900 including a neck between the flag 11904 and the tail 11902 with a bend 11920a including turns 11921a and 11921b. In the illustrated embodiment, at least one turn 11921a abuts the top of the tail or potentially the tower 11910 of the sensor 11900. This orientation can be advantageous in reducing the overall footprint of the sensor even taking into account the additional material used to generate the bend 11920a. This arrangement can provide multiple overlapping horizontal layers that are vertically aligned between the turns.

[0134] 15E shows another embodiment of a sensor 11900 including a neck with a bend 11920b that generally forms a spiral pattern including at least turns 11923a, 11923b, and 11923c between the flag 11904 and the tail 11902. In this embodiment, the turns again abut the top of the tail or tower 11910 of the sensor 11900. In addition to maintaining the overall footprint of the sensor, this orientation can allow for additional balancing of horizontally and vertically oriented stresses. Optionally, the overlapping layers in this winding arrangement are substantially balanced along both the horizontal and vertical axes.

[0135] 15F shows another embodiment of a sensor 11900 including a neck with a bend 11920c including turns 11925a, 11925b, and 11925c between the flag 11904 and the tail 11902. In the illustrated embodiment, the turn 11925c connects a region of the tail 11902 of the sensor near its top end or the tower 11910 of the sensor to the remainder of the bend 11920c. In addition to reducing the overall footprint of the sensor, this orientation is believed to provide additional flexibility in the horizontally oriented axis. This arrangement can provide multiple overlapping vertical layers that are horizontally aligned between the turns.

[0136] FIG. 15G shows another embodiment of the sensor 11900 including a neck having a bend 11920d including turns 11927a, 11927b, and 11927c between the flag 11904 and the tail 11902. In the illustrated embodiment, the bend 11920d occurs primarily within the tail 11902 of the sensor connecting the tail 11902 and the tower 11910, whereas the run of the sensor between the tower 11910 and the flag 11904 is generally continuous. Turn 11927a connects the tower 11910 generally to the remainder of the bend 11920d, while turn 11927c connects the tail 11902 to the remainder of the bend 11920d. This orientation is believed to provide additional flexibility in the vertically oriented axis. This arrangement can provide multiple overlapping vertical layers with horizontal alignment between the turns.

[0137] The neck turns can be produced by folding the neck of the sensor from a larger neck structure, laser cutting the sensor from a sheet of material that contains the sensor, printing the sensor with a configuration having the turns, stamping the sensor from a sheet of material the sensor is constructed from, or other manufacturing process suitable for providing a precise bend in the neck.

[0138] 16A and 16B are isometric and partially exploded isometric views of an exemplary connector assembly 12000 according to one or more embodiments. As shown, the connector assembly 12000 can include a connector 12002, and FIG. 17C is an isometric bottom view of the connector 12002. The connector 12002 can include an injection molded portion that is used to help secure one or more flexible carbon impregnated polymer modules 12004 (four are shown in FIG. 16B) to the mount 12006. More specifically, the connector 12002 can help secure the module 12004 in a defined location adjacent the sensor 11900 and in contact with a sensor contact 11914 (FIG. 15C) located on the flag 11904 (FIG. 15C). The module 12004 may be fabricated from a conductive material to provide conductive communication between the sensor 11900 and corresponding circuit contacts (not shown) provided in the mount 12006 .

[0139] As can be seen most clearly in FIG. 16C, the connector 12002 can define a pocket 12008 sized to receive the module 12004. Additionally, in some embodiments, the connector 12002 can further define one or more recesses 12010 configured to mate with one or more corresponding flanges 12012 ( FIG. 16B ) on the mount 12006. Mating the recesses 12010 with the flanges 12012 can secure the connector 12002 to the mount 12006, such as by an interference fit. In other embodiments, the connector 12002 can be secured to the mount 12006 using an adhesive or by sonic welding.

[0140] 16D and 16E are isometric and partially exploded isometric views of another exemplary connector assembly 12100 according to one or more embodiments. As shown, the connector assembly 12100 can include a connector 12102, with FIG. 16F being an isometric bottom view of the connector 12102. The connector 12102 can include an injection molded portion that is used to help keep one or more flexible metal contacts 12104 (four are shown in FIG. 16E) fixed to the sensor 11900 on the mount 12106. More specifically, the connector 12102 can help secure the contacts 12104 in a defined location adjacent the sensor 11900 and in contact with a sensor contact 11914 (FIG. 15C) provided on the flag 11904. The contacts 12104 may be fabricated from a conductive material, optionally a stamped conductive material, that provides conductive communication between the sensor 11900 and corresponding circuit contacts (not shown) provided in the mount 12106. In some embodiments, for example, the contacts 12104 may be soldered to a PCB (not shown) positioned within the mount 12106.

[0141] As can be seen most clearly in FIG. 16F, the connector 12102 can define a pocket 12108 sized to receive the contact 12104. Additionally, in some embodiments, the connector 12102 can further define one or more recesses 12110 configured to mate with one or more corresponding flanges 12112 ( FIG. 120B ) on the mount 12106. Mating the recesses 12110 with the flanges 12112 can help secure the connector 12102 to the mount 12106, such as by an interference fit. In other embodiments, the connector 12102 can be secured to the mount 12106 using an adhesive or by sonic welding.

[0142] Exemplary Capture Materials The device according to the presently disclosed subject matter may include one or more capture materials as described above. The capture material may be disposed within a chamber defined by the housing 20702. The capture material is configured to adsorb volatile materials from the chamber, as described in more detail below. For example, the capture material may include one or more inorganic materials, such as, for example, alumina. Additionally or alternatively, the capture material may include one or more organic materials, such as a polymer. For example, as embodied herein, the capture material may include at least one of activated carbon, silica gel, and one or more molecular sieves, or a combination thereof. The capture material may further include additional materials suitable for adsorbing volatile materials from within the chamber.

[0143] As specifically illustrated herein, the capture material can be a selective capture material, i.e., a capture material configured to adsorb specific volatile organic compounds. For example, the pore size of the capture material can be selected based on the molecular size of the volatile organic compounds to be adsorbed. Larger pore sizes may be more suitable for adsorbing larger molecules. Additionally or alternatively, capture materials with smaller pore sizes can adsorb volatile organic compounds with smaller molecular sizes. By way of example and not limitation, carbon and polymer capture materials can have a wide range of pore sizes and thus can adsorb multiple different sizes of volatile organic compounds at once. By way of example and not limitation, suitable capture materials can include an average pore size between about 0.1 Å and about 1,000 Å. Additionally or alternatively, suitable capture materials can include an average pore size between about 1 Å and about 500 Å. Additionally or alternatively, suitable capture materials can include an average pore size between about 1 Å and about 100 Å. Additionally or alternatively, suitable capture materials can include an average pore size between about 1 Å and about 400 Å. Additionally or alternatively, suitable capture materials can include an average pore size between about 1 Å and about 300 Å. Additionally or alternatively, suitable capture materials can include an average pore size between about 1 Å and about 200 Å. Additionally or alternatively, suitable capture materials can include an average pore size between about 1 Å and about 100 Å. Additionally or alternatively, suitable capture materials can include an average pore size between about 1 Å and about 10 Å. Additionally or alternatively, suitable capture materials can include an average pore size between about 30 Å and about 300 Å. Additionally or alternatively, suitable capture materials can include an average pore size between about 0.1 Å and about 100 Å. Additionally or alternatively, suitable capture materials can include an average pore size between about 0.1 Å and about 50 Å. Additionally or alternatively, suitable capture materials can include an average pore size between about 0.1 Å and about 10 Å. Techniques for measuring pore size are known in the art.For example, pore size can be measured using gas adsorption, mercury intrusion, and / or capillary flow porosimetry.

[0144] Additionally or alternatively, the capture material can be selected based on its affinity for the target volatile organic compounds. For example, the capture material can be selected based on a desired hydrophilic or hydrophobic selectivity, as described in more detail herein. By way of example and not limitation, a carbon capture material may not be completely hydrophobic or completely hydrophilic, and thus may have an affinity for both polar and non-polar volatile organic compounds. Additionally or alternatively, multiple capture materials or mixtures thereof can be used.

[0145] As discussed above, an analyte measurement device according to aspects of the presently disclosed subject matter may include an analyte sensor configured to measure an analyte level, the analyte sensor including a tail portion suitable for subcutaneous placement and having an analyte responsive enzyme disposed thereon. The analyte measurement device may further include an applicator for delivery of the analyte sensor having a housing defining an airtight sealed chamber, the tail portion being disposed within the chamber prior to subcutaneous placement, and a capture material being disposed within the chamber, the capture material configured to adsorb at least one substance within the chamber, the capture material including at least one of activated charcoal, molecular sieves, and silica gel.

[0146] As specifically shown herein, the capture material can surround the tail portion. By way of example and not limitation, the capture material can have a tubular shape and can surround the tail portion within a chamber. By way of example and not limitation, the capture material can be contained within a sensor sleeve and the sensor sleeve can surround the tail portion, as discussed in more detail herein. Additionally or alternatively, the capture material can be contained within a collar and the collar can surround the tail portion, as discussed in more detail herein.

[0147] As more particularly shown herein, the tail portion of the analyte sensor can have a length and the capture material can surround the tail portion along the length. By way of example and not limitation, the capture material can have a generally tubular shape and the tail portion can be received within a tube along its length. By way of example and not limitation, as more particularly shown herein, the capture material can be contained within a sensor sleeve and the sensor sleeve can surround the tail portion along its length. Without being bound by theory, surrounding the tail portion along its length can facilitate the capture material adsorbing volatile organic compounds that are exhaled as a gas from the sensor tail.

[0148] Additionally or alternatively, the capture material can be located in the chamber proximate to the tail portion. For purposes of illustration, as specifically shown herein, the tail portion can be received within a hollow or recessed portion of the sharp, and the capture material can be immediately adjacent to the tail portion and sharp in the chamber. As described in more detail herein, the materials used to construct the sensor tail, the electrodes, and / or the enzymes or other chemical agents contained on the sensor tail can exude volatile organic compounds as a gas, and the capture material can be used to adsorb the volatile organic compounds that are exuded as a gas from the sensor tail. Without being bound by theory, positioning the capture material in close proximity to the sensor tail can facilitate the capture material adsorbing the volatile organic compounds that are exuded as a gas from the sensor tail.

[0149] The capture material may be included in any suitable location within the chamber. For example, capture material 20708M may be included within the housing 20702 or the applicator cap 20708. As specifically shown herein, the capture material may be adhered to a sidewall of the cap 20708 as shown in FIG. 7N(ii). Additionally or alternatively, the capture material may be coupled to the cap 20708 using clips 20708H as described above. Additionally or alternatively, the capture material may take the form of a stick, powder, patch, or pouch disposed within the cap 20708.

[0150] Additionally or alternatively, one or more components of or within the chamber, such as the housing 20702 and the cap 20708, can include a capture material. By way of example and not limitation, the capture material can be combined with at least one polymeric material to form a mixture, which can be molded to form the components including the capture material, such as the housing 20702 and / or the cap 20708. Techniques for combining a capture material with a polymeric material are known in the art. For example, a channel former can be used to disperse the capture material within the polymeric material for injection molding. Examples of combining a capture material with a polymeric material are disclosed in U.S. Pat. Nos. 6,174,952 and 6,316,520, the disclosures of which are incorporated herein by reference.

[0151] Additionally or alternatively, the capture material can form a coating. For example, the capture material can be a coating over the housing 20702 and / or the cap 20708. For example, the capture material can be overmolded onto the housing 20702 and / or the cap 20708. Additionally or alternatively, the capture material can be included in an adhesive used to secure the components of the system. Although the housing 20702 and cap 20708 have been mentioned for illustrative purposes, additional components of the applicator device can be formed or coated with the capture material using the techniques described above.

[0152] It may be advantageous to include a capture material in the applicator. For example, as described above, the analyte sensor may include an enzyme or other chemical or biological agent, and in some embodiments, the membrane may cover the chemical agent. The sensor's chemical agent and / or membrane may be sensitive to substances such as volatile organic compounds that may be outgassed by surrounding polymeric compounds in the chamber. For example, the cap 20708 and / or the housing 20702 may be constructed from a polymeric material such as polycarbonate, which may outgas or emit such volatile organic compounds, such as chlorobenzene. Additionally or alternatively, the elastomeric plug 9130A, the sealing ring 5028, and / or the collar 5112 may be constructed from an elastomeric material such as rubber, silicone, silicone-polyurethane hybrid, polyurethane, polysulfide, latex, styrene-butadiene, and / or flexible plastic, which may outgas siloxanes, such as PDMS derivatives. Additionally or alternatively, the elastomeric plug 9130A, the sealing ring 5028, and / or the collar 5112 may include a material having a durometer hardness of about 5 Shore A to about 80 Shore A. Additionally or alternatively, the sensor 5010 may outgas formaldehyde or benzaldehyde as described above. The outgassed volatile compounds may interact with the sensor chemistry and / or membrane and may adversely affect the stability and performance of the sensor. Furthermore, the interaction between the outgassed volatile compounds and the sensor chemistry and / or membrane may build up over time, which may affect the shelf life of the product. Additional substances such as water or moisture may also be present in the applicator and adversely interact with the sensor chemistry and / or membrane.

[0153] The capture material can be configured to adsorb these substances, which can result in improved sensor shelf life and performance. For example, the activated carbon capture material can have a large surface area due to the porosity of the material described above, and can adsorb volatile compounds to the surface of the activated carbon as a result of van der Waals forces and / or chemical interactions between the activated carbon surface and the volatile compounds. The capture material can be selected based on the type of volatile organic compounds to be adsorbed. For example, the capture material can have high selectivity for hydrophilic or hydrophobic volatile organic compounds.

[0154] Exemplary Sharp Module FIG. 17A is a perspective view depicting an exemplary embodiment of a sharps module 2500 prior to assembly into a sensor module 504 (FIG. 6B). The sharps 2502 can include a distal tip 2506 that can pierce the skin while carrying the sensor tail in a hollow or recessed portion of the sharps shaft 2504 to place the active surface of the sensor tail in contact with bodily fluids. The hub pressing cylinder 2508 can provide a surface for the sharps carrier to press against during insertion. The hub small cylinder 2512 can provide space for the extension of the sharps hub contact surface 1622 (FIG. 10B). The hub snap claw positioning cylinder 2514 can provide a distal facing surface of the hub snap claw 2516 for the sharps hub contact surface 1622 to abut against. The hub snap claw 2516 can include a conical surface that opens the clip 1620 during installation of the sharps module 2500.

[0155] 17B-17H illustrate exemplary embodiments of a sharps module suitable for use during insertion of a dermal analyte sensor at various stages of assembly. According to one aspect of these embodiments, angling of the sensor and / or insertion sharps relative to a reference point can enable co-localization of the tip of the insertion needle with the tip of the sensor, and can also create a single contact point at the surface of the skin. Thus, the sharps can create a leading edge at the surface of the skin to form an insertion path for the sensor into the dermal layer when the sensor is inserted into the subject's body. In some embodiments, for example, the sharps and / or dermal sensor can be angled relative to a reference point (e.g., each other, the surface of the skin, or the base of the applicator) for insertion, where the angle of the sharps is different from the angle of the sensor. For example, the reference point can be the surface of the skin to be cleaved for dermal insertion, or can be a reference or component of a sensor applicator set. In some embodiments, the sharps can be positioned at an angle relative to the sensor. For example, when the sharp is designed to be angled relative to the sensor, the needle creates a leading edge for the sensor during actuation of the applicator set. Furthermore, the needle design itself and the positioning of the needle relative to the sensor can be implemented in any desired configuration, including all of the configurations disclosed in U.S. Patent Publication No. 2014 / 0171771, the entire contents of which are incorporated herein by reference for all purposes.

[0156] Additionally, although many of the exemplary embodiments described with respect to Figures 17B through 17J are described with respect to dermal analyte sensors and dermal insertion, it will be understood by one of ordinary skill in the art that any of these embodiments can be sized and configured to be suitable for use with analyte sensors that can be placed beyond the dermal space, such as into (or even completely through) the subcutaneous tissue (e.g., 3 to 10 mm below the skin surface depending on the location of the skin on the body).

[0157] 17B is a perspective view depicting an exemplary embodiment of a sharps module 2550 that can be used for insertion of a dermal sensor. In this view, the sharps module 2550 is shown prior to assembly with the sensor module 504 (FIG. 6B), and can include similar components to the embodiment described with respect to FIG. 17A, including a sharp 2552, a sharp shaft 2554, a sharp distal tip 2556, a hub pressing cylinder 2558, a hub minor cylinder 2562, a hub snap pawl 2566, and a hub snap pawl positioning cylinder 2564. The sharps 2552 can be positioned in the sharps module 2550 at an eccentric location relative to a longitudinal axis 2545 that extends through the center of the hub snap pawl 2566, the hub minor cylinder 2562, and the hub pressing cylinder 2558. Additionally, the sharps module 2550 can include a sharps spacer 2568 parallel to and adjacent to a portion of the sharps 2552. A sharp spacer 2568 can be positioned between the sensor 104 (not shown) and the sharp 2552 along a proximal portion of the sharp 2552 to ensure that the sensor 104 and the sharp 2552 remain spaced apart at the proximal portion of the sharp 2552. The sharp 2552 can be positioned in an eccentric location during the molding process with hub components 2558, 2562, 2566, each of which can include a hard plastic material.

[0158] 17C and 17D are two side views depicting the sharp module 2550 prior to assembly with the sensor module 504 (FIG. 6B), including the sharp 2552, the spacer 2568, the hub pressing cylinder 2558, the hub small cylinder 2562, and the hub snap claw 2566. In some embodiments, the relative distances between the sharp 2552 and the hub components can be positioned as follows: For example, the distance S1 between the sharp 2552 and the radial center of the hub can range from 0.50 mm to 1 mm (e.g., 0.89 mm). The height S2 of the sharp spacer 2568 can range from 3 mm to 5 mm (e.g., 3.26 mm). The height S3 of the hub can range from 5 mm to 10 mm (e.g., 6.77 mm). The length S4 of the sharp 2552 can range from 1.5 mm to 25 mm (e.g., 8.55 mm) and can be based on the location of the insertion site on the subject.

[0159] FIG. 17E depicts a cross-sectional side view of the sharps module 2550, including the sharps 2552, the sharps spacer 2568, and the hub components (hub snap tab 2566, hub small cylinder 2562, and hub pressing cylinder 2558), assembled with the sensor module 504. As can be seen in FIG. 17E, the sharps 2552 are disposed within the sharps slot 2208 of the sensor module 504, which includes a curved inner surface 2250 located at a distal end. The curved inner surface 2250 of the sensor module 504 can be in contact with a portion of the sharps 2552, causing the sharps distal tip 2556 to deflect toward the central longitudinal axis 2545. As can be seen most clearly in FIG. 17H, the sharps 2552 are spaced apart from the sharps 2552 at an acute angle S between the distal portion and the central longitudinal axis 2545, which can range between 5° and 20°. θ In some embodiments, for example, S θ may range from 5° to 17°, 7° to 15°, or 9° to 13°, for example, 9°, 10°, 11°, 12°, or 13°.

[0160] 17E, near the distal end of the sensor module 504 is a protrusion 2251 that can promote perfusion of bodily fluids, such as dermal fluid. Although shown as curved in FIG. 17E, the protrusion 2251 can be shaped in any desired manner. Additionally, in some embodiments, there can be multiple protrusions. U.S. Patent Publication No. 2014 / 0275907, the entire contents of which are incorporated herein by reference for all purposes, describes sensor devices having various protrusion configurations, each of which can be implemented in the embodiments described herein. While many of the embodiments described herein show a needle exiting the protrusion, in other embodiments, the needle can extend from the base of the sensor device adjacent the protrusion and from this location extend above the tip of the sensor 104.

[0161] 17E and 17F, the sensor 104 may be a dermal sensor and may include a sensor tail 2408 that may be positioned at a distal end of the sensor 104 and oriented substantially parallel to the central longitudinal axis 2545. The distal end of the sensor tail 2408 may be in spaced relation to, or nested within, or abut a portion of the sharp shaft 2554 proximal to the distal sharp tip 2556. As further shown in FIG. 17E, a sharp spacer 2568 may provide a spaced relation between a proximal portion of the sharp 2552 and the sensor 104 such that the proximal portion of the sharp 2552 and the sensor 104 are not in contact. The sensor module 504 may further include a sensor connector 2300 for housing a proximal portion of the sensor 104 relatively perpendicular to the distal end of the sensor 104.

[0162] 17F is a top cross-sectional view of the sensor module 504. The sensor module 504 may include one or more sensor module snaps 2202 for coupling with a housing (not shown) of the sensor control device 102. The sensor module 504 may further include a sensor connector 2300 that may have sensor contacts 2302 for coupling with a proximal portion of the sensor 104. The sensor connector 2300 may be fabricated from silicone rubber encapsulating a flexible carbon impregnated polymer module that acts as a conductive contact 2302 between the sensor 104 and electrical circuit contacts for the electronics in the sensor control device 102. The connector may act as a moisture barrier for the sensor 104 when assembled in a compressed state after transfer from the container to the applicator and after application to the user's skin. Although three contacts 2302 are shown, it is understood that the connector 2300 may have fewer (e.g., two) or more (e.g., four, five, six, etc.) contacts depending on the particular type or configuration of the sensor 104. The sensor connector 2300 may further be coupled to the sensor module 504 by two connector posts 2206 positioned through a like number of openings therein. Although two connector posts 2206 are shown, it is understood that any number of connector posts 2206 may be used to couple the connector 2300 to the sensor module 504.

[0163] 17G and 17H are perspective and side views, respectively, of another exemplary embodiment 2600 of a sharps module that can be used for insertion of a dermal sensor. In this view, the sharps module 2600 is shown prior to assembly with the sensor module 504 (FIG. 6B), and can include similar components to the embodiment described with respect to FIGS. 17A and 17B, including a sharp 2602, a sharp shaft 2604, a sharp distal tip 2606, a hub pressing cylinder 2608, a hub small cylinder 2612, a hub snap pawl 2616, and a hub snap pawl positioning cylinder 2614. In some embodiments, the sharp 2602 can be a "pre-curved" needle that includes a proximal portion 2603 that proceeds from a point on the exterior of the sharps module 2600 and intersects at an angle with the center point of the hub (e.g., through the hub pressing cylinder 2608). The sharp 2602 may further include a distal portion 2605 that extends distally at an angle from a point near the distal portion of the hub toward an insertion point on the user's skin. As shown in FIG. 17H, the sharp 2602 may include an angled portion 2607 that may be positioned outside of the hub pressing cylinder 2608 and have a substantially 90° angle between the proximal portion 2603 and the distal portion 2605 of the sharp 2602. The sharp module 2600 may further include a bent fin guide 2620 to maintain the "pre-curved" sharp 2602 in a defined position during assembly and / or use and may prevent lateral or rotational movement of the sharp 2602 relative to the hub components. The proximal portion 2603 of the sharp 2602 may be "trimmed" from the hub after the molding process is completed and prior to assembly of the sharp module 2600 with the sensor module 504.

[0164] 17I and 17J are side cross-sectional and side views, respectively, of the sharps module 2600 (including the hub snap claws 2616, the hub small cylinder 2612, and the hub pressing cylinder 2608) assembled with the sensor module 504. As can be seen in FIG. 17I, the sensor module 504 includes a sharps slot 2208 that allows the sharps 2602 to extend therethrough in an oblique and distal direction. As mentioned above, the proximal portion of the sharps 2602 passes through a bent fin guide 2620 that is coupled to a distal portion of the sensor module 504. The sensor module 504 can further include a sensor 104, which can be a dermal sensor. As shown in FIG. 17I, the sharps 2602 and the sensor tail 2408 form an acute angle S at the point where their respective longitudinal axes converge. θ The angle S can be formed. θ can range between 5° and 20°. In some embodiments, for example, S θ can range from 5° to 17°, 7° to 15°, or 9° to 13°, for example, 9°, 10°, 11°, 12°, or 13°. In some embodiments, the distal sharp tip 2606 is positioned at a distance S6 proximal to the end of the sensor tail 2408. Distance S6 can range between 0.02 mm and 0.10 mm, for example, 0.05 mm, 0.06 mm, or 0.07 mm.

[0165] 17I and 17J, the sensor module 504 may further include a sensor connector 2300 for housing a proximal portion of the sensor 104 relatively perpendicular to the distal end of the sensor 104. It may include one or more sensor module snaps 2202 for coupling with a housing (not shown) of the sensor control device 102. The sensor connector 2300 may include the same structure as described with respect to FIG.

[0166] In the above-described embodiments, the sharp may be made of stainless steel or a similar flexible material (e.g., a material used to make acupuncture needles) and may be sized to allow insertion of at least a portion of the dermal sensor into, but not through, the dermal layer of the skin by the applicator. According to certain embodiments, the sharp has a cross-sectional diameter (width) of 0.1 mm to 0.5 mm. For example, the sharp may have a diameter of 0.1 mm to 0.3 mm, such as 0.15 mm to 0.25 mm, e.g., 0.16 mm to 0.22 mm. A given sharp may have a constant or uniform width along its entire length, or may have a varying or changing width along at least a portion of its length, e.g., the tip portion used to pierce the surface of the skin. For example, with respect to the embodiment illustrated in FIG. 17I, the width of the sharp 2602 may be reduced along a distal portion between the bent fin guide 1620 and the distal sharp tip 2606.

[0167] The sharp can have a length that allows the dermal sensor to be inserted precisely into the dermal layer and not further. The insertion depth can be controlled by the length of the sharp, the configuration of the base and / or other applicator components that limit the insertion depth. The sharp can have a length between 1.5mm and 25mm. For example, the sharp can have a length of 1mm to 3mm, 3mm to 5mm, 5mm to 7mm, 7mm to 9mm, 9mm to 11mm, 11mm to 13mm, 13mm to 15mm, 15mm to 17mm, 17mm to 19mm, 19mm to 21mm, 21mm to 23mm, 23mm to 25mm, or a length greater than 25mm. The sharp can have a length up to 25mm, but it will be appreciated that in certain embodiments the entire length of the sharp will not be inserted into the subject as it would extend beyond the dermal space. The non-inserted sharp length can allow for handling and manipulation of the sharp with the applicator set. Thus, although the sharps can have a length of up to 25 mm, the insertion depth of the sharps in the subject's skin in certain embodiments described above will be limited to the dermis layer, e.g., about 1.5 mm to 4 mm depending on the location of the skin as described in more detail below. However, in all of the embodiments disclosed herein, the sharps can be configured to extend beyond the dermis space, e.g., into (or even completely through) the subcutaneous tissue (e.g., 3 mm to 10 mm below the skin surface depending on the location of the skin on the body). In addition to this, in some exemplary embodiments, the sharps described herein can include hollow or partially hollow insertion needles with an internal space or lumen. However, in other embodiments, the sharps described herein can include solid insertion needles without an internal space or lumen. Furthermore, the sharps of the subject applicator set can be bladed or non-bladed.

[0168] Similarly, in the above-described embodiments, the dermal sensor is also sized such that at least a portion of it is positioned at the dermal layer and not beyond, with a portion extending outside the skin in percutaneous positioning embodiments, i.e., the dermal sensor is sized such that when it is fully or substantially fully inserted into the dermal layer, a distal-most portion (insertion portion or insertion length) of the sensor is positioned within the dermis of the subject, and when the sensor is operably positioned in the dermis, no portion of the sensor is inserted beyond the dermis layer of the subject.

[0169] Since the depth and thickness of the epidermis and dermis vary to some extent depending on the location of the skin, the dimensions (e.g., length) of the sensor can be selected according to the part of the subject's body where the sensor is to be inserted. For example, the epidermis is only about 0.05 mm thick on the eyelid, but about 1.5 mm thick on the palm and sole. The dermis is the thickest of the three layers of skin, and ranges from about 1.5 mm to 4 mm thick depending on the location of the skin. For implantation of the distal end of the sensor into, but not penetrating, the dermis layer of the subject, the length of the insertion portion of the dermal sensor should be longer than the thickness of the epidermis, but not exceed the combined thickness of the epidermis and dermis. The method includes determining an insertion site on the user's body, determining the depth of the dermis layer at the site, and selecting an applicator set of an appropriate size for the site.

[0170] In certain aspects, the sensor is an elongated sensor having a longest dimension (or "length") of 0.25 mm to 4 mm. The insertion length of the sensor ranges from 0.5 mm to 3 mm, such as 1 mm to 2 mm, e.g., 1.5 mm, in embodiments where only a portion of the sensor is inserted into the dermis. The dimensions of the sensor can be expressed using the aspect ratio of the sensor. In certain embodiments, the dermal sensor has a length to width (diameter) aspect ratio of about 30:1 to about 6:1. For example, the aspect ratio can be about 25:1 to about 10:1, including 20:1 and 15:1. The insertion portion of the dermal sensor contains the sensing chemical agent.

[0171] However, all of the embodiments disclosed herein can be configured such that at least a portion of the sensor is positioned beyond the dermis layer, for example, in (or through) the subcutaneous tissue (or fat). For example, the sensor can be dimensioned such that when it is fully or substantially fully inserted into the body, the most distal portion (insertion portion or insertion length) of the sensor is positioned in the subcutaneous tissue (beyond the dermis of the subject), and when the sensor is operatively positioned, no portion of the sensor is inserted beyond the subcutaneous tissue of the subject. As mentioned above, typically, the subcutaneous tissue is in the region of 3 mm to 10 mm below the outer skin surface, depending on the location of the skin on the body.

[0172] Exemplary applicator and sensor control device for one-piece architecture Briefly referring back to FIG. 1 and FIG. 3A-3G, for a two-piece architecture system, the sensor tray 202 and the sensor applicator 102 are provided to the user as separate packages, thus requiring the user to unpack each package and ultimately assemble the system. In some applications, these separate sealed packages allow the sensor tray 202 and the sensor applicator 102 to be sterilized in separate sterilization steps that are unique to the contents of each package and cannot be shared with the contents of the other. More specifically, the sensor tray 202, including the plug assembly 207, including the sensor 110 and the sharps 220, can be sterilized using radiation sterilization, such as electron beam (or "e-beam") irradiation. However, radiation sterilization may damage electrical components positioned within the electronics housing of the sensor control device 102. As a result, if the sensor applicator 102, including the electronics housing of the sensor control device 102, needs to be sterilized, it can be sterilized by another method, such as gas chemical sterilization, for example, using ethylene oxide. However, gas chemical sterilization may damage enzymes or other chemical and biological agents contained on the sensors 110. Due to this sterilization incompatibility, the sensor tray 202 and the sensor applicator 102 are typically sterilized in separate sterilization processes and then packaged separately, thereby requiring the user to ultimately assemble the components for use.

[0173] According to the disclosed embodiments of the present invention, the sensor control device 102 can be modified to provide a one-piece architecture that can apply sterilization techniques specifically designed for the one-piece architecture sensor control device. The one-piece architecture allows the sensor applicator 150 and the sensor control device 102 to be shipped to the user in a single sealed package that does not require any final user assembly steps. In other words, the user only needs to unpack one package and then deliver the sensor control device 102 to the target monitoring location. The one-piece system architecture described herein can prove advantageous by eliminating component parts, various processing steps, and user assembly steps. This results in less packaging and waste, and less potential for user error or contamination of the system.

[0174] 18A and 18B are isometric and side views, respectively, of another exemplary sensor control device 5002 in accordance with one or more embodiments of the present disclosure. The sensor control device 5002 may be similar in some respects to the sensor control device 102 of FIG 1 and therefore may be best understood with reference thereto. Moreover, the sensor control device 5002 may replace the sensor control device 102 of FIG 1 and therefore may be used in conjunction with the sensor applicator 102 of FIG 1, which may deliver the sensor control device 5002 to a target monitor location on the user's skin.

[0175] However, unlike the sensor control device 102 of FIG. 1, the sensor control device 5002 may include a one-piece system architecture that does not require a user to unpack multiple packages and final assemble the sensor control device 5002 prior to application. In other words, upon receipt by the user, the sensor control device 5002 is already fully assembled and properly positioned within the sensor applicator 150 (FIG. 1). To use the sensor control device 5002, the user need only open one barrier (e.g., applicator cap 708 of FIG. 3B) before dispatching the sensor control device 5002 to a target monitoring location ready for use.

[0176] As illustrated, the sensor control device 5002 includes an electronics housing 5004 that can be generally disk-shaped and have a circular cross-section. However, in other embodiments, the electronics housing 5004 can be provided with other cross-sectional shapes, such as oval or polygonal, without departing from the scope of the present disclosure. The electronics housing 5004 can be configured to house or otherwise enclose various electrical components used to operate the sensor control device 5002. In at least one embodiment, an adhesive patch (not shown) can be positioned on the bottom of the electronics housing 5004. The adhesive patch can be similar to the adhesive patch 105 of FIG. 1 and can thus aid in adhering the sensor control device 5002 to a user's skin for use.

[0177] In some embodiments, the electronics housing 5004 can include the capture material described above. The capture material can be separate from or incorporated into the electronics housing 5004. In certain embodiments, the capture material can be a separate component disposed within the electronics housing 5004. For example, the capture material can take the form of a stick, powder, patch, or pouch disposed within the electronics housing 5004. Additionally or alternatively, the capture material 5018A can be glued within the electronics housing 5004 as shown in FIG. 20B. In other embodiments, the electronics housing 5004 can be formed entirely from the capture material. In other embodiments, the capture material can be combined with one or more polymeric materials to form a mixture, which can be molded to form the electronics housing 5004. In still other embodiments, the capture material can be a coating or resin applied to all or a portion of the electronics housing 5004.

[0178] As illustrated, the sensor control device 5002 includes an electronics housing 5004 including a shell 5006 and a mateable mount 5008. The shell 5006 can be secured to the mount 5008 by a variety of techniques, such as a snap engagement, an interference fit, sonic welding, one or more mechanical fasteners (e.g., screws), a gasket, an adhesive, or any combination thereof. In some cases, the shell 5006 can be secured to the mount 5008 such that a sealed interface occurs therebetween.

[0179] The sensor control device 5002 may further include a sensor 5010 (partially visible) and a sharp 5012 (partially visible) that is used to aid in transdermal delivery of the sensor 5010 beneath the skin of a user during application of the sensor control device 5002. As shown, corresponding portions of the sensor 5010 and sharp 5012 extend distally from a bottom (e.g., mount 5008) of the electronics housing 5004. The sharp 5012 may include a sharp hub 5014 configured to securely carry it. As can be seen most clearly in FIG. 18B, the sharp hub 5014 may include or otherwise define a mating member 5016. To couple the sharp 5012 to the sensor control device 5002, the sharp 5012 may be advanced axially through the electronics housing 5004 until the sharp hub 5014 engages an upper surface of the shell 5006 and the mating member 5016 extends distally from the bottom of the mount 5008. When the sharp 5012 penetrates the electronics housing 5004, the exposed portion of the sensor 5010 can be received within the hollow or recessed (arcuate) portion of the sharp 5012. The remainder of the sensor 5010 is positioned within the electronics housing 5004.

[0180] The sensor control device 5002 may further include a sensor cap 5018, which is shown exploded or separated from the electronics housing 5004 in FIGS. 18A-18B. The sensor cap 5016 may be removably coupled to the sensor control device 5002 (e.g., the electronics housing 5004) at or near the bottom of the mount 5008. The sensor cap 5018 may help provide a hermetic barrier surrounding exposed portions of the sensor 5010 and the sharps 5012 to protect against gas chemical sterilization. As shown, the sensor cap 5018 may include a generally cylindrical body having a first end 5020a and an opposing second end 5020b. The first end 5020a may be open to provide access into an interior chamber 5022 defined within the body. In contrast, the second end 5020b may be closed and may provide or otherwise define an engagement feature 5024. As described herein, the engagement features 5024 can aid in mating the sensor cap 5018 to a cap (e.g., applicator cap 708 of FIG. 3B) of a sensor applicator (e.g., sensor applicator 150 of FIGS. 1 and 3A-3G) and can aid in removing the sensor cap 5018 from the sensor control device 5002 when the cap is removed from the sensor applicator.

[0181] The sensor cap 5018 can be removably coupled to the electronics housing 5004 at or near the bottom of the mount 5008. More specifically, the sensor cap 5018 can be removably coupled to a mating member 5016 that extends distally from the bottom of the mount 5008. In at least one embodiment, for example, the mating member 5016 can define a set of male threads 5026a (FIG. 18B) that can mate with a set of female threads 5026b (FIG. 18A) defined by the sensor cap 5018. In some embodiments, the male and female threads 5026a, 5026b can include a flat thread design (e.g., lacking a helical curvature), which can prove advantageous for molding these parts. Alternatively, the male and female threads 5026a, 5026b can form a helical threaded engagement. Thus, the sensor cap 5018 can be threadably coupled to the sensor control device 5002 with the mating member 5016 of the Sharp hub 5014. In other embodiments, the sensor cap 5018 can be removably coupled to the mating member 5016 by other types of engagement including, but not limited to, an interference or friction fit, or a frangible member or material that can be broken with a small separation force (e.g., axial or rotational force).

[0182] In some embodiments, the sensor cap 5018 may include a monolithic (single) structure extending between the first end 5020a and the second end 5020b. However, in other embodiments, the sensor cap 5018 may include two or more component parts. In the illustrated embodiment, for example, the sensor cap 5018 may include a sealing ring 5028 positioned at the first end 5020a and a desiccant cap 5030 positioned at the second end 5020b. The sensor cap 5018 may at least partially define a sensor cap chamber 5022, also referred to herein as the inner chamber 2022. The sensor cap chamber (inner chamber) 5022 may be generally enclosed within a hermetically sealed chamber defined by the housing 20702 and the applicator cap 20708. The sealing ring 5028 may be configured to help seal the inner chamber 5022, as described in more detail below. The inner chamber 5022 may be hermetically sealed. In at least one embodiment, the sealing ring 5028 can include an elastomeric O-ring. Additionally or alternatively, the sealing ring 5028 can include rubber, silicone, silicone-polyurethane hybrid, polyurethane, polysulfide, latex, styrene-butadiene, and / or flexible plastic. Additionally or alternatively, the sealing ring 5028 can include a material having a durometer hardness of about 5 Shore A to about 80 Shore A. The desiccant cap 5030 can house or include a desiccant that helps maintain a preferred humidity level within the inner chamber 5022. Additionally, the desiccant cap 5030 can define or otherwise provide an engagement feature 5024 for the sensor cap 5018.

[0183] In some embodiments, the sensor cap 5018 can include the capture material 5018A described above. The capture material can be separate from or incorporated into the sensor cap 5018. In certain embodiments, the capture material can be a separate component disposed within a hermetically sealed chamber formed between the sensor cap 5018 and the electronics housing 5004. For example, the capture material can take the form of a stick, powder, patch, or pouch disposed within the sensor cap 5018. Additionally or alternatively, the capture material 5018A can be glued within the sensor cap 5018 as shown in FIG. 20C. In other embodiments, the sensor cap 5018 can be formed entirely from the capture material. In other embodiments, the capture material can be combined with one or more polymeric materials to form a mixture, which can be molded to form the sensor cap. In still other embodiments, the capture material can be a coating or resin applied to all or a portion of the sensor cap 5018.

[0184] 19A and 19B(i) are exploded isometric top and bottom views, respectively, of a sensor control device 5002 according to one or more embodiments. The shell 5006 and mount 5008 act as opposing clamshell halves that encapsulate or otherwise substantially encapsulate various electronic components of the sensor control device 5002. More specifically, the electronic components may include, but are not limited to, a printed circuit board (PCB), one or more resistors, transistors, capacitors, inductors, diodes, and switches. A data processing unit and a battery may be mounted on the PCB or may otherwise interact with the PCB. The data processing unit may include, for example, an application specific integrated circuit (ASIC) configured to perform one or more functions or routines related to the operation of the sensor control device 3702. More specifically, the data processing unit may be configured to perform data processing functions, where such functions may include, but are not limited to, filtering and encoding a plurality of data signals each corresponding to a sampled analyte level of a user. The data processing unit may further include or otherwise communicate with an antenna for communicating with the reader device 120 (FIG. 1). The battery may provide power to the sensor control device 5002, and more specifically, to the electronic components of the PCB. For example, the battery may be any battery known to those skilled in the art, such as a coin cell battery or a button battery as shown in FIG. 19C. In certain embodiments, the battery 1900 may include a silver oxide battery. The battery 1900 may be laser welded to the PCB and positioned to ensure that the outer diameter of the battery remains within the perimeter of the PCB. In some embodiments, the battery 1900 may be connected to the PCB using a negative battery tab 1900a and a positive battery tab 1900b.For example, the negative battery tab 1900a of the battery 1900 can be substantially planar and in the same plane as the negative terminal of the battery 1900, whereas the positive battery tab 1900b can include one or more bends such that one end of the positive terminal 1900b is in contact with and in the same plane as the positive battery tab, while a second end configured to couple to the PCB is in the same plane as the negative battery tab 1900a. Additionally, the battery 1900 can be placed in a battery opening on the PCB to eliminate electrical interference between the negative battery tab 1900a and the PCB. Although not shown, the sensor control device 5002 can further include an adhesive patch that can be provided on the bottom 5102 (FIG. 19B(i)) of the mount 5008 and can help adhere the sensor control device 5002 to the skin of a user for use.

[0185] The sensor control device 5002 may provide or otherwise include a sealed subassembly including, among other component parts, a shell 5006, a sensor 5010, sharps 5012, and a sensor cap 5018. The sealed subassembly of the sensor control device 5002 may help isolate the sensor 5010 and sharps 5012 within an inner chamber 5022 (FIG. 19A) of the sensor cap 5018 during a gas chemical sterilization process that could otherwise adversely affect chemical agents disposed on the sensor 5010.

[0186] The sensor 5010 can include a tail portion 5104 that extends from an opening 5106 ( FIG. 19B(i) ) defined in the mount 5008 for transdermal reception beneath the skin of the user. The tail portion 5104 can have an enzyme or other chemical agent included thereon to help facilitate analyte monitoring. The sharp 5012 can include a sharp tip 5108 extendable through an opening 5110 ( FIG. 19A ) defined by the shell 5006, which opening 5110 can be coaxially aligned with the opening 5106 of the mount 5008. When the sharp tip 5108 penetrates the electronics housing 5004, the tail portion 5104 of the sensor 5010 can be received within a hollow or recessed portion of the sharp tip 5108. As specifically shown herein, the sharp tip 5108 can penetrate the electronics housing 5004, with the sharp tip 5108 being received through the opening 5110. The sharp tip 5108 can be configured to pierce the skin while carrying the tail portion 5104, bringing the active chemical agent of the tail 5104 into contact with bodily fluids.

[0187] The sharp tip 5108 can be advanced through the electronics housing 5004 until the sharp hub 5014 engages the top surface of the shell 5006 and the mating member 5016 extends from the opening 5106 in the bottom 5102 of the mount 5008. In some embodiments, a sealing member (not shown), such as an O-ring or sealing ring, can be sandwiched between the sharp hub 5014 and the top surface of the shell 5006 to help seal the interface between these two components. In some embodiments, the sealing member can include a separate component part, or alternatively, can form an integral part of the shell 5006, such as a co-molded or overmolded component part.

[0188] The sealing subassembly may further include a collar 5112 positioned within the electronics housing 5004 and extending at least partially into the opening 5106. The collar 5112 may be a generally annular structure defining or otherwise providing an annular ridge 5114 on an upper surface thereof. In some embodiments, as shown, a groove 5116 may be defined within the annular ridge 5114, which may be configured to house or otherwise receive a portion of the sensor 5010 that extends laterally within the electronics housing 5004.

[0189] When assembling the sealing subassembly, the bottom 5118 of the collar 5112 can be exposed at the opening 5106, and the bottom 5118 can sealingly engage the first end 5020a of the sensor cap 5018, and more specifically, the sealing ring 5028. In contrast, the annular ridge 5114 on the top of the collar 5112 can sealingly engage an inner surface (not shown) of the shell 5006. In at least one embodiment, a seal member (not shown) can be sandwiched between the annular ridge 5114 and the inner surface of the shell 5006 to form a sealing interface. In such an embodiment, the seal member can extend (flow) into a groove 5116 defined in the annular ridge 5114, thereby sealing around the sensor 5010 extending laterally within the electronics housing 5004. The seal member can include, for example, an adhesive, a gasket, or an ultrasonic weld, and can help isolate enzymes and other chemical agents contained on the tail portion 5104.

[0190] As embodied in more detail herein, the sensor control device 5002 can include a sensor sleeve 5119. Referring to FIG. 19B(ii), the sensor sleeve 5119 can define a tube and can surround the tail portion 5104 of the sensor 5010. For example, as embodied herein, the sensor sleeve 5119 can surround the tail portion 5104 within the sensor cap 5018. Additionally or alternatively, the sensor sleeve can partially surround the tail portion 5104 of the sensor 5010. As embodied herein, the sensor tail portion 5104 can have a length and the sensor sleeve 5119 can surround the tail portion 5104 along the length of the tail portion 5104.

[0191] Additionally or alternatively, as more particularly shown herein, the sensor sleeve 5119 can be disposed proximate to the tail portion 5104. For purposes of illustration, as particularly shown herein, the tail portion 5104 can be received within a hollow or recessed portion of the sharp 5012, and the sensor sleeve 5119 can be immediately adjacent to the tail portion 5104 and the sharp 5012.

[0192] The sensor sleeve 5119 can be disposed within the sensor cap 5018 in any suitable manner. For example, as specifically shown herein, the sensor sleeve 5119 can be interfaced with an elastomeric plug 5120. Additionally or alternatively, the sensor sleeve 5119 can be secured within the sensor cap 5018 using an adhesive. The sensor sleeve 5119 can include a capture material, as described in more detail herein. The sensor sleeve 5119 can be formed to include the capture material using any of the techniques described herein. For example, the sensor sleeve 5119 can be manufactured of a thermoplastic combined with the capture material. Additionally or alternatively, the sensor sleeve 5119 can be manufactured entirely of the capture material or the capture material can be overmolded onto another material, such as polycarbonate, to form the sensor sleeve 5119. Additionally or alternatively, the sensor sleeve 5119 can include a desiccant, either alone or in combination with the capture material. As described in more detail herein, the scavenging material can be, for example, activated carbon, silica gel, molecular sieves, and / or combinations thereof.

[0193] As described in more detail herein, the scavenging material can be included in additional or alternative components of the system. Referring to FIG. 19(B)(iii), the sensor cap 5018 can include a sensor cap base 5018B with a flexible seal 5018C overmolded thereon. The sensor cap base and the flexible seal can be formed of any suitable material. For example, as specifically shown herein, the sensor cap base 5018B can be formed of polycarbonate, and silicone can be overmolded onto the polycarbonate to form the flexible seal 5018C. Additionally or alternatively, the flexible seal 5018C can include rubber, silicone-polyurethane hybrid, polyurethane, polysulfide, latex, styrene-butadiene, and / or flexible plastic. Additionally or alternatively, the flexible seal 5018C can include a material having a durometer hardness of about 5 Shore A to about 80 Shore A. As described in more detail herein, the capture material may be combined with the sensor cap base material, the flexible seal material, or both.

[0194] According to aspects of the presently disclosed subject matter, the capture material can be disposed within the electronics housing 5004. For example, referring to FIG. 19(B)(iv), the collar 5112 can include the capture material. As embodied herein, the collar 5112 can at least partially surround the sensor 5010 and the sensor tail portion 5104. As embodied herein, the collar 5112 can include a collar base 5121 having a flexible seal 5122 overmolded thereon. The collar base and the flexible seal can be formed of any suitable material. For example, as embodied herein, the collar base 5121 can be formed of polycarbonate, and silicone can be overmolded onto the polycarbonate to form the flexible seal 5122. Additionally or alternatively, the flexible seal 5122 can include rubber, silicone-polyurethane hybrid, polyurethane, polysulfide, latex, styrene-butadiene, and / or flexible plastic. Additionally or alternatively, the flexible seal 5122 can include a material having a durometer hardness of about 5 Shore A to about 80 Shore A. As described in more detail herein, the acquisition material can be combined with the color base material, the flexible seal material, or both.

[0195] 20A is a cross-sectional side view of an assembled seal subassembly 5200 according to one or more embodiments. The seal subassembly 5200 may form a portion of the sensor control device 5002 of FIGS. 18A-18B and 19A-19B and may include portions of the shell 5006, the sensor 5010, the sharp 5012, the sensor cap 5018, and the collar 5112. The seal subassembly 5200 may be assembled in a variety of ways. In one assembly process, the sharp 5012 may be coupled to the sensor control device 5002 by extending the sharp tip 5108 through an opening 5110 defined in a top portion of the shell 5006 and advancing the sharp 5012 through the shell 5006 until the sharp hub 5014 engages the top portion of the shell 5006 and the mating member 5016 extends distally from the shell 5006. In some embodiments, as described above, a sealing member 5202 (e.g., an O-ring or sealing ring) can be sandwiched between the sharp hub 5014 and the top surface of the shell 5006 to help seal the interface between these two components.

[0196] The collar 5112 may then be received over (and around) the mating member 5016 and advanced toward the inner surface 5204 of the shell 5006 to allow the annular ridge 5114 to engage the inner surface 5204. The seal member 5206 may be sandwiched between the annular ridge 5114 and the inner surface 5204, thereby forming a sealed interface. The seal member 5206 may extend (flow) into a groove 5116 (FIGS. 19A-20B) defined in the annular ridge 5114, thereby sealing around the sensor 5010 extending laterally within the electronics housing 5004 (FIGS. 19A-20B). However, in other embodiments, the collar 5112 may first be sealed to the inner surface 5204 of the shell 5006, followed by the extension of the sharps 5012 and sharps hub 5014 through the opening 5110 as described above.

[0197] The sensor cap 5018 can be removably coupled to the sensor control device 5002 by threadably mating the female threads 5026b of the sensor cap 5018 with the male threads 5026a of the fitting member 5016. Tightening (rotating) the mating engagement between the sensor cap 5018 and the fitting member 5016 can urge the first end 5020a of the sensor cap 5018 into sealing engagement with the bottom 5118 of the collar 5112. Additionally, tightening the mating engagement between the sensor cap 5018 and the fitting member 5016 can enhance the sealing interface between the sharp hub 5014 and the top of the shell 5006 and between the annular ridge 5114 and the inner surface 5204 of the shell 5006.

[0198] The inner chamber 5022 may be sized and otherwise configured to receive the tail portion 5104 and the sharp tip 5108. Additionally, the inner chamber 5022 may be sealed to isolate the tail portion 5104 and the sharp tip 5108 from substances that may adversely interact with the chemical agents of the tail portion 5104. In some embodiments, a desiccant 5208 (shown in dashed lines) may be present within the inner chamber 5022 to maintain the proper humidity level.

[0199] Once properly assembled, the sealed subassembly 5200 can be subjected to any of the radiation sterilization processes mentioned herein to properly sterilize the sensor 5010 and the sharps 5012. This sterilization step can be performed on the remainder of the sensor control device (FIGS. 18A-18B and 19A-20B) to prevent damage to sensitive electrical components. The sealed subassembly 5200 can be provided with radiation sterilization before or after coupling the sensor cap 5018 to the sharps hub 5014. When sterilized after coupling the sensor cap 5018 to the sharps hub 5014, the sensor cap 5018 can be made of a material that allows the penetration of radiation. In some embodiments, the sensor cap 5018 can be transparent or translucent, but can otherwise be opaque without departing from the scope of this disclosure.

[0200] 21A-21C are step-by-step cross-sectional side views illustrating the assembly of a sensor applicator 102 and a sensor control device 5002 according to one or more embodiments. Once the sensor control device 5002 is fully assembled, it can be installed within the sensor applicator 102. With reference to FIG. 21A, the sharps hub 5014 can include or otherwise define hub snap tabs 5302 configured to assist in coupling the sensor control device 5002 to the sensor applicator 102. More specifically, the sensor control device 5002 can be advanced into the sensor applicator 102 and the hub snap tabs 5302 can be received by corresponding arms 5304 of a sharps carrier 5306 positioned within the sensor applicator 102.

[0201] 21B shows the sensor control device 5002 received by the sharps carrier 5306, and thus secured within the sensor applicator 102. With the sensor control device 5002 loaded into the sensor applicator 102, the applicator cap 210 can be coupled to the sensor applicator 102. In some embodiments, the applicator cap 210 and housing 208 can have a set of opposing matable threads 5308 that allow the applicator cap 210 to be threaded onto the housing 208 in a clockwise (or counterclockwise) direction, thereby securing the applicator cap 210 to the sensor applicator 102.

[0202] As illustrated, a sheath 212 is further positioned within the sensor applicator 102, which can include a sheath locking mechanism 5310 configured to ensure that the sheath 212 does not prematurely collapse during an impact event. In the illustrated embodiment, the sheath locking mechanism 5310 can provide a threaded engagement between the applicator cap 210 and the sheath 212. More specifically, one or more female threads 5312a can be defined or otherwise provided on an inner surface of the applicator cap 210, and one or more male threads 5312b can be defined or otherwise provided on the sheath 212. The female threads 5312a and male threads 5312b can be configured to threadably mate when the applicator cap 210 is threadedly engaged with the sensor applicator 102 via threads 5308. The female and male threads 5312 a , 5312 b can have the same thread pitch as the threads 5308 that allow the applicator cap 210 to be screwed onto the housing 208 .

[0203] 21C shows the applicator cap 210 fully threadedly coupled to the housing 208. As shown, the applicator cap 210 may further provide or otherwise define a cap post 5314 centrally located therein and extending proximally from a bottom thereof. The cap post 5314 may be configured to receive at least a portion of the sensor cap 5018 when the applicator cap 210 is threaded onto the housing 208.

[0204] With the sensor control device 5002 loaded into the sensor applicator 102 and the applicator cap 210 properly secured, the sensor control device 5002 can then be subjected to a gas chemical sterilization configured to sterilize its electronics housing 5004 and any other exposed portions. Because the sensor 5010 and distal portion of the sharps 5012 are sealed within the sensor cap 5018, the chemicals used during the gas chemical sterilization process cannot interact with the enzymes, chemical and biological agents provided on the in vivo portion 5104, as well as other sensor components, such as membrane coatings that regulate analyte inflow.

[0205] In some embodiments, the applicator cap 210 and the housing 208 may be gas impermeable such that an airtight sealed chamber is formed between them.

[0206] In some embodiments, the applicator cap 210 can include a capture material as described above. The capture material can be separate from or incorporated into the applicator cap 210. In certain embodiments, the capture material can be a separate component disposed within a hermetically sealed chamber formed between the applicator cap 210 and the housing 208. In other embodiments, the applicator cap 210 can be formed entirely from the capture material. In other embodiments, the capture material can be combined with one or more polymeric materials to form a mixture, and the mixture can be molded to form the applicator cap 210. In still other embodiments, the capture material can be a coating or resin applied to all or a portion of the applicator cap 210.

[0207] 22A and 22B are perspective and top views, respectively, of a cap post 5314 in accordance with one or more additional embodiments. In the depicted depiction, a portion of a sensor cap 5018 is received within the cap post 5314, and more specifically, a desiccant cap 5030 of the sensor cap 5018 is disposed within the cap post 5314.

[0208] As shown, the cap post 5314 can define a receiver feature 5402 configured to receive the engagement feature 5024 of the sensor cap 5018 when the applicator cap 210 ( FIG. 21C ) is coupled (e.g., threaded) to the sensor applicator 102 ( FIGS. 21A-21C ). However, when the applicator cap 210 is removed from the sensor applicator 102, the receiver feature 5402 can prevent the engagement feature 5024 from reversing direction, thereby preventing the sensor cap 5018 from separating from the cap post 5314. Conversely, removing the applicator cap 210 from the sensor applicator 102 simultaneously detaches the sensor cap 5018 from the sensor control device 5002 (Figures 18A-18B and 21A-21C), thereby exposing the sensor 5010 (Figures 21A-21C) and distal portions of the sharps 5012 (Figures 21A-21C).

[0209] Many design variations of the receiver feature 5402 can be used without departing from the scope of this disclosure. In the illustrated embodiment, the receiver feature 5402 includes one or more flexible members 5404 (two shown) that are expandable or flexible to receive an engagement feature 5024 (FIGS. 18A-18B). The engagement feature 5024 can include, for example, an enlarged head, and the flexible members 5404 can include a collet-type device that includes a plurality of flexible fingers configured to flex radially outward to receive the enlarged head.

[0210] The flexible member 5404 may further provide or otherwise define a corresponding ramp surface 5406 configured to interact with one or more opposing cam surfaces 5408 provided on an outer wall of the engagement feature 5024. The configuration and alignment of the ramp surface 5406 and the opposing cam surface 5408 is such that the applicator cap 210 can rotate in a first direction A (e.g., clockwise) relative to the sensor cap 5018, but when the applicator cap 210 is rotated in a second direction B (e.g., counterclockwise), the cap post 5314 locks against the sensor cap 5018. More specifically, when the applicator cap 210 (and thus the cap post 5314) rotates in the first direction A, the cam surface 5408 engages the ramp surface 5406, which engagement urges the flexible member 5404 to bend radially outward or otherwise deflect, providing a ratcheting effect. However, rotating the applicator cap 210 (and thus the cap post 5314) in the second direction B drives the inclined surface 5410 of the cam surface 5408 into the opposing inclined surface 5412 of the ramp surface 5406, thereby causing the sensor cap 5018 to adhere to the flexible member 5404.

[0211] 23 is a cross-sectional side view of a sensor control device 5002 disposed within an applicator cap 210 according to one or more embodiments. As shown, an opening to the receiver feature 5402 presents a first diameter D3, whereas an engagement feature 5024 of the sensor cap 5018 provides a second diameter D4 that is larger than the first diameter D3 and larger than the outer diameter of the remainder of the sensor cap 5018. When the sensor cap 5018 extends into the cap post 5314, the flexible member 5404 of the receiver feature 5402 can bend (expand) radially outward to accommodate the engagement feature 5024. In some embodiments, as shown, the engagement feature 5024 can provide or otherwise define a sloped or frusto-conical outer surface that helps bias the flexible member 5404 radially outward. Once the engagement feature 5024 advances beyond the receiver feature 5402 , the flexible member 5404 can bend back to (or towards) its natural state, thereby locking the sensor cap 5018 within the cap post 5314 .

[0212] As the applicator cap 210 is threaded (twisted onto) the housing 208 (FIGS. 21A-21C) in a first direction A, the cap post 5314 rotates correspondingly in the same direction, gradually introducing the sensor cap 5018 into the cap post 5314. As the cap post 5314 rotates, the ramped surface 5406 of the flexible member 5404 ratchets against the opposing cam surface 5408 of the sensor cap 5018. This continues until the applicator cap 210 is fully threaded (screwed) onto the housing 208. In some embodiments, the ratcheting may occur for two full rotations of the applicator cap 210 before the applicator cap 210 reaches its final position.

[0213] To remove the applicator cap 210, the applicator cap 210 is rotated in the second direction B, causing the cap post 5314 to correspondingly rotate in the same direction, such that the cam surface 5408 (i.e., the inclined surface 5410 in FIGS. 22A-22B ) locks it against the ramp surface 5406 (i.e., the inclined surface 5412 in FIGS. 22A-22B ). As a result, continued rotation of the applicator cap 210 in the second direction B causes the sensor cap 5018 to correspondingly rotate in the same direction, thereby unscrewing from the mating member 5016 and allowing the sensor cap 5018 to detach from the sensor control device 5002. Decoupling the sensor cap 5018 from the sensor control device 5002 exposes the distal portions of the sensor 5010 and the sharps 5012, thus placing the sensor control device 5002 in a defined position for firing (use).

[0214] 24A and 24B are cross-sectional side views of a sensor applicator 102 ready to deploy a sensor control device 5002 at a target monitoring location according to one or more embodiments. More specifically, FIG. 24A illustrates the sensor applicator 102 ready to deploy (fire) the sensor control device 5002, and FIG. 24B illustrates the sensor applicator 102 in the process of deploying (fire) the sensor control device 5002. As shown, the applicator cap 210 (FIGS. 21A-21C and 23) is removed and correspondingly the sensor cap 5018 (FIGS. 21A-21C and 23) is disconnected (removed), thereby exposing the tail portion 5104 of the sensor 5010 and the sharp tip 5108 of the sharp 5012, as described above. With respect to the sheath 212 and the sharps carrier 5306 , the sensor applicator 102 further includes a sensor carrier 5602 (alternatively referred to as a “puck” carrier) that helps position and secure the sensor control device 5002 within the sensor applicator 102 .

[0215] 24A, as shown, the sheath 212 includes one or more sheath arms 5604 (one shown) configured to interact with one or more corresponding detents 5606 (one shown) defined within the housing 208. Alternatively, the detents 5606 are referred to as "firing" detents. When the sensor control device 5002 is initially installed within the sensor applicator 102, the sheath arms 5604 may be received within the detents 5606, thereby placing the sensor applicator 102 in a fired position. In the fired position, the engagement member 5016 extends distally beyond the bottom of the sensor control device 5002. As discussed below, the process of firing the sensor applicator 102 retracts the engagement member 5016 from contacting the user's skin.

[0216] The sensor carrier 5602 may further include one or more carrier arms 5608 (one shown) configured to interact with a corresponding one or more grooves 5610 (one shown) defined on the sharps carrier 5306. A spring 5612 may be positioned within a cavity defined by the sharps carrier 5306, and the spring 5612 may passively bias the sharps carrier 5306 upwardly within the housing 208. However, when the carrier arm 5608 is properly received within the groove 5610, the sharps carrier 5306 is maintained in a defined position and prevented from moving upwardly. The carrier arm 5608 is sandwiched between the sheath 212 and the sharps carrier 5306, and a radial shoulder 5614 defined on the sheath 212 may be sized to maintain the carrier arm 5608 engaged within the groove 5610, thereby maintaining the sharps carrier 5306 in a defined position.

[0217] In FIG. 24B, the sensor applicator 102 is in the firing process. As discussed herein with reference to FIGS. 3F-3G, this firing 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 on the sensor applicator 102 against the skin can cause the sheath arms 5604 to disengage from the corresponding detents 5606, thereby allowing the sheath 212 to collapse into the housing 208. As the sheath 212 begins to collapse, the radial shoulder 5614 eventually disengages from radial engagement with the carrier arm 5608, thereby allowing the carrier arm 5608 to disengage from the groove 5610. The passive spring force of the spring 5612 is then free to push the sharps carrier 5306 upward, thereby forcing the carrier arm 5608 out of engagement with the groove 5610, thereby allowing the sharps carrier 5306 to move slightly upward within the housing 208. In some embodiments, fewer coils may be incorporated into the design of the spring 5612 in increasing the spring force required to overcome engagement between the carrier arm 5608 and the groove 5610. In at least one embodiment, one or both of the carrier arm 5608 and the groove 5610 may be angled to help facilitate easier disengagement.

[0218] As the sharps carrier 5306 moves upward within the housing 208, the sharps hub 5014 can move correspondingly in the same direction, which can result in a partial retraction of the mating member 5016 such that the mating member 5016 is flush, substantially flush, or near-flush with the bottom of the sensor control device 5002. As will be appreciated, such flushness ensures that the mating member 5016 does not come into contact with the user's skin, which could otherwise adversely affect sensor insertion, or cause undue pain, or prevent an adhesive patch (not shown) positioned on the bottom of the sensor control device 5002 from properly adhering to the skin.

[0219] 25A-25C are step-by-step cross-sectional side views illustrating assembly and disassembly of an alternative embodiment of a sensor applicator 102 and a sensor control device 5002 in accordance with one or more additional embodiments. As generally described above, the fully assembled sensor control device 5002 can be loaded into the sensor applicator 102 by coupling the hub snap prongs 5302 into the arms 5304 of a sharps carrier 5306 positioned within the sensor applicator 102.

[0220] In the illustrated embodiment, the sheath arm 5604 of the sheath 212 can be configured to interact with a first detent 5702a and a second detent 5702b defined within the housing 208. The first detent 5702a may alternatively be referred to as a "locking" detent and the second detent 5702b may alternatively be referred to as a "firing" detent. When the sensor control device 5002 is initially installed within the sensor applicator 102, the sheath arm 5604 may be received within the first detent 5702a. As described below, the sheath 212 may be actuated to move the sheath arm 5604 to the second detent 5702b, thereby placing the sensor applicator 102 in a fired position.

[0221] 25B, applicator cap 210 is aligned with and advanced toward housing 208 such that sheath 212 is received within applicator cap 210. Instead of rotating applicator cap 210 relative to housing 208 to couple applicator cap 210 to housing 208, threads of applicator cap 210 can be snapped onto corresponding threads of housing 208. Axial breaks or slots 5703 (one shown) defined in applicator cap 210 can allow a portion of applicator cap 210 proximate its threads to flex outwardly and be snapped into threaded engagement with housing 208. As applicator cap 210 is snapped onto housing 208, sensor cap 5018 can correspondingly be snapped into cap post 5314.

[0222] 21A-21C , the sensor applicator 102 can include a sheath locking mechanism configured to ensure that the sheath 212 does not prematurely collapse during an impact event. In the illustrated embodiment, the sheath locking mechanism includes one or more ribs 5706 (two shown) defined near a base of the sheath 212 and near a base of the applicator cap 210, and one or more ribs 5704 (one shown) configured to interact with a shoulder 5708. The rib 5704 can be configured to engage between the rib 5706 and the shoulder 5708 while attaching the applicator cap 210 to the housing 208. More specifically, once applicator cap 210 is snapped onto housing 208, applicator cap 210 can be rotated (e.g., clockwise) such that rib 5704 of sheath 212 is positioned between rib 5706 and shoulder 5708 of applicator cap 210, which "locks" applicator cap 210 in place until a user counter-rotates applicator cap 210 to remove it for use. Engagement of rib 5704 between rib 5706 and shoulder 5708 of applicator cap 210 can prevent sheath 212 from prematurely collapsing.

[0223] In Figure 25C, the applicator cap 210 has been removed from the housing 208. As with the embodiment of Figures 21A-21C, the applicator cap 210 can be removed by counter-rotating it, which correspondingly rotates the cap post 5314 in the same direction, unscrewing the sensor cap 5018 from the mating member 5016, as generally described above. Additionally, disconnecting the sensor cap 5018 from the sensor control device 5002 exposes the distal portions of the sensor 5010 and sharps 5012.

[0224] When the applicator cap 210 is twisted off of the housing 208, a rib 5704 defined on the sheath 212 can slidingly engage an upper portion of a rib 5706 defined on the applicator cap 210. The upper portion of the rib 5706 can provide a corresponding ramp surface that causes an upward displacement of the sheath 212 when the applicator cap 210 is rotated, this upward movement of the sheath 212 bending the sheath arm 5604 out of engagement with the first detent 5702a and into receipt in the second detent 5702b. As the sheath 212 moves to the second detent 5702b, the radial shoulder 5614 disengages from radial engagement with the carrier arm 5608, thereby allowing the passive spring force of the spring 5612 to push the sharp carrier 5306 upward, forcing the carrier arm 5608 out of engagement with the groove 5610. As the sharps carrier 5306 moves upward within the housing 208, the engaging member 5016 can correspondingly retract until it is flush, substantially flush, or near-flush with the bottom of the sensor control device 5002. At this point, the sensor applicator 102 is in the fired position. Thus, in this embodiment, removing the applicator cap 210 correspondingly retracts the engaging member 5016.

[0225] 26A is an isometric bottom view of the housing 208 according to one or more embodiments. As shown, one or more longitudinal ribs 5802 (four shown) may be defined within the housing 208. The ribs 5802 may be spaced equidistantly or unequally spaced from one another and may extend substantially parallel to a centerline of the housing 208. First and second detents 5702a, 5702b may be defined on one or more of the longitudinal ribs 5802.

[0226] 27A is an isometric bottom view of the housing 208 having the sheath 212 and other components at least partially positioned therein. As shown, the sheath 212 can provide or otherwise define one or more longitudinal slots 5804 configured to mate with longitudinal ribs 5802 of the housing 208. As generally described above, when the sheath 212 collapses into the housing 208, the ribs 5802 can be received within the slots 5804 to help maintain the sheath 212 aligned with the housing during movement of the sheath 212. As will be appreciated, this reception can result in tighter circumferential and radial alignment within the same dimensional and tolerance constraints as the housing 208.

[0227] In the illustrated embodiment, the sensor carrier 5602 can be configured to hold the sensor control device 5002 in place axially (e.g., after the sensor cap 5018 has been removed) and circumferentially therewith. To achieve this retention, the sensor carrier 5602 can include or otherwise define one or more support ribs 5806 and one or more flexible arms 5808. The support ribs 5806 extend radially inward to provide radial support to the sensor control device 5002. The flexible arms 5808 can extend partially around the circumference of the sensor control device 5002 and receive ends of the flexible arms 5808 within corresponding grooves 5810 defined in the sides of the sensor control device 5002. Thus, the flexible arms 5808 may be able to provide both axial and radial support to the sensor control device 5002. In at least one embodiment, the end of the flexible arm 5808 is biased into a groove 5810 in the sensor control device 5002 and can be locked into place by a corresponding sheath locking rib 5812 otherwise provided by the sheath 212.

[0228] In some embodiments, the sensor carrier 5602 may be ultrasonically welded to the housing 208 at one or more points 5814. However, in other embodiments, the sensor carrier 5602 may instead be coupled to the housing 208 by a snap fit engagement without departing from the scope of the present disclosure. This may help hold the sensor control device 5002 in place during transport and firing.

[0229] 28 is an enlarged cross-sectional side view of a sensor applicator 102 having a sensor control device 5002 mounted thereon according to one or more embodiments. As discussed above, the sensor carrier 5602 can include one or more carrier arms 5608 (two shown) engageable with the sharps carrier 5306 in corresponding grooves 5610. In at least one embodiment, the grooves 5610 can be defined by a pair of protrusions 5902 defined on the sharps carrier 5306. Receiving the carrier arms 5608 within the grooves 5610 can help stabilize the sharps carrier 5306 from undesired tilting during all stages of retraction (firing).

[0230] In the illustrated embodiment, the arms 5304 of the Sharp carrier 5306 can be made stiff enough to provide greater control over the radial and biaxial motion of the Sharp hub 5014. In some embodiments, relative control of the height of the Sharp hub 5014 may be more critical to the design, for example, so that the clearance between the Sharp hub 5014 and the arms 5304 can be more tightly constrained in both axial directions.

[0231] In the illustrated embodiment, the sensor carrier 5602 defines or otherwise provides a central boss 5904 sized to receive the Sharp hub 5014. In some embodiments, as shown, the Sharp hub 5014 can be provided with one or more radial ribs 5906 (two shown). In at least one embodiment, the inner diameter of the central boss 5904 helps provide radial and tilt support to the Sharp hub 5014 during the life of the sensor applicator 102 and through all phases of operation and assembly. Additionally, having multiple radial ribs 5906 increases the length to width ratio of the Sharp hub 5014, thereby further improving support against tilt.

[0232] 29A is an isometric top view of applicator cap 210 according to one or more embodiments. In the illustrated embodiment, two axial slots 5703 are shown separating an upper portion of applicator cap 210 near its threads. As discussed above, slots 5703 can aid applicator cap 210 in flexing outward to snap into engagement with housing 208 (FIG. 25B). In contrast, applicator cap 210 can be twisted off (unscrewed) from housing 208 by an end user.

[0233] FIG. 29A further illustrates ribs 5706 (one visible) defined by applicator cap 210. By interlocking with ribs 5704 (FIG. 25C) defined on sheath 212 (FIG. 25C), ribs 5706 can help lock sheath 212 in all directions to prevent premature collapse during an impact or drop event. Sheath 212 can be unlocked when a user twists applicator cap 210 off of the housing, as generally described above. As described herein, the top of each rib 5706 can provide a corresponding ramp surface 6002 that slideably engages with rib 5704 defined on sheath 212 as applicator cap 210 is rotated off of housing 208, resulting in upward displacement of sheath 212 into housing 208.

[0234] In some embodiments, additional features may be provided within applicator cap 210 to hold a desiccant component that maintains proper moisture levels over the shelf life. Such additional features may be snaps, posts for press fitting, heat staking, ultrasonic welding, or the like.

[0235] 29B is an enlarged cross-sectional view of the engagement between applicator cap 210 and housing 208 in accordance with one or more embodiments. As shown, applicator cap 210 can define a set of female threads 6004, and housing 208 can define a set of male threads 6006 engageable with female threads 6004. As described herein, applicator cap 210 can be snapped onto housing 208, which can be accomplished by advancing female threads 6004 axially past male threads 6006 in the direction shown by the arrow, thereby bending applicator cap 210 outward. To help facilitate this displacement, the corresponding surfaces 6008 of female and male threads 6004, 6006 can be curved, beveled, or chamfered, as shown. Corresponding flat surfaces 6010 can be provided on each thread 6004, 6006 and configured to matingly engage when applicator cap 210 is properly snapped into place on housing 208. These flat surfaces 6010 can slidingly engage one another when a user unscrews applicator cap 210 from housing 208.

[0236] The threaded engagement between the applicator cap 210 and the housing 208 provides a sealed engagement that protects the internal components from moisture, dust, and the like. In some embodiments, the housing 208 may define or otherwise provide a stabilizing feature 6012 configured to be received within a corresponding groove 1914 defined on the applicator cap 210. The stabilizing feature 6012 may help stabilize and stiffen the applicator cap 210 when it is snapped onto the housing 208. The stabilizing feature 6012 may prove advantageous by providing additional drop robustness to the sensor applicator 102. Additionally, the stabilizing feature 6012 may also help increase the removal torque of the applicator cap 210.

[0237] 30A and 30B are isometric views of a sensor cap 5018 and a collar 5112, respectively, according to one or more embodiments. Referring to FIG. 30A, in some embodiments, the sensor cap 5018 can include an injection molded portion. This can prove advantageous to mold the internal threads 5026a defined within the inner chamber 5022, as opposed to installing a threaded core or threading the inner chamber 5022. In some embodiments, one or more stop ribs 6102 (one visible) can be defined within the inner chamber 5022 to prevent overtravel of the sharp hub 5014 (FIGS. 18A-18B) relative to the mating member 5016.

[0238] 30A and 30B, in some embodiments, one or more protrusions 6104 (two shown) may be defined on the first end 5020a of the sensor cap 5018 and may be configured to mate with one or more corresponding recesses 6106 (two shown) defined on the collar 5112. However, in other embodiments, the protrusions 6104 may instead be defined on the collar 5112 and the recesses 6106 may instead be defined on the sensor cap 5018 without departing from the scope of the present disclosure.

[0239] The matable projections 6104 and recesses 6106 may prove advantageous in rotationally locking the sensor cap 5018 to prevent accidental twisting of the sensor cap 5018 from the collar 5112 (and thus from the sensor control device 5002) during the life of the sensor applicator 102 and throughout all phases of operation / assembly. In some embodiments, as shown, the recesses 6106 may be formed or otherwise defined in an approximately kidney bean shape. This shape may prove advantageous in allowing some over-rotation of the sensor cap 5018 relative to the collar 5112. Alternatively, the same benefit may be achieved by a flat-ended threaded engagement between the two parts.

[0240] The collar 5112 can include an acquisition material, as described in more detail herein. The collar 5112 can be manufactured from the acquisition material, or the acquisition material can be overmolded onto the collar 5112. For example, the collar 5112 can include a polycarbonate piece with silicone overmolded thereon. The polycarbonate piece and / or silicone can be combined with the acquisition material.

[0241] Embodiments disclosed herein include the following:

[0242] A. A sensor control device including an electronics housing, a sensor disposed within the electronics housing, the sensor having a tail portion extending from a bottom of the electronics housing, a sharp extending through the electronics housing, the sharp having a sharp tip extending from the bottom of the electronics housing, and a sensor cap removably coupled to the bottom of the electronics housing, the sensor cap defining a sealed inner chamber for receiving the tail portion and the sharp.

[0243] B. An analyte monitor system including a sensor applicator and a sensor control device disposed within the sensor applicator, the sensor control device including an electronics housing, a sensor disposed within the electronics housing, the sensor having a tail portion extending from a bottom of the electronics housing, a sharp extending through the electronics housing, the sharp having a tip extending from the bottom of the electronics housing, and a sensor cap removably coupled to the bottom of the electronics housing, the sensor cap defining an engagement feature, the tail portion, and a sealed inner chamber that receives the sharp. The analyte monitor system may further include a cap coupled to the sensor applicator, the cap providing a cap post that defines a receiver feature that receives the engagement feature when the cap is coupled to the sensor applicator, wherein removing the cap from the sensor applicator separates the sensor cap from the electronics housing, thereby exposing the tail portion and the tip of the sharp.

[0244] C. A method of preparing an analyte monitor system comprising mounting a sensor control device into a sensor applicator, the sensor control device including an electronics housing, a sensor disposed within the electronics housing, the sensor having a tail portion extending from a bottom of the electronics housing, a sharp extending through the electronics housing, the sharp having a tip extending from the bottom of the electronics housing, and a sensor cap removably coupled to the bottom of the electronics housing, the sensor cap defining a sealed inner chamber for receiving the tail portion and the sharp, the method further including securing the cap to the sensor applicator, sterilizing the sensor control device by gas chemical sterilization while the sensor control device is disposed within the sensor applicator, and isolating the tail portion and the tip of the sharp from the gas chemical sterilization in the inner chamber.

[0245] Each of embodiments A, B, and C may have one or more of the following additional elements in any combination: Element 1: the sensor cap includes a cylindrical body having a first end open to access the inner chamber and a second end opposite the first end providing an engagement feature engageable with a cap of a sensor applicator, whereby removal of the cap from the sensor applicator correspondingly removes the sensor cap from the electronics housing, thereby exposing the tail portion and the sharp tip. Element 2: the electronics housing includes a shell matable with the mount, the sensor control device further includes a sharp and sensor locator defined on an inner surface of the shell and a collar received thereabout, and the sensor cap is removably coupled to the collar. Element 3: the sensor cap is removably coupled to the collar by one or more of an interference fit, a threaded engagement, a frangible member, and a frangible material. Element 4: The annular ridge surrounding the sharp and the sensor locator and collar provides a column and an annular shoulder extending radially outward therefrom, with the seal member sandwiched between the annular shoulder and the annular ridge to form a sealing interface. Element 5: The annular ridge defines a groove, with a portion of the sensor seated in the groove and the seal member extending into the groove to seal around the portion of the sensor. Element 6: The seal member is a first seal member, and the sensor control device further includes a second seal member sandwiched between the annular shoulder and a portion of the mount to form a sealing interface. Element 7: The electronics housing includes a shell matable with the mount, the sensor control device further includes a sharp hub carrying the sharp and engageable with a top surface of the shell, and a mating member defined by the sharp hub and extending from a bottom of the electronics housing, and the sensor cap is removably coupled to the mating member. Element 8: Further includes a collar at least partially receivable within an opening defined in the mount and sealingly engaging the sensor cap with an inner surface of the shell. Element 9: A seal member is sandwiched between the collar and the inner surface of the shell to form a sealed interface.Element 10: The collar defines a groove, a portion of the sensor seats in the groove, and the seal member extends into the groove to seal around the portion of the sensor.

[0246] Element 11: the receiver feature includes one or more flexible members that flex to receive the engagement feature, the one or more flexible members preventing the engagement feature from slipping out of the cap post when the cap is removed from the sensor applicator. Element 12: further including a ramp surface defined on at least one of the one or more flexible members and one or more cam surfaces provided by the engagement feature and engageable with the ramp surface, the ramp surface and the one or more cam surfaces allowing the cap and cap post to rotate in a first direction relative to the sensor cap but preventing the cap and cap post from rotating in a second direction opposite the first direction relative to the sensor cap. Element 13: the electronics housing includes a shell matable with the mount, the sensor control device further includes a sharps hub carrying a sharp and engageable with a top surface of the shell, and a mating member defined by the sharps hub and extending from a bottom of the electronics housing, the sensor cap is removably coupled to the mating member, and the sensor cap is disengaged from the mating member by rotating the cap in the second direction. Element 14: The electronics housing includes a shell that is mateable with the mount, and the sensor control device further includes a sharp and sensor locator defined on an inner surface of the shell and a collar received therearound, and the sensor cap is removably coupled to the collar.

[0247] Element 15: The cap provides a cap post defining a receiver feature, the sensor cap defining an engagement feature, the method further comprising receiving the engagement feature by the receiver feature when the cap is secured to the sensor applicator. Element 16: The method further comprises removing the cap from the sensor applicator and engaging the engagement feature onto the receiver feature when the cap is removed, thereby decoupling the sensor cap from the electronics housing and exposing the tail portion and the sharp tip. Element 17: The step of sterilizing the tail and sharp tip by radiation sterilization and sealing the tail and sharp tip within the inner chamber precedes the step of loading the sensor control device into the sensor applicator.

[0248] As non-limiting examples, exemplary combinations applicable to A, B, and C include elements 2 and 3, elements 2 and 4, elements 4 and 5, elements 4 and 6, elements 7 and 8, elements 8 and 9, elements 9 and 10, elements 11 and 12, and elements 15 and 16.

[0249] Exemplary Embodiments of Seal Arrangements for Analyte Monitoring Systems 31A and 31B are side and isometric views, respectively, of an exemplary sensor control device 9102 in accordance with one or more embodiments of the present disclosure. The sensor control device 9102 may be similar in some respects to the sensor control device 102 of FIG. 1 and therefore may be best understood with reference thereto. Moreover, the sensor control device 9102 may replace the sensor control device 102 of FIG. 1 and therefore may be used in conjunction with the sensor applicator 102 of FIG. 1, which may deliver the sensor control device 9102 to a target monitor location on the user's skin.

[0250] As illustrated, the sensor control device 9102 includes an electronics housing 9104 that may be generally disk-shaped and have a circular cross-section. However, in other embodiments, the electronics housing 9104 may exhibit other cross-sectional shapes, such as oval, elliptical, or polygonal, without departing from the scope of the present disclosure. The electronics housing 9104 includes a shell 9106 and a mount 9108 matable therewith. The shell 9106 may be secured to the mount 9108 by a variety of techniques, such as a snap engagement, an interference fit, sonic welding, laser welding, one or more mechanical fasteners (e.g., screws), a gasket, an adhesive, or any combination thereof. In certain embodiments, the shell 9106 may be secured to the mount 9108 such that a sealed interface occurs between the shell 9106 and the mount 9108. An adhesive patch 9110 may be positioned or otherwise attached to the underside of the mount 9108. Similar to the adhesive patch 108 of FIG. 1, the adhesive patch 9110 can be configured to securely maintain the sensor control device 9102 in a defined position on the user's skin during operation.

[0251] The sensor control device 9102 may further include a sensor 9112 and a sharp 9114 used to aid in transdermal delivery of the sensor 9112 beneath the skin of a user during application of the sensor control device 9102. Corresponding portions of the sensor 9112 and sharp 9114 extend distally from a bottom (e.g., mount 9108) of the electronics housing 9104. A sharp hub 9116 may be overmolded onto the sharp 9114 and configured to fixedly support the sharp 9114. As can be seen most clearly in FIG. 31A, the sharp hub 9116 may include or otherwise define a mating member 9118. As can be seen most clearly in FIG. 27A, the sharp hub 9116 may include or otherwise define a mating member 9118. As described below, in at least one embodiment, the sharp hub 9116 may sealingly engage an upper portion of a seal overmolded onto the mount 9108. When the sharp 9114 penetrates the electronics housing 9104, an exposed portion of the sensor 9112 can be received within a hollow or recessed (arcuate) portion of the sharp 9114. The remainder of the sensor 9112 is disposed within the electronics housing 9104.

[0252] The sensor control device 9102 may further include a sensor cap 9120, shown in FIGS. 31A-31B separated from the electronics housing 9104. The sensor cap 9120 may help provide a sealing barrier that surrounds and protects exposed portions of the sensor 9112 and the sharps 9114. As shown, the sensor cap 9120 may include a generally cylindrical body having a first end 9122a and an opposing second end 9122b. The first end 9122a may be open to provide access into an interior chamber 9124 defined within the body. In contrast, the second end 9122b may be closed and may provide or otherwise define an engagement feature 9126. As described in more detail below, the engagement features 9126 can assist in fitting the sensor cap 9120 to an applicator cap of a sensor applicator (e.g., the sensor applicator 102 of FIG. 1) and can also assist in removing the sensor cap 9120 from the sensor control device 9102 when the sensor cap is removed from the sensor applicator.

[0253] The sensor cap 9120 can be removably coupled to the electronics housing 9104 at or near the bottom of the mount 9108. More specifically, the sensor cap 9120 can be removably coupled to a mating member 9118 extending distally from the bottom of the mount 9108. In at least one embodiment, for example, the mating member 9118 can define a set of male threads 9128a (FIG. 31A) that can mate with a set of female threads 9128b (FIG. 31B) defined within the inner chamber 9124 of the sensor cap 9120. In some embodiments, the male and female threads 9128a, 9128b can include a flat thread design (e.g., lacking a helical curvature), but can alternatively comprise a helical threaded engagement. Thus, in at least one embodiment, the sensor cap 9120 can be threadably coupled to the sensor control device 9102 with the mating member 9118 of the sharp hub 9116. In other embodiments, the sensor cap 9120 can be removably coupled to the mating member 9118 by other types of engagement, including but not limited to an interference or friction fit, or a frangible member or substance (e.g., wax, adhesive, etc.) that can be broken by a slight separation force (e.g., axial or rotational force).

[0254] In some embodiments, the sensor cap 9120 may include a monolithic (single) structure extending between the first end 9122a and the second end 9122b. However, in other embodiments, the sensor cap 9120 may include two or more component parts. In the illustrated embodiment, for example, the body of the sensor cap 9120 may include a desiccant cap 9130 disposed at the second end 9122b. The desiccant cap 9130 may contain or include a desiccant that helps maintain a preferred humidity level within the inner chamber 9124. Additionally, the desiccant cap 9130 may define or otherwise provide an engagement feature 9126 for the sensor cap 9120. In at least one embodiment, the desiccant cap 9130 may include an elastomeric plug that is inserted into a bottom end of the sensor cap 9120.

[0255] 32A and 32B are exploded isometric top and bottom views, respectively, of a sensor control device 9102 according to one or more embodiments. The shell 9106 and mount 9108 act as opposing clamshell halves that enclose or otherwise substantially enclose various electronic components (not shown) of the sensor control device 9102. Exemplary electronic components that may be disposed between the shell 9106 and the mount 9108 include, but are not limited to, batteries, resistors, transistors, capacitors, inductors, diodes, and switches.

[0256] The shell 9106 can define a first opening 9202a and the mount 9108 can define a second opening 9202b, where the openings 9202a, 9202b can align when the shell 9106 is properly mounted to the mount 9108. As can be seen most clearly in FIG. 32A , the mount 9108 can provide or otherwise define a pedestal 9204 that protrudes from an inner surface of the mount 9108 at the second opening 9202b. The pedestal 9204 can define at least a portion of the second opening 9202b. Additionally, a channel 9206 can be defined on an inner surface of the mount 9108, where the channel 9206 can surround the pedestal 9202. In the illustrated embodiment, the channel 9206 is circular in shape, but it is contemplated that the channel 9206 could alternatively be another shape, such as elliptical, oval, or polygonal.

[0257] The mount 9108 may include a molded part made of a rigid material such as plastic or metal. In some embodiments, the seal 9208 may be overmolded onto the mount 9108, and the seal 9208 may be made of an elastomer, rubber, polymer, or another flexible material suitable for facilitating a sealing interface. In embodiments in which the mount 9108 is made of plastic, the mount 9108 may be molded in a first "shot" of injection molding, and the seal 9208 may be overmolded onto the mount 9108 in a second "shot" of injection molding. Thus, the mount 9108 may be referred to or otherwise characterized as a "two-shot mount."

[0258] In the illustrated embodiment, the seal 9208 is overmolded onto the mount 9108 at the pedestal 9204 and may also be overmolded onto the bottom of the mount 9108. More specifically, the seal 9208 may define or otherwise be provided with a first seal element 9210a overmolded onto the pedestal 9204 and a second seal element 9210b (FIG. 32B) interconnected therewith and overmolded onto the mount 9108 at the bottom of the mount 9108. In some embodiments, one or both of the seal elements 9210a, 9210b may help form a corresponding section of the second opening 9202b. Although the seal 9208 is described herein as being overmolded onto the mount 9108, it is also contemplated that one or both of the seal elements 9210a, 9210b may include an elastomeric component part separate from the mount 9208, such as an O-ring or gasket.

[0259] The sensor control device 9102 may further include a collar 9212, which may be a generally annular structure disposed between the shell 9106 and the mount 9208 and defines a central opening 9214. The central opening 9214 may be sized to receive the first seal element 9210a and may align with the first and second openings 9202a, 9202b when the sensor control device 9102 is properly assembled. The shape of the central opening 9214 may generally match the shape of the second opening 9202b and the first seal element 9210a.

[0260] In some embodiments, the collar 9212 can define or otherwise provide an annular lip 9216 on its bottom surface. The annular lip 9216 can be sized or otherwise configured to fit or be received within a channel 9206 defined on an inner surface of the mount 9108. In some embodiments, a groove 9218 can be defined on the annular lip 9216 and configured to house or otherwise receive a portion of the sensor 9112 that extends laterally within the mount 9108. In some embodiments, the collar 9212 can further define or otherwise provide a collar channel 9220 ( FIG. 32A ) on its top surface that is sized to receive and otherwise fit within an annular ridge 9222 ( FIG. 32B ) defined on an inner surface of the shell 9106 when the sensor control device 9102 is properly assembled. In some embodiments, the collar 9212 can further include a plurality of tabs 9212a ( FIG. 32C ) on its outer edge. The tabs 9212a can be positioned flush with the top surface of the collar 9212 to create a shelf for the circuit board. In some embodiments, the circuit board can be a foldable and / or flexible PCB as described in U.S. Provisional Patent Application No. 63 / 081,223, the entire contents of which are incorporated herein by reference. For example, the PCB 4000 can be mounted on the tabs 9212a within the electronics housing. As can be seen in FIG. 32D, after the PCB 4000 is loaded onto the sensor mount 9108, the first portion 4000a of the PCB can be positioned under the tabs 9212a (not shown in FIG. 32D) and rest on the sensor mount 9108. The second portion 4000b of the PCB 4000 can then be folded over the first portion 4000a and mounted on the tabs 9212a. In some embodiments, the tabs 9212a can be the same size or different sizes and can be evenly spaced along the outer edge of the collar 9212. In some embodiments, the tabs 9212a can extend from a top surface of the collar 9212, a bottom surface of the collar 9212, or a location midway along the collar 9212 between the top and bottom surfaces.32C, the collar 9212 can include three tabs 9212a, which can be of different sizes, e.g., two of the tabs are the same size as one another and longer than the third tab (i.e., when measured along the outer edge of the collar 9212). In addition, the tabs 9212a can be of the same or different widths (i.e., when measured as the distance they extend radially outward). In some embodiments, as can be seen in FIG. 32E, the PCB 4000 can include one or more tabs 4000c mated and secured to the tabs 9212a in correspondence therewith.

[0261] The sensor 9112 can include a tail portion 9224 extending through a second opening 9202b defined in the mount 9108 for transcutaneous reception beneath the skin of a user. The tail portion 9224 can have an enzyme or other chemical agent included thereon to help facilitate analyte monitoring. The sharp 9114 can include a sharp tip 9226 extendable through a first opening 9202a defined by the shell 9106. The tail portion 9224 of the sensor 9112 can be received within a hollow or recessed portion of the sharp tip 9226 as the sharp tip 9226 penetrates the electronics housing 9104. The sharp tip 9226 can be configured to penetrate the skin while carrying the tail portion 9224 to place the active chemical agent of the tail portion 9224 in contact with bodily fluids.

[0262] The sensor control device 9102 can provide a sealing subassembly including, among other component parts, the shell 9106, the sensor 9112, the sharp 9114, the seal 9208, the collar 9212, and a portion of the sensor cap 9120. The sealing subassembly can help isolate the sensor 9112 and the sharp 9114 in the inner chamber 9124 (FIG. 32A) of the sensor cap 9120. In assembling the sealing subassembly, the sharp tip 9226 is advanced through the electronics housing 9104 until the sharp hub 9116 engages the seal 9208, more specifically the first seal element 9210a. The mating member 9118 provided at the bottom of the sharp hub 9116 can extend out of the second opening 9202b in the bottom of the mount 9108, and the sensor cap 9120 can be coupled to the sharp hub 9116 with the mating member 9118. Coupling the sensor cap 9120 to the Sharp hub 9116 with the mating member 9118 can bias the first end 9122a of the sensor cap 9120 into sealing engagement with the seal 9208, and more specifically, with the second seal element 9210b on the bottom of the mount 9108. In some embodiments, when the sensor cap 9120 is coupled to the Sharp hub 9116, a portion of the first end 9122a of the sensor cap 9120 can abut (engage) with the bottom of the mount 9108, and the sealing engagement between the Sharp hub 9116 and the first seal element 9210a may be able to accommodate any tolerance variations between features.

[0263] 33 illustrates a cross-sectional side view of a sensor control device 9102 according to one or more embodiments. As noted above, the sensor control device 9102 can include or otherwise incorporate a sealing subassembly 9302 that can be advantageous for isolating the sensor 9112 and the sharps 9114 within the inner chamber 9124 of the sensor cap 9120. To assemble the sealing subassembly 9302, the sensor 9112 can be positioned within the mount 9108 such that the tail portion 9224 extends through the second opening 9202b at the bottom of the mount 9108. In at least one embodiment, a positioning feature 9304 can be defined on an inner surface of the mount 9108, and the sensor 9112 can define a groove 9306 that can mate with the positioning feature 9304 to properly position it within the mount 9108.

[0264] With the sensor 9112 properly positioned, the collar 9212 can be placed on the mount 9108. More specifically, the collar 9212 can be positioned such that a first seal element 9210a of the seal 9208 is received within a central opening 9214 defined by the collar 9212, with the first seal element 9210a generating a radial seal against the collar 9212 at the central opening 9214. Additionally, an annular lip 9216 defined on the collar 9212 can be received within a channel 9206 defined on the mount 9108, and a groove 9218 defined through the annular lip 9216 can be aligned to receive a portion of the sensor 9112 that traverses the channel 9206 in the mount 9108. In some embodiments, an adhesive can be injected into the channel 9206 to secure the collar 9212 to the mount 9108. The adhesive can facilitate a sealed interface between these two components and create a seal around the sensor 9112 at the location of the groove 9218, thereby isolating the tail portion 9224 from the interior of the electronics housing 9104.

[0265] The shell 9106 may then be mated or otherwise coupled to the mount 9108. In some embodiments, as shown, the shell 9106 may be mated to the mount 9108 through a tongue and groove engagement 9308 at the outer periphery of the electronics housing 9104. An adhesive may be injected (applied) into the groove portion of the engagement 9308 to secure the shell 9106 to the mount 9108 and further create a sealed mating interface. By mating the shell 9106 to the mount 9108, an annular ridge 9222 defined on an inner surface of the shell 9106 may be received within a collar channel 9220 defined on an upper surface of the collar 9212. In some embodiments, an adhesive may be injected into the collar channel 9220 to secure the shell 9106 to the collar 9212 and further facilitate a sealed interface between the two components at this location. When the shell 9106 is mated to the mount 9108, the first seal element 9210a can extend at least partially through (into) a first opening 9202a defined in the shell 9106.

[0266] The sharp 9114 can then be coupled to the sensor control device 9102 by extending the sharp tip 9226 through aligned first and second openings 9202a, 9202b defined in the shell 9106 and the mount 9108, respectively. The sharp 9114 can be advanced until the sharp hub 9116 engages the seal 9208, and more specifically, the first seal element 9210a. The mating member 9118 can extend (protrude) out of the second opening 9202b at the bottom of the mount 9108 when the sharp hub 9116 engages the first seal element 9210a.

[0267] The sensor cap 9120 can then be removably coupled to the sensor control device 9102 by threadably mating the female threads 9128b of the sensor cap 9120 with the male threads 9128a of the fitting 9118. The inner chamber 9124 can be sized or otherwise configured to receive the tail portion 9224 and sharp tip 9226 extending from the bottom of the mount 9108. Additionally, the inner chamber 9124 can be sealed to isolate the tail portion 9224 and sharp tip 9226 from substances that may adversely interact with the chemical agents of the tail portion 9224. In some embodiments, a desiccant (not shown) can be present in the inner chamber 9124 to maintain the proper humidity level.

[0268] Tightening (rotating) the mating engagement between the sensor cap 9120 and the mating member 9118 can urge the first end 9122a of the sensor cap 9120 into axial (e.g., along the centerline of the openings 9202a, 9202b) sealing engagement with the second seal element 9210b, further enhancing the axial sealing interface between the sharp hub 9116 and the first seal element 9210a. Furthermore, tightening the mating engagement between the sensor cap 9120 and the mating member 9118 can compress the first seal element 9210a, thereby providing a strong radial sealing engagement between the first seal element 9210a and the collar 9212 at the central opening 9214. Thus, in at least one embodiment, the first seal element 9210a can help facilitate axial and radial sealing engagement.

[0269] As mentioned above, the first and second seal elements 9210a, 9210b can be overmolded onto the mount 9108 and physically connected or otherwise interconnected. Thus, a single injection molding shot can flow through the second opening 9202b of the mount 9108 to generate both ends of the seal 9208. This can prove advantageous in that multiple sealing interfaces can be generated with only a single injection molding shot. An additional benefit of the two-shot molding design is that the bond between the first and second shots is a more reliable adhesive than a mechanical seal, as opposed to using separate elastomeric components (e.g., O-rings, gaskets, etc.). Thus, the effective number of mechanical sealing barriers is essentially halved. Additionally, the two-shot components with a single elastomeric shot also have the implication of minimizing the number of two-shot components required to achieve all the necessary sterility barriers. Once properly assembled, a radiation sterilization process can be applied to the sealing subassembly 9302 to sterilize the sensor 9112 and the sharps 9114. The sealed subassembly 9302 may be subjected to radiation sterilization before or after coupling the sensor cap 9120 to the Sharp hub 9116. If the sensor cap 9120 is sterilized after being coupled to the Sharp hub 9116, the sensor cap 9120 may be made of a material that allows the transmission of radiation therethrough. In some embodiments, the sensor cap 9120 may be transparent or translucent, but may otherwise be opaque without departing from the scope of this disclosure.

[0270] FIG. 33A shows an exploded isometric view of a portion of another embodiment of the sensor control device 9102 of FIGS. 31A-31B and 32A-32B. The embodiments included above described the mount 9108 and the seal 9208 being manufactured by a two-shot injection molding process. However, in other embodiments, as briefly indicated above, one or both of the seal elements 9210a, 9210b of the seal 9208 can include elastomeric component parts that are separate from the mount 9208. In the illustrated embodiment, for example, the first seal element 9210a can be overmolded onto the collar 9212 and the second seal element 9210b can be overmolded onto the sensor cap 9120. Alternatively, the first and second seal elements 9210a, 9210b may include separate component parts such as a gasket or O-ring 9210a disposed on the top surface of the collar 9212 (FIGS. 32C and 33A) and the sensor cap 9120, respectively. By tightening (rotating) the mating engagement between the sensor cap 9120 and the mating member 9118, the second seal element 9210b may be urged into axial sealing engagement with the bottom of the mount 9108, enhancing the axial sealing interface between the sharp hub 9116 and the first seal element 9210a. In some embodiments, as shown in FIG. 33B, the sharp hub 9116 may include a raised mating surface 9116a (e.g., a ledge) configured to mate with the seal element 9210a. Thus, tightening (rotating) the mating engagement between the sensor cap 9120 and the mating member 9118 can enhance the axial sealing interface between the mating surface 9116a and the first seal element 9210a.

[0271] FIG. 34A illustrates an isometric bottom view of a mount 9108 according to one or more embodiments, and FIG. 34B illustrates an isometric top view of a sensor cap 9120 according to one or more embodiments. As shown in FIG. 34A, the mount 9108 can provide or otherwise define one or more recesses or pockets 9402 at or near its opening to the second opening 9202b. As shown in FIG. 34B, the sensor cap 9120 can provide or otherwise define one or more protrusions 9404 at or near its first end 9122a. The protrusions 9404 can be received within the pockets 9402 when the sensor cap 9120 is coupled to the Sharp hub 9116 (FIGS. 32A-32B and 93). More specifically, as described above, when the sensor cap 9120 is coupled to the mating member 9118 (FIGS. 32A-32B and 93) of the Sharp hub 9116, the first end 9122a of the sensor cap 9120 is brought into sealing engagement with the second seal element 9210b. In this process, the protrusion 9404 can be received within the pocket 9402, which can help prevent premature unscrewing of the sensor cap 9120 from the Sharp hub 9116.

[0272] 35A and 35B are side and cross-sectional side views, respectively, of an exemplary sensor applicator 9502 according to one or more embodiments. The sensor applicator 9502 can be similar in some respects to the sensor applicator 102 of FIG. 1 and, therefore, can be designed to deliver (fire) a sensor control device, such as the sensor control device 9102. FIG. 35A illustrates how the sensor applicator 9502 may be shipped to and received by a user, and FIG. 35B depicts the sensor control device 9102 disposed within the sensor applicator 9502.

[0273] 35A , the sensor applicator 9502 includes a housing 9504 and an applicator cap 9506 removably coupled thereto. In some embodiments, the applicator cap 9506 can be threadedly engaged with the housing 9504 and can include an unsealing ring 9508. When the applicator cap 9506 is rotated (e.g., twisted off) relative to the housing 9504, the unsealing ring 9508 can be twisted off, thereby releasing the applicator cap 9506 from the sensor applicator 9502.

[0274] 35B, the sensor control device 9102 is positioned within the sensor applicator 9502. Once the sensor control device 9102 is fully assembled, it can then be loaded into the sensor applicator 9502 and an applicator cap 9506 can be coupled to the sensor applicator 9502. In some embodiments, the applicator cap 9506 and housing 9504 can have opposing matable thread sets that allow the applicator cap 9506 to be twisted onto the housing 9504 in a clockwise (or counterclockwise) direction, thereby securing the applicator cap 9506 to the sensor applicator 9502.

[0275] By securing the applicator cap 9506 to the housing 9504, the second end 9122b of the sensor cap 9120 can be received within a cap post 9510 positioned within the applicator cap 9506 and extending proximally from a bottom of the applicator cap 9506. The cap post 9510 can be configured to receive at least a portion of the sensor cap 9120 when the applicator cap 9506 is coupled to the housing 9504.

[0276] 36A and 36B are perspective and top views, respectively, of a cap post 9510 in accordance with one or more additional embodiments. In the depicted depiction, a portion of a sensor cap 9120 is received within the cap post 9510, and more specifically, a desiccant cap 9130 of the sensor cap 9120 is positioned within the cap post 9510. The cap post 9510 can define a receiver feature 9602 configured to receive an engagement feature 9126 of the sensor cap 9120 when the applicator cap 9506 (FIG. 35B) is coupled (e.g., threaded) to the sensor applicator 9502 (FIGS. 35A-35B). However, when the applicator cap 9506 is removed from the sensor applicator 9502, the receiver feature 9602 can prevent the engagement feature 9126 from reversing direction, thereby preventing the sensor cap 9120 from separating from the cap post 9510. Instead, removing the applicator cap 9506 from the sensor applicator 9502 simultaneously detaches the sensor cap 9120 from the sensor control device 9102 (Figures 31A-31B and 32A-32B), thereby exposing the sensor 9112 (Figures 32A-32B) and distal portions of the sharps 9114 (Figures 32A-32B).

[0277] Many design variations of the receiver feature 9602 can be used without departing from the scope of this disclosure. In the illustrated embodiment, the receiver feature 9602 includes one or more flexible members 9604 (two shown) that are stretchable or flexible to receive the engagement feature 9126. The engagement feature 9126 can include, for example, an enlarged head, and the flexible members 9604 can include a collet-type device that includes a plurality of flexible fingers configured to flex radially outward to receive the enlarged head.

[0278] The flexible member 9604 may further provide or otherwise define a corresponding ramp surface 9606 configured to interact with one or more opposing cam surfaces 9608 provided on an outer wall of the engagement feature 9126. The configuration and alignment of the ramp surface 9606 and the opposing cam surface 9608 is such that the applicator cap 9506 can rotate in a first direction A (e.g., clockwise) relative to the sensor cap 9120, but when the applicator cap 9506 is rotated in a second direction B (e.g., counterclockwise), the cap post 9510 locks against the sensor cap 9120. More specifically, as the applicator cap 9506 (and thus the cap post 9510) rotates in the first direction A, the cam surface 9608 engages the ramp surface 9606, thereby urging the flexible member 9604 to bend or otherwise deflect radially outward, creating a ratcheting effect. However, by rotating the applicator cap 9506 (and thus the cap post 9510) in the second direction B, the inclined surface 9610 of the cam surface 9608 is driven to collide with the opposing inclined surface 9612 of the ramp surface 9606, resulting in the sensor cap 9120 becoming attached to the flexible member 9604.

[0279] 37 is a cross-sectional side view of the sensor control device 9102 positioned within the applicator cap 9506 according to one or more embodiments. As shown, the opening to the receiver feature 9602 exhibits a first diameter D3, whereas the engagement feature 9126 of the sensor cap 9120 exhibits a second diameter D4 that is larger than the first diameter D3 and larger than the outer diameter of the remainder of the sensor cap 9120. When the sensor cap 9120 extends into the cap post 9510, the flexible member 9604 of the receiver feature 9602 can bend (expand) radially outward to accommodate the engagement feature 9126. In some embodiments, as shown, the engagement feature 9126 can provide or otherwise define a sloped outer surface that helps bias the flexible member 9604 radially outward. Once the engagement feature 9126 advances beyond the receiver feature 9602 , the flexible member 9604 can bend back to (or towards) its natural state, thereby locking the sensor cap 9120 within the cap post 9510 .

[0280] As the applicator cap 9506 is threaded (twisted onto) the housing 9504 (FIGS. 35A-35B) in a first direction A, the cap post 9510 is correspondingly rotated in the same direction, gradually introducing the sensor cap 9120 into the cap post 9510. As the cap post 9510 rotates, the ramp surface 9606 of the flexible member 9604 ratchets against the opposing cam surface 9608 of the sensor cap 9120. This continues until the applicator cap 9506 is fully threaded (screwed) onto the housing 9504. In some embodiments, the ratcheting action can occur for two full revolutions of the applicator cap 9506 before the applicator cap 9506 reaches its final position.

[0281] To remove the applicator cap 9506, the applicator cap 9506 is rotated in a second direction B, which correspondingly rotates the cap post 9510 in the same direction, such that the cam surface 9608 (i.e., the inclined surface 9610 in FIGS. 36A-36B ) locks it against the ramp surface 9606 (i.e., the inclined surface 9612 in FIGS. 36A-36B ). As a result, continued rotation of the applicator cap 9506 in the second direction B correspondingly rotates the sensor cap 9120 in the same direction, thereby unscrewing it from the mating member 9118 and allowing the sensor cap 9120 to detach from the sensor control device 9102. Decoupling the sensor cap 9120 from the sensor control device 9102 exposes the sensor 9112 and distal portions of the sharps 9114, thereby placing the sensor control device 9102 in a defined position for firing (use).

[0282] FIG. 38A is a cross-sectional view of a sensor control device 9800 illustrating an example interaction between the sensor and the sharp. After assembly of the sharp, the sensor should be seated within the channel defined by the sharp. Although the sensor control device in FIG. 9 does not show the sensor deflected inward and otherwise perfectly aligned with the sharp, such deflection and alignment may be the case upon full assembly where the sensor may experience some biasing force at the location indicated by the two arrows A. Biasing the sensor against the sharp may have the advantage that any relative movement between the sensor and the sharp during subcutaneous insertion does not result in exposure of the sensor tip (i.e., tail portion) outside the sharp channel, which could potentially result in failure of insertion.

[0283] 38B-38D show an exemplary Sharp hub 205014 and Sharp 209114 configured to not bias the sensor 11900 prior to delivery, e.g., during shipping and storage (FIG. 15B), and to bias the sensor 11900 during delivery of the sensor (FIG. 38C). By storing and transporting the sensor in an unbiased (relaxed or unstressed) position, the sensor can have a longer shelf life and lower overall stress. Furthermore, by storing and transporting the sensor in an unbiased position, stress relaxation over the shelf life can be reduced, thus limiting loss of bias due to stress relaxation. Thus, the bias during delivery of the sensor can be more predictable and bias during delivery can be as designed. The Sharp 209114 can include a window 209114A. Prior to use, the window 209114A can be aligned with the protrusion 11912 on the top end 11908b of the sensor 11900, and the protrusion 11912 can extend through the window 209114. In such a configuration, the bottom end 11908a is not biased towards the sharp, thus allowing the sensor 11900 to be in a relaxed state. During firing, the needle carrier 201102 can be partially retracted, thereby pulling the sharp 209114 to a partially retracted position. The partial retraction can occur when the sheath 20704 initially moves proximally relative to the sensor carrier 20710 during firing. Each sharps carrier locking arm 20710K (see FIG. 9D) of the sensor carrier 20710 can extend radially outward when the rib 20710M of the retention arm 20710L engages a respective slot 20704Q (see FIG. 8M) of the sheath 20704, thereby allowing the sharps carrier retention feature 20710L to pass through the pre-partially retracted retention surface 201102A of the sharps carrier 201102 and engage the post-partially retracted retention surface 201102B (see FIG. 10C). In the partially retracted position, the window 209114A no longer receives the protrusion 11912 and the sharps 209114 engage the protrusion 11912, thereby biasing the bottom end 11908a towards the sharps 209114 into the proper position for delivery as described above.

[0284] Embodiments disclosed herein include the following:

[0285] D. An electronics housing including a shell and a mount defining a first opening, the mount defining a second opening alignable with the first opening when the shell is coupled to the mount; a seal overmolded on the mount at the second opening, the seal including a first seal element overmolded on a pedestal protruding from an inner surface of the mount and a second seal element interconnected with the first seal element and overmolded on a bottom of the mount; and a sensor disposed within the electronics housing, the sensor having a tail portion extending through the second opening and past the bottom of the mount, and a sharp extending through the first and second openings and past the bottom of the electronics housing.

[0286] E. An assembly including a sensor applicator, a sensor control device disposed within the sensor applicator, an electronics housing including a shell defining a first opening and a mount, the mount defining a second opening alignable with the first opening when the shell is mated to the mount, a seal overmolded on the mount at the second opening, the seal including a first seal element overmolded on a pedestal projecting from an inner surface of the mount and a second seal element interconnected with the first seal element and overmolded on a bottom of the mount, a sensor disposed within the electronics housing, the sensor having a tail portion extending through the second opening and past the bottom of the mount, and a sharp extending through the first and second openings and past the bottom of the electronics housing. The assembly further includes a sensor cap removably coupled to the sensor control device at the bottom of the mount, the sensor cap defining a sealed inner chamber that receives the tail portion and the sharp, and an applicator cap coupled to the sensor applicator.

[0287] Each of embodiments D and E may have one or more of the following additional elements in any combination: Element 1: the mount includes a first injection molded part molded in a first shot, and the seal includes a second injection molded part overmolded on the first injection molded part in a second shot. Element 2: further including a Sharps hub carrying a Sharp and sealingly engaging the first seal element, and a sensor cap removably coupled to the Sharps hub at a bottom of the mount and sealingly engaging the second seal element, the sensor cap defining a tail portion and an inner chamber for receiving the Sharps. Element 3: the Sharps hub provides a fitting member extending past the bottom of the mount, the sensor cap removably coupled to the fitting member. Element 4: further including one or more pockets defined on the bottom of the mount at the second opening, and one or more protrusions defined on an end of the sensor cap receivable in the one or more pockets when the sensor cap is coupled to the Sharps hub. Element 5: further comprising a collar positioned within the electronics housing, the collar defining a central opening for radially receiving and sealingly engaging the first seal element. Element 6: further comprising a channel defined on an inner surface of the mount surrounding the pedestal, an annular lip defined on an underside of the collar matable with the channel, and an adhesive provided within the channel for securing and sealing the collar to the mount at the channel. Element 7: further comprising a groove defined through the annular lip for receiving a portion of the sensor extending laterally within the mount, the adhesive sealing around the sensor at the groove. Element 8: further comprising a collar channel defined on an upper surface of the collar, an annular ridge defined on an inner surface of the shell matable with the collar channel, and an adhesive provided within the collar channel for securing and sealing the shell to the collar. Element 9: one or both of the first and second seal elements defining at least a portion of the second opening. Element 10: the first seal element extending at least partially through the first opening when the shell is coupled to the mount.

[0288] Element 11: The sensor control device further includes a Sharps hub that carries a Sharps and sealingly engages the first seal element, and the sensor cap is removably coupled to the Sharps hub at a bottom of the mount and sealingly engages the second seal element. Element 12: The sensor control device further includes one or more pockets defined on the bottom of the mount at the second opening and one or more protrusions defined on an end of the sensor cap that are receivable in the one or more pockets when the sensor cap is coupled to the Sharps hub. Element 13: The sensor control device further includes a collar positioned within the electronics housing, the collar defining a central opening that radially receives and sealingly engages the first seal element. Element 14: The sensor control device further includes a channel defined on an inner surface of the mount and surrounding the pedestal, an annular lip defined on an underside of the collar that is mateable with the channel, and an adhesive provided in the channel to secure and seal the collar to the mount at the channel. Element 15: further including a groove defined through the annular lip for receiving a portion of the sensor extending laterally within the mount, the adhesive sealing around the sensor in the groove. Element 16: further including a collar channel defined on a top surface of the collar, an annular ridge defined on an inner surface of the shell matable with the collar channel, and adhesive provided within the collar channel to secure and seal the shell to the collar. Element 17: one or both of the first and second sealing elements defines at least a portion of the second opening. Element 18: the first sealing element extends at least partially through the first opening.

[0289] As non-limiting examples, exemplary combinations applicable to D and E include elements 2 and 3, elements 2 and 4, elements 5 and 6, elements 6 and 7, elements 5 and 8, elements 11 and 12, elements 13 and 14, elements 14 and 15, and elements 13 and 16.

[0290] Exemplary Firing Mechanisms for One-Piece and Two-Piece Applicators 39A-39F illustrate exemplary details of an embodiment of an internal device that "fires" the applicator 216 to apply the sensor control device 222 to a user, including safely retracting the sharpener 1030 back into the applicator 216 after use. These figures, taken together, depict an exemplary sequence of driving the sharpener 1030 (carrying a sensor coupled to the sensor control device 222) into the user's skin, withdrawing the sharpener while leaving the sensor in operative contact with the user's interstitial fluid, and adhering the sensor control device to the user's skin using an adhesive. With reference to these figures, one skilled in the art will be able to recognize modifications of such activities for use with alternative applicator assembly embodiments and components. Additionally, the applicator 216 can be a sensor applicator having a one-piece or two-piece architecture as disclosed herein.

[0291] 39A, the sensor 1102 is supported within the sharp 1030 just above the user's skin 1104. Rails 1106 (optionally three rails 1106) on the upper guide section 1108 can be provided to control movement of the applicator 216 relative to the sheath 318. The sheath 318 is held within the applicator 216 by detent features 1110 such that an appropriate downward force along the longitudinal axis of the applicator 216 will overcome the resistance provided by the detent features 1110 such that the sharp 1030 and sensor control device 222 can be translated along the longitudinal axis into (and onto) the user's skin 1104. Additionally, the catch arm 1112 of the sensor carrier 1022 engages the sharp retraction assembly 1024 to maintain the sharp 1030 in position relative to the sensor control device 222.

[0292] 39B, a user force is applied to overcome or disable the detent feature 1110, and the sheath 318 collapses into the housing 314, driving the sensor control device 222 (along with the attached portions) to translate downward along the longitudinal axis as shown by arrow L. The inner diameter of the upper guide section 1108 of the sheath 318 constrains the position of the carrier arm 1112 throughout the entire stroke of the sensor / sharp insertion process. The retention of the stop surface 1114 of the carrier arm 1112 against the complementary surface 1116 of the sharp retraction assembly 1024 maintains the position of these members with the return spring 1118 fully biased.

[0293] In Fig. 39C, the sensor 1102 and sharp 1030 reach maximum insertion depth. In doing so, the carrier arm 1112 passes through the inner diameter of the upper guide section 1108. The compression force of the coil return spring 1118 then drives the angled stop surface 1114 radially outward, releasing a force that drives the sharp carrier 1102 of the sharp retraction assembly 1024 to pull the (slotted or otherwise configured) sharp 1030 out of the user and away from the sensor 1102, as shown by arrow R in Fig. 39D.

[0294] With the sharp 1030 fully retracted as shown in Figure 39E, the upper guide section 1108 of the sheath 318 is set with the final locking feature 1120. As shown in Figure 39F, the used applicator assembly 216 is removed from the insertion site, leaving the sensor control device 222 behind and the sharp 1030 safely secured inside the applicator assembly 216. At this point, the used applicator assembly 216 can be discarded.

[0295] The actuation of the applicator 216 when applying the sensor control device 222 is designed to give the user the sensation that both the insertion and retraction of the sharpener 1030 are performed automatically by the internal mechanism of the applicator 216. In other words, the present invention avoids the user from experiencing the sensation of forcing the sharpener 1030 into his / her skin. Thus, after the user applies sufficient force to overcome the resistance from the detent feature of the applicator 216, the resulting action of the applicator 216 is perceived as an automatic response to the applicator being "triggered". Even though all the driving force to insert the sharpener 1030 is provided by the user and no additional biasing / driving means are used, the user does not perceive that he / she is providing additional force to drive the sharpener 1030 to penetrate the skin. As detailed above in FIG. 39C, the retraction of the sharpener 1030 is automated by the coil return spring 1118 of the applicator 216.

[0296] With respect to any of the applicator embodiments described herein, as well as any of the components of the applicator embodiments, including but not limited to the sharps, sharps module, and sensor module embodiments, those skilled in the art will appreciate that these embodiments can be sized and configured for use with a sensor configured to sense an analyte level in a bodily fluid in the epidermis, dermis, or subcutaneous tissue of a subject. In some embodiments, for example, the sharps and distal portions of the analyte sensor disclosed herein can be sized and configured to be positioned at a particular distal depth (i.e., the deepest penetration point into a tissue or layer of the subject's body, e.g., the epidermis, dermis, or subcutaneous tissue). With respect to some applicator embodiments, those skilled in the art will appreciate that certain embodiments of the sharps can be sized and configured to be positioned at a different distal depth within the subject's body as compared to the final distal depth of the analyte sensor. In some embodiments, for example, the sharps can be positioned at a first distal depth within the epidermis of the subject prior to retraction, whereas the distal portion of the analyte sensor can be positioned at a second distal depth within the dermis of the subject. In other embodiments, the sharp may be positioned at a first distal depth within the dermis of the subject prior to retraction, while a distal portion of the analyte sensor may be positioned at a second distal depth within subcutaneous tissue of the subject. In yet other embodiments, the sharp may be positioned at a first distal depth prior to retraction, and the analyte sensor may be positioned at a second distal depth, both of which are within the same layer or tissue of the subject's body.

[0297] In addition, one of ordinary skill in the art will appreciate that for any of the applicators described herein, the analyte sensor and one or more structured components coupled to the analyte sensor, including but not limited to one or more spring mechanisms, may be positioned within the applicator at an eccentric location relative to one or more axes thereof. In some applicator embodiments, for example, the analyte sensor and spring mechanism may be positioned at an eccentric location on a first side of the applicator relative to the applicator axis, and the sensor electronics may be positioned at an eccentric location on a second side of the applicator relative to the applicator axis. In other applicator embodiments, the analyte sensor, spring mechanism, and sensor electronics may be positioned at eccentric locations on the same side of the applicator axis. One of ordinary skill in the art will appreciate that other permutations and configurations in which any or all of the analyte sensor, spring mechanism, sensor electronics, and other components of the applicator are positioned in central or eccentric locations relative to one or more axes of the applicator are possible and fully within the disclosure of the present invention.

[0298] Several deflectable structures have been described herein, including but not limited to deflectable detent snap 1402, deflectable locking arm 1412, sharp carrier locking arm 1524, sharp retaining arm 1618, and module snap 2202. These deflectable structures include resilient materials such as plastic or metal (or other) and operate in a manner known to those skilled in the art. Each of the deflectable structures has a rest state or position toward which the resilient material is biased. If a force is applied to deflect or move the structure from this rest state or position, when the force is removed (or weakened), this bias of the resilient material will return the structure to this rest state or position. In many instances, these structures are configured as arms with detents or snaps, although other structures or configurations that possess the same characteristics of deflectability and ability to return to a rest position can be used, including but not limited to legs, clips, catches, and supports on the deflectable members.

[0299] The presently disclosed subject matter further includes a method of packaging an analyte sensor. The method according to the presently disclosed subject matter includes providing an analyte sensor configured to measure an analyte level. The analyte sensor includes a tail portion for subcutaneous placement, the tail portion including an analyte responsive enzyme disposed thereon. The method further includes providing an applicator for delivery of the analyte sensor. The applicator includes a housing defining an airtight sealed chamber. The tail portion can be disposed within the chamber prior to subcutaneous placement. The method further includes disposing a capture material within the chamber as described above. The capture material can include at least one of activated charcoal and silica gel and can be configured to adsorb at least one substance within the chamber. The method can include any of the features of the presently disclosed subject matter.

[0300] Additional details of suitable devices, systems, methods, components, and their operation, along with associated features, are described in International Publication No. WO 2018 / 136898 to Rao et al., International Publication No. WO 2019 / 236850 to Thomas et al., International Publication No. WO 2019 / 236859 to Thomas et al., International Publication No. WO 2019 / 236876 to Thomas et al., and U.S. Patent Publication No. 2020 / 0196919, filed June 6, 2019, the entire contents of each of which are incorporated herein by reference. Further details regarding the applicator, embodiments of its components, and variations thereof are described in U.S. Patent Publication Nos. 2013 / 0150691, 2016 / 0331283, and 2018 / 0235520, the entire contents of all of which are incorporated herein by reference for all purposes. Further details regarding the Sharp Module, embodiments of the Sharp, its components, and variations thereof are described in U.S. Patent Publication No. 2014 / 0171771, the entire contents of which are incorporated herein by reference for all purposes.

[0301] It should be noted that all features, elements, components, functions, and steps described with respect to any embodiment provided herein are intended to be freely combinable and interchangeable with any other embodiment. Even if a certain feature, element, component, function, or step is described only with respect to one embodiment, it is understood that such feature, element, component, function, or step can be used in all other embodiments described herein, unless otherwise expressly stated. Thus, this paragraph serves as a reason and written support prior to the introduction of the appended claims for combining features, elements, components, functions, and steps from various embodiments, or substituting features, elements, components, functions, and steps from one embodiment with another, in each case, even if the following description does not expressly state that such combinations or substitutions are possible in a particular case. That is, the above description of specific embodiments of the subject matter of the present disclosure is presented for the purpose of illustration and description. It is expressly recognized that an explicit enumeration of all possible combinations and permutations would be unduly burdensome, especially considering that the permissibility of each and every such combination and permutation would be readily recognized by those skilled in the art.

[0302] While the embodiments are susceptible to various modifications and alternative forms, specific examples thereof have been shown in the drawings and described in detail herein. It will be apparent to those skilled in the art that various modifications and variations can be made in the methods and systems of the presently disclosed subject matter without departing from the spirit or scope of the presently disclosed subject matter. That is, the presently disclosed subject matter is intended to include modifications and variations that are within the scope of the appended claims and their equivalents. Furthermore, any feature, function, step, or element of the above-described embodiments, as well as any feature, function, step, or element not present in the present invention, may be recited in or added to the scope of the appended claims. [Explanation of symbols]

[0303] 100 Sample Monitor System 102 Sensor Control Device 104 In vivo analyte sensors 120 Reader Device 150 Sensor Applicator

Claims

1. A sample sensor configured to measure sample level, wherein the sample sensor includes a tail portion for subcutaneous placement, and the tail portion has a sample-responsive enzyme on which the sample sensor is placed. An applicator for dispensing the sample sensor, wherein the applicator has a housing that defines at least a partially airtight chamber, and the tail portion of the applicator is positioned inside the chamber before subcutaneous placement. A capture material disposed within the chamber, comprising at least one of activated carbon, molecular sieve, and silica gel, and configured to adsorb at least one substance within the chamber, A sample measurement device that includes this.

2. The specimen measuring device according to claim 1, wherein the capture material is configured to surround the tail portion within the chamber.

3. The tail portion has a length, The capturing material is configured to surround the tail portion along its length within the chamber. The sample measuring device according to claim 1.

4. The sample measuring device according to claim 1, further comprising a sensor sleeve containing the capture material, configured to at least partially surround the tail portion within the chamber.

5. The sample measuring device according to claim 4, wherein the sensor sleeve includes the capture material.

6. The sample measuring device according to claim 4, wherein the sensor sleeve comprises the capture material combined with at least one polymer material.

7. The specimen measuring device according to claim 4, wherein the capturing material forms a coating over the sensor sleeve.

8. The sample measurement device according to claim 4, further comprising a sensor cap that defines a sensor cap chamber.

9. The specimen measuring device according to claim 8, wherein the sensor sleeve is disposed within the sensor cap chamber, and the tail portion is received within the sensor sleeve and the sensor cap chamber before subcutaneous placement.

10. An electronic device housing disposed within the applicator, wherein the electronic device housing is configured to be attached to the patient's skin, and the specimen sensor further includes the electronic device housing, which includes a first portion and a tail portion within the electronic device housing. The tail portion extends through an opening in the electronic device housing, A sample measuring device according to any one of claims 1 to 9.

11. The sensor cap further includes a sensor cap that defines the sensor cap chamber, The sensor cap includes a first end, The first end is detachably coupled to the electronic device housing, and the tail portion is received into the sensor cap chamber before subcutaneous placement. The sample measuring device according to claim 10.

12. The specimen measuring device according to claim 8 or 9, wherein the capture material is disposed within the sensor cap chamber.

13. The sample measuring device according to claim 8 or 9, wherein the sensor cap includes the capture material.

14. The sample measuring device according to claim 8 or 9, wherein the sensor cap comprises a compound of the capturing material and at least one polymer material.

15. The specimen measuring device according to claim 8 or 9, wherein the capturing material forms a coating over the sensor cap.

16. The specimen measuring device according to claim 10, wherein the capturing material is disposed within the electronic device housing.

17. The specimen measuring device according to claim 10, wherein the collar positioned within the electronic device housing includes the capture material.

18. The sample measuring device according to claim 10, wherein the electronic device housing includes the capture material.

19. The sample measuring device according to claim 10, wherein the electronic device housing comprises a compound of the capture material and at least one polymer material.

20. The specimen measuring device according to claim 10, wherein the capturing material forms a coating over the electronic device housing.

21. The sample measuring device according to any one of claims 1 to 9, wherein the applicator includes an applicator cap.

22. The sample measuring device according to claim 21, wherein the housing and the applicator cap together define the airtight sealed chamber.

23. The sample measuring device according to claim 21, wherein the applicator cap includes the capture material.

24. The sample measuring device according to claim 21, wherein the applicator cap comprises a compound of the capture material and at least one polymer material.

25. The capturing material forms a coating over the applicator cap, and / or The capturing material is coupled to the applicator cap. The sample measuring device according to claim 21.

26. The specimen measuring device according to any one of claims 1 to 9, wherein the capture material is a selective capture material.

27. The sample measuring device according to any one of claims 1 to 9, wherein the at least one substance comprises at least one volatile organic compound.

28. A method for packaging a sample sensor, A step of providing a sample sensor configured to measure a sample level, wherein the sample sensor includes a tail portion for subcutaneous placement, and a sample-responsive enzyme is placed on the tail portion; The step of providing an applicator for dispensing the sample sensor, wherein the applicator has a housing that defines an airtight chamber, and the tail portion is positioned inside the chamber before subcutaneous placement, The step of placing a capture material in the chamber, wherein the capture material comprises at least one of activated carbon, molecular sieve, and silica gel, and is configured to adsorb at least one substance in the chamber; A method that includes this.

29. The method according to claim 28, wherein the capturing material surrounds the tail portion within the chamber.

30. The tail portion has a length, The capturing material surrounds the tail portion along its length within the chamber. The method according to claim 28.

31. The step includes placing a sensor sleeve inside the chamber that at least partially surrounds the tail portion within the chamber, The sensor sleeve includes the capturing material, The method according to claim 28.

32. The method according to claim 31, wherein the sensor sleeve includes the capturing material.

33. The method according to claim 31, wherein the sensor sleeve comprises a capture material combined with at least one polymer material.

34. The method according to claim 31, wherein the capturing material is coated over the sensor sleeve.

35. The method according to claim 31, wherein the applicator includes a sensor cap that defines the sensor cap chamber.

36. The method according to claim 35, wherein the sensor sleeve is disposed within the sensor cap chamber, and the tail portion is received within the sensor sleeve and sensor cap chamber before subcutaneous placement.

37. The method according to any one of claims 28 to 36, further comprising the step of providing an electronic device housing positioned within the applicator, wherein the electronic device housing is configured to be attached to the skin of a patient, and the specimen sensor includes a first portion within the electronic device housing and a tail portion extending through an opening within the electronic device housing.

38. The method according to claim 37, wherein the applicator further includes a sensor cap defining a sensor cap chamber, the sensor cap having a first end, the first end being detachably coupled to the electronic equipment housing, and the tail portion being received into the sensor cap chamber before subcutaneous placement.

39. The method according to claim 37, wherein the step of placing the capture material in the chamber includes the step of placing the capture material in the electronic device housing.

40. The method according to claim 35, wherein the step of placing the capture material in the chamber includes the step of placing the capture material in the sensor cap chamber.

41. The method according to claim 28, wherein the applicator includes an applicator cap, and the step of placing the capture material in the chamber includes the step of coupling the capture material with the applicator cap.

42. The method according to claim 28, wherein the capturing material is a selective capturing material.

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