Systems, apparatus, and devices for analyte monitors

Abstract

A continuous analyte sensor system for monitoring an analyte level in a bodily fluid of a user. The system includes a sensor electronics system and an analyte sensor. The sensor includes a distal portion for positioning below the user's skin surface in contact with the bodily fluid to monitor the analyte level in the bodily fluid, and a proximal portion for positioning above the skin surface and operatively connected to the sensor electronics system. The sensor electronics system receives a sensor signal indicative of the analyte level from the analyte sensor and generates data related to the analyte level. The sensor electronics system includes a transceiver for transmitting an outgoing signal including data related to the analyte level and for receiving an incoming signal. The transceiver includes an electromagnetic signal generating component having first and second signal feed points. The sensor electronics system operates in a first and / or second communication mode. In the first communication mode, the sensor electronics system provides a first outgoing signal to a first signal feed point. In the second communication mode, the sensor electronics system provides a second outgoing signal to a second signal feed point.

Description

[Technical Field]

[0001] Priority This application claims the benefit under 35 U.S.C. § 119(e) of U.S. Provisional Patent Application No. 63 / 402,744, filed August 31, 2022, which is incorporated herein by reference.

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

[0003] Detecting and / or monitoring analyte levels, such as glucose, ketones, lactate, oxygen, hemoglobin, or A1C, can be extremely important with respect 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 generally need to monitor their glucose levels to ensure they are maintained within a clinically safe range, and can also use this information to determine when they need and / or require insulin to reduce glucose levels in the body, or when they need additional glucose to raise glucose levels in the body.

[0004] Growing clinical data reveals a strong correlation between glucose monitoring frequency and glycemic control. However, despite such correlation, many individuals diagnosed with the diabetic condition do not monitor their glucose levels as 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 requiring analyte monitoring. To increase comfort and convenience for the individual, the sensor-controlling device can have a small form factor and can be assembled and applied by the individual using a sensor applicator. The application process involves inserting a sensor, such as a skin sensor that senses a user's analyte level in a bodily fluid located in the dermal layer of the human body, using the applicator or insertion mechanism so that the sensor is in contact with the bodily fluid. The sensor-controlling device can also be configured to transmit analyte data to a receiving device from which the individual or their healthcare provider ("HCP") can review the data and make therapeutic decisions.

[0006] Transmission of analyte data from a sensor to a receiving device can be performed using wired or wireless transmission. However, prior art systems place a high emphasis on wireless transmission, performed using near field communication (NFC) and / or Bluetooth communication. Wireless transmission allows for manual or automatic transmission of monitored analyte levels by a user to a receiving device, improving the usability of the analyte monitor sensor. To ensure transmission, a reliable wireless transmission signal must be maintained between the sensor control device and the receiving device. Summary of the Invention [Problem to be solved by the invention]

[0007] Thus, a need exists for systems, apparatus, and methods that ensure reliable wireless transmission of analyte levels monitored by an individual or HCP from a sensor to a receiving device. [Means for solving the problem]

[0008] The objects and advantages of the disclosed subject matter will be set forth in and obvious from the description which follows, as well as be learned by practice of the disclosed subject matter. Additional advantages of the disclosed subject matter will be realized and obtained by the methods and systems particularly pointed out in the description and claims hereof, as well as the appended drawings.

[0009] In accordance with the subject matter of the present disclosure, there is provided a continuous analyte sensor system for monitoring an analyte level in a bodily fluid of a user, the system including a sensor electronics system and an analyte sensor including a proximal portion and a distal portion, the distal portion configured to be positioned below a skin surface of a user in contact with the bodily fluid to monitor an analyte level in the bodily fluid, the proximal portion configured to be positioned above the skin surface of the user and in operative connection with the sensor electronics system, the sensor electronics system configured to receive a sensor signal from the analyte sensor indicative of the analyte level and generate data related to the analyte level from the sensor signal for wireless transmission, The sensor electronics system includes a transceiver for transmitting outgoing signals and receiving incoming signals including data associated with the rule, the transceiver including an electromagnetic signal generating component configured to be supplied with the outgoing signals, the electromagnetic signal generating component having a first signal feed point and a second signal feed point, the sensor electronics system configured to operate in a first communication mode and further configured to operate in a second communication mode, wherein in the first communication mode the sensor electronics system is configured to supply the first outgoing signal to the first signal feed point of the electromagnetic signal generating component and wherein in the second communication mode the sensor electronics system is configured to supply the second outgoing signal to the second signal feed point of the electromagnetic signal generating component.

[0010] Optionally, the electromagnetic signal-generating component includes a conductive coil having one or more loops, the coil having a first end and a second end. Optionally, the first signal feed point is at one of the first and second ends. Optionally, the second signal feed point is at a location on the coil between the first and second ends. Optionally, the second signal feed point is at a location on the coil substantially midway between the first and second ends. Optionally, in the second communication mode, the electromagnetic signal-generating component is configured to operate as a dipole antenna. Optionally, in the second communication mode, the sensor electronics system is configured for wireless communication according to a Bluetooth or Bluetooth Low Energy protocol. Optionally, in the first communication mode, the electromagnetic signal-generating component is configured to operate as an inductive antenna. Optionally, in the first communication mode, the sensor electronics system is configured for wireless communication according to an NFC or RFID protocol.

[0011] To achieve these and other advantages, and in accordance with the objects of the disclosed subject matter as embodied and outlined, the disclosed subject matter relates to a device that can include a printed circuit board configured to monitor an analyte level. In certain non-limiting embodiments, the device can also include a battery connected to the printed circuit board and configured to power the printed circuit board. The printed circuit board can include multiple layers. Additionally, the device can include a connector connected to the printed circuit board and configured to establish an electrical connection between the analyte sensor and the printed circuit board, and / or a processor connected to the printed circuit board and configured to process data associated with the monitored analyte level. Furthermore, the device can include antennas for transmitting the monitored analyte level located on multiple risers. The risers can extend a fixed distance from the plane of the printed circuit board.

[0012] In certain non-limiting embodiments, the analyte level can include a glucose level. The antenna can be a Bluetooth low energy antenna. The plurality of risers can include four risers, two of the four risers configured to electrically connect the antenna to the printed circuit board. One or more of the plurality of risers can include a folded portion of the antenna. The printed circuit board can include FR4 material. At least a portion of the plurality of risers can be pre-plated tin over nickel. The antenna can include a crossbar positioned between a first set of the plurality of risers and a second set of the plurality of risers. The crossbar can form a portion of an H-shape. In some non-limiting embodiments, the antenna can include two or more ends forming a Y-shape. In certain non-limiting embodiments, the antenna can include a free end extending a fixed distance from the surface of the printed circuit board. In other non-limiting embodiments, the first set of the plurality of risers can be positioned proximate to the connector, while the second set of the plurality of risers can be positioned proximate to the battery. The second set or the first set of the plurality of risers can be configured to electrically connect the antenna to the printed circuit board, and the risers can extend a fixed distance from the plane of the printed circuit board, which can be greater than 1.5 millimeters (mm).

[0013] In some non-limiting embodiments, the antenna can be curved around the circumference of the battery. The antenna can be configured as an inverted H-shape or a J-shape. The antenna can have, for example, at least one of a deployed width of about 9.33 mm (or between about 5 and 14 mm), a deployed length of about 12.04 mm (or between about 7 and 18 mm), and / or a mass of 0.024 grams (or between about 0.01 and 0.04 grams). In other non-limiting embodiments, the device can include a separate NFC antenna for transmitting the monitored analyte level. The NFC antenna can be embedded within and / or around the circumference of the printed circuit board. In certain non-limiting embodiments, the connector can include at least one of silicone rubber or carbon-impregnated polymer. In other non-limiting embodiments, the connector can include a connector having metal contacts.

[0014] In certain other non-limiting embodiments, the system can include an analyte sensor. A portion of the analyte sensor can be configured to be positioned in contact with the fluid below the skin layer to monitor the analyte level in the fluid. The system can also include a printed circuit board connected to the analyte sensor and / or a battery connected to the printed circuit board and configured to power the printed circuit board. Additionally, the system can include a connector connected to the printed circuit board and configured to establish an electrical connection between the analyte sensor and the printed circuit board, and / or a processor connected to the printed circuit board and configured to process data associated with the monitored analyte level. Further, the system can include antennas for transmitting the monitored analyte level located on a plurality of risers. The risers can extend a predetermined distance from the plane of the printed circuit board. The system can include any of the features described above with respect to the device.

[0015] To achieve these and other advantages and in accordance with the objectives of the presently disclosed subject matter, as embodied and broadly described, the presently disclosed subject matter relates to a device that can include a printed circuit board configured to monitor analyte levels. In certain non-limiting embodiments, the device can also include the printed circuit board. In certain non-limiting embodiments, the device can also include a connector connected to the printed circuit board and configured to establish an electrical connection between an analyte sensor having a proximal portion and a distal portion, the proximal portion electrically coupled to the printed circuit board and the distal portion configured to extend below the user's skin to monitor the level of one or more analytes in the bodily fluid. In certain non-limiting embodiments, the device can also include a battery connected to the printed circuit board and configured to power the printed circuit board. In certain non-limiting embodiments, the device can also include a processor connected to the printed circuit board and configured to process data associated with the monitored one or more analyte levels. In certain non-limiting embodiments, the device can also include an antenna for transmitting the processed data, the antenna including at least one conductive trace on at least one layer of the printed circuit board, the antenna including a first set of contacts for transmitting the processed data at a first frequency and at least one second contact for transmitting the processed data at a second frequency.

[0016] In certain non-limiting embodiments, the first frequency can be for transmission using Bluetooth Low Energy, and the second frequency can be for transmission using Near Field Communication. In certain non-limiting embodiments, the at least one conductive trace on at least one layer of the printed circuit board can form multiple loops that traverse the periphery of the printed circuit board. In certain non-limiting embodiments, the at least one conductive trace on the at least one layer of the printed circuit board can include at least one conductive trace that at least partially traverses the periphery of the printed circuit board to form at least three loops. In certain non-limiting embodiments, the at least one conductive trace on the at least one layer of the printed circuit board can form at least three loops that traverse the periphery of the printed circuit board. In certain non-limiting embodiments, the at least one conductive trace on the at least one layer of the printed circuit board can include at least one conductive trace on each of multiple layers of the printed circuit board. In certain non-limiting embodiments, the at least one conductive trace on each of the multiple layers of the printed circuit board can be connected by a via between two layers of the printed circuit board. In certain non-limiting embodiments, the first set of contacts can include contacts at ends of the conductive traces, the conductive traces being between the first set of contacts. In certain non-limiting embodiments, the at least one second contact can include at least one contact near a center of the conductive traces. In certain non-limiting embodiments, the conductive traces and the at least one second contact can form a dipole antenna. In certain non-limiting embodiments, the printed circuit board can include a ground plane configured on its own plane.

[0017] In certain other non-limiting embodiments, the system can include a printed circuit board. In certain other non-limiting embodiments, the system can include an analyte sensor having a proximal portion and a distal portion, the distal portion configured to extend below the user's skin to monitor one or more analyte levels in a bodily fluid. In certain other non-limiting embodiments, the system can include a connector connected to the printed circuit board and configured to establish an electrical connection between the proximal portion of the analyte sensor and the printed circuit board. In certain other non-limiting embodiments, the system can include a battery connected to the printed circuit board and configured to power the printed circuit board. In certain other non-limiting embodiments, the system can include a processor connected to the printed circuit board and configured to process data associated with the monitored one or more analyte levels. In certain other non-limiting embodiments, the system can include an antenna for transmitting the processed data, the antenna including at least one conductive trace on at least one layer of the printed circuit board, the antenna including a first set of contacts for transmitting the processed data at a first frequency and at least one second contact for transmitting the processed data at a second frequency.

[0018] Details of the subject matter recited herein, both as to its structure and operation, can be apparent from inspection of the accompanying drawings, in which like reference numerals refer to like parts. The components in the figures are not necessarily to scale, emphasis instead being placed upon illustrating the principles of the subject matter. Moreover, all illustrations are intended to convey concepts, and relative sizes, shapes, and other detailed attributes may be illustrated schematically, rather than literally or precisely. [Brief explanation of the drawings]

[0019] [Figure 1] FIG. 1 is a conceptual diagram depicting an exemplary analyte monitor system that may incorporate one or more embodiments of the present disclosure. [Figure 2A]FIG. 1 is an isometric view of an exemplary sensor control device in accordance with certain non-limiting embodiments. [Figure 2B] FIG. 1 is a side view of an exemplary sensor control device in accordance with certain non-limiting embodiments. [Figure 3A] FIG. 2C is an isometric view of the plug assembly of FIGS. 2A and 2B in accordance with certain non-limiting embodiments. [Figure 3B] FIG. 2C is an exploded view of the plug assembly of FIGS. 2A and 2B according to certain non-limiting embodiments. [Figure 4A] FIG. 2C is an exploded view of the electronic device housing of FIGS. 2A and 2B according to certain non-limiting embodiments. [Figure 4B] FIG. 2C is a bottom isometric view of the electronic device housing of FIGS. 2A and 2B in accordance with certain non-limiting embodiments. [Figure 5A] FIG. 2 is a side view of the sensor applicator of FIG. 1 with a cap coupled thereto in accordance with certain non-limiting embodiments. [Figure 5B] 2 is a cross-sectional side view of the sensor applicator of FIG. 1 with a cap coupled thereto in accordance with certain non-limiting embodiments. [Figure 6A] FIG. 10 is an enlarged cross-sectional side view of a sensor control device mounted within a cap in accordance with certain non-limiting embodiments. [Figure 6B] FIG. 10 is an enlarged cross-sectional side view of another embodiment of a sensor control device mounted within a sensor applicator in accordance with certain non-limiting embodiments. [Figure 7] FIG. 1 is an isometric view of an exemplary sensor control device in accordance with certain non-limiting embodiments. [Figure 8] FIG. 2 is a side view of the sensor applicator of FIG. 1 in accordance with certain non-limiting embodiments. [Figure 9] FIG. 1 is a cross-sectional side view of a sensor applicator according to certain non-limiting embodiments. [Figure 10A] FIG. 1 is an isometric view of an exemplary sensor control device in accordance with certain non-limiting embodiments. [Figure 10B] FIG. 1 is a side view of an exemplary sensor control device in accordance with certain non-limiting embodiments. [Figure 11A] FIG. 1 is an isometric view of a plug assembly according to certain non-limiting embodiments. [Figure 11B] FIG. 1 is an exploded view of a plug assembly according to certain non-limiting embodiments. [Figure 11C] FIG. 1 is an exploded isometric bottom view of a plug and storage vial according to certain non-limiting embodiments. [Figure 12A] FIG. 1 illustrates an exploded view of an electronic device housing according to certain embodiments. [Figure 12B] FIG. 1 illustrates a bottom isometric view of an electronic device housing according to certain embodiments. [Figure 13A] FIG. 1 is a side view of a sensor applicator according to certain non-limiting embodiments. [Figure 13B] FIG. 1 is a cross-sectional side view of a sensor applicator according to certain non-limiting embodiments. [Figure 14] 1A and 1B are perspective views of an exemplary embodiment of a cap according to certain embodiments. [Figure 15] FIG. 10 is a cross-sectional side view of a sensor control device positioned within a cap according to certain embodiments. [Figure 16A] FIG. 1 is an isometric view of an exemplary sensor control device according to certain embodiments. [Figure 16B] FIG. 1 is a side view of an exemplary sensor control device according to certain embodiments. [Figure 17A] FIG. 1 is an exploded perspective top view of a sensor control device according to certain embodiments. [Figure 17B] FIG. 1 is an exploded perspective bottom view of a sensor control device according to certain embodiments. [Figure 18A] FIG. 1 is an isometric view of an exemplary sensor control device according to certain embodiments. [Figure 18B] FIG. 1 is a side view of an exemplary sensor control device according to certain embodiments. [Figure 18C] FIG. 2 is a bottom view of an exemplary sensor control device according to certain embodiments. [Figure 19A]FIG. 1 illustrates an isometric exploded top view of a sensor control device according to certain embodiments. [Figure 19B] FIG. 1 is an isometric exploded bottom view of a sensor control device according to certain embodiments. [Figure 20A] 1A-1C illustrate fabrication of a sensor control device according to certain embodiments. [Figure 20B] 1A-1C illustrate fabrication of a sensor control device according to certain embodiments. [Figure 21] FIG. 1 is a side view of an exemplary sensor according to certain embodiments. [Figure 22A] FIG. 1 is an isometric view of an exemplary connector assembly according to certain embodiments. [Figure 22B] FIG. 1 is a partially exploded isometric view of an exemplary connector assembly according to certain embodiments. [Figure 22C] FIG. 22C is an isometric bottom view of the connector of FIGS. 22A-22B. [Figure 22D] FIG. 10 is an isometric view of another exemplary connector assembly in accordance with certain embodiments. [Figure 22E] FIG. 10 is a partially exploded isometric view of another exemplary connector assembly in accordance with certain embodiments. [Figure 22F] FIG. 22D-FIG. 22E is an isometric bottom view of the connector of FIG. [Figure 23A] FIG. 1 is a side view of an exemplary sensor control device according to certain embodiments. [Figure 23B] FIG. 1 is an isometric view of an exemplary sensor control device according to certain embodiments. [Figure 24A] FIG. 1 illustrates an exploded isometric top view of a sensor control device according to certain embodiments. [Figure 24B] FIG. 1 is an exploded isometric bottom view of a sensor control device according to certain embodiments. [Figure 25A] 23A-23B and 24A-24B are cross-sectional side views of the sensor control device illustrated in FIGS. 23A-23B and 24A-24B in accordance with certain embodiments. [Figure 25B]FIG. 24A is an exploded isometric view of a portion of another embodiment of the sensor control device illustrated in FIGS. 23A-23B and 24A-24B. [Figure 26A] FIG. 24A is an isometric bottom view of the mount illustrated in FIGS. 23A-23B and 24A-24B. [Figure 26B] FIG. 24A is an isometric top view of the sensor cap illustrated in FIGS. 23A-23B and 24A-24B. [Figure 27A] FIG. 1 is a side view of an exemplary sensor applicator according to certain embodiments. [Figure 27B] FIG. 1 is a cross-sectional side view of an exemplary sensor applicator according to certain embodiments. [Figure 28A] FIG. 27C is a perspective view of the cap post illustrated in FIG. 27B according to certain embodiments. [Figure 28B] FIG. 27C is a top view of the cap post illustrated in FIG. 27B in accordance with certain embodiments. [Figure 29] FIG. 1 is a cross-sectional side view of a sensor control device positioned within an applicator cap according to one or more embodiments. [Figure 30] 1 is a cross-sectional view of a sensor control device illustrating an exemplary interaction between a sensor and a sharp. [Figure 31A] FIG. 1 illustrates a printed circuit board according to certain embodiments. [Figure 31B] FIG. 1 illustrates a printed circuit board according to certain embodiments. [Figure 32] FIG. 1 illustrates a printed circuit board according to certain embodiments. [Figure 33A] 1A and 1B illustrate antenna embodiments in accordance with certain embodiments. [Figure 33B] 1A and 1B illustrate antenna embodiments in accordance with certain embodiments. [Figure 33C] 1A and 1B illustrate embodiments of antennas in accordance with certain embodiments. [Figure 33D] 1A and 1B illustrate antenna embodiments in accordance with certain embodiments. [Figure 34A]1 illustrates an exemplary PCB including an antenna in accordance with the subject matter of the present disclosure. [Figure 34B] 1 illustrates an exemplary PCB including an antenna in accordance with the subject matter of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0020] Before describing the present subject matter in detail, it is to be understood that the present disclosure is not limited to particular embodiments described, as such may, of course, vary. The scope of the present disclosure is not limited, except as by the claims, and the terminology used herein is for the purpose of describing particular embodiments only.

[0021] The documents discussed herein are provided solely for their disclosure prior to the filing date of the present application. Nothing herein should be construed as an admission that the present disclosure is not entitled to antedate such document by virtue of prior disclosure. Further, the dates of the documents provided may be different from the actual publication dates, which may need to be independently confirmed.

[0022] The present disclosure will now be described more fully hereinafter with reference to the accompanying drawings, which form a part hereof and which show, as embodiments, certain exemplary embodiments. However, the intended or claimed subject matter can be embodied in a variety of different forms and, therefore, is not intended to be construed as limited to any exemplary embodiments listed herein, which are provided as examples only. Likewise, a reasonably broad scope for the intended or claimed subject matter is intended. Among other things, for example, the subject matter can be embodied as a method, device, component, or system. Thus, embodiments can take the form of, for example, hardware, software, firmware, or any combination thereof (excluding software itself). Accordingly, the following detailed description is not intended to be taken in a limiting sense.

[0023] In the detailed description herein, references to "an embodiment," "one embodiment," "one non-limiting embodiment," "in various embodiments," etc., indicate that the described embodiment may include a particular feature, structure, or characteristic, but that not all embodiments necessarily include such a particular feature, structure, or characteristic. Moreover, such phrases do not necessarily refer to the same embodiment. Furthermore, when a particular feature, structure, or characteristic is described with respect to an embodiment, it is understood by those skilled in the art that such feature, structure, or characteristic affects other embodiments, whether or not explicitly described. After reading and understanding this description, it will be apparent to those skilled in the art how to implement the present disclosure in alternative embodiments.

[0024] Generally, terms will be understood, at least in part, from their use in context. For example, terms such as "and," "or," or "and / or" used herein may depend, at least in part, on the context in which they are used. Typically, when used to link a list of items such as A, B, or C, "or" is intended to mean A, B, and C, in which case it is used in an inclusive sense, and to mean A, B, or C, in which case it is used in an exclusive sense. Additionally, as used herein, "one or more" can be used to describe any feature, structure, or characteristic in a singular sense, or can be used to describe a combination of features, structures, or characteristics in a plural sense, depending, at least in part, on the context. Similarly, terms such as "a," "an," and "the" can be understood to convey a singular referent or a plural referent, again depending, at least in part, on the context. Additionally, it can be understood that the term "based on" is not necessarily intended to convey an exclusive set of factors, but instead may allow for the presence of additional factors not necessarily explicitly described, again depending, at least in part, on the context.

[0025] As used herein, "comprises," "comprising," or any other variation thereof, is intended to cover an open-ended inclusion such that a process, method, article, or apparatus that includes the listed elements may include not only those elements, but also other elements not expressly listed or elements inherent in such process, method, article, or apparatus.

[0026] Various types of in-vivo analyte monitor systems exist. A "continuous analyte monitor" system (or "continuous glucose monitor" system), for example, can transmit data continuously, e.g., automatically according to a schedule, from the sensor control device to the reader device without requiring an acknowledgement. As another example, an "intermittent analyte monitor" system (or "intermittent glucose monitor" system or simply "intermittent" system) can transfer data from the sensor control device in response to a scan or request for data by the reader device using, for example, a near-field communication (NFC) protocol or a radio frequency identification (RFID) protocol. An in-vivo analyte monitor system can also operate without the need for fingerstick calibration.

[0027] In vivo analyte monitor systems can be distinguished from "in vitro" systems, which contact a biological sample outside the body (or "ex vivo") and generally have a port for accepting an analyte test strip having a user's bodily fluid that can be analyzed to determine the user's blood glucose level.

[0028] An in-vivo monitoring system may include a sensor that contacts a user's bodily fluid while positioned in vivo 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 containing the electronics and power source that enable and control the analyte sensing. Sensor control devices and variations thereof may be referred to as "sensor control units," "on-body electronics" devices or units, "on-body" devices or units, or "sensor data communication" devices or units, to name a few.

[0029] An in-vivo monitoring system may include a device that accepts sensed analyte data from the sensor control device and processes and / or displays it to a user in any number of forms. This device and variations thereof may be referred to as a "handheld reader device," "reader device" (or simply "reader"), "handheld electronic device" (or simply "handheld"), "portable data processing" device or unit, "data receiver," "receiver" device or unit (or simply "receiver"), or "remote" device or unit, to name a few. Other devices, such as personal computers, may also be used in conjunction with or incorporated into in-vivo or in-vitro monitoring systems.

[0030] 1 is a conceptual diagram illustrating an exemplary analyte monitor system 100 that can incorporate one or more embodiments of the present disclosure. System 100 (hereinafter "system 100") can be used to detect and quantify a variety of analytes, including, but not limited to, acetylcholine, amylase, bilirubin, cholesterol, chorionic gonadotropin, creatine kinase (e.g., CK-MB), creatine, DNA, fructosamine, glucose, glutamine, growth hormone, hormones, ketones (e.g., ketone bodies), lactate, oxygen, peroxide, prostate-specific antigen, prothrombin, RNA, thyroid-stimulating hormone, and troponin. Concentrations of drugs, including, but not limited to, antibiotics (e.g., gentamicin and vancomycin), digitoxin, digoxin, drugs of abuse, theophylline, and warfarin, can be determined.

[0031] As shown, system 100 includes a sensor applicator 102 (alternatively referred to as an "insertor"), a sensor control device 104 (also referred to as an "in vivo analyte sensor control device"), and a reader device 106. The sensor applicator 102 is used to deliver the sensor control device 104 to a target monitoring location on a user's skin (e.g., the user's arm). Once delivered, the sensor control device 104 is maintained in place on the skin using an adhesive patch 108 coupled to its bottom surface. A portion of a sensor 110 extends from the sensor control device 104 and is positioned transcutaneously and otherwise such that it can be held below the surface of the user's skin during monitoring.

[0032] An introducer can be included to facilitate the introduction of the sensor 110 into the tissue. The introducer can include, for example, a needle, often referred to as a "sharp." Alternatively, the introducer can include other types of devices, such as a sheath or blade. The introducer can be temporarily present around the sensor 110 prior to tissue insertion and then withdrawn. While present, the introducer can facilitate the insertion of the sensor 110 into the tissue by opening an access path for the sensor 110 to follow. For example, the introducer can penetrate the epidermis to provide an access path to the dermis to allow subcutaneous implantation of the sensor 110. After opening the access path, the introducer can be withdrawn (retracted) so that the introducer does not present an obstruction while the sensor 110 remains in place.

[0033] In exemplary embodiments, introducers can be solid or hollow, beveled or non-beveled, and / or have a circular or non-circular cross-section. In more specific embodiments, suitable introducers can be equivalent in cross-sectional diameter and / or tip design to acupuncture needles, which can have a cross-sectional diameter of approximately 250 microns. However, it will be recognized that suitable introducers can have larger or smaller cross-sectional diameters as required for a particular application.

[0034] In some embodiments, the tip of the introducer (while present) can be angled over the end of the sensor 110 so that the introducer first penetrates the tissue to open an access pathway for the sensor 110. In other exemplary embodiments, the sensor 110 can reside within a lumen or channel in the introducer, which also opens an access pathway for the sensor 110. In either case, the introducer can be withdrawn after facilitating insertion of the sensor. Additionally, the introducer (sharp) can be made of a variety of materials, such as various types of metals and plastics.

[0035] When the sensor control device 104 is properly assembled, the sensor 110 is placed in communication (e.g., electrically, mechanically) with one or more electrical components or sensor electronics contained within the sensor control device 104. In some applications, for example, the sensor control device 104 may include a printed circuit board (PCB) having a data processor (e.g., an application specific integrated circuit or ASIC) mounted thereon, and the sensor 110 may be operatively coupled to the data processor, which may further be coupled to an antenna and a power source.

[0036] The sensor control device 104 and the reader device 106 are configured to communicate with each other through a local communication path or link 112, which may be wired or wireless, one-way or two-way, and encrypted or unencrypted. According to some embodiments, the reader device 106 includes an output medium for viewing the analyte concentration and alerts or notifications determined by the sensor 110 or its associated processor, and may further allow for one or more user inputs. The reader device 106 may be a general-purpose smart phone or a dedicated electronic reading meter. Although only one reader device 106 is shown, in certain instances, multiple reader devices 106 may be present.

[0037] The reader device 106 may also be in communication with a remote terminal 114 and / or a trusted computer system 116 through communication paths / links 118 and / or 120, respectively, which may be wired or wireless, one-way or two-way, and encrypted or unencrypted. The reader device 106 may also or alternatively be in communication with a network 122 (e.g., a cellular network, the Internet, or a cloud server) through communication path / link 124. The network 122 may further be communicatively coupled to the remote terminal 114 through communication path / link 126 and / or to the trusted computer system 116 through communication path / link 128.

[0038] Alternatively, the sensor control device 104 may communicate directly with the remote terminal 114 and / or trusted computer system 116, without the presence of an intervening reader device 106. For example, according to some embodiments, the sensor 110 may communicate with the remote terminal 114 and / or trusted computer system 116 through a direct communications link to the network 122, as described in U.S. Pat. No. 10,136,816, the entire contents of which are incorporated herein by reference.

[0039] Any suitable electronic communication protocol may be used for each of the communication paths or links, such as an NFC protocol, a radio frequency identification (RFID) protocol, a BLUETOOTH® protocol, a BLUETOOTH® low energy protocol, or a wireless local area network. According to some embodiments, the remote terminal 114 and / or the trusted computer system 116 may be accessible by individuals other than the primary user who have an interest in the user's analyte levels. The reader device 106 may include a display 130 and an optional input component 132. According to some embodiments, the display 130 may include a touch screen interface.

[0040] In some embodiments, the sensor control device 104 can automatically transfer data to the reader device 106. For example, analyte concentration data can be communicated automatically and periodically, such as when the data is acquired or at a predetermined frequency (e.g., every minute, every five minutes, or other predetermined period) after a predetermined period of time has elapsed where the data is stored in memory before transmission. In other embodiments, the sensor control device 104 can communicate with the reader device 106 in a non-automatic manner and without following a set schedule. For example, data can be communicated from the sensor control device 104 using RFID technology when the sensor electronics are brought within communication range of the reader device 106. The data can remain stored in the memory of the sensor control device 104 until communicated to the reader device 106. Thus, the patient need not maintain close proximity to the reader device 106 at all times, but can instead upload data at a convenient time. In still other embodiments, a combination of automatic and non-automatic data transfer can be implemented. For example, data transfer may continue on an automatic basis until the reader device 106 is no longer within communication range of the sensor control device 104 .

[0041] The sensor control device 104 is often included with the sensor applicator 104 in what is known as a "two-piece" architecture that requires final assembly by the user before the sensor 110 can be properly delivered to a target monitoring location. More specifically, the sensor 110 and the associated electrical components included in the sensor control device 104 are provided to the user in multiple (two) packages, and the user must unpack the packages and manually assemble these components according to instructions before delivering the sensor 110 to a target monitoring location with the sensor applicator 102.

[0042] More recently, however, advanced designs of sensor control devices and sensor applicators have resulted in a one-piece architecture that allows the system to be shipped to the user in a single sealed package, eliminating the need for any final user assembly steps. Rather, the user need only unpack the single package and then deliver the sensor control device to the target monitoring location. The one-piece system architecture can prove advantageous by eliminating component parts, various fabrication process steps, and user assembly steps. This results in reduced packaging and waste, and mitigates user error or system contamination.

[0043] In an exemplary embodiment, system 100 may be configured as a “two-piece architecture” that requires final assembly by the user before sensor 110 can be properly delivered to a target monitoring location. More specifically, sensor 110 and the associated electrical components contained within sensor control device 104 are provided to the user in multiple (two) packages, each of which may or may not be sealed with a sterile barrier, but is at least enclosed within the package. The user must unpack the packages and manually assemble the components according to the instructions, and then deliver sensor 110 to a target monitoring location using sensor applicator 102. However, in certain other embodiments, system 100 may be configured as a “one-piece” architecture.

[0044] 2A and 2B are isometric and side views, respectively, of an exemplary sensor control device 202 in accordance with one or more embodiments of the present disclosure. The sensor control device 202 (alternatively referred to as a "puck") may be similar in some respects to the sensor control device 104 of FIG. 1 and, therefore, may be best understood with reference thereto. The sensor control device 202 may replace the sensor control device 104 of FIG. 1 and, therefore, may be used in conjunction with the sensor applicator 102 (FIG. 1), which delivers the sensor control device 202 to a target monitoring location on the user's skin.

[0045] However, the sensor control device 202 can be incorporated into a one-piece system architecture. Unlike a two-piece architecture, for example, a user is not required to unpack multiple packages and finally assemble the sensor control device 202. Instead, upon receipt by the user, the sensor control device 202 is already fully assembled and properly positioned within the sensor applicator 102. To use the sensor control device 202, the user need only break a single barrier, for example, an applicator cap, before immediately dispatching the sensor control device 202 to a target monitoring location.

[0046] As shown, the sensor control device 202 includes an electronics housing 204 that is a generally disk-shaped electronics housing and / or a puck shaped to have a circular cross-section. However, in other embodiments, the electronics housing 204 can exhibit other cross-sectional shapes, such as an oval (e.g., pill-shaped), a rounded square, or a polygonal shape, without departing from the scope of this disclosure. The electronics housing 204 can be configured to house or otherwise enclose various electrical components used to operate the sensor control device 202.

[0047] The electronics housing 204 may include a shell 206 and a mateable mount 208. The shell 206 may be secured to the mount 208 by various methods, such as a snap fit, an interference fit, sonic welding, or one or more mechanical fasteners (e.g., screws). In some cases, the shell 206 may be secured to the mount 208 such that a sealed interface occurs between them. In such embodiments, a gasket or other type of sealing material may be positioned at or near the outer diameter (periphery) of the shell 206 and the mount 208, and securing the two components together may compress the gasket, thereby creating a sealed interface. In other embodiments, an adhesive may be applied to the outer diameter (periphery) of one or both of the shell 206 and the mount 208. The adhesive may not only secure the shell 206 to the mount 208 and provide structural integrity, but may also seal the interface between the two components, thereby isolating the interior of the electronics housing 204 from outside contamination. If the sensor control device 202 is assembled in a controlled environment, it may not be necessary to terminally sterilize the internal electrical components. Rather, adhesive bonding can provide a sufficient sterility barrier for the assembled electronics housing 204.

[0048] The sensor control device 202 may further include a plug assembly 210 that can be coupled to the electronics housing 204. For example, the plug assembly 210 may include a sensor module 212 (partially visible) that can be interconnected with a sharps module 214 (partially visible). The sensor module 212 may be configured to carry and otherwise include a sensor 216 (partially visible), and the sharps module 214 may be configured to carry and otherwise include a sharps 218 (partially visible) that is used to aid in transcutaneously delivering the sensor 216 beneath the user's skin during application of the sensor control device 202. As shown, corresponding portions of the sensor 216 and sharps 218 extend from the electronics housing 204, and more specifically, from the bottom of the mount 208. An exposed portion of the sensor 216 may be received within a hollow or recessed portion of the sharps 218. The remaining portion of the sensor 216 is positioned within the electronics housing 204.

[0049] 3A and 3B are isometric and exploded views, respectively, of a plug assembly 210 according to one or more embodiments. The sensor module 212 can include a sensor 216, a plug 302, and a connector 304. The plug 302 can be designed to receive and support both the sensor 216 and the connector 304. As shown, a channel 306 can be defined through the plug 302 to receive a portion of the sensor 216. Additionally, the plug 302 can provide one or more deflectable arms 307 configured to snap into corresponding features on the bottom of the electronics housing 204 (FIGS. 2A and 2B).

[0050] The sensor 216 includes a tail 308, a flag 310, and a neck 312 interconnecting the tail 308 and the flag 310. The tail 308 can be configured to extend at least partially through the channel 306 and extend distally from the plug 302. The tail 308 includes an enzyme or other chemical or biological agent, and in some embodiments, a membrane can cover the chemical agent. During use, the tail 308 is transdermally received under the user's skin, and the chemical agent contained on the tail helps facilitate analyte monitoring in the presence of bodily fluids.

[0051] Flag 310 may include a generally flat surface with one or more sensor contacts 314 (three are shown in FIG. 3B) positioned thereon. Sensor contacts 314 may be configured to align with a corresponding number of flexible carbon-impregnated polymer modules (not shown) enclosed within connector 304.

[0052] The connector 304 includes one or more hinges 318 that allow it to move between an open and a closed state. While FIGS. 3A and 3B show the connector 304 in a closed state, the connector 304 can pivot to the open state to receive the flag 310 and flexible carbon-impregnated polymer module therein. The flexible carbon-impregnated polymer module provides electrical contacts 320 (three shown) configured to provide conductive communication between the sensor 216 and corresponding circuit contacts provided within the electronics housing 204 ( FIGS. 2A and 2B ). The connector 304 can be fabricated from silicone rubber and can function as a moisture barrier to the sensor 216 when assembled in a compressed state and after application to the user's skin.

[0053] The sharps module 214 includes a sharps 218 and a sharps hub 322 that carries the sharps 218. The sharps 218 include an elongated shaft 324 and a sharps tip 326 at its distal end. The shaft 324 can be configured to extend through the channel 306 and extend distally from the plug 302. Additionally, the shaft 324 can include a hollow or recessed portion 328 that at least partially surrounds the tail 308 of the sensor 216. The sharps tip 326 can be configured to pierce the skin while carrying the tail 308 to bring the active chemical present on the tail 308 into contact with bodily fluids.

[0054] The sharp hub 322 can include a hub mini-cylinder 330 and a hub snap locking pawl 332, each of which can be configured to assist in coupling the plug assembly 210 (and the entire sensor control device 202) to the sensor applicator 102 (FIG. 1).

[0055] 4A and 4B are exploded and bottom isometric views, respectively, of electronics housing 204 according to one or more embodiments. Shell 206 and mount 208 act as opposing clamshell halves that enclose or otherwise substantially enclose the various electronic components of sensor control device 202 (FIGS. 2A and 2B).

[0056] A printed circuit board (PCB) 402 may be disposed within the electronics housing 204. The PCB 402 may be populated with a plurality of electronic modules (not shown), including, but not limited to, a data processing unit, resistors, transistors, capacitors, inductors, diodes, and switches. The data processing unit may include, for example, an application specific integrated circuit (ASIC) configured to perform one or more functions or routines associated with the operation of the sensor control device 202. 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 data signals each corresponding to a sampled analyte level of a user. The data processing unit may include an antenna for communication with or otherwise communicate with the reader device 106 (FIG. 1).

[0057] As shown, shell 206, mount 208, and printed circuit board 402 each define corresponding central openings 404, 406, and 408, respectively. When electronics housing 304 is assembled, central openings 404, 406, and 408 are coaxially aligned for receiving portions of plug assembly 210 (FIGS. 3A and 3B) therethrough. A battery 410 may be stored within electronics housing 204 and configured to power sensor control device 202.

[0058] 4B , a plug receptacle 412 is defined at the bottom of the mount 208 and can provide a location where the plug assembly 210 ( FIGS. 3A and 3B ) can be received and coupled to the electronics housing 204, thereby fully assembling the sensor control device 202 ( FIGS. 2A and 2B ). The contours of the plug 302 ( FIGS. 3A and 3B ) can be shaped in a manner that matches or is complementary to the plug receptacle 412, which can provide one or more snap-lock ledges 414 (two shown) configured to mate with and receive the deflectable arm 307 ( FIGS. 3A and 3B ) of the plug 302. The plug assembly 210 is coupled to the electronics housing 204 by inserting the plug 302 into the plug receptacle 412 and allowing the deflectable arm 307 to engage in the corresponding snap-lock ledge 414. When the plug assembly 210 (FIGS. 3A and 3B) is properly coupled to the electronics housing 204, one or more circuit contacts 416 (three shown) defined on the underside of the PCB 402 can be in conductive communication with the electrical contacts 320 (FIGS. 3A and 3B) of the connector 304 (FIGS. 3A and 3B).

[0059] 5A and 5B are side and cross-sectional side views, respectively, of the sensor applicator 102 with an applicator cap coupled thereto. More specifically, FIGS. 5A and 5B depict how the sensor applicator 102 may be shipped and received by a user according to at least one embodiment. However, in some embodiments, the sensor applicator 102 may be further sealed in a bag (not shown) and delivered to a user within the bag. The bag may be made of various materials that help prevent moisture from entering the sensor applicator 102, which may adversely affect the sensor 216. In at least one embodiment, for example, the sealed bag may be made of foil. Any and all of the sensor applicators described or discussed herein may be sealed in a bag and delivered to a user within the bag.

[0060] In accordance with the present disclosure, as can be seen in FIG. 5B , the sensor control device 202 is already assembled and installed in the sensor applicator 102 before being delivered to a user. The applicator cap may be threaded onto the housing and may include a tamper ring 502. Upon rotating (e.g., twisting off) the applicator cap relative to the housing, the tamper ring 502 threads off, thereby allowing the applicator cap to be released from the sensor applicator 102. The user may then deliver the sensor control device 202 to a target monitoring location.

[0061] In some embodiments, as described above, an applicator cap can be secured to the housing by a sealing engagement to protect the internal components of the sensor applicator 102. In at least one embodiment, for example, an O-ring or another type of sealing gasket can seal the interface between the housing and the applicator cap. The O-ring or sealing gasket can be a separate component part, or alternatively, can be molded onto one of the housing and the applicator cap.

[0062] The housing can be made of a variety of rigid materials. In some embodiments, for example, the housing can be made of a thermoplastic polymer such as polyketone. In other embodiments, the housing can be made of a cyclic olefin copolymer (COC), which can help prevent moisture ingress into the sensor applicator 102. As will be apparent, any and all of the housings described or discussed herein can be made of polyketone or COC.

[0063] 5B , the sensor control device 202 can be loaded into the sensor applicator 102 by mating the sharp hub 322 with the sensor carrier 504 contained within the sensor applicator 102. With the sensor control device 202 mated with the sensor carrier 504, the applicator cap can then be secured to the sensor applicator 102.

[0064] In the exemplary embodiment, a collimator 506 is positioned within the applicator cap and may generally serve to support the sensor control device 202 while it is contained within the sensor applicator 102. In some embodiments, the collimator 506 may form an integral part or extension of the applicator cap, such as by being molded with or overmolded onto the applicator cap. In other embodiments, the collimator 506 may comprise a separate structure fitted within or attached to the applicator cap without departing from the scope of this disclosure. In still other embodiments, the collimator 506 is omitted from the packaging received by the user, but may be used elsewhere during sterilization and preparation of the sensor applicator 102 for delivery, as discussed below.

[0065] The collimator 506 can be designed to receive and help protect portions of the sensor control device 202 that need to be sterile, isolating the sterile components of the sensor applicator 102 from microbial contamination from elsewhere within the sensor control device 202. To provide this isolation, the collimator 506 can define or otherwise provide a sterile zone 508 (alternatively referred to as a "sterile barrier enclosure" or "sterile sensor pathway") configured to receive the sensors 216 and sharps 218 extending from the bottom of the electronics housing 204. The sterile zone 508 can generally comprise a hole or passageway that extends at least partially through the body of the collimator 506. In an exemplary embodiment, the sterile zone 508 extends through the entire body of the collimator 506, although it could alternatively extend only partially through the body without departing from the scope of the present disclosure.

[0066] When the sensor control device 202 is loaded into the sensor applicator 102 and the applicator cap having the collimator 506 is secured to the sensor applicator 102, the sensor 216 and sharps 218 can be positioned within a sealed area 510 defined at least in part by a sterile zone 508. The sealed area 510 is configured to isolate the sensor 216 and sharps 218 from external contamination and can include (encompass) selected portions within the electronics housing 204. Certain embodiments can include the sterile zone 508 of the collimator 506.

[0067] In certain embodiments, the fully assembled sensor control device 202 can be subjected to radiation sterilization 512 while positioned within the sensor applicator 102. Radiation sterilization 512 can include, for example, electron beam irradiation, although other sterilization methods can alternatively be used, including, but not limited to, low-energy x-ray irradiation. In some embodiments, radiation sterilization 512 can be delivered by either continuous process irradiation or pulsed beam irradiation. In pulsed beam irradiation, the beam of radiation sterilization 512 is focused at a target location, and the component part or device to be sterilized is moved to the target location, at which point radiation sterilization 512 is activated to provide an induced radiation pulse. Radiation sterilization 512 is then stopped, and another component part or device to be sterilized is moved to the target location, and the process is repeated.

[0068] Collimator 506 can be configured to focus radiation (e.g., beams, waves, energy, etc.) from radiation sterilization 512 toward components that need to be sterile, such as sensor 216 and sharps 218. More specifically, the holes or passages in sterilization zone 508 allow the transmission of radiation that is incident on and sterilizes sensor 216 and sharps 218, while the remainder of collimator 506 prevents (blocks) the propagating radiation from destroying or damaging electronic components within electronics housing 204.

[0069] Sterilization zone 508 may exhibit any suitable cross-sectional shape necessary to properly focus radiation onto sensor 216 and sharps 218 for sterilization. In an exemplary embodiment, for example, sterilization zone 508 is cylindrical, although it is contemplated that sterilization zone 508 may alternatively exhibit a polygonal cross-sectional shape, such as a cube or rectangle (including, for example, a parallelogram) without departing from the scope of the present disclosure.

[0070] In the exemplary embodiment, the sterilization zone 508 provides a first opening 514a at a first end and a second opening 514b at a second end opposite the first end. The first opening 514a can be configured to admit the sensor 316 and the sharp 318 into the sterilization zone 508, and the second opening 514b can allow radiation (e.g., beam, wave, etc.) from the radiation sterilization 512 to enter the sterilization zone 508 and be incident on the sensor 216 and the sharp 218. In the exemplary embodiment, the first opening 514a and the second opening 514b exhibit the same diameter.

[0071] The body of collimator 506 reduces or eliminates radiation sterilization 512 from penetrating the body material and thereby damaging electronic components within electronics housing 204. To provide this reduction or elimination, in some embodiments, collimator 506 may be manufactured from a material having a mass density greater than 0.9 grams per cubic centimeter (g / cc). One exemplary material for collimator 506 is polyethylene, although it is contemplated that any material having a mass density similar to or greater than polyethylene may alternatively be included. In some embodiments, for example, the material for collimator 506 may comprise, but is not limited to, a metal (e.g., lead, stainless steel) or a high-density polymer.

[0072] In at least one embodiment, the design of collimator 506 can be modified so that it can be made of a material that has a mass density lower than 0.9 grams per cubic centimeter (g / cc) but still reduces or eliminates radiation sterilization 512 from being incident on the electronic components within electronics housing 204. To effect this design modification, in some embodiments, the size (e.g., length) of collimator 506 can be increased so that electrons propagating from radiation sterilization 512 must pass through a larger volume of material before being incident on potentially sensitive electronics. This larger volume of material can help absorb or dissipate the radiation intensity of radiation sterilization 512 so that the radiation sterilization 512 is harmless to the sensitive electronics. However, in other embodiments, the opposite may equally be true. More specifically, the size (e.g., length) of collimator 506 can be reduced as long as the material for collimator 506 exhibits a sufficiently high mass density.

[0073] In addition to the radiation shielding properties of the body of the collimator 506, in some embodiments, one or more shields 516 (one shown) may be disposed within the sensor housing 304 to protect sensitive electronic components while the sensor control device 302 undergoes radiation sterilization 512. The shield 516 may be positioned, for example, to be sandwiched between the data processing unit 518 and the radiation source (e.g., an electron beam electron accelerator). In such embodiments, the shield 516 may be positioned adjacent to the data processing unit 518 and otherwise aligned with the data processing unit 518 and the radiation source to block or mitigate radiation (e.g., electron beam radiation or energy) exposure that could otherwise damage the sensitive electronic circuitry of the data processing unit 518.

[0074] The shield 516 can be made of any material capable of blocking (or substantially blocking) the penetration of radiation. Suitable materials for the shield 516 include, but are not limited to, lead, tungsten, iron-based metals (e.g., stainless steel), copper, tantalum, tungsten, osmium, or any combination thereof. Suitable metals can be corrosion-resistant, austenitic, and any non-magnetic metal with a density ranging between about 5 grams per cubic centimeter (g / cc) and about 15 g / cc. The shield 516 can be fabricated by a variety of manufacturing techniques, including, but not limited to, stamping, casting, injection molding, sintering, two-shot molding, or any combination thereof.

[0075] However, in other embodiments, shield 516 may comprise a metal-filled thermoplastic polymer such as, but not limited to, polyamide, polycarbonate, or polystyrene. In such embodiments, shield 516 may be fabricated by mixing the shielding material into an adhesive matrix and dripping the combination onto a component to be molded or otherwise directly onto data processing unit 518. Further, in such embodiments, shield 516 may include an enclosure that encapsulates (or substantially encapsulates) data processing unit 518.

[0076] In some embodiments, a collimator seal 520 can be added to the end of the collimator 506 to completely seal the sterilization zone 508 and therefore the sealed area 510. As shown, the collimator seal 520 can seal the second opening 514b. The collimator seal 520 can be added before or after radiation sterilization 512. In embodiments where the collimator seal 520 is added before providing radiation sterilization 512, the collimator seal 520 can be made of a radio-transparent microbial barrier material that allows radiation to propagate therethrough. By having the collimator seal 520 in place, the sealed area 510 can maintain a sterile environment for the assembled sensor control device 202 until the user removes (unscrews) the applicator cap.

[0077] In some embodiments, the collimator seal 520 can include two or more layers composed of different materials. The first layer can be made of a synthetic material (e.g., flash-spun high-density polyethylene fiber) such as Tyvek®, available from DuPont®. Tyvek® is highly durable and puncture-resistant while allowing vapor transmission. The Tyvek® layer can be applied prior to or subsequently to radiation sterilization 512, and foil and other steam- and moisture-resistant material layers can be sealed (e.g., heat-sealed) onto the Tyvek® layer to prevent ingress of contaminants and moisture into the sterilization zone 508 and sealing area 510. In other embodiments, the collimator seal 520 can include only a single protective layer applied to the end of the collimator 506. In such embodiments, this single layer is gas-permeable toward the sterilization process but also provides protection against moisture and other harmful elements after the sterilization process is complete. Thus, the collimator seal 520 can act as a moisture barrier and a contamination barrier without departing from the scope of the present disclosure.

[0078] It should be noted that the sensor 216 and sharps 218 extend from the bottom of the electronics housing 204 into the sterilization zone 508 generally concentric with the centerline of the sensor applicator 102 and applicator cap, although they are considered to have an eccentric arrangement herein. More specifically, in at least one embodiment, the sensor 216 and sharps 218 extend from the bottom of the electronics housing 204 eccentrically relative to the centerline of the sensor applicator 102 and applicator cap. In such an embodiment, the sterilization zone 508 may be eccentrically positioned and the collimator 506 redesigned or otherwise configured to accommodate the sensor 216 and sharps 218 without departing from the scope of this disclosure.

[0079] In some embodiments, collimator 506 may include a first or "internal" collimator that may be housed within an applicator cap or otherwise within sensor applicator 102 as generally described above. A second or "external" collimator (not shown) may be included or otherwise used within the assembly (manufacturing) process to aid in sterilizing sensor applicator 102. In such embodiments, the external collimator may be positioned external to sensor applicator 102 and applicator cap and may be used in conjunction with internal collimator 506 to aid in focusing sterilizing radiation 512 onto sensor 216 and sharps 218.

[0080] In one embodiment, for example, the external collimator can initially receive radiation sterilization 512. Like the internal collimator 506, the external collimator can also provide or define holes or passages extending therethrough. The beam of radiation sterilization 512 passing through the passages of the external collimator can be focused and received into the sterilization zone 508 of the internal collimator 506 through the second opening 514b. Thus, the external collimator can be operated to pre-focus the radiation energy, and the internal collimator 506 can fully focus the radiation energy onto the sensor 216 and the sharp 218.

[0081] In some embodiments, the internal collimator 506 can be omitted if the external collimator functions to properly and completely focus the radiation sterilization 512 to properly sterilize the sensor 216 and the sharps 218. In such embodiments, the sensor applicator can be positioned adjacent to the external collimator before the sensor applicator is subjected to radiation sterilization 512, and the external collimator can prevent the radiation energy from damaging sensitive electronics within the electronics housing 204. Furthermore, in such embodiments, the sensor applicator 102 can be delivered to a user without the internal collimator 506 positioned within the applicator cap, thereby eliminating complications in manufacturing and use.

[0082] 6A is an enlarged cross-sectional side view of the sensor control device 202 mounted within an applicator cap according to one or more embodiments. As noted above, a portion of the sensor 216 and the sharps 218 may be positioned within a sealed area 510, thereby isolating them from external contamination. The sealed area 510 may include (encompass) the interior of the electronics housing 204 and a select portion of the sterile zone 508 of the collimator 506. In one or more embodiments, the sealed area 510 may be defined and otherwise formed by at least a first seal 602a, a second seal 602b, and a collimator seal 520.

[0083] The first seal 602a can be positioned to seal the interface between the sharp hub 322 and the top of the electronics housing 204. More specifically, the first seal 602a can seal the interface between the sharp hub 322 and the shell 206. Furthermore, the first seal 602a can surround the first central opening 404 defined in the shell 206 to prevent contaminants from entering the electronics housing 204 through the first central opening 404. In some embodiments, the first seal 602a can form part of the sharp hub 322. For example, the first seal 602a can be overmolded onto the sharp hub 322. In other embodiments, the first seal 602a can be overmolded onto the top surface of the shell 206. In still other embodiments, the first seal 602a can include a separate structure, such as an O-ring, sandwiched between the sharp hub 322 and the top surface of the shell 206 without departing from the scope of this disclosure.

[0084] The second seal 602b can be positioned to seal the interface between the collimator 506 and the bottom of the electronics housing 204. More specifically, the second seal 602b can be positioned to seal the interface between the mount 208 and the collimator 506, or alternatively, between the collimator 506 and the bottom of the plug 302 received in the bottom of the mount. In applications including the plug 302 as shown, the second seal 602b can be configured to seal around and otherwise surround the plug receptacle 412. In embodiments excluding the plug 302, the second seal 602b can instead surround the second central opening 406 ( FIG. 4A ) defined in the mount 208. As a result, the second seal 602b can prevent contaminants from entering the sterile zone 508 of the collimator 506 and further from entering the electronic device housing 204 through the plug receptacle 412 (or alternatively, the second central opening 406).

[0085] In some embodiments, the second seal 602b can form part of the collimator 506. For example, the second seal 602b can be overmolded onto the top of the collimator 506. In other embodiments, the second seal 602b can be overmolded onto the plug 302 or onto the bottom of the mount 208. In still other embodiments, the second seal 602b can include a separate structure, such as an O-ring, that is sandwiched between the collimator 506 and the plug 302 or the bottom of the mount 208 without departing from the scope of this disclosure.

[0086] After loading the sensor control device 202 into the sensor applicator 102 (FIG. 5B) and securing the applicator cap to the sensor applicator 102, the first and second seals 602a, 602b are in compression, creating a corresponding sealed interface. The first and second seals 602a, 602b can be made of a variety of materials capable of creating a sealed interface between opposing structures. Suitable materials include, but are not limited to, silicone, thermoplastic elastomer (TPE), polytetrafluoroethylene (PTFE or Teflon®), or any combination thereof.

[0087] As discussed above, the collimator seal 520 can be configured to completely seal the bottom of the sterilization zone 508, and therefore the bottom of the sealed area 510. Thus, the first and second seals 602a, b and the collimator seal 520 each create a barrier corresponding to their respective sealed location. The combination of these seals 602a, b and 520 allows for terminal sterilization of the sealed area 510, including the sensor 216 and sharps 218.

[0088] FIG. 6B is an enlarged cross-sectional side view of another embodiment of the sensor control device 302 mounted within the sensor applicator 102 according to one or more embodiments. More specifically, FIG. 6B depicts alternative embodiments of the first and second seals 602a, 602b. Again, the first seal 602a is positioned to seal the interface between the sharp hub 322 and the top of the electronics housing 204, and more specifically to completely seal the first central opening 404 defined within the shell 206. However, in exemplary embodiments, the first seal 602a can be configured to seal both axially and radially. More specifically, when the sensor control device 202 is introduced into the sensor applicator 102, the sharp hub 322 is received by the sensor carrier 504. The first seal 602a can be configured to simultaneously bias one or more axial extension members 604 of the sensor carrier 504 and one or more radial extension members 606 of the sensor carrier 504. Such dual bias engagement compresses the first seal 602a both axially and radially, thereby enabling the first seal 602a to seal against the top of the electronic device housing 204 both radially and axially.

[0089] The second seal 602b is again positioned to seal the interface between the collimator 506 and the bottom of the electronics housing 204, more specifically between the mount 208 and the collimator 506, or alternatively between the collimator 506 and the bottom of the plug 302 received in the bottom of the mount 208. However, in the exemplary embodiment, the second seal 602b extends into the sterile zone 508 and defines or otherwise provides a cylindrical well 608 sized to receive the sensor 216 and sharps extending from the bottom of the mount 208. In some embodiments, a desiccant 610 can be disposed in the cylindrical well to help maintain a low humidity environment for moisture-sensitive biological components.

[0090] In some embodiments, the second seal 602b can be eliminated, and the collimator 506 can be directly coupled to the electronics housing 204. More specifically, in at least one embodiment, the collimator 506 can be threadably coupled to the underside of the mount 208. In such embodiments, the collimator 506 can be provided with or otherwise defined with a threaded extension configured to fit into a threaded opening defined in the bottom of the mount 208. Threadably coupling the collimator 506 to the mount 208 can serve to seal the interface between the collimator 506 and the bottom of the electronics housing 204, thus isolating the sealed region 510. Furthermore, in such embodiments, the pitch and gauge of the threads defined on the collimator 506 and the mount 208 can match that of the threaded engagement between the applicator cap and the sensor applicator 102. As a result, when the applicator cap is threaded onto or off the sensor applicator 102, the collimator 506 can be threaded onto or off the electronics housing 304 accordingly.

[0091] 7 is an isometric view of an exemplary sensor control device 702 in accordance with one or more additional embodiments of the present disclosure. The sensor control device 702 may be the same as or similar to the sensor control device 104 of FIG. 1 and, therefore, may be used in conjunction with the sensor applicator 102 (FIG. 1), which delivers the sensor control device 702 to a target monitoring location on the user's skin. Additionally, the sensor control device 702 may alternatively be characterized as a medical device. As such, the sensor control device 702 may require proper sterilization before use.

[0092] As shown, the sensor control device 702 includes an electronics housing 704 that is generally disk-shaped and may have a circular cross-section. However, in other embodiments, the electronics housing 704 may exhibit other cross-sectional shapes, such as an oval (e.g., pill-shaped), a rounded square, or a polygonal shape, without departing from the scope of the present disclosure. The electronics housing 704 may be configured to house or otherwise enclose various electronic components used to operate the sensor control device 702.

[0093] The electronics housing 704 may include a shell 706 and a mateable mount 708. The shell 706 may be secured to the mount 708 by various methods, such as a snap fit, an interference fit, sonic welding, one or more mechanical fasteners (e.g., screws), or any combination thereof. In some cases, the shell 706 may be secured to the mount 708 such that a sealed interface occurs between the shell 706 and the mount 708. In such embodiments, a gasket or other type of sealing material may be positioned at or near the outer diameter (periphery) of the shell 706 and the mount 708, and securing the two components together may compress the gasket, thereby creating a sealed interface. In other embodiments, an adhesive may be applied to the outer diameter (periphery) of one or both of the shell 706 and the mount 708. The adhesive may not only secure the shell 706 to the mount 708 and provide structural integrity, but may also seal the interface between the two components, thereby isolating the interior of the electronics housing 704 from outside contamination.

[0094] In an exemplary embodiment, the sensor control device 702 may further include a plug assembly 710 that may be coupled to the electronics housing 704. For example, the plug assembly 710 may include a sensor module 712 (partially visible) that may be interconnected with a sharps module 714 (partially visible). The sensor module 712 may be configured to carry, and among other things, a sensor 716 (partially visible), and the sharps module 714 may be configured to carry, and among other things, a sharps 718 (partially visible) that is used to aid in transcutaneously delivering the sensor 716 beneath the user's skin during application of the sensor control device 702. The sharps module 714 may include a sharps hub 720 that carries the sharps 718.

[0095] As shown, corresponding portions of sensor 716 and sharp 718 extend from electronics housing 704, and more specifically from the bottom of mount 708. An exposed portion of sensor 716 (alternatively referred to as the "tail") may be received within a hollow or recessed portion of sharp 718. The remainder of sensor 716 is positioned within electronics housing 704.

[0096] 8 is a side view of the sensor applicator 102 of FIG. 1. As shown, the sensor applicator 102 includes a housing 902 and an applicator cap 904 that can be removably coupled thereto. In some embodiments, the applicator cap 904 can be threaded onto the housing 902 and can include a tamper ring 906. When the applicator cap 904 is rotated (e.g., unscrewed) relative to the housing 902, the tamper ring 906 threads off, thereby allowing the applicator cap 904 to be released from the sensor applicator 102. With the applicator cap 904 removed, the user can then use the sensor applicator 102 to place the sensor control device 702 (FIG. 7) at a target monitoring location on the user's body.

[0097] In some embodiments, the applicator cap 904 can be secured to the housing 902 by a sealing engagement to protect the internal components of the sensor applicator 102. In at least one embodiment, for example, an O-ring or another type of sealing gasket can seal the interface between the housing 902 and the applicator cap 904. The O-ring or sealing gasket can be a separate component part or alternatively can be molded onto one of the housing 902 and the applicator cap 904.

[0098] FIG. 9 is a cross-sectional side view of the sensor applicator 102 of FIG. 1. As shown, a sensor control device 902 can be received within the sensor applicator 102, and an applicator cap 904 can be coupled to the sensor applicator 102 to secure the sensor control device 702 within the applicator cap 904. The sensor control device 702 can include one or more radiation-sensitive components 708 positioned within an electronics housing 704. The radiation-sensitive components 708 can include electronic components or modules such as, but not limited to, a data processing unit, resistors, transistors, capacitors, inductors, diodes, switches, or any combination thereof. The data processing unit can include, for example, an application-specific integrated circuit (ASIC) configured to perform one or more functions or routines associated with the operation of the sensor control device 702. In operation, the data processing unit can perform data processing functions such as filtering and encoding data signals corresponding to a user's sampled analyte level. The data processing unit can include an antenna for communication with or otherwise communicate with the reader device 106 (FIG. 1).

[0099] In an exemplary embodiment, a cap filler 910 may be disposed within the applicator cap 1404 and may generally serve to support the sensor control device 702 within the sensor applicator 102. In one or more embodiments, the cap filler 910 may comprise an integral part of or an extension of the applicator cap 904, such as by being molded with or overmolded onto the applicator cap 904. In other embodiments, the cap filler 910 may comprise a separate structure fitted within or otherwise attached to the applicator cap 904 without departing from the scope of this disclosure.

[0100] The sensor control device 702, and more specifically the distal ends of the sensor 716 and sharps 718 extending from the bottom of the electronics housing 1304, can be sterilized while positioned within the sensor applicator 102. In certain embodiments, the fully assembled sensor control device 702 can be subjected to radiation sterilization. The radiation sterilization 912 can be delivered by either continuous process irradiation or pulsed beam irradiation. In pulsed beam irradiation, the beam of radiation sterilization 912 is focused at a target location, and the component part or device to be sterilized is moved to the target location, at which point the irradiation is activated to provide a stimulated radiation pulse. The radiation sterilization 912 is then stopped, and another component part or device to be sterilized is moved to the target location, and the process is repeated.

[0101] In accordance with the present disclosure, an external sterilization assembly 914 can be used to help focus the radiation 912 to sterilize the distal ends of the sensor 716 and the sharps 718 while simultaneously preventing (blocking) the propagating radiation 912 from damaging the radiation-sensitive components 908. As shown, the external sterilization assembly 914 (hereinafter "assembly 914") can include a radiation shield 916 positioned at least partially external to the sensor applicator 102. The radiation shield 916 can provide or define an external collimator 918 configured to help focus the radiation 912 (e.g., beam, wave, energy, etc.) toward the components to be sterilized. More specifically, the external collimator 918 allows transmission of the radiation 912 incident on and sterilizing the sensor 716 and the sharps 718, but prevents the radiation 912 from damaging the radiation-sensitive components 908 within the electronics housing 704.

[0102] In the exemplary embodiment, the outer collimator 918 is designed to align with the inner collimator 920 defined by the cap filler 910. Similar to the outer collimator 918, the inner collimator 920 can help focus the radiation 912 toward the component being sterilized. As shown, the cap filler 910 can define a radial shoulder 922 sized to receive and otherwise fit the end of the radiation shield 916, with the outer collimator 918 transitioning into the inner collimator 920 at the radial shoulder 922. In some embodiments, the transition between the outer collimator 918 and the inner collimator 920 can be continuous, flush, or smooth. However, in other embodiments, the transition can be intermittent or gradual without departing from the scope of this disclosure.

[0103] The external collimator 918 and the internal collimator 920 may cooperate to focus the radiation 912 and define a sterilization zone 924 within which the distal ends of the sensor 916 and the sharps 918 may be positioned. The propagated radiation 912 may pass through the sterilization zone 924 and impinge on and sterilize the sensor 716 and the sharps 718. However, the cap filler 910 and the radiation shield 916 may each be made of a material that substantially prevents the radiation 912 from penetrating the inner walls of the sterilization zone 924 and thereby damaging the radiation-sensitive components 908 within the housing 704. In other words, the cap filler 910 and the radiation shield 916 may each be made of a material that has a density sufficient to absorb the dose of beam energy being delivered thereto. In some embodiments, for example, one or both of the cap filler 910 and the radiation shield 916 may be made of a material that has a mass density greater than 0.9 grams per cubic centimeter (g / cc). However, in other embodiments, the mass density of suitable materials can be lower than 0.9 g / cc without departing from the scope of this disclosure. Suitable materials for the cap filler 910 and radiation shield 916 include, but are not limited to, high density polymers (e.g., polyethylene, polypropylene, polystyrene, polytetrafluoroethylene, etc.), metals (e.g., lead, stainless steel, aluminum, etc.), any combination thereof, or any material having a mass density higher than 0.9 g / cc. In at least one embodiment, the cap filler 910 can be made of machined or 3D printed polypropylene, and the radiation shield 916 can be made of stainless steel.

[0104] In some embodiments, one or both of the cap filler 910 and the radiation shield 916 can be manufactured from a material having a mass density lower than 0.9 g / cc, but the design of the sterilization zone 924 can be modified so that they can still operate to prevent radiation sterilization 912 from damaging the radiation-sensitive component 908. In such embodiments, the size (e.g., length) of the sterilization zone 924 can be increased so that electrons propagating from the radiation sterilization 912 must pass through a larger amount of material before potentially impinging on the radiation-sensitive component 908. The larger amount of material can help absorb or dissipate the irradiance of the radiation 912 so that the radiation sterilization 912 is harmless to sensitive electronics. However, in other embodiments, the opposite may equally be true. More specifically, the size (e.g., length) of the sterilization zone 924 can be reduced as long as the material for the cap filler 910 and / or the radiation shield 916 exhibits a sufficiently large mass density.

[0105] The sterilization zone 924 defined by the outer and inner collimators 918, 920 can exhibit any suitable cross-sectional shape necessary to properly focus the radiation 912 onto the sensor 716 and the sharp 718 for sterilization. In the exemplary embodiment, for example, the outer and inner collimators 918, 920 each exhibit a circular cross-section having parallel sides. However, in other embodiments, one or both of the outer and inner collimators 918, 920 can exhibit a polygonal cross-sectional shape, such as a cuboid or rectangle (including, for example, a parallelogram), without departing from the scope of this disclosure.

[0106] In the exemplary embodiment, the sterilization zone 924 provides a first opening 926a defined by the outer collimator 918 and a second opening 926b defined by the inner collimator 920, where the first opening 926a and the second opening 926b are positioned at opposite ends of the sterilization zone 924. The first opening 926a allows the radiation 912 to enter the sterilization zone 924, and the second opening 926b provides a location where the radiation 912 can impinge on the sensor 716 and the sharps 718. In the exemplary embodiment, the second opening 926b also provides a location where the sensor 716 and the sharps 718 can be received within the sterilization zone 924. In embodiments where the sterilization zone 924 has a circular cross-section, the diameter of the first opening 926a and the diameter of the second opening 926b can be substantially the same.

[0107] In some embodiments, the sterilization zone 924 defined by the outer and inner collimators 918 may be substantially cylindrical and may otherwise exhibit a circular or polygonal cross-section. In such embodiments, the first opening 926a and the second opening 926b may exhibit equal diameters, and the walls of the sterilization zone 924 may be substantially parallel between the first and second ends of the sterilization zone 924.

[0108] In some embodiments, a cap seal 928 (shown in dashed lines) can be disposed at the interface between the cap fill 910 and the radiation shield 916. The cap seal 928 can include a radio-permeable microbial barrier. In some embodiments, for example, the cap seal 928 can be manufactured from a synthetic material (e.g., flash-spun high-density polyethylene fiber) such as TYVEK® available from DuPont®. The cap seal 928 can completely seal off a portion of the sterile zone 924 to help form part of a sealed area 930 configured to isolate the sensor 716 and sharps 718 from external contamination.

[0109] The sealed area 930 can include (encompass) the interior of the electronics housing 704 and select portions of the sterilization zone 924. In one or more embodiments, the sealed area 930 can be defined and otherwise formed by at least a cap seal 928, a first or "top" seal 932a, and a second or "bottom" seal 932b. The cap seal 928 and the top and bottom seals 932a, 932b each create a barrier corresponding to their respective sealing locations, thereby enabling terminal sterilization of the sterilization zone 924, including the sensor 716 and the sharps 718.

[0110] The top seal 932a can be positioned to seal the interface between the sharp hub 720 and the top of the electronics housing 704 (i.e., the shell 906 in FIG. 8 ), thereby preventing contaminants from entering the electronics housing 704. In some embodiments, the top seal 932a can form part of the sharp hub 720, such as by being overmolded onto the sharp hub 720. However, in other embodiments, the top seal 932a can form part of or be overmolded onto the top surface of the shell 706. In still other embodiments, the top seal 932a can include a separate structure, such as an O-ring, sandwiched between the sharp hub 720 and the top surface of the shell 706 without departing from the scope of this disclosure.

[0111] The bottom seal 932b can be positioned to seal the interface between the cap fill 910 and the bottom of the electronics housing (i.e., mount 708 in FIG. 7). The bottom seal 932b can prevent contaminants from entering the sterilization zone 924 and from entering the electronics housing 704. In some embodiments, the bottom seal 932b can form part of the cap fill 910, such as by being overmolded onto the top of the cap fill 910. In other embodiments, the bottom seal 932b can form part of or be overmolded onto the bottom of the mount 708. In still other embodiments, the bottom seal 932b can include a separate structure, such as an O-ring, sandwiched between the cap fill 910 and the bottom of the mount 708 without departing from the scope of this disclosure.

[0112] After the sensor control device 702 is loaded into the sensor applicator 102 and the applicator cap 904 is secured to the sensor applicator 102, the top and bottom seals 932 a, 932 b can be compressed to create a corresponding sealed interface. The top and bottom seals 932 a, 932 b can be made of a variety of materials capable of creating a sealed interface between opposing structures. Suitable materials include, but are not limited to, silicone, thermoplastic elastomer (TPE), polytetrafluoroethylene (e.g., TEFLON®), or any combination thereof.

[0113] It should be noted that the sensor 716 and sharps 718 extend from the bottom of the electronics housing 704 into the sterilization zone 924 generally concentric with the centerline of the sensor applicator 102 and applicator cap 904, although they are considered to have an eccentric arrangement herein. More specifically, in at least one embodiment, the sensor 716 and sharps 718 extend from the bottom of the electronics housing 704 eccentrically relative to the centerline of the sensor applicator 102 and applicator cap 904. In such embodiments, the outer and inner collimators 918, 920 can be redesigned or otherwise configured so that the sterilization zone 924 is also eccentrically positioned to accommodate the sensor 716 and sharps 718 without departing from the scope of this disclosure.

[0114] In some embodiments, the external sterilization assembly 914 may further include a sterilization housing or sterilization "pod" 934 coupled to or forming part of the radiation shield 916. The sterilization pod 934 provides or otherwise defines a chamber 936 sized to receive all or a portion of the sensor applicator 102. Once properly seated (received) within the sterilization pod 934, the sensor applicator 102 may be subjected to radiation sterilization 912 to sterilize the sensors 716 and sharps 718. The sterilization pod 934 may be fabricated from any of the materials described herein for the radiation shield 916, which helps prevent the radiation 912 from propagating through the walls of the sterilization pod 934.

[0115] In some embodiments, the radiation shield 916 may be removably coupled to the sterilization pod 934 using one or more mechanical fasteners 938 (one shown), although it is contemplated that the radiation shield 916 may alternatively be removably coupled via an interference fit, snap engagement, etc. Removably coupling the radiation shield 916 to the sterilization pod 934 allows the radiation shield 916 to be interchangeable with shields designed (e.g., sized) to fit particular sterilization applications suitable for various types and designs of sensor applicators 102. Thus, the sterilization pod 934 may include a universal mount that allows the radiation shield 916 to be interchangeable with other shield designs having different parameters with respect to the external collimator 918, as needed.

[0116] In some embodiments, the external sterilization assembly 914 can further include a mounting tray 940 coupled to or forming a part of the sterilization pod 934. The sterilization pod 934 can be removably coupled to the mounting tray 940 using, for example, one or more mechanical fasteners 942 (one shown). The mounting tray 940 can provide or define a central opening 944 sized to receive the sensor applicator 102 and alignable with the chamber 936 to allow the sensor applicator 102 to enter the chamber 936. As described below, in some embodiments, the mounting tray 940 can define a plurality of central openings 944 for receiving a corresponding plurality of sensor applicators for sterilization.

[0117] 10A and 10B are isometric and side views, respectively, of an exemplary sensor control device 1002 in accordance with one or more embodiments of the present disclosure. The sensor control device 1002 (alternatively referred to as a "puck") may be similar in some respects to the sensor control device 104 of FIG. 1 and, therefore, may be best understood with reference thereto. The sensor control device 1002 may replace the sensor control device 104 of FIG. 1 and, therefore, may be used in conjunction with the sensor applicator 102 (FIG. 1), which delivers the sensor control device 1002 to a target monitoring location on the user's skin.

[0118] However, in contrast to the sensor control device 104 of Figure 1, the sensor control device 1002 can be incorporated into a one-piece system architecture. Unlike a two-piece architecture, for example, a user is not required to unpack multiple packages and finally assemble the sensor control device 1002. Instead, upon receipt by the user, the sensor control device 1002 is already fully assembled and properly positioned within the sensor applicator 102 (Figure 1). To use the sensor control device 1002, the user need only open a single barrier (e.g., an applicator cap) before immediately dispatching the sensor control device 1002 to a target monitoring location.

[0119] As shown, the sensor control device 1002 includes an electronics housing 1004 that is generally disk-shaped and may have a circular cross-section. However, in other embodiments, the electronics housing 1004 may exhibit other cross-sectional shapes, such as oval or polygonal, without departing from the scope of the present disclosure. The electronics housing 1004 may be configured to house or otherwise enclose various electrical components used to operate the sensor control device 1002.

[0120] The electronics housing 1004 can include a shell 1006 and a mateable mount 1008. The shell 1006 can be secured to the mount 1008 by a variety of methods, such as a snap fit, an interference fit, sonic welding, or one or more mechanical fasteners (e.g., screws). In some cases, the shell 1006 can be secured to the mount 1008 such that a sealed interface occurs between them. In such embodiments, a gasket or other type of sealing material can be positioned at or near the outer diameter (periphery) of the shell 1006 and the mount 1008, and securing the two components together can compress the gasket, thereby creating a sealed interface. In other embodiments, an adhesive can be applied to the outer diameter (periphery) of one or both of the shell 1006 and the mount 1008. The adhesive not only secures the shell 1006 to the mount 1008 and provides structural integrity, but can also seal the interface between the two components, thereby isolating the interior of the electronics housing 1004 from outside contamination. If the sensor control device 1002 is assembled in a controlled environment, it may not be necessary to terminally sterilize the internal electrical components. Rather, adhesive bonding can provide a sufficient sterility barrier for the assembled electronics housing 1004.

[0121] The sensor control device 1002 may further include a plug assembly 1010 that can be coupled to the electronics housing 1004. The plug assembly 1010 may be similar in some respects to the plug assemblies described above. For example, the plug assembly 1010 may include a sensor module 1012 (partially visible) that is interconnectable with a sharps module 1014 (partially visible). The sensor module 1012 may be configured to carry and otherwise include a sensor 2616 (partially visible), and the sharps module 1014 may be configured to carry and otherwise include a sharps 1018 (partially visible) that are used to aid in transcutaneously delivering the sensor 1016 beneath the user's skin during application of the sensor control device 1002. As shown, corresponding portions of the sensor 1016 and sharps 1018 extend from the electronics housing 1004, and more specifically, from the bottom of the mount 1008. An exposed portion of the sensor 1016 may be received within a hollow or recessed portion of the sharps 1018. The remainder of the sensor 1016 is positioned within the electronics housing 1004 .

[0122] As discussed in more detail below, the sensor control device 1002 may further include a sensor storage vial 1020 that surrounds the exposed portions of the sensor 1016 and sharps 1018 to provide a storage barrier that protects them from gas-chemical sterilization.

[0123] 11A and 11B are isometric and exploded views, respectively, of a plug assembly 1110 according to one or more embodiments. The sensor module 1012 can include a sensor 1016, a plug, and a connector. The plug can be designed to receive and support both the sensor 1016 and the connector 1104. As shown, a channel can be defined through the plug to receive a portion of the sensor 1016. Additionally, the plug can provide one or more deflectable arms configured to snap into corresponding features on the bottom of the electronics housing 1004.

[0124] The sensor 1016 includes a tail 1108, a flag 1110, and a neck 1112 interconnecting the tail 1108 and the flag 1110. The tail 1108 can be configured to extend at least partially through the channel 1106 and extend distally from the plug 1102. The tail 1108 includes an enzyme or other chemical or biological agent, and in some embodiments, a membrane can cover the chemical agent. During use, the tail 1108 is transdermally received under a user's skin, and the chemical agent contained on the tail helps facilitate analyte monitoring in the presence of bodily fluids.

[0125] The flag 1110 can include a generally flat surface with one or more sensor contacts 114 (three are shown in FIG. 11B) positioned thereon. The sensor contacts 114 can be configured to align with a corresponding number of flexible carbon-impregnated polymer modules (tops of which are shown at 1120) enclosed within the connector 1104.

[0126] The connector 1104 includes one or more hinges 1118 that allow it to move between an open and a closed state. While FIGS. 11A and 11B show the connector 1104 in a closed state, the connector 1104 can pivot to the open state to receive the flag 1110 and flexible carbon-impregnated polymer module therein. The flexible carbon-impregnated polymer module provides electrical contacts 1120 (three shown) configured to provide conductive communication between the sensor 1016 and corresponding circuit contacts provided within the electronics housing 1004 ( FIGS. 10A and 10B ). The connector 1104 can be fabricated from silicone rubber and can function as a moisture barrier to the sensor 1016 when assembled in a compressed state and after application to the user's skin.

[0127] The sharps module 1014 includes a sharps 1018 and a sharps hub 1122 that carries the sharps 1018. The sharps 1018 include an elongated shaft 1124 and a sharps tip 1126 at its distal end. The shaft 1124 can be configured to extend through the channel 1106 and extend distally from the plug 1102. Additionally, the shaft 1124 can include a hollow or recessed portion 1128 that at least partially surrounds the tail 1108 of the sensor 1016. The sharps tip 1126 can be configured to pierce the skin while carrying the tail 1108 to bring an active chemical agent present on the tail 1108 into contact with bodily fluids.

[0128] The sharp hub 1122 can include a hub mini-cylinder 2730 and a hub snap locking pawl 2732, each of which can assist in coupling the plug assembly 2610 (and the entire sensor control device 2602) to the sensor applicator 102 (FIG. 1).

[0129] 11B , the storage vial 1020 can include a generally cylindrical, elongated body 1134 having a first end 1136a and an opposing second end 1136b. The first end 1136a can be open to provide access to an interior chamber 1138 defined within the body 1134. In contrast, the second end 1136b can be closed and can be provided with or otherwise defined by an enlarged head 1140. The enlarged head 1140 exhibits an outer diameter that is larger than the outer diameter of the remainder of the body 1134. However, in other embodiments, the enlarged head 1140 can be located at a location intermediate the first end 1136a and the second end 1136b.

[0130] 11C is an exploded isometric bottom view of the plug 1102 and the storage vial 1020. As shown, the plug 1102 can define an opening 1142 configured to receive the storage vial 1020, and more specifically, the first end 1136a of the body 1134. The channel 1106 can terminate at the opening 1142 such that components extending distally out of the channel 1106 will be received within the internal chamber 1138 when the storage vial 1020 is coupled to the plug 1102.

[0131] The storage vial 1020 can be removably coupled to the plug 1102 at the opening 1142. In some embodiments, for example, the storage vial 1020 can be received in the opening 1142 by an interference fit or a friction fit. In other embodiments, the storage vial 1020 can be secured within the opening 1142 using a frangible member (e.g., a shear ring) or frangible material that can be broken by a small separation force. In such embodiments, for example, the storage vial 1020 can be secured within the opening 1142 using a glue tag (spot), a small amount of wax, or can include a peelable glue. As described below, the storage vial 1020 can be separated from the plug 1102 before delivering the sensor control device 1102 ( FIGS. 10A-10B ) to a target monitoring location on the user's skin.

[0132] 11A and 11B , the inner chamber 1138 can be sized and otherwise configured to receive the tail 1108, the distal section of the shaft 1124, and the sharp tip 1126, collectively referred to as the “distal portions of the sensor 1016 and sharp 1018.” The inner chamber 1138 can be sealed or otherwise isolated to prevent the ingress of substances into the inner chamber 1138 that could potentially interact adversely with the chemical formulation of the sensor 1016. More specifically, because gases used during gas-chemical sterilization can adversely affect enzymes provided on the tail 1108 (and other sensor components, such as membrane coatings that regulate the influx of analytes), the inner chamber 1128 can be sealed to protect or isolate the distal portions of the sensor 1016 and sharp 1018 during the gas-chemical sterilization process.

[0133] In some embodiments, the seal 1144 (FIG. 11B) can provide a sealing barrier between the inner chamber 1138 and the external environment. In at least one embodiment, the seal 1144 can be disposed within the inner chamber 1138, although it is contemplated that the seal 1144 can alternatively be disposed external to the body 1134 without departing from the scope of the present disclosure. The distal portions of the sensor 1016 and the sharp 1018 can extend through the seal 1144 into the inner chamber 1138, while the seal 1144 can maintain a sealed interface around the distal portions of the sensor 1016 and the sharp 1018 to prevent ingress of contaminants into the inner chamber 1138. The seal 1144 can be made of, for example, a moldable elastomer or wax.

[0134] In other embodiments (or in addition to the seal 1144), a sensor storage fluid 1146 (FIG. 11B) can be present within the inner chamber 1138, and the sensor 1016 and the distal portion of the sharp 1018 can be immersed in or otherwise encapsulated by the storage fluid 1146. The storage fluid 1146 can create a sealed interface that prevents sterilizing gas from interacting with the enzyme disposed on the tail 1108.

[0135] To properly sterilize the sensor 1016 and the sharp 1018, the plug assembly 1010 can be subjected to radiation sterilization. Suitable radiation sterilization processes include, but are not limited to, electron beam (e-beam) irradiation, gamma irradiation, X-ray irradiation, or any combination thereof. In some embodiments, the plug assembly 1010 can be subjected to radiation sterilization before the storage vial 1020 is coupled to the plug 1102. However, in other embodiments, the plug assembly 1010 can be sterilized after the storage vial 1020 is coupled to the plug 1102. In such embodiments, the body 2734 and storage fluid 1146 of the storage vial 1020 can include materials and / or substances that allow the propagation of radiation therethrough to facilitate radiation sterilization of the distal portions of the sensor 1016 and the sharp 1018.

[0136] Suitable materials for the body 1134 include, but are not limited to, non-magnetic metals (e.g., aluminum, copper, gold, silver, etc.), thermoplastic ceramics, rubbers (e.g., ebonite), composite materials (e.g., fiberglass, carbon fiber reinforced polymer, etc.), epoxies, or any combination thereof. In some embodiments, the material for the body 1134 can be transparent or translucent, while in others it can be opaque without departing from the scope of the present disclosure.

[0137] The preservation fluid 1146 can include any inert biocompatible fluid (i.e., liquid, gas, gel, wax, or any combination thereof) that functions to encapsulate the sensor 1016 and the distal portion of the sharp 1018. In some embodiments, the preservation fluid 1146 can allow the propagation of radiation therethrough. The preservation fluid 1146 can include a fluid that is insoluble in the chemicals involved in gas-chemical sterilization. Suitable examples of the preservation fluid 1146 include, but are not limited to, silicone oil, mineral oil, gel (e.g., petrolatum), wax, fresh water, saline, synthetic fluids, glycerin, sorbitan esters, or any combination thereof. Obviously, more viscous gels and fluids can be preferred so that the preservation fluid 1146 does not flow easily.

[0138] In some embodiments, the preservation fluid 1146 may include an anti-inflammatory agent such as nitric oxide or another known anti-inflammatory agent. An anti-inflammatory agent may prove advantageous in minimizing the local inflammatory response caused by the penetration of the sharpener 1018 and sensor 1016 into the user's skin. It has been observed that inflammation can affect the accuracy of glucose readings, and the inclusion of an anti-inflammatory agent can speed up the healing process, resulting in more rapid acquisition of accurate readings.

[0139] 12A and 12B are exploded and bottom isometric views, respectively, of an electronics housing 1004 according to one or more embodiments. The shell 1006 and mount 1008 act as opposing clamshell halves that enclose or otherwise substantially enclose the various electronic components of the sensor control device 1002 (FIGS. 10A and 10B).

[0140] A printed circuit board (PCB) 1202 may be disposed within the electronics housing 1004. The PCB 1202 may be populated with a plurality of electronic modules (not shown), including, but not limited to, a data processing unit, resistors, transistors, capacitors, inductors, diodes, and switches. The data processing unit may include, for example, an application specific integrated circuit (ASIC) configured to perform one or more functions or routines associated with the operation of the sensor control device 1002. 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 data signals each corresponding to a sampled analyte level of a user. The data processing unit may include an antenna for communication with or otherwise communicate with the reader device 106 (FIG. 1).

[0141] As shown, shell 1006, mount 1008, and printed circuit board 1202 each define corresponding central openings 1204, 1206, and 1208, respectively. When electronics housing 1204 is assembled, central openings 1204, 1206, and 1208 are coaxially aligned for receiving portions of plug assembly 1010 ( FIGS. 11A and 11B ) therethrough. A battery 1210 can be housed within electronics housing 1004 and configured to power sensor control device 1002.

[0142] 12B, a plug receptacle 1212 can be defined at the bottom of the mount 1208 and can provide a location where the plug assembly 1010 (FIGS. 10A and 10B) can be received to couple to the electronics housing 1004, thereby fully assembling the sensor control device 1002. The contours of the plug 1102 (FIGS. 11A-11C) can be shaped in a matching or complementary manner to the plug receptacle 1212, which can provide one or more snap-lock ledges 1214 (two shown) configured to mate with and receive the deflectable arm 1107 (FIGS. 11A and 11B) of the plug 1102. The plug assembly 1010 is coupled to the electronics housing 1004 by advancing the plug 1102 into the plug receptacle 1212 and allowing the deflectable arms 1107 to engage in corresponding snap-lock ledges 1214. When the plug assembly 1010 is properly coupled to the electronics housing 1004, one or more circuit contacts 1216 (three shown) defined on the underside of the PCB 1202 can establish conductive communication with electrical contacts 1120 (FIGS. 11A and 11B) of the connector 1104 (FIGS. 11A and 11B).

[0143] 13A and 13B are side and cross-sectional side views, respectively, of an exemplary embodiment of a sensor applicator 102 with an applicator cap coupled thereto. More specifically, FIGS. 13A and 13B illustrate how the sensor applicator 102 may be shipped and received by a user. In accordance with the present disclosure, as can be seen in FIG. 13B, the sensor control device 1002 is already assembled and installed within the sensor applicator 102 prior to delivery to the user.

[0144] As noted above, the plug assembly 1010 may be subjected to radiation sterilization to sterilize the distal portions of the sensor 1016 and sharps 1018 prior to coupling the plug assembly 1010 to the electronics housing 1004. Once properly sterilized, the plug assembly 1010 may then be coupled to the electronics housing 1004 as generally described above, thereby forming the fully assembled sensor control device 1002. The sensor control device 1002 may then be loaded into the sensor applicator 102, and an applicator cap may be coupled to the sensor applicator 102. The applicator cap may thread onto the housing and may include a tamper ring. When the applicator cap is rotated (e.g., twisted off) relative to the housing, the tamper ring threads off, thereby allowing the applicator cap to be released from the sensor applicator 102.

[0145] In accordance with the present disclosure, the sensor control device 1002 can be subjected to gas chemical sterilization configured to sterilize the electronics housing 1004 and any other exposed portions of the sensor control device 1002 while loaded into the sensor applicator 102. To accomplish this, chemicals can be injected into a sterilization chamber 1306 cooperatively defined by the sensor applicator 102 and the interconnect cap 210. In some applications, chemicals can be injected into the sterilization chamber 1306 through one or more vents 1308 defined in the proximal end 1310 of the applicator cap. Exemplary chemicals that can be used for gas chemical sterilization 1304 include, but are not limited to, ethylene oxide, hydrogen peroxide vapor, and nitrogen oxides (e.g., nitrous oxide, nitric oxide, etc.).

[0146] The distal portion of the sensor 1016 and the sharp 1018 are sealed in a storage vial 1020 so that the chemicals used during the gas chemical sterilization process do not interact with the enzymes, chemicals, or biologicals provided on the tail 1108.

[0147] Once the desired sterility assurance level has been achieved within the sterilization chamber 1306, the gas solution is removed and the sterilization chamber 1306 is aerated. Aeration can be achieved by applying a vacuum followed by a series of circulating nitrogen gas or sterile air through the sterilization chamber 1306. Once the sterilization chamber 1306 is properly aerated, the vent port 1308 can be blocked with a seal 1312 (shown in dashed lines).

[0148] In some embodiments, the seal 1312 may include two or more layers composed of different materials. The first layer may be made of a synthetic material (e.g., flash-spun high-density polyethylene fiber) such as Tyvek®, available from DuPont®. Tyvek® is durable and puncture-resistant while allowing vapor transmission. The Tyvek® layer may be applied prior to and following a gas-chemical sterilization process, and a foil or other vapor- and moisture-resistant material layer may be sealed (e.g., heat-sealed) over the Tyvek® layer to prevent the ingress of contaminants and moisture into the sterilization chamber 1306. In other embodiments, the seal 1312 may include only a single protective layer applied to the applicator cap. In such embodiments, this single layer is not only gas-permeable for the sterilization process, but also provides protection against moisture and other harmful elements after the sterilization process is complete.

[0149] With the seal 1312 in place, the applicator cap provides a barrier to outside contamination, which maintains a sterile environment for the assembled sensor control device 1002 until the user removes (unscrews) the applicator cap. The applicator cap can create a dust-free environment during shipping and storage that prevents contamination of the adhesive patch 1314 used to secure the sensor control device 1002 to the user's skin.

[0150] 14 is a perspective view of an exemplary embodiment of an applicator cap in accordance with the present disclosure. As shown, the applicator cap has a generally circular cross-section and defines a series of threads that are used to couple the applicator cap to the sensor applicator 102. A vent 1308 can be seen at the bottom of the applicator cap.

[0151] The applicator cap may further provide, and may define, a cap post 1404 centrally positioned therein and extending proximally from the bottom of the applicator cap. The cap post 1404 may be configured to generally serve to support the sensor control device 1002 while it is included within the sensor applicator 102. Additionally, the cap post 1404 may define an opening 1406 configured to receive the storage vial 1020 when the applicator cap 210 is coupled to the sensor applicator 102.

[0152] In some embodiments, the opening 1406 to the cap post 1404 can include one or more stretchable or flexible flexible features 1408 that allow the storage vial 1020 to pass therethrough. In some embodiments, for example, the flexible feature 1408 can include a collet-type device including a plurality of flexible fingers configured to flex radially outward to accept the storage vial 1020. However, in other embodiments, the flexible feature 1408 can include an elastomer or another type of flexible material configured to expand radially to accept the storage vial 1020.

[0153] 15 is a cross-sectional side view of a sensor control device 1002 positioned within an applicator cap in accordance with one or more embodiments. As shown, the cap post 1404 defines a post chamber 1502 configured to receive a storage vial 1020. An opening 3006 into the cap post 1404 provides access into the post chamber 1502 and exhibits a first diameter D1. In contrast, the enlarged head 1140 of the storage vial 1020 exhibits a second diameter D2 that is larger than the first diameter D1 and larger than the outer diameter of the remainder of the storage vial 1020. Thus, as the storage vial 2620 extends into the post chamber 1502, the flexible feature 1408 of the opening 1406 can flex (expand) radially outward to accommodate the enlarged head 1140.

[0154] In some embodiments, the expansion head 1140 can provide or otherwise define a sloped outer surface that helps bias the flexible feature 1408 radially outward. However, the expansion head 1140 can define an upper shoulder 1504 that prevents the storage vial 1020 from backing out of the post chamber 1502. More specifically, the shoulder 1504 can include a steep surface at the second diameter D2 that will engage the flexible feature 1408 but will not bias the flexible feature 1408 to deflect radially outward in the reverse direction.

[0155] Once the enlarged head 1140 has advanced beyond the opening 1406, the flexible feature 1408 flexes back to (or toward) its natural state. In some embodiments, the flexible feature 1408 can engage the outer surface of the storage vial 1020, yet still allow the applicator cap 210 to rotate relative to the storage vial 1020. Thus, when a user removes the applicator cap by rotating it relative to the sensor applicator 102, the storage vial 1020 can remain stationary relative to the cap post 1404.

[0156] When the applicator cap is removed from the sensor applicator 102, thereby also separating the sensor control device 1002 from the applicator cap, a shoulder 1504 defined on the enlarged head 1140 will engage the flexible feature 1408 at the opening 1406. Because the diameter of the shoulder 1504 is larger than the diameter of the opening 1406, the shoulder 1504 will rest against the flexible feature 1408, thereby separating the storage vial 1020 from the sensor control device 1002 and exposing the distal portions of the sensor 1016 and the sharp 1018. Thus, when the applicator cap is separated from the sensor applicator 102 and the sensor control device 1002, the flexible feature 1408 can prevent the enlarged head 1140 from slipping out of the post chamber 1502 through the opening 1406. The separated storage vial 1020 will fall into and remain in the post chamber 1502.

[0157] In some embodiments, instead of the opening 1406 including the flexible feature 1408 as generally described above, the opening 1406 can instead be threaded. In some embodiments, a small portion near the distal end of the storage vial 1020 can also be threaded and configured to threadingly engage the opening 1406. The storage vial 1020 can be received into the post chamber 1502 by a threaded rotation. However, when the applicator cap is removed from the sensor applicator 102, the opposing threads on the opening 1406 and the storage vial 1020 can separate from the sensor control device 1002.

[0158] Thus, there are several advantages to incorporating the sensor control device 1002 into an analyte monitoring system (e.g., the analyte monitoring system 100 of FIG. 1). Because the sensor control device 1002 is finally assembled in a controlled environment, tolerances can be reduced or eliminated entirely, thereby allowing the sensor control device 1002 to be thin and small. Furthermore, because the sensor control device 1002 is finally assembled in a controlled environment, full pre-testing of the sensor control device 1002 can be performed at the factory, thus allowing the sensor unit to be fully tested before being packaged for final delivery.

[0159] 16A and 16B are isometric and side views, respectively, of an exemplary sensor control device 1602 in accordance with one or more embodiments of the present disclosure. The sensor control device 1602 (alternatively referred to as a "puck") may be similar in some respects to the sensor control device 104 of FIG. 1 and, therefore, may be best understood with reference thereto. In some applications, the sensor control device 1602 may replace the sensor control device 104 of FIG. 1 and, therefore, may be used in conjunction with the sensor applicator 102 (FIG. 1), which delivers the sensor control device 1602 to a target monitoring location on the user's skin.

[0160] However, in contrast to the sensor control device 104 of Figure 1, the sensor control device 1602 can be incorporated into a one-piece system architecture. Unlike a two-piece architecture, for example, a user is not required to unpack multiple packages and finally assemble the sensor control device 1602 before use. Instead, upon receipt by the user, the sensor control device 1602 is already fully assembled and properly positioned within the sensor applicator 102 (Figure 1). To use the sensor control device 1602, the user need only open one barrier (e.g., remove the applicator cap) before immediately dispatching the sensor control device 1602 to a target monitoring location.

[0161] As shown, the sensor control device 1602 includes an electronics housing 1604 that is generally disk-shaped and may have a circular cross-section. However, in other embodiments, the electronics housing 1604 may exhibit other cross-sectional shapes, such as oval or polygonal, without departing from the scope of this disclosure. The electronics housing 1604 may be configured to house or otherwise enclose various electrical components used to operate the sensor control device 1602.

[0162] The electronics housing 1604 can include a shell 1606 and a mateable mount 1608. The shell 1606 can be secured to the mount 1608 by a variety of methods, such as a snap fit, an interference fit, sonic (or ultrasonic) welding, using one or more mechanical fasteners (e.g., screws), or any combination thereof. In some embodiments, the interface between the shell 1606 and the mount 1608 can be sealed. In such embodiments, a gasket or other type of sealing material can be disposed at or near the outer diameter (perimeter) of the shell 1606 and the mount 1608. Securing the shell 1606 to the mount 1608 can compress the sealing material, thereby creating a sealed interface. In at least one embodiment, an adhesive can be applied to the outer diameter (perimeter) of one or both of the shell 1606 and the mount 1608, and the adhesive can not only secure the shell 1606 to the mount 1608 but also seal the interface.

[0163] In embodiments in which a sealed interface is provided between the shell 1606 and the mount 1608, the interior of the electronics housing 1604 can be substantially isolated from outside contamination between these two components. In such embodiments, when the sensor control device 1602 is assembled in a controlled sterile environment, it may not be necessary to sterilize the internal electrical components (e.g., by gas-chemical sterilization). Rather, an adhesive bond can provide a sufficient sterility barrier for the assembled electronics housing 1604.

[0164] The sensor control device 1602 may further include a sensor module 1610 (partially visible in FIG. 16B ) and a sharps module 1612 (partially visible). The sensor module 1610 and sharps module 1612 may be interconnectable and coupled to the electronics housing 1604. The sensor module 1610 may be configured to carry and otherwise include a sensor 1614 ( FIG. 16B ), and the sharps module 1612 may be configured to carry and otherwise include a sharps 1616 ( FIG. 16B ) used to help transcutaneously deliver the sensor 1614 under the user's skin during application of the sensor control device 1602.

[0165] 16B, corresponding portions of the sensor 1614 and the sharp 1616 extend from the electronics housing 1604, and more specifically from the bottom of the mount 1608. The exposed portion of the sensor 1614 can be received within a hollow or recessed portion of the sharp 1616. The remainder of the sensor 1614 is positioned within the electronics housing 1604.

[0166] An adhesive patch 1618 may be positioned on and attached to the underside of the mount 1608. Similar to the adhesive patch 108 of FIG. 1, the adhesive patch 1618 may be configured to securely hold the sensor control device 1602 in place on the user's skin during operation. In some embodiments, a transfer adhesive 1620 may be sandwiched between the adhesive patch 1618 and the bottom of the mount 1608. The transfer adhesive 1620 may help facilitate the assembly process of the sensor control device 1602.

[0167] 17A and 17B are exploded perspective top and bottom views, respectively, of a sensor control device 1602 according to one or more embodiments. As shown, the shell 1606 and mount 1608 of the electronics housing 1604 act as opposing clamshell halves that enclose or otherwise substantially enclose the various electronic components of the sensor control device 1602.

[0168] A printed circuit board (PCB) 1702 can be disposed within the electronics housing 1604. As shown in FIG. 17B, multiple electronic modules 1704 can be mounted on the underside of the PCB 1702. Exemplary electronic modules 1704 include, but are not limited to, resistors, transistors, capacitors, inductors, diodes, and switches. A data processing unit 1706 ( FIG. 17B ) can also be mounted on the PCB 1702 and can include, for example, an application specific integrated circuit (ASIC) configured to perform one or more functions or routines associated with the operation of the sensor control device 1602. More specifically, the data processing unit 1706 can be configured to perform data processing functions such as filtering and encoding multiple data signals, each corresponding to a sampled analyte level of the user. The data processing unit 1706 can include or otherwise communicate with an antenna for communication with the reader device 106 ( FIG. 1 ).

[0169] As shown, the shell 1606, the mount 1608, and the PCB 1702 each define a corresponding central opening 1708a, 1708b, and 1708c, respectively. When the electronics housing 1602 is assembled, the central openings 1708a-1708c are coaxially aligned to receive portions of the sensor module and the sharps module 1610, 1612 therethrough.

[0170] A battery 1710 and a corresponding battery mount 1712 may be housed within the electronics housing 1604. The battery 1710 may be configured to power the sensor control device 1602.

[0171] The sensor module 1610 may include a sensor 1614 and a connector 1714. The sensor 1614 may include a tail 1716, a flag 1718, and a neck 1720 interconnecting the tail 1716 and the flag 1718. The tail 1716 may be configured to extend through a central opening 1708b defined in the mount 1608 and extend distally from an underside of the mount 1608. The tail 1716 may include an enzyme or other chemical or biological agent, and in some embodiments, a membrane may cover the chemical agent. During use, the tail 1716 is transdermally received under the user's skin, and the chemical agent contained on the tail helps facilitate analyte monitoring in the presence of bodily fluids.

[0172] The flag 1718 may include a generally flat surface with one or more sensor contacts 1722 (three are shown in FIG. 17A ) positioned thereon. The flag 1718 may be configured to be received within the connector 1714, where the sensor contacts 1722 align with a corresponding number of flexible carbon-impregnated polymer modules (not shown) enclosed within the connector 1714.

[0173] The connector 1714 includes one or more hinges 1724 that allow it to move between an open and a closed state. While FIGS. 17A and 17B show the connector 1714 in a closed state, the connector 1714 can be moved to the open state to receive the flag 1718 and flexible carbon-impregnated polymer module therein. The flexible carbon-impregnated polymer module provides electrical contacts 1726 (three shown in FIG. 17A ) configured to provide conductive communication between the sensor 1614 and corresponding circuit contacts 1728 provided on the PCB 1702. When the sensor module 1610 is properly coupled to the electronics housing 1604, the circuit contacts 1728 establish conductive communication with the electrical contacts 1726 of the connector 1714. The connector 1714 can be fabricated from silicone rubber and can act as a moisture barrier for the sensor 1614.

[0174] The sharps module 1612 includes a sharps 1616 and a sharps hub 1730 that carries the sharps 1616. The sharps 1616 include an elongated shaft 1732 and a sharps tip 1734 at its distal end. The shaft 1732 can be configured to extend through each of the coaxially aligned central openings 1708a-1708c and extend distally from the bottom of the mount 1608.

[0175] Additionally, the shaft 1732 can include a hollow or recessed portion 1736 that at least partially surrounds the tail 1716 of the sensor 1614. The sharp tip 1734 can be configured to pierce the skin while carrying the tail 1716 to bring the active chemical agent of the tail 1716 into contact with bodily fluids.

[0176] The sharp hub 1730 can include a hub mini-cylinder 1738 and a hub snap pawl 1740, each of which can assist in coupling the sensor control device 1602 to the sensor applicator 102 (FIG. 1).

[0177] 17A , in some embodiments, the sensor module 1610 can be at least partially received within a sensor mounting pocket 1742 included within the electronics housing 1604. In some embodiments, the sensor mounting pocket 1742 can comprise a separate structure, but can alternatively form an integral part of or extension of the mount 1608. The sensor mounting pocket 1742 can be shaped and otherwise configured to receive and seat the sensor 1614 and connector 1714. As shown, the sensor mounting pocket 1742 defines an outer perimeter 1744 that generally surrounds the area in which the sensor 1614 and connector 1714 will be received. In at least one embodiment, the outer perimeter 1744 can be sealed to the underside of the PCB 1702 when the electronics housing 1604 is fully assembled. In such embodiments, a gasket (e.g., an O-ring, etc.), adhesive, or another type of sealing material can be applied to the outer perimeter 1744 and serve to seal the interface between the sensor mounting pocket and the PCB 1702.

[0178] Sealing the interface between the sensor mounting pocket 1742 and the underside of the PCB 1702 can help create or define a sealed zone or area within the electronics housing 1604. This sealed area can prove advantageous by helping to isolate (protect) the tail 1716 of the sensor 1614 from potentially harmful sterilizing gases used during gas-chemical sterilization.

[0179] 17B , a plurality of channels or grooves 1746 can be provided or otherwise defined on the bottom of the mount 1608. As shown, the grooves 1746 can form a plurality of concentric rings in combination with the radially extending channels. An adhesive patch 1618 ( FIGS. 16A and 16B ) can be attached to the underside of the mount 1608, and in some embodiments, a transfer adhesive 1620 ( FIGS. 16A and 16B ) can be sandwiched between the adhesive patch 1618 and the bottom of the mount 1608. The grooves 1746 can prove advantageous by facilitating the egress of moisture beneath the adhesive patch 1618 and away from the center of the electronics housing 1604.

[0180] In some embodiments, a cap post sealing interface 1748 can be defined on the bottom of the mount 1608 and at the center of the mount 1608. As shown, the cap post sealing interface 1748 can include a substantially flat portion of the bottom of the mount 1608. A second central opening 1708b can be defined at the center of the cap post sealing interface 1748, and the groove 1746 can surround the cap post sealing interface 1748. The cap post sealing interface 1748 can provide a sealing surface that can help isolate (protect) the tail 1716 of the sensor 1614 from potentially harmful sterilization gases used during gas-chemical sterilization.

[0181] 18A-18C are isometric, side, and bottom views, respectively, of an exemplary sensor control device 1802 in accordance with one or more embodiments of the present disclosure. The sensor control device 1802 (alternatively referred to as a "puck") may be similar in some respects to the sensor control device 104 of FIG. 1 and, therefore, may be most clearly understood with reference thereto. The sensor control device 1802 may replace the sensor control device 104 of FIG. 1 and, therefore, may be used in conjunction with the sensor applicator 102 (FIG. 1), which delivers the sensor control device 1802 to a target monitoring location on the user's skin. However, in contrast to the sensor control device 104 of FIG. 1, various structural advantages and improvements allow the sensor control device 1802 to be incorporated into a one-piece system architecture.

[0182] 1 , for example, a user is not required to unpack multiple packages and finally assemble the sensor control device 1802 prior to delivery to a target monitoring location. Instead, upon receipt by a user, the sensor control device 1802 may already be fully assembled and properly positioned within the sensor applicator 102. To use the sensor control device 1802, a user need only break a single barrier (e.g., an applicator cap) before immediately delivering the sensor control device 1802 to a target monitoring location.

[0183] Referring initially to FIG. 18A , sensor control device 1802 includes electronics housing 1804, which may be generally disc-shaped and have a generally circular cross-section. However, in other embodiments, electronics housing 1804 may exhibit other cross-sectional shapes, such as oval or polygonal, without departing from the scope of this disclosure. Electronics housing 1804 may include shell 1806 and a mount 1808 mateable therewith. An adhesive patch 1810 is positioned on the underside of mount 1808 and may be attached thereto. Similar to adhesive patch 108 of FIG. 1 , adhesive patch 1810 may be configured to securely maintain sensor control device 1802 in place on a user's skin during operation.

[0184] In some embodiments, the shell 1806 can define a reference feature 1812. As shown, the reference feature 1812 can include a recess or light-blocking pocket defined in the shell 1806 and extending a short distance into the electronics housing 3704. The reference feature 1812 can act as a “datum c” feature configured to help facilitate control of at least one degree of freedom of the sensor control device 1802 during factory assembly. In contrast, conventional sensor control devices (e.g., the sensor control device 104 of FIG. 1 ) typically include a tab extending radially from the side of the shell. This tab is used as a manufacturing clocking datum but must be removed at the end of fabrication; this removal step is followed by inspection of the shell where the tab once resided, thereby adding complexity to the conventional fabrication process.

[0185] The shell 1806 may also define a central opening 1814 sized to receive a sharp (not shown) that is extendable through the center of the electronics housing 1804 .

[0186] 18B depicts a portion of the sensor 1816 extending from the electronics housing 1804. The remainder of the sensor 1816 is positioned within the electronics housing 1804. Similar to the sensor 110 of FIG. 1, the exposed portion of the sensor 1816 is configured to be positioned transcutaneously beneath the skin of a user during use. The exposed portion of the sensor 1816 may include an enzyme or other chemical or biological agent, and in some embodiments, a membrane may cover the chemical agent.

[0187] Sensor control device 1802 offers structural improvements that result in a height H and diameter D that can be smaller than conventional sensor control devices (e.g., sensor control device 104 of FIG. 1). In at least one embodiment, for example, height H can be about 1 mm or more less than the height of a conventional sensor control device, and diameter D can be about 2 mm or more less than the diameter of a conventional sensor control device. In certain other embodiments, height H and diameter D can be any other suitable value less than the height or diameter of a conventional sensor device, such as between 1 mm and 5 mm, or between 1 mm and 10 mm.

[0188] Additionally, structural improvements to sensor control device 1802 enable shell 1806 to provide or otherwise define a chamfered or beveled outer perimeter 1818. In contrast, conventional sensor control devices typically require a rounded or outwardly arcuate outer perimeter to accommodate internal components. The lower height H, smaller diameter D, and beveled outer perimeter 1818 may each prove advantageous by resulting in a sensor control device 1802 that is thinner, smaller, and less prone to catching on sharp corners or the like and prematurely detaching while attached to a user's skin.

[0189] 18C depicts a central opening 1820 defined on the underside of mount 1808. Central opening 1820 can be sized to receive the combination of a sharp (not shown) and sensor 1816, where sensor 1816 is received within a hollow or recessed portion of the sharp. When electronics housing 1804 is assembled, central opening 1820 is coaxially aligned with central opening 1814 (FIG. 18A) of shell 1806 (FIG. 18A), and the sharp penetrates the electronics housing by extending through each central opening 1814, 1820 simultaneously.

[0190] 19A and 19B are exploded top and bottom views, respectively, of a sensor control device 1802 in accordance with one or more embodiments. A shell 1806 and a mount 1808 act as opposing clamshell halves that enclose or otherwise substantially enclose the various electronic components of the sensor control device 1802. As shown, the sensor control device 1802 may include a printed circuit board assembly (PCBA) 1902 that includes a printed circuit board (PCB) 1904 having a plurality of electronic modules 1906 coupled thereto. Exemplary electronic modules 1906 include, but are not limited to, resistors, transistors, capacitors, inductors, diodes, and switches. Conventional sensor control devices typically stack PCB components on only one side of the PCB. In contrast, the PCB components 1906 in the sensor control device 1802 may be distributed across the surface area of ​​both sides (i.e., the top and bottom) of the PCB 1904.

[0191] Separate from the electronic module 1906, the PCBA 1902 may further include a data processing unit 1908 mounted on the PCB 1904. The data processing unit 1908 may include, for example, an application specific integrated circuit (ASIC) configured to perform one or more functions or routines associated with the operation of the sensor control device 1802. More specifically, the data processing unit 1908 may be configured to perform data processing functions, where such functions may include, but are not limited to, filtering and encoding multiple data signals each corresponding to a sampled analyte level of the user. The data processing unit 1908 may include or otherwise communicate with an antenna for communication with the reader device 106 (FIG. 1).

[0192] A battery opening 1910 may be defined in the PCB 1904 and sized to receive and seat a battery 1912 configured to power the sensor control device 1802. An axial battery contact 1914a and a radial battery contact 1914b may be coupled to the PCB 1904 and may extend into the battery opening 1910 to facilitate the transfer of power from the battery 1912 to the PCB 1904. As the names suggest, the axial battery contact 1914a may be configured to provide an axial contact for the battery 1912, whereas the radial battery contact 1914b may provide a radial contact for the battery 1912. Positioning the battery 1912 in the battery opening 1910 using the battery contacts 1914a, 1914b helps reduce the height H ( FIG. 18B ) of the sensor control device 1802, thereby allowing the PCB 1904 to be centered and its components to be distributed on both sides (i.e., top and bottom). These help facilitate the chamfer 1818 (FIG. 18B) provided on the electronics housing 1804.

[0193] The sensor 1916 may be centrally positioned relative to the PCB 1904 and may include a tail 1916, a flag 1918, and a neck 1920 interconnecting the tail 1916 and the flag 1918. The tail 1916 may be configured to extend through a central opening 1820 in the mount 1808 for transcutaneous reception beneath the skin of a user. Additionally, the tail 1916 may include an enzyme or other chemical agent thereon to help facilitate analyte monitoring.

[0194] The flag 1918 can include a generally flat surface on which one or more sensor contacts 1922 (three shown in FIG. 19B ) are positioned. The sensor contacts 1922 can be configured to align with and engage one or more corresponding circuit contacts 1924 (three shown in FIG. 19A ) provided on the PCB 1904. In some embodiments, the sensor contacts 1922 can comprise carbon-impregnated polymer printed or otherwise applied as fingers to the flag 1918. Conventional sensor control devices typically include connectors made of silicone rubber encapsulating one or more flexible carbon-impregnated polymer modules that function as conductive contacts between the sensor and the PCB. In contrast, the disclosed sensor contacts 1922 provide a direct connection between the sensor 1816 and the PCB 1904, thereby eliminating the need for prior art connectors and advantageously reducing the height H ( FIG. 18B ). Furthermore, eliminating the flexible carbon-impregnated polymer modules eliminates significant circuit resistance, thus improving circuit conductivity.

[0195] The sensor control device 1802 may further include a flexible member 1926 that may be positioned to be sandwiched between the flag 1918 and the inner surface of the shell 1806. More specifically, when the shell 1806 and the mount 1808 are assembled together, the flexible member 1926 may be configured to provide a passive biasing load against the flag 1918 that urges the sensor contacts 1922 into seamless engagement with corresponding circuit contacts 1924. In an exemplary embodiment, the flexible member 1926 is an elastomeric O-ring, although it is contemplated that the flexible member 1926 may alternatively include any other type of biasing device or mechanism, such as a compression spring or the like, without departing from the scope of the present disclosure.

[0196] The sensor control device 1802 may further include one or more electromagnetic shields, shown as a first shield 1928 a and a second shield 1928 b. The shields 1928 a, 1928 b may be disposed between the shell 1806 and the mount 1808, i.e., within the electronics housing 1804. In an exemplary embodiment, the first shield 1928 a is positioned above the PCB 1904 to face the top surface of the PCB 1904, and the second shield 1928 b is positioned below the PCB 1904 to face the bottom surface of the PCB 1904.

[0197] The shields 1928a, 1928b can be configured to protect sensitive electronic components from radiation while the sensor control device 1802 undergoes radiation sterilization. More specifically, at least one of the shields 1928a, 1928b can be positioned to be sandwiched between the data processing unit 1908 and a radiation source, such as an electron beam electron accelerator. In some embodiments, for example, at least one of the shields 1928a, 1928b can be positioned adjacent to and aligned with the data processing unit 1908 and the radiation source to block or mitigate an absorbed dose of radiation that could otherwise damage sensitive electronic circuitry of the data processing unit 1908.

[0198] In the exemplary embodiment, the data processing unit 1908 is sandwiched between the first shield 1928a and the second shield 1928b such that the first shield 1928a and the second shield 1928b substantially axially sandwich the data processing unit 1908. However, in at least one embodiment, only one of the shields 1928a, 1928b may be required to adequately protect the data processing unit 1908 during radiation sterilization. For example, if the sensor control device 1802 is to undergo radiation sterilization directed toward the bottom of the mount 1808, only the second shield 1928b need be sandwiched between the data processing unit 1908 and the radiation source, and the first shield 1928a can be omitted. Alternatively, if the sensor control device 1802 is to be subjected to radiation sterilization directed toward the top of the shell 1806, only the first shield 1928a need be sandwiched between the data processing unit 1908 and the radiation source, and the second shield 1928b can be omitted. However, in other embodiments, both shields 1928a, 1928b can be used without departing from the scope of the present disclosure.

[0199] The shields 1928a, 1928b can be made of any material capable of attenuating (or substantially attenuating) the penetration of radiation. Suitable materials for the shields 1928a, 1928b include, but are not limited to, lead, tungsten, iron-based metals (e.g., stainless steel), copper, tantalum, tungsten, osmium, aluminum, carbon, or any combination thereof. Suitable materials for the shields 1928a, 1928b can be corrosion-resistant, austenitic, and any non-magnetic metal with a density ranging between about 2 grams per cubic centimeter (g / cc) and about 23 g / cc. The shields 1928a, 1928b can be fabricated by a variety of manufacturing techniques, including, but not limited to, stamping, casting, injection molding, sintering, two-shot molding, or any combination thereof.

[0200] However, in other embodiments, the shields 1928a, 1928b may comprise a metal-filled thermoplastic polymer such as, but not limited to, polyamide, polycarbonate, or polystyrene. In such embodiments, the shields 1928a, 1928b may be fabricated by mixing the shielding material into an adhesive matrix and dripping this combination onto a component to be molded or otherwise directly onto the data processing unit 1908. Further, in such embodiments, the shields 1928a, 1928b may include an enclosure that encapsulates (or substantially encapsulates) the data processing unit 1908. In such embodiments, the shields 1928a, 1928b may comprise a metal-filled thermoplastic polymer as described above, or alternatively, may be fabricated from any of the materials described herein that have the ability to attenuate (or substantially attenuate) the transmission of radiation.

[0201] Shell 1806 may provide or otherwise define a first clocking receptacle 1930a (FIG. 19B) and a second clocking receptacle 1930b (FIG. 19B), and mount 1808 may provide or otherwise define a first clocking post 1932a (FIG. 19A) and a second clocking post 1932b (FIG. 19A). Mating of first and second clocking receptacles 1930a, 1930b with first and second clocking posts 1932a, 1932b, respectively, results in proper alignment of shell 1806 with mount 1808.

[0202] 18A , the inner surface of mount 1808 can provide or otherwise define a plurality of pockets or recesses configured to receive various component parts of sensor control device 1802 when shell 1806 is mated to mount 1808. For example, the inner surface of mount 1808 can define a battery locator 1934 configured to receive a portion of battery 1912 when sensor control device 1802 is assembled. An adjacent contact pocket 1936 can be configured to receive a portion of axial contact 1914a.

[0203] Additionally, a plurality of module pockets 1938 may be defined on the inner surface of the mount 1808 to receive various electronic modules 1906 positioned on the bottom of the PCB 1904. Additionally, a shield locator 1940 may be defined on the inner surface of the mount 1808 to receive at least a portion of the second shield 1928b when the sensor control device 1802 is assembled. The battery locator 1934, contact pocket 1936, module pocket 1938, and shield locator 1940 all extend a short distance into the inner surface of the mount 1808, thereby reducing the overall height H ( FIG. 18B ) of the sensor control device 1802 compared to conventional sensor control devices. The module pockets 1938 may help minimize the diameter of the PCB 1904 by allowing PCB components to be positioned on both sides (i.e., the top and bottom).

[0204] Continuing with reference to FIG. 19A , the mount 1808 can further include a plurality of carrier gripping features 1942 (two shown) defined around its outer periphery. The carrier gripping features 1942 are axially offset from a bottom 1944 of the mount 1808, to which a transfer adhesive (not shown) can be applied during assembly. In contrast to conventional sensor control devices that typically include a conical carrier gripping feature that intersects the bottom of the mount, the disclosed carrier gripping features 1942 are offset from the plane (i.e., bottom 1944) to which the transfer adhesive is applied. This offset can prove advantageous by helping to ensure that the delivery system does not inadvertently adhere to the transfer adhesive during assembly. Furthermore, the disclosed carrier gripping features 1942 eliminate the need for a corrugated transfer adhesive, thereby simplifying the manufacture of the transfer adhesive and eliminating the need to precisely clock the transfer adhesive to the mount 1808. This also increases the bonding area and, therefore, the bond strength.

[0205] 19B , a bottom 1944 of the mount 1808 may provide or otherwise define a plurality of grooves 1946 that may be defined at or near the outer periphery of the mount 1808 and spaced equidistant from one another. A transfer adhesive (not shown) may be bonded to the bottom 1944, and the grooves 1946 may be configured to aid in transporting moisture away from the sensor control device 1802 and around the mount 1808 during use. In some embodiments, the spacing of the grooves 1946 may intersect with module pockets 1938 ( FIG. 19A ) defined on the opposite (inner) side of the mount 1808. As will be apparent, alternating the locations of the grooves 1946 and the module pockets 1938 ensures that opposing features on either side of the mount 1808 do not extend into one another. This may help maximize material utilization for the mount 1808, thereby helping to maintain a minimum height H ( FIG. 18B ) of the sensor control device 1802. The module pocket 1938 can significantly reduce mold sink and improve the flatness of the bottom 1944 where the transfer adhesive adheres.

[0206] 19B , the inner surface of the shell 1806 can provide or otherwise define a plurality of pockets or recesses configured to receive various component parts of the sensor control device 1802 when the shell 1806 is mated to the mount 1808. For example, the inner surface of the shell 1806 can define an opposing battery locator 1948 positionable opposite the battery locator 1934 ( FIG. 19A ) of the mount 1808 and configured to receive a portion of the battery 1912 when the sensor control device 1802 is assembled. Additionally, the inner surface of the shell 1806 can define a shield locator 1950 that receives at least a portion of the first shield 1928 a when the sensor control device 1802 is assembled. The opposing battery locator 1948 and the shield locator 1950 extend a short distance into the inner surface of the shell 1806, which extension helps reduce the overall height H ( FIG. 19B ) of the sensor control device 1802.

[0207] A sharp and sensor locator 1952 may also be provided by or otherwise defined on the inner surface of the shell 1806. The sharp and sensor locator 1952 may be configured to receive both a sharp (not shown) and a portion of the sensor 1816. Furthermore, the sharp and sensor locator 1952 may be configured to align and / or mate with a corresponding sharp and sensor locator provided on the inner surface of the mount 1808.

[0208] 20A and 20B depict fabrication of a sensor control device according to certain embodiments. In a first step of process 2000, holes 2002 can be punched or otherwise formed in a base substrate 2004, which can include a sheet of material that can ultimately form the base or lower cover 2008 of the sensor control device. The base substrate 2004 can comprise a belt or thin film made of a variety of different materials, including, but not limited to, plastic, metal, composite material, or any combination thereof. In at least one embodiment, the base substrate 2004 can comprise a laminated aluminum foil having a polyester film on one side (e.g., the bottom side) and a polyolefin heat seal layer on the other side (e.g., the top side).

[0209] In a second step of process 2000, a sensor holder can be bonded to a base substrate 2004. The sensor holder can be the same as or similar to any of the plurality of sensor holders. Accordingly, the sensor holder can define a channel 2006 sized to receive the tail of the sensor. In some embodiments, the sensor holder can be ultrasonically welded or heat sealed to the base substrate, thereby providing a hermetic and watertight engagement. However, in at least one embodiment, the base substrate can comprise or otherwise include an adhesive substrate on its upper side for securing and sealing the sensor holder in place.

[0210] In a third step of process 2000, a first adhesive substrate 2008 can be attached to the top of the sensor holder. The first adhesive substrate 2008 can be similar to any known adhesive substrate and, therefore, can comprise a pressure-sensitive adhesive tape that forms a bond when pressure is applied. In at least one embodiment, the first adhesive substrate 2008 can comprise a double-sided polyolefin foam tape and can be pressure-sensitive on both sides.

[0211] In a fourth step of process 2000, sensor 2016 can be secured to the sensor holder using a first adhesive substrate 2008. More specifically, the tail can be extended through channel 2006, and the flag can be bent approximately perpendicular to the tail 10314 and bonded to the underlying first adhesive substrate 2008.

[0212] 20B, in a fifth step of the process 2000, a printed circuit board (PCB) 2010 can be disposed on the base substrate 2004 and around the sensor holder. The PCB 2010 can include a plurality of electronic modules 2012 mounted thereon. The electronic modules 2012 can include at least one of a Bluetooth antenna and a near field communication (NFC) antenna. As shown, the PCB 2010 can define two opposing lobes 2014a and 2014b interconnected by a neck portion 2016. Opposing battery contacts 2018a and 2018b can be provided on the opposing lobes 2014a, 2014b to facilitate electrical communication with a battery 2020.

[0213] In a sixth step of process 2000, a second adhesive substrate 2008b can be applied to the first battery contact 2018a to receive the battery 2020 in an immediately following seventh step of process 2000. The second adhesive substrate can comprise a pressure-sensitive adhesive tape used to bond the battery 2020 to the first battery contact 2018a. However, the second adhesive substrate can comprise a Z-axis anisotropic (or conductive) pressure-sensitive adhesive tape that also facilitates electrical communication (i.e., transfer of power) between the battery 2020 and the first battery contact 2018a.

[0214] 21 is a side view of an exemplary sensor 2100 in accordance with one or more embodiments of the present disclosure. The sensor 2100 may be similar in some respects to any of the sensors described herein and, therefore, may be used to detect a particular analyte concentration in an analyte monitoring system. As shown, the sensor 2100 includes a tail 2102, a flag 2104, and a neck 2106 interconnecting the tail 2102 and the flag 2104. The tail 2102 includes an enzyme or other chemical or biological agent, and in some embodiments, a membrane can cover the chemical agent. During use, the tail 2102 is transdermally received under a user's skin, and the chemical agent contained on the tail helps facilitate analyte monitoring in the presence of bodily fluids.

[0215] The tail 2102 may be received within a hollow or recessed portion of a sharp (not shown) that at least partially surrounds the tail 2102 of the sensor 2100. As shown, the tail 2102 may extend at an angle Q offset from horizontal. In some embodiments, the angle Q may be approximately 85°. Thus, in contrast to other sensor tails, the tail 2102 may not extend perpendicularly from the flag 2104, but instead may extend at an angular offset from vertical. This angular offset may prove advantageous by helping to maintain the tail 2102 within the recessed portion of the sharp.

[0216] The tail 2102 includes a first or bottom end 2108a and an opposite second or top end 2108b. A tower 2110 can be provided at or near the top end 2108b and can extend vertically upward from where the neck 2106 interconnects the tail 2102 to the flag 2104. When the sharp moves laterally during actuation, the tower 2110 pivots the tail 2102 toward the sharp and otherwise helps the tail 2102 remain within the recessed portion of the sharp. Additionally, in some embodiments, the tower 2110 can provide or otherwise define a protrusion 2112 extending laterally therefrom. When the sensor 2100 is mated with the sharp and the tail 2102 extends into the recessed portion of the sharp, the protrusion 2112 can engage an inner surface of the recessed portion. When actuated, the protrusion 2112 can help keep the tail 2102 within the recessed portion.

[0217] The flag 2104 can include a generally flat surface with one or more sensor contacts 2114 positioned thereon. The sensor contacts 2114 can be configured to align with a corresponding number of flexible carbon-impregnated polymer modules enclosed within the connector.

[0218] In some embodiments, as shown, the neck 2106 may provide or otherwise define a recess or bend 2116 that extends between the flag 2104 and the tail 2102. The bend 2116 may prove advantageous by adding flexibility to the sensor 2100 and helping to prevent bending of the neck 2106.

[0219] In some embodiments, a notch 2118 (shown in dashed lines) can optionally be defined in the flag near the neck 2106. The notch 2118 can provide additional flexibility and tolerance to the sensor 2100 when the sensor 2100 is mounted in a mount. More specifically, the notch 2118 can help absorb interference forces that may occur when the sensor 2100 is mounted in a mount.

[0220] 22A and 22B are isometric and partially exploded isometric views of an exemplary connector assembly 2200 according to one or more embodiments. As shown, the connector assembly 2200 can include a connector 2202. The connector 2202 can include an injection molded portion used to help secure one or more flexible carbon-impregnated polymer modules 2204 (four are shown in FIG. 22B ) to a mount 2206. More specifically, the connector 2202 can help secure the module 2204 in place adjacent the sensor 2100 in contact with the sensor contacts 2114 ( FIG. 21 ) provided on the flag 2104 ( FIG. 21 ). The module 2204 can be fabricated from a conductive material that provides conductive communication between the sensor 2100 and corresponding circuit contacts (not shown) provided in the mount 2206.

[0221] 22C, the connector 2202 can define a pocket 2208 sized to receive the module 2204. Additionally, in some non-limiting embodiments, the connector 2202 can further define one or more recesses 2210 configured to mate with one or more corresponding flanges 2212 (FIG. 22B) on the mount 2206. Mating the recesses 2210 with the flanges 2212 can secure the connector 2202 to the mount 2206, such as by an interference fit. In other embodiments, the connector 2202 can be secured to the mount 2206 using an adhesive or by sonic welding.

[0222] 22D and 22E are isometric and partially exploded isometric views of another exemplary connector assembly 2200 according to one or more embodiments. As shown, the connector assembly 2200 can include a connector 2202, and FIG. 22F is an isometric bottom view of the connector 2202. The connector 2202 can comprise an injection molded portion, a flexible carbon-impregnated polymer, a silicon or doped silicon, or a Molex connector used to help secure one or more flexible carbon-impregnated polymer modules 2204 (four are shown in FIG. 22E ) to the sensor 2100 on the mount 2206. More specifically, the connector 2202 can help secure the contacts 2204 in a defined location adjacent the sensor 2100 in contact with the sensor contacts 2114 ( FIG. 21 ) provided on the flag 2104. In other non-limiting embodiments, the connector 2202 can comprise any other material known in the art. The contacts 2204 may be fabricated from a stamped conductive material that provides conductive communication between the sensor 2100 and corresponding circuit contacts (not shown) provided in the mount 2206. In some embodiments, for example, the contacts 2204 may be soldered to a PCB (not shown) positioned within the mount 2206.

[0223] 22F , connector 2202 can define pockets 2208 sized to receive contacts 2204. Additionally, in some embodiments, connector 2202 can further define one or more recesses 2210 configured to mate with one or more corresponding flanges 2212 on mount 2206. Mating recesses 2210 with flanges 2212 can aid in securing connector 2202 to mount 2206, such as by an interference fit. In other embodiments, connector 2202 can be secured to mount 2206 using an adhesive or by sonic welding.

[0224] 23A and 23B are side and isometric views, respectively, of an exemplary sensor control device 2302 in accordance with one or more embodiments of the present disclosure. The sensor control device 2302 may be similar in some respects to the sensor control device 102 of FIG. 1 and, therefore, may be best understood with reference thereto. Furthermore, the sensor control device 2302 may replace the sensor control device 104 of FIG. 1 and, therefore, may be used in conjunction with the sensor applicator 102 of FIG. 1, which delivers the sensor control device 2302 to a target monitoring location on the user's skin.

[0225] As shown, the sensor control device 2302 includes an electronics housing 2304 that is generally disk-shaped and can have a circular cross-section. However, in other embodiments, the electronics housing 2304 can exhibit other cross-sectional shapes, such as oval, elliptical, or polygonal, without departing from the scope of this disclosure. The electronics housing 2304 includes a shell 2306 and a mount 2308 that is matable therewith. The shell 2306 can be secured to the mount 2308 by various methods, 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 some non-limiting embodiments, the shell 2306 can be secured to the mount 2308 such that a sealed interface occurs between the shell 2306 and the mount 2308. An adhesive patch 2310 can be positioned on the underside of the mount 2308 and attached thereto. Similar to adhesive patch 108 of FIG. 1, adhesive patch 2310 can be configured to securely maintain sensor control device 2302 in place on a user's skin during operation.

[0226] The sensor control device 2302 can further include a sensor 2312 and a sharp 2314 that is used to aid in transcutaneous delivery of the sensor 2312 beneath the user's skin during application of the sensor control device 2302. Corresponding portions of the sensor 2312 and sharp 2314 extend distally from a bottom of the electronics housing 2304 (e.g., mount 2308). A sharp hub 2316 can be overmolded onto the sharp 2314 and configured to securely carry the sharp 2314. As shown in FIG. 23A , the sharp hub 2316 can include or otherwise define a mating member 2318. During assembly of the sharp 2314 to the sensor control device 2302, the sharp hub 2316 engages the top surface of the electronics housing 2304 or an internal component of the electronics housing 2304, and the sharp 2314 can be advanced axially through the electronics housing 2304 until the mating member 2318 extends distally from the bottom of the mount 2308. As described below, in at least one embodiment, the sharp hub 2316 can sealingly engage an upper portion of a sealing overmold on the mount 2308. As the sharp 2314 penetrates the electronics housing 2304, the exposed portion of the sensor 2312 can be received within the hollow or recessed (arcuate) portion of the sharp 2314. The remainder of the sensor 2312 is disposed within the electronics housing 2304.

[0227] The sensor control device 2302 may further include a sensor cap 2320, shown separated from the electronics housing 2304 in FIGS. 23A-23B. The sensor cap 2320 may help provide a sealed barrier that surrounds and protects the exposed portions of the sensor 2312 and sharps 2314. As shown, the sensor cap 2320 may include a generally cylindrical body having a first end 2322a and an opposing second end 2322b. The first end 2322a may be open to provide access into an interior chamber 2324 defined within the body. In contrast, the second end 2322b may be closed, and may be provided with or otherwise defined by an engagement feature 2326. As described in more detail below, the engagement feature 2326 can assist in fitting the sensor cap 2320 to an applicator cap of a sensor applicator (e.g., sensor applicator 102 of FIG. 1) and can also assist in removing the sensor cap 2320 from the sensor control device 2302 when the sensor cap is removed from the sensor applicator.

[0228] The sensor cap 2320 can be removably coupled to the electronics housing 2304 at or near the bottom of the mount 2308. More specifically, the sensor cap 2320 can be removably coupled to a mating member 2318 extending distally from the bottom of the mount 2308. In at least one embodiment, for example, the mating member 2318 can define a set of male threads 2328a ( FIG. 23A ) that can mate with a set of female threads 2328b ( FIG. 23B ) defined in the inner chamber 2324 of the sensor cap 2320. In some embodiments, the male and female threads 2328a, 2328b can include a flat threaded design (e.g., lacking a helical curvature), but can alternatively include a helical threaded engagement. Thus, in at least one embodiment, the sensor cap 2320 can be threadably coupled to the sensor control device 2302 at the mating member 2318 of the sharp hub 2316. In other embodiments, the sensor cap 2320 can be removably coupled to the mating member 2318 by other types of engagement, including, but not limited to, an interference fit or a friction fit, or a frangible member or substance (e.g., wax, adhesive, etc.) that can be broken by a slight separation force (e.g., axial or rotational force).

[0229] In some embodiments, the sensor cap 2320 may include a monolithic (single) structure extending between the first end 2322a and the second end 2322b. However, in other embodiments, the sensor cap 2320 may include two or more component parts. In an exemplary embodiment, for example, the body of the sensor cap 2320 may include a desiccant cap 2330 positioned at the second end 2322b. The desiccant cap 2330 may contain or comprise a desiccant that helps maintain a preferred humidity level within the inner chamber 2324. Additionally, the desiccant cap 2330 may define or otherwise provide an engagement feature 2326 for the sensor cap 2320. In at least one non-limiting embodiment, the desiccant cap 2330 may include an elastomeric plug inserted into the bottom end of the sensor cap 2320.

[0230] 24A and 24B are exploded isometric top and bottom views, respectively, of sensor control device 2302 in accordance with certain embodiments. Shell 2306 and mount 2308 act as opposing clamshell halves that enclose or otherwise substantially enclose various electronic components (not shown) of sensor control device 2302. Exemplary electronic components that may be disposed between shell 2306 and mount 2308 include, but are not limited to, batteries, resistors, transistors, capacitors, inductors, diodes, and switches.

[0231] The shell 2306 can define a first opening 2402a, and the mount 2308 can define a second opening 2402b, which openings 2402a, 2402b can align when the shell 2306 is properly attached to the mount 2308. As best seen in FIG. 24A , the mount 2308 can provide or otherwise define a seat 2404 that protrudes from an inner surface of the mount 2308 at the second opening 2402b. The seat 2404 can define at least a portion of the second opening 2402b. Additionally, a channel 2406 can be defined on the inner surface of the mount 2308, and the channel 2406 can surround the seat 2402b. In the exemplary embodiment, the channel 2406 is circular in shape, although it is contemplated that the channel 2406 could alternatively be another shape, such as oval, elliptical, or polygonal.

[0232] The mount 2308 can include a molded portion made of a rigid material such as plastic or metal. In some embodiments, a seal 2408 can be overmolded onto the mount 2308, and the seal 2408 can be made of an elastomer, rubber, polymer, or another easily moldable material suitable for facilitating a hermetic bond. In embodiments in which the mount 2308 is made of plastic, the mount 2308 can be molded in a first "shot" of injection molding, and the seal 2408 can be overmolded onto the mount 2308 in a second "shot" of injection molding. Thus, the mount 2308 can be referred to or otherwise characterized as a "two-shot mount."

[0233] In an exemplary embodiment, the seal 2408 is overmolded onto the mount 2308 at the base 2404 and may also be overmolded onto the bottom of the mount 2308. More specifically, the seal 2408 may define or otherwise provide a first sealing element 2410a overmolded onto the base 2404 and a second sealing element 2410b ( FIG. 24B ) connected thereto or interconnected therewith and overmolded onto the mount 2308 at the bottom of the mount 2308. In some embodiments, one or both of the sealing elements 2410a, 2410b may help form a corresponding section of the second opening 2402b. While the seal 2408 is described herein as being overmolded onto the mount 2308, it is also contemplated that one or both of the sealing elements 2410a, 2410b may comprise an elastomeric component part separate from the mount 2408, such as an O-ring or gasket.

[0234] The sensor control device 2302 may further include a collar 2412, which may be a generally annular structure that defines a central opening 2414. The central opening 2414 may be sized to receive the first sealing element 2410a and may align with the first and second openings 2402a, 2402b when the sensor control device 2302 is properly assembled. The shape of the central opening 2414 may generally match the shape of the second opening 2402b and the first sealing element 2410a.

[0235] In some embodiments, the collar 2412 may define or otherwise be provided with an annular lip 2416 on its bottom surface. The annular lip 2416 may be sized or otherwise configured to fit within or be received within a channel 2406 defined on an inner surface of the mount 2308. In some embodiments, a groove 2418 may be defined on the annular lip 2416 and may be configured to fit within or otherwise receive a portion of the sensor 2312 that extends laterally within the mount 2308. In some embodiments, the collar 2412 may further define or otherwise be provided with a collar channel 2420 ( FIG. 24A ) on its upper surface that is sized to receive and otherwise fit within an annular ridge 2422 ( FIG. 24B ) defined on an inner surface of the shell 2306 when the sensor control device 2302 is properly assembled.

[0236] The sensor 2312 may include a tail 2424 that extends through a second opening 2402b defined in the mount 2308 and is transcutaneously received under the user's skin. The tail 2424 may have an enzyme or other chemical agent included thereon to help facilitate analyte monitoring. The sharp 2314 may include a sharp tip 2426 extendable through the first opening 2402a defined by the shell 2306. The tail 2424 of the sensor 2312 may be received within a hollow or recessed portion of the sharp tip 2426 as the sharp tip 2426 penetrates the electronics housing 2304. The sharp tip 2426 may be configured to pierce the skin while carrying the tail 2424 to bring the active chemical agent of the tail 2424 into contact with bodily fluids.

[0237] The sensor control device 2302 can provide a sealing subassembly including, among other component parts, portions of the shell 2306, the sensor 2312, the sharp 2314, the seal 2408, the collar 2412, and the sensor cap 2320. The sealing subassembly can help isolate the sensor 2312 and the sharp 2314 within the inner chamber 2324 ( FIG. 24A ) of the sensor cap 2320. In assembling the sealing subassembly, the sharp tip 2426 is advanced through the electronics housing 2304 until the sharp hub 2316 engages the seal 2408, more specifically, the first sealing element 2410 a. A mating member 2318 on the bottom of the sharp hub 2316 can extend out of the second opening 2402 b in the bottom of the mount 2308, and the sensor cap 2320 can be coupled to the sharp hub 2316 at the location of the mating member 2318. Coupling the sensor cap 2320 to the sharp hub 2316 at the fitting member 2318 can bias the first end 2322a of the sensor cap 2320 into sealing engagement with the seal 2408, and more specifically with the second sealing element 2410b on the bottom of the mount 2308. In some embodiments, when the sensor cap 2320 is coupled to the sharp hub 2316, a portion of the first end 2322a of the sensor cap 2320 can reach (engage) the bottom of the mount 2308, which may allow the sealing engagement between the sharp hub 2316 and the first sealing element 2410a to accommodate any tolerance variations between the features.

[0238] 25A shows a cross-sectional side view of a sensor control device 2302 according to certain embodiments. As noted above, the sensor control device 2302 can include or otherwise incorporate a sealing subassembly 2502, which can be advantageous for isolating the sensor 2312 and the sharps 2314 within the inner chamber 2324 of the sensor cap 2320. To assemble the sealing subassembly 2502, the sensor 2312 can be positioned within the mount 2308 such that the tail 2424 extends through the second opening 2402b at the bottom of the mount 2308. In at least one embodiment, a positioning feature 2504 can be defined on an inner surface of the mount 2308, and the sensor 2312 can define a groove 2506 that can mate with the positioning feature 2504 to properly position the sensor 2312 within the mount 2308.

[0239] With the sensor 2312 properly positioned, the collar 2412 can be installed on the mount 2308. More specifically, the collar 2412 can be positioned such that the first sealing element 2410a of the seal 2408 is received in a central opening 2414 defined by the collar 2412, with the first sealing element 2410a creating a radial seal against the collar 2412 at the central opening 2414. Furthermore, the annular lip 2416 defined on the collar 2412 can be received in the channel 2406 defined on the mount 2308, and a groove 2418 defined through the annular lip 2416 can be aligned to receive the portion of the sensor 2312 that traverses the channel 2406 within the mount 2308. In some embodiments, an adhesive can be injected into the channel 2406 to secure the collar 2412 to the mount 2308. The adhesive can facilitate a hermetic bond between these two components and create a seal around the sensor 2312 at the location of the groove 2418, thereby isolating the tail 2424 from the interior of the electronics housing 2304.

[0240] The shell 2306 may then be mated or otherwise coupled to the mount 2308. In some embodiments, as shown, the shell 2306 may be mated to the mount 2308 through a tongue and groove mating portion 2508 around the outer periphery of the electronics housing 2304. An adhesive may be injected (applied) into the groove portion of the mating portion 2508 to secure the shell 2306 to the mount 2308 and to create a sealed mating interface. Mating the shell 2306 to the mount 2308 allows an annular ridge 2422 defined on the inner surface of the shell 2306 to be received within a collar channel 2420 defined on the top surface of the collar 2412. In some embodiments, an adhesive may be injected into the collar channel 2420 to secure the shell 2306 to the collar 2412 and to facilitate a sealed bond between the two components at this location. When the shell 2306 is mated with the mount 2308 , the first sealing element 2410 a can extend at least partially through (into) a first opening 2402 a defined in the shell 2306 .

[0241] The sharp 2314 can then be coupled to the sensor control device 2302 by extending the sharp tip 2426 through first and second openings 2402 a, 2402 b defined in the shell 2306 and the mount 2308, respectively. The sharp 2314 can be advanced until the sharp hub 2316 engages the seal 2408, more specifically the first sealing element 2410 a. The mating member 2318 can extend (protrude) out of the second opening 2402 b at the bottom of the mount 2308 when the sharp hub 2316 engages the first sealing element 2410 a.

[0242] The sensor cap 2320 can then be removably coupled to the sensor control device 2302 by threadably mating the internal threads 2328b of the sensor cap 2320 with the external threads 2328a of the fitting 2318. The internal chamber 2324 can be sized and otherwise configured to receive the tail 2424 and sharp tip 2426 extending from the bottom of the mount 2308. Additionally, the internal chamber 2324 can be sealed to isolate the tail 2424 and sharp tip 2426 from substances that could adversely interact with the chemical formulation of the tail 2424. In some embodiments, a desiccant (not shown) can be present in the internal chamber 2324 to maintain the proper humidity level.

[0243] Tightening (rotating) the mating engagement between the sensor cap 2320 and the fitting member 2318 can press the first end 2322a of the sensor cap 2320 into axial (e.g., along the centerline of the openings 2402a, 2402b) sealing engagement with the second sealing element 2410b, further strengthening the axial sealing bond between the sharp hub 2316 and the first sealing element 2410a. Additionally, tightening the mating engagement between the sensor cap 2320 and the fitting member 2318 can compress the first sealing element 2410a, thereby providing a strong radial sealing engagement between the first sealing element 2410a and the collar 2412 at the central opening 2414. Thus, in at least one embodiment, the first sealing element 2410a can help facilitate both axial and radial sealing engagement.

[0244] As described above, the first and second sealing elements 2410a, 2410b can be overmolded onto the mount 2308 and physically connected or otherwise interconnected. Thus, a single injection molding shot can flow through the second opening 2402b in the mount 2308 to create both ends of the seal 2408. This can prove advantageous in that multiple sealing interfaces can be generated with only a single injection molding shot. An additional benefit of the two-shot molding design is that, as opposed to using separate elastomeric components (e.g., O-rings, gaskets, etc.), the bond between the first and second shots is a more secure adhesive than a mechanical seal. Thus, the actual number of mechanical sealing barriers is essentially halved. Furthermore, two-shot components with a single elastomeric shot also minimize the number of two-shot components required to achieve all necessary sterility barriers.

[0245] Once properly assembled, the sealing subassembly 2502 can be subjected to a radiation sterilization process to sterilize the sensor 2312 and the sharp 2314. The sealing subassembly 2502 can be subjected to radiation sterilization before or after coupling the sensor cap 2320 to the sharp hub 2316. The sensor cap 2320 can be made of a material that allows the transmission of radiation therethrough when sterilized after coupling the sensor cap 2320 to the sharp hub 2316. In some embodiments, the sensor cap 2320 can be transparent or translucent, although it can otherwise be opaque without departing from the scope of this disclosure.

[0246] FIG. 25B shows an exploded isometric view of a portion of another embodiment of the sensor control device 2302 of FIGS. 23A-23B and 24A-24B. The embodiments included above described the mount 2308 and seal 2408 being manufactured by a two-shot injection molding process. However, in other embodiments, as briefly indicated above, one or both of the sealing elements 2410a, 2410b of the seal 2408 can comprise elastomeric component parts separate from the mount 2408. In an exemplary embodiment, for example, the first sealing element 2410a can be overmolded onto the collar 2412, and the second sealing element 2410b can be overmolded onto the sensor cap 2320. Alternatively, the first and second sealing elements 2410a, 2410b can comprise separate component parts, such as gaskets or O-rings, positioned on the collar 2412 and the sensor cap 2320, respectively. By tightening (rotating) the mating engagement between the sensor cap 2320 and the mating member 2318, the second sealing element 2410b can be pressed into axial sealing engagement with the bottom of the mount 2308, strengthening the axial sealing interface between the sharp hub 2316 and the first sealing element 2410a.

[0247] FIG. 26A shows an isometric bottom view of a mount 2308 according to certain embodiments, and FIG. 26B shows an isometric top view of a sensor cap 2320 according to certain embodiments. As shown in FIG. 26A, the mount 2308 can provide or otherwise define one or more recesses or pockets 2602 at or near the opening to the second opening 2402b. As shown in FIG. 26B, the sensor cap 2320 can provide or otherwise define one or more protrusions 2604 at or near its first end 9122a. The protrusions 2604 can be received within the pockets 2602 when the sensor cap 2320 is coupled to the Sharp hub 2316. More specifically, as described above, when the sensor cap 2320 is coupled to the fitting member 2318 of the Sharp hub 2316, the first end 9122a of the sensor cap 2320 is placed into sealing engagement with the second sealing element 2410b. In the process, the protrusion 2604 can be received within the pocket 2602, which can help prevent premature unscrewing of the sensor cap 2320 from the sharp hub 2316.

[0248] 27A and 27B are a side view and a cross-sectional side view, respectively, of an exemplary sensor applicator 2702 in accordance with certain embodiments. The sensor applicator 2702 may be similar in some respects to the sensor applicator 102 of FIG. 1 and, as such, may be designed to deliver (eject) a sensor control device such as the sensor control device 2302. FIG. 27A illustrates how the sensor applicator 2702 may be shipped to and received by a user, and FIG. 27B depicts the sensor control device 2302 positioned within the sensor applicator 2702.

[0249] 27A , sensor applicator 2702 includes housing 2704 and applicator cap 2706 removably coupled thereto. In some embodiments, applicator cap 2706 can be threaded onto housing 2704 and can include tamper ring 2708. When applicator cap 2706 is rotated (e.g., twisted off) relative to housing 2704, tamper ring 2708 threads off, thereby allowing applicator cap 2706 to be released from sensor applicator 2702.

[0250] 27B, the sensor control device 2302 is positioned within the sensor applicator 2702. Once the sensor control device 2302 is fully assembled, it can then be loaded into the sensor applicator 2702, and an applicator cap 2706 can be coupled to the sensor applicator 2702. In some embodiments, the applicator cap 2706 and the housing 2704 can have opposing matable thread sets that allow the applicator cap 2706 to be threaded onto the housing 2704 in a clockwise (or counterclockwise) direction, thereby securing the applicator cap 2706 to the sensor applicator 2702.

[0251] By securing the applicator cap 2706 to the housing 2704, the second end 9122b of the sensor cap 2320 can be received in a cap post 2710 positioned within the applicator cap 2706 and extending proximally from a bottom of the applicator cap 2706. The cap post 2710 can be configured to receive at least a portion of the sensor cap 2320 when the applicator cap 2706 is coupled to the housing 2704.

[0252] 28A and 28B are perspective and top views, respectively, of a cap post 2710 in accordance with one or more additional embodiments. In the depicted depiction, a portion of a sensor cap 2320 is received within the cap post 2710, and more specifically, the desiccant cap 2330 of the sensor cap 2320 is positioned within the cap post 2710. The cap post 2710 can define a receiver feature 2802 configured to receive the engagement feature 2326 of the sensor cap 2320 when the applicator cap 2706 ( FIG. 27B ) is coupled (e.g., threaded) to the sensor applicator 2702 ( FIGS. 27A-27B ). However, when the applicator cap 2706 is removed from the sensor applicator 2702, the receiver feature 2802 can prevent the engagement feature 2326 from reversing direction, thereby preventing the sensor cap 2320 from separating from the cap post 2710. Instead, removing the applicator cap 2706 from the sensor applicator 2702 simultaneously detaches the sensor cap 2320 from the sensor control device 2302 (FIGS. 23A-24B and 24A-24B), thereby exposing the sensor 2312 (FIGS. 24A-24B) and the distal portion of the sharp 2314 (FIGS. 24A-24B).

[0253] Many design variations of the receiver feature 2802 can be employed without departing from the scope of this disclosure. In an exemplary embodiment, the receiver feature 2802 includes one or more flexible members 2804 (two shown) that are stretchable or flexible to receive the engagement feature 2326. The engagement feature 2326 can include, for example, an enlarged head, and the flexible feature 2804 can include a collet-type device including a plurality of flexible fingers configured to flex radially outward to receive the enlarged head.

[0254] Flexible member 2804 may further provide or otherwise define corresponding raised surfaces 2806 configured to interact with one or more opposing cam surfaces 2808 provided on an outer wall of engagement feature 2326. The configuration and alignment of raised surfaces 2806 and opposing cam surfaces 2808 is such that applicator cap 2706 can rotate in a first direction A (e.g., clockwise) relative to sensor cap 2320, but cap post 2710 binds to sensor cap 2320 when applicator cap 2706 is rotated in a second direction B (e.g., counterclockwise). More specifically, when applicator cap 2706 (and thus cap post 2710) rotates in first direction A, cam surfaces 2808 engage raised surfaces 2806, thereby urging flexible member 2804 to bend or otherwise deflect radially outward, creating a ratchet effect. However, by rotating the applicator cap 2706 (and therefore the cap post 2710) in the second direction B, the inclined surface 2810 of the cam surface 2808 is driven to collide with the opposing inclined surface 2812 of the raised surface 2806, thereby binding the sensor cap 2320 to the flexible member 2804.

[0255] 29 is a cross-sectional side view of the sensor control device 2302 positioned within the applicator cap 2706 in accordance with one or more embodiments. As shown, the opening to the receiver feature 2802 exhibits a first diameter D3, while the engagement feature 2326 of the sensor cap 2320 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 2320. When the sensor cap 2320 extends into the cap post 2710, the flexible member 2804 of the receiver feature 2802 can flex (expand) radially outward to accommodate the engagement feature 2326. In some embodiments, as shown, the engagement feature 2326 can provide or otherwise define a sloped outer surface that helps bias the flexible member 2804 radially outward. Once the engagement feature 2326 advances beyond the receiver feature 2802, the flexible member 2804 can bend back to (or towards) its natural state, thereby locking the sensor cap 2320 into the cap post 2710.

[0256] As the applicator cap 2706 is threaded onto the housing 2704 ( FIG. 29 ) in a first direction A, the cap post 2710 is correspondingly rotated in the same direction, gradually introducing the sensor cap 2320 into the cap post 2710. As the cap post 2710 rotates, the raised surface 2806 of the flexible member 2804 ratches against the opposing cam surface 2808 of the sensor cap 2320. This action continues until the applicator cap 2706 is fully threaded onto the housing 2704. In some embodiments, the ratcheting action can occur over two full revolutions of the applicator cap 2706 before the applicator cap 2706 reaches its final position.

[0257] To remove the applicator cap 2706, the applicator cap 2706 is rotated in the second direction B, which correspondingly rotates the cap post 2710 in the same direction, causing the cam surface 2808 (i.e., the inclined surface 2810 in FIGS. 28A-28B ) to engage the raised surface 2806 (i.e., the inclined surface 2812 in FIGS. 28A-28B ). Accordingly, continued rotation of the applicator cap 2706 in the second direction B correspondingly rotates the sensor cap 2320 in the same direction, thereby unscrewing it from the fitting member 2318 and allowing the sensor cap 2320 to detach from the sensor control device 2302. Detaching the sensor cap 2320 from the sensor control device 2302 exposes the sensor 2312 and the distal portion of the sharp 2314, thereby positioning the sensor control device 2302 in a predetermined location for discharge (use).

[0258] FIG. 30 is a cross-sectional view of a sensor control device 2800 illustrating an exemplary interaction between the sensor and the sharp. After assembly of the sharp, the sensor must seat in the channel defined by the sharp. In certain non-limiting embodiments, the sensor can be deflected inward and otherwise perfectly aligned with the sharp. In some other non-limiting embodiments, the sensor can have a slight biasing force at the location indicated by the two arrows A, as shown in FIG. 30. Biasing the sensor against the sharp can have the advantage that any relative movement between the sensor and sharp during subcutaneous insertion does not expose the sensor tip (i.e., tail) outside the sharp channel, which could potentially result in insertion failure.

[0259] 31A and 31B illustrate a printed circuit board according to certain embodiments. The printed circuit board (PCB) 3102 can be included in a device such as a sensor control device. The PCB 3102 can have 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, or more layers. Vias can connect components or traces on one layer to components or traces on another layer. The PCB can be fabricated from FR4 or FR-4 composite materials, which can include, for example, woven fiberglass with an epoxy resin binder. In other non-limiting embodiments, the PCB can include any other material known in the art. In some embodiments, a button-type or cylindrical battery 3104 can be connected or attached to the PCB 3102. For example, the battery 3104 can be connected or attached to the PCB 3102 using spot soldering and / or battery tabs 3118. Using battery tabs can help reduce battery size while eliminating battery contacts. The battery 3104 can be configured to power the PCB and / or one or more components connected or attached thereto. The PCB 3102 can include one or more modules 3110, such as resistors, transistors, capacitors, inductors, diodes, and / or switches. The one or more modules 3110 can be attached, connected, or mounted to the PCB 3102.

[0260] The analyte sensors shown in Figures 1-3B, 5B, 6A, 6B, 7, 9-11B, 13B, 15, 16B-17B, 18B, 19A, 19B, 21, 22A, 22B, 22D, 22E, 23A, 23B, 24A, 24B, 25A, 25B, 27B, 29, and / or 30 can be attached or connected to PCB 3102. To monitor the analyte level in the bodily fluid, a portion of the analyte sensor can be configured to be positioned in contact with the bodily fluid below the skin layer. In certain non-limiting embodiments, the sensor includes a tail, a flag, and a neck interconnecting the tail and the flag. To receive and support both the sensor and the connector, an assembly 3108, such as the plug assembly shown in Figures 3A, 3B, 22B, and 22E, can be included as part of the sensor assembly. When the assembly 3108 is properly coupled to the electronics housing, for example, one or more circuit contacts defined on the underside of the PCB 3110 can be in conductive communication with the electrical contacts of the connector. Thus, in some non-limiting embodiments, the connector can be connected to the PCB and configured to establish an electrical connection between the analyte sensor and the PCB.

[0261] In certain embodiments, the connector can take the form shown in FIGS. 3A, 3B, 11A, 11B, 17A, and / or 17B, while in other embodiments, the connector can be any other shape, such as a collar shape. At least a portion of the connector can include at least one of silicone rubber and / or a flexible carbon-impregnated polymer. While some embodiments included herein describe the use of a plug to connect the connector to a PCB, in certain other embodiments, the connector can connect directly to the PCB. For example, the assembly 3108 can include a Molex connector and a sensor flag, as shown in FIGS. 22B and 22E. In some embodiments, one or more parts of the sensor, such as the tail, flag, and neck, can be shaped to help secure and hold the sensor within the sharp channel. For example, the neck can include a bias tower to help secure or properly align the sensor within the sharp channel. In some non-limiting embodiments, a sharp hub 3114 can be used to help hold or secure the sensor to the PCB.

[0262] In some non-limiting embodiments, the PCB 3102 can be coupled to a processor 3112. The processor 3112 can be embodied by any computer or data processing device, such as a general-purpose data processing unit, a central processing unit (CPU), a digital signal processor (DSP), an application specific integrated circuit (ASIC), a programmable logic device (PLD), a field programmable gate array (FPGA), an input / output (I / O) circuit, a digital expansion circuit, or equivalent devices, or any combination thereof. The PCB 3102 can include a single processor or controller or multiple controllers or computers. For example, the PCB 3102 can include the general-purpose data processing unit 3112 or the ASIC 3116, or both the general-purpose data processing unit 3112 and the ASIC 3116. In certain non-limiting embodiments, the processor, whether the general-purpose data processing unit 3112 and / or the ASIC 3116, can be configured to process data associated with the monitored analyte level.

[0263] In certain non-limiting embodiments, one or more antennas may be attached to the PCB. The one or more antennas may include, for example, a Bluetooth low energy antenna, an NFC antenna, or any other antenna used for wireless communication that may be used to transmit monitored analyte levels. In addition to transmitting monitored analyte levels, the antenna may be used to send and / or receive other commands or information to and / or from another device. For example, the antenna may be used to receive device configuration information. The monitored analyte levels may be, for example, glucose levels, ketone levels, lactate levels, oxygen levels, or hemoglobin AIC levels, which may be of significant importance to the health of an individual with diabetes. Additionally or alternatively, the one or more antennas may be used to transmit any other information obtained by the sensor or stored in the sensor control device. The monitored analyte levels or other information may be transmitted from the sensor control device to a reader device, such as the reader device 106 shown in FIG. 1 . The reader device may be any user equipment, including, for example, a mobile device such as a smartphone used by an individual or a healthcare provider.

[0264] The antenna can be, for example, a Bluetooth Low Energy antenna. Bluetooth (including Bluetooth Low Energy) typically operates at or about 2.45 GHz, e.g., between 2.4 GHz and 2.484 GHz. The antenna can be configured as an inverted H-shape, a J-shape, an inverted F-shape, or can take any other form. For example, the antenna 3106 in FIG. 31A is J-shaped, while the antenna 3218 in FIG. 32 is H-shaped. The antenna 3106 can be shaped to curve around the periphery of the battery 3104. In other non-limiting embodiments, instead of curving around the periphery of the battery 3104, the antenna 3106 can simply be positioned in a different location on the PCB so that it does not overlap the battery 3104.

[0265] As shown in FIG. 31A , the antenna 3106 can be placed on multiple risers that extend a fixed distance from the face of the PCB. The risers can help elevate the antenna above the PCB and / or one or more other components attached thereto. In some embodiments, elevating the antenna above the PCB and / or one or more other components attached thereto can help reduce interference and / or improve the quality of signals transmitted to or received from the antenna 3106. The multiple risers can range in number from 2 to 10, 1 to 15, or any other number of risers. In other embodiments, only a single riser may be provided. The fixed distance that the multiple risers extend from the face of the PCB can be greater than 1.5 millimeters. In particular, the fixed distance of the multiple risers can be between 0.1 mm and 5 mm, between 1.2 mm and 1.8 mm, or between 1.525 mm and 1.675 mm. One or more of the plurality of risers can be configured to electrically connect the antenna to the PCB, while one or more of the plurality of risers can be configured simply to structurally support the antenna. In some non-limiting embodiments, one or more of the risers can be a portion of the antenna that is folded over to extend a fixed distance from the plane of the PCB. Thus, one or more of the plurality of risers can include the folded portion of the antenna. In other non-limiting embodiments, one or more of the risers can be a separate component on which the antenna rests or to which the antenna is connected.

[0266] In certain non-limiting embodiments, the antenna 3106 can be a Bluetooth low energy antenna and the antenna 3118 can be an NFC antenna. However, in other embodiments, a single antenna can be provided for both Bluetooth low energy and NFC communications. As shown in FIGS. 31A and 31B , either the antenna 3106 or a separate NFC antenna 3118 can be used to transmit monitored analyte levels. The separate NFC antenna 3118 can be provided as a module attached to the PCB. In some non-limiting embodiments, as shown in FIG. 31B , the NFC antenna 3118 can be embedded within and / or around the perimeter of the PCB. For example, as shown in FIG. 31B , the NFC antenna 3118 can be embedded within the material of the PCB 3102, e.g., FR4. In another embodiment, the NFC antenna 3118 can be embedded within a lobe during fabrication of the PCB 3102.

[0267] FIG. 32 illustrates a printed circuit board according to certain embodiments. The PCB 3102 can be included in a device such as a sensor control device and can include a battery 3204, an antenna 3206, an assembly 3208, and a module 3210. The antenna 3206 can be a Bluetooth low energy antenna. As shown in FIG. 32, the antenna 3206 can be h-shaped and / or can be placed on multiple risers. For example, the antenna 3206 can rest on four risers 3214, 3216, 3218, and 3220. In some embodiments, two of the four risers are configured to electrically connect the antenna to the PCB, and the other two risers are associated with support. In other embodiments, all four risers can be configured to electrically connect the antenna to the PCB. A first set of the plurality of risers (e.g., two of four risers 3214, 3216) can be positioned proximate the connector, while a second set of the plurality of risers (e.g., two of four risers 3218, 3220) can be positioned proximate the battery. The antenna 3206 can have, for example, a crossbar 3212 positioned between the first and second sets of risers. In some embodiments, one or more of the plurality of risers is at least partially pre-plated tin over nickel. In other embodiments, the plurality of risers can comprise any other material or materials known in the art.

[0268] 33A-33D illustrate embodiments of an antenna according to certain embodiments. In particular, FIG. 33A illustrates a front view of an h-shaped antenna 3206. As shown in FIG. 33A, the antenna 3206 includes five ends, four of which are risers 3302, 3304, 3306, and 3308. The risers 3306 and 3308 are positioned at the base of the h-shaped antenna 3306 and are separated from each other by approximately the length of the crossbar 3310. In addition to the four risers, the antenna 3206 includes a portion having a free end 3312, e.g., a rounded end 3312, that is not directly connected to the PCB surface. Thus, in certain non-limiting embodiments, the antenna can include a free end 3312 that extends a fixed distance from the surface of the printed circuit board. The free end can form a hook with the edge of free end 3312 facing the crossbar 3310 as shown in FIG. 33A , although in other non-limiting embodiments, the edge of rounded end 3312 can point away from the crossbar 3310. Risers 3302 and 3304 are positioned closer to each other than risers 3306 and 3308. As shown in FIG. 33A , the portion of the antenna including risers 3302 and 3304 can be bifurcated or Y-shaped, with the antenna portion culminating in 3304 having a curved tip. Thus, the antenna can include two or more ends forming a Y-shape. Meanwhile, the portion of the antenna culminating in 3302 has two straight segments that intersect at approximately a right angle. For example, the two straight segments intersect at an angle between 75 and 100 degrees. In other embodiments, the two straight segments can intersect at an angle between 45 and 130 degrees, 55 and 120 degrees, or 65 and 110 degrees.

[0269] Figure 33B shows a side view of h-shaped antenna 3206, which includes risers 3302, 3304, 3306, and 3308. These risers have lengths or fixed distances ranging between 1.525 and 1.675 millimeters. The bottom surface of one or more of the risers can be attached or mounted to a PCB. For example, the bottom surface, which can be rectangular in shape, can be soldered or welded to the PCB.

[0270] FIG. 33C shows a front view of the h-shaped antenna 3206 with the risers deployed. The antenna can have a deployed width of approximately 9.33 millimeters as shown in FIG. 33C. In other non-limiting embodiments, the deployed width can range from approximately 1 mm to 20 mm, 5 mm to 15 mm, or 7.5 mm to 12.5 mm. Additionally, the antenna can have a deployed length of approximately 12.04 millimeters. In other non-limiting embodiments, the deployed length can range from approximately 1 mm to 22 mm, 7 mm to 17 mm, or 10 mm to 14 mm. The deployed width or length can be the width or length of the antenna when, for example, the folding risers, which can be part of the antenna, are deployed or straightened as shown in FIG. 33C. In certain non-limiting embodiments, the antenna can have a mass of 0.024 grams. In other non-limiting embodiments, the antenna can have a mass ranging from 0.005 grams to 1.0 grams, 0.01 grams to 0.04 grams, or 0.02 grams to 0.03 grams. Figure 33D shows an isometric view of the h-shaped antenna 3206 with risers 3302, 3304, 3306, 3308 and crossbar 3310.

[0271] It may be advantageous to provide a system with a transceiver for communication via Bluetooth or Bluetooth low energy and another transceiver for communication via NFC or RFID. However, such an arrangement requires a certain electronics footprint. Alternative arrangements, particularly those that offer a smaller footprint, may also be advantageous. A dual-function transceiver will now be described below.

[0272] In an exemplary arrangement, the transceiver is provided within a continuous analyte sensor system. The continuous analyte sensor system is used to monitor an analyte level within a bodily fluid of a user. The bodily fluid may be interstitial fluid of the user. The analyte may be glucose. Alternatively, the analyte may be ketone or lactate.

[0273] In this arrangement, the continuous analyte sensor system includes a sensor electronics system and an analyte sensor having a proximal portion and a distal portion, the distal portion configured to be positioned below the surface of a user's skin in contact with the bodily fluid to monitor the analyte level in the bodily fluid, and the proximal portion configured to be positioned above the surface of the user's skin and in operative communication with the sensor electronics system.

[0274] The sensor electronics system is configured to receive a sensor signal from the analyte sensor indicative of an analyte level. The sensor electronics system is configured to generate data related to the analyte level based on the sensor signal. The data related to the analyte level can include one or more of a current analyte level, a historical analyte level, and a predicted analyte level. Additionally or alternatively, the data related to the analyte level can include information related to a rate of change of the analyte level. Additionally or alternatively, the data related to the analyte level can include alert and / or alarm information, including actual alerts and / or alarms to a user or a third party, such as a caregiver or medical professional. The data related to the analyte level is at least temporarily stored in one or more memories of the sensor electronics system. Such storage may be solely for the purpose of immediate or substantially immediate wireless transmission of the data. Alternatively, the storage may not transmit the data immediately, but may be long-term so that it can be transmitted either automatically or as needed (on-demand). For example, the data can be requested at any time by a user, for example, by using a reader device that uses an NFC protocol or an RFID protocol to request the data. Alternatively or additionally, the sensor electronics system is configured to automatically wirelessly transmit data when a given condition is met. For example, the condition may be that a particular amount of time has elapsed since the most recent data transmission, such as 30 seconds, 1 minute, 2 minutes, or 5 minutes. An alternative or additional condition may be that a particular analyte level has been reached or passed or is expected to be reached or passed within a given time window.

[0275] In this arrangement, wireless communication is achieved by a transceiver. In particular, the sensor electronics system includes a transceiver configured to transmit an outgoing signal including data related to the analyte level. The transceiver is also configured to receive an incoming signal, for example, from a reader device. To generate the outgoing signal and receive the incoming signal, the transceiver includes an electromagnetic signal-generating component capable of operating as an antenna. The electromagnetic signal-generating component is configured to be supplied with or driven by the outgoing signal from the sensor electronics system. The electromagnetic signal-generating component is configured to be supplied with or driven in two communication modes. For the different communication modes, the electromagnetic signal-generating component has different signal feed points. In particular, the electromagnetic signal-generating component has a first signal feed point and a second signal feed point. The sensor electronics system is configured to operate in a first communication mode by supplying a first outgoing signal to the first signal feed point of the electromagnetic signal-generating component. Operation of the electromagnetic signal-generating component by supplying the first outgoing signal to the first feed point in the first communication mode causes the electromagnetic signal-generating component to transmit a signal according to a first set of physical principles. The sensor electronics system is also configured to operate in a second communication mode to provide a second emitted signal to a second signal feed point of the electromagnetic signal-generating component. Operating the electromagnetic signal-generating component by providing the second emitted signal to the second feed point in the second communication mode causes the electromagnetic signal-generating component to transmit signals according to a second set of physical principles that are different from the first set.

[0276] In this manner, the transceiver is configured to perform wireless communication in the first and / or second communication modes. Instead of providing a separate dedicated transceiver for each communication mode, this arrangement provides both communication modes using the same transceiver. This arrangement is therefore advantageous in providing space and / or resource efficiency.

[0277] Optionally, the electromagnetic signal generating component includes a conductive coil. The coil can have one or more loops or turns, and the coil has a first end and a second end. The coil can have two loops or turns. The coil can have three loops or turns. The coil can have four or more loops or turns.

[0278] A first signal feed point for the first communication mode is provided at one of the first and second ends of the coil. In this manner, the electromagnetic signal generating component is driven as a coil (or loop). When supplied or fed with the first transmission signal in this manner, an alternating current is induced in the coil, causing the electromagnetic signal generating component to act as an inductive antenna. Thus, the transceiver can wirelessly communicate with the reader device. In this manner, in the first communication mode, the sensor electronics system is configured for wireless communication according to an NFC protocol or an RFID protocol. It will be appreciated that a reader device can be brought into close proximity with the continuous analyte sensor system, and the reader device can provide an energizing signal to the transceiver in the first communication mode and request data to be transmitted, all using the NFC protocol or the RFID protocol.

[0279] A second signal feed point for the second communication mode is provided at a location on the coil between the first and second ends of the coil. Specifically, the second signal feed point is at a location on the coil that is substantially midway or centered between the first and second ends. The electromagnetic signal-generating component is driven by feeding a second transmit signal to the second feed point. In this manner, when fed or fed with the second transmit signal, the electromagnetic signal-generating component does not operate as a coil or inductor. Instead, with a central or substantially central feed, the electromagnetic signal-generating component operates as a dipole antenna. Thus, the transceiver can wirelessly communicate with the reader device using interactions based on radiated RF waves. Thus, in the second communication mode, the sensor electronics system is configured for wireless communication according to the Bluetooth protocol or the Bluetooth low energy protocol. It will be appreciated that either the continuous analyte sensor system or the reader device can initiate communication with the other device to send or request data using the Bluetooth protocol or the Bluetooth low energy protocol.

[0280] As mentioned above, the coil can have one loop or turn. However, advantageously, the coil is provided with two, three, four, five or more loops or turns on a substantially coplanar layer. In this manner, the coil can be provided on a single layer of a substrate, such as one layer of a PCB. Providing electrical coupling to the first and second ends of the coil can include the use of one or more vias through the substrate to prevent electrical traces from crossing each other.

[0281] The coil can be advantageously mounted at or near one or more outer edges of the substrate. This helps to increase or maximize the effective radius of the coil, allowing other components of the sensor electronics system to be mounted within the space inside the coil. For example, the coil can follow the periphery of a substrate, such as a PCB, on which it is mounted.

[0282] Additionally or alternatively, the coil can include two, three, four, or five or more substantially parallel coil layers. For example, the coil can include one loop or turn on one layer or plane and another loop or turn on a second layer or plane. Alternatively, the coil can include two, three, four, or five or more substantially coplanar loops or turns on one layer or plane and two, three, four, or five or more substantially coplanar loops or turns on a second layer or plane. This arrangement provides a larger number of loops or turns in the coil than would be possible if the loops or turns were only on one layer, without increasing the area or footprint of the coil. In one advantageous arrangement, the coil has three substantially coplanar loops or turns on one layer and three substantially coplanar loops or turns on a second layer parallel to the first layer.

[0283] The electromagnetic signal generating components can be provided on one or more substrate layers of the substrate. At least two of the substrate layers can be electrically coupled by one or more vias. The vias can provide electrical coupling between the material of the coil from one layer to another to provide conductive continuity to the coil. Alternatively, the vias can provide electrical coupling between the coil, particularly the first or second ends of the coil, and electrical traces, contacts, or connections to one or more other components of the sensor electronics system.

[0284] In an optional arrangement, the substrate includes two outer substrate layers and two inner substrate layers, with the outer substrate layers on either side of the inner substrate layers. In this arrangement, electromagnetic signal-generating components are provided on one or both of the inner substrate layers but not on the outer substrate layers. This arrangement can provide a convenient layout and help avoid component interference.

[0285] The sensor electronics system can be configured to provide a first transmitted signal to the electromagnetic signal-generating component in a first communication mode and substantially simultaneously provide a second transmitted signal to the electromagnetic signal-generating component in a second communication mode. The RF frequencies used for the first communication mode and the second communication mode can be configured to be different from each other. This allows for simultaneous generation of the first and second transmitted signals from the transceiver. This also allows for resolution of the first and second incoming signals received by the transceiver according to the first and second communication modes.

[0286] To help facilitate such communication, or even if separate communication windows, slots, or intervals are used for the first and second communication modes, the sensor electronics system may include a first processor for controlling the first communication mode and a second processor for controlling the second communication mode. In this manner, data to be transmitted or received may be processed by the respective processors according to the associated communication mode. This processing may occur simultaneously, substantially simultaneously, or at different times, as desired.

[0287] The dual function transceiver described above can be used for continuous analyte monitor systems as described elsewhere herein. Thus, the sensor electronics system can include components the same as or similar to those described herein with respect to the sensor control device, although other implementations are contemplated.

[0288] An example of a dual function transceiver is provided below with respect to Figures 34A and 34B.

[0289] 34A and 34B illustrate an example antenna 3405 in accordance with the presently disclosed subject matter. The antenna 3405 can be formed on one or more layers of a PCB 3102. The PCB 3102 can have any of the PCB features (e.g., electrical components) described above. The PCB 3102 can include a single layer. In accordance with the presently disclosed subject matter, the PCB 3102 can include 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, or 12 or more layers. Traces can be connected between two or more layers by vias.

[0290] In accordance with the subject matter of the present disclosure, the antenna 3405 can include at least one conductive trace on at least one layer of the PCB 3102. The antenna 3405 can be configured to operate at multiple protocols, modes, and / or frequencies. For example, the antenna 3405 can be configured to be an NFC antenna operating at or around 13.56 MHz, or alternatively, can be configured as a Bluetooth antenna or Bluetooth Low Energy antenna operating at or around 2.45 GHz or at or around 432 MHz. In such a configuration, the antenna 3405 can include a first set of contacts for transmitting the monitored analyte level and / or processed data associated with the monitored analyte level at a first frequency and at least one second contact for transmitting the monitored analyte level and / or processed data associated with the monitored analyte level at a second frequency. When a signal is input to the second contact, the antenna 3405 acts as a dipole antenna.

[0291] In accordance with the subject matter of the present disclosure, PCB 3102 can include electronics for a first set of frequencies connected between the ends of the loop generated by the antenna. These electronics can include components for resonating the loop to the first set of frequencies. In accordance with the subject matter of the present disclosure, PCB 3102 can include electronics for a second set of frequencies connected to the midpoint of the loop, including an impedance matching network and DC block for the second set of frequencies. Together, the electronics for the first set of frequencies and the electronics for the second set of frequencies can form a network that allows operation at both frequencies and some electromagnetic immunity from other frequencies.

[0292] An antenna 3405 configured to transmit on two different sets of frequencies may be referred to as a "diplex" antenna. Antenna 3405 may be further configured to transmit on 3, 4, 5, 6, 7, 8, 9, or 10 different frequencies.

[0293] In accordance with the subject matter of this disclosure, the conductive trace of the antenna 3405 can follow the periphery of the PCB 3102. For example, the conductive trace of the antenna 3405 can follow the periphery of the PCB 3102 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, or 12 or more times to form a looped or spiral conductive trace on one layer of the PCB 3102. The conductive trace of the antenna 3405 can form 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, or 13 or more spiral loops that at least partially follow the periphery of the PCB 3102. For example, the path of the conductive trace can partially deviate from the periphery of the PCB 3102. The conductive trace can take the shape of any polygon, such as a square, rectangle, triangle, or another polygon.

[0294] The antenna 3405 may include conductive traces on two or more layers of the PCB 3102. The traces between any two layers may be connected by vias between the layers. For example, the antenna 3405 may include a first continuous trace forming one or more spiral loops on a first layer of the PCB 3102 and a second continuous trace forming two or more spiral loops on a second layer of the PCB 3102. As another example, the antenna 3405 may include a first continuous trace forming three or more spiral loops on the first layer of the PCB 3102 and a second continuous trace forming three or more spiral loops on the second layer of the PCB 3102. Similarly, the antenna 3405 may include a first continuous trace forming four or more spiral loops on the first layer of the PCB 3102 and a second continuous trace forming four or more spiral loops on the second layer of the PCB 3102. The antenna 3405 can include a first conductive trace forming five or more spiral loops on a first layer of the PCB 3102 and a second conductive trace forming five or more spiral loops on a second layer of the PCB 3102. In accordance with the subject matter of the present disclosure, different layers of the PCB 3102 can have the same number of spiral loops (e.g., 1, 2, 3, 4, 5) or different numbers of spirals (e.g., three spirals on the first layer and two spirals on the second layer). The antenna 3405 can include conductive traces spanning three, four, five, six, seven, eight, nine, ten, or eleven or more layers of the PCB 3102.

[0295] For NFC, the portion of the antenna 3405 formed by the first set of contacts can be capacitance at a first set of frequencies. Under normal operating conditions, either end of this portion of the antenna 3405 formed by the first set of contacts can be connected to ground through the NFC electronics. At a second frequency (e.g., for Bluetooth or Bluetooth Low Energy), this capacitor can be low impedance, effectively shorting the ends of the loop together, thereby connecting both ends to ground at the second set of frequencies.

[0296] The PCB 3102 may further include a network of inductors and capacitors to provide proper matching of the antenna 3405 at the second set of frequencies and high impedance at the first set of frequencies.

[0297] In a non-limiting exemplary embodiment, antenna 3405 may include, at least in part, a conductive element that is not on PCB 3102. For example, antenna 3405 may include a conductive element mount on or above PCB 3102.

[0298] Additional details of suitable devices, systems, methods, components, and their operation, along with related features, are described in WO 2018 / 136898 to Rao et al., WO 2019 / 236850 to Thomas et al., WO 2019 / 236859 to Thomas et al., WO 2019 / 236876 to Thomas et al., and U.S. Patent Publication No. 2020 / 0196919, filed June 6, 2019, the entire contents of each of which are incorporated herein by reference. Additional details regarding embodiments of the applicator, its components, and variations thereof are described in U.S. Patent Publication Nos. 2013 / 0150691, 2016 / 0331283, and 2018 / 0235520, the entire contents of all of which are incorporated herein by reference for all purposes. Additional details regarding the Sharp Module, Sharp, embodiments of 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.

[0299] Embodiments disclosed herein include the following.

[0300] A. A device comprising: a printed circuit board; a connector connected to the printed circuit board and configured to establish an electrical connection between an analyte sensor, the analyte sensor having a proximal portion and a distal portion, the proximal portion electrically coupled to the printed circuit board and the distal portion configured to extend below a user's skin for monitoring the level of one or more analytes in a bodily fluid; a battery connected to the printed circuit board and configured to power it; a processor connected to the printed circuit board and configured to process data associated with the monitored one or more analyte levels; and an antenna for transmitting the processed data, the antenna comprising at least one conductive trace on at least one layer of the printed circuit board, the antenna including a first set of contacts for transmitting the processed data at a first frequency and at least one second contact for transmitting the processed data at a second frequency.

[0301] B. A system comprising: a printed circuit board; an analyte sensor having a proximal portion and a distal portion configured to extend below a user's skin for monitoring the level of one or more analytes in a bodily fluid; a connector connected to the printed circuit board and configured to establish an electrical connection between the proximal portion of the analyte sensor and the printed circuit board; a battery connected to and configured to power the printed circuit board; a processor connected to the printed circuit board and configured to process data associated with the monitored one or more analyte levels; and an antenna for transmitting the processed data, the antenna comprising at least one conductive trace on at least one layer of the printed circuit board, the antenna including a first set of contacts for transmitting the processed data at a first frequency and at least one second contact for transmitting the processed data at a second frequency.

[0302] Each of embodiments A and B can have one or more of the following additional elements in any combination. Element 1: The first frequency is for transmission using Bluetooth Low Energy, and the second frequency is for transmission using Near Field Communication. Element 2: The at least one conductive trace on at least one layer of the printed circuit board includes a trace that follows an outer periphery of the printed circuit board and forms multiple loops. Element 3: The at least one conductive trace on at least one layer of the printed circuit board includes a conductive trace that follows at least partially an outer periphery of the printed circuit board and forms at least three loops. Element 4: The at least one conductive trace on at least one layer of the printed circuit board includes a concentric trace that forms at least three loops that follow an outer periphery of the printed circuit board. Element 5: The at least one conductive trace on at least one layer of the printed circuit board includes at least one conductive trace on each of multiple layers of the printed circuit board. Element 6: The at least one conductive trace on each of the multiple layers of the printed circuit board is connected by a via between two layers of the printed circuit board. Element 7: The first set of contacts includes contacts at ends of the conductive traces, the conductive traces being between the first set of contacts. Element 8: The at least one second contact includes at least one contact near a center of the conductive trace. Element 8: The conductive traces and the at least one second contact form a dipole antenna.

[0303] Additionally or alternatively, any of the elements and combinations applicable to embodiments A and B are applicable to any of the other elements and combinations applicable to embodiments A and B.

[0304] It should be noted that all features, elements, components, functions, and steps described with respect to any embodiment provided herein are intended to be freely combinable and interchangeable with any other embodiment. Even if a certain feature, element, component, function, or step is described only with respect to one embodiment, it should be understood that such feature, element, component, function, or step can be used in the case of all other embodiments described herein, unless expressly stated otherwise. Therefore, this paragraph serves in each case as a rationale and written support prior to the introduction of claims for combining features, elements, components, functions, and steps from various embodiments, or substituting features, elements, components, functions, and steps from one embodiment for another, even if the following description does not explicitly state that such combinations or substitutions are possible in a particular instance. Accordingly, the foregoing descriptions of specific embodiments of the disclosed subject matter have been presented for purposes of illustration and description. It should be expressly recognized that an explicit enumeration of all possible combinations and permutations would be unduly burdensome, particularly considering that the permissible scope of each and every such combination and permutation would be readily recognized by one of ordinary skill in the art.

[0305] While the above-described embodiments are susceptible to various modifications and alternative forms, specific examples thereof have been shown in the drawings and are described in detail herein. It will be apparent to those skilled in the art that various modifications and variations can be made to the methods and systems of the disclosed subject matter without departing from the spirit or scope of the disclosed subject matter. Accordingly, the disclosed subject matter is intended to include modifications and variations that come within the scope of the appended claims and their equivalents. Furthermore, negative limitations that define claims of the invention by any feature, function, step, or element of the above-described embodiments, as well as features, functions, steps, or elements not within the invention, may be recited in or added to the claims. [Explanation of symbols]

[0306] 100 Sample Monitor System 102 Sensor applicator 106 Reader Device 108 Adhesive Patches 112 Local communication paths or links

Claims

1. 1. A continuous analyte sensor system for monitoring a level of an analyte in a bodily fluid of a user, comprising: a sensor electronics system; an analyte sensor including a proximal portion and a distal portion, the distal portion configured to be positioned below a user's skin surface in contact with the bodily fluid to monitor the level of an analyte in the bodily fluid, and the proximal portion configured to be positioned above the user's skin surface and in operative connection with the sensor electronics system; Including, the sensor electronics system is configured to receive a sensor signal indicative of the analyte level from the analyte sensor and generate data related to the analyte level from the sensor signal for wireless transmission, the sensor electronics system including a transceiver for transmitting outgoing signals and for receiving incoming signals including the data related to the analyte level; the transceiver includes an electromagnetic signal generating component configured to receive an outgoing signal, the electromagnetic signal generating component having a first signal feed point and a second signal feed point; the sensor electronics system is configured to operate in a first communication mode and further configured to operate in a second communication mode, wherein in the first communication mode the sensor electronics system is configured to provide a first emitted signal to the first signal feed point of the electromagnetic signal-emitting component, and in the second communication mode the sensor electronics system is configured to provide a second emitted signal to the second signal feed point of the electromagnetic signal-emitting component. Continuous analyte sensor system.

2. 10. The continuous analyte sensor system of claim 1, wherein the electromagnetic signal generating component comprises a conductive coil having one or more loops, the coil having a first end and a second end.

3. 3. The continuous analyte sensor system of claim 2, wherein the first signal feed point is at one of the first and second ends.

4. 4. The continuous analyte sensor system of claim 2 or claim 3, wherein the second signal feed point is at a location on the coil between the first and second ends.

5. 5. The continuous analyte sensor system of claim 2, wherein the second signal feed point is at a location on the coil substantially midway between the first and second ends.

6. The continuous analyte sensor system of claim 1 , wherein in the second communication mode, the electromagnetic signal generating component is configured to operate as a dipole antenna.

7. 7. The continuous analyte sensor system of claim 1, wherein in the second communication mode, the sensor electronics system is configured for wireless communication according to a Bluetooth or Bluetooth Low Energy protocol.

8. The continuous analyte sensor system of claim 1 , wherein in the first communication mode, the electromagnetic signal generating component is configured to operate as an inductive antenna.

9. 9. The continuous analyte sensor system of claim 1, wherein in the first communication mode, the sensor electronics system is configured for wireless communication according to an NFC or RFID protocol.

10. 10. The continuous analyte sensor system of claim 2, wherein the coil comprises two or three or four or five or more loops arranged in a substantially coplanar layer.

11. 11. The continuous analyte sensor system of claim 2, wherein the coil comprises two or three or four or five or more substantially parallel layers of coils.

12. the electromagnetic signal generating component is disposed on one or more substrate layers of a substrate; at least two of the substrate layers are electrically coupled by one or more vias; 12. The continuous analyte sensor system of any one of claims 1 to 11.

13. 13. The continuous analyte sensor system of claim 12, wherein the substrate includes two outer substrate layers and two inner substrate layers, and the electromagnetic signal generating component is disposed on one or both of the inner substrate layers.

14. 14. The continuous analyte sensor system of claim 1, wherein the sensor electronics system is configured to provide the first emitted signal to the electromagnetic signal generating component in the first communication mode and to substantially simultaneously provide the second emitted signal to the electromagnetic signal generating component in the second communication mode.

15. 15. The continuous analyte sensor system of claim 1, wherein the sensor electronics system includes a first processor for controlling the first communication mode and a second processor for controlling the second communication mode.

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