Systems, devices, and apparatus for analyte monitoring

Abstract

A continuous analyte sensor system for monitoring an analyte level in a user's bodily fluid. The system includes a sensor electronics system and an analyte sensor. The sensor includes a distal portion for placement under a skin surface of a user for contact with a bodily fluid to monitor an analyte level in the bodily fluid and a proximal portion for placement over the skin surface and operably connected with a sensor electronics system. The sensor electronics receive a sensor signal indicative of an analyte level from the analyte sensor and generate data related to the analyte level. The sensor electronics system includes a transceiver for transmitting an output signal including data related to an analyte level and receiving an input signal. The transceiver includes an electromagnetic signal generating component having first and second signal feed points. The sensor electronics operate in a first and / or second communication mode. In a first communication mode, the sensor electronics provide a first output signal to a first signal feed point. In a second communication mode, the sensor electronics provide a second output signal to a second signal feed point.

Description

[0001] priority

[0002] This application claims the benefit under 35 U.S.C. §119(e) of U.S. Provisional Patent Application No. 63 / 402,744, filed on August 31, 2022, which is incorporated herein by reference. Technical Field

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

[0004] The detection and / or monitoring of analyte levels such as blood glucose, ketones, lactate, oxygen, hemoglobin AIC, etc. is crucial to the health of individuals with diabetes. Patients with diabetes may experience complications including loss of consciousness, cardiovascular disease, retinopathy, neuropathy, and kidney disease. Diabetic patients typically need to monitor their blood glucose levels to ensure that blood glucose levels remain within a clinically safe range and may also use this information to determine if and / or when insulin is needed to lower their blood glucose levels or when additional blood glucose is needed to raise their blood glucose levels.

[0005] Growing clinical data demonstrates a strong correlation between frequency of blood glucose monitoring and glycemic control. However, despite this correlation, many individuals diagnosed with diabetes do not monitor their blood glucose levels as frequently as they should due to a combination of factors, including convenience, the haphazard nature of testing, pain associated with blood glucose testing, and cost.

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

[0007] Transmission of analyte data from the sensor to the receiving device can be performed using either wired or wireless transmission. However, prior art systems are increasingly focusing on wireless transmission using near-field communication (NFC) and / or Bluetooth communication. Wireless transmission improves the usability of analyte monitoring sensors, allowing for manual or automated transmission of analyte levels to a receiving device for user monitoring. To ensure transmission, a reliable wireless transmission signal must be maintained between the sensor control device and the receiving device.

[0008] Therefore, there is a need for a system, apparatus, and method to ensure reliable wireless transmission of analyte levels from a sensor to a receiving device monitored by an individual or HCP. Summary of the Invention

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

[0010] According to the disclosed subject matter, a continuous analyte sensor system for monitoring an analyte level in a bodily fluid of a user is provided, the system comprising: a sensor electronics system; and an analyte sensor, the analyte sensor comprising a proximal portion and a distal portion, the distal portion being configured to be positioned below the surface of the user's skin to contact the bodily fluid to monitor the analyte level in the bodily fluid, and the proximal portion being configured to be positioned above the surface of the user's skin and operatively connected to the sensor electronics system; wherein the sensor electronics system is configured to receive a sensor signal indicative of the analyte level from the analyte sensor and to generate data related to the analyte level from the sensor signal for wireless transmission, the sensor electronics system comprising a transceiver for wireless communication. for transmitting an output signal comprising data related to an analyte level and for receiving an input signal; wherein the transceiver comprises an electromagnetic signal generating component configured to provide an output signal, the electromagnetic signal generating component having a first signal feed point and a second signal feed point, wherein the sensor electronic system is configured to operate in a first communication mode and is also configured to operate in a second communication mode, wherein in the first communication mode the sensor electronic system is configured to provide the first output signal to the first signal feed point of the electromagnetic signal generating component, and in the second communication mode the sensor electronic system is configured to provide the second output signal to the second signal feed point of the electromagnetic signal generating component.

[0011] 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 located at one of the first end and the second end. Optionally, the second signal feed point is located at a position on the coil between the first end and the second end. Optionally, the second signal feed point is located at a position on the coil approximately halfway between the first end and the second end. 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 electronic system is configured to perform 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 electronic system is configured to perform wireless communication according to an NFC or RFID protocol.

[0012] To achieve these and other advantages, and in accordance with the purposes of the disclosed subject matter, as specifically embodied and broadly described, the disclosed subject matter relates to a device that may include a printed circuit board configured to monitor analyte levels. In some non-limiting embodiments, the device may also include a battery connected to the printed circuit board and configured to power the printed circuit board. The printed circuit board may include multiple layers. In addition, the device may 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 related to the monitored analyte levels. In addition, the device may include an antenna for transmitting the monitored analyte levels on a plurality of risers. The support may extend a fixed distance from the surface of the printed circuit board.

[0013] In some non-limiting embodiments, the analyte level may include a blood glucose level. The antenna may be a Bluetooth low energy antenna. The plurality of brackets may include four brackets, two of the four brackets being configured to electrically connect the antenna to a printed circuit board. One or more of the plurality of brackets may include a folded portion of the antenna. The printed circuit board may include FR4 material. At least a portion of the plurality of brackets may be pre-tinned over nickel. The antenna may include a crossbar located between the first plurality of brackets and the second plurality of brackets. The crossbar may form a portion of an H-shape. In some non-limiting embodiments, the antenna may include two or more ends forming a Y-shape. In some non-limiting embodiments, the antenna may include a free end extending a fixed distance from the surface of the printed circuit board. In other non-limiting embodiments, the first plurality of brackets may be located near the connector, while the second plurality of brackets may be located near the battery. The second plurality of brackets or the first plurality of brackets may be configured to electrically connect the antenna to the printed circuit board. The bracket may extend a fixed distance from the surface of the printed circuit board, which distance may be greater than 1.5 millimeters (mm).

[0014] In some non-limiting embodiments, the antenna can be bent around the periphery of the battery. The antenna can be configured as an inverted H-shape or a J-shape. For example, the antenna can have at least one of an expanded width of approximately 9.33 mm (or approximately between 5-14 mm), an expanded length of approximately 12.04 mm (or approximately between 7-18 mm) and / or a mass of 0.024 gram (or approximately between 0.01-0.04 gram). In other non-limiting embodiments, the device may include a separate NFC antenna for transmitting the monitored analyte level. The NFC antenna may be embedded in and / or around a printed circuit board. In some non-limiting embodiments, the connector may include at least one of silicone rubber or a carbon impregnated polymer. In other non-limiting embodiments, the connector may include a connector with metal contacts.

[0015] In some other non-limiting embodiments, the system may include an analyte sensor. A portion of the analyte sensor may be configured to be positioned in contact with the fluid beneath the skin layer to monitor the analyte level in the fluid. The system may 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. In addition, the system may 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 related to the monitored analyte level. In addition, the system may include antennas for transmitting the monitored analyte levels located on a plurality of supports. The supports may extend a predetermined distance from the surface of the printed circuit board. The system may include any of the above-mentioned features of the device.

[0016] To achieve these and other advantages, and in accordance with the purposes of the disclosed subject matter, as specifically implemented and broadly described, the disclosed subject matter relates to a device that may include a printed circuit board configured to monitor analyte levels. In some non-limiting embodiments, the device may further include a printed circuit board. In some non-limiting embodiments, the device may further 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, wherein the proximal portion is electrically coupled to the printed circuit board, and wherein the distal portion is configured to extend beneath the user's skin to monitor one or more analyte levels in a bodily fluid. In some non-limiting embodiments, the device may further include a battery connected to the printed circuit board and configured to power the printed circuit board. In some non-limiting embodiments, the device may further include a processor connected to the printed circuit board and configured to process data associated with the monitored one or more analyte levels. In some non-limiting embodiments, the device may further include an antenna for transmitting processed data, the antenna comprising at least one conductive trace on at least one layer of the printed circuit board, wherein the antenna includes 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.

[0017] In some non-limiting embodiments, the first frequency may be used for transmission using Bluetooth Low Energy, and the second frequency may be used for transmission using Near Field Communication. In some non-limiting embodiments, at least one conductive trace on at least one layer of the printed circuit board may extend along the periphery of the printed circuit board to form multiple loops. In some non-limiting embodiments, the at least one conductive trace on at least one layer of the printed circuit board may include at least one conductive trace that extends at least partially along the periphery of the printed circuit board to form at least three loops. In some non-limiting embodiments, the at least one conductive trace on at least one layer of the printed circuit board may extend along the periphery of the printed circuit board to form at least three loops. In some non-limiting embodiments, the at least one conductive trace on at least one layer of the printed circuit board may include at least one conductive trace on each of the multiple layers of the printed circuit board. In some non-limiting embodiments, the at least one conductive trace on each of the multiple layers of the printed circuit board may be connected via a via between two layers of the printed circuit board. In some non-limiting embodiments, the first set of contacts may include contacts at the ends of the conductive trace, and the conductive trace may be between the first set of contacts. In some non-limiting embodiments, the at least one second contact may include at least one contact near the center of the conductive trace. In some non-limiting embodiments, the conductive trace and the at least one second contact can form a dipole antenna.In some non-limiting embodiments, the printed circuit board can include a ground plane configured on a plane of the printed circuit board itself.

[0018] In some other non-limiting embodiments, a system may include a printed circuit board. In some other non-limiting embodiments, the system may include an analyte sensor having a proximal portion and a distal portion, wherein the distal portion is configured to extend beneath the user's skin to monitor one or more analyte levels in body fluids. In some other non-limiting embodiments, the system may include a connector that is connected to the printed circuit board and is configured to establish an electrical connection between the proximal portion of the analyte sensor and the printed circuit board. In some other non-limiting embodiments, the system may include a battery that is connected to the printed circuit board and is configured to power the printed circuit board. In some other non-limiting embodiments, the system may include a processor that is connected to the printed circuit board and is configured to process data associated with the one or more analyte levels being monitored. In some other non-limiting embodiments, the system may include an antenna for transmitting processed data, the antenna including at least one conductive trace on at least one layer of the printed circuit board, wherein the antenna includes a first set of contacts for transmitting processed data at a first frequency and at least one second contact for transmitting processed data at a second frequency. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] The details of the subject matter described herein, including its structure and operation, will become apparent by studying the accompanying drawings, in which like reference numerals represent like parts. The components in the drawings are not necessarily drawn to scale; emphasis is instead placed on illustrating the principles of the subject matter. Furthermore, all illustrations are intended to convey concepts, in which relative sizes, shapes, and other detailed attributes may be shown schematically rather than literally or precisely.

[0020] Figure 1 is a conceptual diagram depicting an example analyte monitoring system that may incorporate one or more embodiments of the present disclosure.

[0021] Figure 2A and Figure 2B are an isometric view and a side view, respectively, of an example sensor control device according to some non-limiting embodiments.

[0022] Figure 3A and Figure 3B According to some non-limiting embodiments Figure 2A and Figure 2B Isometric and exploded views of the plug assembly.

[0023] Figure 4A and Figure 4B According to some non-limiting embodiments Figure 2A and Figure 2B Exploded view and isometric bottom view of the electronic housing.

[0024] Figure 5A and Figure 5B According to some non-limiting embodiments Figure 1 Side view and cross-sectional side view of a sensor applicator with a cover coupled to the applicator.

[0025] Figure 6A is an enlarged cross-sectional side view of a sensor control device mounted within a cover, according to some non-limiting embodiments.

[0026] Figure 6B is an enlarged cross-sectional side view of another embodiment of a sensor control device installed within a sensor applicator, according to some non-limiting embodiments.

[0027] Figure 7 is an isometric view of an example sensor-controlled device, according to some non-limiting embodiments.

[0028] Figure 8 According to some non-limiting embodiments Figure 1 Side view of the sensor applicator.

[0029] Figure 9is a cross-sectional side view of a sensor applicator according to some non-limiting embodiments.

[0030] Figure 10A and Figure 10B are an isometric view and a side view, respectively, of an example sensor control device according to some non-limiting embodiments.

[0031] Figure 11A and Figure 11B are an isometric view and an exploded view, respectively, of a plug assembly according to some non-limiting embodiments.

[0032] Figure 11C is an exploded isometric bottom view of a plug and preservation bottle according to some non-limiting embodiments.

[0033] Figure 12A and Figure 12B 1 and 2 are exploded views and isometric bottom views, respectively, of an electronics housing according to some embodiments.

[0034] Figure 13A and Figure 13B are side and cross-sectional side views of a sensor applicator according to some non-limiting embodiments.

[0035] Figure 14 is a perspective view of an exemplary embodiment of a cover according to some embodiments.

[0036] Figure 15 is a cross-sectional side view of a sensor control device located within a cover according to some embodiments.

[0037] Figure 16A and Figure 16B 2 are an isometric view and a side view, respectively, of an example sensor control device according to some embodiments.

[0038] Figure 17A and Figure 17B 1 and 2 are exploded perspective top and bottom views, respectively, of a sensor control device according to some embodiments.

[0039] 18A to 18C 1 and 2 are isometric, side, and bottom views, respectively, of an example sensor-controlled device according to some embodiments.

[0040] Figure 19A and Figure 19B 1 and 2 are isometric exploded top and bottom views, respectively, of a sensor control device according to some embodiments.

[0041] Figure 20A and Figure 20B The fabrication of a sensor control device according to some embodiments is shown.

[0042] Figure 21 is a side view of an example sensor according to some embodiments.

[0043] Figure 22A and Figure 22B An isometric view and a partially exploded isometric view of an example connector assembly are shown, according to some embodiments.

[0044] Figure 22C Shown Figure 22A and Figure 22B Isometric bottom view of the connector.

[0045] Figure 22D and Figure 22E An isometric view and a partially exploded isometric view of another example connector assembly are shown, according to some embodiments.

[0046] Figure 22F Shown Figures 22D to 22E Isometric bottom view of the connector.

[0047] Figure 23A and Figure 23B Shown are a side view and an isometric view, respectively, of an example sensor control device according to some embodiments.

[0048] Figure 24A and Figure 24B Exploded, isometric top and bottom views, respectively, of a sensor control device according to some embodiments are shown.

[0049] Figure 25A According to some embodiments Figure 23A and Figure 23B as well as Figure 24A and Figure 24B A cross-sectional side view of a sensor control device is shown.

[0050] Figure 25B yes Figure 23A and Figure 23B as well as Figure 24A and Figure 24B An exploded isometric view of a portion of another embodiment of a sensor control device is shown.

[0051] Figure 26A yes Figure 23A and Figure 23B as well as Figure 24A and Figure 24B An isometric bottom view of the base is shown.

[0052] Figure 26B yes Figure 23A and Figure 23B as well as Figure 24A and Figure 24B An isometric top view of the sensor cover is shown.

[0053] Figure 27A and Figure 27B Shown are a side view and a cross-sectional side view, respectively, of an example sensor applicator according to some embodiments.

[0054] Figure 28A and Figure 28B According to some embodiments Figure 27B Perspective and top views of the cap column are shown.

[0055] Figure 29 Shown is a cross-sectional side view of a sensor control device positioned within an applicator cap, according to one or more embodiments.

[0056] Figure 30 A cross-sectional view of a sensor control device is shown, illustrating an example interaction between a sensor and a sharp object.

[0057] Figure 31A and Figure 31B A printed circuit board is shown according to some embodiments.

[0058] Figure 32 A printed circuit board is shown according to some embodiments.

[0059] Figures 33A to 33D Implementations of antennas according to some embodiments are shown.

[0060] Figure 34A and Figure 34B An exemplary PCB including an antenna according to the disclosed subject matter is shown. DETAILED DESCRIPTION

[0061] Before describing the present subject matter in detail, it should be understood that this disclosure is not limited to the particular embodiments described, as such embodiments may, of course, vary. It should also be understood that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting, as the scope of the present disclosure will be limited only by the appended claims.

[0062] The publications discussed herein are provided solely for their disclosed content prior to the filing date of the present application. Anything herein should not be construed as admitting that the present disclosure will not precede such disclosure due to prior disclosure. In addition, the publication date provided may be different from the actual publication date, which may require separate confirmation.

[0063] The present disclosure will now be described more fully hereinafter with reference to the accompanying drawings, which form a part hereof and show, by way of illustration, some example embodiments. However, subject matter may be embodied in a variety of different forms and, therefore, subject matter covered or claimed is intended to be construed as not being limited to any example embodiment set forth herein; example embodiments are provided for illustration only. Likewise, a reasonably broad scope of subject matter claimed or covered is intended. Among other things, the subject matter may be embodied as a method, device, component, or system. Thus, embodiments may, for example, take the form of hardware, software, firmware, or any combination thereof (in addition to the software itself). Therefore, the following detailed description should not be construed as limiting.

[0064] In the detailed description herein, references to "an embodiment," "one embodiment," "a non-limiting embodiment," "in various embodiments," etc. indicate that the described embodiment may include a particular feature, structure, or characteristic, but not every embodiment necessarily includes the particular feature, structure, or characteristic. Furthermore, these phrases do not necessarily refer to the same embodiment. Furthermore, when a particular feature, structure, or characteristic is described in conjunction with an embodiment, it is considered to be within the knowledge of those skilled in the art to affect such feature, structure, or characteristic in conjunction with other embodiments, whether or not explicitly described. After reading the description, it will be clear to those skilled in the relevant art how to implement the present disclosure in alternative embodiments.

[0065] In general, terms can be understood at least in part from their usage in context. For example, as used herein, terms (e.g., "and," "or," "and / or") can include multiple meanings, which can depend at least in part on the context in which the terms are used. Typically, "or," if used in connection with a list, e.g., A, B, or C, is intended to mean A, B, and C (used herein in an inclusive sense) as well as A, B, or C (used herein in an exclusive sense). Furthermore, as used herein, the term "one or more" depends at least in part on the context and 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. Similarly, terms such as "a," "an," or "the" can also be understood to express singular usage or to express plural usage, depending at least in part on the context. Furthermore, the term "based on" can be understood to not necessarily be intended to express a set of exclusive factors, but can allow for the presence of additional factors that are not necessarily explicitly described, again depending at least in part on the context.

[0066] As used herein, the terms "comprises," "comprising," or any other variations thereof, are intended to cover a non-exclusive inclusion such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus.

[0067] There are various types of in vivo analyte monitoring systems. For example, a "continuous analyte monitoring" system (or "continuous glucose monitoring" system) can continuously transmit data from a sensor control device to a reader device without prompting, e.g., automatically according to a schedule. As another example, a "flash analyte monitoring" system (or "flash glucose monitoring" system or simply a "flash" system) can transmit data from a sensor control device in response to a scan or data request from a reader device, e.g., using a near field communication (NFC) or radio frequency identification (RFID) protocol. In vivo analyte monitoring systems can also operate without the need for finger stick calibration.

[0068] In vivo analyte monitoring systems can be distinguished from "in vitro" systems, which contact a biological sample outside the subject (or "in vitro") and typically include a metering device having a port for receiving an analyte test strip containing a user's bodily fluid, which can be analyzed to determine the user's blood glucose level.

[0069] The in-vivo monitoring system may include a sensor that, when located in the body, contacts the user's bodily fluids and senses the level of an analyte contained therein. The sensor may be part of a sensor control device that is located on the user's body and includes electronics and a power source that enable and control analyte sensing. The sensor control device and variations thereof may also be referred to as a "sensor control unit," "on-body electronics" device or unit, "on-body" device or unit, or "sensor data communication" device or unit, to name a few.

[0070] The in vivo monitoring system may also include a device that receives the sensed analyte data from the sensor control device and processes and / or displays the sensed analyte data to the user in various forms. Such a device and its variants may be referred to as a "handheld reader device," a "reader device" (or simply a "reader"), a "handheld electronic device" (or simply a "handheld device"), a "portable data processing" device or unit, a "data receiver," a "receiver" device or unit (or simply a "receiver"), or a "remote" device or unit, to name a few. Other devices, such as personal computers, have also been used with or incorporated into in vivo and in vitro monitoring systems.

[0071] Figure 11 is a conceptual diagram depicting an example analyte monitoring system 100 that can be incorporated with one or more embodiments of the present disclosure. Using system 100 (hereinafter referred to as "system 100"), a variety of analytes can be detected and quantified, including but not limited to acetylcholine, amylase, bilirubin, cholesterol, human 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. The concentration of drugs such as, but not limited to, antibiotics (e.g., gentamicin, vancomycin, etc.), digitoxin, digoxin, drugs of abuse, theophylline, and warfarin can also be determined.

[0072] As shown, system 100 includes a sensor applicator 102 (also referred to as an "inserter"), 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 the user's skin (e.g., a user's arm). Once delivered, the sensor control device 104 is maintained in place on the skin by an adhesive patch 108 coupled to the bottom of the sensor control device 104. A portion of a sensor 110 extends from the sensor control device 104 and is positioned so that it can be transcutaneously positioned and otherwise maintained below the user's skin surface during monitoring.

[0073] An introducer may be included to facilitate the introduction of the sensor 110 into the tissue. The introducer may comprise, for example, a needle, commonly referred to as a "sharp". Alternatively, the introducer may comprise other types of devices, such as a sheath or a blade. Prior to insertion into the tissue, the introducer may be temporarily stationed near the sensor 110 and then withdrawn. When present, the introducer may facilitate the insertion of the sensor 110 into the tissue by opening an entry channel along which the sensor 110 may pass. For example, the introducer may penetrate the epidermis to provide an entry channel to the dermis, thereby allowing subcutaneous implantation of the sensor 110. After opening the entry channel, the introducer may be withdrawn (retracted) so that the introducer does not pose a hazard while the sensor 110 remains in place.

[0074] In illustrative embodiments, the introducer can be solid or hollow, beveled or non-beveled, and / or circular or non-circular in cross-section. In a more specific embodiment, a suitable introducer can be comparable in cross-sectional diameter and / or tip design to an acupuncture needle, which can have a cross-sectional diameter of approximately 250 microns. However, it should be appreciated that a suitable introducer can have a larger or smaller cross-sectional diameter if desired for a particular application.

[0075] In some embodiments, the tip of the introducer (when present) can be angled above the distal end of the sensor 110 so that the introducer first penetrates the tissue and opens an access channel for the sensor 110. In other illustrative embodiments, the sensor 110 can be positioned within a lumen or groove of the introducer, which similarly opens an access channel for the sensor 110. In either case, after facilitating insertion of the sensor 110, the introducer is subsequently withdrawn. Furthermore, the introducer (sharp body) can be made of a variety of materials, such as various types of metals and plastics.

[0076] When the sensor control device 104 is properly assembled, the sensor 110 is placed in communication with one or more electrical components or sensor electronics (e.g., electrical, mechanical) contained within the sensor control device 104. For example, in some applications, 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 operably coupled to the data processor, which in turn may be coupled to an antenna and a power source.

[0077] The sensor control device 104 and the reader device 106 are configured to communicate with each other via a local communication path or link 112, which can be wired or wireless, unidirectional or bidirectional, encrypted or unencrypted. According to some embodiments, the reader device 106 can constitute an output medium for viewing the analyte concentration determined by the sensor 110 or a processor associated therewith and an alarm or notification, as well as allowing one or more user inputs. The reader device 106 can be a multi-purpose smartphone or a dedicated electronic reader instrument. Although only one reader device 106 is shown, in some cases, multiple reader devices 106 can be present.

[0078] The reader device 106 may also communicate with the remote terminal 114 and / or the trusted computer system 116 via communication paths / links 118 and / or 120, respectively, which may also be wired or wireless, unidirectional or bidirectional, and encrypted or unencrypted. The reader device 106 may also or alternatively communicate with a network 122 (e.g., a mobile phone network, the Internet, or a cloud server) via a communication path / link 124. The network 122 may further be communicatively coupled to the remote terminal 114 via a communication path / link 126 and / or to the trusted computer system 116 via a communication path / link 128.

[0079] Alternatively, the sensor control device 104 may communicate directly with the remote terminal 114 and / or the trusted computer system 116 without the presence of an intermediary reader device 106. For example, according to some embodiments, the sensor 110 may communicate with the remote terminal 114 and / or the trusted computer system 116 via a direct communication link to the network 122, as described in U.S. Patent No. 10,136,816, which is incorporated herein by reference in its entirety.

[0080] Any suitable electronic communication protocol may be used for each communication path or link, for example, NFC, radio frequency identification (RFID), or Low energy protocols, wireless local area networks, etc. According to some embodiments, in addition to the primary user, individuals interested in the user's analyte level may also access the remote terminal 114 and / or the trusted computer system 116. 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.

[0081] In some embodiments, the sensor control device 104 can automatically forward data to the reader device 106. For example, analyte concentration data can be automatically and periodically transmitted, for example, when the data is obtained or at a specific frequency after a specific time period has passed, and the data is stored in a memory until transmission (for example, every minute, every five minutes, or other predetermined time period). In other embodiments, the sensor control device 104 can communicate with the reader device 106 in a non-automatic manner rather than according to a set schedule. For example, when the sensor electronics enter the communication range of the reader device 106, RFID technology can be used to transmit data from the sensor control device 104. Before being transmitted to the reader device 106, the data can remain stored in the memory of the sensor control device 104. Therefore, the patient does not have to remain in close proximity to the reader device 106 at all times, but can upload data when it is convenient. In other embodiments, a combination of automatic and non-automatic data transmission can be implemented. For example, data transmission can continue automatically until the reader device 106 is no longer within the communication range of the sensor control device 104.

[0082] The sensor control device 104 is typically included with the sensor applicator 102, in what is referred to as a "two-piece" architecture, requiring final assembly by the user before the sensor 110 can be properly delivered to the target monitoring location. More specifically, the sensor 110 and associated electrical components included in the sensor control device 104 are provided to the user in multiple (two) packages, and the user must open the packages and manually assemble the components according to instructions before delivering the sensor 110 to the target monitoring location using the sensor applicator 102.

[0083] However, recent advances in the design of sensor control devices and sensor applicators have resulted in a single-piece architecture that allows the system to be shipped to the user in a single sealed package that does not require any final user assembly steps. Instead, the user only needs to open a single package and then deliver the sensor control device to the target monitoring location. This single-piece system architecture can be advantageous in eliminating component parts, various manufacturing process steps, and user assembly steps. This reduces packaging and waste, and reduces the potential for user error or system contamination.

[0084] In the illustrated embodiment, the system 100 can be configured as a "two-piece" architecture that requires final assembly by the user before the sensor 110 can be properly delivered to the target monitoring location. More specifically, the sensor 110 and associated electrical components included in the 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 in a package. The user must open the package and manually assemble the components according to the instructions, and then deliver the sensor 110 to the target monitoring location using the sensor applicator 102. However, in some other embodiments, the system 100 can be configured as a "single-piece" architecture.

[0085] Figure 2A and Figure 2B Figures 2 and 3 are isometric and side views, respectively, of an example sensor control device 202 according to one or more embodiments of the present disclosure. The sensor control device 202 (also referred to as a "puck") is similar in some respects to a Figure 1 The sensor control device 104 of FIG. 1 is used as a reference, so the sensor control device 202 may be better understood with reference to the sensor control device 104. The sensor control device 202 may replace Figure 1 The sensor control device 104 can therefore be used with the sensor applicator 102 ( Figure 1 ) in conjunction with the sensor applicator, the sensor control device 202 is delivered to the target monitoring location on the user's skin.

[0086] However, the sensor control device 202 can be integrated into a single-piece system architecture. Unlike a two-piece system, for example, the user does not need to open multiple packaging pieces and ultimately assemble the sensor control device 202. Instead, the sensor control device 202 arrives fully assembled and properly positioned within the sensor applicator 102 upon receipt by the user. To use the sensor control device 202, the user only needs to break a barrier, such as the applicator cap, and then quickly deliver the sensor control device 202 to the intended monitoring location.

[0087] As shown, the sensor control device 202 includes an electronics housing 204 having a generally disk-shaped and / or disc-shaped cross-section and a circular cross-section. However, in other embodiments, the electronics housing 204 may have other cross-sectional shapes, such as oval (e.g., pill-shaped), elliptical, or polygonal, without departing from the scope of the present disclosure. The electronics housing 204 may be configured to house or otherwise contain various electronic components used to operate the sensor control device 202.

[0088] The electronics housing 204 may include a housing 206 and a base 208 that mates with the housing 206. The housing 206 may be secured to the base 208 in a variety of ways, such as a snap-fit ​​connection, an interference fit, sonic welding, or one or more mechanical fasteners (e.g., screws). In some cases, the housing 206 may be secured to the base 208 so as to create a sealed interface therebetween. In such embodiments, a gasket or other type of sealing material may be positioned at or near the outer diameter (periphery) of the housing 206 and base 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 housing 206 and base 208. The adhesive secures the housing 206 to the base 208 and provides structural integrity, but also seals the interface between the two components, thereby isolating the interior of the electronics housing 204 from external contaminants. If the sensor control device 202 is assembled in a controlled environment, terminal sterilization of the internal electrical components is not required. In contrast, the adhesive coupling may provide an adequate sterile barrier for the assembled electronics housing 204 .

[0089] The sensor control device 202 may also 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 sharp module 214 (partially visible). The sensor module 212 can be configured to carry or otherwise include a sensor 216 (partially visible), and the sharp module 214 can be configured to carry or otherwise include a sharp body 218 (partially visible) that is used to help deliver the sensor 216 transcutaneously beneath the user's skin during application of the sensor control device 202. As shown, corresponding portions of the sensor 216 and the sharp body 218 extend from the electronics housing 204, more specifically, from the bottom of the base 208. The exposed portion of the sensor 216 can be housed within a hollow or recessed portion of the sharp body 218. The remainder of the sensor 216 is located within the interior of the electronics housing 204.

[0090] Figure 3A and Figure 3B304. The plug 302 may be configured to receive and support the sensor 216 and the connector 304. As shown, a channel 306 may be defined through the plug 302 to accommodate a portion of the sensor 216. In addition, the plug 302 may provide one or more deflectable arms 307 that are configured to snap into corresponding features provided on the bottom of the electronics housing 204. Figure 2A and Figure 2B ).

[0091] Sensor 216 includes a tail portion 308, a flag portion 310, and a neck portion 312 interconnecting tail portion 308 and flag portion 310. Tail portion 308 can be configured to extend at least partially through channel 306 and extend distally from plug 302. Tail portion 308 includes an enzyme or other chemical or biological substance, and in some embodiments, a membrane can cover the chemical substance. In use, tail portion 308 is transcutaneously received beneath the user's skin, and the chemical substance contained thereon helps facilitate analyte monitoring in the presence of body fluids.

[0092] The flag 310 may include one or more sensor contacts 314 ( Figure 3B The sensor contacts 314 may be configured to align with a corresponding number of compliant carbon-impregnated polymer modules (not shown) encapsulated within the connector 304 .

[0093] The connector 304 includes one or more hinges 318 that enable the connector 304 to move between an open position and a closed position. Figure 3A and Figure 3B 216 and corresponding circuit contacts disposed within the electronics housing 204. Figure 2A and Figure 2B ). The connector 304 can be made of silicone rubber and can serve as a moisture barrier for the sensor 216 when assembled in a compressed state and after being applied to the user's skin.

[0094] The sharp module 214 includes a sharp body 218 and a sharp hub 322 that carries the sharp body 218. The sharp body 218 includes an elongated shaft 324 and a tip 326 located at the distal end of the shaft 324. The shaft 324 can be configured to extend through the channel 306 and extend distally from the plug 302. In addition, the shaft 324 can include a hollow or grooved portion 328 that at least partially surrounds the tail 308 of the sensor 216. The tip 326 can be configured to penetrate the skin while carrying the tail 308 so that the active chemical present on the tail 308 comes into contact with the body fluid.

[0095] The sharpened hub 322 may include a hub cylindrical body 330 and a hub snap-on claw 332, each of which may be configured to assist in coupling the plug assembly 210 (and the entire sensor control device 202) to the sensor applicator 102 ( Figure 1 ).

[0096] Figure 4A and Figure 4B 204, and isometric bottom views, respectively, of the electronics housing 204 according to one or more embodiments. The housing 206 and base 208 operate as opposing flip-top halves that enclose or otherwise generally enclose the various electronic components ( Figure 2A and Figure 2B ).

[0097] A printed circuit board (PCB) 402 may be located within the electronics housing 204. A plurality of electronic modules (not shown) may be mounted to the PCB 402, 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 implement 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, wherein such functions may include, but are not limited to, filtering and encoding of data signals, each data signal corresponding to a sampled analyte level of a user. The data processing unit may also include a processor for communicating with the reader device 106 ( Figure 1 ) communicating with the antenna, or otherwise communicating with the antenna.

[0098] As shown, the housing 206, the base 208, and the PCB 402 are each defined with corresponding central holes 404, 406, and 408. When the electronic housing 304 is assembled, the central holes 404, 406, and 408 are coaxially aligned to accommodate the plug assembly 210 ( Figure 3A and Figure 3B A battery 410 may also be housed within the electronics housing 204 and configured to provide power to the sensor control device 202 .

[0099] exist Figure 4B In the embodiment, the socket 412 can be defined at the bottom of the base 208 and provide a plug assembly 210 ( Figure 3A and Figure 3B ) can be received and coupled to the electronics housing 204, thereby fully assembling the sensor control device 202 ( Figure 2A and Figure 2B Plug 302 ( Figure 3A and Figure 3B ) can be contoured to match or be shaped in a complementary manner to the socket 412, and the socket 412 can provide one or more snap flanges 414 (two shown) that are configured to engage the deflectable arms 307 ( Figure 3A and Figure 3B ) docks and accommodates the deflectable arm. The plug assembly 210 is coupled to the electronics housing 204 by pushing the plug 302 into the receptacle 412 and allowing the deflectable arm 307 to lock into the corresponding snap flange 414. When the plug assembly 210 ( Figure 3A and Figure 3B ) is properly coupled to the electronics housing 204, one or more circuit contacts 416 (three are shown) defined on the underside of the PCB 402 can engage with the connector 304 ( Figure 3A and Figure 3B ) of the electrical contacts 320 ( Figure 3A and Figure 3B ) for conductive communication.

[0100] Figure 5A and Figure 5B 1 and 2 are side views and cross-sectional side views, respectively, of a sensor applicator 102 and an applicator cap coupled to the sensor applicator. More specifically, according to at least one embodiment, Figure 5A and Figure 5B The sensor applicator 102 is depicted as being transported to and received by a user. However, in some embodiments, the sensor applicator 102 can be further sealed within a bag (not shown) and delivered to the user within the bag. The bag can be made of a variety of materials that help prevent moisture from entering the sensor applicator 102, which could adversely affect the sensor 216. For example, in at least one embodiment, the sealed backing can be made of foil. Any and all sensor applicators described or discussed herein can be sealed within a bag and delivered to the user within the bag.

[0101] According to this disclosure, Figure 5BAs shown, the sensor control device 202 is assembled and installed in the sensor applicator 102 before being delivered to the user. The applicator cap can be screwed onto the housing and includes an anti-tamper ring 502. When the applicator cap is rotated relative to the housing (e.g., unscrewed), the anti-tamper ring 502 can be torn, thereby releasing the applicator cap from the sensor applicator 102. Thereafter, the user can deliver the sensor control device 202 to the target monitoring location.

[0102] In some embodiments, as described above, the applicator cap can be secured to the housing via a sealing interface to protect the internal components of the sensor applicator 102. For example, in at least one embodiment, 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 or alternatively molded onto one of the housing and the applicator cap.

[0103] The housing can be made of a variety of rigid materials. For example, in some embodiments, the housing can be made of a thermoplastic polymer, such as polyketone. In other embodiments, the housing can be made of cyclic olefin copolymer (COC), which helps prevent moisture from entering the interior of the sensor applicator 102. It is understood that any and all housings described or discussed herein can be made of polyketone or COC.

[0104] Specific reference Figure 5B The sensor control device 202 can be loaded into the sensor applicator 102 by mating the sharpened hub 322 with the sensor carrier 504 included within the sensor applicator 102. Once the sensor control device 202 is mated with the sensor carrier 504, the applicator cap can be secured to the sensor applicator 102.

[0105] In the illustrated embodiment, the collimator 506 is positioned within the applicator cap and, when included within the sensor applicator 102, can generally help support the sensor control device 202. In some embodiments, the collimator 506 can form an integral part or extension of the applicator cap, for example, molded with or overmolded onto the applicator cap. In other embodiments, the collimator 506 can include a separate structure mounted within or attached to the applicator cap without departing from the scope of the present disclosure. In other embodiments, as described below, the collimator 506 can be omitted from the package received by the user, but used when sterilizing and preparing the sensor applicator 102 for shipment.

[0106] The collimator 506 can be designed to receive and help protect portions of the sensor control device 202 that require sterilization, and to isolate the sterile components of the sensor applicator 102 from microbial contamination from other locations within the sensor control device 202. To accomplish this, the collimator 506 can define or otherwise provide a sterile zone 508 (alternatively referred to as a "sterile barrier enclosure" or "sterile sensor path") that is configured to receive the sensor 216 and sharps 218 extending from the bottom of the electronics housing 204. The sterile zone 508 can generally include a hole or passageway that extends at least partially through the body of the collimator 506. In the illustrated embodiment, the sterile zone 508 extends through the entire body of the collimator 506, but alternatively, may extend only partially therethrough without departing from the scope of the present disclosure.

[0107] When the sensor control device 202 is loaded into the sensor applicator 102 and the applicator cap with the collimator 506 is secured thereto, the sensor 216 and the sharp 218 can be positioned within a sealed region 510 at least partially defined by a sterile zone 508. The sealed region 510 is configured to isolate the sensor 216 and the sharp 218 from external contamination and can include (enclose) selected portions of the interior of the electronics housing 204. Some embodiments can include a sterile zone 508 for the collimator 506.

[0108] While positioned within the sensor applicator 102, in some embodiments, the fully assembled sensor control device 202 can be subjected to radiation sterilization 512. Radiation sterilization 512 can include, for example, electron beam irradiation, but 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 via continuous process irradiation or via pulsed beam irradiation. In pulsed beam irradiation, the beam of the radiation sterilization 512 is focused at a target location, and the component or device to be sterilized is moved to the target location, at which point the radiation sterilization 512 is activated to provide a targeted pulse of radiation. The radiation sterilization 512 is then turned off, and another component or device to be sterilized is moved to the target location, and the process is repeated.

[0109] The collimator 506 can be configured to focus radiation (e.g., beam, wave, energy, etc.) from the radiation sterilization 512 toward the components to be sterilized (e.g., the sensor 216 and the sharp body 218). More specifically, the aperture or channel of the sterilization zone 508 allows the radiation to be transmitted to be incident on and sterilize the sensor 216 and the sharp body 218, while the remainder of the collimator 506 prevents (blocks) the transmitted radiation from damaging or destroying the electronic components within the electronics housing 204.

[0110] The sterilization zone 508 can have any suitable cross-sectional shape required to properly focus radiation on the sensor 216 and the sharp body 218 for sterilization. For example, in the illustrated embodiment, the sterilization zone 508 is cylindrical, but may alternatively have a polygonal cross-sectional shape, such as a cube or a rectangle (e.g., including a parallelogram), without departing from the scope of the present disclosure.

[0111] In the illustrated embodiment, the sterilization zone 508 provides a first aperture 514a at a first end and a second aperture 514b at a second end opposite the first end. The first aperture 514a can be configured to accommodate the sensor 316 and the sharp body 318 into the sterilization zone 508, and the second aperture 514b can allow radiation (e.g., beam, wave, etc.) from the radiation sterilization 512 to enter the sterilization zone 508 and impinge on the sensor 216 and the sharp body 218. In the illustrated embodiment, the first aperture 514a and the second aperture 514b have the same diameter.

[0112] The body of the collimator 506 reduces or eliminates the radiation sterilization 512 from penetrating the body material and damaging the electronic components within the electronics housing 204. To achieve this, in some embodiments, the collimator 506 can be made of a material having a mass density greater than 0.9 grams per cubic centimeter (g / cc). An example material for the collimator 506 is polyethylene, but alternatively, any material having a mass density similar to or greater than polyethylene can be included. For example, in some embodiments, the material of the collimator 506 can include, but is not limited to, metal (e.g., lead, stainless steel) or a high-density polymer.

[0113] In at least one embodiment, the design of the collimator 506 can be modified so that the collimator 506 can be made of a material with a mass density of less than 0.9 grams per cubic centimeter (g / cc), while still reducing or eliminating the impact of the sterilization radiation 512 on the electronic components within the electronics housing 204. To achieve this, in some embodiments, the size (e.g., length) of the collimator 506 can be increased so that the electrons from the sterilization radiation 512 need to pass through a larger amount of material before potentially impacting sensitive electronic equipment. The larger amount of material can help absorb or dissipate the dose intensity of the sterilization radiation 512, making it harmless to sensitive electronic equipment. However, in other embodiments, the reverse is also true. More specifically, as long as the material of the collimator 506 has a sufficiently large mass density, the size (e.g., length) of the collimator 506 can be reduced.

[0114] In addition to the radiation blocking properties of the body of the collimator 506, in some embodiments, one or more shields 516 (one shown) can be positioned within the sensor housing 304 to protect sensitive electronic components from radiation when the sensor control device 302 is subjected to radiation sterilization 512. For example, the shield 516 can be positioned between the data processing unit 518 and a radiation source (e.g., an electron beam electron accelerator). In such embodiments, the shield 516 can be positioned adjacent to or aligned with the data processing unit 518 and the radiation source to block or mitigate radiation exposure (e.g., electron beam irradiation or energy) that could otherwise damage sensitive electronic circuitry of the data processing unit 518.

[0115] The shield 516 can be made of any material that can block (or substantially block) the transmission of radiation. Suitable materials for the shield 516 include, but are not limited to, lead, tungsten, ferrous metals (e.g., stainless steel), copper, tantalum, tungsten, osmium, or any combination thereof. Suitable metals can be any non-magnetic metal that is corrosion-resistant, austenitic, and has a density between about 5 grams per cubic centimeter (g / cc) and about 15 g / cc. The shield 516 can be manufactured via a variety of manufacturing techniques, including, but not limited to, stamping, casting, injection molding, sintering, two-shot molding, or any combination thereof.

[0116] 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 manufactured by mixing the shielding material in an adhesive matrix and dispensing the composition onto a formed part or otherwise directly onto data processing unit 518. Furthermore, in such embodiments, shield 516 may comprise a housing that encloses (or substantially encapsulates) data processing unit 518.

[0117] In some embodiments, a collimator seal 520 can be applied to the end of the collimator 506 to seal the sterilization zone 508, thereby sealing the sealing area 510. As shown, the collimator seal 520 can seal the second hole 514b. The collimator seal 520 can be applied before or after radiation sterilization 512. In the embodiment in which the collimator seal 520 is applied before performing radiation sterilization 512, the collimator seal 520 can be made of a radiation-permeable microbial barrier material that allows radiation to propagate through. With the collimator seal 520 in place, the sealing area 510 can maintain a sterile environment for the assembled sensor control device 202 until the user removes (unscrews) the applicator cap.

[0118] In some embodiments, the collimator seal 520 may include two or more layers of different materials. The first layer may be made of a synthetic material (e.g., flash spun high-density polyethylene fiber), such as Obtained Very durable, puncture-resistant, and allows steam penetration. Can be applied before or after radiation sterilization 512 layer, and after radiation sterilization 512, can be The collimator seal 520 may be sealed (e.g., heat sealed) with a foil or other vapor and moisture resistant material layer to prevent contaminants and moisture from entering the sterilization zone 508 and the sealing area 510. In other embodiments, the collimator seal 520 may comprise only a single protective layer applied to the end of the collimator 506. In such embodiments, the single layer is gas permeable for the sterilization process, but is also able to prevent moisture and other harmful elements once the sterilization process is complete. Thus, the collimator seal 520 can function as a moisture and contaminant barrier without departing from the scope of the present disclosure.

[0119] Note that while the sensor 216 and sharp 218 extend from the bottom of the electronics housing 204 and into the sterile zone 508, generally concentric with the centerline of the sensor applicator 102 and the applicator cap, an eccentric arrangement is contemplated herein. More specifically, in at least one embodiment, the sensor 216 and sharp 218 can extend from the bottom of the electronics housing 204 eccentrically with respect to the centerline of the sensor applicator 102 and the applicator cap. In such an embodiment, the collimator 506 can be redesigned or otherwise configured so that the sterile zone 508 is also positioned eccentrically to receive the sensor 216 and sharp 218 without departing from the scope of the present disclosure.

[0120] In some embodiments, the collimator 506 can include a first or "inner" collimator that can be housed within the applicator cap or otherwise housed within the sensor applicator 102, as generally described above. A second or "outer" collimator (not shown) can also be included or otherwise used during the assembly (manufacturing) process to assist in sterilizing the sensor applicator 102. In such embodiments, the outer collimator can be positioned on the exterior of the sensor applicator 102 and the applicator cap and used simultaneously with the inner collimator 506 to assist in focusing the sterilizing radiation 512 on the sensor 216 and the sharp body 218.

[0121] For example, in one embodiment, the outer collimator can initially receive the sterilizing radiation 512. Similar to the inner collimator 506, the outer collimator can provide or define an aperture or channel extending through the outer collimator. The beam of sterilizing radiation 512 passing through the channel of the outer collimator can be focused and received in the sterilization zone 508 of the inner collimator 506 through the second aperture 514b. Thus, the outer collimator can operate to pre-focus the radiation energy, and the inner collimator 506 can fully focus the radiation energy on the sensor 216 and the sharp body 218.

[0122] In some embodiments, the internal collimator 506 can be omitted if the external collimator is capable of properly and completely focusing the radiation sterilization 512 to properly sterilize the sensor 216 and the sharp body 218. In such an embodiment, the sensor applicator can be positioned near the external collimator and then subjected to the radiation sterilization 512, and the external collimator can prevent the radiation energy from damaging the sensitive electronics within the electronics housing 204. Furthermore, in such an embodiment, the sensor applicator 102 can be shipped to the user without the internal collimator 506 located within the applicator cap, thereby eliminating manufacturing and usage complexities.

[0123] Figure 6A is an enlarged cross-sectional side view of the sensor control device 202 mounted within the applicator cap according to one or more embodiments. As described above, portions of both the sensor 216 and the sharp body 218 can be disposed within the sealed region 510, thereby isolating them from external contamination. The sealed region 510 can include (enclose) selected portions of the interior of the electronics housing 204 and the sterilization zone 508 of the collimator 506. In one or more embodiments, the sealed region 510 can be defined or otherwise formed by at least a first seal 602a, a second seal 602b, and a collimator seal 520.

[0124] The first seal 602a can be arranged 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 housing 206. In addition, the first seal 602a can surround the first central aperture 404 defined in the housing 206, thereby preventing contaminants from migrating into the interior of the electronics housing 204 via the first central aperture 404. In some embodiments, the first seal 602a can form a portion 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 housing 206. In other embodiments, the first seal 602a can include a separate structure, such as an O-ring or the like, that is interposed between the sharp hub 322 and the top surface of the housing 206 without departing from the scope of this disclosure.

[0125] The second seal 602b can be arranged to seal the interface between the collimator 506 and the bottom of the electronics housing 204. More specifically, the second seal 602b can be arranged to seal the interface between the base 208 and the collimator 506, or, alternatively, the interface between the collimator 506 and the bottom of the plug 302 housed within the bottom of the base. In applications that include the plug 302, as shown, the second seal 602b can be configured to seal around or otherwise surround the receptacle 412. In embodiments where the plug 302 is omitted, the second seal 602b can alternatively surround the second central aperture 406 ( Figure 4A Thus, the second seal 602b can prevent contaminants from migrating into the sterile region 508 of the collimator 506 and can also prevent contaminants from migrating into the interior of the electronics housing 204 via the receptacle 412 (or, alternatively, the second central aperture 406).

[0126] 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 bottom of the plug 302 or the base 208. In other embodiments, the second seal 602b can include a separate structure, such as an O-ring or the like, interposed between the collimator 506 and the bottom of the plug 302 or the base 208 without departing from the scope of the present disclosure.

[0127] Before loading the sensor control device 202 into the sensor applicator 102 ( Figure 5B ) and secure the applicator cap to the sensor applicator 102, the first seal 602a and the second seal 602b are compressed and create a corresponding sealing interface. The first seal 602a and the second seal 602b can be made of a variety of materials that can create a sealing interface between opposing structures. Suitable materials include, but are not limited to, silicone, thermoplastic elastomer (TPE), polytetrafluoroethylene (PTFE or ) or any combination thereof.

[0128] As described above, the collimator seal 520 can be configured to seal the bottom of the sterilization zone 508 and, therefore, the bottom of the sealed area 510. Thus, the first seal 602a, the second seal 602b, and the collimator seal 520 each create a corresponding barrier in their respective sealing positions. The combination of these seals 602a, 602b, and 520 allows the sealed area 510 containing the sensor 216 and the sharp body 218 to be terminally sterilized.

[0129] Figure 6Bis an enlarged cross-sectional side view of another embodiment of a sensor control device 302 installed within a sensor applicator 102 according to one or more embodiments. More specifically, Figure 6B An alternative embodiment of a first seal 602a and a second seal 602b is depicted. The first seal 602a is again arranged to seal the interface between the sharp hub 322 and the top of the electronics housing 204, and more specifically, the first central aperture 404 defined in the housing 206. However, in the illustrated embodiment, 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 axially extending members 604 of the sensor carrier 504 and one or more radially extending members 606 of the sensor carrier 504. This dual biasing engagement compresses the first seal 602a both axially and radially, thereby allowing the first seal 602a to seal both radially and axially against the top of the electronics housing 204.

[0130] The second seal 602b is again arranged to seal the interface between the collimator 506 and the bottom of the electronics housing 204, more specifically, the interface between the base 208 and the collimator 506, or, alternatively, the interface between the collimator 506 and the bottom of the plug 302 housed within the bottom of the base 208. However, in the illustrated embodiment, the second seal 602b can extend into the sterilization zone 508 and define or otherwise provide a cylindrical well 608 sized to accommodate the sensor 216 and sharp extending from the bottom of the base 208. In some embodiments, a desiccant 610 can be located within the cylindrical well to help maintain a low humidity environment for moisture-sensitive biological components.

[0131] In some embodiments, the second seal 602b can be omitted, and the collimator 506 can be coupled directly to the electronics housing 204. More specifically, in at least one embodiment, the collimator 506 can be screwed into the underside of the base 208. In such an embodiment, the collimator 506 can provide or otherwise define a threaded extension configured to mate with a threaded hole defined in the bottom of the base 208. Threading the collimator 506 to the base 208 can seal the interface between the collimator 506 and the bottom of the electronics housing 204, thereby operating to isolate the seal area 510. Furthermore, in such an embodiment, the pitch and gauge of the threads defined on the collimator 506 and the base 208 can match the pitch and gauge of the threaded engagement between the applicator cap and the sensor applicator 102. As a result, when the applicator cap is screwed into or unscrewed from the sensor applicator 102, the collimator 506 can be screwed into or unscrewed from the electronics housing 304 accordingly.

[0132] Figure 7 is an isometric view of an example sensor control device 702 according to one or more additional embodiments of the present disclosure. The sensor control device 702 may be used with Figure 1 The sensor control device 104 is the same as or similar to the sensor applicator 102 ( Figure 1 ) is used in conjunction with a sensor applicator to deliver the sensor control device 702 to the target monitoring location on the user's skin. In addition, the sensor control device 702 can alternatively be represented as a medical device. Therefore, the sensor control device 702 also needs to be properly sterilized before use.

[0133] As shown, the sensor control device 702 includes an electronics housing 704 that is generally disc-shaped and may have a circular cross-section. However, in other embodiments, the electronics housing 704 may have other cross-sectional shapes, such as oval (e.g., pill-shaped), elliptical, or polygonal, without departing from the scope of the present disclosure. The electronics housing 704 may be configured to house or otherwise contain various electronic components used to operate the sensor control device 702.

[0134] The electronic housing 704 may include a housing 706 and a base 708 that can be matched with the housing 706. The housing 706 can be fixed to the base 708 in a variety of ways, such as snap-fit ​​engagement, interference fit, sonic welding, one or more mechanical fasteners (e.g., screws), or any combination thereof. In some cases, the housing 706 can be fixed to the base 708 so that a sealed interface is generated between them. In such an embodiment, a gasket or other type of sealing material can be positioned at or near the outer diameter (periphery) of the housing 706 and the base 708, and the two components can be fixed together to compress the gasket, thereby generating a sealed interface. In other embodiments, an adhesive can be applied to the outer diameter (periphery) of one or both of the housing 706 and the base 708. The adhesive fixes the housing 706 to the base 708 and provides structural integrity, but can also seal the interface between the two components, thereby isolating the interior of the electronic housing 704 from external contamination.

[0135] In the illustrated embodiment, the sensor control device 702 can also include a plug assembly 710 that can be coupled to the electronics housing 704. The plug assembly 710 can include a sensor module 712 (partially visible) that can be interconnected with a sharp module 714 (partially visible). The sensor module 712 can be configured to carry or otherwise include a sensor 716 (partially visible), and the sharp module 714 can be configured to carry or otherwise include a sharp body 718 (partially visible) that is used to facilitate transcutaneous delivery of the sensor 716 beneath the user's skin during application of the sensor control device 702. The sharp module 714 can include a sharp hub 720 that carries the sharp body 718.

[0136] As shown, sensor 716 and corresponding portions of sharp body 718 extend from electronics housing 704, and more specifically, from the bottom of base 708. The exposed portion of sensor 716 (also referred to as the "tail") can be received within the hollow or recessed portion of sharp body 718. The remainder of sensor 716 is located within the interior of electronics housing 704.

[0137] Figure 8 yes Figure 1 904 . As shown, the sensor applicator 102 includes a housing 902 and an applicator cap 904 that can be removably coupled to the housing 902. In some embodiments, the applicator cap 904 can be screwed to the housing 902 and include an anti-tamper ring 906. When the applicator cap 904 is rotated (e.g., unscrewed) relative to the housing 902, the anti-tamper ring 906 can be torn, thereby releasing the applicator cap 904 from the sensor applicator 102. Once the applicator cap 904 is removed, the user can then use the sensor applicator 102 to remove the sensor control device 702 ( Figure 7) is positioned at the target monitoring location on the user's body.

[0138] In some embodiments, the applicator cap 904 can be secured to the housing 902 via 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 or, alternatively, molded onto one of the housing 902 and the applicator cap 904.

[0139] Figure 9 is a cross-sectional side view of the sensor applicator 102. As shown, the sensor control device 902 can be housed within the sensor applicator 102, and the applicator cover 904 can be coupled to the sensor applicator 102 to secure the sensor control device 702 therein. The sensor control device 702 can include one or more radiation sensitive components 708 disposed within the electronics housing 704. The radiation sensitive components 708 can include electronic components or modules, such as, but not limited to, a data processing unit, a resistor, a transistor, a capacitor, an inductor, a diode, a switch, or any combination thereof. The data processing unit can include, for example, an application specific integrated circuit (ASIC) configured to implement 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 the user's sampled analyte levels. The data processing unit can also include a reader device 106 ( Figure 1 ) communicating with the antenna, or otherwise communicating with the antenna.

[0140] In the illustrated embodiment, the cap filler 910 can be positioned within the applicator cap 1404 and can generally help support the sensor control device 702 within the sensor applicator 102. In one or more embodiments, the cap filler 910 can comprise an integral portion or extension of the applicator cap 904, e.g., molded with or overmolded onto the applicator cap 904. In other embodiments, the cap filler 910 can comprise a separate structure mounted within or otherwise attached to the applicator cap 904 without departing from the scope of the present disclosure.

[0141] When positioned within the sensor applicator 102, the sensor control device 702 (more specifically, the distal ends of both the sensor 716 and the sharp body 718 extending from the bottom of the electronics housing 1304) can be sterilized. In some embodiments, the fully assembled sensor control device 702 can be subjected to radiation sterilization. Radiation sterilization 912 can be delivered by continuous process irradiation or pulsed beam irradiation. In pulsed beam irradiation, the beam of the 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 directed pulse of radiation. The radiation sterilization 912 is then turned off, and another component part or device to be sterilized is moved to the target location, and the process is repeated.

[0142] According to the present disclosure, an external sterilization assembly 914 can be used to help focus radiation 912 when sterilizing the distal ends of both the sensor 716 and the sharp body 718, while preventing (blocking) the propagating radiation 912 from damaging the radiation-sensitive components 908. As shown, the external sterilization assembly 914 (hereinafter referred to as "assembly 914") can include a radiation shield 916 that is at least partially located outside the sensor applicator 102. The radiation shield 916 can provide or define an external collimator 918 that is configured to help focus radiation 912 (e.g., a beam, wave, energy, etc.) toward the component to be sterilized. More specifically, the external collimator 918 allows radiation 912 to be transmitted to strike and sterilize the sensor 716 and the sharp body 718, but prevents radiation 912 from damaging the radiation-sensitive components 908 within the electronics housing 704.

[0143] In the illustrated embodiment, the external collimator 918 is designed to align with the internal collimator 920 defined by the cap filler 910. Similar to the external collimator 918, the internal collimator 920 can help focus the radiation 912 toward the components to be sterilized. As shown, the cap filler 910 can define a radial shoulder 922 that is sized to accommodate the end of the radiation shield 916 and otherwise cooperate therewith, and the external collimator 918 transitions to the internal collimator 920 at the radial shoulder 922. In some embodiments, the transition between the external collimator 918 and the internal collimator 920 can be continuous, flush, or smooth. However, in other embodiments, the transition can be discontinuous or stepped without departing from the scope of this disclosure.

[0144] The outer collimator 918 and the inner collimator 920 can collectively define a sterilization zone 924 for the focused radiation 912, and the distal ends of both the sensor 916 and the sharp body 918 can be positioned within the sterilization zone 924. The propagating radiation 912 can pass through the sterilization zone 924 to irradiate and sterilize the sensor 716 and the sharp body 718. However, both the cover filler 910 and the radiation shield 916 can 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, both the cover filler 910 and the radiation shield 916 can be made of a material having a density sufficient to absorb the delivered beam energy dose. For example, in some embodiments, one or both of the cover filler 910 and the radiation shield 916 can be made of a material having 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 less than 0.9 g / cc without departing from the scope of the present disclosure. Suitable materials for the lid filler 910 and the 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 greater than 0.9 g / cc. In at least one embodiment, the lid filler 910 can be made of machined or 3D-printed polypropylene, and the radiation shield 916 can be made of stainless steel.

[0145] In some embodiments, the design of the sterilization zone 924 can be modified so that one or both of the cover filler 910 and the radiation shield 916 can be made of a material with a mass density less than 0.9 g / cc, while still preventing the radiation sterilization 912 from damaging the radiation-sensitive components 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 need to pass through a larger amount of material before potentially striking the radiation-sensitive components 908. The larger amount of material can help absorb or dissipate the dose intensity of the radiation 912, making it harmless to sensitive electronic devices. However, in other embodiments, the reverse is also true. More specifically, as long as the materials used for the cover filler 910 and / or the radiation shield 916 have a sufficiently large mass density, the size (e.g., length) of the sterilization zone 924 can be reduced.

[0146] The sterilization zone 924 defined by the external collimator 918 and the internal collimator 920 can have any suitable cross-sectional shape required to properly focus the radiation 912 on the sensor 716 and the sharp body 718 for sterilization. For example, in the illustrated embodiment, both the external collimator 918 and the internal collimator 920 have circular cross-sections with parallel sides. However, in other embodiments, one or both of the external collimator 918 and the internal collimator 920 can have a polygonal cross-sectional shape, such as a cube or a rectangle (e.g., including a parallelogram), without departing from the scope of the present disclosure.

[0147] In the illustrated embodiment, the sterile region 924 provides a first aperture 926a defined by the outer collimator 918 and a second aperture 926b defined by the inner collimator 920, wherein the first aperture 926a and the second aperture 926b are located at opposite ends of the sterile region 924. The first aperture 926a allows radiation 912 to enter the sterile region 924, and the second aperture 926b provides a location where the radiation 912 can act on the sensor 716 and the sharp object 718. In the illustrated embodiment, the second aperture 926b also provides a location where the sensor 716 and the sharp object 718 will be accommodated in the sterile region 924. In embodiments where the sterile region 924 has a circular cross-section, the diameters of the first aperture 926a and the second aperture 926b can be substantially the same.

[0148] In some embodiments, the sterile zone 924 defined by the outer collimator 918 and the inner collimator 920 can be substantially cylindrical, and can otherwise have a circular or polygonal cross-section. In such embodiments, the first aperture 926a and the second aperture 926b can have the same diameter, and the walls of the sterile zone 924 can be substantially parallel between the first and second ends of the sterile zone 924.

[0149] In some embodiments, a lid seal 928 (shown in phantom) can be disposed at the interface between the lid filler 910 and the radiation shield 916. The lid seal 928 can include a radiation-permeable microbial barrier. In some embodiments, for example, the lid seal 928 can be made of a synthetic material (e.g., flash-spun high-density polyethylene fiber), such as that available from Obtained The cover seal 928 can seal a portion of the sterilization region 924 to help form a portion of a sealed area 930 that is configured to isolate the sensor 716 and sharp 718 from external contamination.

[0150] The sealing area 930 can include (enclose) a selected portion of the interior of the electronics housing 704 and the sterilization zone 924. In one or more embodiments, the sealing area 930 can be defined or otherwise formed by at least a lid seal 928, a first or "top" seal 932a, and a second or "bottom" seal 932b. The lid seal 928 and the top seal 932a and the bottom seal 932b can each create a respective barrier in their respective sealing positions, thereby allowing the sterilization zone 924 containing the sensor 716 and the sharp body 718 to be terminally sterilized.

[0151] The top seal 932a can be arranged to seal the sharp hub 720 and the electronics housing 704 (ie, Figure 8 The top seal 932a forms an interface between the sharpened hub 720 and the top surface of the housing 906, thereby preventing contaminants from migrating into the interior of the electronics housing 704. In some embodiments, the top seal 932a can form a portion of the sharpened hub 720, for example, be overmolded onto the sharpened hub 720. However, in other embodiments, the top seal 932a can form a portion of the housing 706 or be overmolded onto the top surface of the housing 706. In other embodiments, the top seal 932a can include a separate structure, such as an O-ring or the like, interposed between the sharpened hub 720 and the top surface of the housing 706 without departing from the scope of the present disclosure.

[0152] The bottom seal 932b may be arranged to seal the cover filler 910 and the electronics housing (ie, Figure 7 708). The bottom seal 932b can prevent contaminants from migrating into the sterilization zone 924 and the interior of the electronics housing 704. In some embodiments, the bottom seal 932b can form a portion of the lid filler 910, e.g., be overmolded on top of the lid filler 910. In other embodiments, the bottom seal 932b can form a portion of the bottom of the base 708 or be overmolded on the bottom of the base 708. In other embodiments, the bottom seal 932b can include a separate structure, e.g., an O-ring or the like, interposed between the lid filler 910 and the bottom of the base 708 without departing from the scope of this disclosure.

[0153] When 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 seal 932a and the bottom seal 932b can be compressed and create a corresponding sealing interface. The top seal 932a and the bottom seal 932b can be made of various materials that can create a sealing interface between opposing structures. Suitable materials include, but are not limited to, silicone, thermoplastic elastomers (TPE), polytetrafluoroethylene (e.g., ) or any combination thereof.

[0154] Note that while the sensor 716 and sharp 718 extend from the bottom of the electronics housing 704 and into the sterile zone 924, generally concentric with the centerline of the sensor applicator 102 and the applicator cap 904, an eccentric arrangement is contemplated herein. More specifically, in at least one embodiment, the sensor 716 and sharp 718 can extend from the bottom of the electronics housing 704 eccentrically with respect to the centerline of the sensor applicator 102 and the applicator cap 904. In such an embodiment, the outer collimator 918 and the inner collimator 920 can be redesigned and otherwise configured so that the sterile zone 924 is also positioned eccentrically to accommodate the sensor 716 and sharp 718 without departing from the scope of the present disclosure.

[0155] In some embodiments, the external sterilization assembly 914 can further include a sterilization housing or "pod" 934 coupled to or forming a portion of the radiation shield 916. The sterilization pod 934 provides and otherwise defines a chamber 936 sized to accommodate all or a portion of the sensor applicator 102. Once properly positioned (housed) within the sterilization pod 934, the sensor applicator 102 can be subjected to radiation sterilization 912 to sterilize the sensor 716 and sharps 718. The sterilization pod 934 can be made of any of the materials mentioned herein for the radiation shield 916 to help prevent radiation 912 from propagating through the walls of the sterilization pod 934.

[0156] In some embodiments, the radiation shield 916 can be removably coupled to the sterilization chamber 934 using one or more mechanical fasteners 938 (one shown), but can alternatively be removably coupled via an interference fit, a snap-fit ​​engagement, etc. Removably coupling the radiation shield 916 to the sterilization chamber 934 enables the radiation shield 916 to be interchangeable with shields of different designs (sizes) to accommodate specific sterilization applications of different types and designs of sensor applicators 102. Thus, the sterilization chamber 934 can include a universal base that allows the radiation shield 916 to be interchanged with other shield designs having different parameters for the external collimator 918, as needed.

[0157] In some embodiments, the external sterilization assembly 914 can further include a base tray 940 coupled to or forming a portion of the sterilization chamber 934. The sterilization chamber 934 can be removably coupled to the base tray 940 using, for example, one or more mechanical fasteners 942 (one shown). The base tray 940 can provide or define a central aperture 944 that is sized to accommodate the sensor applicator 102 and can be aligned with the cavity 936 to enable the sensor applicator 102 to enter the cavity 936. As described below, in some embodiments, the base tray 940 can define a plurality of central apertures 944 for accommodating a corresponding plurality of sensor applicators for sterilization.

[0158] Figure 10A and Figure 10B Figures 10 and 10 are isometric and side views, respectively, of an example sensor control device 1002 according to one or more embodiments of the present disclosure. The sensor control device 1002 (also referred to as a "puck") is similar in some respects to the Figure 1 The sensor control device 1002 may be substituted for the sensor control device 104. Figure 1 The sensor control device 104 can therefore be used with the sensor applicator 102 ( Figure 1 ) in conjunction with the sensor applicator 102, the sensor control device 1002 is delivered to the target monitoring location on the user's skin.

[0159] However, with Figure 1 Compared to the sensor control device 104 of FIG. 1 , the sensor control device 1002 can be incorporated into a single-piece system architecture. Unlike a two-piece architecture, for example, the user does not need to open multiple packaging pieces and finally assemble the sensor control device 1002. Instead, the sensor control device 1002 is already fully assembled and properly positioned within the sensor applicator 102 when the user receives it. Figure 1 To use the sensor control device 1002, the user need only open a barrier (eg, an applicator cap) and then quickly deliver the sensor control device 1002 to the target monitoring location.

[0160] As shown, the sensor control device 1002 includes an electronics housing 1004 that is generally disc-shaped and may have a circular cross-section. However, in other embodiments, the electronics housing 1004 may have other cross-sectional shapes, such as an oval or polygonal shape, without departing from the scope of the present disclosure. The electronics housing 1004 may be configured to house or otherwise contain various electronic components used to operate the sensor control device 1002.

[0161] Electronics housing 1004 may include a housing 1006 and a base 1008 that mates with housing 1006. Housing 1006 may be secured to base 1008 in a variety of ways, such as a snap-fit ​​connection, an interference fit, sonic welding, or one or more mechanical fasteners (e.g., screws). In some cases, housing 1006 may be secured to base 1008 so as to create a sealed interface therebetween. In such embodiments, a gasket or other type of sealing material may be positioned at or near the outer diameter (periphery) of housing 1006 and base 1008, 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 housing 1006 and base 1008. The adhesive secures housing 1006 to base 1008 and provides structural integrity, but may also seal the interface between the two components, thereby isolating the interior of electronics housing 1004 from external contaminants. If sensor control device 1002 is assembled in a controlled environment, terminal sterilization of the internal electrical components is not required. In contrast, the adhesive coupling may provide an adequate sterile barrier for the assembled electronics housing 1004 .

[0162] The sensor control device 1002 may also include a plug assembly 1010 that may be coupled to the electronics housing 1004. The plug assembly 1010 is similar to the plug assembly in some respects. For example, the plug assembly 1010 may include a sensor module 1012 (partially visible) that may be interconnected with a sharp module 1014 (partially visible). The sensor module 1012 may be configured to carry or otherwise include a sensor 2616 (partially visible), and the sharp module 1014 may be configured to carry or otherwise include a sharp body 1018 (partially visible) that is used to help deliver the sensor 1016 transcutaneously to the user's skin during application of the sensor control device 1002. As shown, the corresponding portions of the sensor 1016 and the sharp body 1018 extend from the electronics housing 1004, more specifically, from the bottom of the base 1008. The exposed portion of the sensor 1016 may be housed within a hollow or recessed portion of the sharp body 1018. The remainder of sensor 1016 is located inside electronics housing 1004 .

[0163] As discussed in more detail below, the sensor control device 1002 may also include a sensor preservation bottle 1020 that provides a preservation barrier that surrounds and protects the sensor 1016 and exposed portions of the sharp body 1018 from gaseous chemical sterilization.

[0164] Figure 11A and Figure 11BFigures 10 and 10 are an isometric view and an exploded view, respectively, of a plug assembly 1110 according to one or more embodiments. The sensor module 1012 may include a sensor 1116, a plug, and a connector. The plug may be designed to accommodate and support the sensor 1116 and the connector 1104. As shown, a channel may be defined through the plug to accommodate a portion of the sensor 1116. Furthermore, the plug may include one or more deflectable arms configured to snap into corresponding features provided on the bottom of the electronics housing 1004.

[0165] Sensor 1116 includes a tail portion 1108, a flag portion 1110, and a neck portion 1112 interconnecting tail portion 1108 and flag portion 1110. Tail portion 1108 can be configured to extend at least partially through channel 1106 and extend distally from plug 1102. Tail portion 1108 includes an enzyme or other chemical or biological substance, and in some embodiments, a membrane can cover the chemical substance. In use, tail portion 1108 is transcutaneously received beneath the user's skin, and the chemical substance contained thereon helps facilitate analyte monitoring in the presence of bodily fluids.

[0166] The flag portion 1110 may include one or more sensor contacts 114 ( Figure 11B The sensor contacts 114 may be configured to align with a corresponding number of compliant carbon-impregnated polymer modules (shown at 1120 on the top thereof) encapsulated within the connector 1104.

[0167] The connector 1104 includes one or more hinges 1118 that enable the connector 1104 to move between an open state and a closed state. Figure 11A and Figure 11B 1004. The compliant carbon-impregnated polymer module 1100 is depicted in a closed position, but can be pivoted to an open position to accommodate the flag 1110 and the compliant carbon-impregnated polymer module therein. The compliant carbon-impregnated polymer module provides electrical contacts 1120 (three shown) configured to provide conductive communication between the sensor 1016 and corresponding circuit contacts disposed within the electronics housing 1004. Figure 10A and Figure 10B ). The connector 1104 can be made of silicone rubber and can serve as a moisture barrier for the sensor 1016 when assembled in a compressed state and after being applied to the user's skin.

[0168] The sharp module 1014 includes a sharp body 1018 and a sharp hub 1122 that carries the sharp body 1018. The sharp body 1018 includes an elongated shaft 1124 and a tip 1126 located at the distal end of the shaft 1124. The shaft 1124 can be configured to extend through the channel 1106 and extend distally from the plug 1102. In addition, the shaft 1124 can include a hollow or grooved portion 1128 that at least partially surrounds the tail 1108 of the sensor 1016. The tip 1126 can be configured to penetrate the skin while carrying the tail 1108 so that the active chemical present on the tail 1108 contacts the body fluid.

[0169] The sharpened hub 1122 may include a hub cylinder 2730 and a hub snap pawl 2732, each of which may be configured to assist in coupling the plug assembly 2610 (and the entire sensor control device 2602) to the sensor applicator 102 ( Figure 1 ).

[0170] Specific reference Figure 11B , the preservation bottle 1020 may include a generally cylindrical, elongated body 1134 having a first end 1136a and a second end 1136b opposite the first end 1136a. The first end 1136a may be open to provide access to an interior cavity 1138 defined within the body 1134. In contrast, the second end 1136b may be closed and may provide or otherwise define an enlarged head 1140. The enlarged head 1140 may have an outer diameter that is greater than the outer diameter of the remainder of the body 1134. However, in other embodiments, the enlarged head 1140 may be located intermediate between the first end 1136a and the second end 1136b.

[0171] Figure 11C 1 is an exploded isometric bottom view of plug 1102 and vial 1020. As shown, plug 1102 can define a bore 1142 configured to receive vial 1020, and more specifically, first end 1136a of body 1134. Channel 1106 can terminate in bore 1142 such that, when vial 1020 is coupled to plug 1102, components extending outwardly and distally from channel 1106 are received within lumen 1138.

[0172] The preservation bottle 1020 can be removably coupled to the plug 1102 at the hole 1142. For example, in some embodiments, the preservation bottle 1020 can be received in the hole 1142 via an interference fit or a friction fit. In other embodiments, the preservation bottle 1020 can be secured within the hole 1142 with a frangible member (e.g., a tear ring) or a substance that can be broken with minimal separation force. In such embodiments, for example, the preservation bottle 1020 can be secured within the hole 1142 with a label (dot) of glue, a small amount of wax, or the preservation bottle 1020 can include easily peelable glue. As described below, after the sensor control device 1002 ( Figure 10A and Figure 10B ) before delivery to the target monitoring location on the user's skin, the preservation bottle 1020 can be separated from the plug 1102.

[0173] Reference again Figure 11A and Figure 11B , the lumen 1138 can be sized and otherwise configured to accommodate the tail 1108, the distal portion of the shaft 1124, and the tip 1126, collectively referred to as the "distal portions of both the sensor 1016 and the sharp body 1018." The lumen 1138 can be sealed or otherwise isolated to prevent substances that could adversely interact with the chemistry of the sensor 1016 from migrating into the lumen 1138. More specifically, the lumen 1128 can be sealed to protect or isolate the distal portions of both the sensor 1016 and the sharp body 1018 during gas chemical sterilization processes, as the gases used during gas chemical sterilization processes can adversely affect the enzymes disposed on the tail 1108 (and other sensor components, e.g., membrane coatings that regulate analyte influx).

[0174] In some embodiments, seal 1144 ( Figure 11B ) can provide a sealing barrier between the inner cavity 1138 and the external environment. In at least one embodiment, the seal 1144 can be disposed within the inner cavity 1138, but can alternatively be positioned on the exterior of the body 1134 without departing from the scope of the present disclosure. The distal portions of the sensor 1016 and the sharp body 1018 can penetrate the seal 1144 and extend into the inner cavity 1138, but the seal 1144 can maintain a sealed interface around the distal portions of the sensor 1016 and the sharp body 1018 to prevent contaminants from migrating into the inner cavity 1138. The seal 1144 can be made of, for example, a flexible elastomer or wax.

[0175] In other embodiments (or in addition to seal 1144), the sensor retaining fluid 1146 ( Figure 11B) can be present in lumen 1138, and the sensor 1016 and distal portion of the sharp body 1018 can be immersed in or otherwise encapsulated by a preservation fluid 1146. The preservation fluid 1146 can create a sealed interface that prevents the sterilizing gas from interacting with the enzyme provided on the tail 1108.

[0176] The plug assembly 1010 can be subjected to radiation sterilization to appropriately sterilize the sensor 1016 and the sharp body 1018. 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 preservation bottle 1020 is coupled to the plug 1102. However, in other embodiments, the plug assembly 1010 can be sterilized after the preservation bottle 1020 is coupled to the plug 1102. In such embodiments, the body 1134 of the preservation bottle 1020 and the preservation fluid 1146 can include materials and / or substances that allow radiation to propagate therethrough to facilitate radiation sterilization of the distal portion of the sensor 1016 and the sharp body 1018.

[0177] Suitable materials for the body 1134 include, but are not limited to, non-magnetic metals (e.g., aluminum, copper, gold, silver, etc.), thermoplastics, ceramics, rubbers (e.g., hard rubber), composite materials (e.g., fiberglass, carbon fiber reinforced polymer, etc.), epoxy resins, or any combination thereof. In some embodiments, the material of the body 1134 can be transparent or translucent, but can also be opaque without departing from the scope of the present disclosure.

[0178] Preservation fluid 1146 can comprise any inert and biocompatible fluid (that is, liquid, gas, gel, wax or its any combination) that can encapsulate sensor 1016 and the distal portion of sharp body 1018. In some embodiments, preservation fluid 1146 can also allow radiation to propagate through. Preservation fluid 1146 can comprise fluid that is insoluble in the chemical substances involved in gaseous chemical sterilization. Suitable examples of preservation fluid 1146 include but are not limited to silicone oil, mineral oil, gel (for example, vaseline), wax, fresh water, saline, synthetic fluid, glycerol, dehydrated sorbitol ester or its any combination. As will be understood, gel and more viscous fluid can be preferred so that preservation fluid 1146 is not easy to flow.

[0179] In some embodiments, the preservation fluid 1146 can include an anti-inflammatory agent, such as nitric oxide or other known anti-inflammatory agents. Anti-inflammatory agents can be advantageous in minimizing local inflammatory reactions caused by the sharp body 1018 and sensor 1016 penetrating the user's skin. Inflammation has been observed to affect the accuracy of blood glucose readings, and the inclusion of an anti-inflammatory agent can accelerate the healing process, which can result in obtaining accurate readings more quickly.

[0180] Figure 12A and Figure 12B 1004 according to one or more embodiments. The housing 1006 and base 1008 operate as opposing flip-top halves that enclose or otherwise substantially enclose the various electronic components of the sensor control device 1002 ( Figure 10A and Figure 10B ).

[0181] A printed circuit board (PCB) 1202 may be located within the electronics housing 1004. A plurality of electronic modules (not shown) may be mounted to the PCB 1202, 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 implement 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, wherein such functions may include, but are not limited to, filtering and encoding of data signals, each data signal corresponding to a sampled analyte level of a user. The data processing unit may also include a processor for communicating with the reader device 106 ( Figure 1 ) communicating with the antenna, or otherwise communicating with the antenna.

[0182] As shown, the housing 1006, base 1008, and PCB 1202 each define corresponding central holes 1204, 1206, and 1208. When the electronic housing 1204 is assembled, the central holes 1204, 1206, and 1208 are coaxially aligned to accommodate the plug assembly 1010 ( Figure 11A and Figure 11B A battery 1210 may also be housed within the electronics housing 1004 and configured to provide power to the sensor control device 1002 .

[0183] exist Figure 12B In the embodiment, the socket 1212 can be defined at the bottom of the base 1208 and the plug assembly 1010 ( Figure 10A and Figure 10B ) can be received and coupled to the electronics housing 1004, thereby fully assembling the sensor control device 1002. Figures 11A-11C) can be contoured to match or be shaped in a complementary manner to the receptacle 1212, and the receptacle 1212 can provide one or more snap flanges 1214 (two shown) configured to engage the deflectable arms 1107 ( Figure 11A and Figure 11B ) mates with and receives the deflectable arm 1107. The plug assembly 1010 is coupled to the electronics housing 1004 by pushing the plug 1102 into the receptacle 1212 and allowing the deflectable arm 1107 to lock into the corresponding snap flange 1214. When the plug assembly 1010 is properly coupled to the electronics housing 1004, one or more circuit contacts 1216 (three are shown) defined on the underside of the PCB 1202 can engage the connector 1104 ( Figure 11A and Figure 11B ) of the electrical contacts 1120 ( Figure 11A and Figure 11B ) for conductive communication.

[0184] Figure 13A and Figure 13B 1 and 2 are side views and cross-sectional side views, respectively, of an exemplary embodiment of a sensor applicator 102 coupled with an applicator cap. More specifically, Figure 13A and Figure 13B Depicts the manner in which the sensor applicator 102 may be shipped to and received by a user. Figure 13B As shown, the sensor control device 1002 is assembled and installed within the sensor applicator 102 before being shipped to the user.

[0185] As described above, before the plug assembly 1010 is coupled to the electronics housing 1004, the plug assembly 1010 can be subjected to radiation sterilization to sterilize the distal portions of both the sensor 1016 and the sharp body 1018. Once properly sterilized, the plug assembly 1010 can then be coupled to the electronics housing 1004, as generally described above, and thereby form a fully assembled sensor control device 1002. The sensor control device 1002 can then be loaded into the sensor applicator 102, and the applicator cap can be coupled to the sensor applicator 102. The applicator cap can be screwed to the housing and include an anti-theft ring. When the applicator cap is rotated (e.g., unscrewed) relative to the housing, the anti-theft ring can be torn, thereby releasing the applicator cap from the sensor applicator 102.

[0186] According to the present disclosure, when loaded in the sensor applicator 102, the sensor control device 1002 can be subjected to gaseous chemical sterilization that is configured to sterilize the electronics housing 1004 and any other exposed portions of the sensor control device 1002. To accomplish this, chemicals can be injected into a sterilization chamber 1306 defined by the sensor applicator 102 and the interconnect cover 210. In some applications, the chemicals can be injected into the sterilization chamber 1306 through one or more vents 1308 defined in the applicator cover at its proximal end 1310. Example chemicals that can be used for gaseous chemical sterilization 1304 include, but are not limited to, ethylene oxide, vaporized hydrogen peroxide, and nitrogen oxides (e.g., nitrous oxide, nitrogen dioxide, etc.).

[0187] Because the distal portions of both the sensor 1016 and the sharp body 1018 are sealed within the preservation bottle 1020, the chemicals used in the gaseous chemical sterilization process will not interact with the enzymes, chemicals, or biological substances provided on the tail 1108.

[0188] Once the desired sterility assurance level is achieved within the sterilization chamber 1306, the gaseous solution is removed and the sterilization chamber 1306 is vented. Ventilation may be achieved by a series of vacuum and then circulating nitrogen or filtered air through the sterilization chamber 1306. Once the sterilization chamber 1306 is properly vented, the vent 1308 may be closed with a seal 1312 (shown in phantom).

[0189] In some embodiments, the seal 1312 may include two or more layers of different materials. The first layer may be made of a synthetic material (e.g., flash spun high-density polyethylene fiber), such as Obtained Very durable, puncture-resistant, and steam-permeable. Can be applied prior to gaseous chemical sterilization processes layer, and after the gaseous chemical sterilization process, can be The sterilization chamber 1306 is sealed (e.g., heat sealed) with a foil or other vapor- and moisture-resistant material layer to prevent contaminants and moisture from entering the sterilization chamber 1306. In other embodiments, the seal 1312 may comprise only a single protective layer applied to the applicator cap. In such embodiments, the single layer is gas permeable for the sterilization process, but also provides protection against moisture and other harmful elements once the sterilization process is complete.

[0190] With the seal 1312 in place, the applicator cap provides a barrier to external contamination, thereby maintaining a sterile environment for the assembled sensor control device 1002 until the user removes (unscrews) the applicator cap. The applicator cap also creates a dust-free environment during shipping and storage, preventing the adhesive patch 1314 used to secure the sensor control device 1002 to the user's skin from becoming dirty.

[0191] Figure 14 1 is a perspective view of an exemplary embodiment of an applicator cap according to the present disclosure. As shown, the applicator cap has a generally circular cross-section and defines a series of threads for coupling the applicator cap to the sensor applicator 102. Ventilation holes 1308 can also be seen at the bottom of the applicator cap.

[0192] The applicator cap may also provide or otherwise define a cap post 1404 that is centrally located within the applicator cap and extends proximally from its bottom. The cap post 1404 can be configured to help support the sensor control device 1002 when contained within the sensor applicator 102. Additionally, the cap post 1404 can define an opening 1406 that is configured to accommodate the preservation bottle 1020 when the applicator cap 210 is coupled to the sensor applicator 102.

[0193] In some embodiments, the opening 1406 of the cap post 1404 can include one or more compliant features 1408 that are expandable or flexible to allow passage of the vial 1020 therethrough. For example, in some embodiments, the compliant feature 1408 can include a collet-type device comprising a plurality of compliant fingers configured to flex radially outward to accommodate the vial 1020. However, in other embodiments, the compliant feature 1408 can include an elastomer or other type of compliant material configured to expand radially to accommodate the vial 1020.

[0194] Figure 15 1 is a cross-sectional side view of the sensor control device 1002 positioned within the applicator cap according to one or more embodiments. As shown, the cap post 1404 defines a column chamber 1502 that is configured to accommodate a preservation bottle 1020. An opening 1406 of the cap post 1404 provides access to the column chamber 1502 and has a first diameter D1. In contrast, the enlarged head 1140 of the preservation bottle 1020 has a second diameter D2 that is greater than the first diameter D1 and greater than the outer diameter of the remainder of the preservation bottle 1020. Thus, when the preservation bottle 2620 is extended into the column chamber 1502, the compliant feature 1408 of the opening 1406 can flex (expand) radially outward to accommodate the enlarged head 1140.

[0195] In some embodiments, the enlarged head 1140 can provide or otherwise define an angled outer surface that helps bias the compliance feature 1408 radially outward. However, the enlarged head 1140 can also define an upper shoulder 1504 that prevents the vial 1020 from backing out of the column chamber 1502. More specifically, the shoulder 1504 can include a sharp surface at the second diameter D2 that will engage but not cause the compliance feature 1408 to flex radially outward in the opposite direction.

[0196] Once the enlarged head 1140 passes through the opening 1406, the compliance feature 1408 bends back to (or toward) its natural state. In some embodiments, the compliance feature 1408 can engage the outer surface of the preservation bottle 1020, but still allow the applicator cap 210 to rotate relative to the preservation bottle 1020. Thus, when the user removes the applicator cap by rotating it relative to the sensor applicator 102, the preservation bottle 1020 can remain fixed relative to the cap post 1404.

[0197] When the applicator cap is removed from the sensor applicator 102 and the sensor control device 1002 is thereby separated from the applicator cap, the shoulder 1504 defined on the enlarged head 1140 will engage the compliance 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 abut the compliance feature 1408, thereby separating the preservation bottle 1020 from the sensor control device 1002, exposing the distal end portion of the sensor 1016 and the sharp body 1018. Therefore, when the applicator cap is separated from the sensor applicator 102 and the sensor control device 1002, the compliance feature 1408 can prevent the enlarged head 1140 from exiting the column chamber 1502 through the opening 1406. The separated preservation bottle 1020 will fall into and be retained within the column chamber 1502.

[0198] In some embodiments, instead of the opening 1406 including the compliance feature 1408, as generally described above, the opening 1406 may alternatively be threaded. In such embodiments, a small portion near the distal end of the preservation bottle 1020 may also be threaded and configured to threadably engage the threads of the opening 1406. The preservation bottle 1020 can be rotated and accommodated within the column chamber 1502 via the threads. However, when the applicator cap is removed from the sensor applicator 102, the opening 1406 and the opposing threads on the preservation bottle 1020 engage, and the preservation bottle 1020 can be separated from the sensor control device 1002.

[0199] Therefore, incorporating the sensor control device 1002 into an analyte monitoring system (e.g., Figure 1The analyte monitoring system 100 of the present invention has several advantages. Because the sensor control device 1002 is ultimately assembled in a controlled environment, tolerances can be reduced or eliminated entirely, allowing the sensor control device 1002 to be thin and small. Furthermore, because the sensor control device 1002 is ultimately assembled in a controlled environment, the sensor control device 1002 can be fully pre-tested at the factory, thereby fully testing the sensor unit before packaging for final delivery.

[0200] Figure 16A and Figure 16B Figures 16 and 16 are isometric and side views, respectively, of an example sensor control device 1602 according to one or more embodiments of the present disclosure. The sensor control device 1602 (also referred to as a "puck") is similar in some respects to the Figure 1 The sensor control device 104 of FIG. 104 is thus better understood with reference to the sensor control device. In some applications, the sensor control device 1602 may replace the sensor control device 104 of FIG. Figure 1 The sensor control device 104 can therefore be used with the sensor applicator 102 ( Figure 1 ) in conjunction with the sensor applicator 102, the sensor control device 1602 is delivered to the target monitoring location on the user's skin.

[0201] However, with Figure 1 Compared to the sensor control device 104 of FIG. 1 , the sensor control device 1602 can be incorporated into a single-piece system architecture. Unlike a two-piece architecture, for example, the user does not need to open multiple packaging pieces and finally assemble the sensor control device 1602 before use. Instead, the sensor control device 1602 is already fully assembled and properly positioned within the sensor applicator 102 when the user receives it. Figure 1 To use the sensor control device 1602, the user need only open a barrier (e.g., remove the applicator cap) and then quickly deliver the sensor control device 1602 to the target monitoring location.

[0202] As shown, sensor control device 1602 includes an electronics housing 1604 that is generally disc-shaped and may have a circular cross-section. However, in other embodiments, electronics housing 1604 may have other cross-sectional shapes, such as oval or polygonal, without departing from the scope of this disclosure. Electronics housing 1604 may be configured to house or otherwise contain various electronic components used to operate sensor control device 1602.

[0203] The electronic housing 1604 can include a housing 1606 and a base 1608 that can be mated with the housing 1606. The housing 1606 can be secured to the base 1608 in a variety of ways, such as a snap-fit ​​connection, 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 housing 1606 and the base 1608 can be sealed. In such embodiments, a gasket or other type of sealing material can be positioned or applied at or near the outer diameter (periphery) of the housing 1606 and the base 1608. Securing the housing 1606 to the base 1608 compresses the sealing material, thereby creating a sealed interface. In at least one embodiment, an adhesive can be applied to the outer diameter (periphery) of one or both of the housing 1606 and the base 1608, and the adhesive can not only secure the housing 1606 to the base 1608, but also seal the interface.

[0204] In embodiments where a sealed interface is formed between the housing 1606 and the base 1608, the interior of the electronics housing 1604 can be effectively isolated from external contamination between the two components. In such embodiments, if the sensor control device 1602 is assembled in a controlled and sterile environment, it is not necessary to sterilize the internal electrical components (e.g., by gaseous chemical sterilization). Instead, the sealed joint can provide an adequate sterile barrier for the assembled electronics housing 1604.

[0205] The sensor control device 1602 may also include a sensor module 1610 (in Figure 16B The sensor module 1610 and the sharp module 1612 can be interconnected and coupled to the electronics housing 1604. The sensor module 1610 can be configured to carry or otherwise include a sensor 1614 ( Figure 16B ), and the sharp module 1612 can be configured to carry or otherwise include a sharp body 1616 ( Figure 16B ) is used to help deliver the sensor 1614 transcutaneously beneath the user's skin during the application of the sensor control device 1602.

[0206] like Figure 16B As shown, sensor 1614 and corresponding portions of sharp body 1616 extend from electronics housing 1604, and more specifically, from the bottom of base 1608. The exposed portion of sensor 1614 can be received within a hollow or recessed portion of sharp body 1616. The remainder of sensor 1614 is located within the interior of electronics housing 1604.

[0207] Adhesive patch 1618 may be positioned on or otherwise attached to the underside of base 1608. Figure 116. The adhesive patch 1618 can be configured to secure and maintain the sensor control device 1602 in place on the user's skin during operation. In some embodiments, a transfer adhesive 1620 can be interposed between the adhesive patch 1618 and the bottom of the base 1608. The transfer adhesive 1620 can help facilitate the assembly process of the sensor control device 1602.

[0208] Figure 17A and Figure 17B 1602 , according to one or more embodiments. As shown, housing 1606 and base 1608 of electronics housing 1604 operate as opposing flip-top halves that enclose or otherwise generally enclose the various electronic components of sensor control device 1602.

[0209] Printed circuit board (PCB) 1702 may be located within electronics housing 1604. Figure 17B As shown, a plurality of electronic modules 1704 may be mounted to the underside of the PCB 1702. Example electronic modules 1704 include, but are not limited to, resistors, transistors, capacitors, inductors, diodes, and switches. Figure 17B ) may also be mounted to the PCB 1702 and may include, for example, an application specific integrated circuit (ASIC) configured to implement one or more functions or routines associated with the operation of the sensor control device 1602. More specifically, the data processing unit 1706 may be configured to perform data processing functions, such as filtering and encoding of data signals, each data signal corresponding to a user's sampled analyte level. The data processing unit 1706 may also include a processor for communicating with the reader device 106 ( Figure 1 ) communicating with the antenna, or otherwise communicating with the antenna.

[0210] As shown, the housing 1606, base 1608, and PCB 1702 each define corresponding central apertures 1708a, 1708b, 1708c. When the sensor control device 1602 is assembled, the central apertures 1708a-1708c are coaxially aligned to accommodate portions of the sensor module 1610 and the sharp module 1612 therethrough.

[0211] A battery 1710 and corresponding battery holder 1712 may also be housed within electronics housing 1604. Battery 1710 may be configured to power sensor control device 1602.

[0212] The sensor module 1610 may include a sensor 1614 and a connector 1714. The sensor 1614 includes 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 hole 1708b defined in the base 1608 and extend distally from its underside. The tail 1716 may include an enzyme or other chemical or biological substance, and in some embodiments, a membrane may cover the chemical substance. In use, the tail 1716 is transcutaneously received beneath the user's skin, and the chemical substance contained thereon helps facilitate analyte monitoring in the presence of bodily fluids.

[0213] The flag portion 1718 may include one or more sensor contacts 1722 ( Figure 17A Flags 1718 may be configured to be received within connector 1714 with sensor contacts 1722 aligned with a corresponding number of compliant carbon-impregnated polymer modules (not shown) encapsulated within connector 1714.

[0214] The connector 1714 includes one or more hinges 1724 that enable the connector 1714 to pivot between an open position and a closed position. Figure 17A and Figure 17B The compliant carbon-impregnated polymer module 1726 is provided with electrical contacts 1726. Figure 17A 17), the electrical contacts are 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 are in conductive communication with the electrical contacts 1726 of the connector 1714. The connector 1714 can be made of silicone rubber and can serve as a moisture barrier for the sensor 1614.

[0215] The sharp module 1612 includes a sharp body 1616 and a sharp hub 1730 that carries the sharp body 1616. The sharp body 1616 includes an elongated shaft 1732 and a tip 1734 located at the distal end of the shaft 1732. The shaft 1732 can be configured to extend through each of the coaxially aligned central holes 1708a-1708c and extend distally from the bottom of the base 1608.

[0216] Additionally, shaft 1732 can include a hollow or recessed portion 1736 that at least partially surrounds tail 1716 of sensor 1614. Tip 1734 can be configured to penetrate the skin while carrying tail 1716 to contact the active chemical of tail 1716 with bodily fluids.

[0217] The sharpened hub 1730 may include a hub cylinder 1738 and a hub snap claw 1740, each of which may be configured to assist in coupling the sensor control device 1602 to the sensor applicator 102 ( Figure 1 ).

[0218] Specific reference Figure 17A In some embodiments, the sensor module 1610 can be at least partially housed within a sensor base recess 1742 included within the electronics housing 1604. In some embodiments, the sensor base recess 1742 can comprise a separate structure, but can alternatively form an integral part or extension of the base 1608. The sensor base recess 1742 can be shaped or otherwise configured to receive and house the sensor 1614 and the connector 1714. As shown, the sensor base recess 1742 defines a periphery 1744 that generally surrounds the area in which the sensor 1614 and the connector 1714 will be housed. In at least one embodiment, when the electronics housing 1604 is fully assembled, the periphery 1744 can be sealed to the underside of the PCB 1702. In such embodiments, a gasket (e.g., an O-ring, etc.), adhesive, or other type of sealing material can be applied (disposed) at the periphery 1744 and can operate to seal the interface between the sensor base recess and the PCB 1702.

[0219] Sealing the interface between sensor base pocket 1742 and the underside of PCB 1702 can help create or define a sealed region or area within electronics housing 1604. The sealed area can be advantageous in helping to isolate (protect) tail portion 1716 of sensor 1614 from potentially harmful sterilizing gases used during gaseous chemical sterilization.

[0220] Specific reference Figure 17B , a plurality of channels or grooves 1746 may be provided or otherwise defined in the bottom of the base 1608. As shown, the grooves 1746 may be combined with the plurality of radially extending channels to form a plurality of concentric rings. Figure 16A and Figure 16B ) can be attached to the underside of the base 1608, and in some embodiments, the transfer adhesive 1620 ( Figure 16A and Figure 16B ) can be between adhesive patch 1618 and the bottom of base 1608. Groove 1746 can be useful in promoting moisture drainage from the center of electronics housing 1604 below adhesive patch 1618.

[0221] In some embodiments, a cap post sealing interface 1748 can be defined on the bottom of the base 1608 at the center of the base 1608. As shown, the cap post sealing interface 1748 can include a generally flat portion of the bottom of the base 1608. A second central aperture 1708b is defined in the center of the cap post sealing interface 1748, and a 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 portion 1716 of the sensor 1614 from potentially harmful sterilizing gases used during gaseous chemical sterilization.

[0222] 18A to 18C Figures 1 and 2 are isometric, side, and bottom views, respectively, of an example sensor control device 1802 according to one or more embodiments of the present disclosure. The sensor control device 1802 (also referred to as an on-body patch or unit) is similar in some respects to the Figure 1 The sensor control device 104 of FIG. 1802 can be replaced by the sensor control device 104 of FIG. 1802 . Figure 1 The sensor control device 104 can therefore be used with the sensor applicator 102 ( Figure 1 ) is used in conjunction with the sensor applicator 102 to deliver the sensor control device 1802 to the target monitoring location on the user's skin. However, Figure 1 Various structural advantages and improvements compared to the sensor control device 104 allow the sensor control device 1802 to be incorporated into a single-piece system architecture.

[0223] and Figure 1 Unlike the sensor control device 104, for example, the user does not need to open multiple packaging pieces and ultimately assemble the sensor control device 1802 before delivering it to the target monitoring site. Instead, the sensor control device 1802 can be already assembled and properly positioned within the sensor applicator 102 when the user receives it. To use the sensor control device 1802, the user only needs to break a barrier (e.g., the applicator cover) and then quickly deliver the sensor control device 1802 to the target monitoring site.

[0224] First reference Figure 18A , the sensor control device 1802 includes an electronics housing 1804 that is generally disc-shaped and may have a generally circular cross-section. However, in other embodiments, the electronics housing 1804 may have other cross-sectional shapes, for example, oval or polygonal, without departing from the scope of the present disclosure. The electronics housing 1804 may include a housing 1806 and a base 1808 that may mate with the housing 1806. An adhesive patch 1810 may be positioned on or otherwise attached to the underside of the base 1808. Similar to Figure 1Adhesive patch 108, adhesive patch 1810 can be configured to secure and maintain the sensor control device 1802 in place on the user's skin during operation.

[0225] In some embodiments, housing 1806 can define a reference feature 1812. As shown, reference feature 1812 can include a recess or blind pocket defined in housing 1806 and extend a short distance into the interior of electronics housing 3704. Reference feature 1812 can serve as a "datum c" feature configured to help facilitate control of sensor control device 1802 in at least one degree of freedom during factory assembly. In contrast, existing sensor control devices (e.g., Figure 1 The sensor control device 104 of the embodiment of the present invention generally includes a protrusion extending radially from the side of the housing. The protrusion is used as a timing reference during the process, but must be removed at the end of manufacturing and the housing where the protrusion was once inspected must be removed, which increases the complexity of the previous manufacturing process.

[0226] The housing 1806 may also define a central aperture 1814 sized to receive a spike (not shown) that may extend through the center of the electronics housing 1804 .

[0227] Figure 18B A portion of sensor 1816 is depicted extending from electronics housing 1804. The remainder of sensor 1816 is located inside electronics housing 1804. Figure 1 In the sensor 110, the exposed portion of the sensor 1816 is configured to be transcutaneously positioned beneath the user's skin during use. The exposed portion of the sensor 1816 may include an enzyme or other chemical or biological substance, and in some embodiments, the membrane may cover the chemical.

[0228] The sensor control device 1802 provides a structural improvement such that the height H and diameter D can be smaller than existing sensor control devices (e.g., Figure 1 For example, in at least one embodiment, the height H can be approximately 1 mm or more smaller than the height of existing sensor control devices, and the diameter D can be approximately 2 mm or more smaller than the diameter of existing sensor control devices. In some other embodiments, the height H and the diameter D can be any other suitable values, such as 1 mm to 5 mm or 0.1 mm to 10 mm smaller than the height or diameter of existing sensor devices.

[0229] Furthermore, the structural improvements to the sensor control device 1802 allow the housing 1806 to provide or otherwise define a chamfered or angled periphery 1818. In contrast, existing sensor control devices typically require a rounded or outwardly curved periphery to accommodate internal components. The reduced height H, reduced diameter D, and angled periphery 1818 can all contribute to providing a thinner, smaller sensor control device 1802 that is less prone to premature detachment from a user's skin due to snagging on sharp corners, etc.

[0230] Figure 18C A central hole 1820 is depicted defined on the underside of the base 1808. The central hole 1820 can be sized to accommodate a combined sharp body (not shown) and sensor 1816, wherein the sensor 1816 is housed within a hollow or recessed portion of the sharp body. When the electronics housing 1804 is assembled, the central hole 1820 is aligned with the housing 1806 ( Figure 18A ) center hole 1814( Figure 18A ) are coaxially aligned and the sharp body penetrates the electronic housing by extending through each center hole 1814, 1820 simultaneously.

[0231] Figure 19A and Figure 19B 1802 , according to one or more embodiments. The housing 1806 and base 1808 operate as opposing flip-top halves that enclose or otherwise generally encapsulate 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, which includes a printed circuit board (PCB) 1904 having a plurality of electronic modules 1906 coupled thereto. Example electronic modules 1906 include, but are not limited to, resistors, transistors, capacitors, inductors, diodes, and switches. Existing 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 dispersed across the surface area of ​​both sides (i.e., the top and bottom surfaces) of the PCB 1904.

[0232] In addition to the electronic module 1906, the PCBA 1902 may also 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 implement 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, wherein these functions may include, but are not limited to, filtering and encoding of data signals, wherein each data signal corresponds to a sampled analyte level of a user. The data processing unit 1908 may also include a processor for communicating with the reader device 106 ( Figure 1 ) communicating with the antenna, or otherwise communicating with the antenna.

[0233] A battery aperture 1910 can be defined in the PCB 1904 and sized to accommodate and position a battery 1912 configured to power the sensor control device 1802. Axial battery contacts 1914a and radial battery contacts 1914b can be coupled to the PCB 1904 and extend into the battery aperture 1910 to facilitate transmission of power from the battery 1912 to the PCB 1904. As the names suggest, the axial battery contacts 1914a can be configured to provide axial contact for the battery 1912, while the radial battery contacts 1914b can provide radial contact for the battery 1912. Positioning the battery 1912 within the battery aperture 1910 with the battery contacts 1914a, 1914b helps reduce the height H ( Figure 18B ), which allows the PCB 1904 to be located in the center and its components to be spread out on both sides (i.e., top and bottom surfaces). This also helps provide chamfers 1818 ( Figure 18B ).

[0234] The sensor 1916 can be centrally located relative to the PCB 1904 and include a tail 1916, a flag 1918, and a neck 1920 interconnecting the tail 1916 and the flag 1918. The tail 1916 can be configured to extend through the central hole 1820 of the base 1808 for transcutaneous placement beneath the user's skin. In addition, the tail 1916 can have an enzyme or other chemical contained thereon to help facilitate analyte monitoring.

[0235] The flag portion 1918 may include one or more sensor contacts 1922 ( Figure 19B The sensor contacts 1922 may be configured to mate with corresponding one or more circuit contacts 1924 (shown as three) provided on the PCB 1904. Figure 19AIn some embodiments, the sensor contacts 1922 may include a carbon impregnated polymer printed or otherwise digitally applied to the flag 1918. Existing sensor control devices typically include a connector made of silicone rubber that encapsulates one or more compliant carbon impregnated polymer modules that serve as conductive contacts between the sensor and the PCB. In contrast, the currently disclosed sensor contacts 1922 provide a direct connection between the sensor 1816 and the PCB 1904 connection, which eliminates the need for the prior art connector and advantageously reduces the height H ( Figure 18B ). Additionally, eliminating the compliant carbon-impregnated polymer module eliminates significant circuit impedance, thereby improving circuit conductivity.

[0236] The sensor control device 1802 may also include a compliant member 1926 that may be disposed between the flag 1918 and the inner surface of the housing 1806. More specifically, when the housing 1806 and the base 1808 are assembled with one another, the compliant member 1926 may be configured to provide a passive biasing load against the flag 1918 that forces the sensor contacts 1922 into continuous engagement with the corresponding circuit contacts 1924. In the illustrated embodiment, the compliant member 1926 is an elastomeric O-ring, but may alternatively include any other type of biasing device or mechanism, such as a compression spring, without departing from the scope of the present disclosure.

[0237] The sensor control device 1802 may also include one or more electromagnetic shields, shown as a first shield 1928a and a second shield 1928b. Shields 1928a and 1928b may be disposed between the housing 1806 and the base 1808; i.e., within the electronics housing 1804. In the illustrated embodiment, the first shield 1928a is disposed above the PCB 1904 so as to face the top surface of the PCB 1904, and the second shield 1928b is disposed below the PCB 1904 so as to face the bottom surface of the PCB 1904.

[0238] Shields 1928a, 1928b can be configured to protect sensitive electronic components from radiation when sensor control device 1802 is subjected to radiation sterilization. More specifically, at least one shield 1928a, 1928b can be positioned between data processing unit 1908 and a radiation source, such as an electron beam electron accelerator. In some embodiments, for example, at least one of shields 1928a, 1928b can be positioned adjacent to or aligned with data processing unit 1908 and the radiation source to block or mitigate radiation absorption dose that could otherwise damage sensitive electronic circuitry of data processing unit 1908.

[0239] In the illustrated embodiment, data processing unit 1908 is interposed between first shield 1928a and second shield 1928b, such that first shield 1928a and second shield 1928b are generally positioned axially on opposite sides of data processing unit 1908. However, in at least one embodiment, only one of shields 1928a and 1928b may be required to properly protect data processing unit 1908 during radiation sterilization. For example, if sensor control device 1802 is sterilized by radiation directed toward the bottom of base 1808, only second shield 1928b is required to interpose data processing unit 1908 and the radiation source, and first shield 1928a may be omitted. Alternatively, if sensor control device 1802 is sterilized by radiation directed toward the top of housing 1806, only first shield 1928a is required to interpose data processing unit 1908 and the radiation source, and second shield 1928b may be omitted. However, in other embodiments, two shields 1928a, 1928b may be employed without departing from the scope of the present disclosure.

[0240] Shields 1928a, 1928b can be made of any material capable of attenuating (or substantially attenuating) the transmission of radiation. Suitable materials for shields 1928a, 1928b include, but are not limited to, lead, tungsten, ferrous metals (e.g., stainless steel), copper, tantalum, tungsten, osmium, aluminum, carbon, or any combination thereof. Suitable metals for shields 1928a, 1928b can be any non-magnetic metal that is corrosion-resistant, austenitic, and has a density between approximately 2 grams per cubic centimeter (g / cc) and approximately 23 g / cc. Shields 1928a, 1928b can be manufactured using a variety of manufacturing techniques, including, but not limited to, stamping, casting, injection molding, sintering, two-shot molding, or any combination thereof.

[0241] However, in other embodiments, shields 1928a, 1928b may comprise a metal-filled thermoplastic polymer, such as, but not limited to, polyamide, polycarbonate, or polystyrene. In such embodiments, shields 1928a, 1928b may be manufactured by mixing the shielding material in an adhesive matrix and dispensing the composition onto a formed part or directly onto data processing unit 1908. Furthermore, in such embodiments, shields 1928a, 1928b may comprise a housing that encapsulates (or substantially encapsulates) data processing unit 1908. In such embodiments, shields 1928a, 1928b may comprise a metal-filled thermoplastic polymer, as described above, or may alternatively be made of any material described herein that is capable of attenuating (or substantially attenuating) radiation transmission.

[0242] The housing 1806 may provide or otherwise define a first clock receptacle 1930a ( Figure 19B ) and the second clocking socket 1930b ( Figure 19B ), and the base 1808 may provide or otherwise define a first clock column 1932a ( Figure 19A ) and the second clock column 1932b ( Figure 19A Mating the first clock socket 1930a and the second clock socket 1930b with the first clock post 1932a and the second clock post 1932b, respectively, will properly align the housing 1806 with the base 1808.

[0243] Specific reference Figure 18A , the interior surface of the base 1808 may provide or otherwise define a plurality of pockets or recesses configured to receive various components of the sensor control device 1802 when the housing 1806 is mated to the base 1808. For example, the interior surface of the base 1808 may define a battery retainer 1934 configured to receive a portion of the battery 1912 when the sensor control device 1802 is assembled. An adjacent contact pocket 1936 may be configured to receive a portion of the axial contact 1914a.

[0244] In addition, a plurality of module pockets 1938 may be defined in the inner surface of the base 1808 to accommodate various electronic modules 1906 disposed on the bottom of the PCB 1904. In addition, a shield retainer 1940 may be defined in the inner surface of the base 1808 to accommodate at least a portion of the second shield 1928b when the sensor control device 1802 is assembled. The battery retainer 1934, the contact pockets 1936, the module pockets 1938, and the shield retainer 1940 all extend a short distance into the inner surface of the base 1808, thereby reducing the overall height H ( ) of the sensor control device 1802 compared to existing sensor control devices. Figure 18B ) can be reduced. Module pocket 1938 can also help minimize the diameter of PCB 1904 by allowing PCB components to be arranged on both sides (ie, top and bottom surfaces).

[0245] Still refer to Figure 19A, the base 1808 may also include a plurality of carrier gripping features 1942 (two are shown) defined around the periphery of the base 1808. The carrier gripping features 1942 are axially offset from the bottom 1944 of the base 1808, and a transfer adhesive (not shown) can be applied to the bottom during assembly. Compared to existing sensor control devices that typically include conical carrier gripping features that intersect the bottom of the base, the currently disclosed carrier gripping features 1942 deviate from the plane (i.e., the bottom 1944) to which the transfer adhesive is applied. This can be beneficial in helping to ensure that the delivery system does not inadvertently stick to the transfer adhesive during assembly. In addition, the currently disclosed carrier gripping features 1942 eliminate the need for fan-shaped transfer adhesive, which simplifies the manufacture of the transfer adhesive and eliminates the need for precisely synchronizing the transfer adhesive relative to the base 1808. This also increases the bonding area, thereby increasing the bond strength.

[0246] refer to Figure 19B , the bottom 1944 of the base 1808 can provide or otherwise define a plurality of grooves 1946 that can be defined at or near the periphery of the base 1808 and spaced equidistantly from one another. A transfer adhesive (not shown) can be coupled to the bottom 1944, and the grooves 1946 can be configured to help transfer (transfer) moisture from the sensor control device 1802 to the periphery of the base 1808 during use. In some embodiments, the spacing of the grooves 1946 can be between the module pockets 1938 ( Figure 19A ). As will be appreciated, the locations of the alternating grooves 1946 and module pockets 1938 ensure that opposing features on either side of the base 1808 do not extend into each other. This can help maximize the use of the material of the base 1808, thereby helping to maintain a minimum height H ( Figure 18B ). The mold cavity 1938 can also significantly reduce mold sinkage and improve the flatness of the bottom 1944 to which the transfer adhesive is bonded.

[0247] Still refer to Figure 19B , the interior surface of the housing 1806 may also provide or otherwise define a plurality of recesses or depressions that are configured to accommodate various components of the sensor control device 1802 when the housing 1806 is mated to the base 1808. For example, the interior surface of the housing 1806 may define opposing battery locators 1948 that may be arranged to align with the battery locators 1934 ( Figure 19A) and are configured to accommodate a portion of the battery 1912 when the sensor control device 1802 is assembled. In addition, a shield retainer 1950 can be defined in the inner surface of the housing 1806 to accommodate at least a portion of the first shield 1928a when the sensor control device 1802 is assembled. The opposing battery retainers 1948 and shield retainer 1950 extend a short distance into the inner surface of the housing 1806, which helps to reduce the overall height H ( Figure 18B ).

[0248] A sharp and sensor locator 1952 may also be provided by or otherwise defined on an inner surface of the housing 1806. The sharp and sensor locator 1952 may be configured to receive 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 corresponding sharps and sensor locators provided on an inner surface of the base 1808.

[0249] Figure 20A and Figure 20B The fabrication of a sensor control device according to some embodiments is depicted. In a first step of process 2000, a hole 2002 may be punched or otherwise formed in a base substrate 2004, which may comprise a sheet of material that may ultimately form the base or lower cover 2008 of the sensor control device. Base substrate 2004 may comprise a tape or film made from a variety of different materials, including but not limited to plastic, metal, composite materials, or any combination thereof. In at least one embodiment, base substrate 2004 may comprise a laminated aluminum foil having a polyester film on one side (e.g., the bottom side) and a polyolefin heat seal layer on an opposite side (e.g., the top side).

[0250] In the second step of process 2000, the sensor holder can be coupled to a base substrate 2004. The sensor holder can be the same or similar to any other sensor holder. Thus, the sensor holder can define a channel 2006 sized to accommodate the tail portion of the sensor. In some embodiments, the sensor holder can be ultrasonically welded or heat-sealed to the base substrate, thereby creating a sealed and waterproof joint. However, in at least one embodiment, the base substrate can include or otherwise incorporate an adhesive substrate on the top side to secure and seal the sensor holder in place.

[0251] In the third step of process 2000, a first adhesive substrate 2008 can be attached to the top of the sensor holder. First adhesive substrate 2008 can be similar to any known adhesive substrate and thus can include a pressure-bonded tape that forms a bond when pressure is applied. In at least one embodiment, first adhesive substrate 2008 can include a double-sided polyolefin foam tape and can be pressure-sensitive on both sides.

[0252] In a fourth step of process 2000, sensor 2016 can be secured to the sensor holder using first adhesive substrate 2008. More specifically, the tail portion can extend through channel 2006, and the flag portion can be bent generally perpendicular to the tail portion 10314 and coupled to the underlying first adhesive substrate 2008.

[0253] Now refer to Figure 20B In the fifth step of process 2000, a printed circuit board (PCB) 2010 can be positioned on base substrate 2004 and around the sensor bracket. PCB 2010 can include a plurality of electronic modules 2012 mounted thereon. Electronic modules 2012 can include at least one of a Bluetooth antenna and a near-field communication (NFC) antenna. As shown, PCB 2010 can define two opposing protrusions 2014a and 2014b interconnected by a neck 2016. Opposing battery contacts 2018a and 2018b can be disposed on opposing protrusions 2014a and 2014b to facilitate electrical communication with a battery 2020.

[0254] In the sixth step of process 2000, a second adhesive substrate 2008b can be applied to the first battery contact 2018a in preparation for receiving the battery 2020 in the adjacent seventh step of process 2000. The second adhesive substrate can include a pressure-sensitive adhesive tape for coupling the battery 2020 to the first battery contact 2018a. However, the second adhesive substrate can also include a Z-axis anisotropic (or conductive) pressure tape that also facilitates electrical communication (i.e., power transfer) between the battery 2020 and the first battery contact 2018a.

[0255] Figure 21 Shown is a side view of an example sensor 2100 according to one or more embodiments of the present disclosure.Sensor 2100 can be similar to any sensor described herein in some respects, and therefore can be used in analyte monitoring systems to detect specific analyte concentrations.As shown, sensor 2100 can include tail 2102, flag 2104 and neck 2106 interconnecting tail 2102 and flag 2104. Tail 2102 includes enzyme or other chemical substances or biological substances, and in some embodiments, film can cover the chemical substances.In use, tail 2102 can be percutaneously accommodated below the user's skin, and the chemical substances included thereon help promote analyte monitoring when there is body fluid.

[0256] The tail portion 2102 can be received within a hollow or recessed portion of a sharp body (not shown) to at least partially enclose the tail portion 2102 of the sensor 2100. As shown, the tail portion 2102 can extend from the horizontal at an offset angle Q. In some embodiments, the angle Q can be approximately 85°. Thus, compared to other sensor tails, the tail portion 2102 does not extend perpendicularly from the flag portion 2104, but rather at an angle offset from the vertical. This can be advantageous in helping to retain the tail portion 2102 within the recessed portion of the sharp body.

[0257] The tail portion 2102 can include a first or bottom end 2108a and a second or top end 2108b opposite the bottom end 2108a. A tower portion 2110 can be disposed at or near the top end 2108b and can extend vertically upward from the location where the neck portion 2106 interconnects the tail portion 2102 to the flag portion 2104. During operation, if the sharp object moves laterally, the tower portion 2110 can help the tail portion 2102 move toward the sharp object and thereby remain within the recessed portion of the sharp object. In addition, in some embodiments, the tower portion 2110 can provide or otherwise define a protrusion 2112 extending laterally therefrom. When the sensor 2100 is engaged with the sharp object and the tail portion 2102 extends within the recessed portion of the sharp object, the protrusion 2112 can engage the inner surface of the recessed portion. During operation, the protrusion 2112 can help retain the tail portion 2102 within the recessed portion.

[0258] The flag 2104 may include a generally planar surface on which is disposed one or more sensor contacts 2114. The sensor contacts 2114 may be configured to align with a corresponding number of compliant carbon-impregnated polymer modules encapsulated within the connector.

[0259] In some embodiments, as shown, the neck 2106 can provide or otherwise define a depression or bend 2116 extending between the flag 2104 and the tail 2102. The bend 2116 can be advantageous in increasing the flexibility of the sensor 2100 and helping to prevent the neck 2106 from bending.

[0260] In some embodiments, a notch 2118 (shown in phantom) can optionally be defined in the flag portion near the neck 2106. The notch 2118 can increase the flexibility and tolerance of the sensor 2100 when the sensor 2100 is mounted to the base. More specifically, the notch 2118 can help absorb disturbance forces that may occur when the sensor 2100 is mounted within the base.

[0261] Figure 22A and Figure 22B2 is an isometric view and a partially exploded isometric view of an example connector assembly 2200 according to one or more embodiments. As shown, the connector assembly 2200 may include a connector 2202. The connector 2202 may include a connector for facilitating the connection of one or more compliant carbon-impregnated polymer modules 2204 ( Figure 22B More specifically, connector 2202 can help secure module 2204 in place adjacent sensor 2100 and can be used in conjunction with a connector provided on flag 2104 (four shown in FIG. Figure 21 ) on the sensor contact 2114 ( Figure 21 ) contacts. The module 2204 can be made of a conductive material to provide conductive communication between the sensor 2100 and corresponding circuit contacts (not shown) disposed within the base 2206.

[0262] like Figure 22C As shown, the connector 2202 can define a cavity 2208 sized to accommodate the module 2204. In addition, in some non-limiting embodiments, the connector 2202 can further define one or more recesses 2210 configured to align with one or more corresponding flanges 2212 ( Figure 22B ) Mating the recess 2210 with the flange 2212 can secure the connector 2202 to the base 2206 via an interference fit or the like. In other embodiments, the connector 2202 can be secured to the base 2206 using an adhesive or via sonic welding.

[0263] Figure 22D and Figure 22E An isometric view and a partially exploded isometric view of another example connector assembly 2200 according to one or more embodiments are shown. As shown, the connector assembly 2200 may include a connector 2202, and Figure 22F 22 is an isometric bottom view of connector 2202. Connector 2202 may comprise an injection molded component, a compliant carbon impregnated polymer, silicon or doped silicon, or a Molex connector to help retain one or more compliant metal contacts 2204 ( Figure 22E More specifically, connector 2202 can help secure contact 2204 in place adjacent sensor 2100 and mate with sensor contacts 2114 ( Figure 21) contacts. In other non-limiting embodiments, connector 2202 can comprise any other material known in the art. Contacts 2204 can be made of stamped conductive material that provides conductive communication between sensor 2100 and corresponding circuit contacts (not shown) disposed within base 2206. For example, in some embodiments, contacts 2204 can be soldered to a PCB (not shown) disposed within base 2206.

[0264] like Figure 22F As shown, connector 2202 can define a recess 2208 sized to accommodate 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 base 2206. Mating recesses 2210 with flanges 2212 can help secure connector 2202 to base 2206 via an interference fit or the like. In other embodiments, connector 2202 can be secured to base 2206 using an adhesive or via sonic welding.

[0265] Figure 23A and Figure 23B Figures 230 and 230 show a side view and an isometric view of an example sensor control device 2302 according to one or more embodiments of the present disclosure. The sensor control device 2302 is similar in some respects to the Figure 1 The sensor control device 102 of FIG. 102 can be replaced by the sensor control device 2302. Figure 1 The sensor control device 104 can therefore be used with Figure 1 Used in conjunction with the sensor applicator 102 of the present invention, the sensor applicator can deliver the sensor control device 2302 to the target monitoring location on the user's skin.

[0266] As shown, the sensor control device 2302 includes an electronic housing 2304 that is generally disc-shaped and may have a circular cross-section. However, in other embodiments, the electronic housing 2304 may have other cross-sectional shapes, for example, oval, elliptical, or polygonal, without departing from the scope of the present disclosure. The electronic housing 2304 includes a housing 2306 and a base 2308 that can be mated with the housing 2306. The housing 2306 can be secured to the base 2308 in a variety of ways, for example, a snap-fit ​​joint, an interference fit, sonic welding, laser welding, one or more mechanical fasteners (e.g., screws), washers, adhesives, or any combination thereof. In some non-limiting embodiments, the housing 2306 can be secured to the base 2308 so that a sealed interface is created therebetween. The adhesive patch 2310 can be positioned on the underside of the base 2308 or otherwise attached to the underside of the base 2308. Similar to Figure 1Adhesive patch 108, adhesive patch 2310 can be configured to secure and maintain the sensor control device 2302 in place on the user's skin during operation.

[0267] The sensor control device 2302 may also include a sensor 2312 and a sharp body 2314 for facilitating transcutaneous delivery of the sensor 2312 beneath the user's skin during application of the sensor control device 2302. Respective portions of the sensor 2312 and the sharp body 2314 extend distally from the bottom (e.g., base 2308) of the electronics housing 2304. A sharp hub 2316 may be overmolded onto the sharp body 2314 and configured to secure and support the sharp body 2314. Figure 23A As shown, the sharp hub 2316 can include or otherwise define a mating member 2318. When assembling the sharp body 2314 to the sensor control device 2302, the sharp body 2314 can be advanced axially through the electronics housing 2304 until the sharp hub 2316 engages an upper surface of the electronics housing 2304 or an internal component thereof, and the mating member 2318 extends distally from the bottom of the base 2308. As described below, in at least one embodiment, the sharp hub 2316 can sealingly engage an upper portion of a seal overmolded onto the base 2308. When the sharp body 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 body 2314. The remainder of the sensor 2312 is disposed within the interior of the electronics housing 2304.

[0268] The sensor control device 2302 may further include a sensor cover 2320. Figure 23A and Figure 23B 23. The sensor cover 2320 is shown as being removed from the electronics housing 2304. The sensor cover 2320 can help provide a sealed barrier that surrounds and protects the exposed portions of the sensor 2312 and the sharp body 2314. As shown, the sensor cover 2320 can include a generally cylindrical body having a first end 2322a and a second end 2322b opposite the first end 2322a. The first end 2322a can be open to provide access to an interior cavity 2324 defined within the body. In contrast, the second end 2322b can be closed and can provide or otherwise define an engagement feature 2326. As described in more detail below, the engagement feature 2326 can help mate the sensor cover 2320 to a sensor applicator (e.g., Figure 1 The sensor cover 2320 may be provided with a sensor applicator 102 and may assist in removing the sensor cover 2320 from the sensor control device 2302 when removing the sensor cover from the sensor applicator.

[0269] The sensor cover 2320 can be removably coupled to the electronics housing 2304 at or near the bottom of the base 2308. More specifically, the sensor cover 2320 can be removably coupled to a mating member 2318 that extends distally from the bottom of the base 2308. For example, in at least one embodiment, the mating member 2318 can define a set of external threads 2328a ( Figure 23A ), the set of external threads can be connected to a set of internal threads 2328b ( Figure 23B ) engagement. In some embodiments, the external threads 2328a and the internal threads 2328b can include a flat thread design (e.g., without a helical curvature), but can alternatively include a helical thread engagement. Thus, in at least one embodiment, the sensor cover 2320 can be threadably coupled to the sensor control device 2302 at the mating member 2318 of the sharpened hub 2316. In other embodiments, the sensor cover 2320 can be removably coupled to the mating member 2318 via other types of engagement, including but not limited to an interference fit or a friction fit, or a frangible member or substance (e.g., wax, adhesive, etc.) that can be broken with minimal separation force (e.g., axial force or rotational force).

[0270] In some embodiments, the sensor cover 2320 can include a single unitary structure extending between a first end 2322a and a second end 2322b. However, in other embodiments, the sensor cover 2320 can include two or more components. For example, in the illustrated embodiment, the body of the sensor cover 2320 can include a desiccant cover 2330 disposed at the second end 2322b. The desiccant cover 2330 can contain or include a desiccant to help maintain a preferred humidity level within the inner cavity 2324. In addition, the desiccant cover 2330 can also define or otherwise provide an engagement feature 2326 of the sensor cover 2320. In at least one non-limiting embodiment, the desiccant cover 2330 can include a resilient plug inserted into the bottom end of the sensor cover 2320.

[0271] Figure 24A and Figure 24B Exploded, isometric top and bottom views, respectively, of sensor control device 2302, according to some embodiments, are shown. Housing 2306 and base 2308 operate as opposing flip-top halves that enclose or otherwise generally enclose various electronic components (not shown) of sensor control device 2302. Example electronic components that may be disposed between housing 2306 and base 2308 include, but are not limited to, batteries, resistors, transistors, capacitors, inductors, diodes, and switches.

[0272] The housing 2306 can define a first hole 2402a, the base 2308 can define a second hole 2402b, and when the housing 2306 is properly mounted to the base 2308, the holes 2402a, 2402b can be aligned. Figure 24A As best shown, the base 2308 may provide or otherwise define a base 2404 that protrudes from the inner surface of the base 2308 at the second aperture 2402b. The base 2404 may define at least a portion of the second aperture 2402b. Additionally, a channel 2406 may be defined on the inner surface of the base 2308 and may surround the base 2402. In the illustrated embodiment, the channel 2406 is circular, but may also be another shape, such as an elliptical, oval, or polygonal shape.

[0273] Base 2308 can include a molded component made of a rigid material, such as plastic or metal. In some embodiments, seal 2408 can be overmolded onto base 2308 and can be made of an elastomer, rubber, polymer, or another pliable material suitable for promoting a sealing interface. In embodiments where base 2308 is made of plastic, base 2308 can be molded in a first "shot" of injection molding, and seal 2408 can be overmolded onto base 2308 in a second "shot" of injection molding. Thus, base 2308 can be referred to or otherwise characterized as a "two-shot base."

[0274] In the illustrated embodiment, the seal 2408 can be overmolded onto the base 2308 at the base 2404 or can be overmolded on the bottom of the base 2308. More specifically, the seal 2408 can define or otherwise provide a first sealing element 2410a overmolded onto the base 2404 and a second sealing element 2410b interconnected with the first sealing element 2410a and overmolded onto the bottom of the base 2308. Figure 24B In some embodiments, one or both of the sealing elements 2410a, 2410b can help form corresponding portions (segments) of the second bore 2402b. Although the seal 2408 is described herein as being overmolded onto the base 2308, it is also contemplated herein that one or both of the sealing elements 2410a, 2410b can include a resilient member independent of the base 2408, such as an O-ring or a gasket.

[0275] The sensor control device 2302 may also include a collar 2412, which may be a generally annular structure defining a central aperture 2414. When the sensor control device 2302 is properly assembled, the central aperture 2414 is sized to accommodate the first sealing element 2410a and to align with the first aperture 2402a and the second aperture 2402b. The shape of the central aperture 2414 may generally match the shape of the second aperture 2402b and the first sealing element 2410a.

[0276] In some embodiments, the collar 2412 can define or otherwise provide an annular lip 2416 on its bottom surface. The annular lip 2416 can be sized and otherwise configured to mate with or be received within the channel 2406 defined on the inner surface of the base 2308. In some embodiments, a groove 2418 can be defined on the annular lip 2416 and can be configured to receive or otherwise receive a portion of the sensor 2312 extending laterally within the base 2308. In some embodiments, the collar 2412 can also define or otherwise provide a collar channel 2420 ( Figure 24A ), the collar channel is sized to accommodate an annular ridge 2422 ( Figure 24B ) and otherwise cooperate therewith.

[0277] The sensor 2312 may include a tail portion 2424 that extends through the second hole 2402b defined in the base 2308 for transcutaneous placement beneath the user's skin. The tail portion 2424 may have an enzyme or other chemical contained thereon to help facilitate analyte monitoring. The sharp body 2314 may include a tip 2426 that may extend through the first hole 2402a defined by the housing 2306. When the tip 2426 penetrates the electronics housing 2304, the tail portion 2424 of the sensor 2312 may be accommodated within the hollow or recessed portion of the tip 2426. The tip 2426 may be configured to penetrate the skin while carrying the tail portion 2424 so that the active chemical of the tail portion 2424 comes into contact with bodily fluids.

[0278] The sensor control device 2302 may provide a sealed subassembly that includes, among other components, the housing 2306, the sensor 2312, the sharp body 2314, the seal 2408, the collar 2412, and the sensor cover 2320. The sealed subassembly may help isolate the interior cavity 2324 of the sensor cover 2320. Figure 24A) within the sensor 2312 and sharp body 2314. When assembling the sealed subassembly, the tip 2426 is advanced through the electronics housing 2304 until the tip hub 2316 engages the seal 2408, and more specifically, the first sealing element 2410a. A mating member 2318 disposed at the bottom of the sharp hub 2316 can extend out of the second hole 2402b at the bottom of the base 2308, and the sensor cover 2320 can be coupled to the sharp hub 2316 at the mating member 2318. Coupling the sensor cover 2320 to the sharp hub 2316 at the mating member 2318 can cause the first end 2322a of the sensor cover 2320 to sealingly engage the seal 2408, and more specifically, the second sealing element 2410b on the bottom of the base 2308. In some embodiments, when the sensor cover 2320 is coupled to the sharpened hub 2316, a portion of the first end 2322a of the sensor cover 2320 can be lowered against (engaged with) the bottom of the base 2308, and the sealing engagement between the sensor hub 2316 and the first sealing element 2410a can accommodate any tolerance variations between the features.

[0279] Figure 25A A cross-sectional side view of a sensor control device 2302 is shown, according to some embodiments. As described above, the sensor control device 2302 can include or otherwise incorporate a sealing subassembly 2502 that can be used to isolate the sensor 2312 and the sharp body 2314 within the interior cavity 2324 of the sensor cover 2320. To assemble the sealed subassembly 2502, the sensor 2312 can be positioned within the base 2308 such that the tail 2424 extends through the second aperture 2402b at the bottom of the base 2308. In at least one embodiment, a positioning feature 2504 can be defined on an inner surface of the base 2308, and the sensor 2312 can define a recess 2506 that mates with the positioning feature 2504 to properly position the sensor 2312 within the base 2308.

[0280] Once the sensor 2312 is properly positioned, the collar 2412 can be installed on the base 2308. More specifically, the collar 2412 can be positioned such that the first sealing element 2410a of the seal 2408 is received within the central aperture 2414 defined by the collar 2412, and the first sealing element 2410a creates a radial seal against the collar 2412 at the central aperture 2414. Additionally, an annular lip 2416 defined on the collar 2412 can be received within the channel 2406 defined on the base 2308, and a groove 2418 defined through the annular lip 2416 can be aligned to accommodate the portion of the sensor 2312 that extends transversely through the channel 2406 within the base 2308. In some non-limiting embodiments, an adhesive can be injected into the channel 2406 to secure the collar 2412 to the base 2308. The adhesive may also facilitate a sealed interface between the two components and create a seal around sensor 2312 at groove 2418 , which may isolate tail 2424 from the interior of electronics housing 2304 .

[0281] The housing 2306 can then be mated with or otherwise coupled to the base 2308. In some embodiments, as shown, the housing 2306 can be mated with the base 2308 via a tongue-and-groove joint 2508 on the periphery of the electronics housing 2304. Adhesive can be injected (applied) into the groove portion of the joint 2508 to secure the housing 2306 to the base 2308 and also create a sealed joint interface. Mating the housing 2306 to the base 2308 can also allow the annular ridge 2422 defined on the inner surface of the housing 2306 to be accommodated within the collar channel 2420 defined on the upper surface of the collar 2412. In some embodiments, adhesive can be injected into the collar channel 2420 to secure the housing 2306 to the collar 2412 and also to promote a sealed interface between the two components at this location. When the housing 2306 is mated with the base 2308 , the first sealing element 2410 a can extend at least partially through (into) the first aperture 2402 a defined in the housing 2306 .

[0282] The sharp body 2314 can then be coupled to the sensor control device 2302 by extending the tip 2426 through the aligned first and second holes 2402a, 2402b defined in the housing 2306 and the base 2308, respectively. The sharp body 2314 can be advanced until the tip hub 2316 engages the seal 2408, more specifically, the first sealing element 2410a. When the tip hub 2316 engages the first sealing element 2410a, the mating member 2318 can extend (protrude) from the second hole 2402b at the bottom of the base 2308.

[0283] The sensor cover 2320 is then removably coupled to the sensor control device 2302 by threadingly engaging the internal threads 2328b of the sensor cover 2320 with the external threads 2328a of the mating member 2318. The internal cavity 2324 can be sized and otherwise configured to accommodate the tail 2424 and the tip 2426 extending from the bottom of the base 2308. In addition, the internal cavity 2324 can be sealed to isolate the tail 2424 and the tip 2426 from substances that may adversely interact with the chemicals in the tail 2424. In some embodiments, a desiccant (not shown) can be present in the internal cavity 2324 to maintain an appropriate humidity level.

[0284] Tightening (rotating) the mating engagement between the sensor cover 2320 and the mating member 2318 can cause the first end 2322a of the sensor cover 2320 to sealably engage the second sealing element 2410b in the axial direction (e.g., along the centerline of the holes 2402a, 2402b), and can further enhance the sealing interface between the sharpened hub 2316 and the first sealing element 2410a in the axial direction. Furthermore, tightening the mating engagement between the sensor cover 2320 and the mating member 2318 can compress the first sealing element 2410a, which can result in enhanced radial sealing engagement between the first sealing element 2410a and the collar 2412 at the central hole 2414. Thus, in at least one embodiment, the first sealing element 2410a can help promote both axial and radial sealing engagement.

[0285] As described above, the first sealing element 2410a and the second sealing element 2410b can be overmolded onto the base 2308 and can be physically linked or otherwise interconnected. Thus, a single injection molding injection can flow through the second hole 2402b of the base 2308 to produce both ends of the seal 2408. This proves to be advantageous because multiple sealing interfaces can be produced using only a single injection molding shot. Another advantage of the double-shot molding design is that the interface between the first and second injections is a reliable bond rather than a mechanical seal, compared to using separate elastomeric components (e.g., O-rings, gaskets, etc.). Therefore, the effective number of mechanical seal barriers is effectively halved. In addition, having a double-shot component with a single elastomer injection also means that the number of double-shot components required to achieve all necessary sterile barriers is minimized.

[0286] Once properly assembled, the sealing subassembly 2502 can be subjected to a radiation sterilization process to sterilize the sensor 2312 and the sharp body 2314. The sealing subassembly 2502 can be subjected to radiation sterilization before or after the sensor cover 2320 is coupled to the sharp hub 2316. When sterilized after the sensor cover 2320 is coupled to the sharp hub 2316, the sensor cover 2320 can be made of a material that allows radiation to propagate through it. In some embodiments, the sensor cover 2320 can be transparent or translucent, but can also be opaque without departing from the scope of the present disclosure.

[0287] Figure 25B Shown Figure 23A and Figure 23B and Figure 24A and Figure 24B 2408 . The embodiments included above describe base 2308 and seal 2408 manufactured via a two-shot injection molding process. However, in other embodiments, as briefly mentioned above, one or both of the sealing elements 2410a, 2410b of seal 2408 can comprise resilient components separate from base 2408. For example, in the illustrated embodiment, first sealing element 2410a can be overmolded onto collar 2412, and second sealing element 2410b can be overmolded onto sensor cover 2320. Alternatively, first sealing element 2410a and second sealing element 2410b can comprise separate components, such as gaskets or O-rings located on collar 2412 and sensor cover 2320, respectively. Tightening (rotating) the mating engagement between the sensor cover 2320 and the mating member 2318 can force the second sealing element 2410b to axially seal with the bottom of the base 2308 and can axially enhance the sealing interface between the sharpened hub 2316 and the first sealing element 2410a.

[0288] Figure 26A An isometric bottom view of the base 2308 is shown, Figure 26B 23 shows an isometric top view of a sensor cover 2320 according to some embodiments. Figure 26A As shown, the base 2308 may provide or otherwise define one or more recesses or pockets 2602 at or near the opening of the second aperture 2402b. Figure 26BAs shown, the sensor cover 2320 can provide or otherwise define one or more protrusions 2604 at or near the first end 9122a of the sensor cover 2320. When the sensor cover 2320 is coupled to the sharpened hub 2316, the protrusions 2604 can be received within the recesses 2602. More specifically, as described above, when the sensor cover 2320 is coupled to the mating member 2318 of the sensor hub 2316, the first end 9122a of the sensor cover 2320 sealingly engages the second sealing element 2410b. During this process, the protrusions 2604 can also be received within the recesses 2602, which can help prevent the sensor cover 2320 from being prematurely unscrewed from the sharpened hub 2316.

[0289] Figure 27A and Figure 27B A side view and a cross-sectional side view, respectively, of an example sensor applicator 2702 are shown according to some embodiments. The sensor applicator 2702 can be similar in some respects to Figure 1 The sensor applicator 102 , therefore, can be designed to transmit (emit) a sensor control device, for example, the sensor control device 2302 . Figure 27A depicts how the sensor applicator 2702 might be shipped to and received by a user, Figure 27B A sensor control device 2302 is depicted disposed inside a sensor applicator 2702 .

[0290] like Figure 27A As shown, the sensor applicator 2702 includes a housing 2704 and an applicator cap 2706 removably coupled to the housing 2704. In some embodiments, the applicator cap 2706 can be screwed to the housing 2704 and include an anti-tamper ring 2708. When the applicator cap 2706 is rotated (e.g., unscrewed) relative to the housing 2704, the anti-tamper ring 2708 can be torn, thereby releasing the applicator cap 2706 from the sensor applicator 2702.

[0291] exist Figure 27B , the sensor control device 2302 is located within the sensor applicator 2702. Once the sensor control device 2302 is fully assembled, it can be loaded into the sensor applicator 2702, and the 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 sets of threads such that the applicator cap 2706 can be screwed onto the housing 2704 in a clockwise (or counterclockwise) direction, thereby securing the applicator cap 2706 to the sensor applicator 2702.

[0292] Securing the applicator cover 2706 to the housing 2704 can also cause the second end 2322b of the sensor cover 2320 to be received within a cover post 2710, which is located within the interior of the applicator cover 2706 and extends proximally from the bottom thereof. When the applicator cover 2706 is coupled to the housing 2704, the cover post 2710 can be configured to receive at least a portion of the sensor cover 2320.

[0293] Figure 28A and Figure 28B 2706 ( FIG. 2707 ) are perspective and top views, respectively, of a cover post 2710 according to one or more additional embodiments. In the depiction shown, a portion of the sensor cover 2320 is housed within the cover post 2710, and more specifically, the desiccant cover 2330 of the sensor cover 2320 is disposed within the cover post 2710. The cover post 2710 can define a receiver feature 2802 configured to receive the applicator cap 2706 ( Figure 27B ) is coupled (eg, screwed into) the sensor applicator 2702 ( Figures 27A-27B ) when receiving the engagement feature 2326 of the sensor cover 2320. However, when the applicator cover 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 cover 2320 from separating from the cover post 2710. Conversely, removing the applicator cover 2706 from the sensor applicator 2702 will simultaneously separate the sensor cover 2320 from the sensor control device 2302 ( Figures 23A-24B and Figures 24A-24B ), thereby exposing sensor 2312 ( Figure 24A and Figure 24B ) and sharp body 2314 ( Figure 24A and Figure 24B )The distal parts of both.

[0294] Many design variations of the receiver feature 2802 may be employed without departing from the scope of the present disclosure. In the illustrated embodiment, the receiver feature 2802 includes one or more compliant members 2804 (two are shown) that are expandable or flexible to receive the engagement feature 2326. The engagement feature 2326 may include, for example, an enlarged head, and the compliant member 2804 may include a collet-type device including a plurality of flexible fingers configured to flex radially outward to accommodate the enlarged head.

[0295] The compliant member 2804 may also provide or otherwise define corresponding inclined surfaces 2806 that are configured to interact with one or more opposing cam surfaces 2808 provided on the outer wall of the engagement feature 2326. The configuration and alignment of the inclined surfaces 2806 and the opposing cam surfaces 2808 enable the applicator cover 2706 to rotate relative to the sensor cover 2320 in a first direction A (e.g., clockwise), but when the applicator cover 2706 is rotated in a second direction B (e.g., counterclockwise), the cover post 2710 abuts the sensor cover 2320. More specifically, when the applicator cover 2706 (and therefore the cover post 2710) is rotated in the first direction A, the cam surfaces 2808 engage the inclined surfaces 2806, which causes the compliant member 2804 to bend or otherwise deflect radially outward and result in a ratcheting action. However, rotating the applicator cap 2706 (and therefore the cap post 2710 ) in the second direction B drives the angled surface 2810 of the cam surface 2808 into the oppositely angled surface 2812 of the ramped surface 2806 , which causes the sensor cap 2320 to abut the compliant member 2804 .

[0296] Figure 29 FIG2 is a cross-sectional side view of the sensor control device 2302 positioned within the applicator cap 2706, according to one or more embodiments. As shown, the opening of the receiver component 2802 has a first diameter D3, while the engagement feature 2326 of the sensor cap 2320 has 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 is extended into the cap post 2710, the compliant member 2804 of the receiver feature 2802 can flex (expand) radially outward to receive the engagement feature 2326. In some embodiments, as shown, the engagement feature 2326 can provide or otherwise define an angled outer surface that helps bias the compliant member 2804 radially outward. Once the engagement feature 2326 bypasses the receiver feature 2802, the compliant member 2804 can flex back to (or toward) its natural state, thereby locking the sensor cap 2320 within the cap post 2710.

[0297] When the applicator cap 2706 is screwed onto the housing 2704 ( Figure 29), the cover post 2710 rotates accordingly in the same direction, and the sensor cover 2320 is gradually drawn into the cover post 2710. As the cover post 2710 rotates, the ratcheting action of the inclined surface 2806 of the compliant member 2804 acts on the opposing cam surface 2808 of the sensor cover 2320. This continues until the applicator cover 2706 is fully threaded onto the housing 2704. In some embodiments, the ratcheting action may occur over two complete rotations of the applicator cover 2706 before the applicator cover 2706 reaches its final position.

[0298] To remove the applicator cap 2706, the applicator cap 2706 is rotated in the second direction B, which in turn rotates the cap post 2710 in the same direction and causes the cam surface 2808 (ie, Figures 28A-28B The angled surface 2810) is against the inclined surface 2806 (ie, Figures 28A-28B 23. The angled surface 2812 of the applicator cap 2706 is formed on the applicator cap 2706. Thus, continued rotation of the applicator cap 2706 in the second direction B causes the sensor cap 2320 to correspondingly rotate in the same direction, thereby unscrewing from the mating member 2318, allowing the sensor cap 2320 to be removed from the sensor control device 2302. Removing the sensor cap 2320 from the sensor control device 2302 exposes distal portions of both the sensor 2312 and the sharp body 2314, thereby placing the sensor control device 2302 in the proper position for activation (use).

[0299] Figure 30 is a cross-sectional view of a sensor control device 2800 illustrating an example interaction between a sensor and a sharp body. After the sharp body is assembled, the sensor should be positioned within the channel defined by the sharp body. In some non-limiting embodiments, the sensor can be deflected inwardly and otherwise aligned with the sharp body. In some other non-limiting embodiments, such as Figure 30 As shown, a slight biasing force may be borne by the sensor at the location indicated by the two arrows A. Biasing the sensor against the sharp body may be advantageous so that any relative movement between the sensor and the sharp body during subcutaneous insertion does not expose the sensor tip (i.e., tail) outside of the sharp body channel, which could potentially lead to insertion failure.

[0300] Figure 31A and Figure 31BA printed circuit board according to some embodiments is shown. A printed circuit board (PCB) 3102 can be included in a device, such as a sensor control device. PCB 3102 can have one, two, three, four, five, six, seven, eight, nine, ten, eleven, twelve, or more layers. Vias can connect components or traces on one layer to components or traces on another layer. For example, the PCB can be made of FR4 or FR-4 composite material, which can include woven fiberglass cloth with an epoxy resin adhesive. In other non-limiting embodiments, the PCB can include any other material known in the art. In some embodiments, a button cell or cylindrical battery 3104 can be connected or attached to PCB 3102. For example, battery 3104 can be connected or attached to PCB 3102 using spot welds and / or battery tabs 3118. Using battery tabs helps reduce battery size while eliminating battery contacts. Battery 3104 can be configured to power the PCB and / or one or more components connected or attached to the PCB. The PCB 3102 may also include one or more modules 3110 , such as resistors, transistors, capacitors, inductors, diodes, and / or switches. The one or more modules 3110 may be attached, connected, or mounted to the PCB 3102 .

[0301] like Figures 1-3B 、 Figure 5B 、 Figure 6A 、 Figure 6B 、 Figure 7 、 Figures 9-11B 、 Figure 13B 、 Figure 15 、 Figures 16B-17B 、 Figure 18B 、 Figure 19A 、 Figure 19B 、 Figure 21 、 Figure 22A 、 Figure 22B 、 Figure 22D 、 Figure 22E 、 Figure 23A 、 Figure 23B 、 Figure 24A 、 Figure 24B 、 Figure 25A 、 Figure 25B 、 Figure 27B 、 Figure 29 and / or Figure 30 As shown, the analyte sensor can be attached or connected to the PCB 3102. A portion of the analyte sensor can be configured to be positioned in contact with the fluid beneath the skin layer to monitor the level of the analyte in the fluid. In some non-limiting embodiments, the sensor can include a tail, a flag, and a neck interconnecting the tail and the flag. Component 3108 can be included, for example, Figure 3A 、 Figure 3B 、 Figure 22B and Figure 22EThe plug assembly shown, as part of the sensor assembly, houses and supports the sensor and connector. When assembly 3108 is properly coupled to an electronics housing, for example, one or more circuit contacts defined on the underside of PCB 3110 can be in conductive communication with electrical contacts of the connector. Thus, in some non-limiting embodiments, the connector can be connected to the PCB and can be configured to establish an electrical connection between the analyte sensor and the PCB.

[0302] Although in some embodiments, the connector may take Figure 3A 、 Figure 3B 、 Figure 11A 、 Figure 11B 、 Figure 17A and / or Figure 17B 3108. The connector may be in the form shown, but in other embodiments, the connector may be any other shape, for example, a collar shape. At least a portion of the connector may include at least one of silicone rubber and / or carbon impregnated polymer. Although some embodiments included herein describe using a plug to connect the connector to the PCB, in some other embodiments, the connector may be directly connected to the PCB. For example, assembly 3108 may include a Molex connector and a sensor flag, such as Figure 22B and Figure 22E In some embodiments, one or more portions of the sensor (e.g., the tail, flag, and neck) can be shaped to help secure and retain the sensor within the sharp channel. For example, the neck can include offset towers and / or the flag can include one or more holes to help secure or retain the sensor in proper alignment within the sharp channel. In some non-limiting embodiments, a sharp hub 3114 can be used to help secure or retain the sensor to the PCB.

[0303] In some non-limiting embodiments, a processor 3112 can be connected to the PCB 3102. The processor 3112 can be implemented by any computing 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 enhancement circuit, or the like, or any combination thereof. The PCB 3102 can include a single processor or controller, or multiple controllers or processors. For example, the PCB 3102 can include a general-purpose data processing unit 3112 or an ASIC 3116, or both the general-purpose data processing unit 3112 and the ASIC 3116. In some 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 levels.

[0304] In some non-limiting embodiments, one or more antennas may be attached to the PCB. The one or more antennas may, for example, include a Bluetooth low energy antenna, an NFC antenna, and / or any other antenna for wireless communication that may be used to transmit the monitored analyte levels. In addition to transmitting the monitored analyte levels, the antenna may be used to transmit 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, for example, be blood glucose levels, ketone levels, lactate levels, oxygen levels, hemoglobin AIC levels, etc., which are critical to the health of individuals with diabetes. Additionally or alternatively, 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, for example, Figure 1 A reader device 106 is shown. The reader device can be any user device used by an individual or healthcare provider, including a mobile device such as a smartphone, for example.

[0305] For example, the antenna may be a Bluetooth low energy antenna. Bluetooth (including Bluetooth low energy) typically operates at or near 2.45 GHz, for example, between 2.4 GHz and 2.484 GHz. The antenna may be configured as an inverted H-shape, a J-shape, an inverted F-shape, or may take any other form. For example, Figure 31A The antenna 3106 in is j-shaped, and Figure 32 The antenna 3218 in FIG. 3 is H-shaped. The antenna 3106 can be shaped to bend around the periphery of the battery 3104. In other non-limiting embodiments, rather than being bent around the periphery of the battery 3104, the antenna 3106 can simply be located at a different location on the PCB so as not to overlap the battery 3104.

[0306] like Figure 31AAs shown, antenna 3106 can be positioned on multiple risers that extend a fixed distance from the PCB surface. The risers help elevate the antenna above the PCB and / or one or more other components attached to the PCB. In some embodiments, elevating the antenna above the PCB and / or one or more other components attached to the PCB can help reduce interference and / or improve the quality of signals transmitted or received by antenna 3106. The multiple risers can range from 2 to 10 risers, 1 to 15 risers, or any other number of risers. In other embodiments, only a single riser may be provided. The fixed distance between the multiple risers extending from the PCB surface can be greater than 1.5 mm. Specifically, the fixed distance between the multiple risers can be between 0.1 mm and 5 mm, 1.2 mm and 1.8 mm, or 1.525 mm and 1.675 mm. One or more of the multiple risers can be configured to electrically connect the antenna to the PCB, while one or more of the multiple risers can be configured solely to structurally support the antenna. In some non-limiting embodiments, one or more of the risers can be a portion of the antenna that folds to extend a fixed distance from the PCB surface. Thus, one or more of the plurality of supports may comprise a foldable portion of the antenna. In other non-limiting embodiments, one or more of the supports may be a separate component that houses or connects to the antenna.

[0307] In some non-limiting embodiments, antenna 3106 may be a Bluetooth low energy antenna and antenna 3118 may be an NFC antenna. However, in other embodiments, a single antenna may be provided for both Bluetooth low energy and NFC communications. Figure 31A and Figure 31B As shown, antenna 3106 or a separate NFC antenna 3118 can be used to transmit the monitored analyte level. A separate NFC antenna 3118 can be provided as a module attached to the PCB. In some non-limiting embodiments, such as Figure 31B As shown, the NFC antenna 3118 can be embedded within and / or near the periphery of the PCB. For example, the NFC antenna 3118 can be embedded in a material, such as FR4 of the PCB 3102, such as Figure 31B In another embodiment, the NFC antenna 3118 can be embedded in a protrusion during the manufacturing process of the PCB 3102 .

[0308] Figure 32 31 shows a printed circuit board according to some embodiments. PCB 3102 may be included in an apparatus (e.g., a sensor control device) and may include a battery 3204, an antenna 3206, components 3208, and a module 3210. Antenna 3206 may be a Bluetooth low energy antenna. Figure 32As shown, antenna 3206 can be H-shaped and / or can be placed on multiple supports. For example, antenna 3206 can be placed on four supports (risers) 3214, 3216, 3218, and 3220. In some embodiments, two of the four supports are configured to electrically connect the antenna to the PCB, while the other two supports are used for support. In other embodiments, all four supports can be configured to electrically connect the antenna to the PCB. A first group of the multiple supports (e.g., two of the four supports 3214, 3216) can be located near the connector, while a second group of the multiple supports (e.g., two of the four supports 3218, 3220) can be located near the battery. For example, antenna 3206 can have a crossbar 3212 located between the first group of supports and the second group of supports. In some embodiments, one or more of the multiple supports are at least partially pre-tinned over nickel. In other embodiments, the multiple supports can be composed of any other material or materials known in the art.

[0309] Figures 33A to 33D Detailed description of an antenna according to some embodiments is provided. Figure 33A 3206 is shown in a front view. Figure 33A As shown, antenna 3206 includes five ends, four of which are brackets 3302, 3304, 3306 and 3308. Brackets 3306 and 3308 are located at the base of the h-shaped antenna 3306 and are separated from each other by a distance approximately the length of crossbar 3310. In addition to the four brackets, antenna 3206 also includes a portion having a free end (e.g., a rounded end) 3312 that is not directly connected to the PCB surface. Therefore, in some 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, such as Figure 33A As shown, the edge of the free end 3312 faces the crossbar 3310, but in other non-limiting embodiments, the edge of the rounded end 3312 can face away from the crossbar 3310. Brackets 3302 and 3304 are closer to each other than brackets 3306 and 3308. Figure 33A As shown, the antenna portion including brackets 3302 and 3304 can be branched or Y-shaped, with the antenna portion leading to bracket 3304 having a curved shape. Thus, the antenna can include two or more ends forming a Y-shape. Alternatively, the antenna portion leading to bracket 3302 has two straight segments that intersect at approximately a right angle. For example, the two straight segments may intersect at an angle of 75° to 100°. In other embodiments, the two straight segments may intersect at an angle of 45° to 130°, 55° to 120°, or 65° to 110°.

[0310] Figure 33BA side view of an H-shaped antenna 3206 is shown, including brackets 3302, 3304, 3306, and 3308. The length or fixed distance of the brackets is between 1.525 and 1.675 mm. The bottom surface of one or more brackets can be attached or mounted to a PCB. For example, the bottom surface, which can be rectangular, can be soldered or welded to the PCB.

[0311] Figure 33C A front view of the h-shaped antenna 3206 is shown, wherein the bracket has been unfolded. Figure 33C As shown, the antenna can have an expanded width of approximately 9.33 mm. In other non-limiting embodiments, the expanded width can be in the range of approximately 1 to 20 mm, 5 to 15 mm, or 7.5 to 12.5 mm. The antenna can also have an expanded length of approximately 12.04 mm. In other non-limiting embodiments, the expanded length can be in the range of approximately 1 to 22 mm, 7 to 17 mm, or 10 to 14 mm. The expanded width or length can be, for example, the width or length of the antenna, wherein a folding stand, which can be part of the antenna, is expanded or straightened, such as Figure 33C In some non-limiting embodiments, the antenna can have a mass of 0.024 grams. In other non-limiting embodiments, the antenna can have a mass in the range of 0.005 to 1.0 grams, 0.01 to 0.04 grams, or 0.02 to 0.03 grams. Figure 33D An isometric view of an h-shaped antenna 3206 with brackets 3302, 3304, 3306, 3308 and a crossbar 3310 is shown.

[0312] It may be advantageous to provide the system with a transceiver for communicating via Bluetooth or Bluetooth Low Energy and another transceiver for communicating via NFC or RFID. However, this arrangement requires a certain electronic footprint. Alternative arrangements (particularly those that provide a reduced footprint) may also be advantageous. A transceiver with dual functionality will now be described.

[0313] In an example arrangement, a transceiver is provided in a continuous analyte sensor system. The continuous analyte sensor system is used to monitor an analyte level in a bodily fluid of a user. The bodily fluid may be the user's interstitial fluid. The analyte may be blood glucose. Alternatively, the analyte may be ketones or lactate.

[0314] In this arrangement, the continuous analyte sensor system includes a sensor electronics system and an analyte sensor. The analyte sensor has a proximal portion and a distal portion. The distal portion is configured to be positioned below the surface of the user's skin to contact bodily fluids and monitor the level of an analyte in the bodily fluids. The proximal portion is configured to be positioned above the surface of the user's skin and operably connected to the sensor electronics system.

[0315] The sensor electronics system is configured to receive a sensor signal indicating an analyte level from an analyte sensor. Based on the sensor signal, the sensor electronics system is configured to generate data related to the analyte level. The data related to the analyte level may include one or more of the current analyte level, the past analyte level, and the predicted analyte level. Additionally or alternatively, the data related to the analyte level may include information about the rate of change of the analyte level. Additionally or alternatively, the data related to the analyte level may include alarm and / or warning information, including actual alarms and / or warnings to a user or a third party (e.g., a caregiver or medical staff). The data related to the analyte level is at least temporarily stored in one or more memories of the sensor electronics system. This storage can simply be used for instant or approximately instant wireless transmission of data. Alternatively, the storage time is longer, so that the data does not have to be transmitted immediately, but can be transmitted automatically or on request (on demand) when needed. For example, a user can request data at any time, for example, by using a reader device to request data using an NFC protocol or an RFID protocol. Alternatively or additionally, the sensor electronics system is configured to automatically transmit data wirelessly when given conditions are met. For example, a condition may be that a certain length of time has elapsed since the last data transmission, e.g., 30 seconds, 1 minute, 2 minutes, or 5 minutes. An alternative or additional condition may be that a certain analyte level has been reached or exceeded, or is predicted to be reached or exceeded within a given time window.

[0316] In this arrangement, wireless communication is achieved by a transceiver. Specifically, the sensor electronics system includes a transceiver configured to transmit an output signal including data related to the analyte level. The transceiver is also configured to receive an input signal, for example, from a reader device. To generate the output signal and receive the input signal, the transceiver includes an electromagnetic signal generating component that can operate as an antenna. The electromagnetic signal generating component is configured to be powered or driven by the output signal from the sensor electronics system. The electromagnetic signal generating component is configured to be powered or driven in two communication modes. The electromagnetic signal generating component has different signal feed points for different communication modes. Specifically, 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, in which the sensor electronics system provides a first output signal to the first signal feed point of the electromagnetic signal generating component. Providing the first output signal to the first feed point causes the electromagnetic signal generating component to operate in the first communication mode, causing the electromagnetic signal generating component to transmit a signal according to a first set of physical principles. The sensor electronics system is further configured to operate in a second communication mode in which the sensor electronics system provides a second output signal to a second signal feed point of the electromagnetic signal generating component. Providing the second output signal to the second feed point to cause the electromagnetic signal generating component to operate in the second communication mode causes the electromagnetic signal generating component to transmit a signal according to a second set of physical principles that is different from the first set.

[0317] In this way, the transceiver is configured to perform wireless communication in the first and / or second communication modes. Rather than providing a separate, dedicated transceiver for each communication mode, this arrangement provides both communication modes using the same transceiver. Therefore, this arrangement is advantageous in terms of providing space and / or resource efficiency.

[0318] Optionally, the electromagnetic signal generating component includes a conductive coil. The coil may have one or more loops or turns, and the coil may have a first end and a second end. The coil may have two loops or turns. The coil may have three loops or turns. The coil may have four or more loops or turns.

[0319] The first signal feeding point for the first communication mode is arranged at one of the first end and the second end of the coil. In this way, the electromagnetic signal generating component is driven as a coil (or loop). When the first output signal is supplied or fed in this way, the alternating current generated in the coil causes the electromagnetic signal generating component to operate as an inductive antenna. Therefore, the transceiver can use the interaction of the inductive coupling type to carry out wireless communication with the reader device. In this way, in the first communication mode, the sensor electronic system is configured to carry out wireless communication according to NFC or RFID protocol. It should be understood that the reader device can be located near the continuous analyte sensor system, provide an energizing signal to the transceiver in the first communication mode, and request that data be transferred to the reader device, all of which use NFC or RFID protocol.

[0320] A second signal feed point for the second communication mode is provided at a position on the coil between the first end and the second end of the coil. Specifically, the second signal feed point is located at a substantially middle or center position between the first end and the second end on the coil. The electromagnetic signal generating component is driven by feeding a second output signal to the second feed point. When the second output signal is provided or fed in this manner, the electromagnetic signal generating component does not operate as a coil or inductor. Instead, the center or approximately center feed causes the electromagnetic signal generating component to operate as a dipole antenna. Therefore, the transceiver can wirelessly communicate with the reader device using the interaction of radiation-based RF waves. Thus, in the second communication mode, the sensor electronics system is configured to wirelessly communicate according to a Bluetooth or Bluetooth low energy protocol. It should be understood that the continuous analyte sensor system or reader device can initiate communication with another device to send or request data using the Bluetooth or Bluetooth low energy protocol.

[0321] As described above, the coil may have a single loop or turn. However, advantageously, the coil is provided with two, three, or four or more loops or turns arranged in substantially coplanar layers. This allows the coil to be provided on a single layer of a substrate, for example, a single layer of a PCB. Providing electrical connections to the first and second ends of the coil may involve the use of one or more vias through the substrate to prevent electrical traces from crossing each other.

[0322] The coil can be advantageously positioned at or near one or more outer edges of the substrate. This helps increase or maximize the effective radius of the coil and allows other components of the sensor electronics to be positioned within the space within the coil. For example, the coil can be positioned along the periphery of the substrate (e.g., a PCB) on which it is positioned.

[0323] Additionally or alternatively, the coil may include two or three or four or more generally parallel layers of coils. For example, the coil may include one loop or turn in one layer or plane and another loop or turn in a second layer or plane. Alternatively, the coil may include two or three or four or more generally coplanar loops or turns in one layer or plane and two or three or four or more generally coplanar loops or turns in a second layer or plane. This arrangement provides a greater number of loops or turns in the coil without increasing the area or footprint of the coil compared to providing the loops or turns in only one layer. In one advantageous arrangement, the coil has three generally coplanar loops or turns in one layer and three generally coplanar loops or turns in a second layer parallel to the first layer.

[0324] The electromagnetic signal generating component can be disposed on one or more substrate layers of the substrate. At least two substrate layers can be electrically connected via one or more through-holes. The through-holes can provide an electrical connection from one layer of coil material to another layer, thereby providing conductive continuity for the coil. Alternatively, the through-holes can provide an electrical connection between the coil (particularly the first end or the second end of the coil) and an electrical trace, contact, or connection to one or more other components of the sensor electronics system.

[0325] In an alternative arrangement, the substrate includes two outer substrate layers and two inner substrate layers, with the outer substrate layers positioned on either side of the inner substrate layers. In this arrangement, the electromagnetic signal generating components are located on one or both of the inner substrate layers, rather than on the outer substrate layers. This arrangement provides a convenient layout and helps avoid component interference.

[0326] The sensor electronics can be configured to provide a first output signal to the electromagnetic signal generating component in a first communication mode and, substantially simultaneously, provide a second output signal to the electromagnetic signal generating component in a second communication mode. The RF frequencies used in the first and second communication modes can be configured to differ from each other. This allows the corresponding first and second output signals to be generated simultaneously from the transceiver. This also allows the first and second input signals received by the transceiver to be parsed according to the corresponding first and second communication modes.

[0327] To help facilitate this communication, or even to have separate communication windows, time slots, or intervals for the first and second communication modes, the sensor electronics system can include a first processor for controlling the first communication mode and a second processor for controlling the second communication mode. In this way, data to be transmitted or data being received can be processed by the respective processors according to the relevant communication mode. This can occur simultaneously or approximately simultaneously, or at different times, as desired.

[0328] The dual function transceiver as described above may be used in the continuous analyte monitoring system described elsewhere in this specification.Thus, the sensor electronics system may include the same or similar components as the sensor control device described herein, although other embodiments are also contemplated.

[0329] The following combination Figure 34A and Figure 34B An example of a dual-function transceiver is provided.

[0330] Figure 34A and Figure 34B An example antenna 3405 according to the disclosed subject matter is shown. Antenna 3405 can be formed on one or more layers of PCB 3102. PCB 3102 can have any of the features of the PCBs described above (e.g., electronic components). PCB 3102 can include a single layer. According to the disclosed subject matter, PCB 3102 can include two, three, four, five, six, seven, eight, nine, ten, eleven, or more layers. Traces can be connected between two or more layers using vias.

[0331] According to the disclosed subject matter, antenna 3405 can include at least one conductive trace on at least one layer of PCB 3102. Antenna 3405 can be configured to operate under multiple protocols, modes and / or frequencies. For example, antenna 3405 can be configured as an NFC antenna operating at or near 13.56MHz, or a Bluetooth or Bluetooth low energy antenna operating at or near 2.45GHz or 432MHz. In this configuration, antenna 3405 may include a first set of contacts for transmitting the monitored analyte level and / or the 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 the processed data associated with the monitored analyte level at a second frequency. When a signal is input to the second contact, antenna 3405 acts as a dipole antenna.

[0332] In accordance with the disclosed subject matter, PCB 3102 may include electronics for a first set of frequencies connected between the two ends of the loop created by the antenna. These electronics may include components that cause the loop to resonate at the first set of frequencies. In accordance with the disclosed subject matter, PCB 3102 may include electronics for a second set of frequencies connected to the midpoint of the loop, including an impedance matching network and a DC barrier for the second set of frequencies. Together, the electronics for the first and second frequencies may form a network that allows the antenna to operate at both frequencies without being affected by the other to a certain extent.

[0333] An antenna 3405 configured to transmit on two different sets of frequencies may be referred to as a "duplex" antenna. Antenna 3405 may also be configured to transmit on three, four, five, six, seven, eight, nine, or ten different frequencies.

[0334] In accordance with the disclosed subject matter, the conductive trace of antenna 3405 can follow the periphery of PCB 3102. For example, the conductive trace of antenna 3405 can follow the periphery of PCB 3102 one, two, three, four, five, six, seven, eight, nine, ten, eleven, or more times to form a loop or spiral of the conductive trace on a layer of PCB 3102. The conductive trace of antenna 3405 can form two, three, four, five, six, seven, eight, nine, ten, eleven, twelve, or more spiral loops that at least partially follow the periphery of PCB 3102. For example, the path of the conductive trace can partially deviate from the periphery of PCB 3102. The conductive trace can take any polygonal shape, such as a square, rectangle, triangle, or other polygon.

[0335] Antenna 3405 may include conductive traces on two or more layers of PCB 3102. Traces between any two layers may be connected via interlayer vias. For example, antenna 3405 may include a first continuous trace forming one or more spiral loops on a first layer of PCB 3102 and a second continuous trace forming two or more spiral loops on a second layer of PCB 3102. As another example, antenna 3405 may include a first continuous trace forming three or more spiral loops on a first layer of PCB 3102 and a second continuous trace forming three or more spiral loops on a second layer of PCB 3102. Similarly, antenna 3405 may include a first continuous trace forming four or more spiral loops on a first layer of PCB 3102 and a second continuous trace forming four or more spiral loops on a second layer of PCB 3102. As another example, antenna 3405 can include a first conductive trace forming five or more spiral loops on a first layer of PCB 3102 and a second conductive trace forming five or more spiral loops on a second layer of PCB 3102. In accordance with the disclosed subject matter, different layers of PCB 3102 can have the same number of spiral loops (e.g., one, two, three, four, five) or a different number of spirals (e.g., three spirals on the first layer and two spirals on the second layer). Antenna 3405 can include conductive traces that span three, four, five, six, seven, eight, nine, ten, or more layers of PCB 3102.

[0336] With respect to NFC, the portion of antenna 3405 formed by the first set of contacts can be at a first set of frequencies via a capacitor. Under normal operating conditions, either end of the portion of antenna 3405 formed by the first set of contacts can be grounded by the NFC electronics. At a second frequency (e.g., for Bluetooth or Bluetooth Low Energy), the capacitor can be of low impedance, effectively shorting both ends of the loop together, thereby grounding both ends at the second set of frequencies.

[0337] PCB 3102 may also include a network of inductors and capacitors to provide proper matching of antenna 3405 at the second set of frequencies and to provide high impedance at the first set of frequencies.

[0338] In a non-limiting example embodiment, the antenna 3405 may at least partially include a conductive element that is not on the PCB 3102. For example, the antenna 3405 may include a conductive element mounted on or above the PCB 3102.

[0339] Additional details of suitable devices, systems, methods, assemblies, and operations thereof, as well as related features, are set forth in International Publication No. WO 2018 / 136898 to Rao et al., International Publication No. WO 2019 / 236850 to Thomas et al., International Publication No. WO 2019 / 236859 to Thomas et al., International Publication No. WO 2019 / 236876 to Thomas et al., and in U.S. Patent Publication No. 2020 / 0196919, filed June 6, 2019, each of which is incorporated herein by reference in its entirety. Further details regarding embodiments of applicators, assemblies thereof, and variations thereof are described in U.S. Patent Publication Nos. 2013 / 0150691, 2016 / 0331283, and 2018 / 0235520, all of which are incorporated herein by reference in their entirety and for all purposes. Further details regarding embodiments of the sharp modules, sharp bodies, components thereof, and variations thereof are described in U.S. Patent Publication No. 2014 / 0171771, which is incorporated herein by reference in its entirety and for all purposes.

[0340] Embodiments disclosed herein include:

[0341] 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 having a proximal portion and a distal portion, wherein the proximal portion is electrically coupled to the printed circuit board and wherein the distal portion is configured to extend beneath the skin of a user to monitor one or more analyte levels in a bodily fluid; a battery connected to the printed circuit board and configured to power the printed circuit board; a processor connected to the printed circuit board and configured to process data associated with the one or more analyte levels being monitored; and an antenna for transmitting processed data, the antenna comprising at least one conductive trace on at least one layer of the printed circuit board, wherein the antenna comprises 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.

[0342] B. A system comprising a printed circuit board; an analyte sensor having a proximal portion and a distal portion, wherein the distal portion is configured to extend beneath the skin of a user to monitor one or more analyte levels 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 the printed circuit board and configured to power the printed circuit board; a processor connected to the printed circuit board and configured to process data associated with the one or more monitored analyte levels; and an antenna for transmitting processed data, the antenna comprising at least one conductive trace on at least one layer of the printed circuit board, wherein the antenna comprises a first set of contacts for transmitting processed data at a first frequency and at least one second contact for transmitting processed data at a second frequency.

[0343] Each of embodiments A and B may have one or more of the following additional elements, in any combination: Element 1: wherein the first frequency is used for transmission using Bluetooth Low Energy and the second frequency is used for transmission using Near Field Communication. Element 2: wherein the at least one conductive trace on at least one layer of the printed circuit board includes a trace along a periphery of the printed circuit board to form a plurality of loops. Element 3: wherein the at least one conductive trace on at least one layer of the printed circuit board includes a conductive trace that at least partially follows the periphery of the printed circuit board to form at least three loops. Element 4: wherein the at least one conductive trace on at least one layer of the printed circuit board includes concentric traces that form at least three loops along the periphery of the printed circuit board. Element 5: wherein 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 the multiple layers of the printed circuit board. Element 6: wherein 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: wherein the first set of contacts includes contacts at ends of the conductive trace, and wherein the conductive trace is between the first set of contacts. Element 8: wherein the at least one second contact comprises at least one contact near a center of the conductive trace. Element 9: wherein the conductive trace and the at least one second contact form a dipole antenna.

[0344] Additionally or alternatively, any elements and combinations applicable to embodiments A and B are also applicable to any other elements and combinations applicable to embodiments A and B.

[0345] 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 those from any other embodiment. If a feature, element, component, function, or step is described with respect to only one embodiment, it should be understood that such feature, element, component, function, or step can be used with every other embodiment described herein, unless expressly stated otherwise. Therefore, this paragraph serves at any time as a prerequisite and written support for introducing claims that combine features, elements, components, functions, and steps from different embodiments, or substitute features, elements, components, functions, and steps from one embodiment for features, elements, components, functions, and steps from another embodiment, even if the following description does not expressly state that such combination or substitution is possible in a particular case. Therefore, for the purposes of illustration and description, the foregoing description of specific embodiments of the disclosed subject matter has been presented. It is expressly acknowledged that explicitly enumerating every possible combination and substitution would be unduly cumbersome, particularly given that the permissibility of each such combination and substitution would be readily recognized by one of ordinary skill in the art.

[0346] Although the embodiments are susceptible to various modifications and substitutions, specific examples thereof have been shown in the accompanying drawings and 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. Therefore, it is intended that the disclosed subject matter include modifications and variations within the scope of the appended claims and their equivalents. In addition, any feature, function, step, or element of the embodiment may be recited in or added to the claims, as well as a negative limitation that limits the scope of the invention of the claims by not including such features, functions, steps, or elements within the scope.

Claims

1. A continuous analyte sensor system for monitoring an analyte level in a bodily fluid of a user, the system comprising: Sensor electronics; and an analyte sensor comprising a proximal portion and a distal portion, the distal portion being configured to be positioned below a user's skin surface to contact a bodily fluid to monitor an analyte level in the bodily fluid, and the proximal portion being configured to be positioned above the user's skin surface and operatively connected to the sensor electronics system; wherein the sensor electronics system is configured to receive a sensor signal indicative of the analyte level from the analyte sensor and to generate data related to the analyte level from the sensor signal for wireless transmission, the sensor electronics system comprising a transceiver for transmitting an output signal including the data related to the analyte level and for receiving an input signal; The transceiver comprises an electromagnetic signal generating component, the electromagnetic signal generating component is configured to provide an output signal, the electromagnetic signal generating component has a first signal feeding point and a second signal feeding point, Wherein, the sensor electronic system is configured to operate in a first communication mode and is also configured to operate in a second communication mode, wherein, in the first communication mode, the sensor electronic system is configured to provide a first output signal to the first signal feeding point of the electromagnetic signal generating component, and in the second communication mode, the sensor electronic system is configured to provide a second output signal to the second signal feeding point of the electromagnetic signal generating component.

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

3. The continuous analyte sensor system of claim 2, wherein: The first signal feeding point is located at one of the first end and the second end.

4. The continuous analyte sensor system according to claim 2 or 3, wherein: The second signal feeding point is located on the coil between the first end and the second end.

5. The continuous analyte sensor system according to any one of claims 2 to 4, wherein: The second signal feed point is located on the coil approximately midway between the first end and the second end.

6. A continuous analyte sensor system according to any one of the preceding claims, wherein: In the second communication mode, the electromagnetic signal generating component is configured to operate as a dipole antenna.

7. A continuous analyte sensor system according to any one of the preceding claims, wherein: In the second communication mode, the sensor electronics system is configured to communicate wirelessly according to the Bluetooth or Bluetooth Low Energy protocol.

8. A continuous analyte sensor system according to any one of the preceding claims, wherein: In the first communication mode, the electromagnetic signal generating component is configured to operate as an inductive antenna.

9. A continuous analyte sensor system according to any one of the preceding claims, wherein: In the first communication mode, the sensor electronics system is configured to communicate wirelessly according to the NFC or RFID protocol.

10. The continuous analyte sensor system according to any one of claims 2 to 9, wherein: The coil comprises two or three or four or more than four loops arranged in substantially coplanar layers.

11. The continuous analyte sensor system according to any one of claims 2 to 10, wherein: The coil comprises two, three, four or more layers of substantially parallel coils.

12. A continuous analyte sensor system according to any one of the preceding claims, wherein: The electromagnetic signal generating component is disposed on one or more substrate layers of a substrate, wherein at least two of the substrate layers are electrically connected via one or more through holes.

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 two inner substrate layers.

14. A continuous analyte sensor system according to any one of the preceding claims, wherein: The sensor electronics system is configured to provide the first output signal to the electromagnetic signal generating component in the first communication mode and to provide the second output signal to the electromagnetic signal generating component substantially simultaneously in the second communication mode.

15. A continuous analyte sensor system according to any one of the preceding claims, 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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