Multiplex antenna wireless communication system

Abstract

A system, apparatus, or device comprising a sample sensor for monitoring sample levels. The system, apparatus, or device may include a printed circuit board. The system, apparatus, or device may also include a connector configured to connect to the printed circuit board and establish an electrical connection between the proximal portion of the sample sensor and the printed circuit board. The system, apparatus, or device may also include a battery configured to connect to the printed circuit board and supply power to the printed circuit board. The system, apparatus, or device may also include a processor configured to connect to the printed circuit board and process data associated with one or more monitored sample levels. The sample sensor may have a proximal portion and a distal portion, the distal portion configured to extend beneath the user's skin to monitor one or more sample levels in body fluids.

Description

Background Art

[0001] This application claims the benefit under "35 U.S.C.§119(e)" of U.S. Provisional Patent Application No. 63 / 465,971, filed May 12, 2023, which is incorporated herein by reference.

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

[0003] Detection and / or monitoring of analyte levels, such as glucose, ketones, lactate, oxygen, hemoglobin, or A1C, can be extremely important with respect to the health of individuals with diabetes. Patients suffering from diabetes mellitus may experience complications including loss of consciousness, cardiovascular disease, retinopathy, neuropathy, and kidney damage. Diabetic patients generally need to monitor their glucose levels to ensure that they are maintained within clinically safe ranges, and can also use this information to determine when they need insulin and / or when they need additional glucose to lower the glucose level in the body or when they need additional glucose to raise the glucose level in the body.

[0004] Increasing clinical data has revealed a strong correlation between the frequency of glucose monitoring and glycemic control. However, despite such a correlation, many individuals diagnosed with diabetes mellitus do not monitor their glucose levels as often as they should due to a combination of factors including convenience, discretion in testing, pain associated with glucose testing, and cost.

[0005] To increase patient adherence to frequent glucose monitoring schedules, an in vivo sample monitoring system can be utilized, which allows a sensor-controlled device to be worn on the body of the individual requiring sample monitoring. To enhance comfort and convenience for the individual, the sensor-controlled device can have a small shape factor and can be assembled by the individual and applied using a sensor applicator. The application process includes inserting a sensor, such as a skin sensor that senses the user's sample level in bodily fluids positioned in the skin layer of the human body, using an applicator or insertion mechanism so that the sensor is in contact with the bodily fluids. The sensor-controlled device can also be configured to transmit sample data to a receiving device from which the individual or their healthcare provider ("HCP") can scrutinize the data and make therapeutic decisions.

[0006] The transmission of sample data from a sensor to a receiving device can be performed using wired or wireless transmission. However, conventional systems place a high emphasis on wireless transmission performed using near-field communication (NFC) and / or Bluetooth communication. Wireless transmission improves the usefulness of sample monitoring sensors by considering manual or automatic transmission of user-monitored sample levels to a receiving device. To ensure transmission, a reliable wireless transmission signal must be maintained between the sensor control device and the receiving device. [Prior art documents] [Patent Documents]

[0007] [Patent Document 1] U.S. Patent Application Publication No. 10,136,816 [Patent Document 2] International Publication No. 2018 / 136898 [Patent Document 3] International Publication No. 2019 / 236850 [Patent Document 4] International Publication No. 2019 / 236859 [Patent Document 5] International Publication No. 2019 / 236876 [Patent Document 6] U.S. Patent Application Publication No. 2020 / 0196919 [Patent Document 7] U.S. Patent Application Publication No. 2013 / 0150691 [Patent Document 8] U.S. Patent Application Publication No. 2016 / 0331283 [Patent Document 9] U.S. Patent Application Publication No. 2018 / 0235520 [Patent Document 10] U.S. Patent Application Publication No. 2014 / 0171771 [Overview of the Initiative] [Problems that the invention aims to solve]

[0008] In other words, there is a need for systems, apparatus, and methods that ensure reliable wireless transmission from sample-level sensors monitored by individuals or HCPs to receiving devices. [Means for solving the problem]

[0009] The objectives and advantages of the disclosed subject matter are listed in the following description and will be apparent therefrom, as well as will be known through the practice of the disclosed subject matter. Additional advantages of the disclosed subject matter will be realized and obtained by the methods and systems specifically indicated in this specification and its claims, as well as in the accompanying drawings.

[0010] To achieve these and other advantages, and in accordance with the objectives of the disclosed subject matter as embodied and outlined, the disclosed subject matter relates to an apparatus that may include a printed circuit board configured to monitor sample levels. In certain non-limiting embodiments, the apparatus may also include a battery configured to be connected to the printed circuit board and to power the printed circuit board. The printed circuit board may include multiple layers. In addition, the apparatus may include a connector configured to be connected to the printed circuit board and to establish an electrical connection between the sample sensor and the printed circuit board, and / or a processor configured to be connected to the printed circuit board and to process data associated with the monitored sample levels. Furthermore, the apparatus may include an antenna for transmitting the monitored sample levels, which may be placed on a plurality of risers. The risers may extend only a fixed distance from the surface of the printed circuit board.

[0011] In certain non-limiting embodiments, the sample level may include a glucose level. The antenna referred to herein as the first antenna may be a Bluetooth low-energy antenna. The plurality of risers may include four risers, two of which are configured to electrically connect the antenna to the printed circuit board. One or more of the plurality of risers may include a folding portion of the antenna. The printed circuit board may be made of FR4 material. At least some of the plurality of risers may be tin pre-plated over nickel. The antenna may include a crossbar positioned between a first set of plurality of risers and a second set of plurality of risers. The crossbar may form an H-shape. In some non-limiting embodiments, the antenna may include two or more ends that form a Y-shape. In certain non-limiting embodiments, the antenna may include a free end that extends a fixed distance from the surface of the printed circuit board. In other non-limiting embodiments, the first set of plurality of risers may be positioned close to a connector, while the second set of plurality of risers may be positioned close to a battery. A second or first set of multiple risers can be configured to electrically connect the antenna to the printed circuit board. The risers can extend only a fixed distance from the surface of the printed circuit board, which can be longer than 1.5 millimeters (mm).

[0012] In some non-limiting embodiments, the antenna can be curved around the outer circumference of the battery. The antenna can be configured as an inverted H-shape or a J-shape. The antenna can have, for example, an unfolded width of about 9.33 mm (or between about 5 and 14 mm), an unfolded length of about 12.04 mm (or between about 7 and 18 mm), and / or a mass of 0.024 grams (or between about 0.01 and 0.04 grams). In other non-limiting embodiments, the device can include a separate NFC antenna for transmitting monitored sample levels. The NFC antenna is referred to herein as the second antenna. The NFC antenna can be embedded in and / or around the circumference of a printed circuit board. In certain non-limiting embodiments, the connector can include at least one of silicone rubber or a carbon-impregnated polymer. In other non-limiting embodiments, the connector can include a connector having metal contacts.

[0013] In certain other non-limiting embodiments, the system may include a sample sensor. A portion of the sample sensor may be positioned in contact with a fluid beneath the skin layer and configured to monitor the sample level in the fluid. The system may also further include a printed circuit board connected to the sample 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 sample sensor and the printed circuit board, and / or a processor connected to the printed circuit board and configured to process data associated with the monitored sample level. Furthermore, the system may include an antenna for transmitting the monitored sample level, which may be placed on a plurality of risers. The risers may extend by a predetermined distance from the surface of the printed circuit board. The system may include any of the features described above with respect to the apparatus.

[0014] To achieve these and other advantages and in accordance with the objectives of the subject matter of the disclosure of the present invention, as embodied and broadly described, the subject matter of the disclosure of the present invention relates to a device that may include a printed circuit board configured to monitor sample levels. In certain non-limiting embodiments, the device may also include a printed circuit board. In certain non-limiting embodiments, the device may also include a connector connected to the printed circuit board and configured to establish an electrical connection between sample sensors having a proximal portion and a distal portion, the proximal portion being electrically coupled to the printed circuit board and the distal portion being configured to extend below the user's skin to monitor the levels of one or more samples in a body fluid. In certain non-limiting embodiments, the device may also include a battery connected to the printed circuit board and configured to power the printed circuit board. In certain non-limiting embodiments, the device may also include a processor connected to the printed circuit board and configured to process data associated with the monitored one or more sample levels. In certain non-limiting embodiments, the apparatus may also include an antenna for transmitting processed data, the antenna comprising at least one conductive trace on at least one layer of a printed circuit board, and the antenna comprising 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.

[0015] In certain non-limiting embodiments, the first frequency may be for transmissions using Bluetooth Low Energy, and the second frequency may be for transmissions using Short-Range Wireless Communication. In certain non-limiting embodiments, at least one conductive trace on at least one layer of the printed circuit board may form a plurality of loops along the periphery of the printed circuit board. In certain non-limiting embodiments, at least one conductive trace on at least one layer of the printed circuit board may include at least one conductive trace that forms at least three loops along at least partially the periphery of the printed circuit board. In certain non-limiting embodiments, at least one conductive trace on at least one layer of the printed circuit board may form at least three loops along the periphery of the printed circuit board. In certain non-limiting embodiments, 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 a plurality of layers of the printed circuit board. In certain non-limiting embodiments, at least one conductive trace on each of a plurality of layers of the printed circuit board may be connected by vias between two layers of the printed circuit board. In certain non-limiting embodiments, the first set of contacts may include contacts at the ends of the conductive traces, and the conductive traces may be between the first set of contacts. In certain non-limiting embodiments, at least one second contact may include at least one contact near the center of the conductive trace. In certain non-limiting embodiments, the conductive trace and at least one second contact may form a bipolar antenna. In certain non-limiting embodiments, the printed circuit board may include a grounding plate configured on its own plane.

[0016] In certain other non-limiting embodiments, the system may include a printed circuit board. In certain other non-limiting embodiments, the system may include a sample sensor having a proximal and distal portion, the distal portion configured to extend below the user's skin to monitor one or more sample levels in a body fluid. In certain other non-limiting embodiments, the system may include a connector connected to the printed circuit board and configured to establish an electrical connection between the proximal portion of the sample sensor and the printed circuit board. In certain other non-limiting embodiments, the system may include a battery connected to the printed circuit board and configured to power the printed circuit board. In certain other non-limiting embodiments, the system may include a processor connected to the printed circuit board and configured to process data associated with the monitored one or more sample levels. In certain other non-limiting embodiments, the system may include an antenna for transmitting the processed data, the antenna including at least one conductive trace on at least one layer of the printed circuit board, the antenna including a first set of contacts for transmitting the processed data at a first frequency and at least one second contact for transmitting the processed data at a second frequency. This antenna is referred to herein as the first antenna.

[0017] Details of the subject matter enumerated herein with respect to both its structure and operation can be made clear by a close examination of the accompanying drawings, in which the same reference numbers refer to the same parts. The components of the drawings are not necessarily to scale, but rather the emphasis is on illustrating the principles of the subject matter. Furthermore, all examples are intended to convey concepts, and relative sizes, shapes, and other detailed attributes may be illustrated schematically rather than literally or precisely. [Brief explanation of the drawing]

[0018] [Figure 1] This is a conceptual diagram illustrating an exemplary sample monitoring system that may incorporate one or more embodiments of the disclosure of the present invention. [Figure 2A] An isometric projection view of an exemplary sensor control device according to certain non-limiting embodiments. [Figure 2B] A side view of an exemplary sensor control device according to certain non-limiting embodiments. [Figure 3A] An isometric projection view of the plug assembly of FIGS. 2A and 2B according to certain non-limiting embodiments. [Figure 3B] An exploded assembly view of the plug assembly of FIGS. 2A and 2B according to certain non-limiting embodiments. [Figure 4A] An exploded assembly view of the electronic device housing of FIGS. 2A and 2B according to certain non-limiting embodiments. [Figure 4B] A bottom isometric projection view of the electronic device housing of FIGS. 2A and 2B according to certain non-limiting embodiments. [Figure 5A] A side view of the sensor applicator of FIG. 1 with the cap attached according to certain non-limiting embodiments. [Figure 5B] A cross-sectional side view of the sensor applicator of FIG. 1 with the cap attached according to certain non-limiting embodiments. [Figure 6A] An enlarged cross-sectional side view of the sensor control device mounted within the cap according to certain non-limiting embodiments. [Figure 6B] An enlarged cross-sectional side view of another embodiment of the sensor control device mounted within the sensor applicator according to certain non-limiting embodiments. [Figure 7] An isometric projection view of an exemplary sensor control device according to certain non-limiting embodiments. [Figure 8] A side view of the sensor applicator of FIG. 1 according to certain non-limiting embodiments. [Figure 9] A cross-sectional side view of the sensor applicator according to certain non-limiting embodiments. [Figure 10A] An isometric projection view of an exemplary sensor control device according to certain non-limiting embodiments. [Figure 10B]This is a side view of an exemplary sensor control device according to a certain non-limiting embodiment. [Figure 11A] This is an isometric projection view of a plug assembly according to a certain non-limiting embodiment. [Figure 11B] This is an exploded view of a plug assembly according to a certain non-limiting embodiment. [Figure 11C] This is an isoangular bottom view of a disassembled plug and storage vial according to a certain non-limiting embodiment. [Figure 12A] This is a side view of the sensor applicator shown in Figure 1, which has a cap according to a certain embodiment. [Figure 12B] This is a cross-sectional side view of the sensor applicator shown in Figure 1, which has a cap according to a certain embodiment. [Figure 13A] This is a side view of a sensor applicator according to a certain non-limiting embodiment. [Figure 13B] This is a cross-sectional side view of a sensor applicator according to a certain non-limiting embodiment. [Figure 14] This is a perspective view of an exemplary embodiment of a cap according to a certain embodiment. [Figure 15] This is a cross-sectional side view of a sensor control device positioned within a cap according to a certain embodiment. [Figure 16A] This is an isometric projection of an exemplary sensor control device according to a certain embodiment. [Figure 16B] This is a side view of an exemplary sensor control device according to a certain embodiment. [Figure 17A] This is an exploded perspective top view of a sensor control device according to a certain embodiment. [Figure 17B] This is an exploded perspective bottom view of a sensor control device according to a certain embodiment. [Figure 18A] This is an isometric projection of an exemplary sensor control device according to a certain embodiment. [Figure 18B] This is a side view of an exemplary sensor control device according to a certain embodiment. [Figure 18C]This is a bottom view of an exemplary sensor control device according to a certain embodiment. [Figure 19A] This is an isometric top view of a sensor control device according to a certain embodiment. [Figure 19B] This is an isometrically resolved bottom view of a sensor control device according to a certain embodiment. [Figure 20A] This figure shows the fabrication of a sensor control device according to a certain embodiment. [Figure 20B] This figure shows the fabrication of a sensor control device according to a certain embodiment. [Figure 21] This is a side view of an exemplary sensor according to a certain embodiment. [Figure 22A] This is an isometric projection view of an exemplary connector assembly according to a certain embodiment. [Figure 22B] This is a partially exploded isometric projection view of an exemplary connector assembly according to a certain embodiment. [Figure 22C] Figures 22A and 22B are isometric bottom views of the connector. [Figure 22D] This is an isometric projection view of another exemplary connector assembly according to a certain embodiment. [Figure 22E] This is a partially exploded isometric projection view of another exemplary connector assembly according to a certain embodiment. [Figure 22F] Figures 22D and 22E are isometric bottom views of the connector. [Figure 23A] This is a side view of an exemplary sensor control device according to a certain embodiment. [Figure 23B] This is an isometric projection of an exemplary sensor control device according to a certain embodiment. [Figure 24A] This is an exploded, isometric top view of a sensor control device according to a certain embodiment. [Figure 24B] This is an exploded, isometric view of a sensor control device according to a certain embodiment. [Figure 25A] These are cross-sectional side views of a sensor control device illustrated in Figures 23A-23B and 24A-24B according to a certain embodiment. [Figure 25B] Figures 23A-23B and 24A-24B are exploded isometric projection views of a portion of another embodiment of the sensor control device illustrated in Figures 23A-23B and 24A-24B. [Figure 26A] Figures 23A-23B and 24A-24B are isometric base views of the mounts exemplified by these figures. [Figure 26B] Figures 23A-23B and 24A-24B are isometric top views of the sensor caps exemplified by these figures. [Figure 27A] This is a side view of an exemplary sensor applicator according to a certain embodiment. [Figure 27B] This is a cross-sectional side view of an exemplary sensor applicator according to a certain embodiment. [Figure 28A] Figure 27B is a perspective view of a cap post illustrated in a certain embodiment. [Figure 28B] This is a top view of a cap post illustrated in Figure 27B, according to a certain embodiment. [Figure 29] This is a cross-sectional side view of a sensor control device positioned within an applicator cap according to one or more embodiments. [Figure 30] This is a cross-sectional view of a sensor control device illustrating an exemplary interaction between the sensor and Sharp. [Figure 31A] This figure shows a printed circuit board according to a certain embodiment. [Figure 31B] This figure shows a printed circuit board according to a certain embodiment. [Figure 32] This figure shows a radiation element according to a certain embodiment. [Modes for carrying out the invention]

[0019] Before describing the subject matter of the present invention in detail, it should be noted that the disclosure of the present invention is not limited to the specific embodiments described and is therefore naturally subject to change. Since the scope of the disclosure of the present invention is not limited to the claims, it should also be understood that the terms used herein are solely for the purpose of describing specific embodiments.

[0020] The documents discussed herein are provided solely on the grounds that they disclose information prior to the filing date of this application. Nothing in this specification should be construed as accepting that the disclosure of the present invention does not have prior rights to such documents on the grounds that they are prior disclosures. Furthermore, the dates of the documents provided may differ from the actual publication dates, and these publication dates may need to be independently verified.

[0021] Herein, the disclosure of the present invention will be described more fully below with reference to the accompanying drawings illustrating certain exemplary embodiments, which form part thereof. However, the subject matter intended or claimed can be embodied in a variety of different forms and is therefore intended to be interpreted as not being limited to any of the exemplary embodiments listed herein, which are provided merely illustrative. Similarly, a reasonably broad scope of the subject matter intended or claimed is intended. In particular, for example, the subject matter can be embodied as a method, device, component, or system. Thus, embodiments can take the form of, for example, hardware, software, firmware, or any combination thereof (excluding software itself). Accordingly, the following detailed description is not intended to be understood in a restrictive sense.

[0022] In the detailed description herein, references to “embodiments,” “one embodiment,” “one non-limiting embodiment,” and “in various embodiments” indicate that the embodiments described may include certain features, structures, or characteristics, but not all embodiments may necessarily include such features, structures, or characteristics. Furthermore, such phrases do not necessarily refer to the same embodiments. Moreover, when describing certain features, structures, or characteristics in relation to embodiments, whether explicitly stated or not, it is within the knowledge of those skilled in the art that such features, structures, or characteristics may be affected in relation to other embodiments. After reading this description, it will be clear to those skilled in the art how the disclosures of the present invention may be implemented in alternative embodiments.

[0023] In general, terms can be understood, at least partially, from their use in context. For example, terms such as “and,” “or,” or “and / or” used herein may depend at least partially on the context in which they are used. Typically, “or” is used to mean A, B, and C when used to relate an enumeration such as A, B, or C, in which case it is used in an inclusive sense, and further, it is intended to mean A, B, or C, in which case it is used in an exclusive sense. In addition, “one or more” as used herein may, at least partially depending on the context, be used to describe any feature, structure, or characteristic in a single sense, or to describe a combination of features, structures, or characteristics in multiple senses. Similarly, terms such as “a,” “an,” and “the” can, again, at least partially depending on the context, be understood to convey a singular or plural referent. In addition, the term “based on” is not necessarily intended to convey a limited set of factors, and instead may, again, at least partially depending on the context, allow for the presence of additional factors that are not necessarily explicitly described.

[0024] When used herein, “equipped with,” “possessing,” or any other variation thereof is intended to encompass non-limiting inclusion such that a process, method, article, or apparatus containing the enumerated elements may include not only those elements but also other elements not expressly enumerated, or elements inherent to such process, method, article, or apparatus.

[0025] Various types of in vivo sample monitoring systems exist. A "continuous sample monitoring" system (or "continuous glucose monitoring" system) can, for example, automatically transmit data continuously from a sensor control device to a reader device, for example, according to a schedule, without requiring an acknowledgment. As another example, an "intermittent sample monitoring system" (or "intermittent glucose monitoring" system, or simply an "intermittent" system) can transfer data from a sensor control device in response to scanning or data requests by a reader device using protocols such as Near Field Communication (NFC) or Radio Frequency Identification (RFID). In vivo sample monitoring systems can also operate without the need for fingertip puncture calibration.

[0026] In vivo sample monitoring systems can be distinguished from "in vitro" systems, which typically have a port for receiving a sample test strip containing the user's bodily fluids that can be analyzed to determine the user's blood glucose level after coming into contact with a biological sample outside the body (or "outside the body").

[0027] An in vivo monitoring system may include a sensor that comes into contact with the user's bodily fluids while positioned on the body and senses the level of a sample contained therein. The sensor may be part of a sensor control device located on the user's body, which includes electronic equipment and a power supply that enable and control the sample sensing. Sensor control devices and their variations may be referred to, to name a few examples, as a "sensor control unit," a "body electronic device" device or "body electronic device" unit, a "body" device or "body" unit, or a "sensor data communication" device or "sensor data communication" unit.

[0028] In vivo monitoring systems may include devices that receive and process sensing sample data from sensor control devices and / or display it to the user in any number of forms. These devices and their variations may be referred to, to a limited number of examples, as “handheld reader devices,” “reader devices” (or simply “readers”), “handheld electronic devices” (or simply “handheld”), “portable data processing” devices or “portable data processing” units, “data receivers,” “receivers” devices or “receivers” units (or simply “receivers”), or “remote” devices or “remote” units. Other devices, such as personal computers, may also be used in conjunction with or incorporated into in vivo or in vitro monitoring systems.

[0029] Figure 1 is a conceptual diagram illustrating an exemplary sample monitoring system 100 that may incorporate one or more embodiments of the disclosure of the present invention. Using System 100 (hereinafter referred to as "System 100"), a variety of samples can be detected and quantified, including but not limited to acetylcholine, amylase, bilirubin, cholesterol, chorionic gonadotropin, creatine kinase (e.g., CK-MB), creatine, DNA, fructosamine, glucose, glutamine, growth hormone, hormones, ketones (e.g., ketone bodies), lactates, oxygen, peroxides, prostate-specific antigen, prothrombin, RNA, thyroid-stimulating hormone, and troponin. The concentrations of drugs such as antibiotics (e.g., gentamicin and vancomycin), digitoxin, digoxin, addiction drugs, theophylline, and warfarin can be determined.

[0030] As shown in the figure, system 100 includes a sensor applicator 102 (hereinafter referred to as the "insertor"), a sensor control device 104 (also referred to as the "in vivo sample 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., the user's arm). Once delivered, the sensor control device 104 is held in place on the skin using an adhesive patch 108 attached to its base. A portion of the sensor 110 extends from the sensor control device 104 and is positioned percutaneously so that it can be retained beneath the surface of the user's skin during the monitoring period.

[0031] An introducer may be included to facilitate the introduction of the sensor 110 into the tissue. The introducer may include, for example, a needle, often referred to as a "sharp." Alternatively, the introducer may include other types of devices, such as a sheath or blade. The introducer may be temporarily present around the sensor 110 before tissue insertion and then withdrawn. While present, the introducer can facilitate the insertion of the sensor 110 into the tissue by opening an access path for the sensor 110 to follow. For example, the introducer may penetrate the epidermis and provide an access path to the dermis to allow subcutaneous implantation of the sensor 110. After opening the access path, the introducer may be withdrawn (retracted) so as not to obstruct the sensor while the sensor 110 remains in place.

[0032] In exemplary embodiments, the introducer may be solid or hollow, beveled or non-beveled, and / or have a circular or non-circular cross-section. In more specific embodiments, a suitable introducer may have a cross-sectional diameter and / or tip design equivalent to that of an acupuncture needle, which may have a cross-sectional diameter of about 250 microns. However, it should be recognized that a suitable introducer may have a larger or smaller cross-sectional diameter if required for a particular application.

[0033] In some embodiments, the tip of the introducer can be inclined over the end of the sensor 110 (while it is present) so that the introducer first penetrates the tissue and opens an access path for the sensor 110. In other exemplary embodiments, the sensor 110 may be located in the lumen or groove of the introducer, and the introducer also opens an access path for the sensor 110. In either case, the introducer can be withdrawn after facilitating the insertion of the sensor. Furthermore, the introducer (sharp) can be manufactured from various materials such as various types of metals and plastics.

[0034] When the sensor control device 104 is properly assembled, the sensor 110 is in communication (e.g., electrically, mechanically) with one or more electrical components or sensor electronic equipment contained within the sensor control device 104. In some applications, for example, the sensor control device 104 may include a printed circuit board (PCB) having a data processor (e.g., an application-specific integrated circuit or ASIC) mounted thereon, and the sensor 110 may be operationally coupled to this data processor, which may further be coupled to an antenna and a power supply.

[0035] The sensor control device 104 and the reader device 106 are configured to communicate with each other through a local communication path or link 112 that can be wired or wireless, unidirectional or bidirectional, and encrypted or unencrypted. In some embodiments, the reader device 106 includes an output medium for viewing sample concentration and warnings or notifications determined by the sensor 110 or its associated processor, and can further allow one or more user inputs. The reader device 106 can be a multipurpose smart phone or a dedicated electronic reading instrument. Although only one reader device 106 is shown, in certain cases, multiple reader devices 106 may be present.

[0036] The reader device 106 can also communicate with the remote terminal 114 and / or the highly reliable computer system 116 via wired or wireless, unidirectional or bidirectional, and encrypted or unencrypted communication paths / links 118 and / or 120, respectively. The reader device 106 can also communicate with the network 122 (e.g., a mobile phone network, the Internet, or a cloud server) via communication path / link 124, or alternatively. The network 122 can further communicate with the remote terminal 114 via communication path / link 126 and / or with the highly reliable computer system 116 via communication path / link 128.

[0037] Alternatively, without the presence of an intermediary reader device 106, the sensor control device 104 can communicate directly with the remote terminal 114 and / or the highly reliable computer system 116. For example, in some embodiments, the sensor 110 can communicate with the remote terminal 114 and / or the highly reliable computer system 116 through a direct communication link to the network 122, as described in U.S. Patent Application Publication No. 10,136,816, which is incorporated herein by reference in its entirety.

[0038] Any suitable electronic communication protocol, such as NFC protocol, radio frequency identification (RFID) protocol, Bluetooth® protocol or Bluetooth® Low Energy protocol, or wireless land area network, can be used for each communication path or link. In some embodiments, the remote terminal 114 and / or the highly reliable computer system 116 can be made accessible to individuals other than the primary user who are interested in the user's sample level. The reader device 106 may include a display 130 and an optional input component 132. In some embodiments, the display 130 may include a touch screen interface.

[0039] In some embodiments, the sensor control device 104 can automatically transfer data to the reader device 106. For example, sample concentration data can be communicated automatically and periodically, for example, when data is acquired, or at a predetermined frequency (e.g., every minute, every five minutes, or at other predetermined intervals) after a predetermined period has elapsed since the data was stored in memory until transmission. In other embodiments, the sensor control device 104 can communicate with the reader device 106 in an unautomated manner and without following a set schedule. For example, data can be communicated from the sensor control device 104 using RFID technology when the sensor electronic equipment is placed within communication range of the reader device 106. The data can remain stored in the memory of the sensor control device 104 until it is communicated to the reader device 106. Therefore, the patient does not need to maintain close proximity to the reader device 106 at all times, but can instead upload data at a convenient time. In yet another embodiment, a combination of automatic and unautomated data transfer can be implemented. For example, data transfer can continue automatically until the reader device 106 is no longer within communication range of the sensor control device 104.

[0040] The sensor control device 104 is often included with the sensor applicator 104 in what is known as a "two-piece" architecture, which 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 the accompanying electrical components contained within the sensor control device 104 are provided to the user in multiple (two) packages, and the user must unpack the packages and manually assemble these components according to the instructions before delivering the sensor 110 to the target monitoring location using the sensor applicator 102.

[0041] However, very recently, advanced designs for sensor control devices and sensor applicators have made it possible to ship systems to users in a single sealed package, resulting in a one-piece architecture that eliminates the need for any final user assembly stages. Rather, the user only needs to unpack one package and then ship the sensor control device to the target monitoring location. The one-piece system architecture can be demonstrated to be advantageous by eliminating component parts, various manufacturing stages, and user assembly stages. As a result, packaging and waste are reduced, and the risk of user error or system contamination is mitigated.

[0042] In the illustrated embodiment, the system 100 may be configured 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 its accompanying electrical components contained within the sensor control device 104 are provided to the user in multiple (two) packages, in which case each of these may or may not be sealed with a sterile isolation wall, but are at least contained within a package. The user must unpack the packages, manually assemble these components according to the instructions, and then deliver the sensor 110 to the target monitoring location using the sensor applicator 102. However, in certain other embodiments, the system 100 may be configured as a "one-piece" architecture.

[0043] Figures 2A and 2B are isometric and side views, respectively, of an exemplary sensor control device 202 according to one or more embodiments of the disclosure of the present invention. The sensor control device 202 (hereinafter referred to as the “pack”) can be similar in some respects to the sensor control device 104 of Figure 1, and is therefore best understood by referring to it. The sensor control device 202 can replace the sensor control device 104 of Figure 1 and can therefore be used in conjunction with the sensor applicator 102 (Figure 1), which delivers the sensor control device 202 to a target monitoring location on the user’s skin.

[0044] However, the sensor control device 202 can be integrated into a one-piece system architecture. Unlike a two-piece architecture, for example, the user is not required to unpack multiple packages and finally assemble the sensor control device 202. Instead, upon receiving the product, the sensor control device 202 is already fully assembled and properly positioned within the sensor applicator 102. To use the sensor control device 202, the user only needs to break one barrier, such as the applicator cap, before immediately sending the sensor control device 202 to the target monitoring location.

[0045] As shown in the figures, the sensor control device 202 includes an electronic housing 204 which is a pack molded to have a substantially disk-shaped electronic housing and / or a circular cross-section. However, in other embodiments, the electronic housing 204 may have other cross-sectional shapes such as oval (e.g., tablet-shaped), rounded square, or polygonal without departing from the scope of the disclosure of the present invention. The electronic housing 204 may be configured to house or otherwise enclose various electrical components used to operate the sensor control device 202.

[0046] The electronic equipment housing 204 may include a shell 206 and a mount 208 to which it can be mated. The shell 206 can be secured to the mount 208 by a variety of methods, such as snap-fit, interlocking, ultrasonic welding, or one or more mechanical fasteners (e.g., screws). In some cases, the shell 206 can be secured to the mount 208 such that a sealed interface is created between them. In such embodiments, a gasket or other type of sealing material is positioned around or near the outer diameter (circumference) of the shell 206 and the mount 208, and the gasket can be compressed by securing these two components to each other, thereby creating a sealed interface. In other embodiments, an adhesive can be applied to the outer diameter (circumference) of one or both of the shell 206 and the mount 208. The adhesive not only secures the shell 206 to the mount 208 and provides structural integrity, but also seals the interface between these two components, thereby isolating the interior of the electronic equipment housing 204 from external contamination. When the sensor control device 202 is assembled in a controlled environment, it may not be necessary to ultimately sterilize the internal electrical components. Rather, adhesive bonding can provide a sufficient sterile barrier to the assembled electronic equipment housing 204.

[0047] The sensor control device 202 may further include a plug assembly 210 that can be coupled to the electronic housing 204. For example, the plug assembly 210 may include a sensor module 212 (partially visible) that is interconnectable with a sharp module 214 (partially visible). The sensor module 212 may be configured to carry and include a sensor 216 (partially visible), and the sharp module 214 may be configured to carry and include a sharp 218 (partially visible) used to help deliver the sensor 216 transcutaneously under the user's skin during the attachment of the sensor control device 202. As shown, the corresponding portions of the sensor 216 and the sharp 218 extend from the electronic housing 204, more specifically from the bottom of the mount 208. The exposed portion of the sensor 216 can be received in the hollow or recessed portion of the sharp 218. The remaining portion of the sensor 216 is positioned within the electronic housing 204.

[0048] Figures 3A and 3B are isometric and exploded views, respectively, of a plug assembly 210 according to one or more embodiments. The sensor module 212 may include a sensor 216, a plug 302, and a connector 304. The plug 302 may be designed to receive and support both the sensor 216 and the connector 304. As shown, a channel 306 may be defined to receive a portion of the sensor 216 through the plug 302. Furthermore, the plug 302 may provide one or more deflectable arms 307 configured to snap into corresponding feature portions provided on the bottom of the electronic equipment housing 204 (Figures 2A and 2B).

[0049] The sensor 216 includes a tail 308, a flag 310, and a neck 312 interconnecting the tail 308 and the flag 310. The tail 308 can be configured to extend at least partially through the channel 306 and distally from the plug 302. The tail 308 contains an enzyme or other chemical or biological agent, and in some embodiments, a membrane can cover the chemical agent. During use, the tail 308 is received percutaneously under the user's skin, and the chemical agent contained on the tail helps facilitate specimen monitoring in the presence of body fluids.

[0050] The flag 310 may include a substantially flat surface on which one or more sensor contacts 314 (three shown in Figure 3B) are positioned. The sensor contacts 314 may be configured to align with a corresponding number of flexible carbon-impregnated polymer modules (not shown) enclosed within the connector 304.

[0051] The connector 304 includes one or more hinges 318 that allow it to move between an open and a closed state. Figures 3A and 3B show the connector 304 in the closed state, but the connector 304 can pivot and rotate to the open state to receive the flag 310 and the flexible carbon-impregnated polymer module therein. The flexible carbon-impregnated polymer module provides electrical contacts 320 (three shown) configured to give conductive communication between the sensor 216 and the corresponding circuit contacts provided in the electronic housing 204 (Figures 2A and 2B). The connector 304 can be manufactured from silicone rubber and can act as a moisture barrier to the sensor 216 when assembled in a compressed state and after being applied to the user's skin.

[0052] The Sharp module 214 includes a Sharp 218 and a Sharp hub 322 that supports it. The Sharp 218 includes an elongated shaft 324 and a Sharp tip 326 at its distal end. The shaft 324 may be configured to extend through the channel 306 and distally from the plug 302. Furthermore, the shaft 324 may include a hollow or recessed portion 328 that at least partially surrounds the tail 308 of the sensor 216. The Sharp tip 326 may be configured to penetrate the skin while supporting the tail 308 in order to bring the activating agent present on the tail 308 into contact with body fluids.

[0053] The sharp hub 322 may include a hub miniature cylinder 330 and a hub snap locking claw 332, each of which may be configured to help connect the plug assembly 210 (and the entire sensor control device 202) to the sensor applicator 102 (Figure 1).

[0054] Figures 4A and 4B are exploded and assembled views and bottom isometric projection views, respectively, of an electronic device housing 204 according to one or more embodiments. The shell 206 and mount 208 function as opposing clamshell halves that enclose or substantially encapsulate various electronic components of the sensor control device 202 (Figures 2A and 2B).

[0055] A printed circuit board (PCB) 402 can be placed inside the electronic equipment housing 204. The PCB 402 can be fitted with several electronic modules (not shown), including but not limited to data processing units, resistors, transistors, capacitors, inductors, diodes, and switches. The data processing unit may include, for example, an application-specific integrated circuit (ASIC) configured to perform one or more functions or routines associated with the operation of the sensor control device 202. More specifically, the data processing unit may be configured to perform data processing functions, in which case such functions may include, but are not limited to, filtering and encoding of data signals, each corresponding to a user's sampled sample level. The data processing unit may include or otherwise communicate with the reader device 106 (Figure 1), including an antenna for communication with it.

[0056] As shown in the figures, the shell 206, mount 208, and printed circuit board 402 each define corresponding central openings 404, 406, and 408, respectively. When the electronic equipment housing 304 is assembled, the central openings 404, 406, and 408 are coaxially aligned to receive the respective parts of the plug assembly 210 (Figures 3A and 3B) through it. The electronic equipment housing 204 can house a battery 410 and be configured to power the sensor control device 202.

[0057] In Figure 4B, the plug receptacle 412 is positioned at the bottom of the mount 208 and provides a place for the plug assembly 210 (Figures 3A and 3B) to be received and coupled to the electronics housing 204, thereby allowing the sensor control device 202 (Figures 2A and 2B) to be fully assembled. The shape of the plug 302 (Figures 3A and 3B) can be molded to match or complement the plug receptacle 412, and the plug receptacle 412 can provide one or more snap locking ledges 414 (two shown) configured to engage with and receive the deflectable arm 307 (Figures 3A and 3B) of the plug 302. The plug assembly 210 is coupled to the electronics housing 204 by allowing the plug 302 to advance into the plug receptacle 412 and the deflectable arm 307 to engage into the corresponding snap locking ledge 414. When the plug assembly 210 (Figures 3A and 3B) is properly coupled to the electronic equipment housing 204, one or more circuit contacts 416 (three shown) located on the underside of the PCB 402 can establish conductive communication with the electrical contacts 320 (Figures 3A and 3B) of the connector 304 (Figures 3A and 3B).

[0058] Figures 5A and 5B are a side view and a cross-sectional side view, respectively, of the sensor applicator 102 with the applicator cap attached. More specifically, Figures 5A and 5B illustrate how the sensor applicator 102 may be shipped and how it may be received by the user according to at least one embodiment. However, in some embodiments, the sensor applicator 102 may be further sealed in a bag (not shown) and delivered to the user in this bag. The bag may be made of a variety of materials that help prevent moisture from entering the sensor applicator 102, which could adversely affect the sensor 216. In at least one embodiment, for example, the sealed bag may be made of foil. Any and all of the sensor applicators described or discussed herein may be sealed in a bag and delivered to the user in this bag.

[0059] With the disclosure of the present invention, as can be seen in Figure 5B, the sensor control device 202 is already assembled and installed in the sensor applicator 102 before being delivered to the user. The applicator cap can be screwed onto the housing and may include a tamper-evident ring 502. When the applicator cap is rotated relative to the housing (e.g., twisted off), the tamper-evident ring 502 is unscrewed, thereby releasing the applicator cap from the sensor applicator 102. Subsequently, the user can deliver the sensor control device 202 to the target monitoring location.

[0060] In some embodiments, as described above, the applicator cap can be secured to the housing by a sealing engagement to protect the internal components of the sensor applicator 102. In at least one embodiment, for example, an O-ring or another type of sealing gasket can seal the interface between the housing and the applicator cap. The O-ring or sealing gasket may be a separate component or, instead, can be molded onto either the housing or the applicator cap.

[0061] The housing can be manufactured from a variety of rigid materials. In some embodiments, for example, the housing can be manufactured from a thermoplastic polymer such as polyketone. In other embodiments, the housing can be manufactured from a cyclic olefin copolymer (COC) which can help prevent moisture from entering the sensor applicator 102. As is obvious, any and all of the housings described or discussed herein can be manufactured from polyketone or COC.

[0062] Referring particularly to Figure 5B, the sensor control device 202 can be loaded into the sensor applicator 102 by fitting the Sharp hub 322 onto the sensor carrier 504 contained within the sensor applicator 102. With the sensor control device 202 fitted onto the sensor carrier 504, the applicator cap can then be fixed to the sensor applicator 102.

[0063] In exemplary embodiments, the collimator 506 is positioned within the applicator cap, and the collimator 506 can generally be used to support the sensor control device 202 while it is contained within the sensor applicator 102. In some embodiments, the collimator 506 can form an integral part or extension of the applicator cap by molding it together with the applicator cap or by overmolding it. In other embodiments, the collimator 506 may include a separate structure fitted into or attached to the applicator cap, without departing from the scope of the disclosure of the present invention. In yet another embodiment, as discussed below, the collimator 506 is excluded within the package received by the user but can be used elsewhere while the sensor applicator 102 is sterilized and prepared for delivery.

[0064] The collimator 506 can be designed to help receive and protect portions of the sensor control device 202 that require sterility, and to isolate the sterile components of the sensor applicator 102 from microbial contamination from other parts of the sensor control device 202. To achieve this isolation, the collimator 506 may define or otherwise provide a sterile zone 508 (hereinafter referred to as the “sterile barrier enclosure” or “sterile sensor pathway”) configured to receive the sensor 216 and Sharp 218 extending from the bottom of the electronic housing 204. The sterile zone 508 may generally comprise a hole or passage extending at least partially through the body of the collimator 506. In exemplary embodiments, the sterile zone 508 extends through the entire body of the collimator 506, but alternatively, it may extend only partially through the body without departing from the scope of the disclosure of the present invention.

[0065] When the sensor control device 202 is loaded into the sensor applicator 102 and the applicator cap having the collimator 506 is secured to the sensor applicator 102, the sensor 216 and the sharp 218 can be positioned within a sealed area 510, at least partially defined by a sterilization zone 508. The sealed area 510 is configured to isolate the sensor 216 and the sharp 218 from external contamination and may include (contain) a selected portion within the electronic equipment housing 204. Certain embodiments may include a sterilization zone 508 for the collimator 506.

[0066] In certain embodiments, a fully assembled sensor control device 202 can be subjected to radiation sterilization 512 while it is positioned within a sensor applicator 102. Radiation sterilization 512 may include, for example, electron beam irradiation, but other sterilization methods, including but not limited to low-energy X-ray irradiation, can be used instead. In some embodiments, radiation sterilization 512 can be delivered by either continuous irradiation or pulsed beam irradiation. In pulsed beam irradiation, the beam of radiation sterilization 512 is focused to a target location, the component or device to be sterilized is moved to the target location, at which point radiation sterilization 512 is activated to provide an induced radiation pulse. Next, radiation sterilization 512 is stopped, another component or device to be sterilized is moved to the target location, and this process is repeated.

[0067] The collimator 506 can be configured to focus radiation (e.g., beam, wave, energy, etc.) from the radiation sterilization 512 toward components that require sterility, such as the sensor 216 and the Sharp 218. More specifically, the holes or passages in the sterilization zone 508 allow the transmission of radiation that enters onto the sensor 216 and the Sharp 218 to sterilize them, while the remaining portion of the collimator 506 prevents (blocks) the propagating radiation from destroying or damaging electronic components within the electronic equipment housing 204.

[0068] The sterilization zone 508 can have any suitable cross-sectional shape necessary to properly focus radiation onto the sensor 216 and the Sharp 218 for sterilization. In exemplary embodiments, for example, the sterilization zone 508 is cylindrical, but it is conceivable that it could instead have a polygonal cross-sectional shape such as a cube or rectangle (including, for example, a parallelogram) without departing from the scope of the disclosure of the present invention.

[0069] In an exemplary embodiment, the sterilization zone 508 provides a first opening 514a at a first end and a second opening 514b at a second end opposite the first end. The first opening 514a can be configured to receive the sensors 316 and Sharp 318 into the sterilization zone 508, and the second opening 514b can allow radiation (e.g., beam, wave, etc.) from the radiation sterilization 512 to enter the sterilization zone 508 and be incident on the sensors 216 and Sharp 218. In an exemplary embodiment, the first opening 514a and the second opening 514b have the same diameter.

[0070] The body of the collimator 506 reduces or eliminates the possibility of radiation sterilization 512 penetrating the body material and thereby damaging electronic components within the electronic equipment housing 204. To achieve this reduction or elimination, in some embodiments, the collimator 506 can be manufactured from a material having a mass density higher than 0.9 grams per cubic centimeter (g / cc). One exemplary material for the collimator 506 is polyethylene, but it is conceivable that any material similar to or with a higher mass density than polyethylene may be included instead. In some embodiments, for example, the material for the collimator 506 may comprise, but is not limited to, metals (e.g., lead, stainless steel) or density polymers.

[0071] In at least one embodiment, the design of the collimator 506 can be modified so that it is made of a material having a mass density lower than 0.9 grams per cubic centimeter (g / cc), but still reducing or eliminating the incidence of radiation sterilization 512 onto electronic components within the electronic equipment housing 204. To bring about this design modification, in some embodiments, the size (e.g., length) of the collimator 506 can be increased so that electrons propagating from radiation sterilization 512 must pass through a large amount of material before being incident on potentially sensitive electronic equipment. This large amount of material can help absorb or dissipate the irradiation intensity of radiation sterilization 512 so that it is harmless to sensitive electronic equipment. However, in other embodiments, the reverse may be equivalent. More specifically, the size (e.g., length) of the collimator 506 can be reduced as long as the material for the collimator 506 exhibits a sufficiently high mass density.

[0072] In addition to the radiation shielding properties of the collimator 506 body, in some embodiments, one or more shields 516 (shown as one) may be placed inside the sensor housing 304 to protect sensitive electronic components while the sensor control device 302 undergoes radiation sterilization 512. The shields 516 may be positioned, for example, between the data processing unit 518 and the radiation source (e.g., an electron beam electron accelerator). In such embodiments, the shields 516 may be positioned adjacent to the data processing unit 518 and aligned with the data processing unit 518 and the radiation source to block or mitigate exposure to radiation (e.g., radiation or energy from an electron beam) that could otherwise damage the sensitive electronic circuits of the data processing unit 518.

[0073] Shield 516 can be manufactured from any material that has the function of blocking (or substantially blocking) the transmission of radiation. Suitable materials for Shield 516 include, but are not limited to, lead, tungsten, iron-based metals (e.g., stainless steel), copper, tantalum, tungsten, osmium, or any combination thereof. Suitable metals can be corrosion-resistant, austenitic, and any non-magnetic metal having a density in the range of about 5 grams per cubic centimeter (g / cc) to about 15 g / cc. Shield 516 can be manufactured by a variety of manufacturing techniques, including, but not limited to, press working, casting, injection molding, sintering, two-shot molding, or any combination thereof.

[0074] However, in other embodiments, the shield 516 may comprise a metal-filled thermoplastic polymer such as, but not limited to, polyamide, polycarbonate, or polystyrene. In such embodiments, the shield 516 can be manufactured by mixing the shielding material into an adhesive matrix and then dropping the combination onto a molded component or directly onto the data processing unit 518. Furthermore, in such embodiments, the shield 516 may include an enclosure that encapsulates (or substantially encapsulates) the data processing unit 518.

[0075] In some embodiments, a collimator seal 520 can be added to the end of the collimator 506 to completely seal the sterilization zone 508, and thus the sealed area 510. As shown, the collimator seal 520 can seal the second opening 514b. The collimator seal 520 can be added before or after radiation sterilization 512. In embodiments in which the collimator seal 520 is added before radiation sterilization 512, the collimator seal 520 can be manufactured from a radiopermeable microbial barrier material that allows radiation to propagate through it. By having the collimator seal 520 in a designated location, the sealed area 510 can maintain a sterile environment for the assembled sensor control device 202 until the user removes (unscrews) the applicator cap.

[0076] In some embodiments, the collimator seal 520 may include two or more layers made of different materials. The first layer may be made of a synthetic material such as Tyvek®, available from DuPont® (e.g., flash-spun density polyethylene fiber). Tyvek® is highly durable and puncture-resistant and allows vapor permeability. The Tyvek® layer may be added before or after radiation sterilization 512, and foil, as well as other vapor-resistant and moisture-resistant material layers, may be sealed (e.g., thermally sealed) on top of the Tyvek® layer to prevent the intrusion of contaminants and moisture into the sterilization zone 508 and the sealed area 510. In other embodiments, the collimator seal 520 may include only a single protective layer added to the end of the collimator 506. In such embodiments, this single layer is gas-permeable toward the sterilization process but also provides protection against moisture and other harmful elements after the sterilization process is complete. Therefore, the collimator seal 520 can function as a moisture barrier and a contamination prevention layer without departing from the scope of the disclosure of the present invention.

[0077] It should be noted that while the sensors 216 and Sharp 218 extend substantially concentrically with the centerlines of the sensor applicator 102 and applicator cap into the sterilization zone 508 from the bottom of the electronic equipment housing 204, they may have an eccentric arrangement as described herein. More specifically, in at least one embodiment, the sensors 216 and Sharp 218 extend eccentrically with respect to the centerlines of the sensor applicator 102 and applicator cap from the bottom of the electronic equipment housing 204. In such embodiments, without departing from the scope of the disclosure of the present invention, the sterilization zone 508 may be eccentrically positioned and the collimator 506 may be redesigned or otherwise configured to accept the sensors 216 and Sharp 218.

[0078] In some embodiments, the collimator 506 may include a first collimator or “internal” collimator that can be housed inside the applicator cap or otherwise inside the sensor applicator 102, as generally described above. A second collimator or “external” collimator (not shown) may be included in or otherwise used within the assembly (manufacturing) process to help sterilize the sensor applicator 102. In such embodiments, the external collimator may be positioned outside the sensor applicator 102 and applicator cap and may be used in conjunction with the internal collimator 506 to help focus radiation sterilization 512 onto the sensor 216 and sharp 218.

[0079] In one embodiment, for example, an external collimator can initially receive the radiation sterilization 512. Similar to the internal collimator 506, the external collimator can also provide or define an opening or passage extending through it. The beam of radiation sterilization 512 through the passage of the external collimator can be focused into and received in the sterilization zone 508 of the internal collimator 506 through a second opening 514b. Thus, the external collimator can be operated to pre-focus the radiation energy, and the internal collimator 506 can fully focus the radiation energy onto the sensor 216 and the sharp 218.

[0080] In some embodiments, the internal collimator 506 can be omitted if the external collimator has the function of properly and completely focusing the radiation sterilization 512 to properly sterilize the sensor 216 and sharpener 218. In such embodiments, the sensor applicator can be positioned adjacent to the external collimator and then subjected to the radiation sterilization 512, and the external collimator can prevent the radiation energy from damaging the highly sensitive electronics within the electronics housing 204. Furthermore, in such embodiments, the sensor applicator 102 can be delivered to the user without the internal collimator 506 positioned within the applicator cap, thereby eliminating complexity in manufacturing and use.

[0081] Figure 6A is an enlarged cross-sectional side view of a sensor control device 202 mounted in an applicator cap according to one or more embodiments. As shown above, a portion of the sensor 216 and sharp 218 are positioned within a sealed area 510, thereby being isolated from external contamination. The sealed area 510 may include (contain) the interior of the electronic equipment housing 204 and a selected portion of the sterilization zone 508 of the collimator 506. In one or more embodiments, the sealed area 510 may be defined by at least a first seal 602a, a second seal 602b, and a collimator seal 520, and may be otherwise formed.

[0082] The first seal 602a can be positioned to seal the interface between the sharp hub 322 and the upper part of the electronic equipment housing 204. More specifically, the first seal 602a can seal the interface between the sharp hub 322 and the shell 206. Furthermore, the first seal 602a can surround a first central opening 404 defined within the shell 206 to prevent contaminants from entering the electronic equipment housing 204 through the first central opening 404. In some embodiments, the first seal 602a can form part of the sharp hub 322. For example, the first seal 602a can be overmolded onto the sharp hub 322. In other embodiments, the first seal 602a can be overmolded onto the upper surface of the shell 206. In yet another embodiment, without departing from the scope of the disclosure of the present invention, the first seal 602a may include a separate structure, such as an O-ring, sandwiched between the sharp hub 322 and the upper surface of the shell 206.

[0083] The second seal 602b can be positioned to seal the interface between the collimator 506 and the bottom of the electronic equipment housing 204. More specifically, the second seal 602b can be positioned to seal the interface between the mount 208 and the collimator 506, or alternatively, between the collimator 506 and the bottom of the plug 302 received within the bottom of the mount. In applications including the plug 302 as shown, the second seal 602b can be configured to seal around and surround the plug receptacle 412. In embodiments excluding the plug 302, the second seal 602b can instead surround the second central opening 406 (Figure 4A) defined within the mount 208. As a result, the second seal 602b can prevent contaminants from entering the sterile zone 508 of the collimator 506 and further prevent them from entering the electronic equipment housing 204 through the plug receptacle 412 (or alternatively, the second central opening 406).

[0084] In some embodiments, the second seal 602b can form part of the collimator 506. For example, the second seal 602b can be overmolded onto the top of the collimator 506. In other embodiments, the second seal 602b can be overmolded onto the plug 302 or the bottom of the mount 208. In yet another embodiment, without departing from the scope of the disclosure of the present invention, the second seal 602b may include a separate structure, such as an O-ring, that is sandwiched between the collimator 506 and the bottom of the plug 302 or the mount 208.

[0085] After loading the sensor control device 202 into the sensor applicator 102 (Figure 5B) and securing the applicator cap to the sensor applicator 102, the first and second seals 602a and 602b are compressed, generating corresponding sealing interfaces. The first and second seals 602a and 602b can be manufactured from a variety of materials that have the function of generating a sealing interface between opposing structures. Suitable materials include, but are not limited to, silicone, thermoplastic elastomer (TPE), polytetrafluoroethylene (PTFE or Teflon®), or any combination thereof.

[0086] As discussed above, the collimator seal 520 can be configured to completely seal the bottom of the sterilization zone 508, and therefore the bottom of the sealed area 510. Thus, each of the first and second seals 602a, b and the collimator seal 520 creates a barrier corresponding to its respective sealing location. The combination of these seals 602a, b and 520 enables the final sterilization of the sealed area 510, including the sensor 216 and the sharp 218.

[0087] Figure 6B is an enlarged cross-sectional side view of another embodiment of a sensor control device 302 mounted in a sensor applicator 102 according to one or more embodiments. More specifically, Figure 6B depicts alternative embodiments of the first and second seals 602a, 602b. Here again, the first seal 602a is positioned to seal the interface between the sharp hub 322 and the upper part of the electronic equipment housing 204, more specifically to completely seal the first central opening 404 defined within the shell 206. However, in exemplary embodiments, the first seal 602a may 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 may be configured to simultaneously bias one or more axial extension members 604 of the sensor carrier 504 and one or more radial extension members 606 of the sensor carrier 504. Such a dual biasing engagement compresses the first seal 602a in both the axial and radial directions, thereby allowing the first seal 602a to seal against the upper part of the electronic equipment housing 204 in both the radial and axial directions.

[0088] The second seal 602b is again positioned to seal the interface between the collimator 506 and the bottom of the electronic equipment housing 204, more specifically between the mount 208 and the collimator 506, or alternatively between the collimator 506 and the bottom of the plug 302 received within the bottom of the mount 208. However, in exemplary embodiments, the second seal 602b defines or otherwise provides a cylindrical well 608 that extends into the sterile zone 508 and is sized to receive the sensor 216 and Sharp extending from the bottom of the mount 208. In some embodiments, a desiccant 610 may be placed within the cylindrical well to help maintain a low-humidity environment for moisture-sensitive biological components.

[0089] In some embodiments, the second seal 602b can be omitted, and the collimator 506 can be directly coupled to the electronic equipment housing 204. More specifically, in at least one embodiment, the collimator 506 can be screw-connected to the underside of the mount 208. In such embodiments, the collimator 506 may provide or otherwise provide a screw extension configured to fit into a screw opening defined within the bottom of the mount 208. Screw-connecting the collimator 506 to the mount 208 can serve to seal the interface between the collimator 506 and the bottom of the electronic equipment housing 204, and thus isolate the sealed area 510. Furthermore, in such embodiments, the pitch and gauge of the threads defined on the collimator 506 and the mount 208 can match those of the screw engagement between the applicator cap and the sensor applicator 102. As a result, when the applicator cap is screwed onto or unscrewed from the sensor applicator 102, the collimator 506 can be screwed onto or unscrewed from the electronic equipment housing 404 accordingly.

[0090] Figure 7 is an isometric projection of an exemplary sensor control device 702 according to one or more additional embodiments of the disclosure of the present invention. The sensor control device 702 may be the same as or similar to the sensor control device 104 of Figure 1, and can therefore be used in conjunction with the sensor applicator 102 (Figure 1), which delivers the sensor control device 702 to a target monitoring location on the user's skin. Furthermore, the sensor control device 702 may instead be characterized as a medical device. Therefore, the sensor control device 702 may require proper sterilization before use.

[0091] As shown in the figures, the sensor control device 702 is substantially disk-shaped and includes an electronic housing 704 which may have a circular cross-section. However, in other embodiments, the electronic housing 704 may have other cross-sectional shapes such as oval (e.g., tablet-shaped), rounded square, or polygonal, without departing from the scope of the disclosure of the present invention. The electronic housing 704 may be configured to house or otherwise enclose various electronic components used to operate the sensor control device 702.

[0092] The electronic equipment housing 704 may include a shell 706 and a mount 708 to which it can be mated. The shell 706 can be fastened to the mount 708 by a variety of methods, such as snap-fit, interlocking fit, ultrasonic welding, one or more mechanical fasteners (e.g., screws), or any combination thereof. In some cases, the shell 706 can be fastened to the mount 708 such that a sealed interface is created between it and the mount 708. In such embodiments, a gasket or other type of sealing material can be positioned around or near the outer diameter (circumference) of the shell 706 and the mount 708, and the gasket can be compressed by fastening these two components together, thereby creating a sealed interface. In other embodiments, an adhesive can be applied to the outer diameter (circumference) of one or both of the shell 706 and the mount 708. The adhesive not only fastens the shell 706 to the mount 708 and provides structural integrity, but also seals the interface between these two components, thereby isolating the interior of the electronic equipment housing 704 from external contamination.

[0093] In exemplary embodiments, the sensor control device 702 may further include a plug assembly 710 that can be coupled to the electronic housing 704. For example, the plug assembly 710 may include a sensor module 712 (partially visible) that is interconnectable with a Sharp module 714 (partially visible). The sensor module 712 may be configured to carry and include a sensor 716 (partially visible), and the Sharp module 714 may be configured to carry and include a Sharp 718 (partially visible) used to help deliver the sensor 716 transcutaneously under the user's skin during the attachment of the sensor control device 702. The Sharp module 714 may include a Sharp hub 720 that carries the Sharp 718.

[0094] As shown in the figure, the corresponding portions of the sensor 716 and the shaft 718 extend from the electronic housing 704, more specifically from the bottom of the mount 708. The exposed portion of the sensor 716 (referred to as the "tail") can be received within the hollow or recessed portion of the shaft 718. The remaining portion of the sensor 716 is positioned within the electronic housing 704.

[0095] Figure 8 is a side view of the sensor applicator 102 of Figure 1. As shown, the sensor applicator 102 includes a housing 902 and an applicator cap 904 that can be detachably coupled thereto. In some embodiments, the applicator cap 904 can be screwed onto the housing 902 and may include a tamper-evident ring 906. When the applicator cap 904 is rotated (e.g., unscrewed) relative to the housing 902, the tamper-evident ring 906 is unscrewed, thereby releasing the applicator cap 904 from the sensor applicator 102. With the applicator cap 904 removed, the user can then use the sensor applicator 102 to position the sensor control device 702 (Figure 7) at a target monitoring location on the user's body.

[0096] In some embodiments, the applicator cap 904 can be secured to the housing 902 by a sealing engagement to protect the internal components of the sensor applicator 102. In at least one embodiment, for example, an O-ring or another type of sealing gasket can seal the interface between the housing 902 and the applicator cap 904. The O-ring or sealing gasket may be a separate component or, instead, molded onto one of the housing 902 or the applicator cap 904.

[0097] Figure 9 is a cross-sectional side view of the sensor applicator 102 of Figure 1. As shown, the sensor control device 702 can be housed in the sensor applicator 102, and the applicator cap 904 can be coupled to the sensor applicator 102 to secure the sensor control device 702 within the applicator cap 904. The sensor control device 702 may include one or more radiation-sensitive components 708 positioned within the electronic housing 704. The radiation-sensitive components 708 may include, but are not limited to, electronic components or electronic modules such as data processing units, resistors, transistors, capacitors, inductors, diodes, switches, or any combination thereof. The data processing unit may include, for example, an application-specific integrated circuit (ASIC) configured to perform one or more functions or routines associated with the operation of the sensor control device 702. When in operation, the data processing unit may perform data processing functions such as filtering and encoding data signals corresponding to the user's sampled sample level. The data processing unit may include or otherwise communicate with the reader device 106 (Figure 1), including an antenna for communication with it.

[0098] In exemplary embodiments, the cap filler 910 can be placed inside the applicator cap 1404, and the cap filler 910 can generally serve to support the sensor control device 702 within the sensor applicator 102. In one or more embodiments, the cap filler 910 may include an integral part or extension of the applicator cap 904, such as by molding together with the applicator cap 904 or by overmolding thereon. In other embodiments, the cap filler 910 may include separate structures fitted inside or otherwise attached to the applicator cap 904, without departing from the scope of the disclosure of the present invention.

[0099] The sensor control device 702, more specifically the distal ends of the sensors 716 and sharps 718 extending from the bottom of the electronic equipment housing 1304, can be sterilized while positioned within the sensor applicator 102. In certain embodiments, a fully assembled sensor control device 702 can be subjected to radiation sterilization. Radiation sterilization 912 can be delivered by either continuous irradiation or pulsed beam irradiation. In pulsed beam irradiation, the beam of radiation sterilization 912 is focused to a target location, the component or device to be sterilized is moved to the target location, and at this point irradiation is initiated to provide an induced radiation pulse. Next, radiation sterilization 912 is stopped, another component or device to be sterilized is moved to the target location, and this process is repeated.

[0100] The disclosure of the present invention allows the use of an external sterilization assembly 914 to help focus radiation 912 to sterilize the distal ends of the sensor 716 and the Sharp 718, while simultaneously preventing (blocking) the propagating radiation 912 from damaging the radiation-sensitive components 908. As shown in the figures, the external sterilization assembly 914 (hereinafter referred to as "assembly 914") may include a radiation shield 916 positioned at least partially outside the sensor applicator 102. The radiation shield 916 may provide or define an external collimator 918 configured to help focus the radiation 912 (e.g., beam, wave, energy, etc.) toward the components to be sterilized. More specifically, the external collimator 918 allows the transmission of radiation 912 that incident on the sensor 716 and the Sharp 718 to sterilize them, but prevents the radiation 912 from damaging the radiation-sensitive components 908 within the electronic equipment housing 704.

[0101] In exemplary embodiments, the external collimator 918 is designed to align with the internal collimator 920, which is defined by the cap filler 910. Similar to the external collimator 918, the internal collimator 920 can help focus the radiation 912 toward the component being sterilized. As shown, the cap filler 910 can receive the end of the radiation shield 916 and otherwise define a radial shoulder 922 sized to fit therein, 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, without departing from the scope of the disclosure of the present invention, this transition can be discontinuous or stepwise.

[0102] The external collimator 918 and the internal collimator 920 can work together to focus the radiation 912 and define a sterilization zone 924 in which the distal ends of the sensor 916 and the sharp 918 can be positioned. The propagating radiation 912 can pass through the sterilization zone 924 and be incident on the sensor 716 and the sharp 718, thereby sterilizing them. However, each of the cap filler 910 and the radiation shield 916 can be manufactured from a material that substantially prevents the radiation 912 from penetrating the inner wall of the sterilization zone 924 and thereby damaging the radiation-sensitive components 908 within the housing 704. In other words, each of the cap filler 910 and the radiation shield 916 can be manufactured from a material with sufficient density to absorb the dose of the beam energy being emitted. In some embodiments, for example, one or both of the cap filler 910 and the radiation shield 916 can be manufactured from a material with a mass density higher than 0.9 grams per cubic centimeter (g / cc). However, in other embodiments, without departing from the scope of the disclosure of the present invention, the mass density of a suitable material can be lower than 0.9 g / cc. Suitable materials for the cap filler 910 and the radiation shield 916 include, but are not limited to, density polymers (e.g., polyethylene, polypropylene, polystyrene, polytetrafluoroethylene, etc.), metals (e.g., lead, stainless steel, aluminum, etc.), any combination thereof, or any material having a mass density higher than 0.9 g / cc. In at least one embodiment, the cap filler 910 can be manufactured from machine-made or 3D-printed polypropylene, and the radiation shield 916 can be manufactured from stainless steel.

[0103] In some embodiments, one or both of the cap filler 910 and / or radiation shield 916 can be manufactured from a material having a mass density lower than 0.9 g / cc, but the design of the sterilization zone 924 can be modified so that they can still function to prevent radiation sterilization 912 from damaging the radiation-sensitive component 908. In such embodiments, the size (e.g., length) of the sterilization zone 924 can be increased so that electrons propagating from radiation sterilization 912 have to pass through a larger amount of material before potentially entering the radiation-sensitive component 908. The larger amount of material can help absorb or dissipate the irradiation intensity of radiation 912 so that radiation sterilization 912 is harmless to the highly sensitive electronic equipment. However, in other embodiments, the reverse may be equivalent. More specifically, the size (e.g., length) of the sterilization zone 924 can be reduced as long as the material for the cap filler 910 and / or radiation shield 916 exhibits a sufficiently large mass density.

[0104] The sterilization zone 924, defined by the external and internal collimators 918, 920, can exhibit any suitable cross-sectional shape necessary to properly focus the radiation 912 onto the sensor 716 and the sharp 718 for sterilization. In exemplary embodiments, for example, each of the external and internal collimators 918, 920 exhibits a circular cross-section with parallel sides. However, in other embodiments, without departing from the scope of the disclosure of the present invention, one or both of the external and internal collimators 918, 920 may exhibit a polygonal cross-sectional shape, such as a cube or rectangle (including, for example, a parallelogram).

[0105] In an exemplary embodiment, the sterilization zone 924 provides a first opening 926a defined by an external collimator 918 and a second opening 926b defined by an internal collimator 920, in which case the first opening 926a and the second opening 926b are located at opposing ends of the sterilization zone 924. The first opening 926a allows radiation 912 to enter the sterilization zone 924, and the second opening 926b provides a location where radiation 912 can strike the sensor 716 and the sharp 718. In an exemplary embodiment, the second opening 926b also provides a location where the sensor 716 and the sharp 718 can be received within the sterilization zone 924. In embodiments where the sterilization zone 924 has a circular cross-section, the diameters of the first opening 926a and the second opening 926b can be substantially the same.

[0106] In some embodiments, the sterilization zone 924 defined by the external and internal collimators 918 may be substantially cylindrical and otherwise exhibit a circular or polygonal cross-section. In such embodiments, the first opening 926a and the second opening 926b may have equal diameters, and the walls of the sterilization zone 924 may be substantially parallel between the first and second ends of the sterilization zone 924.

[0107] In some embodiments, a cap seal 928 (shown by the dashed line) can be positioned at the interface between the cap packing 910 and the radiation shield 916. The cap seal 928 may include a radiopermeable microbial barrier. In some embodiments, for example, the cap seal 928 may be manufactured from a synthetic material such as TYVEK®, available from DuPont® (e.g., flash-spun density polyethylene fiber). The cap seal 928 can completely seal a portion of the sterile zone 924 to help form a portion of a sealed area 930 configured to isolate the sensor 716 and the sharp 718 from external contamination.

[0108] The sealed area 930 may include (contain) the interior of the electronic equipment housing 704 and a selected portion of the sterilization zone 924. In one or more embodiments, the sealed area 930 is defined by and may otherwise be formed by at least a cap seal 928, a first seal or "top" seal 932a, and a second seal or "bottom" seal 932b. Each of the cap seal 928, as well as the top and bottom seals 932a and 932b, generates a barrier corresponding to its respective sealed location, thereby enabling the sterilization zone 924, including the sensor 716 and Sharp 718, to be ultimately sterilized.

[0109] The upper seal 932a can be positioned to seal the interface between the sharp hub 720 and the upper part of the electronic equipment housing 704 (i.e., the shell 906 in Figure 8), thereby preventing contaminants from entering the electronic equipment housing 704. In some embodiments, the upper seal 932a may form part of the sharp hub 720, such as by overmolding it onto the sharp hub 720. However, in other embodiments, the upper seal 932a may form part of the upper surface of the shell 706 or be overmolded onto the upper surface. In yet another embodiment, without departing from the scope of the disclosure of the present invention, the upper seal 932a may include a separate structure, such as an O-ring, that is sandwiched between the sharp hub 720 and the upper surface of the shell 706.

[0110] The bottom seal 932b can be positioned to seal the interface between the cap filler 910 and the bottom of the electronic equipment housing (i.e., the mount 708 in Figure 13). The bottom seal 932b can prevent contaminants from entering the sterile zone 924 and the electronic equipment housing 704. In some embodiments, the bottom seal 932b can form part of the cap filler 910, such as by overmolding it onto the top of the cap filler 910. In other embodiments, the bottom seal 932b can form part of the bottom of the mount 708 or be overmolded onto it. In yet another embodiment, without departing from the scope of the disclosure of the present invention, the bottom seal 932b may include a separate structure, such as an O-ring, that is sandwiched between the cap filler 910 and the bottom of the mount 708.

[0111] After loading the sensor control device 702 into the sensor applicator 102 and securing the applicator cap 904 to the sensor applicator 102, the top and bottom seals 932a and 932b can be compressed to create the corresponding sealing interface. The top and bottom seals 932a and 932b can be manufactured from a variety of materials that have the function of creating a sealing interface between opposing structures. Suitable materials include, but are not limited to, silicone, thermoplastic elastomer (TPE), polytetrafluoroethylene (e.g., TEFLON®), or any combination thereof.

[0112] It should be noted that while the sensors 716 and 718 extend substantially concentrically with the centerlines of the sensor applicator 102 and applicator cap 904 into the sterilization zone 924 from the bottom of the electronic equipment housing 704, they may have an eccentric arrangement as described herein. More specifically, in at least one embodiment, the sensors 716 and 718 extend eccentrically with respect to the centerlines of the sensor applicator 102 and applicator cap 904 from the bottom of the electronic equipment housing 704. In such embodiments, without departing from the scope of the disclosure of the present invention, the external and internal collimators 918, 920 may be redesigned or otherwise configured so that the sterilization zone 924 is also eccentrically positioned to receive the sensors 716 and 718.

[0113] In some embodiments, the external sterilization assembly 914 may further include a sterilization housing or sterilization "pod" 934 coupled to or forming part of the radiation shield 916. The sterilization pod 934 provides or otherwise provides a chamber 936 sized to receive all or part of the sensor applicator 102. Once properly seated (received) within the sterilization pod 934, the sensor applicator 102 can be subjected to radiation sterilization 912 for sterilizing the sensor 716 and the sharp 718. The sterilization pod 934 may be manufactured from any of the materials described herein with respect to the radiation shield 916, which helps prevent radiation 912 from penetrating and propagating through the walls of the sterilization pod 934.

[0114] In some embodiments, the radiation shield 916 can be detachably coupled to the sterilization pod 934 using one or more mechanical fasteners 938 (one shown), but alternatively, it may be detachably coupled by a crimp fit, snap engagement, or the like. Detachable coupling of the radiation shield 916 to the sterilization pod 934 allows the radiation shield 916 to be interchangeable with shields separately designed (sized) to suit specific sterilization applications suitable for various types and designs of sensor applicators 102. Thus, the sterilization pod 934 may include a universal mount that allows the radiation shield 916 to be swapped as needed with other shield designs having different parameters with respect to the external collimator 918.

[0115] In some embodiments, the external sterilization assembly 914 may further include a mounting tray 940 coupled to or forming part of a sterilization pod 934. The sterilization pod 934 may be removably coupled to the mounting tray 940 using, for example, one or more mechanical fasteners 942 (one shown). The mounting tray 940 may be sized to receive a sensor applicator 102 and may provide or define a central opening 944 that is alignable with the chamber 936 to allow the sensor applicator 102 to enter the chamber 936. As described below, in some embodiments, the mounting tray 940 may define a plurality of central openings 944 for receiving a plurality of corresponding sensor applicators for sterilization.

[0116] Figures 10A and 10B are isometric and side views, respectively, of an exemplary sensor control device 1002 according to one or more embodiments of the disclosure of the present invention. The sensor control device 1002 (hereinafter referred to as the "pack") can be similar in some respects to the sensor control device 104 of Figure 1, and is therefore best understood by referring to it. The sensor control device 1002 can replace the sensor control device 104 of Figure 1 and can therefore be used in conjunction with the sensor applicator 102 (Figure 1), which delivers the sensor control device 1002 to a target monitoring location on the user's skin.

[0117] However, in contrast to the sensor control device 104 in Figure 1, the sensor control device 1002 can be integrated into a one-piece system architecture. Unlike a two-piece architecture, for example, the user is not required to unpack multiple packages and finally assemble the sensor control device 1002. Instead, upon receiving the product, the sensor control device 1002 is already fully assembled and properly positioned within the sensor applicator 102 (Figure 1). To use the sensor control device 1002, the user only needs to open one barrier (e.g., the applicator cap) before immediately sending the sensor control device 1002 to the target monitoring location.

[0118] As shown in the figures, the sensor control device 1002 is substantially disk-shaped and includes an electronic equipment housing 1004 which may have a circular cross-section. However, in other embodiments, the electronic equipment housing 1004 may exhibit other cross-sectional shapes, such as oval or polygonal, without departing from the scope of the disclosure of the present invention. The electronic equipment housing 1004 may be configured to house or otherwise enclose various electrical components used to operate the sensor control device 1002.

[0119] The electronic equipment housing 1004 may include a shell 1006 and a mount 1008 to which it can be mated. The shell 1006 can be fastened to the mount 1008 by a variety of methods, such as snap-fit, interlocking, ultrasonic welding, or one or more mechanical fasteners (e.g., screws). In some cases, the shell 1006 can be fastened to the mount 1008 such that a sealed interface is created between it and the mount 1008. In such embodiments, a gasket or other type of sealing material can be positioned around or near the outer diameter (circumference) of the shell 1006 and the mount 1008, and the gasket can be compressed by fastening these two components together, thereby creating a sealed interface. In other embodiments, an adhesive can be applied to the outer diameter (circumference) of one or both of the shell 1006 and the mount 1008. The adhesive not only fastens the shell 1006 to the mount 1008 and provides structural integrity, but also seals the interface between these two components, thereby isolating the interior of the electronic equipment housing 1004 from external contamination. When the sensor control device 1002 is assembled in a controlled environment, it may not be necessary to ultimately sterilize the internal electrical components. Rather, adhesive bonding can provide a sufficient sterile barrier to the assembled electronic equipment housing 1004.

[0120] The sensor control device 1002 may further include a plug assembly 1010 that can be coupled to the electronic housing 1004. The plug assembly 1010 may be similar in some respects to the plug assembly described above. For example, the plug assembly 1010 may include a sensor module 1012 (partially visible) that is interconnectable with a sharp module 1014 (partially visible). The sensor module 1012 may be configured to carry and include a sensor 2616 (partially visible), and the sharp module 1014 may be configured to carry and include a sharp 1018 (partially visible) used to help deliver the sensor 1016 transcutaneously under the user's skin during attachment of the sensor control device 1002. As shown, the corresponding portions of the sensor 1016 and the sharp 1018 extend from the electronic housing 1004, more specifically from the bottom of the mount 1008. The exposed portion of the sensor 1016 can be received in the hollow or recessed portion of the sharp 1018. The remaining portion of the sensor 1016 is positioned within the electronic equipment housing 1004.

[0121] As will be discussed in more detail below, the sensor control device 1002 may further include a sensor storage vial 1020 that surrounds the exposed portions of the sensor 1016 and sharp 1018 and provides a storage barrier to protect these portions from gas chemical sterilization.

[0122] Figures 11A and 11B are isometric and exploded views, respectively, of a plug assembly 1110 according to one or more embodiments. The sensor module 1012 may include a sensor 1016, a plug, and a connector. The plug may be designed to receive and support both the sensor 1016 and the connector 1104. As shown, a channel may be defined to receive a portion of the sensor 1016 through the plug. Furthermore, the plug may provide one or more deflectable arms configured to snap into corresponding feature portions provided on the bottom of the electronic equipment housing 1004.

[0123] The sensor 1016 includes a tail 1108, a flag 1110, and a neck 1112 interconnecting the tail 1108 and the flag 1110. The tail 1108 can be configured to extend at least partially through the channel 1106 and distally from the plug 1102. The tail 1108 contains an enzyme or other chemical or biological agent, and in some embodiments, a membrane can cover the chemical agent. During use, the tail 1108 is received percutaneously under the user's skin, and the chemical agent contained on the tail helps facilitate specimen monitoring in the presence of body fluids.

[0124] Flag 1110 may include a substantially flat surface on which one or more sensor contacts 114 (three shown in Figure 11B) are positioned. The sensor contacts 114 may be configured to align with a corresponding number of flexible carbon-impregnated polymer modules (with their tops shown at location 1120) enclosed within connector 1104.

[0125] The connector 1104 includes one or more hinges 1118 that allow it to move between an open and a closed state. Figures 11A and 11B show the connector 1104 in the closed state, but the connector 1104 can pivot and rotate to the open state to receive the flag 1110 and the flexible carbon-impregnated polymer module therein. The flexible carbon-impregnated polymer module provides electrical contacts 1120 (three shown) configured to give conductive communication between the sensor 1016 and the corresponding circuit contacts provided within the electronic equipment housing 1004 (Figures 10A and 10B). The connector 1104 can be manufactured from silicone rubber and can function as a moisture barrier to the sensor 1016 when assembled in a compressed state and after being applied to the user's skin.

[0126] The Sharp module 1014 includes a Sharp 1018 and a Sharp hub 1122 that supports it. The Sharp 1018 includes an elongated shaft 1124 and a Sharp tip 1126 at its distal end. The shaft 1124 may be configured to extend through the channel 1106 and distally from the plug 1102. Furthermore, the shaft 1124 may include a hollow or recessed portion 1128 that at least partially surrounds the tail 1108 of the sensor 1016. The Sharp tip 1126 may be configured to penetrate the skin while supporting the tail 1108 in order to bring the activating agent present on the tail 1108 into contact with body fluids.

[0127] The Sharp Hub 1122 may include a hub miniature cylinder 2730 and a hub snap locking claw 2732, each of which can help connect the plug assembly 2610 (and the entire sensor control device 2602) to the sensor applicator 102 (Figure 1).

[0128] Referring particularly to Figure 11B, the storage vial 1020 may include a substantially cylindrical, elongated body 1134 having a first end 1136a and a second end 1136b opposite it. The first end 1136a may be open to provide access to an inner chamber 1138 defined within the body 1134. In contrast, the second end 1136b may be closed and provide or otherwise define an expanding head 1140. The expanding head 1140 has an outer diameter larger than the outer diameter of the remaining portion of the body 1134. However, in other embodiments, the expanding head 1140 may be located at an intermediate position between the first end 1136a and the second end 1136b.

[0129] Figure 11C is an exploded isoangular bottom view of the plug 1102 and the storage vial 1020. As shown, the plug 1102 can have an opening 1142 configured to receive the storage vial 1020, more specifically the first end 1136a of the body 1134. The channel 1106 can be terminated at the opening 1142 such that when the storage vial 1020 is coupled to the plug 1102, any components extending distally out of the channel 1106 are received into the inner chamber 1138.

[0130] The storage vial 1020 can be removably coupled to the plug 1102 at the opening 1142. In some embodiments, for example, the storage vial 1020 can be received into the opening 1142 by a crimp fit or friction fit. In other embodiments, the storage vial 1020 can be secured within the opening 1142 using a fragile member (e.g., a shear ring) or fragile material that can be broken by a small separation force. In such embodiments, for example, the storage vial 1020 can be secured within the opening 1142 using a glue tag (spot), a small amount of wax, or may include an easily removable adhesive. As described below, the storage vial 1020 may be separated from the plug 1102 before the sensor control device 1102 (Figures 10A-10B) is delivered to the target monitoring location on the user's skin.

[0131] Referring again to Figures 11A and 11B, the inner chamber 1138 is sized to receive the tail 1108, the distal section of the shaft 1124, and the sharp tip 1126, collectively referred to as the “distal portion of sensor 1016 and sharp 1018,” and can be otherwise configured. The inner chamber 1138 can be sealed or otherwise isolated to prevent substances that may potentially interact adversely with the chemical formulation of sensor 1016 from entering the inner chamber 1138. More specifically, since the gas used during gas sterilization may adversely affect the enzymes (and other sensor components such as membrane coatings that regulate sample inflow) provided on the tail 1108, the inner chamber 1128 can be sealed to protect or isolate the distal portion of sensor 1016 and sharp 1018 during gas sterilization.

[0132] In some embodiments, the seal 1144 (Figure 11B) can provide a sealing barrier between the inner chamber 1138 and the external environment. In at least one embodiment, the seal 1144 can be located inside the inner chamber 1138, but it is also possible that it can be located outside the body 1134 without departing from the scope of the disclosure of the present invention. The distal portions of the sensor 1016 and the sharp 1018 can extend through the seal 1144 into the inner chamber 1138, but the seal 1144 can maintain a sealing interface around the distal portions of the sensor 1016 and the sharp 1018 to prevent the ingress of contaminants into the inner chamber 1138. The seal 1144 can be manufactured, for example, from an easily moldable elastomer or wax.

[0133] In other embodiments (or in addition to seal 1144), a sensor preservation fluid 1146 (Figure 11B) may be present in the inner chamber 1138, and the distal portions of the sensor 1016 and sharp 1018 may be immersed in or otherwise sealed in the preservation fluid 1146. The preservation fluid 1146 can generate a sealed interface that prevents sterilization gases from interacting with enzymes provided on the tail 1108.

[0134] To properly sterilize the sensor 1016 and the Sharp 1018, the plug assembly 1010 can be subjected to radiation sterilization. Appropriate radiation sterilization includes, but is not limited to, electron beam irradiation, gamma ray irradiation, X-ray irradiation, or any combination thereof. In some embodiments, the plug assembly 1010 can be subjected to radiation sterilization before the storage vial 1020 is coupled to the plug 1102. However, in other embodiments, the plug assembly 1010 can be sterilized after the storage vial 1020 is coupled to the plug 1102. In such embodiments, the body 2734 and storage fluid 1146 of the storage vial 1020 may contain materials and / or substances that allow radiation to propagate through them to facilitate radiation sterilization of the distal portions of the sensor 1016 and the Sharp 1018.

[0135] Suitable materials for the body 1134 include, but are not limited to, non-magnetic metals (e.g., aluminum, copper, gold, silver, etc.), thermoplastic ceramics, rubber (e.g., ebonite), composite materials (e.g., fiberglass, carbon fiber reinforced polymers, etc.), epoxy, or any combination thereof. In some embodiments, the material for the body 1134 may be transparent or translucent, but may otherwise be opaque without departing from the scope of the disclosure of the present invention.

[0136] The preservation fluid 1146 may include any inert biocompatible fluid (i.e., a liquid, gas, gel, wax, or any combination thereof) that has the function of sealing the distal portions of the sensor 1016 and the Sharp 1018. In some embodiments, the preservation fluid 1146 may allow radiation to propagate through it. The preservation fluid 1146 may include a fluid insoluble in the chemicals contained in the gas chemical sterilization. Suitable examples of the preservation fluid 1146 include, but are not limited to, silicone oil, mineral oil, gel (e.g., petrolatum), wax, fresh water, brine, synthetic fluid, glycerin, sorbitan ester, or any combination thereof. As is obvious, more viscous gels and fluids may be preferred so that the preservation fluid 1146 does not flow easily.

[0137] In some embodiments, the storage fluid 1146 may contain an anti-inflammatory agent such as nitric oxide or another known anti-inflammatory agent. Anti-inflammatory agents can be demonstrated to be beneficial in minimizing the local inflammatory response caused by the penetration of the Sharp 1018 and sensor 1016 into the user's skin. Inflammation may affect the accuracy of glucose readings, and it has been observed that including an anti-inflammatory agent can accelerate the healing process, resulting in more rapid acquisition of accurate readings.

[0138] Figures 12A and 12B are exploded and assembled views and bottom isometric projection views, respectively, of the electronic equipment housing 1004 according to one or more embodiments. The shell 1006 and mount 1008 function as opposing clamshell halves that enclose or substantially enclose various electronic components of the sensor control device 1002 (Figures 10A and 10B).

[0139] A printed circuit board (PCB) 1202 can be placed inside the electronic equipment housing 1004. The PCB 1202 can be fitted with a number of electronic modules (not shown) including, but not limited to, data processing units, resistors, transistors, capacitors, inductors, diodes, and switches. The data processing unit may include, for example, an application-specific integrated circuit (ASIC) configured to perform one or more functions or routines associated with the operation of the sensor control device 1002. More specifically, the data processing unit may be configured to perform data processing functions, in which case such functions may include, but are not limited to, filtering and encoding of data signals, each corresponding to a user's sampled sample level. The data processing unit may include or otherwise communicate with the reader device 106 (Figure 1), including an antenna for communication with it.

[0140] As shown in the figures, the shell 1006, mount 1008, and printed circuit board 1202 each define corresponding central openings 1204, 1206, and 1208, respectively. When the electronic equipment housing 1204 is assembled, the central openings 1204, 1206, and 1208 are coaxially aligned to receive each part of the plug assembly 1010 (Figures 11A and 11B) through it. The electronic equipment housing 1004 can be configured to house a battery 1210 and supply power to the sensor control device 1002.

[0141] In Figure 12B, a plug receptacle 1212 can be positioned at the bottom of the mount 1208, providing a place to receive the plug assembly 1010 (Figures 10A and 10B) and connect it to the electronic equipment housing 1004, thereby providing a place to fully assemble the sensor control device 1002. The shape of the plug 1102 (Figures 11A-11C) can be molded in a manner that matches or complements the plug receptacle 1212, and the plug receptacle 1212 can provide one or more snap-locking ledges 1214 (two shown) configured to bond with and receive the deflectable arm 1107 (Figures 11A and 11B) of the plug 1102. The plug assembly 1010 is coupled to the electronic equipment housing 1004 by allowing the plug 1102 to advance into the plug receptacle 1212 and the deflectable arm 1107 to engage in the corresponding snap locking ledge 1214. When the plug assembly 1010 is properly coupled to the electronic equipment housing 1004, one or more circuit contacts 1216 (three shown) located on the underside of the PCB 1202 can generate conductive communication with the electrical contacts 1120 (Figures 11A and 11B) of the connector 1104 (Figures 11A and 11B).

[0142] Figures 13A and 13B are a side view and a cross-sectional side view, respectively, of an exemplary embodiment of the sensor applicator 102 with the applicator cap attached. More specifically, Figures 13A and 13B illustrate the state in which the sensor applicator 102 is expected to be shipped and the state in which the user may receive it. With the disclosure of the present invention, as can be seen in Figure 13B, the sensor control device 1002 is already assembled and installed inside the sensor applicator 102 before being delivered to the user.

[0143] As described above, before coupling the plug assembly 1010 to the electronic equipment housing 1004, the plug assembly 1010 can be subjected to radiation sterilization to sterilize the distal portions of the sensor 1016 and the sharpness 1018. In a properly sterilized state, the plug assembly 1010 can then be coupled to the electronic equipment housing 1004 as generally described above, thereby forming 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 onto the housing and may include a tamper-evident ring. When the applicator cap is rotated (e.g., twisted off) relative to the housing, the tamper-evident ring will break, thereby releasing the applicator cap from the sensor applicator 102.

[0144] The disclosure of the present invention allows for the application of gas chemi-sterilization to the sensor control device 1002 while it is loaded in the sensor applicator 102, configured to sterilize the electronic equipment housing 1004 and any other exposed portion of the sensor control device 1002. To achieve this, a chemical can be injected into a sterilization chamber 1306, which is cooperatively defined by the sensor applicator 102 and the interconnection cap 210. In some applications, the chemical can be injected into the sterilization chamber 1306 through one or more vents 1308 defined at the proximal end 1310 of the applicator cap. Exemplary chemicals that can be used for gas chemi-sterilization 1304 include, but are not limited to, ethylene oxide, hydrogen peroxide vapor, and nitrogen oxides (e.g., nitrous oxide, nitrogen oxide, etc.).

[0145] Since the distal portions of sensor 1016 and sharp 1018 are sealed inside the storage vial 1020, the chemicals used during gas chemical sterilization do not interact with the enzymes, chemical agents, or biological agents provided on the tail 1108.

[0146] Once the desired level of sterility assurance is achieved within the sterilization chamber 1306, the gaseous solution is removed and the sterilization chamber 1306 is aerated. Aeration can be achieved by continuously passing circulating nitrogen gas or germicidal air through the sterilization chamber 1306 following a vacuum. With the sterilization chamber 1306 properly aerated, the vent 1308 can be sealed with the seal 1312 (shown by the dashed line).

[0147] In some embodiments, the seal 1312 may include two or more layers made of different materials. The first layer may be made of a synthetic material such as Tyvek®, available from DuPont® (e.g., flash-spun density polyethylene fiber). Tyvek® is highly durable and puncture-resistant, while allowing vapor permeability. The Tyvek® layer may be added before and after gas chemical sterilization, and a foil or other vapor-resistant and moisture-resistant material layer may be sealed (e.g., heat-sealed) on the Tyvek® layer to prevent the ingress of contaminants and moisture into the sterilization chamber 1306. In other embodiments, the seal 1312 may consist of only a single protective layer added to the applicator cap. In such embodiments, this single layer not only has gas permeability toward the sterilization process but also provides protection against moisture and other harmful elements after the sterilization process is complete.

[0148] The presence of seal 1312 in a designated location provides the applicator cap with a barrier against external contamination, which maintains a sterile environment for the assembled sensor control device 1002 until the user removes (unscrews) the applicator cap. The applicator cap can also create a dust-free environment during transport and storage, preventing contamination of the adhesive patch 1314 used to secure the sensor control device 1002 to the user's skin.

[0149] Figure 14 is a perspective view of an exemplary embodiment of an applicator cap according to the disclosure of the present invention. As shown, the applicator cap has a substantially circular cross-section and defines a series of screw threads used to connect the applicator cap to the sensor applicator 102. A vent 1308 can be seen at the bottom of the applicator cap.

[0150] The applicator cap may further provide and otherwise define a cap post 1404 that is centrally located inside it and extends proximal from the bottom of the applicator cap. The cap post 4104 may be configured to generally serve to support the sensor control device 1002 while it is contained within the sensor applicator 102. Furthermore, the cap post 1404 may define an opening 1406 configured to receive a storage vial 1020 when the applicator cap 210 is coupled to the sensor applicator 102.

[0151] In some embodiments, the opening 1406 to the cap post 1404 may include one or more stretchable or flexible flexible features 1408 that allow the storage vial 1020 to pass through. In some embodiments, for example, the flexible features 1408 may include a collet-type device that includes a plurality of flexible fingers configured to flex radially outward to receive the storage vial 1020. However, in other embodiments, the flexible features 1408 may include an elastomer or another type of flexible material configured to expand radially to receive the storage vial 1020.

[0152] Figure 15 is a cross-sectional side view of a sensor control device 1002 positioned within an applicator cap according to one or more embodiments. As shown, the cap post 1404 defines a post chamber 1502 configured to receive a storage vial 1020. The opening 3006 to the cap post 3004 provides access to the post chamber 1502 and has a first diameter D1. In contrast, the expanding head 1140 of the storage vial 1020 has a second diameter D2 which is larger than the first diameter D1 and larger than the remaining outer diameter of the storage vial 1020. Thus, as the storage vial 2620 extends into the post chamber 1502, the flexible feature 1408 of the opening 1406 can bend (expand) radially outward to receive the expanding head 1140.

[0153] In some embodiments, the expanding head 1140 may provide or otherwise define an inclined outer surface that helps bias the flexible feature portion 1408 radially outward. However, the expanding head 1140 may define an upper shoulder 1504 that prevents the storage vial 1020 from moving backward out of the post chamber 1502. More specifically, the shoulder 1504 may include a steeply sloped surface at a location of a second diameter D2 that will engage with the flexible feature portion 1408 but will not bias the flexible feature portion 1408 to flex radially outward in the backward direction.

[0154] As the expanding head 1140 advances beyond the opening 1406, the flexible feature 1408 flexes back to (or toward) its natural state. In some embodiments, the flexible feature 1408 can engage with the outer surface of the storage vial 1020, but nevertheless, the applicator cap 210 can be allowed to rotate relative to the storage vial 1020. Thus, when the user removes the applicator cap by rotating it relative to the sensor applicator 102, the storage vial 1020 can remain stationary relative to the cap post 1404.

[0155] When the applicator cap is removed from the sensor applicator 102, thereby separating the sensor control device 1002 from the applicator cap, the shoulder 1504 defined on the magnifying head 1140 engages with the flexible feature 1408 at the opening 1406. Since the diameter of the shoulder 1504 is larger than the diameter of the opening 1406, the shoulder 1504 is constrained in contact with the flexible feature 1408, thereby separating the storage vial 1020 from the sensor control device 1002 and exposing the distal portions of the sensor 1016 and sharp 1018. Thus, when the applicator cap is separated from the sensor applicator 102 and the sensor control device 1002, the flexible feature 1408 can prevent the magnifying head 1140 from coming out of the post chamber 1502 through the opening 1406. The separated storage vial 1020 falls into the post chamber 1502 and remains there.

[0156] In some embodiments, instead of the opening 1406 including the flexible feature portion 1408 as generally described above, the opening 1406 may be threaded instead. In some embodiments, a small portion near the distal end of the storage vial 1020 may also be threaded and configured to screw-engage with the opening 1406. The storage vial 1020 can be received into the post chamber 1502 by screw-in rotation. However, when the applicator cap is removed from the sensor applicator 102, the opposite threads on the opening 1406 and the storage vial 1020 can be separated from the sensor control device 1002.

[0157] In other words, there are several advantages to integrating the sensor control device 1002 into a sample monitoring system (e.g., the sample monitoring system 100 in Figure 1). Since the sensor control device 1002 is ultimately assembled in a controlled environment, tolerances can be reduced or eliminated entirely, thereby making the sensor control device 1002 thinner and smaller. Furthermore, since the sensor control device 1002 is ultimately assembled in a controlled environment, a complete preliminary test of the sensor control device 1002 can be performed at the factory, and therefore the sensor unit can be fully tested before packaging for final delivery.

[0158] Figures 16A and 16B are isometric and side views, respectively, of an exemplary sensor control device 1602 according to one or more embodiments of the disclosure of the present invention. The sensor control device 1602 (hereinafter referred to as the “pack”) can be similar in some respects to the sensor control device 104 of Figure 1, and is therefore best understood by referring to it. In some applications, the sensor control device 1602 can replace the sensor control device 104 of Figure 1, and can therefore be used in conjunction with the sensor applicator 102 (Figure 1), which delivers the sensor control device 1602 to a target monitoring location on the user’s skin.

[0159] However, in contrast to the sensor control device 104 in Figure 1, the sensor control device 1602 can be integrated into a one-piece system architecture. Unlike a two-piece architecture, for example, the user is not required to unpack multiple packages and finally assemble the sensor control device 1602 before use. Instead, upon receiving the product, the sensor control device 1602 is already fully assembled and properly positioned within the sensor applicator 102 (Figure 1). To use the sensor control device 1602, the user only needs to open one barrier (e.g., remove the applicator cap) before immediately sending the sensor control device 1602 to the target monitoring location.

[0160] As shown in the figures, the sensor control device 1602 is substantially disk-shaped and includes an electronic equipment housing 1604 which may have a circular cross-section. However, in other embodiments, the electronic equipment housing 1604 may exhibit other cross-sectional shapes, such as oval or polygonal, without departing from the scope of the disclosure of the present invention. The electronic equipment housing 1604 may be configured to house or otherwise enclose various electrical components used to operate the sensor control device 1602.

[0161] The electronic equipment housing 1604 may include a shell 1606 and a mount 1608 to which it can be mated. The shell 1606 can be secured to the mount 1608 by a variety of methods, such as snap engagement, interlocking fit, ultrasonic (or sotopulsive) welding, using one or more mechanical fasteners (e.g., screws), or any combination thereof. In some embodiments, the interface between the shell 1606 and the mount 1608 can be sealed. In such embodiments, a gasket or other type of sealing material can be placed around or near the outer diameter (circumference) of the shell 1606 and the mount 1608. By securing the shell 1606 to the mount 1608, the sealing material can be compressed, thereby creating a sealed interface. In at least one embodiment, an adhesive can be applied to the outer diameter (circumference) of one or both of the shell 1606 and the mount 1608, so that the adhesive can not only secure the shell 1606 to the mount 1608 but also seal its interface.

[0162] In embodiments where a sealed interface is provided between the shell 1606 and the mount 1608, the interior of the electronic equipment housing 1604 can be substantially isolated from external contamination between these two components. In such embodiments, if the sensor control device 1602 is assembled in a controlled sterile environment, it may not be necessary to sterilize the internal electrical components (e.g., by gas sterilization). Rather, the adhesive bond can provide a sufficient sterile barrier to the assembled electronic equipment housing 1604.

[0163] The sensor control device 1602 may further include a sensor module 1610 (partially visible in Figure 16B) and a Sharp module 1612 (partially visible). The sensor module 1610 and the Sharp module 1612 can be interconnected and coupled to the electronic equipment housing 1604. The sensor module 1610 may be configured to carry and include a sensor 1614 (Figure 16B), and the Sharp module 1612 may be configured to carry and include a Sharp 1616 (Figure 16B) used to help deliver the sensor 1614 transcutaneously under the user's skin during the attachment of the sensor control device 1602.

[0164] As shown in Figure 16B, the corresponding portions of the sensor 1614 and the sharp 1616 extend from the electronic housing 1604, more specifically from the bottom of the mount 1608. The exposed portion of the sensor 1614 can be received within the hollow or recessed portion of the sharp 1616. The remaining portion of the sensor 1614 is positioned within the electronic housing 1604.

[0165] An adhesive patch 1618 can be positioned and attached to the underside of the mount 1608. Similar to the adhesive patch 108 in Figure 1, the adhesive patch 1618 can be configured to fix and maintain the sensor control device 1602 in a predetermined position on the user's skin during operation. In some embodiments, a transfer adhesive 1620 can be sandwiched between the adhesive patch 1618 and the bottom of the mount 1608. The transfer adhesive 1620 can help facilitate the assembly process of the sensor control device 1602.

[0166] Figures 17A and 17B are exploded perspective top and bottom views, respectively, of a sensor control device 1602 according to one or more embodiments. As shown, the shell 1606 and mount 1608 of the electronic equipment housing 1604 function as opposing clamshell halves that enclose or substantially encapsulate the various electronic components of the sensor control device 1602.

[0167] A printed circuit board (PCB) 1702 can be placed inside the electronic equipment housing 1604. As shown in Figure 17B, multiple electronic modules 1704 can be mounted on the underside of the PCB 1702. Exemplary electronic modules 1704 include, but are not limited to, resistors, transistors, capacitors, inductors, diodes, and switches. A data processing unit 1706 (Figure 17B) can be further mounted on the PCB 1702, and the data processing unit 1706 may include, for example, an application-specific integrated circuit (ASIC) configured to perform one or more functions or routines associated with the operation of the sensor control device 1602. More specifically, the data processing unit 1706 may be configured to perform data processing functions such as filtering and encoding multiple data signals, each corresponding to a user's sampled sample level. The data processing unit 1706 may include or otherwise communicate with the reader device 106 (Figure 1) by including an antenna for communication with it.

[0168] As shown in the figure, the shell 1606, mount 1608, and PCB 1702 each define corresponding central openings 1708a, 1708b, and 1708c, respectively. When the electronic equipment housing 1602 is assembled, the central openings 1708a to 1708c are coaxially aligned to receive the sensor module and the parts of the Sharp modules 1610 and 1612 through it.

[0169] The electronic equipment housing 1604 can house the battery 1710 and the corresponding battery mount 1712. The battery 1710 can be configured to supply power to the sensor control device 1602.

[0170] 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 opening 1708b defined within the mount 1608 and to extend distally from the underside of the mount 1608. The tail 1716 contains an enzyme or other chemical or biological agent, and in some embodiments, a membrane may cover the chemical agent. During use, the tail 1716 is received percutaneously under the user's skin, and the chemical agent contained on the tail helps facilitate specimen monitoring in the presence of body fluids.

[0171] The flag 1718 may include a substantially flat surface on which one or more sensor contacts 1722 (three shown in Figure 17A) are positioned. The flag 1718 may be configured to be received within a connector 1714, in which case the sensor contacts 1722 align with a corresponding number of flexible carbon-impregnated polymer modules (not shown) enclosed within the connector 1714.

[0172] The connector 1714 includes one or more hinges 1724 that allow it to move between an open and a closed state. Figures 17A and 17B show the connector 1714 in the closed state, but the connector 1714 can move to an open state to receive the flag 1718 and the flexible carbon-impregnated polymer module therein. The flexible carbon-impregnated polymer module provides electrical contacts 1726 (three shown in Figure 17A) configured to give conductive communication between the sensor 1614 and the corresponding circuit contacts 1728 provided on the PCB 1702. When the sensor module 1610 is properly coupled to the electronic housing 1604, the circuit contacts 1728 create conductive communication with the electrical contacts 1726 of the connector 1714. The connector 1714 can be manufactured from silicone rubber and can function as a moisture barrier to the sensor 1614.

[0173] The sharp module 1612 includes a sharp 1616 and a sharp hub 1730 that supports it. The sharp 1616 includes an elongated shaft 1732 and a sharp tip 1734 at its distal end. The shaft 1732 can be configured to extend through each of the coaxially aligned central openings 1708a to 1708c and to extend distally from the bottom of the mount 1608.

[0174] Furthermore, the shaft 1732 may include a hollow or recessed portion 1736 that at least partially surrounds the tail 1716 of the sensor 1614. The sharp tip 1734 may be configured to penetrate the skin while supporting the tail 1716 in order to bring the activated chemical formulation of the tail 1716 into contact with body fluids.

[0175] The Sharp hub 1730 may include a hub miniature cylinder 1738 and a hub snap locking claw 1740, each of which can help connect the sensor control device 1602 to the sensor applicator 102 (Figure 1).

[0176] Referring particularly to Figure 17A, in some embodiments, the sensor module 1610 can be at least partially received in a sensor mounting pocket 1742 contained within the electronic equipment housing 1604. In some embodiments, the sensor mounting pocket 1742 may include a separate structure, but instead, it may form an integral part or extension of the mount 1608. The sensor mounting pocket 1742 is molded to receive and seat the sensor 1614 and connector 1714, and may be otherwise configured. As shown, the sensor mounting pocket 1742 defines an outer perimeter 1744 that substantially surrounds the area where the sensor 1614 and connector 1714 will be received. In at least one embodiment, the outer perimeter 1744 can be sealed to the underside of the PCB 1702 when the electronic equipment housing 1604 is fully assembled. In such embodiments, a gasket (e.g., an O-ring), adhesive, or another type of sealing material may be added (placed) on the outer perimeter 1744, which can serve to seal the interface between the sensor mounting pocket and the PCB 1702.

[0177] Sealing the interface between the sensor mounting pocket 1742 and the underside of the PCB 1702 can help create or define a sealed zone or sealed area within the electronic equipment housing 1604. This sealed area can be proven advantageous by helping to isolate (protect) the tail 1716 of the sensor 1614 from potentially harmful sterilization gases used during gas chemical sterilization.

[0178] Referring particularly to Figure 17B, multiple channels or grooves 1746 may be provided or otherwise defined on the bottom of the mount 1608. As shown, the grooves 1746 can form multiple concentric rings in combination with multiple radially extending channels. An adhesive patch 1618 (Figures 16A and 16B) can be attached to the underside of the mount 1608, and in some embodiments, a transfer adhesive 1620 (Figures 16A and 16B) can be sandwiched between the adhesive patch 1618 and the bottom of the mount 1608. The grooves 1746 can be demonstrated to be advantageous in that they facilitate the release of moisture away from the center of the electronic equipment housing 1604 beneath the adhesive patch 1618.

[0179] In some embodiments, a cap post sealing interface 1748 can be defined at the center of the mount 1608 on the bottom of the mount 1608. As shown, the cap post sealing interface 1748 may include a substantially flat portion of the bottom of the mount 1608. A second central opening 1708b may be defined at the center of the cap post sealing interface 1748, and a groove 1746 may surround the cap post sealing interface 1748. The cap post sealing interface 1748 can provide a sealing surface that can help isolate (protect) the tail 1716 of the sensor 1614 from potentially harmful sterilization gases used during gas chemical sterilization.

[0180] Figures 18A–18C are isometric, side, and bottom views, respectively, of an exemplary sensor control device 1802 according to one or more embodiments of the disclosure of the present invention. The sensor control device 1802 (hereinafter referred to as the “pack”) can be similar in some respects to the sensor control device 104 of Figure 1, and is therefore best understood by referring to it. The sensor control device 1802 can replace the sensor control device 104 of Figure 1 and can therefore be used in conjunction with the sensor applicator 102 (Figure 1), which delivers the sensor control device 1802 to a target monitoring location on the user’s skin. However, in contrast to the sensor control device 104 of Figure 1, various structural advantages and improvements allow the sensor control device 1802 to be incorporated into a one-piece system architecture.

[0181] Unlike the sensor control device 104 in Figure 1, for example, the user is not required to unpack multiple packages and finally assemble the sensor control device 1802 before delivery to the target monitoring location. Instead, the sensor control device 1802 can be fully assembled and properly positioned within the sensor applicator 102 upon receipt by the user. To use the sensor control device 1802, the user only needs to break one barrier (e.g., the applicator cap) before immediately delivering the sensor control device 1802 to the target monitoring location.

[0182] Referring first to Figure 18A, the sensor control device 1802 includes an electronic housing 1804 which is substantially disk-shaped and may have a substantially circular cross-section. However, in other embodiments, the electronic housing 1804 may exhibit other cross-sectional shapes, such as oval or polygonal, without departing from the scope of the disclosure of the present invention. The electronic housing 1804 may include a shell 1806 and a mount 1808 which can be mated thereto. An adhesive patch 1810 may be positioned and attached to the underside of the mount 1808. Similar to the adhesive patch 108 in Figure 1, the adhesive patch 1810 may be configured to fix and maintain the sensor control device 1802 in a predetermined location on the user's skin during operation.

[0183] In some embodiments, the shell 1806 can define a reference feature 1812. As shown, the reference feature 1812 may include a recess or light-shielding pocket defined within the shell 1806 and extending a short distance into the electronic equipment housing 3704. The reference feature 1812 can function as a “datum c” feature configured to facilitate control of at least one degree of freedom of the sensor control device 1802 during factory assembly. In contrast, conventional sensor control devices (e.g., the sensor control device 104 in Figure 1) typically include a tab extending radially from the side of the shell. This tab is used as a clocking datum during the manufacturing process but must be removed at the end of manufacturing, and this removal step is followed by inspection of the shell where the tab once existed, thereby adding complexity to the conventional manufacturing process.

[0184] The shell 1806 may also have a central opening 1814 sized to accommodate a sharp (not shown) that is extendable through the center of the electronic equipment housing 1804.

[0185] Figure 18B depicts the portion of the sensor 1816 extending from the electronic equipment housing 1804. The remaining portion of the sensor 1816 is positioned within the electronic equipment housing 1804. Similar to the sensor 110 in Figure 1, the exposed portion of the sensor 1816 is configured to be positioned transcutaneously beneath the user's skin during use. The exposed portion of the sensor 1816 may contain enzymes or other chemical or biological agents, and in some embodiments, a membrane may cover the chemical agent.

[0186] The sensor control device 1802 provides structural improvements that result in a height H and diameter D that can be smaller than those of conventional sensor control devices (e.g., sensor control device 104 in Figure 1). In at least one embodiment, for example, the height H can be about 1 mm or more lower than the height of a conventional sensor control device, and the diameter D can be about 2 mm or more smaller than the diameter of a conventional sensor control device. In certain other embodiments, the height H and diameter D can be reduced by any other suitable value, such as between 1 mm and 5 mm or between 1 mm and 10 mm, compared to the height or diameter of a conventional sensor device.

[0187] Furthermore, structural improvements to the sensor control device 1802 allow the shell 1806 to provide or otherwise define a chamfered or beveled outer perimeter 1818. In contrast, conventional sensor control devices generally require a rounded or outwardly arc-shaped outer perimeter to accommodate internal components. Each of the low height H, small diameter D, and beveled outer perimeter 1818 can be demonstrated to be advantageous in resulting in a sensor control device 1802 that is thinner, smaller, and less likely to be caught on sharp corners or the like and detached prematurely while attached to the user's skin.

[0188] Figure 18C depicts a central opening 1820 defined on the underside of the mount 1808. The central opening 1820 can be sized to accommodate a combination of a sharp (not shown) and a sensor 1816, in which case the sensor 1816 is received in the hollow or recessed portion of the sharp. When the electronic equipment housing 1804 is assembled, the central opening 1820 is aligned coaxially with the central opening 1814 (Figure 18A) of the shell 1806 (Figure 18A), and the sharp penetrates the electronic equipment housing by extending through each central opening 1814, 1820 simultaneously.

[0189] Figures 19A and 19B are exploded top and bottom views, respectively, of a sensor control device 1802 according to one or more embodiments. The shell 1806 and mount 1808 act as opposing clamshell halves that enclose or substantially encapsulate 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 to which a plurality of electronic modules 1906 are coupled. Exemplary electronic modules 1906 include, but are not limited to, resistors, transistors, capacitors, inductors, diodes, and switches. Conventional sensor control devices generally stack PCB components on only one side of the PCB. In contrast, the PCB components 1906 in the sensor control device 1802 can be distributed on both sides (i.e., the top and bottom) of the PCB 1904.

[0190] Apart from the electronic module 1906, the PCBA 1902 may further include a data processing unit 1908 mounted on the PCB 1904. The data processing unit 1908 may include, for example, an application-specific integrated circuit (ASIC) configured to perform one or more functions or routines associated with the operation of the sensor control device 1802. More specifically, the data processing unit 1908 may be configured to perform data processing functions, in which case such functions may include, but are not limited to, filtering and encoding of multiple data signals, each corresponding to a user's sampled sample level. The data processing unit 1908 may include or otherwise communicate with the reader device 106 (Figure 1), including an antenna for communication with it.

[0191] A battery opening 1910 can be defined within PCB 1904 and sized to accommodate and seat a battery 1912 configured to power the sensor control device 1802. Axial battery contacts 1914a and radial battery contacts 1914b can be coupled to PCB 1904, and these contacts can extend into the battery opening 1910 to facilitate power transfer from the battery 1912 to PCB 1904. As the names suggest, the axial battery contact 1914a can be configured to provide an axial contact to the battery 1912, while the radial battery contact 1914b can provide a radial contact to the battery 1912. Positioning the battery 1912 within the battery opening 1910 using battery contacts 1914a and 1914b helps reduce the height H of the sensor control device 1802 (Figure 18B), thereby allowing PCB 1904 to be centrally positioned and its components distributed to both sides (i.e., top and bottom). These factors help facilitate the chamfering 1818 (Figure 18B) provided on the electronic equipment housing 1804.

[0192] The sensor 1916 can be centrally positioned relative to the PCB 1904 and may include a tail 1916, a flag 1918, and a neck 1920 interconnecting the tail 1916 and the flag 1918. The tail 1916 may extend through the central opening 1820 of the mount 1808 and be configured to be received percutaneously under the user's skin. Furthermore, the tail 1916 may include an enzyme or other chemical preparation on the tail to facilitate sample monitoring.

[0193] Flag 1918 may include a substantially flat surface on which one or more sensor contacts 1922 (three shown in Figure 19B) are positioned. The sensor contacts 1922 can be configured to align with and engage with one or more corresponding circuit contacts 1924 (three shown in Figure 19A) provided on PCB 1904. In some embodiments, the sensor contacts 1922 may comprise a carbon-impregnated polymer printed on or otherwise added to the flag 1918 in a finger-like manner. Generally, conventional sensor control devices include a connector made of silicone rubber that encapsulates one or more flexible carbon-impregnated polymer modules that function as conductive contacts between the sensor and the PCB. In contrast, the disclosed sensor contacts 1922 provide a direct connection between the sensor 1816 and PCB 1904, thereby eliminating the need for a conventional connector and advantageously reducing the height H (Figure 18B). Furthermore, significant circuit resistance is eliminated by eliminating the flexible carbon-impregnated polymer modules, and thus the conductivity of the circuit is improved.

[0194] The sensor control device 1802 may further include a flexible member 1926 that can be positioned between the flag 1918 and the inner surface of the shell 1806. More specifically, when the shell 1806 and the mount 1808 are assembled together, the flexible member 1926 may be configured to impart a passive biasing load to the flag 1918 that presses the sensor contact 1922 into a seamless engagement with the corresponding circuit contact 1924. In exemplary embodiments, the flexible member 1926 is an elastomer O-ring, but it is conceivable that any other type of biasing device or biasing mechanism, such as a compression spring, could be included instead without departing from the scope of the disclosure of the present invention.

[0195] The sensor control device 1802 may further include one or more electromagnetic shields, indicated as a first shield 1928a and a second shield 1928b. The shields 1928a and 1928b may be positioned between the shell 1806 and the mount 1808, i.e., within the electronic equipment housing 1804. In an exemplary embodiment, the first shield 1928a is positioned above the PCB 1904 so as to face the top surface of the PCB 1904, and the second shield 1928b is positioned below the PCB 1904 so as to face the bottom surface of the PCB 1904.

[0196] The shields 1928a and 1928b can be configured to protect sensitive electronic components from radiation while the sensor control device 1802 is undergoing radiation sterilization. More specifically, at least one of the shields 1928a and 1928b can be positioned between the data processing unit 1908 and a radiation source such as an electron beam electron accelerator. In some embodiments, for example, at least one of the shields 1928a and 1928b can be positioned adjacent to and aligned with the data processing unit 1908 and the radiation source, and can also shield or reduce radiation absorbed doses that may otherwise damage the sensitive electronic circuits of the data processing unit 1908.

[0197] In an exemplary embodiment, the data processing unit 1908 is sandwiched between the first shield 1928a and the second shield 1928b such that the first shield 1928a and the second shield 1928b substantially sandwich the data processing unit 1908 axially. However, in at least one embodiment, only one of the shields 1928a or 1928b may be required to adequately protect the data processing unit 1908 during radiation sterilization. For example, when the sensor control device 1802 is subjected to radiation sterilization directed toward the bottom of the mount 1808, only the second shield 1928b may be required between the data processing unit 1908 and the radiation source, and the first shield 1928a may be omitted. Alternatively, when the sensor control device 1802 is subjected to radiation sterilization directed toward the top of the shell 1806, only the first shield 1928a needs to be placed between the data processing unit 1908 and the radiation source, and the second shield 1928b can be omitted. However, in other embodiments, both shields 1928a and 1928b can be used without departing from the scope of the disclosure of the present invention.

[0198] Shields 1928a and 1928b can be manufactured from any material having the function of attenuating (or substantially attenuating) the transmission of radiation. Suitable materials for shields 1928a and 1928b include, but are not limited to, lead, tungsten, iron-based metals (e.g., stainless steel), copper, tantalum, tungsten, osmium, aluminum, carbon, or any combination thereof. Suitable materials for shields 1928a and 1928b can be corrosion-resistant, austenitic, and any non-magnetic metal with densities in the range of about 2 grams per cubic centimeter (g / cc) to about 23 g / cc. Shields 1928a and 1928b can be manufactured by a variety of manufacturing techniques, including, but not limited to, press working, casting, injection molding, sintering, two-shot molding, or any combination thereof.

[0199] However, in other embodiments, the shields 1928a, 1928b may comprise a metal-filled thermoplastic polymer, such as but not limited to polyamide, polycarbonate, or polystyrene. In such embodiments, the shields 1928a, 1928b can be manufactured by mixing the shielding material into an adhesive matrix and dropping this combination onto a molded component or directly onto the data processing unit 1908. Furthermore, in such embodiments, the shields 1928a, 1928b may include an enclosure that encapsulates (or substantially encapsulates) the data processing unit 1908. In such embodiments, the shields 1928a, 1928b may comprise a metal-filled thermoplastic polymer as described above, or alternatively, they may be manufactured from any of the materials described herein having the function of attenuating (or substantially attenuating) the transmission of radiation.

[0200] The shell 1806 may provide or otherwise specify a first clocking receptacle 1930a (Figure 19B) and a second clocking receptacle 1930b (Figure 19B), and the mount 1808 may provide or otherwise specify a first clocking post 1932a (Figure 19A) and a second clocking post 1932b (Figure 19A). By fitting the first and second clocking receptacles 1930a and 1930b with the first and second clocking posts 1932a and 1932b, respectively, the shell 1806 will be properly aligned with the mount 1808.

[0201] Referring particularly to Figure 18A, the inner surface of the mount 1808 may provide or otherwise define a number of pockets or recesses configured to receive various components of the sensor control device 1802 when the shell 1806 is fitted onto the mount 1808. For example, the inner surface of the mount 1808 may define a battery locator 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.

[0202] Furthermore, multiple module pockets 1938 can be defined on the inner surface of the mount 1808 to accommodate various electronic modules 1906 positioned on the bottom of the PCB 1904. Additionally, a shield locator 1940 can be defined on the inner surface of the mount 1808 to accommodate at least a portion of the second shield 1928b when the sensor control device 1802 is assembled. The battery locator 1934, contact pocket 1936, module pockets 1938, and shield locator 1940 all extend only a short distance within the inner surface of the mount 1808, thereby reducing the overall height H (Figure 18B) of the sensor control device 1802 compared to conventional sensor control devices. The module pockets 1938 can help minimize the diameter of the PCB 1904 by allowing PCB components to be positioned on both sides (i.e., top and bottom).

[0203] Continuing to refer to Figure 19A, the mount 1808 may further include a plurality of carrier gripping features 1942 (two shown) defined around its outer circumference. The carrier gripping features 1942 are axially offset from the bottom 1944 of the mount 1808, to which a transfer adhesive (not shown) can be applied during assembly. In contrast to conventional sensor control devices that typically include a conical carrier gripping feature intersecting the bottom of the mount, the disclosed carrier gripping features 1942 are offset from the plane (i.e., the bottom 1944) to which the transfer adhesive is applied. This offset can be demonstrated to be advantageous in that it helps ensure that the delivery system does not inadvertently adhere to the transfer adhesive during assembly. Furthermore, the disclosed carrier gripping features 1942 eliminate the need for corrugated transfer adhesive, thereby simplifying the manufacture of the transfer adhesive and eliminating the need to precisely clock the transfer adhesive against the mount 1808. This also increases the bonding area and, therefore, the bonding strength.

[0204] Referring to Figure 19B, the bottom 1944 of the mount 1808 may be provided or otherwise defined to provide a plurality of grooves 1946 that are defined around or near the outer circumference of the mount 1808 and can be equidistant from each other. A transfer adhesive (not shown) may be bonded to the bottom 1944, and the grooves 1946 may be configured to help transport (transfer) moisture away from the sensor control device 1802 towards the mount 1808 during use. In some embodiments, the spacing of the grooves 1946 may intersect with module pockets 1938 (Figure 19A) defined on the opposite (inner) side of the mount 1808. As is obvious, alternating the positions of the grooves 1946 and the module pockets 1938 ensures that the opposing feature portions on both sides of the mount 1808 do not extend inward from each other. This helps to maximize the material utilization for the mount 1808, thereby helping to maintain the minimum height H (Figure 18B) of the sensor control device 1802. The module pocket 1938 can significantly reduce mold sink and improve the flatness of the bottom 1944 to which the transfer adhesive adheres.

[0205] Continuing to refer to Figure 19B, the inner surface of the shell 1806 may provide or otherwise define a number of pockets or recesses configured to receive various components of the sensor control device 1802 when the shell 1806 is fitted onto the mount 1808. For example, the inner surface of the shell 1806 may define an opposite battery locator 1948 that can be positioned opposite the battery locator 1934 of the mount 1808 (Figure 19A) and is configured to receive a portion of the battery 1912 when the sensor control device 1802 is assembled. Furthermore, a shield locator 1950 may be defined on the inner surface of the shell 1806 to receive at least a portion of the first shield 1928a when the sensor control device 1802 is assembled. The opposite battery locator 1948 and the shield locator 1950 extend only a short distance into the inner surface of the shell 1806, and this short extension helps to reduce the overall height H of the sensor control device 1802 (Figure 18B).

[0206] The Sharp and Sensor Locator 1952 may also be provided by or otherwise defined on the inner surface of the shell 1806. The Sharp and Sensor Locator 1952 may be configured to accept both the Sharp (not shown) and a portion of the sensor 1816. Furthermore, the Sharp and Sensor Locator 1952 may be configured to align and / or mate with a corresponding Sharp and Sensor Locator provided on the inner surface of the mount 1808.

[0207] Figures 20A and 20B illustrate the fabrication of a sensor control device according to a certain embodiment. In the first step of process 2000, holes 2002 can be punched or otherwise formed in a base substrate 2004 which may include a material sheet from which the base or lower cover 2008 of the sensor control device can ultimately be formed. The base substrate 2004 may comprise a belt or thin film manufactured from a variety of different materials, including but not limited to plastics, metals, composite materials, or any combination thereof. In at least one embodiment, the 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 the opposite side (e.g., the top side).

[0208] In the second step of process 2000, a sensor holder can be bonded to the base substrate 2004. The sensor holder can be the same as or similar to any of a plurality of sensor holders. Thus, the sensor holder can define a channel 2006 sized to receive the tail of the sensor. In some embodiments, the sensor holder can be ultrasonically welded or heat-sealed to the base substrate, thereby providing a sealed and watertight engagement. However, in at least one embodiment, the base substrate may include, or otherwise include, an adhesive substrate on top for fixing and sealing the sensor holder in a designated location.

[0209] In the third step of process 2000, the first adhesive substrate 2008 can be attached to the top of the sensor holder. The first adhesive substrate 2008 can be any known adhesive substrate and thus may include a pressure-sensitive adhesive tape that forms an adhesive portion when pressure is applied. In at least one embodiment, the first adhesive substrate 2008 may include a double-sided polyolefin foam tape that is pressure-sensitive on both sides.

[0210] In the fourth step of process 2000, the sensor 2016 can be fixed to the sensor holder using the first adhesive substrate 2008. More specifically, the tail can be extended through the channel 2006, and the flag can be bent at approximately a right angle to the tail 10314 and bonded to the first adhesive substrate 2008 that overlaps it below.

[0211] Next, referring to Figure 20B, in the fifth step of process 2000, a printed circuit board (PCB) 2010 can be positioned on the base substrate 2004 around the sensor holder. The PCB 2010 may include a plurality of electronic modules 2012 mounted thereon. The electronic modules 2012 may include at least one of a Bluetooth antenna and a near-field communication (NFC) antenna. As shown in the figure, the PCB 2010 may define two opposing lobes 2014a and 2014b interconnected by a neck portion 2016. Opposing battery contacts 2018a and 2018b may be provided on the opposing lobes 2014a and 2014b to facilitate electrical communication with the battery 2020.

[0212] In the sixth step of process 2000, a second adhesive substrate 2008b can be attached to the first battery contact 2018a in order to receive the battery 2020 in the seventh step of process 2000, which follows immediately. The second adhesive substrate may comprise a pressure-sensitive adhesive tape used to bond the battery 2020 to the first battery contact 2018a. However, the second adhesive substrate may also comprise a Z-axis anisotropic (or conductive) pressure-sensitive adhesive tape that facilitates electrical communication (i.e., power transmission) between the battery 2020 and the first battery contact 2018a.

[0213] Figure 21 is a side view of an exemplary sensor 2100 according to one or more embodiments of the disclosure of the present invention. The sensor 2100 can be similar in some respects to any of the sensors described herein and can therefore be used to detect a specific sample concentration in a sample monitoring system. As shown, the sensor 2100 includes a tail 2102, a flag 2104, and a neck 2106 interconnecting the tail 2102 and the flag 2104. The tail 2102 contains an enzyme or other chemical or biological agent, and in some embodiments, a membrane can cover the chemical agent. During use, the tail 2102 is received transdermally under the user's skin, and the chemical agent contained on the tail helps facilitate sample monitoring in the presence of body fluids.

[0214] The tail 2102 can be accommodated within a hollow or recessed portion of a sharp (not shown) that at least partially surrounds the tail 2102 of the sensor 2100. As shown, the tail 2102 can extend with an angular Q offset from the horizontal. In some embodiments, the angle Q can be approximately 85°. Thus, in contrast to other sensor tails, the tail 2102 does not extend vertically from the flag 2104, but instead can extend with an angular offset from the vertical. This angular offset can be demonstrated to be advantageous in that it helps to keep the tail 2102 within the recessed portion of the sharp.

[0215] The tail 2102 includes a first end or bottom end 2108a and a second end or top end 2108b on the opposite side. A tower 2110 may be provided at or near the top end 2108b, and the tower 2110 may extend vertically upward from where the neck 2106 interconnects the tail 2102 to the flag 2104. If the sharp moves laterally during operation, the tower 2110 will pivot the tail 2102 toward the sharp and otherwise help keep the tail 2102 within the recessed portion of the sharp. Furthermore, in some embodiments, the tower 2110 may provide or otherwise define a projection 2112 extending laterally from there. When the sensor 2100 is mated with the sharp and the tail 2102 extends within the recessed portion of the sharp, the projection 2112 may engage with the inner surface of the recessed portion. During operation, the projection 2112 can help keep the tail 2102 within the recessed portion.

[0216] Flag 2104 may include a substantially flat surface on which one or more sensor contacts 2114 are positioned. The sensor contacts 2114 may be configured to align with a corresponding number of flexible carbon-impregnated polymer modules enclosed within the connector.

[0217] In some embodiments, as shown in the illustration, the neck 2106 may provide or otherwise define a recess or bend 2116 extending between the flag 2104 and the tail 2102. The bend 2116 may demonstrate advantages in that it adds flexibility to the sensor 2100 and helps prevent bending of the neck 2106.

[0218] In some embodiments, a notch 2118 (shown by a dashed line) can be optionally defined within a flag near the neck 2106. The notch 2118 can add flexibility and tolerance to the sensor 2100 when it is mounted. More specifically, the notch 2118 can help absorb interference forces that may occur when the sensor 2100 is mounted.

[0219] Figures 22A and 22B are isometric and partially exploded isometric views of an exemplary connector assembly 2200 according to one or more embodiments. As shown, the connector assembly 2200 may include a connector 2202. The connector 2202 may include injection-molded portions used to help secure one or more flexible carbon-impregnated polymer modules 2204 (four shown in Figure 22B) to a mount 2206. More specifically, the connector 2202 may help secure the module 2204 to a designated location adjacent to the sensor 2100 in contact with the sensor contacts 2114 (Figure 21) provided on the flag 2104 (Figure 21). The module 2204 may be made of a conductive material that provides conductive communication between the sensor 2100 and the corresponding circuit contacts (not shown) provided in the mount 2206.

[0220] As shown in Figure 22C, the connector 2202 may have a pocket 2208 sized to receive the module 2204. Furthermore, in some non-limiting embodiments, the connector 2202 may further have one or more recesses 2210 configured to mate with one or more corresponding flanges 2212 (Figure 22B) on the mount 2206. By mating the recesses 2210 with the flanges 2212, the connector 2202 can be secured to the mount 2206 by a crimp fit or the like. In other embodiments, the connector 2202 can be secured to the mount 2206 using adhesive or by ultrasonic welding.

[0221] Figures 22D and 22E are isometric and partially exploded isometric views of another exemplary connector assembly 2200 according to one or more embodiments. As shown, the connector assembly 2200 may include a connector 2202, and Figure 22F is an isometric bottom view of the connector 2202. The connector 2202 may comprise an injection-molded portion, a flexible carbon-impregnated polymer, silicone or doped silicone, or a Molex connector used to help secure one or more flexible carbon-impregnated polymer modules 2204 (four shown in Figure 22E) to the sensor 2100 on the mount 2206. More specifically, the connector 2202 may help secure the contacts 2204 in contact with the sensor contacts 2114 (Figure 21) provided on the flag 2104 at a defined location adjacent to the sensor 2100. In other non-limiting embodiments, the connector 2202 may include any other material known in the art. The contact 2204 can be manufactured from a punched conductive material that provides conductive communication between the sensor 2100 and a corresponding circuit contact (not shown) located within the mount 2206. In some embodiments, for example, the contact 2204 can be soldered to a PCB (not shown) positioned within the mount 2206.

[0222] As best seen in Figure 22F, the connector 2202 may have a pocket 2208 sized to receive the contact 2204. Furthermore, in some embodiments, the connector 2202 may further have one or more recesses 2210 configured to mate with one or more corresponding flanges 2212 on the mount 2206. Machining the recesses 2210 with the flanges 2212 can help to secure the connector 2202 to the mount 2206 by a crimp fit or the like. In other embodiments, the connector 2202 may be secured to the mount 2206 using adhesive or by ultrasonic welding.

[0223] Figures 23A and 23B are a side view and an isometric projection view, respectively, of an exemplary sensor control device 2302 according to one or more embodiments of the disclosure of the present invention. The sensor control device 2302 can be similar in some respects to the sensor control device 102 of Figure 1, and is therefore best understood by referring to it. Furthermore, the sensor control device 2302 can replace the sensor control device 104 of Figure 1, and is therefore used in conjunction with the sensor applicator 102 of Figure 1, which delivers the sensor control device 2302 to a target monitoring location on the user's skin.

[0224] As shown in the figures, the sensor control device 2302 includes an electronic equipment housing 2304 which may be substantially disk-shaped and have a circular cross-section. However, in other embodiments, the electronic equipment housing 2304 may exhibit other cross-sectional shapes such as oval, elliptical, or polygonal without departing from the scope of the disclosure of the present invention. The electronic equipment housing 2304 includes a shell 2306 and a mount 2308 to which it can be mated. The shell 2306 can be secured to the mount 2308 by a variety of methods such as snap engagement, interlocking fit, ultrasonic welding, laser welding, one or more mechanical fasteners (e.g., screws), gaskets, adhesive, or any combination thereof. In some non-limiting embodiments, the shell 2306 can be secured to the mount 2308 such that a sealed interface is created between it and the mount 2308. An adhesive patch 2310 can be positioned and attached to the underside of the mount 2308. Similar to the adhesive patch 108 in Figure 1, the adhesive patch 2310 can be configured to fix and maintain the sensor control device 2302 in a predetermined location on the user's skin during operation.

[0225] The sensor control device 2302 may further include a sensor 2312 and a sharp 2314 used to help deliver the sensor 2312 transcutaneously under the user's skin during attachment of the sensor control device 2302. The corresponding portions of the sensor 2312 and the sharp 2314 extend distally from the bottom of the electronic housing 2304 (e.g., mount 2308). A sharp hub 2316 may be overmolded onto the sharp 2314 to fix and support the sharp 2314. As shown in Figure 23A, the sharp hub 2316 may include or otherwise define a mating member 2318. During the assembly of the Sharp 2314 to the sensor control device 2302, the Sharp hub 2316 engages with the upper surface of the electronic housing 2304 or an internal component of the electronic housing 2304, allowing the Sharp 2314 to advance axially through the electronic housing 2304 until the mating member 2318 extends distally from the bottom of the mount 2308. As described below, in at least one embodiment, the Sharp hub 2316 can engage with the upper portion of the sealing overmolded mount 2308. As the Sharp 2314 penetrates the electronic housing 2304, the exposed portion of the sensor 2312 can be received within the hollow or recessed (arc-shaped) portion of the Sharp 2314. The remaining portion of the sensor 2312 is located inside the electronic housing 2304.

[0226] The sensor control device 2302 may further include a sensor cap 2320, shown in Figures 23A-23B where it is separated from the electronic housing 2304. The sensor cap 2320 can help provide a sealing barrier that surrounds and protects the exposed portions of the sensors 2312 and sharp 2314. As shown, the sensor cap 2320 may include a substantially cylindrical body having a first end 2322a and a second end 2322b opposite to it. The first end 2322a may be open to provide access to an inner chamber 2324 defined within the body. In contrast, the second end 2322b may be closed and provide or otherwise define an engagement feature 2326. As will be explained in more detail below, the engagement feature portion 2326 can help to fit the sensor cap 2320 onto the applicator cap of the sensor applicator (for example, the sensor applicator 102 in Figure 1), and further, it can help to remove the sensor cap 2320 from the sensor control device 2302 when removing the sensor cap from the sensor applicator.

[0227] The sensor cap 2320 can be removably coupled to the electronic equipment housing 2304 at or near the bottom of the mount 2308. More specifically, the sensor cap 2320 can be removably coupled to a mating member 2318 extending distally from the bottom of the mount 2308. In at least one embodiment, for example, the mating member 2318 may define a set of male threads 2328a (Figure 23A) that can mate with a set of female threads 2328b (Figure 23B) defined within the inner chamber 2324 of the sensor cap 2320. In some embodiments, the male and female threads 2328a, 2328b may include a flat thread design (e.g., lacking helical curvature), but instead may include a helical thread engagement. Thus, in at least one embodiment, the sensor cap 2320 can be screwably coupled to the sensor control device 2302 at the location of the mating member 2318 on the sharp hub 2316. In other embodiments, the sensor cap 2320 may be removably coupled to the mating member 2318 by other types of engagement, including but not limited to a tight fit, a friction fit, or a fragile member or material (e.g., wax, adhesive, etc.) that can be broken by a small separating force (e.g., an axial or rotational force).

[0228] In some embodiments, the sensor cap 2320 may include a monolithic (single) structure extending between a first end 2322a and a second end 2322b. However, in other embodiments, the sensor cap 2320 may include two or more component parts. In an exemplary embodiment, for example, the body of the sensor cap 2320 may include a desiccant cap 2330 positioned at the second end 9122b. The desiccant cap 2330 may contain or provide a desiccant that helps maintain a preferred humidity level within the inner chamber 2324. Furthermore, the desiccant cap 2330 may define or otherwise provide an engagement feature portion 2326 of the sensor cap 2320. In at least one non-limiting embodiment, the desiccant cap 2330 may include an elastomer plug inserted into the bottom end of the sensor cap 2320.

[0229] Figures 24A and 24B are exploded isometric top and bottom views, respectively, of a sensor control device 2302 according to a certain embodiment. The shell 2306 and mount 2308 act as opposing clamshell halves that enclose or substantially encapsulate various electronic components (not shown) of the sensor control device 2302. Exemplary electronic components that may be placed between the shell 2306 and mount 2308 include, but are not limited to, batteries, resistors, transistors, capacitors, inductors, diodes, and switches.

[0230] The shell 2306 may define a first opening 2402a, and the mount 2308 may define a second opening 2402b, and the openings 2402a and 2402b can be aligned when the shell 2306 is properly mounted on the mount 2308. As best seen in Figure 24A, the mount 2308 may provide or otherwise define a base 2404 that protrudes from the inner surface of the mount 2308 at the second opening 2402b. The base 2404 may define at least a portion of the second opening 2402b. Furthermore, a channel 2406 may be defined on the inner surface of the mount 2308, and the channel 2406 may surround the base 2402. In the exemplary embodiment, the channel 2406 is circular in shape, but it is conceivable that it could instead be of another shape, such as elliptical, oblong, or polygonal.

[0231] The mount 2308 may include a molded portion made of a rigid material such as plastic or metal. In some embodiments, a seal 2408 can be overmolded onto the mount 2308, and the seal 2408 may be made of an elastomer, rubber, polymer, or other easily moldable material suitable for facilitating a sealing bond. In embodiments where the mount 2308 is made of plastic, the mount 2308 can be molded in a first "shot" of injection molding, and the seal 2408 can be overmolded onto the mount 2308 in a second "shot" of injection molding. Thus, the mount 2308 may be referred to as a "two-shot mount" or otherwise characterized.

[0232] In exemplary embodiments, the seal 2408 may be overmolded onto the mount 2308 at the base 2404 and further overmolded onto the bottom of the mount 2308. More specifically, the seal 2408 may be defined or otherwise provided as a first sealing element 2410a overmolded onto the base 2404 and a second sealing element 2410b (Figure 24B) connected thereto or interconnected thereto and overmolded onto the mount 2308 at the bottom of the mount 2308. In some embodiments, one or both of the sealing elements 2410a, 2410b may help form a corresponding portion (section) of the second opening 2402b. Although the seal 2408 is described herein as being overmolded onto the mount 2308, it is also conceivable that one or both of the sealing elements 2410a, 2410b may comprise an elastomer component independent of the mount 2408, such as an O-ring or gasket.

[0233] The sensor control device 2302 may further include a collar 2412, which can be a substantially annular structure defining a central opening 2414. The central opening 2414 can be sized to receive a first sealing element 2410a and can be aligned with the first and second openings 2402a and 2402b when the sensor control device 2302 is properly assembled. The shape of the central opening 2414 can substantially conform to the shapes of the second opening 2402b and the first sealing element 2410a.

[0234] In some embodiments, the collar 2412 may define or otherwise provide an annular lip 2416 on its bottom surface. The annular lip 2416 may be sized or otherwise configured to fit into or be received in a channel 2406 defined on the inner surface of the mount 2308. In some embodiments, a groove 2418 may be defined on the annular lip 2416 and may be configured to fit into or be received in a portion of the sensor 2312 that extends laterally within the mount 2308. In some embodiments, the collar 2412 may further define or otherwise provide a collar channel 2420 (Figure 24A) sized to fit into an annular ridge 2422 (Figure 24B) defined on the inner surface of the shell 2306 when the sensor control device 2302 is properly assembled on its top surface.

[0235] The sensor 2312 may include a tail 2424 that extends through a second opening 2402b defined within the mount 2308 and is received percutaneously beneath the user's skin. The tail 2424 may have an enzyme or other chemical formulation contained on the tail to help facilitate sample monitoring. The sharp 2314 may include a sharp tip 2426 that is extendable through a first opening 2402a defined by the shell 2306. The tail 2424 of the sensor 2312 can be received in a hollow or recessed portion of the sharp tip 2426 as the sharp tip 2426 penetrates the electronic equipment housing 2304. The sharp tip 2426 may be configured to penetrate the skin while carrying the tail 2424 in order to bring the activating chemical formulation of the tail 2424 into contact with body fluids.

[0236] The sensor control device 2302 can provide a sealed subassembly that includes, among other components, the shell 2306, sensor 2312, sharp 2314, seal 2408, collar 2412, and sensor cap 2320. The sealed subassembly can help isolate the sensor 2312 and sharp 2314 within the inner chamber 2324 (Figure 24A) of the sensor cap 2320. During the assembly of the sealed subassembly, the sharp tip 2426 is advanced through the electronic housing 2304 until the sharp hub 2316 engages with the seal 2408, more specifically with the first sealing element 2410a. A mating member 2318 provided at the bottom of the sharp hub 2316 can extend out of a second opening 2402b within the bottom of the mount 2308, and the sensor cap 2320 can be coupled to the sharp hub 2316 at the location of the mating member 2318. By coupling the sensor cap 2320 to the sharp hub 2316 at the location of the fitting member 2318, the first end 2322a of the sensor cap 2320 can be biased into a sealed engagement state with the seal 2408, more specifically, into a sealed engagement state with the second sealing element 2410b on the bottom of the mount 2308. In some embodiments, when the sensor cap 2320 is coupled to the sharp hub 2316, a portion of the first end 9122a of the sensor cap 2320 may reach (engage) the bottom of the mount 2308, and the sealed engagement between the sharp hub 2316 and the first sealing element 2410a may absorb any tolerance changes between the feature portions.

[0237] Figure 25A shows a cross-sectional side view of a sensor control device 2302 according to a certain embodiment. As shown above, the sensor control device 2302 may include or otherwise incorporate a sealing subassembly 2502 which can be advantageous in isolating the sensor 2312 and sharp 2314 within the inner chamber 2324 of the sensor cap 2320. To assemble the sealing subassembly 2502, the sensor 2312 can be positioned within the mount 2308 such that the tail 2424 extends through a second opening 2402b at the bottom of the mount 2308. In at least one embodiment, a positioning feature 2504 can be defined on the inner surface of the mount 2308, and the sensor 2312 may have a groove 2506 that can be fitted with the positioning feature 2504 to properly position it within the mount 2308.

[0238] With the sensor 2312 properly positioned, the collar 2412 can be mounted on the mount 2308. More specifically, the collar 2412 can be positioned such that the first sealing element 2410a of the seal 2408 is received in a central opening 2414 defined by the collar 2412, and the first sealing element 2410a generates a radial seal against the collar 2412 in the central opening 2414. Furthermore, the annular lip 2416 defined on the collar 2412 can be received in a channel 2406 defined on the mount 2308, and the groove 2418 defined to pass through the annular lip 2416 can be aligned to receive the portion of the sensor 2312 that crosses the channel 2406 within the mount 2308. In some embodiments, adhesive can be injected into the channel 2406 to secure the collar 2412 to the mount 2308. The adhesive facilitates a sealed bond between these two components, creating a seal around the sensor 2312 at the location of the groove 2418, thereby isolating the tail 2424 from the inside of the electronic equipment housing 2304.

[0239] Next, the shell 2306 can be fitted to or otherwise bonded to the mount 2308. In some embodiments, as shown, the shell 2306 can be fitted to the mount 2308 through the grooved engagement portion 2508 around the outer perimeter of the electronic equipment housing 2304. To secure the shell 2306 to the mount 2308 and to further create a sealed engagement interface, adhesive can be injected (added) into the grooved portion of the engagement portion 2508. By fitting the shell 2306 to the mount 2308, the annular ridge 2422 defined on the inner surface of the shell 2306 can be received into 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 shell 2306 to the collar 2412 and to further facilitate a sealed bond between the two components at this location. When the shell 2306 is fitted onto the mount 2308, the first sealing element 2410a can extend at least partially through (into) the first opening 2402a defined within the shell 2306.

[0240] Next, the sharp 2314 can be coupled to the sensor control device 2302 by extending the sharp tip 2426 through the first and second openings 2402a and 2402b, which are defined within the shell 2306 and the mount 2308, respectively. The sharp 2314 can be advanced until the sharp hub 2316 engages with the seal 2408, more specifically with the first sealing element 2410a. The mating member 2318 can extend (project) out of the second opening 2402b at the bottom of the mount 2308 when the sharp hub 2316 engages with the first sealing element 2410a.

[0241] Next, the sensor cap 2320 can be removably coupled to the sensor control device 2302 by screw-fitting the female thread 2328b of the sensor cap 2320 with the male thread 2328a of the mating member 2318. The inner chamber 2324 is sized to receive the tail 2424 and sharp tip 2426 extending from the bottom of the mount 2308, and may be otherwise configured. Furthermore, the inner chamber 2324 can be sealed to isolate the tail 2424 and sharp tip 2426 from substances that may potentially interact adversely with the chemical formulation of the tail 2424. In some embodiments, a desiccant (not shown) may be present in the inner chamber 2324 to maintain an appropriate humidity level.

[0242] By tightening (rotating) the fitting engagement between the sensor cap 2320 and the fitting member 2318, the first end 2322a of the sensor cap 2320 can be pressed into an axial sealing engagement (e.g., along the centerlines of the openings 2402a and 2402b) with the second sealing element 2410b, further strengthening the axial sealing joint between the sharp hub 2316 and the first sealing element 2410a. Furthermore, by tightening the fitting engagement between the sensor cap 2320 and the fitting member 2318, the first sealing element 2410a can be compressed, thereby bringing a strong radial sealing engagement between the first sealing element 2410a and the collar 2412 at the central opening 2414. Thus, in at least one embodiment, the first sealing element 2410a can help facilitate axial and radial sealing engagements.

[0243] As described above, the first and second sealing elements 2410a and 2410b can be overmolded onto the mount 2308 and can be physically connected or interconnected to each other. Thus, a single injection molding shot can pass through the second opening 2402b of the mount 2308 to produce both ends of the seal 2408. This can be demonstrated to be advantageous in that multiple sealing interfaces can be generated by only a single injection molding shot. An additional advantage of the two-shot molding design is that the bond between the first and second shots is a more reliable adhesion than a mechanical seal, in contrast to using separate elastomer components (e.g., O-rings, gaskets, etc.). Thus, the actual number of mechanical sealing barriers is substantially halved. Furthermore, two-shot components made by a single elastomer shot also mean minimizing the number of two-shot components required to achieve all the necessary sterile barriers.

[0244] In a properly assembled state, the sealed subassembly 2502 can be subjected to radiation sterilization to sterilize the sensor 2312 and the sharp hub 2314. Radiation sterilization can be applied to the sealed subassembly 2502 before or after coupling the sensor cap 2320 to the sharp hub 2316. When the sensor cap 2320 is sterilized after coupling to the sharp hub 2316, the sensor cap 2320 can be manufactured from a material that allows radiation to propagate through it. In some embodiments, the sensor cap 2320 can be transparent or translucent, but can otherwise be opaque without departing from the scope of the disclosure of the present invention.

[0245] Figure 25B shows an exploded isometric projection of a portion of another embodiment of the sensor control device 2302 shown in Figures 23A-23B and 24A-24B. The embodiments described above illustrate that the mount 2308 and seal 2408 are manufactured by a two-shot injection molding process. However, in other embodiments, as briefly shown above, one or both of the sealing elements 2410a, 2410b of the seal 2408 may include elastomer components independent of the mount 2408. In exemplary embodiments, for example, the first sealing element 2410a may be overmolded onto the collar 2412, and the second sealing element 2410b may be overmolded onto the sensor cap 2320. Alternatively, the first and second sealing elements 2410a, 2410b may include separate components such as gaskets or O-rings positioned on the collar 2412 and the sensor cap 2320, respectively. By tightening (rotating) the fitting engagement between the sensor cap 2320 and the fitting member 2318, the second sealing element 2410b can be pressed into an axial sealing engagement with the bottom of the mount 2308, thereby reinforcing the axial sealing interface between the sharp hub 2316 and the first sealing element 2410a.

[0246] Figure 26A shows an isometric bottom view of a mount 2308 according to a certain embodiment, and Figure 26B shows an isometric top view of a sensor cap 2320 according to a certain embodiment. As shown in Figure 26A, the mount 2308 may provide or otherwise provide one or more recesses or pockets 2602 at or near the opening to the second opening 2402b. As shown in Figure 26B, the sensor cap 2320 may provide or otherwise provide one or more protrusions 2604 at or near its first end 9122a. The protrusions 2604 can be received into the pockets 2602 when the sensor cap 2320 is coupled to the sharp hub 2316. More specifically, as described above, when the sensor cap 2320 is coupled to the fitting member 2318 of the sharp hub 2316, the first end 9122a of the sensor cap 2320 is placed into a sealed engagement with the second sealing element 2410b. In this process, the protrusion 2604 can be received into the pocket 2602, and this receipt can help prevent premature unscrewing of the sensor cap 2320 from the sharp hub 2316.

[0247] Figures 27A and 27B are a side view and a cross-sectional side view, respectively, of an exemplary sensor applicator 2702 according to a certain embodiment. The sensor applicator 2702 can be similar in some respects to the sensor applicator 102 of Figure 1, and can therefore be designed to discharge (release) a sensor control device such as the sensor control device 2302. Figure 27A shows the state in which the sensor applicator 2702 is expected to be shipped to the user and the state in which the user may receive it, and Figure 27B depicts the sensor control device 2302 positioned within the sensor applicator 2702.

[0248] As shown in FIG. 27A, the sensor applicator 2702 includes a housing 2704 and an applicator cap 2706 removably coupled thereto. In some embodiments, the applicator cap 2706 can be screwed onto the housing 2704 and can include a tamper-evident ring 2708. When the applicator cap 2706 is rotated (e.g., twisted off) relative to the housing 2704, the tamper-evident ring 2708 breaks off, thereby enabling the applicator cap 2706 to be removed from the sensor applicator 2702.

[0249] In FIG. 27B, the sensor control device 2302 is positioned within the sensor applicator 2702. Once the sensor control device 2302 is fully assembled, it can then be loaded into the sensor applicator 2702, and further, 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 mating screw thread sets that allow the applicator cap 2706 to be screwed onto the housing 2704 in a clockwise (or counterclockwise) direction, thereby securing the applicator cap 2706 to the sensor applicator 2702.

[0250] By securing the applicator cap 2706 to the housing 2704, the second end portion 9122b of the sensor cap 2320 can be positioned within the applicator cap 2706 and received within a cap post 2710 that extends proximally from the bottom of the applicator cap 2706. The cap post 2710 can be configured to receive at least a portion of the sensor cap 2320 when the applicator cap 2706 is coupled to the housing 2704.

[0251] Figures 28A and 28B are perspective and top views, respectively, of the cap post 2710 according to one or more additional embodiments. In the illustrated depiction, a portion of the sensor cap 2320 is received within the cap post 2710, more specifically, the desiccant cap 2330 of the sensor cap 2320 is positioned within the cap post 2710. The cap post 2710 may have a receiver feature 2802 configured to receive the engagement feature 2326 of the sensor cap 2320 when the applicator cap 2706 (Figure 27B) is coupled (e.g., screwed) to the sensor applicator 2702 (Figures 27A-27B). However, when the applicator cap 2706 is removed from the sensor applicator 2702, the receiver feature 2802 can prevent the engagement feature 2326 from reversing direction, thereby preventing the sensor cap 2320 from separating from the cap post 2710. Alternatively, by removing the applicator cap 2706 from the sensor applicator 2702, the sensor cap 2320 is simultaneously separated from the sensor control device 2302 (Figures 23A-24B and 24A-24B), thereby exposing the distal portions of the sensor 2312 (Figures 24A-24B) and the sharpener 2314 (Figures 24A-24B).

[0252] Many design variations of the receiver feature 2802 can be adopted without departing from the scope of the disclosure of the present invention. In exemplary embodiments, the receiver feature 2802 includes one or more flexible members 2804 (two shown) that are extensible or flexible in order to receive the engagement feature 2326. The engagement feature 2326 may include, for example, an expanding head, and the flexible feature 2804 may include a collet-type device that includes a plurality of flexible fingers configured to flex radially outward in order to receive the expanding head.

[0253] The flexible member 2804 may further provide or otherwise specify a corresponding rising surface 2806 configured to interact with one or more opposing cam surfaces 2808 provided on the outer wall of the engagement feature portion 2326. The configuration and alignment of the rising surface 2806 and the opposing cam surfaces 2808 are such that the applicator cap 2706 can rotate relative to the sensor cap 2320 in a first direction A (e.g., clockwise), but the cap post 2710 engages with the sensor cap 2320 when the applicator cap 2706 is rotated in a second direction B (e.g., counterclockwise). More specifically, when the applicator cap 2706 (and therefore the cap post 2710) rotates in the first direction A, the cam surface 2808 engages with the rising surface 2806, thereby pressing the flexible member 2804 to bend or otherwise deflect radially outward, resulting in a ratchet effect. However, by rotating the applicator cap 2706 (and therefore the cap post 2710) in the second direction B, the inclined surface 2810 of the cam surface 2808 is driven to collide with the opposing inclined surface 2812 of the rising surface 2806, and as a result, the sensor cap 2320 is coupled to the flexible member 2804.

[0254] Figure 29 is a cross-sectional side view of a sensor control device 2302 positioned within an applicator cap 2706 according to one or more embodiments. As shown, the opening to the receiver feature 2802 has a first diameter D3, with respect to the engagement feature 2326 of the sensor cap 2320 having a second diameter D4 which is larger than the first diameter D3 and also larger than the remaining outer diameter of the sensor cap 2320. As the sensor cap 2320 extends into the cap post 2710, the flexible member 2804 of the receiver feature 2802 can bend (expand) radially outward to receive the engagement feature 2326. In some embodiments, as shown, the engagement feature 2326 may provide or otherwise provide an inclined outer surface that helps bias the flexible member 2804 radially outward. As the engaging feature portion 2326 advances beyond the receiving feature portion 2802, the flexible member 2804 can bend back to its natural state (or toward it), thereby locking the sensor cap 2320 into the cap post 2710.

[0255] As the applicator cap 2706 is screwed into the housing 2704 (Figures 35A-35B) in a first direction A, the cap post 2710 rotates correspondingly in the same direction, gradually introducing the sensor cap 2320 into the cap post 2710. As the cap post 2710 rotates, the rising surface 2806 of the flexible member 2804 exerts a ratchet action against the opposing cam surface 2808 of the sensor cap 2320. This action continues until the applicator cap 2706 is fully screwed onto the housing 2704. In some embodiments, the ratchet action can occur over two full rotations of the applicator cap 2706 before it reaches its final position.

[0256] To remove the applicator cap 2706, the applicator cap 2706 is rotated in a second direction B, and the cap post 2710 rotates in the same direction accordingly, so that the cam surface 2808 (i.e., the inclined surface 2810 in Figures 28A-28B) engages with the rising surface 2806 (i.e., the inclined surface 2812 in Figures 28A-28B). Thus, the continued rotation of the applicator cap 2706 in the second direction B causes the sensor cap 2320 to rotate in the same direction accordingly, thereby unscrewing from the fitting member 2318 and allowing the sensor cap 2320 to detach from the sensor control device 2302. By detaching the sensor cap 2320 from the sensor control device 2302, the distal portions of the sensor 2312 and sharp 2314 are exposed, thus positioning the sensor control device 2302 in a designated location for release (use).

[0257] Figure 30 is a cross-sectional view of the sensor control device 2800 illustrating an exemplary interaction between the sensor and the Sharp. After assembly of the Sharp, the sensor must seat in the channel defined by the Sharp. In certain non-limiting embodiments, the sensor may be deflected inward and otherwise perfectly aligned with the Sharp. In some other non-limiting embodiments, the sensor may have a slight bias at the locations indicated by the two arrows A, as shown in Figure 30. Biasing the sensor relative to the Sharp may have the advantage of preventing exposure of the sensor tip (i.e., tail) outside the Sharp channel, which could potentially lead to insertion failure due to any relative movement between the sensor and the Sharp during subcutaneous insertion.

[0258] Figures 31A and 31B illustrate a printed circuit board according to a certain embodiment. The printed circuit board (PCB) 3102 can be included in a device such as a sensor control device. The PCB 3102 may have 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, or 13 or more layers. Vias can connect components or traces on one layer to components or traces on another layer. The PCB can be manufactured from a composite material of FR4 or FR-4, which may include, for example, fiberglass fabric with an epoxy resin binder. In other non-limiting embodiments, the PCB may include any other material known in the art. In some embodiments, a button cell or cylindrical battery 3104 can be mounted on the PCB 3102. For example, the battery 3104 can be mounted on the PCB 3102 using spot soldering and / or battery tabs. Using battery tabs can help reduce the battery size and at the same time eliminate battery contacts. Battery 3104 can be configured to power the PCB and / or one or more components mounted on the PCB. PCB 3102 may also include one or more modules such as resistors, transistors, capacitors, inductors, diodes, and / or switches. One or more modules can be mounted, connected, or installed on PCB 3102.

[0259] The sample sensors shown in Figures 1-3B, 5B, 6A, 6B, 7, 9-11B, 13B, 15, 16B-17B, 18B, 19A, 19B, 21, 22A, 22B, 22D, 22E, 23A, 23B, 24A, 24B, 25A, 25B, 27B, 29, and / or 30 can be attached to or connected to PCB3102. To monitor the sample level in bodily fluids, a portion of the sample sensor may be configured to be positioned in contact with the bodily fluids beneath the skin layer. In certain non-limiting embodiments, the sensor includes a tail, a flag, and a neck connecting the tail and the flag. To accept and support both the sensor and the connector, assembly 3108, for example, the plug assembly shown in Figures 3A, 3B, 22B, and 22E, can be included as part of the sensor assembly. When assembly 3108 is properly coupled to the electronic housing, one or more circuit contacts, for example, located on the underside of PCB 3110, can create conductive communication with the electrical contacts of the connector. Thus, in some non-limiting embodiments, the connector can be connected to the PCB and configured to establish an electrical connection between the sample sensor and the PCB.

[0260] In certain embodiments, the connector may take the form shown in Figures 3A, 3B, 11A, 11B, 17A, and / or 17B, and in other embodiments, the connector may take any other form, such as a collar shape. At least a portion of the connector may include at least one of silicone rubber and / or a flexible carbon-impregnated polymer. Some of these embodiments included herein describe the use of a plug to connect the connector to a PCB, but in certain other embodiments, the connector may be connected directly to a PCB. For example, assembly 3108 may include a Molex connector and a sensor flag, as shown in Figures 22B and 22E. In some embodiments, one or more components of the sensor, such as a tail, a flag, and a neck, may be molded to help secure and keep the sensor within a sharp channel. For example, the neck may include a biasing tower and / or the flag may include one or more openings to help secure or keep the sensor properly aligned within a sharp channel. In some non-limiting embodiments, a Sharp hub 3114 can be used to help hold or fix the sensor to the PBC.

[0261] In certain non-limiting embodiments, a processor 3112 can be connected to PCB 3102. The processor 3112 can be embodied by any computer device 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 unit (PLD), a field-programmable gate array (FPGA), an input / output (I / O) circuit, a digital expansion circuit, or an equivalent device, or any combination thereof. PCB 3102 may include a single processor or controller, or multiple controllers or computers. For example, PCB 3102 may include a general-purpose data processing unit 3112 or an ASIC 3116, or both. In certain non-limiting embodiments, the processor, whether it is a general-purpose data processing unit 3112 or an ASIC 3116, may be configured to process data associated with monitored sample levels.

[0262] In a non-limiting embodiment, thermistor 3118 can be connected to PCB 3102. The thermistor can detect the host's body temperature or ambient temperature. The signal from thermistor 3118 can be output to one or more of the general-purpose data processing units 3112 and ASIC 3116.

[0263] In non-limiting embodiments, one or more antennas may be attached to the PCB 3112. These one or more antennas may be, for example, Bluetooth low-energy antennas used for wireless communication, NFC antennas, or any other antennas that can be used to transmit monitored sample levels. Monitored sample levels, such as glucose levels, ketone levels, lactate levels, oxygen levels, or hemoglobin A1C levels, may be critical to the health of an individual with diabetes. In addition to transmitting monitored sample levels, the antennas may be used to transmit other instructions or information to another device. For example, the antennas may be used to receive device configuration information. In addition to or instead of this, one or more antennas may be used to transmit any other information acquired by the sensor or stored in the sensor control device. Monitored sample levels or other information can be transmitted from the sensor control device to a reader device such as the reader device 106 shown in Figure 1. The reader device may be, for example, a user device or mobile device used by an individual or healthcare provider.

[0264] The antenna can be, for example, a Bluetooth low-energy antenna. Bluetooth (including Bluetooth low-energy) typically operates at one or more of 2.45 GHz and 432 MHz, or around these frequencies. The antenna can be configured as an inverted H-shape, J-shape, inverted F-shape, or any other form. In some non-limiting embodiments, the antenna can be curved around the outer circumference of the battery. In other non-limiting embodiments, instead of curving around the outer circumference of the battery 3104, the antenna 3106 can simply be positioned at a different location on the PCB so as not to overlap with the battery 3104.

[0265] In certain 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 communication and NFC communication. In this specification, antenna 3106 (Bluetooth low-energy antenna) may be referred to as the first antenna, and antenna 3118 (NFC antenna) may be referred to as the second antenna. Either antenna 3106 or the separate NFC antenna 3118 can be used to transmit monitored sample levels, as shown in Figures 31A and 31B. The separate NFC antenna 3118 may be provided as a module mounted on the PCB. In some non-limiting embodiments, as shown in Figure 31B, the NFC antenna 3118 may be embedded within and / or around the circumference of the PCB. The NFC antenna 3118 may also be entirely or partially deviated from the outer circumference of the PCB. The NFC antenna 3118 may deviate and traverse the inner portion of the PCB 3102, for example, as shown in Figures 31A and 31B. As shown in Figure 31B, the NFC antenna 3118 can be embedded in the material of the PCB 3102, for example, FR4. In another embodiment, the NFC antenna 3118 can be embedded in a lobe during the fabrication of the PCB 3102. The NFC antenna 3118 may include one or more helices, each helice optionally having one or more windings / loops (e.g., multiple helical loops) printed on one or more layers of the PCB 3102. The NFC antenna 3118 may include one or more helices, each helice having optionally one or more loops on which each helice is printed on two, three, four, five, six, seven, eight, nine, ten, eleven, twelve, or thirteen or more layers of PCB 3102. Helices of the NFC antenna 3118 on different layers of PCB 3102 can be connected at both ends by vias to form longer helices.

[0266] As shown in Figure 31B, the Bluetooth low-energy antenna 3106 may include a radiating element 3120, referred herein as the first radiating element, on the first layer of PCB 3102, and a radiating element 3122, referred herein as the second radiating element, on the second layer of PCB 3102. The radiating elements 3120 and 3122 may be inverted F-shaped printed elements, as shown in Figure 31B. The radiating elements 3120 and 3122 may be unipolar or bipolar. The radiating elements 3120 and 3122 may be H-shaped, J-shaped, K-shaped, or any other configuration for radiating electromagnetic waves. The Bluetooth low-energy antenna 3106 may include radiating elements on one, two, three, four, five, six, seven, eight, nine, ten, eleven, or twelve layers of PCB 3102. Radiating elements of PCB 3102 on different layers of PCB 3102 can be connected by vias or powered separately. One or more of the radiating elements of the Bluetooth low-energy antenna 3106 may have different resonant frequencies so that the Bluetooth low-energy antenna 3106 can have a wider bandwidth. For example, radiating elements 3120 and 3122 on the first layer of PCB 3102 may have different resonant frequencies. In non-limiting embodiments, the NFC antenna may be on the first and third layers of PCB 3102, the Bluetooth antenna 3106 may include elements on the first and fourth layers of PCB 3102, and the grounding plate 3124 may be on the second layer of PCB 3102. The exemplary grounding plate may be made of copper or other material suitable for the antenna, as disclosed herein. In certain embodiments, the grounding plate may be connected to the negative terminal of the battery.

[0267] Figure 32 shows a radiating element 3120 according to a certain non-limiting embodiment. The radiating element 3120 shown in Figure 32 is in an inverted F configuration. The radiating element 3120 can also be in a k-shape, h-shape, j-shape, or any other suitable configuration. The radiating element 3122 can also be configured according to Figure 32. The radiating element 3120 may include a feed arm 3202 to which a signal can be fed. The signal fed to the feed arm 3202 may be impedance matched. The radiating element 3120 may have an impedance of, for example, around 50 ohms. The radiating element 3120 may include a grounding arm 3204 connected to a grounding plate 3124. In another non-limiting embodiment, the feed arm 3202 may be connected to a grounding plate 3124, and the signal can be fed to the grounding arm 3204. The radiating element 3120 may include a radiating arm 3206 that radiates a signal. As shown in Figure 32, the radiating arm 3206 may include a meandering section. The meandering section can increase the electrical length of the radiating arm 3206. Such a length may be one-quarter wavelength of the above frequency from the antenna feed point to the end of the radiating element. For example, in the Bluetooth frequency band, this length must be less than 30 mm. In a more specific example, the length of the upper radiating element may be 22.1 mm, and the length of the lower radiating element may be 22.6 mm. The length of the feed trace may be 3.8 mm.

[0268] The Bluetooth antenna 3106 can be configured to operate in multiple protocols, modes, and / or frequencies. The Bluetooth antenna 3106 can be configured as a Bluetooth or Bluetooth Low Energy antenna operating at or around 2.45 GHz or 432 MHz. The NFC antenna 3118 can be configured to operate in multiple protocols, modes, and / or frequencies. The NFC antenna 3118 can be configured as an NFC antenna operating at or around 13.56 MHz.

[0269] As per the subject matter of the disclosure of the present invention, PCB 3102 may include electronic equipment for impedance matching of Bluetooth signals from, for example, processor 3112 to Bluetooth antenna 3106. PCB 3102 may include electronic equipment for impedance matching of Bluetooth signals from ASIC 3116 to NFC antenna 3118. PCB 3102 may include a grounding plate 3124 for connection to either or both of Bluetooth antenna 3106 and / or NFC antenna 3118.

[0270] As per the subject matter of the disclosure of the present invention, the conductive trace of the NFC antenna 3118 can follow the outer perimeter of the PCB 3102. For example, the conductive trace of the NFC antenna 3118 can follow the outer perimeter of the PCB 3102 one, two, three, four, five, six, seven, eight, nine, ten, eleven, or twelve or more times to form a loop or helix of conductive traces on one layer of the PCB 3102. The conductive trace of the antenna 3405 can form two, three, four, five, six, seven, eight, nine, ten, eleven, twelve, or thirteen or more loops (e.g., helical loops) that follow the outer perimeter of the PCB 3102 at least partially. For example, the path of the conductive trace can partially deviate from the outer perimeter of the PCB 3102. The conductive trace may take the shape of any polygon, such as a square, quadrilateral, triangle, or another polygon.

[0271] The NFC antenna 3118 can include conductive traces on two or more layers of the PCB 3102. The traces between any two layers can be connected by one or more vias between the layers of the PCB 3102. For example, the NFC antenna 3118 can include a first continuous trace that forms one or more loops (e.g., spiral loops) on the first layer of the PCB 3102, and a second continuous trace that forms two or more loops (e.g., spiral loops) on the second layer of the PCB 3102. As another example, the NFC antenna 3118 can include a first continuous trace that forms three or more loops (e.g., spiral loops) on the first layer of the PCB 3102, and a second continuous trace that forms three or more loops (e.g., spiral loops) on the second layer of the PCB 3102. Similarly, the NFC antenna 3118 can include a first continuous trace that forms four or more loops (e.g., spiral loops) on the first layer of the PCB 3102, and a second continuous trace that forms four or more loops (e.g., spiral loops) on the second layer of the PCB 3102. As another example, the antenna 3405 can include a first conductive trace that forms five or more loops (e.g., spiral loops) on the first layer of the PCB 3102, and a second conductive trace that forms five or more loops (e.g., spiral loops) on the second layer of the PCB 3102. According to the disclosed subject matter of the present invention, different layers of the PCB 3102 can have the same number of loops (e.g., spiral loops) (e.g., one, two, three, four, five) or different numbers of loops (e.g., spiral loops) (e.g., three spirals on the first layer and two spirals on the second layer). The NFC antenna 3118 can include conductive traces that cross three, four, five, six, seven, eight, nine, ten, or eleven or more layers of the PCB 3102.

[0272] With respect to NFC, the portion of the NFC antenna 3118 formed by the first set of contacts can be in the first frequency set by capacitance. Under normal operating conditions, either end of the portion of the NFC antenna 3118 formed by the first set of contacts can be connected to ground through the NFC electronic device.

[0273] In non-limiting exemplary embodiments, antennas disclosed herein may include at least partially conductive elements that are not on the PCB 3102. For example, the Bluetooth antenna 3106 may include conductive elements mounted on or above the PCB 3102.

[0274] Figures 33 to 36 show embodiments of a printed circuit board (PCB) comprising four layers. The non-limiting embodiments depicted in these figures illustrate exemplary configurations of two different types of antennas and grounding plates connected to the antennas.

[0275] Figure 33 shows the first layer 3300 (top layer) of the PCB, with the Bluetooth antenna 3311 configured on the top of the first layer and the NFC antenna 3331 configured on the bottom of the first layer. As shown in Figure 33, the Bluetooth antenna 3311 can be configured in a bent or meandering manner along the upper edge of the first layer, and the NFC antenna 3331 can be configured in multiple loops and cover approximately the lower half of the first layer.

[0276] Figure 34 shows the second layer 3400 of the PCB, and the grounding plate 3411 is configured to extend only partially radially to the edge of the PCB, substantially in the center of the PCB, but such that the radius of the second layer is greater than the radius of the grounding plate 3411. For example, the grounding plate 3411 may be configured to avoid overlapping with a portion of the NFC antenna 3331 (in the first layer) configured around the lower edge of the PCB. Such a configuration reduces the risk of undesirable interference that may occur if the grounding plate overlaps with the NFC antenna. On the other hand, configuring the grounding plate to overlap with the NFC antenna has the desirable effect of increasing the range of the NFC antenna. In an effort to maximize the NFC antenna range while minimizing the risk of undesirable interference, the embodiment shown in Figure 34 consists of a thin strip of grounding plate 3423 extending to the edge of the PCB, or to an area of ​​the PCB where the grounding plate 3423 is considered to overlap with the NFC antenna 3331 in the first layer. Such a configuration allows the NFC antenna to have a larger range, while simultaneously minimizing the risk of undesirable interference by reducing the area in which the grounding plate overlaps with the NFC antenna. As shown in Figure 34, the thin strip of the grounding plate 3423 may be configured in a bent or meandering manner.

[0277] Figure 35 shows the third layer of the PCB, where the NFC antenna 3542 is configured in multiple loops and covers approximately the lower half of the third layer. The NFC antenna 3542 in the third layer may be the same antenna or an extension thereof as the NFC antenna 3331 in the first layer (Figure 33).

[0278] Figure 36 shows the fourth layer (bottom layer) of the PCB, and the Bluetooth antenna 3611 is configured in a bent or meandering form along the upper edge of the fourth layer. The terms “meandering” or “bent” as used herein refer to an antenna having a series of wavy curves that can be distinguished from an antenna that is straight. The Bluetooth antenna 3611 in the fourth layer may be the same antenna or an extension thereof as the Bluetooth antenna 3311 in the first layer (Figure 33). In embodiments, element 3631 represents a ground plate which may be separate from the other ground plates of the device. In embodiments, the Bluetooth antenna 3311 in the first layer and the Bluetooth antenna 3611 in the fourth layer may be configured to be slightly offset from each other such that the meandering curve of one antenna does not substantially overlap with the meandering curve of the other antenna. This offset configuration reduces the overall overlap between the two Bluetooth antennas, which reduces parasitic capacitance associated with undesirable noise, instability, or unwanted coupling.

[0279] In certain embodiments, NFC antennas on one or more layers of the PCB may not be grounded to avoid interference with electronic devices in the system. In certain embodiments, the PCB may include one or more vias to allow components on different layers to be connected as needed.

[0280] In certain modifications, the embodiments shown in Figures 33 to 36 may include an additional layer, namely a fifth layer (not shown). The fifth layer may consist of another grounding plate that can protect the internal circuitry from external sources of signals or other forms of energy (for example, by reducing the risk of undesirable interference from external sources).

[0281] In certain embodiments, a printed circuit board (PCB) comprising four layers may be configured differently from those shown in Figures 33 to 36. For example, and not limited to, the first layer may include a Bluetooth antenna, the second layer may include a grounding plate and an NFC antenna, the third layer may include an NTC antenna, and the fourth layer may include a grounding plate.

[0282] In certain embodiments, the grounding plate may consist of multiple layers to provide improved shielding from signal traces that may cause interference. For example, interference-sensitive components of a PCB may be placed between two adjacent grounding plates to shield them from external interference. As another example, components of a PCB that may cause interference to other components may also be placed between grounding plates to reduce the risk of causing undesirable interference to other components. In other words, embodiments in which the grounding plate consists of multiple layers provide customizable, flexible, and adjustable shielding from both internal and external risks of interference.

[0283] In certain embodiments, the PCB may be constructed with additional layers beyond those described above. For example, the PCB may be constructed with additional upper layers and / or additional lower layers. One or both of these layers may be made of dielectric material. In certain embodiments, such dielectric layers may be manufactured or cut away to avoid overlap with the Bluetooth antenna in other layers. For example, referring to Figure 33, the dielectric layer may be configured to substantially cover the entire layer except for the portion covered by the Bluetooth antenna 3311. The dielectric layer may further include additional cutouts corresponding to the vias discussed above.

[0284] As described in the embodiments above, the antenna (Bluetooth or NFC) can be composed of multiple layers of the PCB. This design allows the antenna to be configured on a larger surface area, enabling longer and larger antennas to be configured on the PCB (e.g., antennas with additional loops), which improves the effectiveness of the antenna (e.g., longer range).

[0285] Appropriate devices, systems, methods, components, and additional details of their operation, along with relevant features, are described in International Publication No. 2018 / 136898 granted to Rao et al., International Publication No. 2019 / 236850 granted to Thomas et al., International Publication No. 2019 / 236859 granted to Thomas et al., International Publication No. 2019 / 236876 granted to Thomas et al., and U.S. Patent Application Publication No. 2020 / 0196919 filed June 6, 2019, the entire contents of each of these documents are incorporated herein by reference. Additional details relating to applicators, embodiments of their components, and variations thereof are described in U.S. Patent Application Publication No. 2013 / 0150691, No. 2016 / 0331283, and No. 2018 / 0235520, the entire contents of all of these documents are incorporated herein by reference for all purposes. Further details relating to Sharp modules, Sharp, embodiments of its components, and variations thereof are described in U.S. Patent Application Publication No. 2014 / 0171771, the entirety of which is incorporated herein by reference for all purposes.

[0286] Embodiments disclosed herein include the following:

[0287] A. A printed circuit board and a connector configured to establish an electrical connection between a sample sensor connected to the printed circuit board and having a proximal portion and a distal portion, wherein the proximal portion is electrically coupled to the printed circuit board and the distal portion is configured to extend under the user's skin to monitor one or more sample levels in body fluids; a battery connected to the printed circuit board and configured to supply power to the printed circuit board; a processor connected to the printed circuit board and configured to process data associated with the monitored one or more sample levels; and a device for transmitting the processed data. An apparatus comprising a first antenna and a second antenna, wherein the first antenna includes a first radiating element including a conductive trace on a first layer of a printed circuit board and a second radiating element including a conductive trace on a second layer of the printed circuit board, the first antenna being for transmitting processed data at a first frequency set, and the second antenna being for transmitting processed data, the second antenna including at least one conductive trace on at least one layer of the printed circuit board, and the second antenna being for transmitting processed data at a second frequency.

[0288] B. A printed circuit board; a sample sensor having a proximal portion and a distal portion configured to extend beneath the user's skin to monitor one or more sample levels in a body fluid; a connector connected to the printed circuit board and configured to establish an electrical connection between the proximal portion of the sample 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 monitored one or more sample levels; and a first antenna and a second antenna for transmitting the processed data, wherein the first antenna includes a first radiating element having a conductive trace on a first layer of the printed circuit board and a second radiating element having a conductive trace on a second layer of the printed circuit board. A system comprising the first antenna and the second antenna, wherein the first antenna is for transmitting processed data at a first frequency set, and the second antenna is for transmitting processed data, and the second antenna includes at least one conductive trace on at least one layer of a printed circuit board, and the second antenna is for transmitting processed data at a second frequency.

[0289] Each of embodiments A and B may have one or more of the following additional elements in any combination: Element 1: A first frequency is for transmission using Bluetooth Low Energy, and a second frequency is for transmission using Short-Range Wireless Communication. Element 2: At least one conductive trace on at least one layer of the printed circuit board includes a trace that follows the outer perimeter of the printed circuit board and forms multiple loops. Element 3: At least one conductive trace on at least one layer of the printed circuit board includes a conductive trace that follows at least partially the outer perimeter of the printed circuit board and forms at least three loops. Element 4: At least one conductive trace on at least one layer of the printed circuit board includes a concentric trace that follows the outer perimeter of the printed circuit board and forms at least three loops. Element 5: 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: At least one conductive trace on each of the multiple layers of the printed circuit board is connected by vias between two layers of the printed circuit board. Element 7: The first set of contacts includes contacts at the ends of the conductive trace, and the conductive trace is between the contacts of the first set. Element 8: At least one second contact includes at least one contact near the center of the conductive trace. Element 8: The conductive trace and at least one second contact form a bipolar antenna.

[0290] In addition to or instead of the above, any element and combination applicable to embodiments A and B may be applicable to any of the other elements and combinations applicable to embodiments A and B.

[0291] It should be noted that all features, elements, components, functions, and steps described in relation to any embodiment provided herein are intended to be freely combined and interchangeable with any other embodiment. Even when certain features, elements, components, functions, or steps are described in relation to only one embodiment, it should be understood that, unless otherwise expressly stated, such features, elements, components, functions, or steps can be used in all other embodiments described herein. Accordingly, this paragraph serves as a basis and written support prior to the introduction of claims that combine features, elements, components, functions, and steps from various embodiments or replace features, elements, components, functions, and steps from one embodiment with another, even if the following description does not expressly state that such combinations or substitutions are possible in a particular case. Accordingly, the above description of specific embodiments of the subject matter disclosed is presented for illustrative and explanatory purposes only. In particular, it should be clearly recognized that an explicit enumeration of all possible combinations and substitutions would be undue, given that the permissible range of each such combination and substitution will be readily apparent to those skilled in the art.

[0292] The embodiments are susceptible to various modifications and alternative forms, specific examples of which are shown in the drawings and described in detail herein. Those skilled in the art will see that various modifications and changes can be made to the methods and systems of the disclosed subject matter without departing from the spirit or scope of the disclosed subject matter. Accordingly, the disclosed subject matter is intended to include modifications and variations within the claims and their equivalents. Furthermore, any features, functions, steps, or elements of any of the embodiments described above, as well as any features, functions, steps, or elements not present in the invention, may be enumerated or added to the claims to negatively limit the scope of the claims of the invention.

[0293] The present invention can also be described in accordance with the following numbering clauses: Clause 1. A printed circuit board including multiple layers, A connector configured to establish an electrical connection between the printed circuit board and the proximal portion of a sample sensor having a distal portion that extends beneath the user's skin and is configured to monitor one or more sample levels in bodily fluids, A battery configured to be connected to a printed circuit board and to supply power to the printed circuit board, A processor connected to a printed circuit board and configured to process data associated with one or more monitored sample levels, A first antenna configured to transmit processed data, comprising a first radiating element including a conductive trace on a first layer of a printed circuit board and a second radiating element including a conductive trace on a second layer of the printed circuit board, and configured to transmit processed data at a first frequency set, A second antenna configured to transmit processed data, comprising at least one conductive trace on at least one layer of a printed circuit board, and configured to transmit processed data at a second frequency, A device that includes this. Clause 2. The apparatus of Clause 1, wherein the first frequency is for transmission using Bluetooth Low Energy and the second frequency is for transmission using Short-Range Wireless Communication. Clause 3. The apparatus of Clause 1 or Clause 2, wherein at least one conductive trace on at least one layer of the printed circuit board optionally follows the outer periphery of the printed circuit board and forms a helix, and the helix optionally has a plurality of loops. Clause 4. An apparatus according to any one of Clauses 1 to 3, wherein at least one conductive trace on at least one layer of the printed circuit board includes at least one conductive trace that at least partially follows the outer periphery of the printed circuit board and forms at least three loops. Clause 5. An apparatus according to any one of Clauses 1 to 4, wherein at least one conductive trace on at least one layer of the printed circuit board forms at least three loops that follow the outer periphery of the printed circuit board. Clause 6. An apparatus according to any one of Clauses 1 to 5, wherein both the first and second radiating elements are unipolar radiating elements. Clause 7. An apparatus according to any one of Clauses 1 to 6, wherein both the first and second radiating elements are inverted F-shaped radiating elements. Clause 8. The apparatus of Clause 7, wherein the inverted F-shaped radiating element includes at least one meandering portion. Clause 9. An apparatus according to any one of Clauses 1 to 8, wherein both the first and second radiating elements are inverted planar F-shaped radiating elements. Clause 10. The apparatus of any one of Clauses 1 to 9, further comprising a grounding plate configured on a third layer of a printed circuit board. Clause 11. The apparatus of Clause 10, wherein the third layer is between the first and second layers. Clause 12. The apparatus of any one of Clause 10 or 11, wherein the grounding plate comprises a first part and a second part, the second part being configured in a bent form and substantially overlapping with at least one conductive trace of a second antenna on at least one layer. Clause 13. The apparatus of Clause 12, wherein the first portion of the grounding plate is configured not to substantially overlap with at least one conductive trace of a second antenna on at least one layer. Clause 14. An apparatus according to any one of Clauses 1 to 13, wherein at least one conductive trace associated with a second antenna is configured on the second layer. Clause 15. The apparatus of any one of Clauses 1 to 14 wherein the conductive trace of a first radiating element on a first layer is configured in a first bending form. Clause 16. The apparatus of Clause 15, wherein the conductive trace of the second radiating element on the second layer is configured in a second bending form, and the conductive trace of the first radiating element and the conductive trace of the second radiating element are configured in an offset manner from each other, and the outer curve of the first bending form is configured not to substantially overlap with the outer curve of the second bending form. Clause 17. The apparatus of any one of Clauses 1 to 16, wherein the printed circuit board further includes a dielectric layer, the dielectric layer being configured not to overlap with the conductive traces of the first radiating element on the first layer. Clause 18. Printed circuit boards including multiple layers, A specimen sensor having a proximal portion and a distal portion, wherein the distal portion is configured to extend beneath the user's skin in order to monitor one or more specimen levels in a body fluid, A connector connected to a printed circuit board and configured to establish an electrical connection between the proximal portion of the sample sensor and the printed circuit board, A battery configured to be connected to a printed circuit board and to supply power to the printed circuit board, A processor connected to a printed circuit board and configured to process data associated with one or more monitored sample levels, A first antenna configured to transmit processed data, comprising a first radiating element including a conductive trace on a first layer of a printed circuit board and a second radiating element including a conductive trace on a second layer of the printed circuit board, and configured to transmit processed data at a first frequency set, A second antenna configured to transmit processed data, comprising at least one conductive trace on at least one layer of a printed circuit board, and configured to transmit processed data at a second frequency, A system that includes this. Clause 19. A system of Clause 18 in which the first frequency is for transmission using Bluetooth Low Energy and the second frequency is for transmission using Short-Range Wireless Communication. Clause 20. The system of Clause 18 or Clause 19 wherein at least one conductive trace on at least one layer of the printed circuit board optionally forms a helix having multiple loops along the outer periphery of the printed circuit board. Clause 21. A system of any one of Clauses 18 to 20, wherein at least one conductive trace on at least one layer of the printed circuit board includes at least one conductive trace that at least partially follows the outer perimeter of the printed circuit board and forms at least three loops. Clause 22. A system of any one of Clauses 18 to 21, wherein at least one conductive trace on at least one layer of the printed circuit board forms at least three loops that follow the outer edge of the printed circuit board. Clause 23. A system according to any one of Clauses 18 to 22, wherein both the first and second radiating elements are unipolar radiating elements. Clause 24. A system of any one of Clauses 18 to 23, wherein both the first and second radiating elements are inverted F-shaped radiating elements. Clause 25. A system of any one of Clauses 18 to 24 in which an inverted F-shaped radiating element includes at least one meandering portion. Clause 26. A system of any one of Clauses 18 to 25, wherein both the first and second radiating elements are inverted planar F-shaped radiating elements. Clause 27. A system according to any one of Clauses 18 to 26, further comprising a grounding plate configured on a third layer of a printed circuit board. Clause 28. The system of Clause 27, in which the third layer is between the first and second layers. Clause 29. A system of any one of Clause 27 or 28, wherein the grounding plate comprises a first part and a second part, the second part being configured in a bent form and substantially overlapping with at least one conductive trace of a second antenna on at least one layer. Clause 30. The system of Clause 29, wherein the first portion of the grounding plate is configured not to substantially overlap with at least one conductive trace of a second antenna on at least one layer. Clause 31. A system of any one of Clauses 18 to 30, wherein at least one conductive trace associated with the second antenna is configured on the second layer. Clause 32. A system of any one of Clauses 18 to 31, wherein the conductive trace of a first radiating element on a first layer is configured in a first bending form. Clause 33. The system of Clause 32, wherein the conductive trace of the second radiating element on the second layer is configured in a second bending form, and the conductive trace of the first radiating element and the conductive trace of the second radiating element are configured in an offset manner from each other, and the outer curve of the first bending form is configured not to substantially overlap with the outer curve of the second bending form. Clause 34. A system of any one of Clauses 18 to 33, wherein the printed circuit board further includes a dielectric layer, the dielectric layer being configured not to overlap with the conductive traces of the first radiating elements on the first layer. [Explanation of symbols]

[0294] 100 Sample Monitoring System 102 Sensor Applicator 106 Reader devices 108 Adhesive Patches 112 Local communication routes or links

Claims

1. A printed circuit board containing multiple layers, A connector connected to the printed circuit board and configured to establish an electrical connection between the printed circuit board and the proximal portion of a sample sensor having a distal portion configured to extend beneath the user's skin to monitor one or more sample levels in a bodily fluid, A battery connected to the printed circuit board and configured to supply power to the printed circuit board, A processor connected to the printed circuit board and configured to process data associated with the monitored one or more sample levels, A first antenna configured to transmit the aforementioned data, comprising a first radiating element including a conductive trace on a first layer of the printed circuit board and a second radiating element including a conductive trace on a second layer of the printed circuit board, and configured to transmit the processed data at a first frequency set, A second antenna configured to transmit the aforementioned data, comprising at least one conductive trace on at least one layer of the printed circuit board, and configured to transmit the processed data at a second frequency, A device that includes this.

2. The apparatus according to claim 1, wherein the first frequency is for transmission using Bluetooth low energy, and the second frequency is for transmission using short-range wireless communication.

3. The apparatus according to claim 1 or claim 2, wherein the at least one conductive trace on at least one layer of the printed circuit board optionally forms a helix by following the outer circumference of the printed circuit board, and the helix optionally has a plurality of loops.

4. The apparatus according to any one of claims 1 to 3, wherein the at least one conductive trace on at least one layer of the printed circuit board includes at least one conductive trace that at least partially follows the outer periphery of the printed circuit board and forms at least three loops.

5. The apparatus according to any one of claims 1 to 4, wherein the at least one conductive trace on at least one layer of the printed circuit board forms at least three loops that follow the outer periphery of the printed circuit board.

6. The apparatus according to any one of claims 1 to 5, wherein both the first radiating element and the second radiating element are unipolar radiating elements.

7. The apparatus according to any one of claims 1 to 6, wherein both the first radiating element and the second radiating element are inverted F-shaped radiating elements.

8. The apparatus according to claim 7, wherein the inverted F-shaped radiating element includes at least one meandering portion.

9. The apparatus according to any one of claims 1 to 8, wherein both the first radiating element and the second radiating element are planar inverted F-shaped radiating elements.

10. The apparatus according to any one of claims 1 to 9, further comprising a grounding plate formed on a third layer of the printed circuit board.

11. The apparatus according to claim 10, wherein the third layer is between the first layer and the second layer.

12. The grounding plate includes a first portion and a second portion, The second part is configured in a bent form, The second portion is configured to substantially overlap with the at least one conductive trace of the second antenna on the at least one layer. The apparatus according to claim 10 or claim 11.

13. The apparatus according to claim 12, wherein the first portion of the grounding plate is configured not to substantially overlap with the at least one conductive trace of the second antenna on the at least one layer.

14. The apparatus according to any one of claims 1 to 13, wherein the at least one conductive trace associated with the second antenna is configured on the second layer.

15. The apparatus according to any one of claims 1 to 14, wherein the conductive trace of the first radiating element on the first layer is configured in a first bending form.

16. The conductive trace of the second radiating element on the second layer is configured in a second bending form, The conductive trace of the first radiating element and the conductive trace of the second radiating element are configured in an offset manner from each other, and the outer curve of the first bent form is configured not to substantially overlap with the outer curve of the second bent form. The apparatus according to claim 15.

17. The printed circuit board further includes a dielectric layer, The dielectric layer is configured such that it does not overlap with the conductive trace of the first radiating element on the first layer. The apparatus according to any one of claims 1 to 16.

18. A printed circuit board containing multiple layers, A specimen 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 specimen levels in a body fluid, A connector connected to the printed circuit board and configured to establish an electrical connection between the proximal portion of the sample sensor and the printed circuit board, A battery connected to the printed circuit board and configured to supply power to the printed circuit board, A processor connected to the printed circuit board and configured to process data associated with the monitored one or more sample levels, A first antenna configured to transmit the aforementioned data, comprising a first radiating element including a conductive trace on a first layer of the printed circuit board and a second radiating element including a conductive trace on a second layer of the printed circuit board, and configured to transmit the processed data at a first frequency set, A second antenna configured to transmit the processed data, the second antenna comprising at least one conductive trace on at least one layer of the printed circuit board, and configured to transmit the processed data at a second frequency, A system that includes this.

19. The system according to claim 18, wherein the first frequency is for transmission using Bluetooth low energy, and the second frequency is for transmission using short-range wireless communication.

20. The system according to claim 18 or 19, wherein the at least one conductive trace on at least one layer of the printed circuit board optionally forms a spiral having a plurality of loops by following the outer circumference of the printed circuit board.

21. The system according to any one of claims 18 to 20, wherein the at least one conductive trace on at least one layer of the printed circuit board includes at least one conductive trace that at least partially follows the outer periphery of the printed circuit board and forms at least three loops.

22. The system according to any one of claims 18 to 21, wherein the at least one conductive trace on at least one layer of the printed circuit board forms at least three loops that follow the outer periphery of the printed circuit board.

23. The system according to any one of claims 18 to 22, wherein both the first radiating element and the second radiating element are unipolar radiating elements.

24. The system according to any one of claims 18 to 23, wherein both the first radiating element and the second radiating element are inverted F-shaped radiating elements.

25. The system according to any one of claims 18 to 24, wherein the inverted F-shaped radiating element includes at least one meandering portion.

26. The system according to any one of claims 18 to 25, wherein both the first radiating element and the second radiating element are planar inverted F-shaped radiating elements.

27. The system according to any one of claims 18 to 26, further comprising a grounding plate formed on a third layer of the printed circuit board.

28. The system according to claim 27, wherein the third layer is between the first layer and the second layer.

29. The grounding plate includes a first portion and a second portion, The second part is configured in a bent form, The second portion is configured to substantially overlap with the at least one conductive trace of the second antenna on the at least one layer. The system according to claim 27 or claim 28.

30. The system according to claim 29, wherein the first portion of the grounding plate is configured not to substantially overlap with the at least one conductive trace of the second antenna on the at least one layer.

31. The system according to any one of claims 18 to 30, wherein the at least one conductive trace associated with the second antenna is configured on the second layer.

32. The system according to any one of claims 18 to 31, wherein the conductive trace of the first radiating element on the first layer is configured in a first bent form.

33. The conductive trace of the second radiating element on the second layer is configured in a second bending form, The conductive trace of the first radiating element and the conductive trace of the second radiating element are configured in an offset manner from each other, and the outer curve of the first bent form is configured not to substantially overlap with the outer curve of the second bent form. The system according to claim 32.

34. The printed circuit board further includes a dielectric layer, The dielectric layer is configured such that it does not overlap with the conductive trace of the first radiating element on the first layer. The system according to any one of claims 18 to 33.

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