Systems, devices, and methods for analyte monitoring with on-body sensor control devices with shields

Abstract

Systems, devices, and methods for analyte monitoring with on-body sensor control devices with shields are described The assembly includes an on-body unit configured to be worn on a skin surface of a subject and a shield. The on-body unit includes a housing, sensor electronics disposed within the housing, an in vivo analyte sensor, and a housing adhesive layer configured to couple the housing of the on-body unit with the skin surface of the subject. The shield includes a cup portion, a skirt portion, and an adhesive stack configured to couple the skirt portion of the shield with the skin surface of the subject.

Description

SYSTEMS, DEVICES, AND METHODS FOR ANALYTE MONITORING WITH ON- BODY SENSOR CONTROL DEVICES WITH SHIELDSCROSS-REFERENCES TO RELATED APPLICATIONS

[0000] This application claims the benefit of U.S. Provisional Application No. 63 / 547,252, filed November 3, 2023, which is incorporated herein by reference in its entirety.FIELD

[0001] The subject matter described herein relates generally to on-body sensor control devices with shields, as well as systems, methods, and devices relating thereto.BACKGROUND

[0002] The monitoring and management of wellness and nutrition in individuals can significantly benefit those at risk of or currently experiencing chronic health problems and those motivated to improve general wellness. These efforts can create several health and economic benefits for the individual, as well as the public at large. According to the CDC, for example, seven out of ten deaths in the United States occur each year from chronic diseases, and almost one out of every two adults has at least one chronic illness. Likewise, almost one in three children in the United States is overweight or obese, which predisposes them to chronic diseases. Many of these chronic diseases are preventable, or can be successfully treated if diagnosed at an early stage. In this regard, the monitoring and management of an individual’s wellness and nutrition can significantly reduce the chance of chronic disease and, as a result, can mitigate future healthcare costs. Additional benefits of wellness and nutrition monitoring can further include enhancing athletic performing either during training, recovery, or during an athletic event.

[0003] The detection and / or monitoring of analyte levels, such as glucose, ketones, lactate, oxygen, hemoglobin A1C, or the like, can be vitally important to the overall health of a person,particularly for an individual having diabetes. Patients suffering from diabetes mellitus can experience complications including loss of consciousness, cardiovascular disease, retinopathy, neuropathy, and nephropathy. Persons with diabetes are generally required to monitor their glucose levels to ensure that they are being maintained within a clinically safe range, and may also use this information to determine if and / or when insulin is needed to reduce glucose levels in their bodies, or when additional glucose is needed to raise the level of glucose in their bodies.

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

[0005] To promote these goals, wearable technology can be utilized. A compact electronic device, for example, may be worn on the body, such as around the wrist, for monitoring an individual’s heart rate or physical activity levels. Because physician visits are episodic (e.g., once per year), wearable technology can serve a useful function in providing timely physiological information to an individual, without the need for a physician visit, and which can ultimately lead to improved wellness. Despite these advantages, however, many people are reluctant to use wearable technology for various reasons, including the complexity of the data presented, a learning curve associated with using the wearable device, and inaccuracies with respect to the data. Some recent studies, for example, claim that existing wearable devices do not accurately measure an individual’s heart rate or the number of calories burned.

[0006] Sensor control devices have been used by patients suffering from diabetes for many years. Many advances in these in vivo analyte monitoring systems have been made to increasecomfort and convenience for the individual. Sensor control devices may have a small formfactor and can be applied by the individual with a sensor applicator. The application process includes inserting at least a portion of a sensor that senses a user’s analyte level in a bodily fluid located in a layer of the human body, using an applicator or insertion mechanism, such that the sensor comes into contact with the bodily fluid. The benefits of analyte monitoring systems are not limited to persons with diabetes. For instance, analyte monitoring systems can provide useful information and insights to individuals interested in improving their health and wellness. As one example, to improve their sports performance, athletes can utilize a sensor control device worn on the body to collect data relating to one or more analytes such as, for example, glucose and / or lactate.

[0007] As sensor control devices are frequently worn by individuals with varying arm circumferences, it is essential that the shields for these sensor control devices accommodate this diversity to ensure a secure and comfortable fit. Moreover, adequate ventilation is crucial to prevent moisture buildup and skin irritation during extended use. Additionally, the importance of ensuring easy alignment and removal of these shields is rooted in user convenience, particularly because these devices are frequently utilized for continuous monitoring, necessitating straightforward application and removal.SUMMARY

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

[0009] To achieve these and other advantages and in accordance with the purpose of the disclosed subject matter, as embodied and broadly described, the disclosed subject matter is directed to systems, devices, and methods for analyte monitoring with on-body sensor control devices with shields. According to some embodiments, the assembly includes an on-body unit configured to be worn on a skin surface of a subject and a shield. The on-body unit includes a housing, sensor electronics disposed within the housing, the sensor electronics comprising one or more processors, and a computer readable medium coupled with the one or more processors, an in vivo analyte sensor, a distal portion of which is configured to be transcutaneously positioned through the skin surface and in contact with a bodily fluid of the subject, wherein the distal portion of the analyte sensor is further configured to sense an analyte level in the bodily fluid, and a housing adhesive layer configured to couple the housing of the on-body unit with the skin surface of the subject. The shield includes a cup portion, a skirt portion, and a skirt adhesive layer which may be in the form of an adhesive stack configured to couple the skirt portion of the shield with the skin surface of the subject. The housing adhesive layer is configured to cover a first surface area of the skin surface, the adhesive stack is configured to cover a second surface area of the skin surface that is different from the first surface area, and the cup portion of the shield may be configured to surround the housing of the on-body unit. In some embodiments, the housing adhesive layer does not overlap with the adhesive stack. In some embodiments, a gap may exist between the housing adhesive layer and the adhesive stack.

[0010] According to some embodiments, the method includes applying an on-body unit to a skin surface of a subj ect and applying a first shield over the on-body unit. The on-body unit includes a housing, sensor electronics disposed within the housing, the sensor electronics comprisingone or more processors, and a computer readable medium coupled with the one or more processors, an in vivo analyte sensor, a distal portion of which is configured to be transcutaneously positioned through the skin surface and in contact with a bodily fluid of the subject, wherein the distal portion of the analyte sensor is further configured to sense an analyte level in the bodily fluid, and a housing adhesive layer configured to couple the housing of the on-body unit with the skin surface of the subject. The shield includes a cup portion, a skirt portion, and an adhesive stack configured to couple the skirt portion of the shield with the skin surface of the subject. The housing adhesive stack is configured to cover a first surface area of the skin surface, the adhesive stack is configured to cover a second surface area of the skin surface that is different from the first surface area, and the housing of the on-body unit is disposed within the cup portion of the shield.

[0011] According to some embodiments, the device includes a shield. The shield includes a cup portion, a skirt portion, and an adhesive layer which may be in the form of an adhesive stack configured to couple the skirt portion of the shield with a skin surface of a subject. A housing of an on-body unit is disposed within the cup portion of the shield, and the on-body unit is configured to be worn on the skin surface of a subject.

[0012] Thus, in some embodiments, the invention can provide shields for on-body sensor control devices that facilitate simple alignment, adapt to various arm circumferences, provide effective ventilation, and allow for effortless removal from the skin without requiring the detachment of the on-body sensor control devices. Systems, devices, and methods for analyte monitoring with on-body sensor control devices with shields are described. The assembly includes an on- body unit configured to be worn on a skin surface of a subject and a shield. The on-body unit includes a housing, sensor electronics disposed within the housing, an in vivo analyte sensor,and a housing adhesive layer configured to couple the housing of the on-body unit with the skin surface of the subject. The shield includes a cup portion, a skirt portion, and an adhesive stack configured to couple the skirt portion of the shield with the skin surface of the subject.BRIEF DESCRIPTION OF THE FIGURES

[0013] The details of the subject matter set forth herein, both as to its structure and operation, may be apparent by study of the accompanying figures, in which like reference numerals refer to like parts. The components in the figures are not necessarily to scale, emphasis instead being placed upon illustrating the principles of the subject matter. Moreover, all illustrations are intended to convey concepts, where relative sizes, shapes and other detailed attributes may be illustrated schematically rather than literally or precisely.

[0014] FIG. l is a system overview of a system that includes a software library, receiving device, and sensor assembly.

[0015] FIG. 2 is a block diagram depicting an example embodiment of a receiving device.

[0016] FIG. 3 is a block diagram depicting an example embodiment of a sensor assembly.

[0017] FIGS. 4A-4B show an exemplary embodiment of a shield.

[0018] FIG. 5 is a side view of the exemplary embodiment of the shield.

[0019] FIG. 6 is a side cross-sectional view of the exemplary embodiment of the shield.

[0020] FIG. 7 is an enlarged view of Section C of FIG. 6.

[0021] FIG. 8 is an exploded view of the exemplary embodiment of the shield and a plurality of adhesive sublayers.

[0022] FIG. 9 is a bottom view of the exemplary embodiment of the shield and on-body unit.

[0023] FIGS. 10 A- 10C show an alternative embodiment of the shield.

[0024] FIG. 11 is a side view of the alternative embodiment of the shield.

[0025] FIG. 12 is a side cross-sectional view of the alternative embodiment of the shield.

[0026] FIG. 13 is a top plan view of the alternative embodiment of the shield attached to an adhesive stack.

[0027] FIG. 14 is an exploded view of the alternative embodiment of the shield and the adhesive stack.

[0028] FIG. 15 is an exploded view of the adhesive stack in the alternative embodiment of the shield comprising a plurality of adhesive sublayers.DETAILED DESCRIPTION

[0029] Reference will now be made in detail to the various exemplary embodiments of the disclosed subject matter, exemplary embodiments of which are illustrated in the accompanying drawings.

[0030] The system can include a device that receives analyte data measured by an analyte monitor and medication delivery data recorded by a delivery device, and processes and / or displays that data, in any number of forms, to the user. This device, and variations thereof, can be referred to as a “receiving device,” “reader device” (or simply a “reader”), “handheld electronics” (or simply a “handheld”), a “portable data processing” device or unit, a “data receiver,” a “receiver” device or unit (or simply a “receiver”), or a “remote” device or unit, to name a few. This device can be a smartphone, a smartwatch, or display device.

[0031] The system can also include an in vivo analyte monitor sensor assembly, which can comprise various types of monitors. For example, “Continuous Analyte Monitoring” systems (or “Continuous Glucose Monitoring” systems), can transmit data from a sensor device to a reader device continuously without prompting, e.g., automatically according to a schedule. “Flash Analyte Monitoring” systems (or “Flash Glucose Monitoring” systems or simply“Flash” systems), as another example, can transfer data from a sensor device in response to a scan or request for data by a reader device, such as with a Bluetooth Low-Energy (BLE), Near Field Communication (NFC) or Radio Frequency Identification (RFID) protocol. An in vivo analyte monitoring sensor assembly can also operate without the need for finger stick calibration.

[0032] In vivo monitoring sensor assemblies can include one or more sensors that, while positioned in vivo, contacts the bodily fluid of the user and generates analyte data indicative of the analyte levels contained therein. The sensor assembly can reside on the body of the user and contain the electronics and power supply that enable and control the analyte sensing. The sensor assembly, and variations thereof, can also be referred to as an “on-body electronics” device or unit, an “on-body” device or unit, or a “sensor data communication” device or unit, or analyte sensor, sensor device, in vivo analyte monitor sensor assembly, sensors, to name a few.

[0033] Further, the system can include an external device for use with the analyte sensor. For example and without limitation, external devices can include delivery devices that use information from the analyte sensor to determine or deliver amounts of a medication or other beneficial agents to a user. Additionally, or alternatively, external devices can include other sensors, such as other analyte sensors, accelerometers, pressures sensors, or can include external computing devices, such as a medical server or a smartphone application configured to use analyte sensor information to provide additional insights to a user, including but not limited to insights related to medical conditions, well-being, fitness, appetite, or other medical or non-medical insights or analysis.

[0034] Generally, and as set forth in greater detail below, the disclosed subject matter provided herein includes a software library within a receiving device for communicating with analyte sensors and permitting third-party applications access to the sensor data for use in medically necessary applications or applications related to the well-being of the user. The system further includes a software library that can be implemented independently of the sensors and integrated within third-party applications to allow access to the sensor data. The sensor control module can further communicate with the sensor assemblies in such a manner to receive data simultaneously or substantially simultaneously from a plurality of such sensor assemblies. The system further enables the transfer of sensor information from the sensor control module to a remote management module.

[0035] The embodiments described herein can be used to monitor and / or process information regarding any number of one or more different analytes. Analytes that may be monitored include, but are not limited to, acetyl choline, amylase, bilirubin, cholesterol, chorionic gonadotropin, glycosylated hemoglobin (HbAlc), creatine kinase (e.g., CK-MB), creatine, creatinine, DNA, fructosamine, glucose, glucose derivatives, glutamine, growth hormones, hormones, ketones, ketone bodies (e.g., P-hydroxybutyrate), lactate, peroxide, prostatespecific antigen, prothrombin, RNA, thyroid stimulating hormone, and troponin. The concentration of drugs, such as, for example, antibiotics (e.g., gentamicin, vancomycin, and the like), digitoxin, digoxin, drugs of abuse, theophylline, and warfarin, may also be monitored. In embodiments that monitor more than one analyte, the analytes may be monitored at the same or different times.

[0036] FIG. 1 is a schematic diagram depicting an example embodiment of a system 100 that includes a modular connectivity framework using a software library 400, various applications 420, a sensor assembly 300, and a receiving device 200.

[0037] In accordance with the disclosed subject matter, a non-transitory computer-readable storage medium includes a software library for use by applications 420 on a receiving device 200, or standalone devices such as a pump, insulin pen, etc., to obtain sensor data. The software library can include a sensor control module, a remote management module, and include software logic for communication with a plurality of sensors and applications. The sensor control module can authenticate the receiving device to allow the receiving device to receive sensor data, including by enabling communication with each of the plurality of sensors to receive sensor data including data indicative of a different signal. The sensor control module can further store the sensor data in a memory of the computing device. The sensor control module can obtain an output indicative of the different signals from the sensor data of each of the plurality of sensors. The sensor control module can provide the output of the different signals from the sensors to the authenticated third-party application running on the computing device.

[0038] The system 100 includes a software library 400 that functions using a modular architecture enabling a sensor control module 500 to communicate with and reside within various applications 420 on the receiving device 200. Applications 420 may further interface with sensor assembly 300 through the sensor control module 500, and in particular, by providing the request to the communication control module 540 (on Figure 5) to interface directly with the sensor assembly 300. The sensor assembly 300 can also be one device with multiple, different sensors 302 or one sensor 302 configured to detect more than one analyte.

[0039] The receiving device 200 includes one or more applications 420, with each application instance embedding software library 400. The receiving device 200 uses a modular connectivity framework for the applications 420. In particular, the applications 420 each include a software library 400 including a remote management module 600 and sensor control module 500 for communicating with the one or more sensor assemblies 300. The software library 400 may also run as a service that executes simultaneously with the underlying application allowing the sensor control module 500 or remote management module 600 to execute as a service alongside one or more applications.

[0040] Sensor control module 500 may further interface with the sensor data. The various modules within the software library 400 implemented within the application 420 can send and receive communication with the sensor assembly 300 via communication link 102.

[0041] While the sensor control module 500 is within the application 420 in a receiving device 200, the sensor control module 500 could have base components in a second receiving device, such as a smartwatch, mobile device, or other wearable device. While such a device may not allow for a user interface experience that would be provided by a smartphone or tablet or computer, the smartwatch or wearable device can incorporate the sensor control module 500 to permit direct communication through the sensor control module 500 on the smartwatch or mobile wearable device with the sensor assembly 300. This would allow for applications specific to wearable devices to use sensor data. The wearable devices can synch separately with the receiving device 200, which can be used to perform the majority of the user login, initialization, authentication, and consent features to implement and initiate the receipt of sensor data.

[0042] Communication link 102 can be a wireless protocol including Bluetooth®, Bluetooth® Low Energy (BLE, BTLE, Bluetooth® SMART, etc.), Near-Field Communication (NFC) and others. The communication links 102 can each use the same or different wireless protocols. The system 100 may be configured to communicate over other wireless data communication links such as, but not limited to, RF communication link, infrared communication link, or any other type of suitable wireless communication connection between two or more electronic devices, which may further be uni-directional or bi-directional communication. Alternatively, the data communication link may include wired cable connection such as, for example, but not limited to, RS232 connection, USB connection, FireWire, Lightning, or serial cable connection.

[0043] For example, and as embodied herein, communication link 102 can be configured to use a Bluetooth protocol, such as BLE, or communication link 102 can be configured to use an NFC protocol. Additionally or alternatively, another communication link not shown may exist between a second sensor assembly and it can be configured to use BLE or both NFC and BLE. The communication links can be configured to perform different operations. For example, communication link 102 can be configured to perform only activation of the sensor assembly. Furthermore, communication links can have different configurations depending on the overall system architecture or the components that are activated or being used in the system at a given time. For example, and as embodied herein, communication link 102 can have a first communication configuration when the receiving device 200 is active in the system and a second communication configuration when the receiving device is not active or not included in the system.

[0044] In the first communication configuration, the communication link 102 can be configured only to perform activation of the sensor using an NFC wireless protocol. In another configuration, BLE capability (if provided) can remain inactive between the sensor assembly 300 and the applications 420. The application 420 can activate the sensor assembly 300 using NFC wireless protocol and obtain sensor context information. Sensor context information can include authentication information for authenticating a communication session with the sensor assembly 300, encryption information to enable encrypted data communication over the communication links, and a BLE communication address to initiate a BLE connection with the sensor assembly 300. The software library 400 may also obtain the sensor context information from the sensor assembly 300 over BLE. Using the sensor context information, the software library 400 includes capabilities to allow a session to switch from an application 420 on the receiving device 200 such as a smartphone to another application 420 on another receiving device 200 such as a smartwatch. The sensor context information can be transmitted within the applications 420.

[0045] In accordance with the disclosed subject matter, the sensor assembly 300 as shown may include sensing elements for detecting different analytes within the same sensor assembly. The system 100 may also include multiple sensor assemblies 300, as shown, connected via a communication link having similar capabilities of communication to the communication link 102 described herein. Two or more sensor assemblies 300 can also be used in conjunction by having multiple sensing elements that together produce the reading for an analyte, or separately produce readings for different analytes. Any number of sensor assemblies could be used together to measure any number of different analyte values, and two sensor assemblies are shown for illustration, not limitation, in this disclosure.

[0046] In some embodiments, the application 420 can be configured to access the software library 400 through a remote cloud 700 infrastructure via wireless communication links 710. In certain embodiments, the communication link 710 includes a wireless communication section configured for bi-directional radio frequency (RF) communication with other devices to transmit and / or receive data to and from the system 100. In addition, the communication link 710 may also be configured to include physical ports or interfaces such as one or more of a USB port, an RS-232 port, a serial port, a IEEE 1394 (Firewire) port, an Ethernet port or any other suitable electrical connection port to allow data communication between the system 100 and receiving device 200, such as a personal computer, a laptop computer, a notebook computer, an iPad, a tablet computing device, a cellular telephone, a smart phone, a personal data assistant, a workstation, a server, a mainframe computer, a cloud computing system, an external medical device, such as an infusion device, an analyte monitoring device, or including an insulin delivery device, or other devices that are configured for similar complementary data communication. In certain embodiments, communication link 710 may include a cellular communication protocol, a Wi-Fi (IEEE 802. lx) communication protocol, or an equivalent wireless communication protocol which would allow secure, wireless communication of several units (for example, per HIPPA requirements) while avoiding potential data collision and interference.

[0047] In other embodiments, the wireless communication section 710 may be configured for infrared communication, Bluetooth communication, wireless USB communication, ZigBee communication, cellular communication, Wi-Fi (IEEE 802.1 lx) communication, RFID (passive or active) communication, or any other suitable wireless communication mechanism to enable the receiving device 200 to communicate with other devices such as infusion devices,analyte monitoring devices, computer terminals, servers, personal computers, laptop computers, notebook computers, iPads, tablet computers, cell phones, smart phones, workstations, mainframe computers, cloud computing systems, communication enabled mobile telephones, personal digital assistants, or any other communication devices with which the patient or user of the device may use in conjunction therewith, in managing the treatment of a health condition, such as diabetes.

[0048] The system 100 may be configured to operate as an open loop system, a closed-loop system, and a hybrid closed-loop system. An open loop system requires manual user input to control certain functionalities related to the sensor assembly 300. A closed-loop system uses data from the sensor assembly 300 and algorithms to control the software library 400 without user input. In a hybrid system, input may be required from a user to control the application 420 and initiate the software library 400. A hybrid closed-loop system can be used in conjunction with, or in place of, a closed-loop system. As disclosed herein, regulatory clearance can be limited to software library 400 irrespective of the type of system configuration used in the system 100.Receiving Device

[0049] FIG. 2 is a block diagram depicting an example embodiment of a receiving device 200. A software library 400 can be provided to a third-party and incorporated within an application 420 for a multi-purpose receiving device 200, such as a mobile phone, tablet, personal receiving device, or other similar receiving device. Receiving device 200 embodying and executing device application software can also be referred to as a computing device or a multipurpose device. Receiving device 200 refers to a suitably configured hardware device which is executing an application 420 that incorporates a software library 400 having a sensor controlmodule 500 configured for communication with the sensor assembly 300. Here, receiving device 200 can include a display 202, input component 204, and a processor 206 coupled with memory 208. Also included can be communication circuity 210 coupled with an antenna 212, and power source 214. As understood by one of skill in the art, these components are electrically and communicatively coupled in a manner to make a functional device. As embodied herein, the memory 208 can include an application and a sensor control module 500 for the sensor assembly 300. The application 420 can also import a software library 400 including the sensor control module 500. The software library 400 and the sensor control module 500 can be developed by the provider of the sensor assembly 300.

[0050] The receiving device can have the majority of the processing capability of the system 100 for rendering end-result data suitable for display to a user. The receiving device 200 can be a smartphone or a smartwatch.

[0051] The receiving device 200 can receive analyte data, such as glucose data and calculate low and high analyte level and generate corresponding alarms and messages. The receiving device 200 can also mirror an alert generated by another device, such as the sensor assembly 300. The receiving device 200 can process analyte data with the processor 206 and render on the display 202 analyte-related information as value, trend, and graph, and provide additional messaging and notification based on the received analyte level.Sensor Assembly

[0052] FIG. 3 is a block diagram depicting an example embodiment of a sensor assembly 300 comprising an analyte sensor 302 and sensor electronics 304 (including analyte monitoring circuitry). Analyte sensor 302 can be an in vivo analyte sensor and have a use period of about 13-30 days. Sensor assembly 300 can be without wide-area network communication capability.

[0053] The analyte sensor 302 generates raw data signals for measurements of the patient's analyte level. Sensor electronics 304 are operatively coupled to the analyte sensor 302, the sensor electronics 304 comprising a memory 316 storing one or more predetermined characteristics 322 associated with the sensor electronics 304. The memory 316 can be a so- called “one-time programmable” (OTP) memory, which can include supporting architectures or otherwise be configured to define the number times to which a particular address or region of the memory can be written, which can be one time or more than one time up to the defined number of times after which the memory can be marked as unusable or otherwise made unavailable for programming. Subject matter disclosed herein relates to systems and method for updating said OTP memories with new information.

[0054] The sensor electronics 304 can include a single semiconductor chip, as depicted, that can be a custom application specific integrated circuit (ASIC 306). Shown within ASIC 306 are certain high-level functional units, including an analog front end (AFE 308), power management (or control) circuitry 310, processor 312, and communication circuitry 314 (which can be implemented as a transmitter, receiver, transceiver, passive circuit, or otherwise according to the communication protocol). As an example, only and not by way of limitation, example communication circuitry 314 can include a Bluetooth Low-Energy (“BLE”) chipset, Near-Field Communication (“NFC”) chipset, or other chipsets for use with similar short-range communication schemes, such as a personal area network according to IEEE 802.15 protocols, IEEE 802.11 protocols, infrared communications according to the Infrared Data Association standards (IrDA), etc. The communication circuitry 314 can transmit and receive data and commands via interaction with similarly capable communication modules. Certain communication chipsets can be embedded in ASIC 306 (e.g., an NFC antennae).

[0055] The sensor assembly 300 can use application layer encryption using one or more block ciphers to establish mutual authentication and encryption of other devices in the system 100. The use of a non-standard encryption design implemented in the application layer has several benefits. One benefit of this approach is that in certain embodiments the user can complete the pairing of the sensor assembly 300 and another device with minimal interaction, e.g., using only an NFC scan and without requiring additional input, such as entering a security pin or confirming pairing. Sensor assembly 300 can be configured to dynamically generate authentication and encryption keys. Sensor assembly 300 can also be pre-programmed with a set of valid authentication and encryption keys to use with particular classes of devices. The ASIC 306 can be further configured to perform authentication procedures with other devices (e.g., handshake, mutual authentication, etc.) using received data and apply the generated key to sensitive data prior to transmitting the sensitive data.

[0056] In this embodiment, both AFE 308 and processor 312 are used as analyte monitoring circuitry, but in other embodiments either circuit can perform the analyte monitoring function. Processor 312 can include one or more processors, microprocessors, controllers, and / or microcontrollers, each of which can be a discrete chip or distributed amongst (and a portion of) a number of different chips.

[0057] Memory 316 is included within ASIC 306 and can be shared by the various functional units present within ASIC 306, or can be distributed amongst two or more of them. Memory 316 can also be a separate chip. Memory 316 can be volatile and / or non-volatile memory. In this embodiment, ASIC 306 is coupled with a power source 318, which can be a coin cell battery, or the like. AFE 308 interfaces with analyte sensor 302 and receives measurement datatherefrom and outputs the data to processor 312 in digital form. This data can then be provided to communication circuitry 314 for sending, by way of antenna 320, to software library 400.

[0058] The analyte sensor 302 can alternatively monitor other analytes, for example, acetyl choline, amylase, bilirubin, cholesterol, chorionic gonadotropin, creatine kinase (e.g., CK- MB), creatine, DNA, fructosamine, glutamine, growth hormones, hormones, ketones, ketone bodies (e.g., P-hydroxybutyrate), lactate, peroxide, prostate-specific antigen, prothrombin, RNA, thyroid stimulating hormone, and troponin.

[0059] The sensor assembly 300 includes a sensor assembly embedded library (not pictured) configured for providing sensor assembly data to the software library 400 based on information received from the sensor assembly 300. Sensor assembly data can include glucose readings, data types, range, real time and historical glucose and trends, sensor operating information, and sensor system information.Shields

[0060] FIGS. 4A-4B show an example embodiment of a shield 40. In some embodiments, the shield 40 can include a cup portion 402 and a skirt portion 404. In some embodiments, the cup portion 402 can have air holes 406a, b for ventilation. The cup portion 402 may have a flat surface 403 and a wall portion 405 that extends from the flat surface 403 that forms the sides of the cup portion 402. As seen in FIG. 6, an inner surface of the cup portion 402 of the shield 40 is configured to contact the outer surface of the housing of the on-body unit with an inner surface of the flat surface 403 sitting flush against the top of the housing and an inner surface of the wall portion 405 contacting the sides of the housing. It is advantageous for the cup portion 402 to sit snugly surrounding and in contact with the housing without any gaps to avoid any buildup of moisture between the shield 40 and the housing. Moreover, it is desirable forthe shield to fit snugly around the housing of the on-body unit to avoid unwanted movement of the on-body-unit such that the sensor is dislodged. Air holes 406a, b may be included in the shield 40 for breathability. The plurality of air holes 406a, b may be located in the flat surface 406a and also may be located in the wall portion 406b. As seen in FIGS. 6 and 7, air holes 406b may extend vertically through the wall portion 405. Optionally, the holes may be located where the cup portion 402 transitions to the skirt portion 404 (not shown). These air holes can help provide adequate ventilation to prevent moisture buildup and skin irritation during extended use. In some embodiments, the air holes 406 located in the flat surface may align with holes in the housing of the on-body unit. Thus, the air holes 406 may also allow ventilation of the on-body unity.

[0061] The cup 402 may be thicker and / or stiffer than the skirt portion 404. In some embodiments, the skirt portion 404 can have a first level of stiffness (57), and the cup portion 402 has a second level of stiffness (s2). In some embodiments, the second level of stiffness (52) is greater than the first level of stiffness (57). A rigid cup portion 402 enables ease of alignment with the on-body unit 300 (the sensor assembly). When in use and after the shield is applied to the body, the housing of the on-body unit 300 is disposed within the cup portion 402. The flexible skirt portion 404 may conform to contours of the skin surface of the subject, e.g., to enable the skirt portion 404 to conform around the arm circumference. The rigid cup portion 402 may enable the user to more easily align the shield 40 with the on-body unit.

[0062] According to some embodiments, the shield 40 can be made of durable materials during extended use. According to some embodiments, the shield 40 can be made of silicone. In other embodiments, the shield 40 can be made of TPE (thermoplastic elastomer). In other embodiments, the shield 40 can be made of TPU (thermoplastic polyurethanes).

[0063] As seen in FIG. 9, according to some embodiments, a housing adhesive layer 416 can be used to couple the housing of the on-body unit 300 with the skin surface of the subject. In some embodiments, an adhesive stack 408 can be used to couple the skirt portion 404 with the skin surface of the subject. In some embodiments, the housing adhesive layer 416 can be configured to cover a first surface area of the skin surface. In some embodiments, the adhesive stack 408 can be configured to cover a second surface area of the skin surface that is different from the first surface area. The second surface area may surround the first surface area. In some embodiments, the housing adhesive layer 416 does not overlap with the adhesive stack 408. A gap 418 may exist between the housing adhesive layer 416 and the adhesive stack 408 to ensure that the housing adhesive layer 416 and the adhesive stack 408 are not in contact and do not overlap. The lack of overlap is to ensure that the on-body unit remains in place where the sensor was inserted when the user removes the shield 40 by peeling back the skirt portion 404.

[0064] In some embodiments, the material from which the shield is made, e.g., by injection molding, has a low surface energy. Thus, many well-known adhesives may not readily adhere to the shield and the shield may delaminate from the adhesive patch. In some embodiments, the adhesive stack 408 attached to the skirt portion 404 of the shield 40 comprises a plurality of adhesive layers, also referred to herein as adhesive sublayers. A layer directly attached to the skirt may contain an adhesive with a material that also has a low surface energy, such as silicone, to assist in bonding with the skirt portion 404. As seen in FIG. 8, the plurality of adhesive layers includes a first adhesive layer or sublayer 410 and a second adhesive layer or sublayer 412. The first adhesive sublayer 410 may be located in between the skirt portion 404 and the second adhesive sublayer 412. On a first side, the first adhesive sublayer 410 may beattached to the underside of the skirt portion 404 that faces the skin surface. On a second side opposite of the first side, the first adhesive sublayer 410 may be attached to one side of the second adhesive sublayer 412. An opposite side of the second adhesive sublayer may be attached to or be configured to be attached to the skin surface. In some embodiments, the first adhesive sublayer 410 includes an adhesive that comprises silicone. In some embodiments, the first adhesive sublayer 410 also includes an adhesive that comprises acrylic. In some embodiments, the first adhesive sublayer is a double-sided tape having a silicone adhesive on the first side and an acrylic adhesive on the opposite side. In some embodiments, the silicone adhesive may be in contact with the skirt portion 404 and the opposite side may be in contact with the second adhesive sublayer 412. In some embodiments, the second adhesive sublayer 412 includes an adhesive that comprises acrylic. Although specific adhesives and adhering methods have been noted for illustrative purposes, it will be apparent to those skilled in the art that a variety of adhesives and methods can be used without departing from the spirit or scope of the disclosed subject matter. For example, the adhesive stack 408 may be sprayed directly onto the skirt portion 404.

[0065] In some embodiments, the shield 40 can be configured to be removed from the skin surface of the subject without displacing the housing of the on-body unit 300. In some embodiments, the cup portion 402 is detachable from the housing of the on-body unit. In some embodiments, the shield 40 is disposable after a predetermined period. In some embodiments, the predetermined period is 7 days. In other embodiments, the predetermined period is 14 to 20 days.

[0066] Referring to FIG. 5, in some embodiments, the skirt portion 404 can have a first height (A7), and the cup portion 402 can have a second height (A2). In some embodiments, the secondheight (A2) can be greater than the first height (hl). This helps to ensure that the cup portion 402 has a fitted contact with the housing of the on-body unit 300. The second height (h2) may be approximately the same height as the height of housing of the on-body unit in order to ensure a snug fit between the cup portion 402 and the housing of the on-body unit.

[0067] Referring to FIG. 6, in some embodiments, the skirt portion 404 can have a first thickness (77), and the cup portion 402 can have a second thickness (t2). According to some embodiments, the second thickness (t2) can be greater than the first thickness tl). According to some embodiments, the first thickness tl can be about 0.5 mm, alternatively between 0.2 - 1 mm, alternatively between 0.1-5 mm. According to other embodiments, the first thickness tl) can be about 0.8 mm, alternatively between 0.5 - 2 mm, alternatively between 0.1 - 5 mm. Although specific ranges of the first thickness tl) have been provided for illustration purposes, it will be apparent to those skilled in the art that skirt portion with various thickness (tl) can be used in the methods and systems of the disclosed subject matter without departing from the spirit or scope of the disclosed subject matter.

[0068] Referring to FIG. 7, in some embodiments, the cup portion 402 can be dimensioned for fitted contact with the housing of the on-body unit. In some embodiments, the cup portion 402 can include a circumferential edge configured to be aligned with a circumferential edge of the housing of the on-body unit.

[0069] In accordance with the disclosed subject matter, FIGS. 10 A- 10C illustrate an alternative embodiment of a shield 50, including a cup portion 502 and a skirt portion 504. The cup portion 502 includes a flat surface 503 with air holes 506. The air holes 506 may be used for ventilation to prevent moisture buildup between the shield 50 and the housing of the on-body unit 300, as well as skin irritation caused by moisture buildup during extended use. Furthermore, the airholes 506 may be aligned with the holes on the housing of the on-body unit 300 to allow for ventilation of the on-body unit 300 itself. The shield 50 may also include at least one vent 507, preferably a plurality of vents 507, about the cup portion 502 of the shield 50 located where the cup portion 502 transitions into the skirt portion 504. The vents 507 may provide additional ventilation and de-couple the rigidity of the cup portion 502 from the skirt portion 504. For example, the vents 507 may provide additional flexibility to the skirt portion 504 allowing for increased movement about the cup portion 502.

[0070] As seen in FIG. 10C the shield 50 may further include at least one concentric rib 520 configured to align with the circumferential edge of the housing of the on-body unit 300. In an alternative embodiment, the shield 50 may have a plurality of concentric ribs 520 along the interior wall 505 of the cup portion 502. The concentric ribs 520 aid to align the shield 50 with the housing of the on-body unit 300 when mounted thereon, and maintain the alignment of the shield 50 and the on-body unit 300 when worn on the user's body. At least one of the plurality of concentric ribs 520 has an increased thickness to aid in the release of the shield 50 from the tool during manufacturing. The shield 50 may also include a plurality of radial fins 519 configured to contact and secure the housing of the on-body unit 300 within the shield 50. The plurality of radial fins 519 are preferably positioned radially along the interior wall 505, and above the ribs 520. As previously noted, it is advantageous for the cup portion 502 of the shield 50 to sit snugly, surrounding and in contact with the housing of the on-body unit 300 to avoid any unwanted movement of the on-body unit 300. The radial fins 519 further aid to tightly secure the housing of the on-body unit within the shield 50 and align the on-body unit 300 within the shield.

[0071] The shield 50 is preferably made of durable materials, allowing for extended use on the user's body, for example up to 14 to 20 days. The shield materials may include, but are not limited to, silicone, TPE (thermoplastic elastomer), and TPU (thermoplastic polyurethanes). The interior of the cup portion 502 may also include a rough surface to prevent the shield 50 from adhering to the housing of the on-body unit 300, preferably a surface roughness of MT- 11010. The shield 50 may be comprised of varying stiffnesses, where the skirt portion 504 has a first level of stiffness ( 7), and the cup portion 502 has a second level of stiffness (s2). Preferably, the second level of stiffness (s2) is greater than the first level of stiffness si). A stiffer cup portion 502 further increases the ease of alignment of the shield 50 with the housing of the on-body unit 300. The skirt portion 504 is preferably produced with more flexibility than the cup portion 502, enabling the skirt portion 504 to conform to the contours of the user's skin and circumference of the user's arm. The flexibility of the skirt portion 504 also allows the shield 50 to move with the user's arm, for example when flexing during exercise.

[0072] As illustrated in FIG. 11, the skirt portion 504 has a first height (hl), and the cup portion 502 has a second height (h2). The second height (h2) may be greater than the first height (hl) to ensure that the cup portion 502 retains a fitted contact with the housing of the on-body unit. Furthermore, the second height (h2) may be approximately equal to the height of housing of the on-body unit to ensure a snug fit between the cup portion 502 and the housing of the on- body unit.

[0073] Referring to FIG. 12, in some embodiments, the skirt portion 504 has a first thickness (tl), and the cup portion 502 has a second thickness (t2). The second thickness (t2) may be greater than the first thickness (tl). Specifically, the first thickness (tl) may be, but is not limited to, 0.2 - 1 mm, or al alternatively 0.1-5 mm. In a preferred embodiment, the firstthickness (77) is 0.5 mm. According to other embodiments, the first thickness (77) can be about 0.8 mm, alternatively 0.5 - 2 mm or 0.1 - 5 mm. Although specific ranges of the first thickness (77) have been provided for illustrative purposes, it will be apparent to those skilled in the art that varying skirt thickness (77) can be used in the methods and systems of the disclosed subject matter without departing from the spirit or scope of the disclosed subject matter.

[0074] Referring to FIGS. 13 and 14, in some embodiments, the shield 50 may also include an adhesive stack 508 coupled to the underside of the skirt portion 504. As previously noted, the injection molding from which the shield 50 is made may have a low surface energy preventing adhesives from readily adhering to the shield 50. The underside of the skirt 504 can contain a PSA bonded surface to strengthen the bond between the adhesives. Although not shown, the adhesive stack 508 is configured to align with the circumferential edge of the housing of the on-body unit 300. The adhesive stack 508 is sized such that it does not overlap with the circumferential edge of the housing of the on-body unit 300 and may form a gap between the two. Furthermore, the adhesive stack is sized such that it does not extend beyond the circumferential edge of the skirt 504 when attached. Although described as a separate adhesive attachment, alternative methods may be used for adhering the adhesive stack 508 to the skirt portion 504 without departing from the spirit or scope of the disclosed subject matter. For example, the adhesive stack 508 may be sprayed directly onto the skirt portion 504.

[0075] As illustrated in FIG. 15, the adhesive stack 508 is comprised of a plurality of adhesive sublayers 511, 512 and release liners 510, 513. The first adhesive sublayer 511 has a first side for adhering to the shield 50 and a second side for adhering to the second adhesive sublayer 512. In an exemplary embodiment the first adhesive sublayer 511 is comprised of a silicone coating. The first adhesive sublayer 511 may also be comprised of an acrylic coating. In someembodiments, the first adhesive sublayer 511 may also be a double-sided tape having a silicone adhesive on the first side and an acrylic adhesive on the opposite side. The second adhesive sublayer 512 has a first side for adhering to the first adhesive sublayer 511 and a second side for adhering to the user's skin. In an exemplary embodiment, the second side is comprised of an acrylic coating.

[0076] Attached to the second adhesive layer 512 is a kiss cut release liner 513. The release liner 513 includes at least one tab on either side of the kiss cut to aid in the removal of the release liner 513 from the adhesive. Although not shown, in another embodiment the release liner 513 may be formed without a kiss cut and a single tab, or alternatively, without any tabs. Furthermore, the release liners 510, 513 and adhesive sublayers 511, 512 include indents 509 along the interior rims to accommodate the corresponding vents 507 of the shield 50. Although illustrated with rectangular indents 509, those skilled in the art will appreciate that the interior rims of the release liners 510, 513 and adhesive sublayers 511, 512 may include any shape or configuration necessary to accommodates the shape of the vents. Furthermore, although specific liner configurations and adhesives have been noted for illustrative purposes, it will be apparent to those skilled in the art that a variety of liners and adhesives can be used in the methods and systems of the disclosed subject matter without departing from the spirit or scope of the disclosed subject matter.

[0077] Various aspects of the present subject matter are set forth below, in review of, and / or in supplementation to, the embodiments described thus far, with the emphasis here being on the interrelation and interchangeability of the following embodiments. In other words, an emphasis is on the fact that each feature of the embodiments can be combined with each and every other feature unless explicitly stated otherwise or logically implausible. Theembodiments described herein are restated and expanded upon in the following paragraphs without explicit reference to the figures.

[0078] In many embodiments, an assembly, includes: (1) an on-body unit configured to be worn on a skin surface of a subject, the on-body unit comprising: a housing; sensor electronics disposed within the housing, the sensor electronics comprising one or more processors, and a computer readable medium coupled with the one or more processors; an in vivo analyte sensor, a distal portion of which is configured to be transcutaneously positioned through the skin surface and in contact with a bodily fluid of the subj ect, wherein the distal portion of the analyte sensor is further configured to sense an analyte level in the bodily fluid; and a housing adhesive layer configured to couple the housing of the on-body unit with the skin surface of the subject; and (2) a shield, comprising: a cup portion; a skirt portion; and an adhesive layer configured to couple the skirt portion of the shield with the skin surface of the subject; and wherein the housing adhesive layer is configured to cover a first surface area of the skin surface, wherein the adhesive layer is configured to cover a second surface area of the skin surface that is different from the first surface area, and wherein the housing of the on-body unit is disposed within the cup portion of the shield.

[0079] In some embodiments, the cup portion of the shield is dimensioned for fitted contact with the housing of the on-body unit.

[0080] In some embodiments, the cup portion of the shield includes a circumferential edge configured to be aligned with a circumferential edge of the housing of the on-body unit.

[0081] In some embodiments, the cup portion includes a plurality of concentric ribs configured to align with the circumferential edge of the housing of the on-body unit.

[0082] In some embodiments, the cup portion includes a plurality of radial ribs configured to secure the housing of the on-body unit.

[0083] In some embodiments, the adhesive layer comprises an adhesive that comprises silicone.

[0084] In some embodiments, the adhesive layer comprises a plurality of adhesive sublayers. In some embodiments, the plurality of adhesive sublayers includes a first adhesive sublayer and a second adhesive sublayer. In some embodiments, the first adhesive sublayer is located in between the skirt portion of the shield and the second adhesive sublayer. In some embodiments, the first adhesive sublayer comprises an adhesive that comprises silicone. In some embodiments, the first adhesive sublayer further comprises an adhesive that comprises acrylic. In some embodiments, the first adhesive sublayer is a double-sided tape having a silicone adhesive on the first side in contact with the skirt portion of the shield and an acrylic adhesive on the opposite side in contact with the second adhesive sublayer. In some embodiments, the second adhesive sublayer comprises an adhesive that comprises acrylic.

[0085] In some embodiments a release liner is attached to each of the first adhesive sublayer and the second adhesive sublayer.

[0086] In some embodiments the release liner on the second adhesive sublayer includes a kiss cut and at least one tab to aid in the removal of the release liner from the second adhesive sublayer.

[0087] In some embodiments, the skirt portion of the shield comprises air holes for ventilation.

[0088] In some embodiments, the cup portion of the shield comprises air holes for ventilation.

[0089] In some embodiments, the shield comprises vents along the perimeter of the cup portion for ventilation.

[0090] In some embodiments, the skirt portion of the shield has a first level of stiffness, and the cup portion of the shield has a second level of stiffness. In some embodiments, the second level of stiffness is greater than the first level of stiffness.

[0091] In some embodiments, the cup portion of the shield has a height that is greater than that of the skirt portion of the shield.

[0092] In some embodiments, the cup portion of the shield has a thickness that is greater than that of the skirt portion of the shield.

[0093] In some embodiments, the shield is made of silicone.

[0094] In some embodiments, the shield is made of TPE (thermoplastic elastomer).

[0095] In some embodiments, the shield is configured to be removed from the skin surface of the subject without displacing the housing of the on-body unit.

[0096] In some embodiments, the shield is made of TPU (thermoplastic polyurethanes).

[0097] In some embodiments, the analyte sensor is a glucose sensor.

[0098] In some embodiments, the skirt portion of the shield is flexible for conforming to contours of the skin surface of the subject.

[0099] In some embodiments, wherein the shield is disposable after a predetermined period. In some embodiments, the predetermined period is 7 days. In some embodiments, the predetermined period is 14 days.[000100] In some embodiments, the cup portion of the shield is detachable from the housing of the on-body unit.[000101] In many embodiments, a method includes: (1) applying an on-body unit to a skin surface of a subject, the on-body unit comprising: a housing; sensor electronics disposed within the housing, the sensor electronics comprising one or more processors, and a computerreadable medium coupled with the one or more processors; an in vivo analyte sensor, a distal portion of which is configured to be transcutaneously positioned through the skin surface and in contact with a bodily fluid of the subject, wherein the distal portion of the analyte sensor is further configured to sense an analyte level in the bodily fluid; a housing adhesive layer configured to couple the housing of the on-body unit with the skin surface of the subject; (2) applying a first shield over the on-body unit, the first shield comprising: a cup portion; a skirt portion; and a adhesive layer configured to couple the skirt portion of the first shield with the skin surface of the subject; and wherein the housing adhesive layer is configured to cover a first surface area of the skin surface, wherein the adhesive layer is configured to cover a second surface area of the skin surface that is different from the first surface area, and wherein the housing of the on-body unit is disposed within the cup portion of the first shield.[000102] In some embodiments, the method further includes removing the first shield from the skin surface of the subject without displacing the housing of the on-body unit. In some embodiments, the method further includes applying a second shield to the skin surface of the subject after removing the first shield from the skin surface of the subject.[000103] In many embodiments, a device includes: a shield, comprising: a cup portion; a skirt portion; and an adhesive layer configured to couple the skirt portion of the shield with a skin surface of a subject; and wherein a housing of an on-body unit is disposed within the cup portion of the shield, and wherein the on-body unit is configured to be worn on the skin surface of a subject.[000104] All references mentioned in the specification and the appendix are hereby expressly incorporated by reference in their entireties for all purposes.Conclusion[000105] It should be noted that all features, elements, components, functions, and steps described with respect to any embodiment provided herein are intended to be freely combinable and substitutable with those from any other embodiment. If a certain feature, element, component, function, or step is described with respect to only one embodiment, then it should be understood that that feature, element, component, function, or step can be used with every other embodiment described herein unless explicitly stated otherwise. This paragraph therefore serves as antecedent basis and written support for the introduction of claims, at any time, that combine features, elements, components, functions, and steps from different embodiments, or that substitute features, elements, components, functions, and steps from one embodiment with those of another, even if the following description does not explicitly state, in a particular instance, that such combinations or substitutions are possible. Thus, the foregoing description of specific embodiments of the disclosed subject matter has been presented for purposes of illustration and description. It is explicitly acknowledged that express recitation of every possible combination and substitution is overly burdensome, especially given that the permissibility of each and every such combination and substitution will be readily recognized by those of ordinary skill in the art.[000106] While the embodiments, including methods of manufacturing, are susceptible to various modifications and alternative forms, specific examples thereof have been shown in the drawings and are herein described in detail. It will be apparent to those skilled in the art that various modifications and variations can be made in the method, system, and manufacture of the disclosed subject matter without departing from the spirit or scope of the disclosed subject matter. Thus, it is intended that the disclosed subject matter include modifications and variations that are within the scope of the appended claims and their equivalents. Furthermore,any features, functions, steps, or elements of the embodiments may be recited in or added to the claims, as well as negative limitations that define the inventive scope of the claims by features, functions, steps, or elements that are not within that scope.[000107] Aspects of the invention are set out in the following numbered clauses.1. An assembly, comprising:(1) an on-body unit configured to be worn on a skin surface of a subject, the on-body unit comprising: a housing; sensor electronics disposed within the housing, the sensor electronics comprising one or more processors, and a computer readable medium coupled with the one or more processors; an in vivo analyte sensor, a distal portion of which is configured to be transcutaneously positioned through the skin surface and in contact with a bodily fluid of the subject, wherein the distal portion of the analyte sensor is further configured to sense an analyte level in the bodily fluid; and a housing adhesive layer configured to couple the housing of the on-body unit with the skin surface of the subject; and(2) a shield, comprising: a cup portion; a skirt portion; and an adhesive stack configured to couple the skirt portion of the shield with a skin surface of the subject; and wherein the housing adhesive layer is configured to cover a first surface area of the skin surface, wherein the adhesive stack is configured to cover a second surface area of the skin surfacethat is different from the first surface area, and wherein the housing of the on-body unit is disposed within the cup portion of the shield.2. The assembly of clause 1, wherein the cup portion of the shield is dimensioned for fitted contact with the housing of the on-body unit.3. The assembly of clause 1 or 2, wherein the cup portion of the shield includes a circumferential edge configured to be aligned with a circumferential edge of the housing of the on-body unit.4. The assembly of any preceding clause, wherein the cup portion comprises at least one concentric rib configured to align with the circumferential edge of the housing of the on-body unit.5. The assembly of clause 3, wherein the cup portion comprises a plurality of concentric ribs each having an equal radius, and wherein at least one concentric rib of the plurality of concentric ribs has a larger thickness compared to each of the plurality of concentric ribs.6. The assembly of any preceding clause, wherein the cup portion comprises a plurality of radial fins configured to contact and secure the housing of the on-body unit.7. The assembly of any preceding clause, wherein the adhesive stack comprises an adhesive that comprises silicone.8. The assembly of any preceding clause, wherein the adhesive stack comprises a plurality of adhesive sublayers.9. The assembly of clause 8, wherein the plurality of adhesive sublayers include a first adhesive sublayer and a second adhesive sublayer.10. The assembly of clause 9, wherein the first adhesive sublayer is located in between the skirt portion of the shield and the second adhesive sublayer.11. The assembly of clause 10, wherein the first adhesive sublayer comprises an adhesive that comprises silicone.12. The assembly of clause 11, wherein the first adhesive sublayer further comprises an adhesive that comprises acrylic.13. The assembly of clause 12, wherein the first adhesive sublayer is a double-sided tape having a silicone adhesive on the first side in contact with the skirt portion of the shield and an acrylic adhesive on the opposite side in contact with the second adhesive sublayer.14. The assembly of any of clauses 9 to 13, wherein the second adhesive sublayer comprises an adhesive that comprises acrylic.15. The assembly of any preceding clause, wherein the skirt portion of the shield comprises air holes for ventilation.16. The assembly of any preceding clause, wherein the cup portion of the shield comprises air holes for ventilation.17. The assembly of any preceding clause, wherein the shield comprises at least one vent for ventilation.18. The assembly of clause 17, wherein the adhesive stack comprises an inner rim having at least one indent, and wherein the at least one indent is sized to accommodate the corresponding at least one vent.19. The assembly of any preceding clause, wherein the skirt portion of the shield has a first level of stiffness, and the cup portion of the shield has a second level of stiffness.20. The assembly of clause 19, wherein the second level of stiffness is greater than the first level of stiffness.21. The assembly of any preceding clause, wherein the cup portion of the shield has a height that is greater than that of the skirt portion of the shield.22. The assembly of any preceding clause, wherein the cup portion of the shield has a thickness that is greater than that of the skirt portion of the shield.23. The assembly of any preceding clause, wherein the shield is made of silicone.24. The assembly of any of clauses 1 to 22, wherein the shield is made of TPE (thermoplastic elastomer).25. The assembly of any preceding clause, wherein the shield is configured to be removed from the skin surface of the subject without displacing the housing of the on-body unit.26. The assembly of any of clauses 1 to 22, or clauses dependent thereon, wherein the shield is made of TPU (thermoplastic polyurethanes).27. The assembly of any preceding clause, wherein the analyte sensor is a glucose sensor.28. The assembly of any preceding clause, wherein the skirt portion of the shield is flexible for conforming to contours of the skin surface of the subject.29. The assembly of any preceding clause, wherein the shield is disposable after a predetermined period of 7 days.30. The assembly of any of clauses 1 to 28, wherein the shield is disposable after a predetermined period of 14-20 days.31. The assembly of any preceding clause, wherein the cup portion of the shield is detachable from the housing of the on-body unit.32. The assembly of clause 9, or any clause dependent thereon, wherein a release liner is attached to one or each of the first adhesive sublayer and the second adhesive sublayer.33. The assembly of clause 32, wherein the release liner on the second adhesive sublayer includes a kiss cut and at least one tab to aid in the removal of the release liner from the second adhesive sublayer.34. A method, comprising:(1) applying an on-body unit to a skin surface of a subject, the on-body unit comprising: a housing; sensor electronics disposed within the housing, the sensor electronics comprising one or more processors, and a computer readable medium coupled with the one or more processors; an in vivo analyte sensor, a distal portion of which is configured to be transcutaneously positioned through the skin surface and in contact with a bodily fluid of the subject, wherein the distal portion of the analyte sensor is further configured to sense an analyte level in the bodily fluid; a housing adhesive layer coupled to the housing of the on-body unit, wherein the housing adhesive layer couples the housing with the skin surface of the subject;(2) applying a first shield over the on-body unit, the first shield comprising: a cup portion; a skirt portion; and an adhesive stack coupled to the skirt portion of the first shield, wherein the adhesive stack couples the skirt portion with the skin surface of the subject; and wherein the housing adhesive layer covers a first surface area of the skin surface, wherein the adhesive stack covers a second surface area of the skin surface that is different from the first surface area, and wherein the housing of the on-body unit is disposed within the cup portion of the first shield.35. The method of clause 34, further comprising removing the first shield from the skin surface of the subject without displacing the housing of the on-body unit.36. The method of clause 35, further comprising applying a second shield to the skin surface of the subject after removing the first shield from the skin surface of the subject.37. The method of clause 34, 35 or 36, wherein the cup portion of the first shield is dimensioned for fitted contact with the housing of the on-body unit.38. The method of any of clauses 34 to 37, wherein the cup portion of the first shield includes a circumferential edge configured to be aligned with a circumferential edge of the housing of the on-body unit.39. The method of any of clauses 34 to 38, wherein the cup portion comprises at least one concentric rib configured to align with the circumferential edge of the housing of the on-body unit.40. The method of any of clauses 34 to 39, wherein the cup portion comprises a plurality of radial fins configured to contact and secure the housing of the on-body unit.41. A device comprising: a shield, comprising: a cup portion; a skirt portion; and an adhesive stack configured to couple the skirt portion of the shield with a skin surface of a subject; and wherein a housing of an on-body unit is disposed within the cup portion of the shield, and wherein the on-body unit is configured to be worn on a skin surface of a subject.42. The device of clause 41, wherein the cup portion of the shield is dimensioned for fitted contact with the housing of the on-body unit.43. The device of clause 41 or 42, wherein the cup portion of the shield includes a circumferential edge configured to be aligned with a circumferential edge of the housing of the on-body unit.44. The device of clause 41, 42 or 43, wherein the shield comprises at least one vent for ventilation.45. The device of clause 44, wherein the adhesive stack comprises an inner rim having at least one indent, and wherein the at least one indent is sized to accommodate the corresponding at least one vent.46. The device of clause 43, wherein the cup portion comprises at least one concentric rib configured to align with the circumferential edge of the housing of the on-body unit.47. The device of any of clauses 41 to 46, wherein the cup portion comprises a plurality of radial fins configured to contact and secure the housing of the on-body unit.48. The device of clause 46, wherein the cup portion comprises a plurality of concentric ribs each having an equal radius, and wherein at least one concentric rib of the plurality of concentric ribs has a larger thickness compared to each of the plurality of concentric ribs.49. The device of any of clauses 41 to 48, wherein the cup portion of the shield is detachable from the housing of the on-body unit.50. The device of any of clauses 41 to 49, wherein the housing of the on-body unit comprises a silicone adhesive layer configured to couple the housing of the on-body unit with the skin surface of the subject.51. The device of any of clauses 41 to 50, wherein the adhesive stack comprises a plurality of adhesive sublayers.52. The device of clause 51, wherein the plurality of adhesive sublayers include a first adhesive sublayer and a second adhesive sublayer.53. The device of clause 52, wherein the first adhesive sublayer is located in between the skirt portion of the shield and the second adhesive sublayer.54. The device of clause 52 or 53, wherein the first adhesive sublayer comprises an adhesive that comprises silicone.55. The device of clause 52, 53 or 54, wherein the first adhesive sublayer further comprises an adhesive that comprises acrylic.56. The device of clause 55, wherein the first adhesive sublayer is a double-sided tape having a silicone adhesive on the first side in contact with the skirt portion of the shield and an acrylic adhesive on the opposite side in contact with the second adhesive sublayer.57. The device of any of clauses 52 to 56, wherein the second adhesive sublayer comprises an adhesive that comprises acrylic.58. The device of any of clauses 52 to 57, wherein a release liner is attached to one or each of the first adhesive sublayer and the second adhesive sublayer.59. The device of clause 58, wherein the release liner on the second adhesive sublayer includes a kiss cut and at least one tab to aid in the removal of the release liner from the second adhesive sublayer.60. The device of any of clauses 41 to 59, wherein the shield is disposable after a predetermined period of 7 days.61. The device of any of clauses 41 to 59, wherein the shield is disposable after a predetermined period of 14 days.

Claims

CLAIMSWe claim:

1. An assembly, comprising:(1) an on-body unit configured to be worn on a skin surface of a subject, the on-body unit comprising: a housing; sensor electronics disposed within the housing, the sensor electronics comprising one or more processors, and a computer readable medium coupled with the one or more processors; an in vivo analyte sensor, a distal portion of which is configured to be transcutaneously positioned through the skin surface and in contact with a bodily fluid of the subject, wherein the distal portion of the analyte sensor is further configured to sense an analyte level in the bodily fluid; and a housing adhesive layer configured to couple the housing of the on-body unit with the skin surface of the subject; and(2) a shield, comprising: a cup portion; a skirt portion; and an adhesive stack configured to couple the skirt portion of the shield with a skin surface of the subject; and wherein the housing adhesive layer is configured to cover a first surface area of the skin surface, wherein the adhesive stack is configured to cover a second surface area of the skin surface that is different from the first surface area, and wherein the housing of the on-body unit is disposed within the cup portion of the shield.

2. The assembly of claim 1, wherein the cup portion of the shield is dimensioned for fitted contact with the housing of the on-body unit.

3. The assembly of claim 1, wherein the cup portion of the shield includes a circumferential edge configured to be aligned with a circumferential edge of the housing of the on-body unit.

4. The assembly of claim 3, wherein the cup portion comprises at least one concentric rib configured to align with the circumferential edge of the housing of the on-body unit.

5. The assembly of claim 3, wherein the cup portion comprises a plurality of concentric ribs each having an equal radius, and wherein at least one concentric rib of the plurality of concentric ribs has a larger thickness compared to each of the plurality of concentric ribs.

6. The assembly of claim 1, wherein the cup portion comprises a plurality of radial fins configured to contact and secure the housing of the on-body unit.

7. The assembly of claim 1, wherein the adhesive stack comprises an adhesive that comprises silicone.

8. The assembly of claim 1, wherein the adhesive stack comprises a plurality of adhesive sublayers.

9. The assembly of claim 8, wherein the plurality of adhesive sublayers include a first adhesive sublayer and a second adhesive sublayer.

10. The assembly of claim 9, wherein the first adhesive sublayer is located in between the skirt portion of the shield and the second adhesive sublayer.

11. The assembly of claim 10, wherein the first adhesive sublayer comprises an adhesive that comprises silicone.

12. The assembly of claim 11, wherein the first adhesive sublayer further comprises an adhesive that comprises acrylic.

13. The assembly of claim 12, wherein the first adhesive sublayer is a double-sided tape having a silicone adhesive on the first side in contact with the skirt portion of the shield and an acrylic adhesive on the opposite side in contact with the second adhesive sublayer.

14. The assembly of claim 9, wherein the second adhesive sublayer comprises an adhesive that comprises acrylic.

15. The assembly of claim 1, wherein the skirt portion of the shield comprises air holes for ventilation.

16. The assembly of claim 1, wherein the cup portion of the shield comprises air holes for ventilation.

17. The assembly of claim 1, wherein the shield comprises at least one vent for ventilation.

18. The assembly of claim 17, wherein the adhesive stack comprises an inner rim having at least one indent, and wherein the at least one indent is sized to accommodate the corresponding at least one vent.

19. The assembly of claim 1, wherein the skirt portion of the shield has a first level of stiffness, and the cup portion of the shield has a second level of stiffness.

20. The assembly of claim 19, wherein the second level of stiffness is greater than the first level of stiffness.

21. The assembly of claim 1, wherein the cup portion of the shield has a height that is greater than that of the skirt portion of the shield.

22. The assembly of claim 1, wherein the cup portion of the shield has a thickness that is greater than that of the skirt portion of the shield.

23. The assembly of claim 1, wherein the shield is made of silicone.

24. The assembly of claim 1, wherein the shield is made of TPE (thermoplastic elastomer).

25. The assembly of claim 1, wherein the shield is configured to be removed from the skin surface of the subject without displacing the housing of the on-body unit.

26. The assembly of claim 1, wherein the shield is made of TPU (thermoplastic polyurethanes).

27. The assembly of claim 1, wherein the analyte sensor is a glucose sensor.

28. The assembly of claim 1, wherein the skirt portion of the shield is flexible for conforming to contours of the skin surface of the subject.

29. The assembly of claim 1, wherein the shield is disposable after a predetermined period of 7 days.

30. The assembly of claim 1, wherein the shield is disposable after a predetermined period of 14- 20 days.

31. The assembly of claim 1, wherein the cup portion of the shield is detachable from the housing of the on-body unit.

32. The assembly of claim 9, wherein a release liner is attached to one or each of the first adhesive sublayer and the second adhesive sublayer.

33. The assembly of claim 32, wherein the release liner on the second adhesive sublayer includes a kiss cut and at least one tab to aid in the removal of the release liner from the second adhesive sublayer.

34. A method, comprising:(1) applying an on-body unit to a skin surface of a subject, the on-body unit comprising: a housing; sensor electronics disposed within the housing, the sensor electronics comprising one or more processors, and a computer readable medium coupled with the one or more processors;an in vivo analyte sensor, a distal portion of which is configured to be transcutaneously positioned through the skin surface and in contact with a bodily fluid of the subject, wherein the distal portion of the analyte sensor is further configured to sense an analyte level in the bodily fluid; a housing adhesive layer coupled to the housing of the on-body unit, wherein the housing adhesive layer couples the housing with the skin surface of the subject;(2) applying a first shield over the on-body unit, the first shield comprising: a cup portion; a skirt portion; and an adhesive stack coupled to the skirt portion of the first shield, wherein the adhesive stack couples the skirt portion with the skin surface of the subject; and wherein the housing adhesive layer covers a first surface area of the skin surface, wherein the adhesive stack covers a second surface area of the skin surface that is different from the first surface area, and wherein the housing of the on-body unit is disposed within the cup portion of the first shield.

35. The method of claim 34, further comprising removing the first shield from the skin surface of the subject without displacing the housing of the on-body unit.

36. The method of claim 35, further comprising applying a second shield to the skin surface of the subject after removing the first shield from the skin surface of the subject.

37. The method of claim 34, wherein the cup portion of the first shield is dimensioned for fitted contact with the housing of the on-body unit.

38. The method of claim 34, wherein the cup portion of the first shield includes a circumferential edge configured to be aligned with a circumferential edge of the housing of the on-body unit.

39. The method of claim 38, wherein the cup portion comprises at least one concentric rib configured to align with the circumferential edge of the housing of the on-body unit.

40. The method of claim 34, wherein the cup portion comprises a plurality of radial fins configured to contact and secure the housing of the on-body unit.

41. A device comprising: a shield, comprising: a cup portion; a skirt portion; and an adhesive stack configured to couple the skirt portion of the shield with a skin surface of a subject; and wherein a housing of an on-body unit is disposed within the cup portion of the shield, and wherein the on-body unit is configured to be worn on a skin surface of a subject.

42. The device of claim 41, wherein the cup portion of the shield is dimensioned for fitted contact with the housing of the on-body unit.

43. The device of claim 41, wherein the cup portion of the shield includes a circumferential edge configured to be aligned with a circumferential edge of the housing of the on-body unit.

44. The device of claim 41, wherein the shield comprises at least one vent for ventilation.

45. The device of claim 41, wherein the adhesive stack comprises an inner rim having at least one indent, and wherein the at least one indent is sized to accommodate the corresponding at least one vent.

46. The device of claim 43, wherein the cup portion comprises at least one concentric rib configured to align with the circumferential edge of the housing of the on-body unit.

47. The device of claim 41, wherein the cup portion comprises a plurality of radial fins configured to contact and secure the housing of the on-body unit.

48. The device of claim 46, wherein the cup portion comprises a plurality of concentric ribs each having an equal radius, and wherein at least one concentric rib of the plurality of concentric ribs has a larger thickness compared to each of the plurality of concentric ribs.

49. The device of claim 41, wherein the cup portion of the shield is detachable from the housing of the on-body unit.

50. The device of claim 41, wherein the housing of the on-body unit comprises a silicone adhesive layer configured to couple the housing of the on-body unit with the skin surface of the subject.

51. The device of claim 41, wherein the adhesive stack comprises a plurality of adhesive sublayers.

52. The device of claim 51, wherein the plurality of adhesive sublayers include a first adhesive sublayer and a second adhesive sublayer.

53. The device of claim 52, wherein the first adhesive sublayer is located in between the skirt portion of the shield and the second adhesive sublayer.

54. The device of claim 53, wherein the first adhesive sublayer comprises an adhesive that comprises silicone.

55. The device of claim 53, wherein the first adhesive sublayer further comprises an adhesive that comprises acrylic.

56. The device of claim 55, wherein the first adhesive sublayer is a double-sided tape having a silicone adhesive on the first side in contact with the skirt portion of the shield and an acrylic adhesive on the opposite side in contact with the second adhesive sublayer.

57. The device of claim 52, wherein the second adhesive sublayer comprises an adhesive that comprises acrylic.

58. The device of claim 52, wherein a release liner is attached to one or each of the first adhesive sublayer and the second adhesive sublayer.

59. The device of claim 58, wherein the release liner on the second adhesive sublayer includes a kiss cut and at least one tab to aid in the removal of the release liner from the second adhesive sublayer.

60. The device of claim 41, wherein the shield is disposable after a predetermined period of 7 days.

61. The device of claim 41, wherein the shield is disposable after a predetermined period of 14 days.

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