WO2025106394A1

WO2025106394A1 - Simplified applicator for on-body units

Info

Publication number: WO2025106394A1
Application number: PCT/US2024/055441
Authority: WO
Inventors: Vivek S. RAO
Original assignee: Abbott Diabetes Care Inc
Current assignee: Abbott Diabetes Care Inc
Priority date: 2023-11-13
Filing date: 2024-11-12
Publication date: 2025-05-22
Anticipated expiration: 2026-05-13

Abstract

An applicator for deploying an on-body unit (OBU) includes an applicator body and one or more OBU engagement members and a working spring section that extend from the applicator body. The OBU engagement member(s) are configured to removably secure an OBU. One or more contact members extend from the working spring section. When the contact member(s) interface with the body of the subject pursuant to deployment of the OBU on the body of the subject, the working spring section is configured to (i) store compressive or bending energy in response to force applied to the applicator body in a first direction until a peak compressive or bending energy is achieved and (ii) in response to continued application of force in the first direction after the peak compressive or bending energy is achieved, release the compressive or bending energy to cause acceleration of the applicator body in the first direction.

Description

SIMPLIFIED APPLICATOR FOR ON-BODY UNITS

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to United States Provisional Application No. 63/598,374, filed on November 13, 2023, and entitled "SIMPLIFIED APPLICATOR FOR ON- BODY UNITS", the entirety of which is incorporated herein by references for all purposes.

BACKGROUND

[0002] The detection and/or monitoring of analyte levels, such as glucose, ketones, lactate, oxygen, hemoglobin AIC, orthe 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.

[0003] 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.

[0004] To increase patient adherence to a plan of frequent glucose monitoring, in vivo analyte monitoring systems can be utilized, in which a sensor control device may be worn on the body of an individual who requires analyte monitoring. Such sensor control devices can be referred to as on-body units (OBUs) or on-body sensors. To increase comfort and convenience for the individual, the sensor control device may have a small form-factor, and can be assembled and/or applied by the individual with a sensor applicator. The application process includes inserting a sensor, such as an analyte sensor that senses a user's analyte level in a bodily fluid, using an applicator or insertion mechanism, such that the sensor comes into contact with a bodily fluid. The sensor control device may also be configured to transmit analyte data to another device, from which the individual or the individual's health care provider ("HCP") can review the data and make therapy decisions.

[0005] Although conventional in vivo analyte monitoring systems can provide various advantages and/or conveniences for individuals, numerous challenges are associated with such systems. For instance, conventional applicator or insertion mechanisms of existing in vivo analyte monitoring systems include numerous components, such as a housing, a sharp, a sharp carrier, a sheath, a firing mechanism, and/or others. The numerous components associated with existing applicator or insertion mechanisms of in vivo analyte monitoring systems can give rise to high device complexity, high manufacturing costs, increased error rates, and/or other challenges.

[0006] The subject matter claimed herein is not limited to embodiments that operate only in environments such as those described above. Rather, this background is only provided to illustrate one example technology area where some embodiments described herein may be practiced.

SUMMARY

[0007] 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 drawings.

[0008] 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 includes an applicator for deploying an on-body unit (OBU). The applicator can include an applicator body and one or more OBU engagement members that extend from the applicator body. The OBU engagement member(s) can be configured to removably secure an OBU. The applicator can include a working spring section that extends from the applicator body. The applicator can further include one or more contact members that extend from the working spring section. The contact member(s) can be configured to interface with the body of a subject (e.g., a human patient) during deployment of the OBU on the body of the subject. When the contact member(s) interface with the body of the subject pursuant to deployment of the OBU on the body of the subject, the working spring section can be configured to (i) store compressive or bending energy in response to force applied to the applicator body in a first direction until a peak compressive or bending energy is achieved and (ii) in response to continued application of force in the first direction after the peak compressive or bending energy is achieved, release the compressive or bending energy to cause acceleration of the applicator body in the first direction to facilitate deployment of the OBU on the body of the subject.

[0009] The disclosed subject matter includes a system that comprises an OBU and an applicator for deploying the OBU. The applicator includes an applicator body and one or more OBU engagement members extending from the applicator body. The OBU engagement member(s) removably secure the OBU. The applicator also includes (i) a working spring section extending from the applicator body and (ii) one or more contact members extending from the working spring section. The contact member(s) are configured to interface with a body of a subject during deployment of the OBU on the body of the subject. When the contact member(s) interface with the body of the subject pursuant to deployment of the OBU on the body of the subject, the working spring section can be configured to (i) store compressive or bending energy in response to force applied to the applicator body in a first direction until a peak compressive or bending energy is achieved and (ii) in response to continued application of force in the first direction after the peak compressive or bending energy is achieved, release the compressive or bending energy to cause acceleration of the applicator body in the first direction to facilitate deployment of the OBU on the body of the subject.

[0010] The disclosed subject matter includes a method for deploying an OBU on a body of a subject. The method includes (i) causing one or more contact members of an applicator to interface with a body of a subject, wherein the one or more contact members extend from a working spring section of the applicator, wherein the working spring section extends from an applicator body of the applicator, wherein an OBU is removably secured by one or more OBU engagement members that extend from the applicator body; (ii) applying a force to the applicator body in a first direction to cause the working spring section to store compressive or bending energy until a peak compressive or bending energy is achieved; and (iii) in response to the peak compressive or bending energy being achieved, continuing to apply force to the applicator body to cause release of the compressive or bending energy to cause acceleration of the applicator body in the first direction to facilitate deployment of the OBU on the body of the subject.

[0011] The accompanying drawings, which are incorporated in and constitute part of this specification, are included to illustrate and provide a further understanding of the methods and systems of the disclosed subject matter. Together with the description, the drawings explain the principles of the disclosed subject matter.

BRIEF DESCRIPTION OF THE DRAWINGS

[0012] 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.

[0013] Figure 1 illustrates a system overview of a sensor applicator, reader device, monitoring system, network, and remote system, in accordance with implementations of the disclosed subject matter.

[0014] Figure 2 illustrates a block diagram depicting an example embodiment of a reader device, in accordance with implementations of the disclosed subject matter.

[0015] Figures 3A and 3B illustrate block diagrams depicting example embodiments of sensor control devices (or on-body sensors), in accordance with implementations of the disclosed subject matter.

[0016] Figure 4 illustrates an example applicator for deploying an on-body unit, in accordance with implementations of the disclosed subject matter.

[0017] Figure 5 illustrates a side perspective cross-sectional view of the example applicator of Figure 4, showing an on-body unit held by the applicator, in accordance with implementations of the disclosed subject matter.

[0018] Figure 6 illustrates a bottom perspective view of the example applicator of Figure 4, in accordance with implementations of the disclosed subject matter.

[0019] Figure 7 illustrates a side cross-sectional view of the example applicator of Figure 4, in accordance with implementations of the disclosed subject matter.

[0020] Figure 8 provides a conceptual representation of using an applicator to facilitate deployment of an on-body unit on a body of a subject, in accordance with implementations of the disclosed subject matter. [0021] Figure 9 illustrates an example flow diagram depicting acts associated with deploying an on-body unit on a body of a subject, in accordance with implementations of the disclosed subject matter.

DETAILED DESCRIPTION

[0022] Before the present subject matter is described in detail, it is to be understood that this disclosure is not limited to the particular embodiments described, as such may, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting, since the scope of the present disclosure will be limited only by the appended claims.

[0023] As used herein and in the appended claims, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise.

[0024] Generally, embodiments of the present disclosure include systems, devices, and methods associated with analyte sensor insertion applicators for use with in vivo analyte monitoring systems. An applicator can be used to position the sensor control device on a human body with an analyte sensor in contact with the wearer's bodily fluid.

[0025] Many embodiments include in vivo analyte sensors structurally configured so that at least a portion of the sensor is, or can be, positioned in the body of a user to obtain information about at least one analyte of the body. It should be noted, however, that the embodiments disclosed herein can be used with in vivo analyte monitoring systems that incorporate in vitro capability, as well as purely in vitro or ex vivo analyte monitoring systems, including systems that are entirely non-invasive.

[0026] As described herein, an applicator for deploying an on-body unit (OBU) (or sensor control device) can include an applicator body and one or more OBU engagement members that extend from the applicator body. The OBU engagement member(s) can be configured to removably secure an OBU. The applicator can include a working spring section that extends from the applicator body. The applicator can further include one or more contact members that extend from the working spring section. The contact member(s) can be configured to interface with a body of a subject (e.g., a human patient) during deployment of the OBU on the body of the subject. When the contact member(s) interface with the body of the subject pursuant to deployment of the OBU on the body of the subject, the working spring section can be configured to (i) store compressive or bending energy in response to force applied to the applicator body in a first direction until a peak compressive or bending energy is achieved and (ii) in response to continued application of force in the first direction after the peak compressive or bending energy is achieved, release the compressive or bending energy to cause acceleration of the applicator body in the first direction to facilitate deployment of the OBU on the body of the subject.

[0027] By implementing these and/or other features disclosed herein, an applicator for an OBU may be constructed with a working spring section integrated with the body of the applicator. The working spring section can be operated by the user applying a force to the applicator, which, after sufficient build-up of compressive/bending energy, can accelerate the OBU toward the skin of the subject. The acceleration of the OBU can enable the OBU to achieve sufficient velocity to allow sharp elements (e.g., microneedles) thereof to penetrate the skin of the subject and adhere to the skin of the subject (e.g., via an adhesive layer of the OBU). An applicator with a working spring section as described herein may thus be constructed with fewer and/or simpler component parts (or even as a single manufacturable unit), which can greatly reduce device complexity, manufacturing costs, error rate, etc. Other improvements and advantages are provided as well.

[0028] Furthermore, for each and every embodiment of a method disclosed herein, systems and devices capable of performing each of those embodiments are covered within the scope of the present disclosure. For example, embodiments of sensor control devices (or OBUs) are disclosed, and these devices can have one or more sensors, analyte monitoring circuits (e.g., an analog circuit), memories (e.g., for storing instructions), power sources, communication circuits, transmitters, receivers, processors and/or controllers (e.g., for executing instructions) that can perform any and all method steps or facilitate the execution of any and all method steps. These sensor control device (OBU) embodiments can be used and can be capable of use to implement those steps performed by a sensor control device from any and all of the methods described herein. [0029] Before describing these aspects of the embodiments in detail, however, it is first desirable to describe examples of devices that can be present within, for example, an in vivo analyte monitoring system (or simply "system"), as well as examples of their operation, all of which can be used with the embodiments described herein. [0030] There are various types of in vivo analyte monitoring systems. "Continuous Analyte Monitoring" systems (or "Continuous Glucose Monitoring" systems), for example, can transmit data from a sensor control 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 control device in response to a scan or request for data by a reader device, such as with a Near Field Communication (NFC) or Radio Frequency Identification (RFID) protocol. In vivo analyte monitoring systems can also operate without the need for finger stick calibration.

[0031] In vivo analyte monitoring systems can be differentiated from "in vitro" systems that contact a biological sample outside of the body (or "ex vivo") and that typically include a meter device that has a port for receiving an analyte test strip carrying bodily fluid of the user, which can be analyzed to determine the user's blood sugar level.

[0032] In vivo monitoring systems can include a sensor (e.g., OBU) that, while positioned in vivo, makes contact with the bodily fluid of the user and senses the analyte levels contained therein. The sensor can be part of the sensor control device that resides on the body of the user and contains the electronics and power supply that enable and control the analyte sensing. The sensor control device, and variations thereof, can also be referred to as a "sensor control unit," an "on-body electronics" device or unit, an "on- body" device or unit, or a "sensor data communication" device or unit, to name a few.

[0033] In vivo monitoring systems can also include a device that receives sensed analyte data from the sensor control device and processes and/or displays that sensed analyte data, in any number of forms, to the user. This device, and variations thereof, can be referred to as a "handheld reader 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. Other devices such as personal computers have also been utilized with or incorporated into in vivo and in vitro monitoring systems.

[0034] Figure 1 is a conceptual diagram depicting an example embodiment of an analyte monitoring system 100 (or simply "system") that includes a sensor applicator 150 (or simply "applicator"), a sensor control device 102 (or "OBU"), and a reader device 120. Sensor applicator 150 can be used to deliver sensor control device 102 to a monitoring location on a user's skin where a sensor 104 is maintained in position for a period of time by an adhesive patch 105. Sensor control device 102 is further described in Figures 3A and 3B, and can communicate with reader device 120 via a communication path 140 using a wired or wireless technique. Example wireless protocols include Bluetooth, Bluetooth Low Energy (BLE, BTLE, Bluetooth SMART, etc.), Near Field Communication (NFC), and others. Users can monitor applications installed in memory on reader device 120 using screen 122 and input 121, and the device battery can be recharged using power port 123. More detail about reader device 120 is set forth with respect to Figure 2 below. Reader device 120 can communicate with local computer system 170 via a communication path 141 using a wired orwireless technique. Local computer system 170 can include one or more of a laptop, desktop, tablet, phablet, smartphone, wearable device, set-top box, video game console, or other computing device, and wireless communication can include any of a number of applicable wireless networking protocols including Bluetooth, Bluetooth Low Energy, Wi-Fi, or others. Local computer system 170 can communicate via communications path 143 with a network 190, similar to how reader device 120 can communicate via a communications path 142 with network 190, by wired or wireless technique as described previously. Network 190 can be any of a number of networks, such as private networks and public networks, local area or wide area networks, and so forth. A trusted computer system 180 can include a server and can provide authentication services and secured data storage and can communicate via communications path 144 with network 190 by wired or wireless technique.

[0035] Figure 2 is a block diagram depicting an example embodiment of a reader device configured as a smartphone. Here, reader device 120 can include a display 122, input component 121, and a processing core 206 including a communications processor 222 coupled with memory 223 and an applications processor 224 coupled with memory 225. Also included can be separate memory 230, RF transceiver 228 with antenna 229, and power supply 226 with power management module 238. Further included can be a multifunctional transceiver 232 which can communicate over Wi-Fi, NFC, Bluetooth, BTLE, and GPS with an antenna 234. As understood by one of skill in the art, these components are electrically and communicatively coupled in a manner to provide a functional device.

[0036] Figures 3A and 3B are block diagrams depicting example embodiments of sensor control device 102 having analyte sensor 104 and sensor electronics 160 (including analyte monitoring circuitry) that can have processing capability for rendering end result data suitable for display to the user. In Figure 3A, a single semiconductor chip 161 is depicted that can be a custom application specific integrated circuit (ASIC). Shown within ASIC 161 are certain high-level functional units, including an analog front end (AFE) 162, power management (or control) circuitry 164, processor 166, and communication circuitry 168 (which can be implemented as a transmitter, receiver, transceiver, passive circuit, or otherwise according to the communication protocol). In this embodiment, both AFE 162 and processor 166 are used as analyte monitoring circuitry, but in other embodiments either circuit can perform the analyte monitoring function. Processor 166 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.

[0037] A memory 163 is also included within ASIC 161 and can be shared by the various functional units present within ASIC 161, or can be distributed amongst two or more of them. Memory 163 can also be a separate chip. Memory 163 can be volatile and/or nonvolatile memory. In this embodiment, ASIC 161 is coupled with power source 172, which can be a coin cell battery, or the like. AFE 162 interfaces with in vivo analyte sensor 104 and receives measurement data therefrom and outputs the data to processor 166 in digital form, which in turn processes the data to arrive at the end-result glucose discrete and trend values, etc. This data can then be provided to communication circuitry 168 for sending, by way of antenna 171, to reader device 120 (not shown), for example, where minimal further processing is needed by the resident software application to display the data.

[0038] Figure 3B is similar to Figure 3A but instead includes two discrete semiconductor chips 162 and 174, which can be packaged together or separately. Here, AFE 162 is resident on ASIC 161. Processor 166 is integrated with power management circuitry 164 and communication circuitry 168 on chip 174. AFE 162 includes memory 163 and chip 174 includes memory 165, which can be isolated or distributed within. In one example embodiment, AFE 162 is combined with power management circuitry 164 and processor 166 on one chip, while communication circuitry 168 is on a separate chip. In another example embodiment, both AFE 162 and communication circuitry 168 are on one chip, and processor 166 and power management circuitry 164 are on another chip. It should be noted that other chip combinations are possible, including three or more chips, each bearing responsibility for the separate functions described, or sharing one or more functions for fail-safe redundancy.

[0039] Figure 4 illustrates an example applicator 400, corresponding to the sensor applicator 150 discussed above. The applicator 400 of Figure 4 comprises an applicator body 402, at least part of which may function as a handle for users to manipulate during operation of the applicator 400 (e.g., to deploy an OBU onto a subject).

[0040] The applicator 400 may be configured to deploy an OBU, such as sensor control device 102. Figure 5 illustrates a cross-sectional view of the applicator 400, with part of the applicator body 402 removed to show an OBU 404. In the example of Figure 5, the OBU 404 is held by the applicator 400 and ready to be deployed via the applicator onto a body of a subject. In some instances, the applicator 400 may be provided in conjunction with the OBU 404 as a system or kit. For instance, the system may be shipped to consumers with the OBU 404 removably secured by the engagement member(s) (see Figure 7) extending from the applicator body 402. In some instances, the OBU 404 and the applicator 400 may be provided with the OBU 404 unsecured by the applicator 400, enabling users to insert the OBU 404 into engagement with the applicator 400 prior to utilizing the applicator 400 to apply the OBU 404 to the body of a subject. In some instances, users may use the same applicator 400 to apply multiple OBUs, such as where OBUs have a limited use period (e.g., a number of days or weeks), necessitating regular replacement to maintain analyte monitoring functionality (or other monitoring functionality).

[0041] Figure 6 illustrates a bottom perspective view of the example applicator 400. Figure 6 illustrates that the OBU 404 may comprise a microneedle array 406 (or other sharp element(s)). The microneedle array 406 may correspond to the analyte sensor 104 discussed hereinabove. The microneedle array 406 may comprise an array of small, short, rigid, and sharp dermal analyte sensors or micro-analyte sensors (also referred to as "micro-sensors").

[0042] In some instances, the array of micro-sensors can enable improved fault checks and accuracy through averaging sensed analyte data. The array of microneedle array 406 can be disposed so as to protrude from the underside of the OBU 404. In some implementations, the micro-sensors of the microneedle array 406 can be within a range of about one millimeter and two millimeters in length. In some embodiments, the microsensors can comprise a shortened sensor tail, which forms a tip portion sufficiently sharpened so as to effectively penetrate the skin of a subject. Such a sensor design can be advantageous in that it would remove the need for a dedicated sharp (as used in conventional medical monitoring OBUs). Further, shorter analyte sensors, such as the micro-sensors of the microneedle array 406, can cause less trauma and could improve or eliminate the risk of early signal attenuation ("ESA") created by wound trauma.

[0043] In some embodiments, the tail of each micro-sensor in the microneedle array 406 can include an enzyme or other chemical or biological composition, which can be covered by a membrane. In some instances, when deployed on a subject, the tail extends beneath a user's skin in a transcutaneous manner. In some embodiments, the tail of each microsensor of the microneedle array 406 can include the same or a different enzyme, chemical composition, or biological composition as the other tails of the microneedle array 406. In some embodiments, the sensor tail is coated with dexamethasone so as to prolong the life of the micro-sensor. Dexamethasone can utilize a control release mechanism and can be used to prevent signal loss associated with shallower penetration depth of the shortened sensor tail and/or possible microphage attack of the inserted sensor tail.

[0044] In some embodiments, the sensor tail comprises an enteric coating composed of a material sufficiently sharp so as to remove the need for a dedicated sharp (as used in conventional medical monitoring OBUs). Specifically, the enteric coating can be configured so as to be hard enough to penetrate the user's skin but also change depending on the environment. For example, in some embodiments, the enteric coating on the tail of each micro-sensor of the microneedle array can be configured to soften and dissolve after the micro-sensor has been inserted into the user's skin. In this regard, once the enteric coating has dissolved, the composition on the tail of the micro-sensor of the microneedle array can help facilitate analyte monitoring in the presence of bodily fluids. [0045] Although Figure 6 illustrates the OBU 404 as comprising a microneedle array 406, an OBU 404 may comprise any quantity of sharp elements (e.g., one or more) to facilitate analyte sensing or other monitoring functionality. Figure 6 also illustrates that the OBU 404 may comprise an adhesive 408 (e.g., corresponding to adhesive patch 105 discussed above). The adhesive 408 can be positioned on the underside of the OBU 404 and can be configured to secure and maintain the OBU 404 in position on a subject's skin surface. As will be described in more detail hereinbelow, the applicator 400 may function to cause the OBU 404 to accelerate toward the skin of a subject to reach a velocity sufficient to allow the microsensors of the microneedle array 406 to penetrate the skin of the subject and to allow the adhesive 408 to become adhered to the skin of the subject.

[0046] Figure 7 illustrates a side cross-sectional view of the applicator 400. In the example of Figure 7, the applicator 400 includes OBU engagement members 410 extending from the applicator body 402. The OBU engagement members 410 of Figure 7 are implemented as engagement arms and are configured to removably secure the OBU 404. For instance, the OBU engagement members 410 may secure or retain the OBU 404 via frictional force prior to deployment of the OBU 404 on the skin of a subject. When the adhesive 408 interfaces with the skin of the user, pursuant to deployment of the OBU 404 on the skin of the subject, the adhesive force may exceed the frictional force between the engagement members 410 and the OBU 404, causing the engagement members 410 to release or disengage from the OBU 404 when the applicator 400 is withdrawn from the subject.

[0047] Although two engagement members 410 are shown in Figure 7, other quantities and/or types of engagement members/features may be utilized to removably secure the OBU 404 to the applicator 400, in accordance with the disclosed subject matter.

[0048] Figure 7 furthermore illustrates that the applicator 400 includes a working spring section 412, which also extends from the applicator body 402. In the example of Figure 7, the working spring section 412 includes multiple annular sections, including section 414, section 416, and section 418. The different sections of the working spring section 412 of Figure 7 can comprise different thicknesses and/or cross-sectional profiles. For instance, in the example of Figure 7, sections 414 and 418 include curved cross-sectional profiles, with the radii of curvature of the profile of section 414 being positioned exterior to an exterior side 420 of the working spring section 412, and with the radii of curvature of the profile of section 418 being positioned interior to an interior side 422 of the working spring section 412. In Figure 7, section 418 is positioned at a greater radius from a central axis 424 of the applicator than section 414.

[0049] Furthermore, in the example of Figure 7, section 416 includes a linear cross- sectional profile that is angularly offset from an outer wall 426 of the applicator body 402. As shown in Figure 7, section 416 comprises a greater thickness than sections 414 and 418. The working spring section 412 may be constructed from one or more polymeric and/or elastomeric materials, such as polypropylene, polyethylene (e.g., HDPE), polyurethane (e.g., thermoplastic polyurethane), thermoplastic elastomers, polyvinyl chloride, ethylene vinyl acetate, silicone, rubber, acrylonitrile butadiene styrene, and/or others.

[0050] With the configuration described above and shown in Figure 7, the working spring section 412 can flex or deform to enable buildup and release of compressive and/or bending forces when force is applied to the applicator 400. For instance, the applicator 400 as shown in Figure 7 further includes contact members 428 that extend from the working spring section 412. The contact members 428 can interface with the body of a subject pursuant to deployment of the OBU 404 on the body of the subject. The contact members 428 (and/or one or more components of the working spring section 412) can at least partially encompass or surround the OBU engagement members 410 prior to deployment of the OBU 404 on the body of a subject (e.g., the configuration shown in Figure 7), which can mitigate disturbance of the OBU 404 prior to deployment.

[0051] When the contact members 428 interface with the body of a subject, force applied to the applicator 400 toward the subject (e.g., via the applicator body 402 acting as a handle) can compress the working spring section 412, enabling the working spring section 412 to store compressive and/or bending energy. When the force applied to the applicator 400 toward the subject exceeds a threshold, the energy stored in the working spring section 412 may release, causing the applicator body 402 to "fire" toward the skin of the subject. The firing of the applicator body 402 toward the skin of the subject can cause the OBU engagement members 410, along with the OBU 404, to accelerate toward the skin of the subject, achieving a velocity that enables the microneedle array 406 to penetrate the skin of the subject and/or enables the adhesive 408 to adhere to the skin of the subject.

[0052] Figure 8 provides a conceptual representation of operation of the working spring section 412 of an applicator 400 to facilitate deployment of an OBU 404 on a body of a subject, in accordance with implementations of the disclosed subject matter. For clarity of illustration, the OBU 404 is not shown in Figure 8. Element 802 of Figure 8 illustrates a conceptual representation of the contact members 428 of the applicator 400 interfacing with a body of a subject. Element 802 conceptually depicts force applied to the applicator 400 via the applicator body 402 in a first direction (e.g., toward the body of the subject interfacing with the contact members 428), indicated in Figure 8 by arrow 803.

[0053] The application of the force to the applicator body 402 in the first direction causes the working spring section 412 to deform or flex, as shown in element 804 of Figure 8. Element 804 also shows the arrow 803 indication application of force to the applicator body 402 in the first direction. Element 804 shows section 416 of the working spring section flexed into a different angular offset relative to the outer wall 426 of the applicator body 402, responsive to the force applied to the applicator body 402 in the first direction. The working spring section 412 can store compressive or bending energy until a peak compressive and/or bending energy is achieved. The applicator body 402 can include stiffening ribs 430 (or a fill or core material) on the interior thereof to mitigate deformation of the applicator body 402 during application of the force in the first direction (Figure 5 also illustrates the stiffening ribs 430). Furthermore, in some implementations, the applicator includes air vents 432 to prevent sealing of the space 805 formed between the applicator 400 and the body of the subject. In some instances, without some form of air vents, air would become compressed in the space 805 during application of force to the applicator body 402 in the first direction, preventing acceleration. The air vents 432 can allow air to escape when the applicator body 402 accelerates in the first direction toward an individual's skin (e.g., as the collapse of the applicator 400 shown in element 806 causes a net negative change in volume within the space 805).

[0054] Element 806 of Figure 8 conceptually depicts that, when the peak or compressive and/or bending energy is achieved, force on the applicator body 402 in the first direction may continue and/or increase, causing release of the compressive and/or bending energy of the working spring section 412. This release causes acceleration of the applicator body 402 in the first direction (e.g., toward the body of the subject) to deploy the OBU 404 (not shown in Figure 8) on the body of the subject. Element 806 illustrates the configuration of the applicator 400 after "firing" of the applicator body 402 toward the body of the subject (e.g., after release of the bending and/or compressive energy of the working spring section 412 responsive to application of force in the first direction). As shown in element 806, the angular orientation of section 416 of the working spring section is further deformed and further angularly offset relative to the outer wall 426 of the applicator body 402. The OBU engagement members 410 and the applicator body 402 are descended relative to the contact members 428, enabling the OBU 404 (not shown in Figure 8) to reach the body of the subject and become deployed thereon.

[0055] The acceleration of the applicator body 402 toward the body of the user can enable the OBU 404 to achieve a velocity that causes the microneedle array 406 thereof to penetrate the skin of the subject, thereby enabling analyte sensing functionality (or other monitoring functionality). The acceleration of the applicator body 402 toward the body of the user can additionally facilitate adhesion of the adhesive of the OBU 404 to the skin of the subject, which can enable the OBU engagement members 410 to release the OBU when the applicator body 402 is withdrawn from the body of the subject.

[0056] In some implementations, the applicator 400 may optionally be reset into its initial configuration (e.g., the configuration shown in element 802 of Figure 8) by forcing the applicator body 402 in a second direction (opposite the first direction) upward from the contact members 428 (e.g., while retaining or securing the contact members 428). The applicator 400 may then be utilized for a subsequent deployment of an OBU on the body of a subject. For instance, a user may insert another OBU into engagement with the OBU engagement members 410 and re-implement the procedure discussed hereinabove with reference to Figure 8 (and discussed hereinafter with reference to Figure 9).

[0057] Although the example applicator 400 discussed hereinabove with reference to Figures 4-8 includes a particular configuration for the working spring section 412 (i.e., a plurality of annular sections, with at least two of the comprising different thicknesses, enabling storage of bending/compressing energy longitudinally along the working spring section 412), other working spring section configurations are within the scope of the present disclosure. For instance, a working spring section of an application as disclosed herein may comprise a plurality of through slots positioned about the working spring section, which can enable the material of the working spring section between the slots to store bending/compressing energy transversely or circumferentially along the working spring section.

[0058] The following discussion now refers to a number of methods and method acts that may be performed. Although the method acts may be discussed in a certain order or illustrated in a flow chart as occurring in a particular order, no particular ordering is required unless specifically stated, or required because an act is dependent on another act being completed prior to the act being performed.

[0059] Figure 9 illustrates an example flow diagram 900 depicting acts associated with deploying an on-body unit on a body of a subject, in accordance with implementations of the disclosed subject matter.

[0060] Act 902 of flow diagram 900 includes causing one or more contact members of an applicator to interface with a body of a subject, wherein the one or more contact members extend from a working spring section of the applicator, wherein the working spring section extends from an applicator body of the applicator, wherein an OBU is removably secured by one or more OBU engagement members that extend from the applicator body. In some instances, the OBU comprises an analyte sensor. In some implementations, the OBU comprises a microneedle array. In some examples, the OBU comprises an adhesive configured to adhere to the body of the subject pursuant to deployment of the OBU on the body of the subject. In some instances, the one or more OBU engagement members comprise a plurality of engagement arms that secure the OBU during deployment of the OBU on the body of the subject. In some implementations, the one or more contact members comprise one or more air vents to prevent sealing of a space formed between the applicator and the body of the subject.

[0061] Act 904 of flow diagram 900 includes applying a force to the applicator body in a first direction to cause the working spring section to store compressive or bending energy until a peak compressive or bending energy is achieved. In some examples, the applicator body comprises one or more stiffening ribs configured to mitigate deformation of the applicator body during application of force to the applicator body in the first direction pursuant to deployment of the OBU on the body of the subject. In some instances, the working spring section comprises an elastomeric material. In some implementations, the working spring section comprises a plurality of annular sections, where at least two annular sections of the plurality of annular sections comprise different thicknesses. In some examples, the working spring section comprises a plurality of through slots.

[0062] Act 906 of flow diagram 900 includes, in response to the peak compressive or bending energy being achieved, continuing to apply force to the applicator body to cause release of the compressive or bending energy to cause acceleration of the applicator body in the first direction to facilitate deployment of the OBU on the body of the subject. In some instances, the one or more OBU engagement members comprise a plurality of engagement arms that release the OBU in response to adhesion of the OBU to the body of the subject and withdrawal of the applicator from the body of the subject. In some implementations, the working spring section or the one or more contact members at least partially encompass the one or more OBU engagement members prior to release of the compressive or bending energy of the working spring section. In some examples, the acceleration of the applicator body in the first direction caused by release of the compressive or bending energy of the working spring section is configured to achieve a velocity that causes microneedles of the microneedle array of the OBU to penetrate skin of the subject. In some instances, the acceleration of or force applied to the applicator body in the first direction is configured to facilitate adhesion of the adhesive of the OBU to skin of the subject.

[0063] In addition to the specific embodiments claimed hereinafter, the disclosed subject matter is also directed to other embodiments having any other possible combination of the dependent features claimed below and those disclosed above and in the attached figures. As such, the particular features disclosed herein can be combined with each other in other manners within the scope of the disclosed subject matter such that the disclosed subject matter should be recognized as also specifically directed to other embodiments having any other possible combinations. Thus, the foregoing description of specific embodiments of the disclosed subject matter has been presented for purposes of illustration and description. It is not intended to be exhaustive or to limit the disclosed subject matter to those embodiments disclosed.

[0064] It will be apparent to those skilled in the art that various modifications and variations can be made in the method and system 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.

[0065] Embodiments disclosed herein can include those in the following numbered clauses:

[0066] 1. An applicator for deploying an on-body unit (OBU), comprising: an applicator body; one or more OBU engagement members extending from the applicator body, the one or more OBU engagement members being configured to removably secure an OBU; a working spring section extending from the applicator body; and one or more contact members extending from the working spring section, wherein the one or more contact members are configured to interface with a body of a subject during deployment of the OBU on the body of the subject, wherein, when the one or more contact members interface with the body of the subject pursuant to deployment of the OBU on the body of the subject, the working spring section is configured to (i) store compressive or bending energy in response to force applied to the applicator body in a first direction until a peak compressive or bending energy is achieved and (ii) in response to continued application of force in the first direction after the peak compressive or bending energy is achieved, release the compressive or bending energy to cause acceleration of the applicator body in the first direction to facilitate deployment of the OBU on the body of the subject.

[0067] 2. The applicator of clause 1, wherein the applicator body comprises one or more stiffening ribs configured to mitigate deformation of the applicator body during application of force to the applicator body in the first direction pursuant to deployment of the OBU on the body of the subject.

[0068] 3. The applicator of clause 1 or clause 2, wherein the one or more OBU engagement members comprise a plurality of engagement arms configured to secure the OBU during deployment of the OBU on the body of the subject and release the OBU in response to adhesion of the OBU to the body of the subject and withdrawal of the applicator from the body of the subject.

[0069] 4. The applicator of any one of clauses 1 through 3, wherein the working spring section comprises an elastomeric material.

[0070] 5. The applicator of any one of clauses 1 through 4, wherein the working spring section or the one or more contact members at least partially encompass the one or more OBU engagement members prior to release of the compressive or bending energy of the working spring section.

[0071] 6. The applicator of any one of clauses 1 through 5, wherein the working spring section comprises a plurality of annular sections, wherein at least two annular sections of the plurality of annular sections comprise different thicknesses.

[0072] 7. The applicator of any one of clauses 1 through 6, wherein the working spring section comprises a plurality of through slots. [0073] 8. The applicator of any one of clauses 1 through 7, wherein the acceleration of the applicator body in the first direction caused by release of the compressive or bending energy of the working spring section is configured to achieve a velocity that causes one or more sharp elements of the OBU to penetrate skin of the subject.

[0074] 9. The applicator of any one of clauses 1 through 8, wherein the acceleration of or force applied to the applicator body in the first direction is configured to facilitate adhesion of an adhesive of the OBU to skin of the subject.

[0075] 10. The applicator of any one of clauses 1 through 9, wherein the one or more contact members comprise one or more air vents to prevent sealing of a space formed between the applicator and the body of the subject.

[0076] 11. A system, comprising: an on-body unit (OBU); and an applicator for deploying the on-body unit, the applicator comprising: an applicator body; one or more OBU engagement members extending from the applicator body, wherein the one or more OBU engagement members removably secure the OBU; a working spring section extending from the applicator body; and one or more contact members extending from the working spring section, wherein the one or more contact members are configured to interface with a body of a subject during deployment of the OBU on the body of the subject, wherein, when the one or more contact members interface with the body of the subject pursuant to deployment of the OBU on the body of the subject, the working spring section is configured to (i) store compressive or bending energy in response to force applied to the applicator body in a first direction until a peak compressive or bending energy is achieved and (ii) in response to continued application of force in the first direction after the peak compressive or bending energy is achieved, release the compressive or bending energy to cause acceleration of the applicator body in the first direction to facilitate deployment of the OBU on the body of the subject.

[0077] 12. The system of clause 11, wherein the OBU comprises an analyte sensor.

[0078] 13. The system of clause 11 or clause 12, wherein the applicator body comprises one or more stiffening ribs configured to mitigate deformation of the applicator body during application of force to the applicator body in the first direction pursuant to deployment of the OBU on the body of the subject.

[0079] 14. The system of any one of clauses 11 through 13, wherein the one or more OBU engagement members comprise a plurality of engagement arms that secure the OBU during deployment of the OBU on the body of the subject and release the OBU in response to adhesion of the OBU to the body of the subject and withdrawal of the applicator from the body of the subject.

[0080] 15. The system of any one of clauses 11 through 14, wherein the working spring section comprises an elastomeric material.

[0081] 16. The system of any one of clauses 11 through 15, wherein the working spring section or the one or more contact members at least partially encompass the one or more OBU engagement members prior to release of the compressive or bending energy of the working spring section.

[0082] 17. The system of any one of clauses 11 through 16, wherein the working spring section comprises a plurality of annular sections, wherein at least two annular sections of the plurality of annular sections comprise different thicknesses.

[0083] 18. The system of any one of clauses 11 through 17, wherein the working spring section comprises a plurality of through slots.

[0084] 19. The system of any one of clauses 11 through 18, wherein the OBU comprises a microneedle array.

[0085] 20. The system of clause 19, wherein the acceleration of the applicator body in the first direction caused by release of the compressive or bending energy of the working spring section is configured to achieve a velocity that causes microneedles of the microneedle array of the OBU to penetrate skin of the subject.

[0086] 21. The system of any one of clauses 11 through 20, wherein the OBU comprises an adhesive configured to adhere to the body of the subject pursuant to deployment of the OBU on the body of the subject.

[0087] 22. The system of clause 21, wherein the acceleration of or force applied to the applicator body in the first direction is configured to facilitate adhesion of the adhesive of the OBU to skin of the subject.

[0088] 23. The system of any one of clauses 11 through 22, wherein the one or more contact members comprise one or more air vents to prevent sealing of a space formed between the applicator and the body of the subject.

[0089] 24. A method for deploying an on-body unit (OBU) on a body of a subject, the method comprising: causing one or more contact members of an applicator to interface with a body of a subject, wherein the one or more contact members extend from a working spring section of the applicator, wherein the working spring section extends from an applicator body of the applicator, wherein an OBU is removably secured by one or more OBU engagement members that extend from the applicator body; applying a force to the applicator body in a first direction to cause the working spring section to store compressive or bending energy until a peak compressive or bending energy is achieved; and in response to the peak compressive or bending energy being achieved, continuing to apply force to the applicator body to cause release of the compressive or bending energy to cause acceleration of the applicator body in the first direction to facilitate deployment of the OBU on the body of the subject.

[0090] 25. The method of clause 24, wherein the OBU comprises an analyte sensor.

[0091] 26. The method of clause 24 or clause 25, wherein the applicator body comprises one or more stiffening ribs configured to mitigate deformation of the applicator body during application of force to the applicator body in the first direction pursuant to deployment of the OBU on the body of the subject.

[0092] 27. The method of any one of clauses 24 through 26, wherein the one or more OBU engagement members comprise a plurality of engagement arms that secure the OBU during deployment of the OBU on the body of the subject and release the OBU in response to adhesion of the OBU to the body of the subject and withdrawal of the applicator from the body of the subject.

[0093] 28. The method of any one of clauses 24 through 27, wherein the working spring section comprises an elastomeric material.

[0094] 29. The method of any one of clauses 24 through 28, wherein the working spring section or the one or more contact members at least partially encompass the one or more OBU engagement members prior to release of the compressive or bending energy of the working spring section.

[0095] 30. The method of any one of clauses 24 through 29, wherein the working spring section comprises a plurality of annular sections, wherein at least two annular sections of the plurality of annular sections comprise different thicknesses.

[0096] 31. The method of any one of clauses 24 through 30, wherein the working spring section comprises a plurality of through slots.

[0097] 32. The method of any one of clauses 24 through 31, wherein the OBU comprises a microneedle array. [0098] 33. The method of clause 32, wherein the acceleration of the applicator body in the first direction caused by release of the compressive or bending energy of the working spring section is configured to achieve a velocity that causes microneedles of the microneedle array of the OBU to penetrate skin of the subject. [0099] 34. The method of any one of clauses 24 through 33, wherein the OBU comprises an adhesive configured to adhere to the body of the subject pursuant to deployment of the OBU on the body of the subject.

[00100] 35. The method of clause 34, wherein the acceleration of or force applied to the applicator body in the first direction is configured to facilitate adhesion of the adhesive of the OBU to skin of the subject.

[00101] 36. The method of any one of clauses 24 through 35, wherein the one or more contact members comprise one or more air vents to prevent sealing of a space formed between the applicator and the body of the subject.

[00102] Also envisaged and encompassed in the disclosure herein are apparatus comprising means for implementing any of the methods described herein, including any of the preferred features.

Claims

CLAIMS We Claim:

1. An applicator for deploying an on-body unit (OBU), comprising: an applicator body; one or more OBU engagement members extending from the applicator body, the one or more OBU engagement members being configured to removably secure an OBU; a working spring section extending from the applicator body; and one or more contact members extending from the working spring section, wherein the one or more contact members are configured to interface with a body of a subject during deployment of the OBU on the body of the subject, wherein, when the one or more contact members interface with the body of the subject pursuant to deployment of the OBU on the body of the subject, the working spring section is configured to (i) store compressive or bending energy in response to force applied to the applicator body in a first direction until a peak compressive or bending energy is achieved and (ii) in response to continued application of force in the first direction after the peak compressive or bending energy is achieved, release the compressive or bending energy to cause acceleration of the applicator body in the first direction to facilitate deployment of the OBU on the body of the subject.

2. The applicator of claim 1, wherein the applicator body comprises one or more stiffening ribs configured to mitigate deformation of the applicator body during application of force to the applicator body in the first direction pursuant to deployment of the OBU on the body of the subject.

3. The applicator of claim 1, wherein the one or more OBU engagement members comprise a plurality of engagement arms configured to secure the OBU during deployment of the OBU on the body of the subject and release the OBU in response to adhesion of the OBU to the body of the subject and withdrawal of the applicator from the body of the subject.

4. The applicator of claim 1, wherein the working spring section comprises an elastomeric material.

5. The applicator of claim 1, wherein the working spring section or the one or more contact members at least partially encompass the one or more OBU engagement members priorto release of the compressive or bending energy of the working spring section.

6. The applicator of claim 1, wherein the working spring section comprises a plurality of annular sections, wherein at least two annular sections of the plurality of annular sections comprise different thicknesses.

7. The applicator of claim 1, wherein the working spring section comprises a plurality of through slots.

8. The applicator of claim 1, wherein the acceleration of the applicator body in the first direction caused by release of the compressive or bending energy of the working spring section is configured to achieve a velocity that causes one or more sharp elements of the OBU to penetrate skin of the subject.

9. The applicator of claim 1, wherein the acceleration of or force applied to the applicator body in the first direction is configured to facilitate adhesion of an adhesive of the OBU to skin of the subject.

10. The applicator of claim 1, wherein the one or more contact members comprise one or more air vents to prevent sealing of a space formed between the applicator and the body of the subject.

11. A system, comprising: an on-body unit (OBU); and an applicator for deploying the on-body unit, the applicator comprising: an applicator body; one or more OBU engagement members extending from the applicator body, wherein the one or more OBU engagement members removably secure the OBU; a working spring section extending from the applicator body; and one or more contact members extending from the working spring section, wherein the one or more contact members are configured to interface with a body of a subject during deployment of the OBU on the body of the subject, wherein, when the one or more contact members interface with the body of the subject pursuant to deployment of the OBU on the body of the subject, the working spring section is configured to (i) store compressive or bending energy in response to force applied to the applicator body in a first direction until a peak compressive or bending energy is achieved and (ii) in response to continued application of force in the first direction after the peak compressive or bending energy is achieved, release the compressive or bending energy to cause acceleration of the applicator body in the first direction to facilitate deployment of the OBU on the body of the subject.

12. The system of claim 11, wherein the OBU comprises an analyte sensor.

13. The system of claim 11, wherein the applicator body comprises one or more stiffening ribs configured to mitigate deformation of the applicator body during application of force to the applicator body in the first direction pursuant to deployment of the OBU on the body of the subject.

14. The system of claim 11, wherein the one or more OBU engagement members comprise a plurality of engagement arms that secure the OBU during deployment of the OBU on the body of the subject and release the OBU in response to adhesion of the OBU to the body of the subject and withdrawal of the applicator from the body of the subject.

15. The system of claim 11, wherein the working spring section comprises an elastomeric material.

16. The system of claim 11, wherein the working spring section or the one or more contact members at least partially encompass the one or more OBU engagement members prior to release of the compressive or bending energy of the working spring section.

17. The system of claim 11, wherein the working spring section comprises a plurality of annular sections, wherein at least two annular sections of the plurality of annular sections comprise different thicknesses.

18. The system of claim 11, wherein the working spring section comprises a plurality of through slots.

19. The system of claim 11, wherein the OBU comprises a microneedle array.

20. The system of claim 19, wherein the acceleration of the applicator body in the first direction caused by release of the compressive or bending energy of the working spring section is configured to achieve a velocity that causes microneedles of the microneedle array of the OBU to penetrate skin of the subject.

21. The system of claim 11, wherein the OBU comprises an adhesive configured to adhere to the body of the subject pursuant to deployment of the OBU on the body of the subject.

22. The system of claim 21, wherein the acceleration of or force applied to the applicator body in the first direction is configured to facilitate adhesion of the adhesive of the OBU to skin of the subject.

23. The system of claim 11, wherein the one or more contact members comprise one or more air vents to prevent sealing of a space formed between the applicator and the body of the subject.

24. A method for deploying an on-body unit (OBU) on a body of a subject, the method comprising: causing one or more contact members of an applicator to interface with a body of a subject, wherein the one or more contact members extend from a working spring section of the applicator, wherein the working spring section extends from an applicator body of the applicator, wherein an OBU is removably secured by one or more OBU engagement members that extend from the applicator body; applying a force to the applicator body in a first direction to cause the working spring section to store compressive or bending energy until a peak compressive or bending energy is achieved; and in response to the peak compressive or bending energy being achieved, continuing to apply force to the applicator body to cause release of the compressive or bending energy to cause acceleration of the applicator body in the first direction to facilitate deployment of the OBU on the body of the subject.

25. The method of claim 24, wherein the OBU comprises an analyte sensor.

26. The method of claim 24, wherein the applicator body comprises one or more stiffening ribs configured to mitigate deformation of the applicator body during application of force to the applicator body in the first direction pursuant to deployment of the OBU on the body of the subject.

27. The method of claim 24, wherein the one or more OBU engagement members comprise a plurality of engagement arms that secure the OBU during deployment of the OBU on the body of the subject and release the OBU in response to adhesion of the OBU to the body of the subject and withdrawal of the applicator from the body of the subject.

28. The method of claim 24, wherein the working spring section comprises an elastomeric material.

29. The method of claim 24, wherein the working spring section or the one or more contact members at least partially encompass the one or more OBU engagement members prior to release of the compressive or bending energy of the working spring section.

30. The method of claim 24, wherein the working spring section comprises a plurality of annular sections, wherein at least two annular sections of the plurality of annular sections comprise different thicknesses.

31. The method of claim 24, wherein the working spring section comprises a plurality of through slots.

32. The method of claim 24, wherein the OBU comprises a microneedle array.

33. The method of claim 32, wherein the acceleration of the applicator body in the first direction caused by release of the compressive or bending energy of the working spring section is configured to achieve a velocity that causes microneedles of the microneedle array of the OBU to penetrate skin of the subject.

34. The method of claim 24, wherein the OBU comprises an adhesive configured to adhere to the body of the subject pursuant to deployment of the OBU on the body of the subject.

35. The method of claim 34, wherein the acceleration of or force applied to the applicator body in the first direction is configured to facilitate adhesion of the adhesive of the OBU to skin of the subject.

36. The method of claim 24, wherein the one or more contact members comprise one or more air vents to prevent sealing of a space formed between the applicator and the body of the subject.