Systems, devices, and methods for analyte sensor insertion

Abstract

An assembly and method for delivering an analyte sensor including a reusable applicator having a proximal portion and a distal portion are disclosed. The reusable applicator can include a housing, a sensor carrier configured to releasably receive a first analyte sensor, a sharp carrier configured to releasably receive a sharp module, and an actuator movable relative to the housing. The actuator can include three positions: a first position with the sensor carrier and the sharp carrier at a proximal portion of the reusable applicator, a second position with the sensor carrier and the sharp carrier at a distal portion of the reusable applicator for delivery of the first analyte sensor, and a third position with the sensor carrier at the distal portion of the reusable applicator and the sharp carrier at the proximal portion of the reusable applicator after delivery of the first analyte sensor from the reusable applicator, wherein the first position, the second position, and the third position are different, and wherein the actuator is configured to return from the third position to the first position for delivery of another analyte sensor.

Description

Technical Field

[0001] The subject matter described herein generally relates to systems, apparatus, and methods for inserting at least a portion of an analyte sensor into a body of an object using an applicator. Background Technology

[0002] The detection and / or monitoring of analyte levels (e.g., glucose, ketones, lactate, oxygen, hemoglobin A1C, etc.) is extremely important for the health of individuals with diabetes. Patients with diabetes may experience complications including loss of consciousness, cardiovascular disease, retinopathy, neuropathy, and nephropathy. Patients with diabetes typically need to monitor their glucose levels to ensure they remain within a clinically safe range, and this information can also be used to determine whether and / or when insulin is needed to lower their glucose levels, or when additional glucose is needed to raise their glucose levels.

[0003] Growing clinical data demonstrate a strong correlation between the frequency of glucose monitoring and glycemic control. However, despite this correlation, many individuals diagnosed with diabetes do not monitor their glucose levels as frequently as they should due to a combination of factors including convenience, test interpretation, pain associated with glucose testing, and cost.

[0004] To increase patient adherence to frequent glucose monitoring programs, an in vivo analyte monitoring system can be used, in which a sensor control device can be worn on the body of the individual requiring analyte monitoring. To enhance individual comfort and convenience, the sensor control device can have a small form factor and can be assembled and applied by the individual using a sensor applicator. The application process involves inserting at least a portion of the sensor, which senses the user's analyte level in bodily fluids located in a layer of the body, using an applicator or insertion mechanism, such that the sensor comes into contact with the bodily fluids. The sensor control device can also be configured to transmit analyte data to another device from which the individual or her healthcare provider (“HCP”) can review the data and make treatment decisions.

[0005] While current sensors can be convenient for users, they are also susceptible to malfunctions. These malfunctions can result from user error, lack of proper training, poor user coordination, overly complex procedures, physiological responses to the inserted sensor, and other issues. For example, some prior art systems may rely excessively on the precise assembly and deployment of the sensor control device and applicator by an individual user. Other prior art systems may utilize sharp insertion and retraction mechanisms that can easily cause damage to the surrounding tissue at the sensor insertion site, leading to inaccurate analyte level measurements. These challenges, and others described herein, can result in incorrect sensor insertion and / or suboptimal analyte measurements, and consequently, inaccurate monitoring of the patient's analyte levels.

[0006] Furthermore, the applicator used for at least a portion of the in vivo analyte sensor may comprise several components typically made of a mixture of plastic materials, which may be difficult to separate after use, making recycling challenging. Additionally, the packaging material used for such applicators must meet numerous engineering design requirements, including providing a tight seal for shelf-life storage requirements, requiring tightly tolerant components made of special plastic materials to achieve low moisture conversion rates, providing sufficient lubrication to maintain insertion force, and so on. Moreover, the applicator is often packaged inside a cardboard box along with an alcohol wipe. As a result, applicators are frequently manufactured for single use and use non-biodegradable materials, making them difficult to recycle and / or insufficiently durable for reuse.

[0007] Therefore, there is a need for more reliable sensor insertion devices, systems, and methods that are easy for patients to use, less prone to errors, and reusable. Furthermore, there is a need for an applicator that meets engineering design requirements but is durable enough for multiple uses and / or recyclable. Summary of the Invention

[0008] The purposes and advantages of the disclosed subject matter will be set forth in and apparent from the following description, and will be learned through practice of the disclosed subject matter. Additional advantages of the disclosed subject matter will be realized and obtained through the methods and systems particularly pointed out in the written description and its claims, as well as from the accompanying drawings.

[0009] To achieve these and other advantages and in accordance with the purposes of the disclosed subject matter, as embodied and broadly described, the disclosed subject matter relates to an assembly for delivering an analyte sensor, the assembly including a reusable applicator having a proximal portion and a distal portion. The reusable applicator is configured to deliver a first analyte sensor and includes a housing, a sensor carrier configured to releasably receive the first analyte sensor, a sharps carrier configured to releasably receive a sharps module, and an actuator movable relative to the housing. The actuator includes a first position, a second position, and a third position, in which the sensor carrier and the sharps carrier are located at the proximal portion of the reusable applicator; in the second position, the sensor carrier and the sharps carrier are located at the distal portion of the reusable applicator for delivering the first analyte sensor from the reusable applicator; and in the third position, after delivering the first analyte sensor, the sensor carrier is located at the distal portion of the reusable applicator and the sharps carrier is located at the proximal portion of the reusable applicator. The first, second, and third positions are distinct. The actuator is configured to return from the third position to the first position for delivering another analyte sensor.

[0010] The reusable applicator may include a drive spring and a retraction spring. The drive spring moves the sensor carrier and the sharp object carrier from a proximal portion to a distal portion, and the retraction spring moves the actuator to a third position. The drive spring can be actuated by movement of the actuator from a first position to a second position. The retraction spring can be actuated by movement of the sensor carrier from a proximal position to a distal position of the reusable applicator.

[0011] According to some embodiments, the reusable applicator may further include a latch to retain the sensor carrier in a proximal portion of the reusable applicator as the actuator moves from a second position to a third position. According to some embodiments, with the actuator in the third position, the sharps carrier can be accessed from the proximal portion of the reusable applicator to release the sharps module. The reusable applicator may include a visual indicator of the actuator's position. The actuator may include a button configured to extend a first predetermined length relative to the housing in a first position, a second predetermined length relative to the housing in a second position, and a third predetermined length relative to the housing in a third position, wherein the third predetermined length is greater than the first predetermined length, and the first predetermined length is greater than the second predetermined length. The button may be configured to open to remove the sharps module.

[0012] According to embodiments of this disclosure, the component may be made of recyclable materials. The reusable applicator may include acetal. The component may include a sealable container to package the reusable applicator. The sealable container may have a low moisture conversion rate. The sealable container may be configured to not require a desiccant. The component may include an applicator cap that is sealed to the housing using a gasket-less seal.

[0013] According to embodiments of this disclosure, a method of using an assembly for delivering an analyte sensor may include providing a reusable applicator having a proximal portion and a distal portion and including a housing, a sensor carrier having a first analyte sensor control device releasably received therein, a sharps carrier having a sharps module releasably received therein, and an actuator movable relative to the housing. The actuator is used to move the assembly's actuator from a first position toward a second position to move the sensor carrier and sharps carrier from the proximal portion of the reusable applicator to the distal portion of the reusable applicator to deliver the first analyte sensor from the sensor carrier, to move the sharps carrier from the distal portion of the reusable applicator to the proximal portion of the reusable applicator, and after delivering the first analyte sensor, to move the assembly's actuator to a third position, and to return the actuator from the third position to the first position to receive another analyte sensor for delivery. The first, second, and third positions are different. The reusable applicator may include a drive spring to move the sensor carrier and sharps carrier from the proximal portion to the distal portion. A reusable applicator may include a retraction spring to move the actuator to a third position.

[0014] According to some embodiments, returning the actuator from the third position to the first position may include using an actuator with components to reload the retraction spring by moving the sharp part carrier from the proximal portion of the reusable applicator to the distal portion of the reusable applicator, and to reload the drive spring by moving the sensor carrier and the sharp part carrier from the distal portion of the reusable applicator to the proximal portion of the reusable applicator.

[0015] The method may further include approaching the sharps carrier from a proximal portion of the reusable applicator for releasing the sharps module. The actuator may include a button, and the method may include activating the button to approach and remove the first sharps module when the actuator is in a third position.

[0016] According to embodiments of the present disclosure, the reusable applicator may include a latch to hold the sensor carrier at the proximal portion of the reusable applicator as the sensor carrier moves from a second position to a third position. Attached Figure Description

[0017] By studying the accompanying drawings, details regarding the structure and operation of the subject matter described herein become readily apparent, in which the same reference numerals denote the same parts. The components in the drawings are not necessarily to scale; rather, the emphasis is on illustrating the principles of the subject matter. Furthermore, all illustrations are intended to convey concepts, where relative dimensions, shapes, and other detailed properties are shown schematically rather than literally or precisely.

[0018] Figure 1 It is a system overview of sensor applicators, reader devices, monitoring systems, networks, and remote systems.

[0019] Figure 2A This is a block diagram depicting an example implementation of a reader device.

[0020] Figure 2B and Figure 2C This is a block diagram depicting an example implementation of a sensor control device.

[0021] Figures 3A to 3G yes Figure 1 A progressive view of the assembly and application of an example implementation of a system, which includes a two-piece architecture.

[0022] Figure 4A This is a side view depicting an example embodiment of an applicator device connected to a cap.

[0023] Figure 4B This is a side perspective view depicting an example embodiment of the applicator device detached from the cap.

[0024] Figure 4C It is a perspective view depicting an example embodiment of the applicator device and the electronic device housing.

[0025] Figure 5 This is a near-side perspective view depicting an example embodiment of a tray with a connected sterilization lid.

[0026] Figure 6A This is a near-side perspective cross-sectional view depicting an example embodiment of a tray with a sensor delivery component.

[0027] Figure 6B It is a near-perspective view depicting the sensor delivery component.

[0028] Figure 7A This is a side view depicting an example implementation of the housing.

[0029] Figure 7B This is a perspective view depicting an example implementation of the housing's distal end.

[0030] Figure 7CThis is a side cross-sectional view depicting an example embodiment of the housing.

[0031] Figure 8A This is a side view depicting an example implementation of the sheath.

[0032] Figure 8B This is a perspective view depicting an example implementation of the proximal end of the sheath.

[0033] Figure 8C This is a close-up perspective view depicting an example implementation of the pawl latch of the sheath.

[0034] Figure 8D This is a side view depicting an example implementation of the features of the sheath.

[0035] Figure 8E This is an end view of an example implementation of the proximal end of the sheath.

[0036] Figure 8F This is a perspective view depicting an example implementation of a compressible distal end of the applicator.

[0037] Figures 8G to 8K It is a cross-sectional view depicting an example geometry of an implementation of a compressible distal end for an applicator.

[0038] Figure 8L This is a perspective view of an example implementation of an applicator with a compressible distal end.

[0039] Figure 8M This is a cross-sectional view depicting an example implementation of an applicator with a compressible distal end.

[0040] Figure 9A This is a near-side perspective view depicting an example implementation of the sensor carrier.

[0041] Figure 9B This is a remote perspective view depicting an example implementation of the sensor carrier.

[0042] Figure 10 This is a near-side perspective view of an example embodiment of a sharp component carrier.

[0043] Figure 11 This is a side cross-section depicting an example embodiment of a sharp component carrier.

[0044] Figures 12A to 12B These are top and bottom perspective views depicting an example implementation of the sensor module.

[0045] Figure 13A and Figure 13B These are perspective views and compressed views depicting an example implementation of the sensor connector.

[0046] Figure 14 It is a perspective view depicting an example implementation of the sensor.

[0047] Figure 15A and Figure 15B These are bottom and top perspective views of an example implementation of the sensor module component.

[0048] Figure 16A and Figure 16B This is a close-up partial view of an example implementation of the sensor module component.

[0049] Figure 17A It is a perspective view depicting an example implementation of the sharp component module.

[0050] Figure 17B This is a perspective view depicting another example implementation of the sharp element module.

[0051] Figure 17C and Figure 17D These are side and perspective views depicting another example implementation of the sharp element module.

[0052] Figure 17E This is a cross-sectional view depicting an example implementation of the applicator.

[0053] Figure 17F This is a flowchart depicting an example implementation method for a disinfection applicator assembly.

[0054] Figure 17G and Figure 17H These are photographs depicting an example implementation of a sharp-pointed component.

[0055] Figure 17I and Figure 17J It is a perspective view depicting an example implementation of the sharp component module.

[0056] Figure 18A This is a front view depicting an example implementation of an applicator based on the disclosed subject.

[0057] Figure 18B It describes Figure 18A Cross-sectional view of the various components of the applicator.

[0058] Figure 19A This is a cross-sectional view depicting an instance implementation of the applicator during the deployment phase.

[0059] Figure 19B and Figure 19C These are perspective views of example implementations of the sheath and sensor carrier, respectively.

[0060] Figure 19DThis is a cross-sectional view depicting an instance implementation of the applicator during the deployment phase.

[0061] Figure 19E and Figure 19F These are perspective views and close-up partial views of an example implementation of the sheath-sensor carrier assembly.

[0062] Figure 19G This is a cross-sectional view depicting an instance implementation of the applicator during the deployment phase.

[0063] Figure 19H and Figure 19I This is a close-up partial view of an example implementation of the sheath-sensor carrier assembly.

[0064] Figure 19J This is a cross-sectional view depicting an instance implementation of the applicator during the deployment phase.

[0065] Figure 19K and Figure 19L This is a close-up partial view of an example implementation of the sheath-sensor carrier assembly.

[0066] Figure 19M This is a front view depicting an instance implementation of the applicator during the deployment phase.

[0067] Figure 19N This is a cross-sectional view depicting an instance implementation of the applicator during the deployment phase.

[0068] Figure 19O This is a cross-sectional view depicting an instance implementation of the applicator during the deployment phase.

[0069] Figure 19P and Figure 19Q This is a perspective view of an example implementation of a disposable sensor carrier for a reusable electric applicator.

[0070] Figure 19R-1 and Figure 19R-2 This is a perspective view of an example implementation of a disposable sensor carrier and a reusable applicator base for a reusable electric applicator.

[0071] Figures 19S to 19U It is a cross-sectional view depicting an example implementation of a reusable electric applicator during various operational phases.

[0072] Figure 19V This is a top view of an example implementation of a reusable electric applicator with a reusable applicator base and a disposable sensor carrier.

[0073] Figure 19W and Figure 19X These are cross-sectional and perspective views of a reusable electric applicator in a ready-to-load state.

[0074] Figures 20A to 20G An example implementation of the applicator is described, wherein Figure 20A This is a front perspective view of this embodiment. Figure 20B This is a front view of this embodiment. Figure 20C This is a rear view of this embodiment. Figure 20D This is the left side view of this embodiment. Figure 20E This is the right-side view of this embodiment. Figure 20F This is a top view of this embodiment, and Figure 20G This is the bottom view of this embodiment.

[0075] Figures 21A to 21G Another example implementation of the applicator is shown, wherein Figure 21A This is a front perspective view of this embodiment. Figure 21B This is a front view of this embodiment. Figure 21C This is a rear view of this embodiment. Figure 21D This is the left side view of this embodiment. Figure 21E This is the right-side view of this embodiment. Figure 21F This is a top view of this embodiment, and Figure 21G This is the bottom view of this embodiment.

[0076] Figures 21H to 21I This is an enlarged cross-sectional side view of the interface between the applicator housing and the applicator cap in an example implementation of the applicator.

[0077] Figures 21J to 21K This is an enlarged cross-sectional side view of the applicator housing and applicator cap.

[0078] Figures 22A to 22G An example implementation of the sensor control device is described, wherein Figure 22A This is a front perspective view of this embodiment. Figure 22B This is a front view of this embodiment. Figure 22C This is a rear view of this embodiment. Figure 22D This is the left side view of this embodiment. Figure 22E This is the right-side view of this embodiment. Figure 22F This is a top view of this embodiment, and Figure 22G This is the bottom view of this embodiment.

[0079] Figures 23A to 23G Another example implementation of the sensor control device is described, wherein Figure 23A This is a front perspective view of this embodiment. Figure 23B This is a front view of this embodiment. Figure 23C This is a rear view of this embodiment. Figure 23D This is the left side view of this embodiment. Figure 23E This is the right-side view of this embodiment. Figure 23F This is a top view of this embodiment, and Figure 23G This is the bottom view of this embodiment.

[0080] Figures 24A to 24G Another example implementation of the sensor control device is described, wherein Figure 24A This is a front perspective view of this embodiment. Figure 24B This is a front view of this embodiment. Figure 24C This is a rear view of this embodiment. Figure 24D This is the left side view of this embodiment. Figure 24E This is the right-side view of this embodiment. Figure 24F This is a top view of this embodiment, and Figure 24G This is the bottom view of this embodiment.

[0081] Figures 25A to 25G Another example implementation of the sensor control device is described, wherein Figure 25A This is a front perspective view of this embodiment. Figure 25B This is a front view of this embodiment. Figure 25C This is a rear view of this embodiment. Figure 25D This is the left side view of this embodiment. Figure 25E This is the right-side view of this embodiment. Figure 25F This is a top view of this embodiment, and Figure 25G This is the bottom view of this embodiment.

[0082] Figures 26A to 26G Another example implementation of the sensor control device is described, wherein Figure 26A This is a front perspective view of this embodiment. Figure 26B This is a front view of this embodiment. Figure 26C This is a rear view of this embodiment. Figure 26D This is the left side view of this embodiment. Figure 26E This is the right-side view of this embodiment. Figure 26F This is a top view of this embodiment, and Figure 26G This is the bottom view of this embodiment.

[0083] Figures 27A to 27G Another example implementation of the sensor control device is described, wherein Figure 27A This is a front perspective view of this embodiment. Figure 27B This is a front view of this embodiment. Figure 27C This is a rear view of this embodiment. Figure 27D This is the left side view of this embodiment. Figure 27E This is the right-side view of this embodiment. Figure 27F This is a top view of this embodiment, and Figure 27G This is the bottom view of this embodiment.

[0084] Figures 28A to 28G Another example implementation of the sensor control device is described, wherein Figure 28A This is a front perspective view of this embodiment. Figure 28B This is a front view of this embodiment. Figure 28C This is a rear view of this embodiment. Figure 28D This is the left side view of this embodiment. Figure 28E This is the right-side view of this embodiment. Figure 28F This is a top view of this embodiment, and Figure 28G This is the bottom view of this embodiment.

[0085] Figures 29A to 29G Another example implementation of the sensor control device is described, wherein Figure 29A This is a front perspective view of this embodiment. Figure 29B This is a front view of this embodiment. Figure 29C This is a rear view of this embodiment. Figure 29D This is the left side view of this embodiment. Figure 29E This is the right-side view of this embodiment. Figure 29F This is a top view of this embodiment, and Figure 29G This is the bottom view of this embodiment.

[0086] Figures 30A to 30G An example implementation of the applicator is described, wherein Figure 30A This is a front perspective view of this embodiment. Figure 30B This is a front view of this embodiment. Figure 30C This is a rear view of this embodiment. Figure 30D This is the left side view of this embodiment. Figure 30E This is the right-side view of this embodiment. Figure 30F This is a top view of this embodiment, and Figure 30G This is the bottom view of this embodiment.

[0087] Figures 31A to 31G Another example implementation of the applicator is described, wherein Figure 31A This is a front perspective view of this embodiment. Figure 31B This is a front view of this embodiment. Figure 31C This is a rear view of this embodiment. Figure 31D This is the left side view of this embodiment. Figure 31E This is the right-side view of this embodiment. Figure 31F This is a top view of this embodiment, and Figure 31GThis is the bottom view of this embodiment.

[0088] Figures 32A to 32G An example implementation of the sensor control device is described, wherein Figure 32A This is a front perspective view of this embodiment. Figure 32B This is a front view of this embodiment. Figure 32C This is a rear view of this embodiment. Figure 32D This is the left side view of this embodiment. Figure 32E This is the right-side view of this embodiment. Figure 32F This is a top view of this embodiment, and Figure 32G This is the bottom view of this embodiment.

[0089] Figures 33A to 33G Another example implementation of the sensor control device is described, wherein Figure 33A This is a front perspective view of this embodiment. Figure 33B This is a front view of this embodiment. Figure 33C This is a rear view of this embodiment. Figure 33D This is the left side view of this embodiment. Figure 33E This is the right-side view of this embodiment. Figure 33F This is a top view of this embodiment, and Figure 33G This is the bottom view of this embodiment.

[0090] Figures 34A to 34G Another example implementation of the sensor control device is described, wherein Figure 34A This is a front perspective view of this embodiment. Figure 34B This is a front view of this embodiment. Figure 34C This is a rear view of this embodiment. Figure 34D This is the left side view of this embodiment. Figure 34E This is the right-side view of this embodiment. Figure 34F This is a top view of this embodiment, and Figure 34G This is the bottom view of this embodiment.

[0091] Figures 35A to 35G Another example implementation of the sensor control device is described, wherein Figure 35A This is a front perspective view of this embodiment. Figure 35B This is a front view of this embodiment. Figure 35C This is a rear view of this embodiment. Figure 35D This is the left side view of this embodiment. Figure 35E This is the right-side view of this embodiment. Figure 35F This is a top view of this embodiment, and Figure 35G This is the bottom view of this embodiment.

[0092] Figure 36It is a chart reflecting certain characteristics of exemplary embodiments of the materials and seals used in packaging. Detailed Implementation

[0093] Before describing this subject matter in detail, it should be understood that this disclosure is not limited to the specific embodiments described, as these embodiments can certainly vary. It should also be understood that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting, as the scope of this disclosure will be limited only by the appended claims.

[0094] As used herein and in the appended claims, the singular forms “a,” “an,” and “the” include plural references unless the context clearly indicates otherwise.

[0095] The publications discussed herein provide only their public disclosure prior to the filing date of this application. Nothing herein is to be construed as an admission that this disclosure is not entitled to precede such publication by any prior disclosure. Furthermore, the publication date provided may differ from the actual publication date, which may require independent verification.

[0096] Generally, embodiments of this disclosure include systems, apparatuses, and methods of use for analyte sensor insertion applicators used with in vivo analyte monitoring systems. The applicator may be provided to the user in a sterile package, wherein an electronic housing of a sensor control device is contained within the sterile package. According to some embodiments, a separate structure from the applicator, such as a container, may also be provided to the user as a sterile package containing a sensor module and a sharps module. The user may attach the sensor module to the electronic housing and may attach the sharps to the applicator using an assembly process that includes inserting the applicator into the container in a specified manner. In other embodiments, the applicator, sensor control device, sensor module, and sharps module may be provided in a single package. The applicator may be used to position the sensor control device on the human body, wherein the sensor comes into contact with the wearer's bodily fluids. The embodiments provided herein are improvements that reduce the likelihood of improper insertion or damage to the sensor or the induction of adverse physiological responses. Other improvements and advantages are also provided. Various constructions of these devices are described in detail by way of embodiments; these embodiments are merely examples.

[0097] Furthermore, many embodiments include in vivo analyte sensors structurally configured such that at least a portion of the sensor is located or can be located within the user's body to obtain information about at least one analyte in the body. However, it should be noted that the embodiments disclosed herein can be used with in vivo analyte monitoring systems incorporating in vitro capabilities, as well as with purely in vitro or ex vivo analyte monitoring systems, including completely non-invasive systems.

[0098] Furthermore, for each and every embodiment of the methods disclosed herein, systems and apparatuses capable of performing each of those embodiments are covered within the scope of this disclosure. For example, embodiments of sensor control devices are disclosed, and these devices may have one or more sensors, analyte monitoring circuitry (e.g., analog circuitry), memory (e.g., for storing instructions), power supply, communication circuitry, a trigger, a receiver, a processor, and / or a controller (e.g., for executing instructions), capable of performing any and all method steps or facilitating the implementation of any and all method steps. These sensor control device embodiments can be used and are capable of being used to implement those steps performed by the sensor control device from any and all methods described herein.

[0099] As described above, this document describes several embodiments of systems, apparatuses, and methods that provide improved assembly and use of analyte sensor insertion devices for use with in vivo analyte monitoring systems. In particular, several embodiments of this disclosure are designed to improve sensor insertion methods for in vivo analyte monitoring systems, specifically to minimize damage to the insertion site during the sensor insertion process. For example, some embodiments include an electrically powered sensor insertion mechanism configured to operate at a higher controlled speed relative to a manual insertion mechanism to reduce damage to the insertion site. In other embodiments, an applicator with a compressible distal end can stretch and flatten the skin surface at the insertion site, and thus reduce the likelihood of failed insertion due to skin bulge. In yet another embodiment, a sharp member with an offset tip, or a sharp member manufactured using plastic materials or die-casting processes, can also reduce damage to the insertion site. In summary, these embodiments increase the likelihood of successful sensor insertion and reduce the amount of damage at the insertion site, which are just a few advantages.

[0100] However, before describing these aspects of the implementation in detail, it is desirable to first describe examples of devices that may exist, for example, within an in vivo analyte monitoring system, and examples of their operation, all of which can be used in conjunction with the implementations described herein.

[0101] Various types of in vivo analyte monitoring systems exist. For example, a "continuous analyte monitoring" system (or "continuous glucose monitoring" system) can automatically and continuously transmit data from a sensor control device to a reader device according to a schedule, without prompting. As another example, a "flash analyte monitoring" system (or "flash glucose monitoring" system, or simply a "flash" system) can transmit data from a sensor control device in response to a reader device scanning or requesting data, for example, using near field communication (NFC) or radio frequency identification (RFID) protocols. In vivo analyte monitoring systems can also operate without the need for manual finger-prick calibration.

[0102] In vivo analyte monitoring systems can be distinguished from "ex vivo" systems, which contact biological samples outside the body (or "extracorporeal") and typically include an instrumentation device with a port for receiving analyte test strips carrying the user's bodily fluids, which can be analyzed to determine the user's blood glucose levels.

[0103] An in vivo monitoring system may include a sensor that, when positioned within the body, comes into contact with the user's bodily fluids and senses the levels of analytes contained therein. The sensor may be part of a sensor control unit located on the user's body and including electronics and a power source that enable and control the sensing of the analytes. The sensor control unit and variations thereof may also be referred to as a "sensor control unit," a "body electronics" device or unit, a "body" device or unit, or a "sensor data communication" device or unit, to name just a few examples.

[0104] In vivo monitoring systems may also include means for receiving sensed analyte data from sensor control devices and processing and / or displaying the sensed analyte data to a user in any quantity or form. Such means and variations thereof may be referred to as a “handheld reader device,” “reader device” (or simply “reader”), “handheld electronics” (or simply “handheld”), “portable data processing” device or unit, “data receiver,” “receiver” device or unit (or simply “receiver”), or “remote” device or unit, to name just a few. Other devices, such as personal computers, have also been used with or incorporated into in vivo and in vitro monitoring systems.

[0105] Example Implementation of In Vivo Analyte Monitoring System

[0106] Figure 1This is a conceptual diagram depicting an example implementation of an analyte monitoring system 100, which includes a sensor applicator 150, a sensor control device 102, and a reader device 120. Here, the sensor applicator 150 is used to deliver the sensor control device 102 to a monitoring location on the user's skin, where the sensor 104 is held in place for a period of time by an adhesive patch 105. The sensor control device 102... Figure 2B and Figure 2C Further description is provided below, and the reader device 120 can be communicated via communication path 140 using wired or wireless technologies. Example wireless protocols include Bluetooth, Bluetooth Low Energy (BLE, BTLE, Bluetooth Smart, etc.), Near Field Communication (NFC), etc. Users can use screen 122 and input 121 to monitor applications installed in the memory on the reader device 120, and can use power port 123 to recharge the device battery. Although only one reader device 120 is shown, the sensor control device 102 can communicate with multiple reader devices 120. Each reader device 120 can communicate with each other and share data. Further details about the reader device 120 are referenced below. Figure 2A The reader device 120 can communicate with the local computer system 170 via communication path 141 using wired or wireless communication protocols. The local computer system 170 may include one or more of a laptop computer, desktop computer, tablet computer, smartphone, set-top box, video game console, or other computing device, and the wireless communication may include any of a variety of applicable wireless networking protocols, including Bluetooth, Bluetooth Low Energy (BTLE), Wi-Fi, etc. The local computer system 170 may communicate with the network 190 via communication path 143, similar to how the reader device 120 may communicate with the network 190 via communication path 142 using the wired or wireless communication protocols described above. The network 190 may be any of a variety of networks, such as private and public networks, local area networks, or wide area networks. The trusted computer system 180 may include a server and may provide authentication services and secure data storage, and may communicate with the network 190 via communication path 144 using wired or wireless technologies.

[0107] Example implementation of the reader device

[0108] Figure 2AThis is a block diagram depicting an exemplary embodiment of a reader device 120 configured as a smartphone. Here, the reader device 120 may include a display 122, an input unit 121, and a processing core 206, which includes a communication processor 222 coupled to a memory 223 and an application processor 224 coupled to a memory 225. It may also include a separate memory 230, an RF transceiver 228 with an antenna 229, and a power supply 226 with a power management module 238. Furthermore, the reader device 120 may also include a multi-function transceiver 232 capable of communicating via Wi-Fi, NFC, Bluetooth, BTLE, and GPS using an antenna 234. As those skilled in the art will understand, these components are electrically and communicatively connected in one manner to form a functional device.

[0109] Example implementation of sensor control device

[0110] Figure 2B and Figure 2C This is a block diagram depicting an exemplary embodiment of a sensor control device 102 having an analyte sensor 104 and sensor electronics 160 (including analyte monitoring circuitry), the sensor electronics having substantial processing capabilities for presenting final result data suitable for display to a user. Figure 2B The image depicts a single semiconductor chip 161, which may be a custom application-specific integrated circuit (ASIC). Within the ASIC 161 are shown certain high-level functional units, including an analog front-end (AFE) 162, power management (or control) circuitry 164, a processor 166, and communication circuitry 168 (which may be implemented as a trigger, receiver, transceiver, passive circuitry, or other means according to a communication protocol). In this embodiment, both the AFE 162 and the processor 166 serve as analyte monitoring circuitry; however, in other embodiments, either circuitry may perform analyte monitoring functions. The processor 166 may include one or more processors, microprocessors, controllers, and / or microcontrollers, each of which may be a discrete chip or distributed among multiple different chips (and portions thereof).

[0111] Memory 163 is also included within ASIC 161 and can be shared by various functional units present within ASIC 161, or distributed among two or more of them. Memory 163 can also be a separate chip. Memory 163 can be volatile and / or non-volatile memory. In this embodiment, ASIC 161 is connected to power supply 172, which can be a button battery, etc. AFE 162 is connected to in vivo analyte sensor 104, receives measurement data from it, and outputs the data in digital form to processor 166, which then processes the data to obtain final results such as glucose discrete values ​​and trend values. This data can then be provided to communication circuitry 168 for transmission via antenna 171 to reader device 120 (not shown), where, for example, a resident software application requires minimal further processing to display the data.

[0112] Figure 2C Similar to Figure 2B However, alternatively, two discrete semiconductor chips 162 and 174 may be included, which may be packaged together or separately. Here, AFE 162 resides 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 that may be isolated or distributed within it. In one example implementation, AFE 162 is combined with power management circuitry 164 and processor 166 on a single chip, while communication circuitry 168 is on a separate chip. In another example implementation, AFE 162 and communication circuitry 168 are both on a single chip, and processor 166 and power management circuitry 164 are on another chip. It should be noted that other chip combinations are also possible, including three or more chips, each responsible for the individual functions described, or sharing one or more functions to achieve fail-safe redundancy.

[0113] Example implementation of the assembly process for a sensor control device

[0114] According to some implementations, the components of the sensor control device 102 may be obtained by the user in multiple packages, and the user is required to perform final assembly before delivery to the appropriate user location. Figures 3A to 3E An example embodiment depicts the assembly process of the sensor control device 102 performed by a user, including preparing individual components before connecting them to prepare the sensor for delivery. In other embodiments, see, for example, reference to... Figures 17B to 17F In the embodiments described, the components of the sensor control device 102 and the applicator 150 can be obtained by the user in a single package. Figures 3F to 3GAn example implementation is described, in which the sensor control device 102 is delivered to the appropriate user location by selecting an appropriate delivery location and applying the device 102 to that location.

[0115] Figure 3A A sensor container or tray 810 with a removable lid 812 is depicted. The user prepares the sensor tray 810 by removing the lid 812, which acts as a sterile barrier to protect the internal contents of the sensor tray 810 and otherwise maintains a sterile internal environment. Removing the lid 812 exposes a platform 808 positioned within the sensor tray 810, and a plug assembly 207 (partially visible) is arranged within the platform 808 and otherwise strategically embedded within it. The plug assembly 207 includes a sensor module (not shown) and a sharps module (not shown). The sensor module carries a sensor 104 (…). Figure 1 The sharp element module carries an associated sharp element for applying pressure to the sensor control device 102. Figure 1 During this process, it helps to deliver sensor 104 percutaneously under the user's skin.

[0116] Figure 3B A sensor applicator 150 and a user preparation of the sensor applicator 150 for final assembly are depicted. The sensor applicator 150 includes a housing 702 sealed at one end with an applicator cap 708. In some embodiments, for example, an O-ring or another type of sealing gasket may seal the interface between the housing 702 and the applicator cap 708. In at least one embodiment, the O-ring or sealing gasket may be molded onto one of the housing 702 and the applicator cap 708. The applicator cap 708 provides a barrier to protect the internal contents of the sensor applicator 150. In particular, the sensor applicator 150 includes an electronics housing (not shown) that holds the sensor control device 102 ( Figure 1 The electrical components of the sensor applicator 150 may or may not be maintained in a sterile environment for the electrical components. Preparation of the sensor applicator 150 includes detaching the housing 702 from the applicator cap 708, which can be achieved by unscrewing the applicator cap from the housing 702. The applicator cap 708 can then be discarded or otherwise placed aside.

[0117] Figure 3C The image depicts a user inserting a sensor applicator 150 into a sensor tray 810. The sensor applicator 150 includes a sheath 704 configured to be received by a platform 808 to temporarily unlock the sheath 704 relative to a housing 702, and also to temporarily unlock the platform 808 relative to the sensor tray 810. Pushing the housing 702 into the sensor tray 810 results in a plug assembly 207 disposed within the sensor tray 810. Figure 3A(Including the sensor and sharp part module) is connected to the electronic device housing arranged within the sensor applicator 150.

[0118] exist Figure 3D In this process, the user removes the sensor applicator 150 from the sensor tray 810 by retracting the housing 702 proximally relative to the sensor tray 810.

[0119] Figure 3E The sensor tray 810 is depicted. Figure 3A and Figure 3C The bottom or interior of the sensor applicator 150 is removed after removal. The sensor applicator 150 is removed from the sensor tray 810, where the sensor control unit 102 is fully assembled and positioned for delivery to the target monitoring location. As shown, a sharp member 2502 extends from the bottom of the sensor control unit 102 and carries a portion of the sensor 104 within its hollow or recessed portion. The sharp member 2502 is configured to penetrate the user's skin, thereby placing the sensor 104 into contact with bodily fluids.

[0120] Figure 3F and Figure 3G An example of sensor control device 102 being transported to target monitoring location 221 (e.g., the back of a user's arm) is depicted. Figure 3F The illustration shows a user advancing the sensor applicator 150 toward the target monitoring location 221. Upon contact with the skin at the target monitoring location 221, the sheath 704 collapses into the housing 702, allowing the sensor control device 102 ( Figure 3E and Figure 3G ) Advance to engage with the skin. In the sharp part 2502 ( Figure 3E With the help of sensor 104, Figure 3E It was percutaneously advanced into the patient's skin at the target monitoring location 221.

[0121] Figure 3G The image shows a user retracting the sensor applicator 150 from the target monitoring location 221, with the sensor control unit 102 successfully attached to the user's skin. An adhesive patch 105 is applied to the bottom of the sensor control unit 102. Figure 1 ) adheres to the skin to secure the sensor control device 102 in place. When the housing 702 is fully advanced at the target monitoring position 221, the sharp part 2502 ( Figure 3E ) automatically retracts, while sensor 104 ( Figure 3E (Leave it in the appropriate position to measure the analyte level.)

[0122] According to some implementation methods, such as regarding Figures 3A to 3GCompared to prior art systems, System 100, as described elsewhere herein, offers a reduced or eliminated chance of accidental breakage, permanent deformation, or improper assembly of the applicator components. Because the applicator housing 702 directly engages the platform 808 upon unlocking of the sleeve 704, rather than indirectly via the sleeve 704, the relative angle between the sleeve 704 and the housing 702 will not result in breakage or permanent deformation of the arm or other components. The likelihood of relatively high forces during assembly (e.g., in conventional devices) is reduced, which in turn lowers the chance of unsuccessful user assembly. Further details regarding embodiments of the applicator, its components, and variations thereof are described in U.S. Patent Publications 2013 / 0150691, 2016 / 0331283, and 2018 / 0235520, all of which are incorporated herein by reference in their entirety and for all purposes.

[0123] Example implementation of sensor applicator device

[0124] Figure 4A This is a side view depicting an example embodiment of the applicator device 150 coupled to the nut 708. This is one example of how the applicator 150 is transported to and received by the user before the user assembles the sensor. In other embodiments, the applicator 150 may be transported to the user along with the sensor and sharp parts contained therein. Figure 4B It is a side perspective view depicting the applicator 150 and cap 708 after disengagement. Figure 4C This is a perspective view depicting an example embodiment of the applicator device 150 when the cap 708 is in place, with the electronic device housing 706 and adhesive patch 105 removed from their positions within the sensor carrier 710 of the sheath 704.

[0125] Example implementation of tray and sensor module components

[0126] Figure 5 It is a near-side perspective view depicting an example embodiment of a tray 810 having a sterilization cap 812 removably attached thereto, which in some embodiments may show how the package is transported to and received by the user prior to assembly.

[0127] Figure 6A This is a near-perspective cross-sectional view depicting a sensor delivery component within a tray 810 according to some embodiments. A platform 808 is slidably coupled within the tray 810. A desiccant 502 is stationary relative to the tray 810. A sensor module 504 is mounted within the tray 810.

[0128] Figure 6BThis is a near-perspective view depicting an exemplary embodiment of the sensor module 504 in more detail. Here, the retaining arm extension 1834 of the platform 808 releasably secures the sensor module 504 in place. The module 2200 is coupled to the connector 2300, the pointed piece module 2500, and the sensor (not shown), such that it can be removed as part of the sensor module 504 during assembly.

[0129] Example implementation of the applicator housing

[0130] Figure 7A This is a side view depicting an exemplary embodiment of an applicator housing 702 that may include an internal cavity with a support structure for applicator function. A user can push the housing 702 in a distal direction to activate the applicator assembly process, which also results in the delivery of the sensor control device 102, after which the cavity of the housing 702 can be used as a container for sharp objects. In the exemplary embodiment, various features are shown, including a housing orientation feature 1302 for orienting the device during assembly and use. A pry ring groove 1304 may be a recess located around the outer circumference of the housing 702, distal to the pry ring protector 1314 and proximal to the pry ring retainer 1306. The pry ring groove 1304 retains the pry ring, allowing the user to identify whether the device has been pried or otherwise used. The housing thread 1310 secures the housing 702 to the cap 708 by aligning with the complementary cap thread and rotating in a clockwise or counterclockwise direction. Figure 4A and Figure 4B The complementary threads on the cap 708. The side grip area 1316 of the housing 702 provides an outer surface position where the user can grip the housing 702 for use. The grip tab 1318 is a ridge that slightly protrudes relative to the side grip area 1316, which helps to easily remove the housing 702 from the cap 708. The shark tooth 1320 may be a raised segment with a flat side located on a clockwise edge to cut the tamper ring (not shown) and hold the tamper ring in place after the user has unscrewed the cap 708 and the housing 702. In the exemplary embodiment, four shark teeth 1320 are used, but more or fewer shark teeth may be used as needed.

[0131] Figure 7BThis is a perspective view depicting the distal end of housing 702. Here, three housing guide structures (or “guide ribs”) 1321 are positioned at a 120-degree angle relative to each other and at a 60-degree angle relative to locking structures (or “locking ribs”) 1340, three of which are also positioned at a 120-degree angle relative to each other. Other symmetrical or asymmetrical angular orientations, and any number or number of structures 1321 and 1340, may be used. Here, each structure 1321 and 1340 is configured as a planar rib, but other shapes may be used. Each guide rib 1321 includes a surface that can be aligned with the sheath 704 (e.g., regarding...). Figure 8A The described guide rail 1418 passes over the guide edge (also referred to as the "sheath rail") 1326. The insertion hard stop 1322 may be a flat, distally facing surface of the housing guide rib 1321 located near the proximal end of the housing guide rib 1321. The insertion hard stop 1322 provides a surface for abutting the sheath 704 during use. Figure 8B The sensor carrier travel limiter surface 1420 is used to prevent further movement of the sensor carrier travel limiter surface 1420 in the proximal direction. During assembly, the carrier interface post 1327 passes through the hole 1510 of the sensor carrier 710. Figure 9A The sensor carrier interface 1328 may be a circular, distally facing surface of the housing guide rib 1321 that is connected to the sensor carrier 710.

[0132] Figure 7C This depicts a side cross-section of an exemplary embodiment of the housing. In the exemplary embodiment, the side cross-sectional profiles of the housing guide rib 1321 and locking rib 1340 are shown. The locking rib 1340 includes a sheath snap-in feature 1330 near the distal end of the locking rib 1340, which flares outwardly distally from the central axis 1346 of the housing 702. As the sheath 704 moves toward the proximal end of the housing 702, each sheath snap-in feature 1330 causes... Figure 8C The pawl latch 1402 of the sheath 704 shown has its circular portion 1404 bent inward toward the central axis 1346. Once past the distal point of the sheath latch introduction feature 1330, the pawl latch 1402 of the sheath 704 locks in the proper position in the locking groove 1332. Thus, the pawl latch 1402 cannot be easily moved in the distal direction due to its surface having a plane approximately perpendicular to the central axis 1346, such as... Figure 8C The pawl latch flat portion 1406 is shown in the diagram.

[0133] As the housing 702 moves further proximally toward the skin surface, and as the sheath 704 advances toward the distal end of the housing 702, the pawl latch 1402 translates into the unlocking recess 1334, and the applicator 150 is in a "standby" position, ready for use. When the user applies further force to the proximal end of the housing 702, while the sheath 704 presses against the skin, the pawl latch 1402 passes over the firing pawl 1344. This initiates a firing sequence by releasing the energy stored in the deflected pawl latch 1402, which travels proximally toward the sheath stop ramp 1338 relative to the skin surface. This sheath stop ramp is slightly outwardly flared relative to the central axis 1346 and slows the movement of the sheath 704 during the firing sequence. After unlocking groove 1334, the next groove encountered by pawl latch 1402 is final locking groove 1336, into which pawl latch 1402 enters at the end of a user-performed stroke or push sequence. Final locking groove 1336 may be a proximal-facing surface perpendicular to the central axis 1346, which engages the pawl latch flat portion 1406 after pawl latch 1402 has passed, and prevents reuse of the device by securely holding the sheath 704 in place relative to housing 702. Insertion hard stop 1322 of housing guide rib 1321 prevents the sheath 704 from advancing proximally relative to housing 702 by engaging sensor carrier stroke limiter surface 1420.

[0134] Example implementation of the applicator sheath

[0135] Figure 8A and Figure 8B The figures depict a side view and a perspective view of an exemplary embodiment of the sheath 704. In this exemplary embodiment, the sheath 704 can place the sensor control device 102 above the user's skin surface before application. The sheath 704 may also include features to help hold the sharp member in place for proper sensor application, determine the force required to apply the sensor, and guide the sheath 704 relative to the housing 702 during application. A pawl latch 1402 is located near the proximal end of the sheath 704, as shown below. Figure 8C Further description. The sheath 704 may have a generally cylindrical cross-section, having a first radius in the proximal segment (closer to the top of the figure) that is shorter than a second radius in the distal segment (closer to the bottom of the figure). A plurality of pawl gaps 1410 are also shown, three in the exemplary embodiment. The sheath 704 may include one or more pawl gaps 1410, each pawl gap being a slit with space for the sheath snap-in feature 1330 to enter distally until the distal surface of the locking rib 1340 contacts the proximal surface of the pawl gap 1410.

[0136] Guide rail 1418 is disposed between the sensor carrier travel limiter surface 1420 at the proximal end of the sheath 704 and the cutout surrounding the locking arm 1412. Each guide rail 1418 may be a channel between two ridges, wherein the guide edge 1326 of the housing guide rib 1321 may slide distally relative to the sheath 704.

[0137] Locking arms 1412 are disposed near the distal end of the sheath 704 and may include an attached distal end and a free proximal end, the free proximal end of which may include a locking arm interface 1416. When the locking arm interface 1416 of the locking arm 1412 engages the locking interface 1502 of the sensor carrier 710, the locking arm 1412 can lock the sensor carrier 710 to the sheath 704. Locking arm reinforcing ribs 1414 may be disposed near the center of each locking arm 1412 and may serve as additional reinforcement points for weak points of each locking arm 1412 to prevent excessive bending or breakage of the locking arm 1412.

[0138] A pawl latch reinforcement feature 1422 may be positioned along the distal section of the pawl latch 1402 and may provide reinforcement for the pawl latch 1402. An alignment notch 1424 may be a cutout near the distal end of the sheath 704, providing an opening for alignment of the user with the sheath orientation feature of the platform 808. A reinforcing rib 1426 may include a support rib, which is triangular in shape here, providing support for the pawl base 1436. A housing guide clearance 1428 may be a cutout for sliding of the distal surface of the housing guide rib 1321 during use.

[0139] Figure 8C This is a close-up perspective view depicting an exemplary embodiment of the pawl latch 1402 of the housing 704. The pawl latch 1402 may include a pawl latch bridge 1408 located near or near its proximal end. The pawl latch 1402 may also include a pawl latch flat portion 1406 located on the distal side of the pawl latch bridge 1408. The outer surface of the pawl latch bridge 1408 may include a pawl latch circular portion 1404, which is a circular surface that allows the pawl latch bridge 1408 to move more easily across the inner surface of the housing 702, such as the locking rib 1340.

[0140] Figure 8D This is a side view depicting an exemplary embodiment of the sheath 704. Here, the alignment notch 1424 is relatively close to the pawl clearance 1410. The pawl clearance 1410 is located at a relatively proximal position on the distal portion of the sheath 704.

[0141] Figure 8E This is an end view depicting an exemplary embodiment of the proximal end of the sheath 704. Here, the rear wall 1446 of the guide rail provides a channel for slidably engaging with the housing guide rib 1321 of the housing 702. The sheath rotation limiter 1448 may be a notch that reduces or prevents rotation of the sheath 704.

[0142] Figure 8F This is a perspective view depicting an exemplary embodiment of a compressible distal end 1450, which can be attached to and / or detached from the sheath 704 of the applicator 150. In a general sense, the embodiments described herein operate by flattening and stretching the skin surface at a predetermined site for sensor insertion. Furthermore, the embodiments described herein can also be used in other medical applications, such as percutaneous drug delivery, needle injection, wound closure sutures, device implantation, application of adhesive surfaces to the skin, and other similar applications.

[0143] From this background, those skilled in the art will understand that, from a biomechanical point of view, skin is a highly anisotropic tissue and varies considerably between individuals. This affects the extent to which communication can be performed between underlying tissues and the surrounding environment, for example, regarding drug diffusion rates, the ability of a sharp object to penetrate the skin, or sensors inserted into the body at a point of insertion guided by a sharp object.

[0144] In particular, the embodiments described herein relate to improving the aforementioned applications by reducing the anisotropic properties of the skin in a predetermined area through flattening and stretching. Smoothing the skin (e.g., flattening to remove wrinkles) before engaging with a similar shape (e.g., a flat, round adhesive pad for a sensor control unit) produces a more consistent surface area contact interface. More consistent contact (or drug dosing) can be achieved when the surface profile of the skin approximates the profile specifications of the device's designed surface (or, for example, the designed contact area for drug delivery). This can also be advantageous for abrasive adhesives that produce continuous adhesive-skin contact in a predetermined area without wrinkles. Other advantages may include (1) increased abrasion duration for devices that functionally rely on skin adhesion, and (2) a more predictable skin contact area, which will improve drug delivery in transdermal drug / drug delivery.

[0145] In addition, combining skin flattening (e.g., due to tissue compression) with stretching can reduce the viscoelastic properties of the skin and increase its rigidity, which in turn can increase the success rate of sensor placement and functionality associated with sharp parts.

[0146] Regarding sensor insertion, puncture wounds can contribute to early signal distortion (ESA) in the sensor, which can be mitigated when the skin has been flattened and stretched rigidly. Some known methods for minimizing puncture wounds include (1) reducing the size of the guide or (2) limiting the length of the needle inserted into the body. However, these known methods may reduce insertion success rates due to skin compliance. For example, when the tip of a sharp object contacts the skin, the skin deforms inward into the body before the tip penetrates the skin; this phenomenon is also known as “skin bulge.” If the sharp object is not rigid enough due to a small cross-sectional area and / or insufficient length, it may not produce a sufficiently large or desired insertion point for the sensor to penetrate the skin and be properly positioned due to deflection. The degree of skin bulge can vary between and within objects, meaning that the distance between the sharp object and the skin surface can vary between insertion cases. Reducing this variation by stretching and flattening the skin allows for more precise and consistent sensor insertion mechanisms.

[0147] See Figure 8F The perspective view depicts an example embodiment of a compressible distal end 1450 of the applicator 150. According to some embodiments, the compressible distal end 1450 may be made of an elastomeric material. In other embodiments, the compressible distal end 1450 may be made of metal, plastic, composite material legs, or springs, or combinations thereof.

[0148] In some embodiments, the compressible distal end 1450 is detachable from the applicator 150 and can be used with a variety of other similar or dissimilar applicators or medical devices. In other embodiments, the compressible distal end 1450 may be manufactured as part of the sheath 704. In still other embodiments, the compressible distal end 1450 may be attached to other portions of the applicator 150 (e.g., a sensor carrier), or alternatively, may be used as a separate, stand-alone device. Furthermore, although... Figure 8F and Figure 8G The compressible distal end 1450 shown has a continuous loop geometry, but other configurations can also be used. For example, Figures 8H to 8K It is a cross-sectional view depicting various instances of compressible distal ends, which have octagonal geometry 1451 ( Figure 8H ), star-shaped geometry 1452 ( Figure 8I ), Non-continuous ring geometry 1453 ( Figure 8J ) and discontinuous rectangular geometry ( Figure 8K ).about Figure 8J and Figure 8K The compressible distal end, having a discontinuous geometry, will have multiple points or spans to contact a predetermined area of ​​the skin. Those skilled in the art will recognize that other geometries are possible and are fully within the scope of this disclosure.

[0149] Figure 8L and Figure 8M These are perspective and cross-sectional views depicting the applicator 150 with a compressible distal end 1450, respectively. Figure 8L and Figure 8M As shown, the applicator 150 may also include an applicator housing 702, a sheath 704 to which a compressible distal end 1450 is attached, a sharp part 2502, and a sensor 104.

[0150] According to some embodiments, in operation, the compressible distal end 1450 of the applicator is first positioned on the skin surface of the object. Then, the object applies a force to the applicator, for example, in a distal direction, which causes the compressible distal end 1450 to stretch and flatten the underlying portion of the skin surface. In some embodiments, for example, the compressible distal end 1450 may be made of an elastomeric material and biased in a radially inward direction. In other embodiments, the compressible distal end 1450 may be biased in a radially outward direction. The force on the applicator can cause the edge portion of the compressible distal end 1450 in contact with the skin surface to shift in a radially outward direction, thereby generating a radially outward force on the portion of the skin surface beneath the applicator and causing the skin surface to be stretched and flattened.

[0151] Furthermore, according to some embodiments, applying force to the applicator also causes a medical device, such as a sensor control unit, to advance from a first position within the applicator to a second position adjacent to the skin surface. According to one aspect of some embodiments, the compressible distal end 1450 may be unloaded in the first position (e.g., before force is applied to the applicator) and loaded in the second position (e.g., after force is applied to the applicator). The medical device is then applied to a stretched and flattened portion of the skin surface located beneath the compressible distal end 1450. According to some embodiments, application of the medical device may include placing the adhesive surface 105 of the sensor control unit 102 on the skin surface and / or positioning at least a portion of the analyte sensor below the skin surface. The analyte sensor may be an in vivo analyte sensor configured to measure the level of an analyte in the body fluids of the subject. In other embodiments, application of the medical device may include placing a drug-loaded patch on the skin surface. Those skilled in the art will understand that the compressible distal end can be used with any of the above-described medical applications and is not intended to be limited to use in applicators for analyte sensor insertion.

[0152] Example implementation of sensor carrier

[0153] Figure 9AThis is a proximal perspective view depicting an exemplary embodiment of a sensor carrier 710 that holds sensor electronics within an applicator 150. It also holds a sharps carrier 1102 with a sharps module 2500. In this exemplary embodiment, the sensor carrier 710 generally has a hollow, round, flattened cylindrical shape and may include one or more deflectable sharps carrier locking arms 1524 (e.g., three) extending proximally from a proximal surface surrounding a centrally located spring alignment ridge 1516 to maintain the alignment of the spring 1104. Each locking arm 1524 has a pawl or retaining feature 1526 located at or near its proximal end. An impact lock 1534 may be a tab extending outwardly on the outer circumference of the sensor carrier 710 and may lock the sensor carrier 710 before firing for added security. A rotation limiter 1506 may be a relatively short protrusion extending proximally on the proximal surface of the sensor carrier 710, which limits rotation of the carrier 710. See below for reference. Figure 10 and Figure 11 As described, the sharp object carrier locking arm 1524 can be connected to the sharp object carrier 1102.

[0154] Figure 9B This is a distal perspective view of the sensor carrier 710. Here, one or more sensor electronics retaining spring arms 1518 (e.g., three) are generally biased toward the position shown and include a pawl 1519 that can pass through the distal surface of the electronics housing 706 of the device 102 when received within a recess or cavity 1521. In some embodiments, after the sensor control device 102 has been adhered to the skin with the applicator 150, the user pulls the applicator 150 in a proximal direction, i.e., away from the skin. The adhesive force holds the sensor control device 102 to the skin and overcomes the lateral force exerted by the spring arms 1518. As a result, the spring arms 1518 deflect radially outward and disengage the pawl 1519 from the sensor control device 102, thereby releasing the sensor control device 102 from the applicator 150.

[0155] Example implementation of sharp component carrier

[0156] Figure 10 and Figure 11 These are a near-side perspective view and a side cross-sectional view depicting an exemplary embodiment of the sharp-piece carrier 1102. The sharp-piece carrier 1102 can grasp the sharp-piece module 2500 and hold it within the applicator 150. Near the distal end of the sharp-piece carrier 1102, there may be an anti-rotation slot 1608, which prevents the sharp-piece carrier 1102 from rotating when it is located in the central region of the sharp-piece carrier locking arm 1524 (e.g., Figure 9A(As shown). The anti-rotation slot 1608 may be located between the segments of the chamfered surface 1610 of the chamfered component carrier base, which ensures that the chamfered component carrier 1102 is fully retracted through the sheath 704 when the chamfered component carrier 1102 is retracted at the end of the deployment process.

[0157] like Figure 11 As shown, the sharps retaining arms 1618 may be located within the sharps carrier 1102 about a central axis, and may include sharps retaining clamps 1620 at the distal end of each arm 1618. The sharps retaining clamps 1620 may have a proximal surface that is nearly perpendicular to the central axis and may abut against the distal-facing surface of the sharps bushing 2516. Figure 17A ).

[0158] Example implementation of sensor module

[0159] Figure 12A and Figure 12B These are top and bottom perspective views, respectively, depicting an exemplary implementation of sensor module 504. Module 504 can hold connector 2300 ( Figure 13A and Figure 13B ) and sensor 104 ( Figure 14 Module 504 can be securely coupled to the electronics housing 706. One or more deflectable arms or module latches 2202 can snap into corresponding features 2010 of the housing 706. A sharp-point slot 2208 provides a position for the sharp-point tip 2502 to pass through and for the sharp-point shaft 2504 to temporarily reside. A sensor ledge 2212 defines the sensor position in the horizontal plane, preventing the sensor from lifting the connector 2300 away from the post and keeping the sensor 104 parallel to the plane of the connector seal. It also defines the sensor bending geometry and minimum bending radius. It limits the sensor's travel in the vertical direction and prevents the ledge from protruding above the electronics housing surface, and defines the length of the sensor tail below the patch surface. A sensor wall 2216 constrains the sensor and defines the sensor bending geometry and minimum bending radius.

[0160] Figure 13A and Figure 13BThese are perspective views depicting an exemplary embodiment of connector 2300 in both open and closed states. Connector 2300 may be made of silicone rubber and encapsulates a compliant impregnated carbon polymer module, which serves as a conductive contact 2302 between sensor 104 and circuit contacts for electronics within housing 706. The connector may also serve as a moisture barrier for sensor 104 when assembled in a compressed state after transfer from container to applicator and after application to user skin. Multiple sealing surfaces 2304 provide a waterproof seal for the electrical contacts and sensor contacts. One or more hinges 2208 connect two distal and proximal portions of connector 2300.

[0161] Figure 14 This is a perspective view depicting an example implementation of sensor 104. Neck 2406 may be an area allowing the sensor to fold, for example, at ninety degrees. A membrane on tail 2408 may cover the active analyte sensing element of sensor 104. Tail 2408 may be the portion of sensor 104 that resides under the user's skin after insertion. Mark 2404 may include contacts and sealing surfaces. Bias tower 2412 may be a tab that biases tail 2408 into a sharp-piece slot 2208. Bias pivot 2414 may be a branch of bias tower 2412 that contacts the inner surface of the needle to bias tail into the slot. Bias adjuster 2416 may reduce localized bending of the tail connection and prevent damage to the sensor trace. Contact 2418 electrically connects the active portion of the sensor to connector 2300. Maintenance loop 2420 may translate the electrical path ninety degrees from the vertical direction and engage with sensor stand 2212. Figure 12B ).

[0162] Figure 15A and Figure 15B These are bottom and top perspective views, respectively, depicting an exemplary embodiment of a sensor module assembly including sensor module 504, connector 2300, and sensor 104. According to one aspect of the above embodiment, during or after insertion, sensor 104 may be subjected to an axial force that pushes sensor 104 upward in the proximal direction and into sensor module 105, such as... Figure 15A The force F1 is shown. According to some embodiments, this results in an unfavorable force F2 being applied to the neck 2406 of the sensor 104, and thus an unfavorable force F3 being transferred to the maintenance loop 2420 of the sensor 104. In some embodiments, for example, the axial force F1 may occur due to the sensor insertion mechanism (where the sensor is designed to push itself through the tissue during insertion), the sharp retraction mechanism, or due to physiological responses generated by the tissue surrounding the sensor 104 (e.g., after insertion).

[0163] Figure 16A and Figure 16B This is a close-up partial view of an example implementation of a sensor module assembly with certain axial reinforcement features. In a general sense, the embodiments described herein relate to mitigating the effects of axial forces on the sensor caused by insertion and / or retraction mechanisms or by physiological responses to the sensor in the body. (As can be seen...) Figure 16A and Figure 16B As seen in the diagram, according to one aspect of the implementation, sensor 3104 includes a proximal portion of hook feature 3106 having a fastening feature 3506 configured to engage sensor module 3504. In some embodiments, sensor module 3504 may also include a gap region 3508 to allow the distal portion of sensor 3104 to swing rearward during assembly, thereby allowing the assembly of hook feature 3106 of sensor 3104 to be above and into the fastening member 3506 of sensor module 3504.

[0164] According to another aspect of the embodiment, the hook feature 3106 and the fastener feature 3506 operate in the following manner. The sensor 3104 includes a proximal sensor portion coupled to the sensor module 3504 as described above, and a distal sensor portion positioned below the skin surface in contact with bodily fluids. (As in...) Figure 16A and 16B As seen in the diagram, the proximal sensor portion includes a hook feature 3106 adjacent to the fastening feature 3506 of the sensor module 3504. During or after sensor insertion, one or more forces are applied in the proximal direction along the longitudinal axis of the sensor 3104. In response to these forces, the hook feature 3106 engages the fastening feature 3506 to prevent the sensor 3104 from shifting in the proximal direction along the longitudinal axis.

[0165] According to another aspect of the embodiment, the sensor 3104 can be assembled with the sensor module 3504 in the following manner. The sensor 3104 is loaded into the sensor module 3504 by shifting the proximal sensor portion in the lateral direction so that the hook feature 3106 approaches the fastener feature 3506 of the sensor module 3504. More specifically, shifting the proximal sensor portion in the lateral direction causes the proximal sensor portion to move into the gap region 3508 of the sensor module 3504.

[0166] although Figure 16A and Figure 16BThe hook feature 3106 is depicted as part of the sensor 3104, and the fastener feature 3506 is depicted as part of the sensor module 3504. However, those skilled in the art will understand that the hook feature 3106 may alternatively be part of the sensor module 3504, and similarly, the fastener feature 3506 may alternatively be part of the sensor 3106. Similarly, those skilled in the art will also recognize that other mechanisms (e.g., pawls, latches, fasteners, screws, etc.) implemented on the sensor 3104 and sensor module 3504 to prevent axial displacement of the sensor 3104 are possible and within the scope of this disclosure.

[0167] Example implementation of the sharp component module

[0168] Figure 17A It describes the assembly of sensor module 504 ( Figure 6B The image shows a perspective view of an example implementation of the sharp element module 2500. The sharp element 2502 may include a distal tip 2506 that can penetrate the skin while carrying a sensor tail within a hollow or recessed portion of the sharp element shaft 2504, such that the movable surface of the sensor tail contacts bodily fluids. A bushing push post 2508 provides a surface for pushing the sharp element carrier during insertion. A bushing small post 2512 provides a surface for the sharp element bushing contact surface 1622. Figure 11 Extended space. The bushing jaw positioning post 2514 provides a distally facing surface of the bushing jaw 2516 so that the sharp element bushing contact surface 1622 abuts. The bushing jaw 2516 may include a conical surface that opens the clamp 1620 during installation of the sharp element module 2500. Further details regarding embodiments of the sharp element module, the sharp element, its components, and variations thereof are described in U.S. Patent Publication No. 2014 / 0171771, which is incorporated herein by reference in its entirety and for all purposes.

[0169] Figure 17B , Figure 17C and Figure 17D An example implementation of a plastic sharps module is described. As background, according to one aspect of the implementation, the plastic sharps can be advantageous in at least two ways.

[0170] First, compared to metal tips, plastic tips can result in reduced tissue damage during the skin insertion process. Metal tips are typically characterized by sharp edges and burrs due to their manufacturing processes, such as chemical etching and mechanical forming, which can cause damage to tissue at the insertion site. Conversely, plastic tips can be designed with rounded edges and smooth surfaces to reduce damage as the tip is positioned through the tissue. Furthermore, those skilled in the art will understand that reduced damage during insertion can lead to a decrease in ESA and improve the accuracy of analyte level readings shortly after insertion.

[0171] Second, plastic sharps simplify the manufacturing and assembly process of the applicator. As previously described, some applicators are provided to the user in two parts: (1) an applicator containing the sharps and sensor electronics within a sensor control unit, and (2) a sensor container. This requires the user to assemble the sensor into the sensor control unit. One reason for the two-piece assembly is to allow electron beam sterilization of the sensor to occur separately from the applicator containing the metal sharps and sensor electronics. Metal sharps, such as those made of stainless steel, have a higher density than sharps made of polymer or plastic materials. As a result, electron beam scattering from impacting the metal sharps can damage the sensor electronics in the sensor control unit. By utilizing plastic sharps, such as those made of polymer materials, and additional shielding features to keep the electron beam path away from the sensor electronics, the applicator and sensor can be sterilized and packaged in a single package, thereby reducing manufacturing costs and simplifying the user's assembly process.

[0172] refer to Figure 17B The diagram shows a perspective view of an exemplary embodiment of a plastic tip module 2550, which may include a bushing 2562 coupled to the proximal end of the tip, a tip shaft 2554, a distal tip 2556 configured to penetrate the skin surface, and a sensor channel 2558 configured to receive at least a portion of an analyte sensor 104. Any or all components of the tip module 2550 may be made of a plastic material, such as a thermoplastic, liquid crystal polymer (LCP), or similar polymeric material. According to some embodiments, the tip module may, for example, include a polyetheretherketone (PEEK) material. In other embodiments, silicone or other lubricants may be applied to the outer surface of the tip module and / or incorporated into the polymeric material of the tip module to reduce damage during insertion. Furthermore, to reduce damage during insertion, one or more of the tip shaft 2554, the distal tip 2556, or the alignment feature 2568 (described below) may include rounded and / or smoothed edges.

[0173] In some embodiments, during assembly, the distal end of the analyte sensor may be positioned proximal to the distal tip 2556 of the sharp member. In other embodiments, the distal end of the analyte sensor and the distal tip 2556 of the sharp member are co-located.

[0174] According to another aspect of some embodiments, the plastic sharps module 2550 may also include an alignment feature 2568 configured to prevent rotational movement along the vertical axis 2545 of the sharps module 2550 during the insertion process, wherein the alignment feature 2568 may be positioned along the proximal portion of the sharps axis 2554.

[0175] Figure 17C and Figure 17D These are a side view and a perspective view depicting another exemplary embodiment of the plastic sharp-point module 2570. (Refer to the reference...) Figure 17B Similarly described embodiments may include a bushing 2582 coupled to the proximal end of the tip, a tip shaft 2574, a distal tip 2576 configured to penetrate the skin surface, and a sensor channel 2578 configured to receive at least a portion of the analyte sensor 104. Any or all components of the tip module 2570 may be made of a plastic material, such as thermoplastic, LCP, or similar polymeric materials. In some embodiments, silicone or other lubricants may be applied to the outer surface of the tip module 2570 and / or incorporated into the polymeric material of the tip module 2570 to reduce damage during insertion.

[0176] According to some embodiments, the pointed shaft 2574 may include a distal portion 2577 terminating at a distal tip 2576, in which at least a portion of the sensor channel 2578 is disposed. The pointed shaft 2574 may also have a proximal portion 2575 adjacent to the distal portion 2577, wherein the proximal portion 2575 is solid, partially solid, or hollow, and is coupled to the bushing 2582. Although Figure 17C and Figure 17D The sensor channel 2578 is depicted as being located only within the distal portion 2577; however, those skilled in the art will understand that the sensor channel 2578 may also extend through the sharp member shaft 2574 (e.g., as shown in the image). Figure 17BThe portion of the sharp point 2575 (shown) or along its entire length, including at least a portion extending through the proximal portion 2575, is included. Additionally, according to another aspect of some embodiments, the wall thickness of at least a portion of the proximal portion 2575 may be greater than the wall thickness of the distal portion 2577 to reduce the likelihood of stress buckling of the sharp point during insertion. According to another aspect of some embodiments, the plastic sharp point module 2570 may include one or more ribs (not shown) adjacent to the sharp point bushing portion 2582 to reduce compressive loads around the bushing 2582 and mitigate stress buckling of the sharp point during insertion.

[0177] Figure 17E This is a cross-sectional view depicting an example embodiment of an applicator 150 with a plastic sharps module during an electron beam sterilization process. As shown in rectangular area A, during the sterilization process, the electron beam is focused onto the sensor 104 and the plastic sharps 2550 of the applicator 150. According to some embodiments, a cap 708 has been attached to the applicator housing 702 to seal the sensor control device 102 within the applicator 150. During the sterilization process, electron beam scattering in the direction and path of the sensor electronics 160 has been reduced, as indicated by the diagonal arrows originating from the plastic sharps 2550, because plastic sharps 2550 have been used instead of metal sharps. Although Figure 17E The focused electron beam sterilization process is described, but those skilled in the art will recognize that an applicator with a plastic sharps module implementation can also be used during the non-focused electron beam sterilization process.

[0178] Figure 17F This is a flowchart illustrating an example embodiment of a method 1100 for sterilizing an applicator assembly according to the above-described embodiments. In step 1105, a sensor control device 102 is loaded into the applicator 150. The sensor control device 102 may include various components, including an electronics housing, a printed circuit board positioned within the electronics housing and containing processing circuitry, an analyte sensor extending from the bottom of the electronics housing, and a plastic sharpener module having a plastic sharpener extending through the electronics housing. According to some embodiments, the plastic sharpener may also receive a portion of the analyte sensor extending from the bottom of the electronics housing. As previously described, in step 1110, a cap 708 is secured to the applicator housing 702 of the applicator 150, thereby sealing the sensor control device 102 within the applicator 150. In step 1115, while the sensor control device 102 is positioned within the applicator 150, the analyte sensor 104 and the plastic sharpener 2550 are sterilized using radiation.

[0179] According to some embodiments, the sensor control device 102 may further include at least one shield positioned within the electronics housing, wherein the one or more shields are configured to protect the processing circuitry from radiation during the sterilization process. In some embodiments, the shield may include a magnet that generates a static magnetic field to deflect radiation away from the processing circuitry. In this way, the combination of the plastic sharp-edged module and the magnetic shield / deflector can work together to protect the sensor electronics from radiation during the sterilization process.

[0180] Another example implementation of a sharp member designed to reduce damage during sensor insertion and retraction will now be described. More specifically, some embodiments described herein relate to sharp members comprising a metallic material (e.g., stainless steel) and manufactured via a die-casting process. According to one aspect of the embodiment, the die-cast sharp member may be characterized by having a sharp tip, wherein all other edges comprise rounded edges. As previously mentioned, metallic sharp members manufactured via chemical etching and mechanical forming processes may result in sharp edges and undesirable hook features. For example, Figure 17G It is a photograph depicting the metal sharp part 2502 manufactured through chemical etching and mechanical forming processes. (See attached image.) Figure 17G As seen in the image, the metal sharp element 2502 includes a distal tip 2506 with a hook-like feature. These and other unintended transition features can lead to increased tissue damage during sensor insertion and retraction. Conversely, Figure 17H It is a photograph depicting die-cast sharp part 2602, that is, a metal sharp part manufactured by the die-casting process. (See attached image.) Figure 17H As seen in the image, the die-cast sharp part 2602 also includes a distal tip 2606. However, the die-cast sharp part 2602 only includes a smooth, rounded edge, without any unintended sharp edges or transitions.

[0181] As with the previously described sharps embodiments, the die-cast sharps 2602 embodiments described herein can also be assembled into a sharps module having a sharps portion and a bushing portion. Similarly, the sharps portion includes a sharps shaft, a sharps proximal end coupled to the distal end of the bushing portion, and a sharps distal tip configured to penetrate the skin surface. According to one aspect of the embodiment, one or all of the sharps portion, sharps shaft, and / or sharps distal tip of the die-cast sharps 2602 may include one or more rounded edges.

[0182] Furthermore, those skilled in the art will understand that the die-cast tip 2602 embodiments described herein can be used similarly with any sensor described herein, including in vivo analyte sensors configured to measure analyte levels in bodily fluids of a subject. For example, in some embodiments, the die-cast tip 2602 may include a sensor channel (not shown) configured to receive at least a portion of the analyte sensor. Similarly, in some embodiments of the tip module assembly utilizing the die-cast tip 2602, the distal end of the analyte sensor may be in a proximal position relative to the distal tip 2606 of the tip. In other embodiments, the distal end of the analyte sensor and the distal tip 2606 of the tip are co-located.

[0183] Other exemplary implementations of sharp parts designed to reduce damage during sensor insertion will now be described. (Return to Reference) Figure 17A An exemplary embodiment of a sharp element module 2500 (analyte sensor not shown) is depicted, and includes a sharp element 2502 having a sensor channel with a U-shaped geometry configured to receive at least a portion of the analyte sensor, and a distal tip 2506 configured to penetrate the skin surface during sensor insertion.

[0184] In some embodiments, the sharp element module may include a sharp element having a distal tip with an offset geometry configured relative to other sharp elements (e.g., Figure 17A The sharp piece 2502 depicted creates a smaller opening in the skin. (Go to...) Figure 17I The image shows a perspective view of an exemplary embodiment of a sharps module 2620 (with an analyte sensor 104) having an offset tip portion. Similar to the previously described sharps module, the sharps module 2620 may include a sharps shaft 2624 coupled to a bushing 2632 at its proximal end, a sensor channel 2628 configured to receive at least a portion of the analyte sensor 104, and a distal tip 2626 configured to penetrate the skin surface during sensor insertion.

[0185] According to one aspect of the embodiment, one or more sidewalls 2629 forming the sensor channel 2628 are disposed along the tip axis 2624 at a predetermined distance Dsc from the distal tip 2626. In some embodiments, the predetermined distance Dsc may be between 1 mm and 8 mm. In other embodiments, the predetermined distance Dsc may be between 2 mm and 5 mm. Those skilled in the art will recognize that other predetermined distances Dsc can be utilized, and are entirely within the scope of this disclosure. In other words, according to some embodiments, the sensor channel 2628 is spaced apart from the distal tip 2626. In this respect, the distal tip 2626 has a reduced cross-sectional coverage area relative to, for example, the distal tip 2506 of the tip module 2500 whose sensor channel is adjacent to the distal tip 2506. According to another aspect of this embodiment, at the end of the distal tip 2626 is an offset tip portion 2627 configured to prevent the sensor tip 2408 from being damaged during insertion and creating a small opening in the skin. In some embodiments, the offset tip portion 2627 may be a separate element coupled to the distal end of the tip axis 2624. In other embodiments, the offset tip portion 2627 may be formed from a portion of the distal tip 2506 or the tip shaft 2624. During insertion, as the tip moves into the skin surface, the offset tip portion 2627 can cause the skin side to stretch and widen in the lateral direction around the skin opening without further cutting the skin tissue. This results in less damage during the sensor insertion process.

[0186] Next reference Figure 17JThe diagram shows a perspective view of another exemplary embodiment of a tip module 2640 (with an analyte sensor 104) having an offset tip portion. Similar to previous embodiments, the tip module 2640 may include a tip shaft 2644 coupled proximally to a bushing 2652, a sensor channel 2648 configured to receive at least a portion of the analyte sensor 104, and a distal tip 2646 configured to penetrate the skin surface during sensor insertion. According to one aspect of the embodiment, the sensor channel 2648 may include a first sidewall 2649a and a second sidewall 2649b, wherein the first sidewall 2649a extends to the distal tip 2646, wherein the end of the first sidewall 2649a forms an offset tip portion 2647, and wherein the second sidewall 2649b is disposed along the tip shaft 2644 at a predetermined distance from the distal tip 2646, and wherein the end of the second sidewall 2649b is proximal to the end of the first sidewall 2649a. Those skilled in the art will understand that in other embodiments, the second sidewall 2649b may extend to the distal tip 2646 to form an offset tip portion 2647, instead of the first sidewall 2649a. Additionally, the offset tip portion 2647 may be formed by a third or fourth sidewall (not shown), and such geometry is entirely within the scope of this disclosure.

[0187] Regarding the sharps and sharps module embodiments described herein, those skilled in the art will recognize that any or all components may comprise metallic materials, such as stainless steel, or plastic materials, such as liquid crystal polymers. Furthermore, those skilled in the art will understand that any sharps and / or sharps module embodiments described herein can be used or combined with any sensor, sensor module, sensor carrier, sheath, applicator device, or any other analyte monitoring system component described herein.

[0188] Example implementation of a reusable electric applicator

[0189] Figure 18A and Figure 18BThese are a front view and a cross-sectional view, respectively, depicting an exemplary embodiment of a reusable electrically operated applicator 4150 for inserting an analyte sensor into a body. According to one aspect of the embodiment, the actuator 4802 of the electrically operated applicator 4150 operates as a trigger, releasing under slight pressure and activating the drive spring 4606 to push the sensor carrier 4710 downward and insert the sharp piece and analyte sensor into the body. After insertion of the analyte sensor, the retraction spring 4604 causes the sharp piece to retract from the object. According to one aspect of the embodiment, after delivering the first analyte sensor, the electrically operated applicator 4150 can be reloaded and reused for subsequently delivering another analyte sensor into the body. For example, the used sharp piece (not shown) can be removed, the retraction spring 4604 and drive spring 4606 can be reloaded, and the actuator 4802 resets, making the electrically operated applicator 4150 reusable, as described in further detail below. According to one aspect of the embodiment, the electrically operated applicator 4150 provides a higher, more controllable insertion speed compared to an applicator that relies on manual insertion force. Compared to an applicator that relies on manual insertion force, the electric applicator 4150 offers the advantage of improved insertion success and reduced damage at the insertion site. Furthermore, the electric applicator 4150 can be advantageous because it is reusable, thereby reducing overall cost and environmental impact.

[0190] refer to Figure 18A and Figure 18B The various components of the electric applicator 4150 will now be described. These can be seen in the front view of the assembled electric applicator 4150 (in its initial state). Figure 18A and a cross-sectional view of the electric applicator Figure 18B As seen in the diagram, the electric applicator 4150 may include the following components: housing 4702, actuator 4802, sharps carrier 4602, retraction spring 4604, sheath 4704, striking pin 4705, drive spring 4606, and sensor carrier 4710. Furthermore, although not shown, the electric applicator 4150 may also include any embodiment of the sensor control unit, analyte sensor, and sharps described herein or incorporated herein by reference in other publications.

[0191] Figures 19A to 19O These are various views depicting example implementations of the reusable electric applicator 4150 during the various stages of deployment and readjustment.

[0192] Figure 19AThis is a cross-sectional view showing the electric applicator 4150 in its initial state, with the distal end of the applicator 4150 ready to be positioned on the skin surface of the object. In the initial state, the drive spring 4606 and the retraction spring 4604 are each in a preloaded state. The drive spring 4606 includes a first end connected to the firing pin 4705 and a second end connected to the sensor carrier 4710. The retraction spring 4604 includes a first end connected to the sharp element carrier 4602 and a second end connected to the sensor carrier 4710. As shown in Figure 19A As best viewed in the initial state, the sensor carrier 4710 and the sharp point carrier 4602 are in a first position within the applicator 4150, spaced apart from the skin surface. Furthermore, as in Figure 19A As best viewed in the initial state, actuator 4802 is in the initial ready-to-fire position within electric applicator 4150. The ready-to-fire position of the actuator can be a first position in which the sensor carrier and the sharp element carrier are in the proximal portion of the reusable applicator.

[0193] According to one aspect of the implementation, in the initial state, the sensor carrier 4710 can be coupled to the sheath 4704 via one or more latch-tab structures. Figure 19B A perspective view of a sheath 4704 including one or more sheath tabs 4706 is depicted. Figure 19C A perspective view of a sensor carrier 4710 including one or more corresponding sensor carrier latches 4603 is depicted. In the initial state, each of the one or more sensor carrier latches 4603 engages with a corresponding sheath latch 4706, as shown in Figure 19A The best view in the middle. Although Figure 19B and Figure 19C Three sheath tabs 4706 and three sensor carrier latches 4603 are depicted, but those skilled in the art will understand that fewer or more latch-tab structures may be used, and those embodiments are well within the scope of this disclosure.

[0194] Figure 19DThis is a cross-sectional view of the electrically operated applicator 4150 in a firing state, wherein a force F1 is applied to the actuator 4802 in the distal direction (as indicated by the arrow). According to one aspect of the embodiment, the application of force F1 causes the actuator 4802 to move in the distal direction, thereby causing the firing pin 4705 to move in the distal direction along the sheath 4704, subsequently disengaging the sheath tab 4706 from the sensor carrier latch 4603 (as indicated by the white arrow). The disengagement of the sheath tab 4706 from the sensor carrier latch 4603 causes the drive spring 4606 to actuate or expand in the distal direction, thereby “firing” the applicator 4150. As the drive spring 4606 expands in the distal direction, the sensor carrier 4710 and the sharps carrier 4602 also shift in the distal direction to a second position adjacent to the skin surface.

[0195] According to some implementations, before the sheath tab 4706 disengages, applying force F1 can increase the load on it by further compressing the drive spring 4606.

[0196] According to one aspect of the implementation, the "cylinder-on-cylinder" design of the sheath 4704 and the firing pin 4705 provides stable and simultaneous release of all three sensor carrier latches 4603. Furthermore, in some embodiments, certain features provide enhanced stability as the sensor carrier 4710 and the sharp element carrier 4602 shift from a first position to a second position. For example, as... Figure 19E As shown, the sensor carrier 4710 may include one or more sensor carrier tabs 4605 configured to travel in a distal direction along one or more sheath tracks 4707 of the sheath 4704. Additionally, as... Figure 19F As shown, according to some embodiments, the sensor carrier 4710 may include one or more sensor carrier buffers 4607, each of which may be biased against the inner surface of the sheath 4704 while the sensor carrier 4710 and the sharp element carrier 4602 are displaced from a first position to a second position.

[0197] Figure 19G This is a cross-sectional view showing the electric applicator 4150 in the inserted state. During the inserted state, a portion of the sharp part and the analyte sensor (not shown) are positioned below the skin surface and in contact with the body fluids of the object. Furthermore, at this stage, the sharp part retraction process has not yet begun. Additionally, as in... Figure 19GAs best seen in the diagram, after the electric applicator 4150 has been "fired," i.e., in the inserted state, the actuator 4802 can be in a second position, for example, flush with the housing 4702, where the sensor carrier 4710 and the sharps carrier 4602 are in the distal portion of the reusable applicator for delivering the first analyte sensor. Although shown flush with the housing, the second position of the actuator 4802 can be any depressed position relative to the first position. In the second position, as in Figure 19D or Figure 19G Ideally, the relative length of actuator 4802 to housing 4702 is less than the relative length of actuator 4802 to housing 4702 in the first position. Furthermore, actuator 4802 can be biased, for example, using a spring housed within housing 4702, so that actuator 4802 returns to its initial position when force F1 is removed. Figure 19I As can be seen best, the sensor carrier locking arm 4524 continues to be constrained by the sheath 4704, thereby preventing the sharp element carrier 4602 (and the sharp element) from retracting.

[0198] According to another aspect of the embodiment, during the insertion state, when the sensor carrier 4710 reaches the second position, the distal portions of the sensor carrier 4710 and the sensor control unit (not shown) coupled to the sensor carrier 4710 are in static contact with the skin surface. According to various aspects of the embodiment, the sheath 4704 may include a latch to hold the sensor carrier 4710 in the second position. In some embodiments, the distal portion of the sensor control unit may be an adhesive surface.

[0199] Furthermore, according to some implementation methods, such as in Figure 19H As best seen in the insertion state, the sensor carrier tab 4605, positioned within the sheath track 4707, has traveled to the second position in the distal direction, but remains positioned above the bottom of the applicator 4150, as indicated by distance R.

[0200] Figure 19J This is a cross-sectional view showing the electric applicator 4150 in the retracted state. According to one aspect of the embodiment, after the insertion state is complete, each of the sensor carrier locking arms 4524 is positioned in the sheath recess 4708, as shown in... Figure 19LThis is best viewed from the center. Therefore, the sensor carrier locking arm 4524, biased in the radially outward direction, expands radially outward through the sheath notch 4708. Next, the sensor carrier locking arm 4524 disengages from and releases the sharp element carrier 4602, and the retraction spring 4604 expands freely or actuates in the proximal direction. As the retraction spring 4604 expands proximally, the sharp element carrier 4602 shifts to a third position within the applicator 4150 (e.g., the top of the sheath 4704), causing the sharp element to retract from the skin surface. Notably, in the third position, because the sensor carrier 4710 is latched to the sheath 4704, the sensor carrier 4710 remains locked in the second distal position. Furthermore, as the sharp element carrier 4602 shifts proximally within the electric applicator 4150, the sharp element carrier 4602 causes the actuator 4802 to extend to the third position. As in Figure 19J As best viewed from the third position, the actuator 4802 extends fully beyond its initial position in the proximal direction, thereby providing a visual indication to the object that the electric applicator 4150 has been used. Thus, the relative length of the actuator 4802 and the housing 4702 in the third position is greater than the relative length of the actuator 4802 and the housing 4702 in the first position.

[0201] According to another aspect of the implementation method, such as Figure 19M As shown, after the first sensor is delivered, the sharp object can be removed from the electric applicator 4150. For example, the actuator 4802 may include a button or cap 4802a, which can be used to access the sharp object carrier (such as...). Figure 19J (as shown) and sharp-piece bushings (e.g., as shown) Figure 17B (See sharps bushing 2562). The patient can then open the button or cap 4802a to access the sharps carrier 4602 (e.g., Figure 19J (As shown) Remove the sharp part bushing (e.g., as shown) Figure 17B The sharp-point bushing 2562 shown is used for safe handling. For example, it can be handled relative to the sharp-point carrier 4602 (such as...). Figure 19J (As shown) Rotate or twist the sharp part bushing to adjust the sharp part bushing (e.g., as shown) Figure 19J The sharp part bushing 2562 and the sharp part carrier 4602 shown are as follows: Figure 19J (As shown) disengage. For example, the sharp part bushing can be rotated or twisted by 15 degrees, 30 degrees, 45 degrees, 60 degrees, 75 degrees, 90 degrees, etc., or any angle within the range of 0-90 degrees.

[0202] Figure 19NThis is a cross-sectional view showing the electric applicator 4150 in its initial re-equipment state, wherein a force F2 is applied to advance the actuator 4802 in the distal direction (as indicated by the arrow). According to one aspect of the embodiment, the application of force F2 causes the sharp element carrier 4602 to move distally toward the sensor carrier 4710 until the sensor carrier locking arm 4524 re-engages the sharp element carrier 4602. Therefore, the sharp element carrier 4602 is recompressed and the retraction spring 4604 is reloaded for subsequent use. Figure 19N Ideally, in the initial refit state, actuator 4802 can be in a fourth position, for example, flush against housing 4702. Furthermore, actuator 4802 can be latched or locked within housing 4702 such that when force F2 is removed, actuator 4802 remains flush against housing 4702.

[0203] Figure 19O This is a cross-sectional view of the electric applicator 4150 in its final re-equipped state, where a force F3 is applied to the sensor carrier 4710 to advance the sensor carrier 4710 and the sharp element carrier 4602 in a proximal direction (as indicated by the arrow). The proximal displacement of the sensor carrier 4710 and the sharp element carrier 4602 causes the firing pin 4705 to move along the sheath 4704 in the proximal direction and causes the drive spring 4606 to compress. Subsequently, the sheath tab 4706 re-engages the sensor carrier latch 4603, causing the drive spring 4606 to fully compress, thereby re-equipping the electric applicator 4150. As discussed previously, the "post-to-post" design of the sheath 4704 and the firing pin 4705 provides stable and simultaneous re-engagement of all three sensor carrier latches 4603. Thus, in the "re-equipped" state, the drive spring 4606 and the retraction spring 4604 are each in a preloaded state. Furthermore, in the "re-equipped" state, the sensor carrier 4710 and the sharp object carrier 4602 have returned to their first positions within the electric applicator 4150, spaced apart from the skin surface. Additionally, as in Figure 19O Ideally, actuator 4802 is in the initial ready-to-fire position within electric applicator 4150.

[0204] According to one aspect of the implementation, the actuator 4802 and / or the electric applicator 4150 may include a visual indicator corresponding to the position of the actuator 4802. More specifically, the actuator 4802 and / or the electric applicator 4150 may include a visual indicator to indicate whether the actuator 4802 is in an initial position, a second position, a third position, or a fourth position. For example, the visual indicator may include color coding along the outer surface 4802a of the actuator 4802, where each position is represented by a different color (e.g., green for the initial position, yellow for the second position, green for the third position, and green for the fourth position), with distance markings and / or words on the outer surface 4802a corresponding to different positions. Thus, during use, the user can quickly determine the position of the actuator 4802.

[0205] Figures 19P to 19X Another exemplary embodiment of a reusable electrically operated applicator 4150' for inserting an analyte sensor into a body is depicted. According to one aspect of the embodiment, the reusable electrically operated applicator 4150' may include a disposable portion comprising a disposable sensor carrier 4710', as shown in... Figure 19P and Figure 19Q The diagram is shown in both top-down and bottom-up perspective views. According to another aspect of the embodiment, the disposable sensor carrier 4710' can be configured to releasably hold a sensor control device 102 having a sharp element 4502 and a sensor module 4504 disposed therethrough. Although in Figure 19P and Figure 19Q Not shown, but disposable parts may also include one or more adhesive patches, adhesive pads, and / or sharps / sensor guards configured to adhere to the user's skin.

[0206] According to another aspect of the embodiment, the reusable electric applicator 4150' may also include a reusable portion, which includes a reusable applicator base 4712. Figure 19R-1 and Figure 19R-2 Perspective views of the reusable applicator base 4712 and the disposable sensor carrier 4710' in their connected and disconnected states are depicted. According to some embodiments, the disposable sensor carrier 4710' may also include one or more latches or latches 4711 for connection to a corresponding stand of the reusable applicator base 4712. Additionally, the reusable applicator base 4712 may include one or more carrier locking arms 4724 for engagement with a sharps carrier.

[0207] Figure 19S , Figure 19T , Figure 19U and Figure 19WThis is a cross-sectional view depicting an example implementation of the reusable electric applicator 4150' in various operational phases. For example, Figure 19S This is a cross-sectional view depicting a reusable electrically operated applicator 4150' in a ready-to-fire state, wherein the distal end of the reusable electrically operated applicator 4150' is prepared to be positioned on the skin surface of an object. In the ready-to-fire state, the drive spring 4606 and the retraction spring 4604 are each in a preloaded state. According to one aspect of the embodiment, the drive spring 4606 may include a first end coupled to the firing pin 4705 and a second end coupled to the reusable applicator base 4712. Figure 19S As shown, in the ready-to-fire state, the disposable sensor carrier 4710', the reusable applicator base 4712, and the sharp point carrier 4602 are in a first position within the reusable electric applicator 4150', spaced apart from the skin surface. Furthermore, as... Figure 19S As shown, actuator 4802' is in the ready-to-fire position, wherein the proximal portion of actuator 4802' is at a predetermined height relative to housing 4702. Furthermore, in the ready-to-fire state, disposable sensor carrier 4710' is configured to hold sensor control device 102, wherein a sharp member 4502 extends through it.

[0208] When force F1 is applied to actuator 4802' in the distal direction (as indicated by the arrow), the reusable electrically operated actuator 4150' is "fired". According to one aspect of the embodiment, the application of force F1 causes actuator 4802' to move in the distal direction, thereby causing striker 4705 to move distally along sheath 4704. As striker 4705 advances distally, it disengages sheath tab 4706 from sensor carrier latch (e.g., as per [reference to...]). Figure 19D (As described), this allows the drive spring 4606 to expand in the distal direction. When the drive spring 4606 expands in the distal direction, the disposable sensor carrier 4710', the reusable applicator base 4712, the sharps carrier 4602, and the sensor control device 102 also shift in the distal direction to a second position adjacent to the skin surface (…). Figure 19T ).

[0209] According to some embodiments, the application of force F1 can increase the load on the drive spring 4606 by further compressing it before the sheath tab 4706 disengages. As previously described, the "post-to-post" design of the sheath 4704 and the firing pin 4705 provides stable and simultaneous release of the sensor carrier latch. Furthermore, in some embodiments, certain features provide enhanced stability while the disposable sensor carrier 4710', the reusable applicator base 4712, and the sharp point carrier 4602 are displaced from a first position to a second position. For example, in some embodiments, the disposable sensor carrier 4710' may include one or more sensor carrier tabs configured to travel in a distal direction along one or more sheath tracks of the sheath 4704, similar to the... Figure 19E The structure described. Similarly, according to some embodiments, the disposable sensor carrier 4710' may include one or more sensor carrier buffers, wherein each sensor carrier buffer may be biased against the inner surface of the sheath 4704 while the disposable sensor carrier 4710', the reusable applicator base 4712, and the sharps carrier 4602 are displaced from a first position to a second position.

[0210] Figure 19T This is another cross-sectional view depicting the reusable electric applicator 4150' in the state after it has been fired and the sensor control device 102 has been deployed. (See image) Figure 19T As shown, actuator 4802' is in a height-increased return position, which provides a visual cue to the user that sensor control device 102 has been applied and at least a portion of sensor 104 has been successfully inserted. In some embodiments, the return position of actuator 4802' may be higher than its position before firing. In other embodiments, the return position of actuator 4802' may be the same as or lower than its position before firing. Figure 19T As further shown, the sharp member 4502 has been automatically retracted from the skin via a retraction mechanism. In several aspects, the retraction mechanism of the reusable electric applicator 4150' operates in a manner similar to the retraction mechanism of the applicator 4150, as previously discussed... Figure 19J Described. Furthermore, according to another aspect of the embodiment, the retraction mechanism of the reusable electric applicator 4150' can be configured to output an audible cue to indicate successful insertion. Subsequently, the reusable electric applicator 4150' can be removed from the insertion site on the skin, leaving the sensor control device 102 deployed on the skin, wherein at least a portion of the insertion sensor 104 is inserted.

[0211] Figure 19UThis is another cross-sectional view depicting the reusable electric applicator 4150' during the sharp object ejection phase. According to one aspect of the embodiment, after the reusable electric applicator 4150' has been removed from the skin, a force F2 can then be applied to the actuator 4802' to cause the sharp object 4502 to eject. Figure 19U As shown, the application of force F2 can cause the proximal portion of actuator 4802' to become substantially or completely depressed relative to the housing 4702 of the reusable electric applicator 4150'. According to another aspect of the embodiment, the application of force F2 can also cause the distal portion 4803 of the actuator to advance in the distal direction until the distal portion 4803 contacts the sharps carrier holding arm 4618 of the sharps carrier 4602. The advancement of the distal portion 4803 by the application of force F2 further causes the sharps carrier holding arm 4618 to unfold and disengage from the sharps bushing 4582 on the proximal end of the sharps 4502. Subsequently, the sharps 4502, no longer held by the sharps carrier holding arm 4618, can be ejected by the distal portion 4803 as it continues to advance in the distal direction. In some implementations, for example, after removal from the skin surface, the reusable electric applicator 4150' can be positioned above the sharps container such that the sharps 4502 are safely ejected from the reusable electric applicator 4150' into the sharps container.

[0212] According to another aspect of the implementation, the sensor carrier ejection stage may occur after or simultaneously with the sharp part ejection stage. Figure 19V It is in a connected state (also) Figure 19R-1 A top view of a reusable applicator base 4712 and a disposable sensor carrier 4710' (shown in the image). The disposable sensor carrier 4710' is configured to disengage from the reusable applicator base 4712 in response to a force applied to one or more latches or latches 4711 on the disposable sensor carrier 4710'. In some embodiments, for example, a force F2 is applied to an actuator 4802' (such as...). Figure 19U As shown, this can further cause the cylindrical base portion of the sharp element carrier 4602 (e.g., as reflected by the dashed circle) to push downwards one or more latches or latches 4711 of the disposable sensor carrier 4710'. In other embodiments, one or more distally extending features (not shown) of the actuator 4802' may each be configured to engage with a corresponding latch or latch 4711 of the disposable sensor carrier 4710'. In response to a downward force applied to the one or more latches or latches 4711, the sensor carrier 4710' disengages from the reusable applicator base 4712 and ejects from the reusable electric applicator 4150'.

[0213] Refer again Figure 19UAccording to another aspect of the embodiment, the application of force F2 can further cause the sharp element carrier 4602 to advance in the distal direction until the carrier locking arm 4724 of the reusable applicator base 4712 re-engages the sharp element carrier 4602. Therefore, the sharp element carrier 4602 is recompressed and the retraction spring 4604 is reloaded for subsequent use. The reloading of the retraction spring 4604 can occur during either or both of the sharp element ejection phase and the sensor carrier ejection phase.

[0214] Figure 19W This is another cross-sectional view depicting the reusable electric applicator 4150' in a ready-to-load state. According to one aspect of the embodiment, in the ready-to-load state, the sharp piece and disposable sensor carrier have been ejected, the sharp piece carrier has been re-latched, the retraction spring has been reloaded, and the reusable electric applicator 4150' is ready to accept a new disposable sensor carrier, as well as a new sensor control device and a new sharp piece. According to some embodiments, the position of the actuator 4802' can be used as a visual indicator of the ready-to-load state. For example, in some embodiments, the height of the actuator 4802' relative to the housing 4702 in the ready-to-load state may be less than the height of the actuator 4802' in the ready-to-fire state. Figure 19S ) or the height of actuator 4802' in the deployment state ( Figure 19T ).

[0215] Figure 19X This is a perspective view depicting a reusable electric applicator 4150' in a ready-to-load state. (As shown in...) Figure 19X As further shown, a new disposable assembly, including a new disposable sensor carrier 4710' and a new sharp member 4502, is positioned below the reusable electric applicator 4150'. In some embodiments, the disposable assembly may be pre-loaded with a new sensor control device 102 (not shown). In other embodiments, the new sensor control device 102 (not shown) may be loaded into the disposable assembly after its insertion into the reusable electric applicator 4150'. According to another aspect of the embodiment, the new disposable assembly is received in the distal end of the reusable electric applicator 4150'. In some embodiments, to prevent misalignment of components, the disposable assembly may include one or more alignment features (e.g., platform, tab, pawl, slot, ridge, rib) associated with one or more corresponding alignment features (e.g., platform, tab, pawl, slot, ridge, rib) of the reusable electric applicator 4150', such that the disposable assembly can only be inserted into the reusable electric applicator 4150' when the corresponding features are aligned.

[0216] According to another aspect of the embodiment, after proper alignment, the disposable component can be inserted into the distal end of the reusable electric applicator 4150', such that the one or more latches or latches 4711 ( Figure 19R-2 Each of the disposable components engages with a corresponding stand of the reusable applicator base 4712 (not shown) within the reusable electric applicator 4150'. When the disposable component is inserted into the distal end of the reusable electric applicator 4150', the sharps bushing 4582 of the sharps 4502 engages the sharps carrier retaining arm of the sharps carrier (not shown). According to some embodiments, the sensor control device 102 can then be loaded into the disposable sensor carrier 4710' (if the sensor control device is not part of the disposable component).

[0217] Regarding the drive spring 4606 and the sharp-piece retraction spring 4604, it should be noted that, although in Figures 18A to 18B and Figures 19A to 19O A compression spring is shown, but those skilled in the art will understand that other types of springs can be used in any of the embodiments described herein, including but not limited to torsion springs, disc springs, leaf springs, etc. Furthermore, those skilled in the art will understand that the insertion and retraction speeds of the applicator embodiments described herein can be changed, respectively, by altering the stiffness or length of the drive spring and the retraction spring. Similarly, those skilled in the art will understand that the timing of the sharp retraction can be modified by altering the depth of the sheath channel (e.g., increasing the depth of the sheath channel may result in earlier sharp retraction).

[0218] Regarding any applicator implementation and any components thereof described herein, including but not limited to sharps, sharps modules, and sensor module implementations, those skilled in the art will understand that the dimensions and construction of these implementations may be designed for use with sensors configured to sense analyte levels in bodily fluids within the epidermis, dermis, or subcutaneous tissue of a subject. In some implementations, for example, the dimensions and construction of both the sharps and the distal portion of the analyte sensor disclosed herein may be designed to be positioned at a specific end depth (i.e., the furthest point of penetration in the tissue or layer of the subject's body, such as in the epidermis, dermis, or subcutaneous tissue). Regarding some applicator implementations, those skilled in the art will understand that the dimensions and construction of certain implementations of the sharps may be designed to be positioned at different end depths within the subject's body relative to the final end depth of the analyte sensor. In some implementations, for example, the sharps may be positioned at a first end depth in the subject's epidermis before retraction, while the distal portion of the analyte sensor may be positioned at a second end depth in the subject's dermis. In other implementations, the sharps may be positioned at a first end depth in the subject's dermis before retraction, while the distal portion of the analyte sensor may be positioned at a second end depth in the subject's subcutaneous tissue. In another embodiment, the sharp part may be positioned at a first end depth before retraction, and the analyte sensor may be positioned at a second end depth, wherein both the first and second end depths are in the same layer or tissue of the object body.

[0219] Additionally, regarding any applicator implementation described herein, including but not limited to... Figure 18A , Figure 18B and Figures 19A to 19O In an electrically operated applicator, those skilled in the art will understand that the analyte sensor and one or more structural components associated therewith, including but not limited to one or more spring mechanisms, may be arranged within the applicator at an eccentric position relative to one or more axes of the applicator. In some applicator embodiments, for example, the analyte sensor and spring mechanism may be positioned at a first eccentric position on a first side of the applicator relative to the axis of the applicator, and the sensor electronics may be positioned at a second eccentric position on a second side of the applicator relative to the axis of the applicator. In other applicator embodiments, the analyte sensor, spring mechanism, and sensor electronics may be positioned at eccentric positions on the same side relative to the axis of the applicator. Those skilled in the art will understand that other arrangements and configurations in which any or all of the analyte sensor, spring mechanism, sensor electronics, and other components of the applicator are positioned at a central or eccentric position relative to one or more axes of the applicator are possible and are fully within the scope of this disclosure.

[0220] This document describes a variety of deflectable structures, including but not limited to a deflectable pawl latch 1402, a deflectable locking arm 1412, a sharps carrier locking arm 1524, a sharps retaining arm 1618, and a module latch 2202. These deflectable structures are made of an elastic material (e.g., plastic or metal (or others)) and operate in a manner well known to those skilled in the art. Each deflectable structure has a rest state or position toward which the elastic material is biased. If a force is applied that causes the structure to deflect or move from this rest state or position, the bias of the elastic material will cause the structure to return to the rest state or position once the force is removed (or reduced). In many cases, these structures are configured as arms with pawls or latches, but other structures or configurations that maintain the same deflectable characteristics and ability to return to a rest position may also be used, including but not limited to legs, clamps, fasteners, adjacent portions on deflectable members, etc.

[0221] Example implementation of an applicator and sensor control device for a one-piece architecture

[0222] As previously stated, certain embodiments of the sensor control device 102 and the applicator 150 may be provided to the user in multiple packages. For example, some embodiments, such as those concerning... Figures 3A to 3G The described types may include a "two-piece" architecture that requires final assembly by the user before the sensor can be properly delivered to the target monitoring location. More specifically, the sensor and associated electrical components, including those in the sensor control unit, are provided to the user in multiple (e.g., two) packages, each of which may or may not be sealed with a sterile barrier, but is at least encapsulated within the package. The user must open the package and manually assemble the components following the instructions before using an applicator to deliver the sensor to the target monitoring location. For example, refer again... Figures 3A to 3G The sensor tray and applicator are supplied to the user in separate packages, requiring the user to open each package and ultimately assemble the system. In some applications, discrete sealed packaging allows the tray and applicator to be sterilized in separate sterilization processes that are unique to the contents of each package and otherwise incompatible with the contents of another package.

[0223] More specifically, the tray containing the plug assembly (including the sensor and the sharp part) can be sterilized using radiation sterilization (e.g., electron beam irradiation). However, radiation sterilization can damage the electrical components housed within the sensor control unit's housing. Therefore, if sterilization of the applicator containing the sensor control unit's housing is required, it can be sterilized via another method, such as gaseous chemical sterilization using ethylene oxide, for example. However, gaseous chemical sterilization can damage enzymes or other chemical and biological materials included on the sensor. Due to this sterilization incompatibility, the tray and applicator can be sterilized in separate sterilization processes and then packaged separately, requiring the user to ultimately assemble the components upon receipt.

[0224] According to other embodiments of this disclosure, the sensor control device (e.g., an analyte sensor device) may include a one-piece architecture incorporating sterilization techniques specifically designed for one-piece architectures. This one-piece structure allows the sensor control device components to be transported to the user in a single sealed package without requiring any final user assembly step. Instead, the user only needs to open one package and then deliver the sensor control device to the target monitoring location. The one-piece system architecture described herein can prove advantageous in eliminating component parts, various manufacturing process steps, and user assembly steps. As a result, packaging and waste are reduced, and the possibility of user error or system contamination is mitigated.

[0225] According to some implementations, a sensor subassembly (SSA) can be constructed and sterilized. This sterilization can be, for example, radiation, such as an electron beam (electron beam radiation), but other sterilization methods can be used alternatively, including but not limited to gamma-ray radiation, X-ray radiation, or any combination thereof. Embodiments of methods for manufacturing an analyte monitoring system using this SSA, as well as embodiments of a sensor control device having this SSA and an applicator used therewith, are now described. The SSA can be manufactured and then sterilized. During sterilization, the SSA may include both an analyte sensor and an insertion point. The sterilized SSA can then be assembled to form a sensor control device (e.g., assembled into a sensor control device), for example, the sterilized SSA can be positioned such that the sensor is in electrical contact with any electronics in the sensor carrier. This sensor control device can then be assembled to form an applicator (e.g., assembled into an applicator) (e.g., as a one-piece assembly), wherein the applicator (also referred to as an analyte sensor inserter) is configured to apply the sensor control device to a user's body. The one-piece assembly can be packaged and / or distributed (e.g., transported) to a user or healthcare professional.

[0226] Figures 20A to 20G A first embodiment of a one-piece applicator for use with a sensor control device having an SSA is described. Figures 21A to 21GA second embodiment of a one-piece applicator for use with a sensor control device having an SSA is described. (As can be seen in...) Figures 21A to 21E As seen in the diagram, the one-piece applicator 5150 may include a housing 4702 and an applicator cap 4802 that mates with the housing 4702. The applicator cap 4802 provides a barrier to protect the internal contents of the one-piece applicator 5150. In some embodiments, the applicator cap 4802 may be threaded onto the housing 4702 and may be released from the housing 4702 when rotated (e.g., loosened) relative to the housing 4702. However, in other embodiments, the applicator cap 4802 may be threaded onto the housing 4702 via an interference fit or a shrink fit. Thus, to insert the analyte sensor using the one-piece applicator 210, the user can remove the applicator cap 210 from the housing 208. Furthermore, although not depicted, the one-piece applicator 5150 may also include any of the embodiments of electric applicators, sensor control units, analyte sensors, and sharp points described herein or incorporated herein by reference.

[0227] As described below herein, the coupling engagement between housing 4702 and applicator cap 4802 provides sterility for components positioned within the one-piece applicator 5150 by maintaining a sterile environment, such as when sealed with applicator cap 4802. The embodiments described below herein can be applied to analyte monitoring systems incorporating either a two-piece or one-piece architecture. More specifically, in embodiments employing a two-piece architecture, the space for sensor control device 102 ( Figure 1 The electronic housing (not shown) of the electrical components of the applicator 5150 can be positioned within housing 4702, and the applicator cap 4802 maintains a sterile environment. Conversely, in embodiments employing a one-piece architecture, the one-piece applicator 5150 can include a fully assembled sensor control unit 102. Figure 1 Furthermore, the applicator cap 4802 maintains a sterile environment for the fully assembled sensor control device.

[0228] Figures 21H to 21K An enlarged cross-sectional side view of the interface between housing 4702 and applicator cap 4802 is shown. As shown, the applicator cap sealing lip 20702U of housing 4702 includes a first axial extension 2002a, and the sealing interface 20708E of applicator cap 4802 provides a cavity 2002d that mates with the first axial extension 2002a. In the illustrated embodiment, the diameter of the cavity 2002d formed by the second axial extension 2002b and the third axial extension 2002c of applicator cap 4802 is designed to receive the diameter of the first axial extension 2002a of housing 4702 within the cavity 2002d. For example, as Figure 21JAs shown, the axial extension 2002a may have a thickness D1 at height H1, as measured from the distal edge of the axial extension 2002a. Similarly, the second axial extension 2002c may have a thickness D5 at height H3, as measured from the proximal edge of the applicator cap 210; and the cavity 2002d may have thicknesses D2, D3, and D4 at heights H2, H3, and H4, respectively, as measured from the proximal edge of the applicator cap 210. In some embodiments, D1 may be measured to be 1 mm with a tolerance of + / - 0.03 mm; D2, D3, and D4 may have any suitable dimensions; H1 may be measured to be 1.66 mm with a tolerance of + / - 0.1 mm; H2 may be measured to be 8.25 mm with a tolerance of + / - 0.1 mm; H3 may be measured to be 9.25 mm with a tolerance of + / - 0.1 mm; and H4 may be measured to be 9.75 mm with a tolerance of + / - 0.1 mm. However, in other embodiments, without departing from the scope of this disclosure, the opposite may be adopted, wherein the diameter of the first axial extension 2002a may be designed to receive the diameter of the second axial extension 2002b.

[0229] In each embodiment, two radial seals 2004, 2006 may be defined or otherwise disposed at the interface between the first axial extension 2002a and the second axial extension 2002b, and the radial seals 2004 and 2006 may help prevent fluid or contaminants from migrating across the interface in either axial direction. Furthermore, the dual radial seals described herein can be adapted to tolerances and thermal variations combined with stress relaxation via a redundant sealing strategy. In the illustrated embodiment, the dual radial seals 2004, 2006 utilize a "wedge" effect to effectively seal between the first axial extension 2002a and the second axial extension 2002b.

[0230] Figures 22A to 22G A first embodiment of a sensor control device with an SSA but without an adhesive patch is described. Figures 23A to 23G A second embodiment of a sensor control device with an SSA and an adhesive patch is shown.

[0231] Figures 24A to 24G A third embodiment of a sensor control device with an SSA and a bottom surface groove but without an adhesive patch is described. Figures 25A to 25G A fourth embodiment of a sensor control device having an SSA, a bottom surface groove, and an adhesive patch is described.

[0232] Figures 26A to 26G A fifth embodiment of a sensor control device with an SSA but without an adhesive patch is described. Figures 27A to 27G A sixth embodiment of a sensor control device having an SSA and an adhesive patch is described.

[0233] Figures 28A to 28G A seventh embodiment of a sensor control device with an SSA and a bottom surface groove but without an adhesive patch is described. Figures 29A to 29G An eighth embodiment of a sensor control device having an SSA, a bottom surface groove, and an adhesive patch is described.

[0234] Suitable apparatus, systems, methods, components, and their operation, as well as additional details of related features, are set forth in Rao et al. International Publication No. WO2018 / 136898, Thomas et al. International Publication No. WO2019 / 236850, Thomas et al. International Publication No. WO2019 / 236859, Thomas et al. International Publication No. WO2019 / 236876, and U.S. Patent Application No. 16 / 433,931 filed on June 6, 2019, each of which is incorporated herein by reference in its entirety.

[0235] According to other embodiments, a sensor control device, including a battery and a sensor, can be built into an applicator as a one-piece component and sterilized using a focused electron beam (FEB). Alternatively, other sterilization methods can be used, including but not limited to gamma-ray radiation, X-ray radiation, or any combination thereof. Embodiments of manufacturing an analyte monitoring system and methods utilizing, for example, FEB sterilization, as well as embodiments of sensor control devices and applicators for use therewith, are now described. A sensor control device including a sensor and a sharp element can be manufactured or assembled, for example, by placing the sensor in electrical contact with any electronics in the sensor carrier of the sensor control device. This sensor control device can then be assembled to form an applicator (e.g., assembled into an applicator) (e.g., as a one-piece component), wherein the applicator is configured to apply the sensor control device to a user's body. This assembled applicator, in which the sensor control device is located, can then be sterilized using, for example, FEB. The sterilized applicator can then be packaged and / or distributed (e.g., transported) to the user or a healthcare professional. In some embodiments, a desiccant and foil seal can be added to the sterilized one-piece component prior to packaging.

[0236] Figures 30A to 30G A first embodiment of an applicator for sterilization using, for example, FEB is described. Figures 31A to 31G A second embodiment of an applicator for sterilization using, for example, FEB is described.

[0237] Figures 32A to 32G A first embodiment of a sensor control device for sterilization using, for example, FEB without the use of adhesive patches is described. Figures 33A to 33G A second embodiment of a sensor control device for sterilization using, for example, FEB together with an adhesive patch is described.

[0238] Figures 34A to 34G A third embodiment of a sensor control device with a bottom surface groove is described, which is used for sterilization using, for example, FEB without the use of adhesive patches. Figures 35A to 35G A fourth embodiment of a sensor control device with a bottom surface groove for sterilization using, for example, FEB along with an adhesive patch is described.

[0239] for Figures 20A to 35G In all embodiments shown and described, solid lines may be depicted as dashed lines, which do not form part of the design. For Figures 22A to 29G and Figures 32A to 35G In all embodiments of the sensor control device described, if shown in solid lines, the adhesive patch may alternatively be shown in dashed lines, and if not shown, the adhesive patch may be shown in either dashed or solid lines.

[0240] The various aspects of this subject are set forth below in a review and / or supplement to the embodiments described to date, with emphasis placed on the interrelationships and interchangeability of the following embodiments. In other words, the emphasis is on the fact that each feature of an embodiment can be combined with every and every other feature, unless otherwise expressly stated or logically unreasonable.

[0241] In many exemplary embodiments, a method is provided for applying a medical device to an object using an applicator, the method comprising: positioning a distal end of the applicator on a skin surface of the object, wherein at least a portion of the distal end comprises a compressible material; applying a force to the applicator to cause the medical device to advance from a first position within the applicator to a second position adjacent to the skin surface, and causing the distal end of the applicator to stretch and flatten a portion of the skin surface adjacent to the applicator; and applying the medical device to the stretched and flattened portion of the skin surface.

[0242] In these method embodiments, applying force to the applicator may further include displacing at least a compressible portion of the distal end of the applicator in a radially outward direction. Displacing at least a compressible portion of the distal end of the applicator may further include generating a radially outward force on a portion of the skin surface adjacent to the applicator.

[0243] In these method implementations, the stretching and flattening portion of applying the medical device to the skin surface may further include placing an adhesive surface on the skin surface.

[0244] In these method embodiments, the stretching and flattening portion of applying the medical device to the skin surface may further include positioning at least a portion of the analyte sensor below the skin surface. The analyte sensor may be an in vivo analyte sensor configured to measure the level of the analyte in the body fluids of the subject.

[0245] In these method implementations, at least the compressible portion of the distal end of the applicator may be biased in a radially inward direction. Alternatively, at least the compressible portion of the distal end of the applicator may be biased in a radially outward direction.

[0246] In these method implementations, at least the compressible portion at the distal end may be in an unloaded state in a first position, and at least the compressible portion at the distal end may be in a loaded state in a second position.

[0247] In these method implementations, at least the compressible portion of the distal end of the applicator may include one or more of an elastomeric material, metal, plastic, or composite leg or spring, or a combination thereof.

[0248] In these method implementations, the cross-section of at least the compressible portion at the distal end of the applicator may include a continuous ring or a discontinuous shape.

[0249] In these method implementations, the distal end of the applicator can be configured to be detached from the applicator.

[0250] In many exemplary embodiments, a device is provided, comprising: a medical device; and an applicator including a distal end configured to be positioned on a skin surface of a subject, wherein at least a portion of the distal end comprises a compressible material, wherein in response to applying a force to the applicator: the medical device is configured to advance from a first position within the applicator to a second position adjacent to the skin, the distal end of the applicator is configured to stretch and flatten a portion of the skin surface adjacent to the applicator, and the medical device is further configured to apply to the stretched and flattened portion of the skin surface.

[0251] In these device embodiments, at least a compressible portion of the distal end of the applicator may be configured to displace in a radially outward direction in response to a force applied to the applicator. The at least compressible portion of the distal end of the applicator may also be configured to generate a radially outward force on a portion of the skin surface adjacent to the applicator.

[0252] In these device implementations, the medical device may include an adhesive surface that can be configured to contact the skin surface.

[0253] In these device embodiments, the medical device may include an analyte sensor, at least a portion of which may be configured to be positioned below the skin surface. The analyte sensor may be an in vivo analyte sensor configured to measure the level of an analyte in a subject's bodily fluids.

[0254] In these device embodiments, at least the compressible portion of the distal end of the applicator may be biased in a radially inward direction. Alternatively, at least the compressible portion of the distal end of the applicator may be biased in a radially outward direction.

[0255] In these device implementations, at least the compressible portion at the distal end may be in an unloaded state in a first position, and at least the compressible portion at the distal end may be in a loaded state in a second position.

[0256] In these device implementations, at least the compressible portion of the distal end of the applicator may include an elastomeric material, metal, plastic, or a composite leg or spring, or one or more combinations thereof.

[0257] In these device implementations, the cross-section of at least the compressible portion at the distal end of the applicator may include a continuous ring or a discontinuous shape.

[0258] In these device implementations, the distal end of the applicator can be configured to detach from the applicator.

[0259] In many embodiments, an assembly for use in an applicator is provided, the assembly comprising: a sharp part module including a sharp part portion and a bushing portion, wherein the sharp part portion may include a sharp part shaft, a sharp part proximal end coupled to a distal end of the bushing portion, and a sharp part distal tip configured to penetrate the skin surface of an object, wherein the sharp part module may also include a plastic material.

[0260] In these component implementations, the sharp element shaft may include one or more rounded edges.

[0261] In these component implementations, the sharp element module may also include a thermoplastic material.

[0262] In these component implementations, the sharp element module may also include polyetheretherketone (PEEK) material.

[0263] In these component implementations, the sharp member shaft may include an alignment stage configured to prevent rotational movement along a vertical axis during the insertion process. The alignment stage may be positioned along a proximal portion of the sharp member shaft.

[0264] In these component embodiments, the component may further include an analyte sensor, wherein the analyte sensor may be an in vivo analyte sensor configured to measure the level of an analyte in the body fluid of the subject. The distal end of the analyte sensor may be in a proximal position relative to the distal tip of the tip. The distal end of the analyte sensor and the distal tip of the tip may be co-located. At least a portion of the analyte sensor may be located within a sensor channel of the tip axis.

[0265] In these component implementations, the sharp element module may also include a liquid crystal polymer material.

[0266] In these component implementations, the component may also include a lubricant disposed on the outer surface of the sharp part module.

[0267] In these component implementations, the plastic material may include a lubricant.

[0268] In these component embodiments, the component may further include a sensor channel, wherein at least a portion of the sensor channel may be disposed in the distal portion of the sharp member shaft. The sensor channel may extend from the proximal portion of the sharp member shaft to the distal portion of the sharp member shaft. The sensor channel may be configured such that it does not extend beyond the distal portion of the sharp member shaft. The proximal portion of the sharp member shaft may be hollow. The proximal portion of the sharp member shaft may be solid. The wall thickness of at least a portion of the proximal portion of the sharp member shaft may be greater than the wall thickness of the distal portion of the sharp member shaft.

[0269] In these component implementations, the component may also include one or more rib structures adjacent to the bushing portion, wherein the one or more rib structures are configured to reduce compressive loads around the bushing portion.

[0270] In many embodiments, a method for preparing an analyte monitoring system is provided, the method comprising: loading a sensor control device into a sensor applicator, the sensor control device including: an electronics housing; a printed circuit board positioned within the electronics housing and including processing circuitry; an analyte sensor extending from the bottom of the electronics housing; and a sharps module comprising a plastic material and removably coupled to the electronics housing, wherein the sharps module includes a sharps, and wherein the sharps extend through the electronics housing and receive a portion of the analyte sensor extending from the bottom of the electronics housing; securing a cap to the sensor applicator to provide a barrier sealing the sensor control device within the sensor applicator; and sterilizing the analyte sensor and the sharps using radiation while the sensor control device is positioned within the sensor applicator.

[0271] In these method embodiments, the sensor control device may further include at least one shielding element positioned within the electronic device housing, and the method may further include using the at least one shielding element to shield the processing circuitry from radiation during sterilization. The at least one shielding element may include a magnet, and shielding the processing circuitry using the at least one shielding element may include: generating a static magnetic field using the magnet; and using the static magnetic field to deflect radiation away from the processing circuitry. Sterilizing the analyte sensor and sharps using radiation may also include sterilizing the analyte sensor and sharps using a non-focused electron beam.

[0272] In these method implementations, the analyte sensor may be an in vivo analyte sensor configured to measure the level of an analyte in bodily fluids located within the body of the subject.

[0273] In these method implementations, the sharp part module may also include a thermoplastic material.

[0274] In these method implementations, the sharp element module may also include a polyetheretherketone (PEEK) material.

[0275] In these method implementations, sterilizing the analyte sensor and the sharps may also include focusing an electron beam onto the analyte sensor and the sharps.

[0276] In many embodiments, an assembly for use in an applicator is provided, the assembly comprising: a sharp part module including a sharp part portion and a bushing portion, wherein the sharp part portion may include a sharp part shaft, a sharp part proximal end coupled to a distal end of the bushing portion, and a sharp part distal tip configured to penetrate the skin surface of an object, wherein the sharp part portion may also include a metallic material and may be formed by a die-casting process.

[0277] In these component implementations, the sharp part may also include stainless steel.

[0278] In these component implementations, the sharp part portion does not include the sharp part edge.

[0279] In these component implementations, the sharp part may include one or more rounded edges.

[0280] In these component implementations, the sharp element shaft may include one or more rounded edges.

[0281] In these component implementations, the sharp member shaft and the distal tip of the sharp member may include one or more rounded edges.

[0282] In these component embodiments, the component may further include an analyte sensor, wherein the analyte sensor may be an in vivo analyte sensor configured to measure the level of an analyte in the body fluid of the subject. The distal end of the analyte sensor may be in a proximal position relative to the distal tip of the tip. The distal end of the analyte sensor and the distal tip of the tip may be co-located. At least a portion of the analyte sensor may be located within a sensor channel of the tip axis.

[0283] In many embodiments, a method is provided for maintaining the structural integrity of a sensor control unit including an analyte sensor and a sensor module, the method comprising: positioning a distal sensor portion of the analyte sensor below the skin surface and in contact with bodily fluids, wherein the analyte sensor may include a proximal sensor portion coupled to the sensor module, and wherein the proximal sensor portion includes a hook feature adjacent to a capture feature of the sensor module; receiving one or more forces in a proximal direction along the longitudinal axis of the analyte sensor; and causing the hook feature to engage the capture feature and prevent displacement of the analyte sensor in the proximal direction along the longitudinal axis.

[0284] In these method implementations, the method may further include loading an analyte sensor into a sensor module by laterally displacing the proximal sensor portion to bring the hook feature closer to the capture feature of the sensor module. Laterally displacing the proximal sensor portion may result in the proximal sensor portion moving into a gap region of the sensor module.

[0285] In these method implementations, the one or more forces can be generated through a sharp member retraction process.

[0286] In these method implementations, the one or more forces can be generated by a physiological response to an analyte sensor.

[0287] In these method implementations, the analyte sensor can be an in vivo analyte sensor configured to measure the level of the analyte in the body fluid of the object.

[0288] In many embodiments, a sensor control unit is provided, comprising: a sensor module including a capture feature; and an analyte sensor including a distal sensor portion and a proximal sensor portion, wherein the distal sensor portion is configured to be positioned below the skin surface and in contact with bodily fluids, and wherein the proximal sensor portion is connectable to the sensor module and may include a hook feature adjacent to the capture feature, wherein the hook feature is configured to engage the capture feature and prevent displacement of the analyte sensor in a proximal direction along the longitudinal axis of the analyte sensor caused by one or more forces received by the analyte sensor.

[0289] In these sensor control unit embodiments, the sensor module may be configured to receive the analyte sensor by displacing the proximal sensor portion in a lateral direction and bringing the hook feature close to the capture feature of the sensor module. The sensor module may also include a gap region configured to receive the proximal sensor portion when it is displaceable in a lateral direction.

[0290] In these sensor control unit implementations, the one or more forces can be generated through a sharp retraction process.

[0291] In these sensor control unit implementations, the one or more forces can be generated by a physiological response to the analyte sensor.

[0292] In these sensor control unit implementations, the analyte sensor may be an in vivo analyte sensor configured to measure the level of the analyte in the body fluid of the object.

[0293] In many embodiments, a method is provided for inserting an analyte sensor into a body using an applicator, the method comprising: positioning a distal end of the applicator on a skin surface, wherein the applicator may include a drive spring, a retraction spring, a sensor carrier, a sharps carrier, and an analyte sensor; applying a first force to the applicator such that the drive spring displaces the sensor carrier and the sharps carrier from a first position spaced apart from the skin surface within the applicator to a second position adjacent to the skin surface, and positions the sharps of the sharps carrier and a portion of the analyte sensor below the skin surface and in contact with bodily fluids of the subject; and applying a second force to the applicator such that the retraction spring displaces the sharps carrier from the second position to a third position within the applicator, and retracts the sharps from the skin surface.

[0294] In these method implementations, applying a first force may include applying a force in a distal direction, and applying a second force may include applying a force in a proximal direction.

[0295] In these method embodiments, the applicator may further include a firing pin and a sheath, and wherein applying a first force to the applicator also causes the firing pin to disengage one or more sheath tabs from one or more sensor carrier latches of the sensor carrier, and causes a drive spring to expand. The drive spring may be in a preloaded state before the first force is applied, and wherein disengagement from the one or more sheath tabs causes the drive spring to expand in a distal direction. Applying the first force to the applicator before causing the firing pin to disengage from the one or more sheath tabs increases the load on the drive spring. The drive spring may be in a preloaded state before the first force is applied, and wherein the drive spring may include a first end coupled to the firing pin and a second end coupled to the sensor carrier.

[0296] In these method embodiments, the applicator may further include a sensor control unit coupled to the sensor carrier, wherein a distal portion of the sensor control unit may contact the skin surface in a second position. Displacing the sensor carrier and the sharps carrier from the first position to the second position may include one or more sensor carrier tabs of the sensor carrier traveling distally along one or more sheath tracks of the sheath. One or more sensor carrier buffers of the sensor carrier may be biased against the inner surface of the sheath while the sensor carrier and the sharps carrier are displaced from the first position to the second position.

[0297] In these method embodiments, applying a second force further causes a plurality of sensor carrier locking arms of the sensor carrier to disengage from the sharp element carrier and causes a retraction spring to expand. Disengaging the plurality of sensor carrier locking arms from the sharp element carrier may include positioning the plurality of sensor carrier locking arms into a plurality of sheath recesses of the sheath. Each of the plurality of sensor carrier locking arms may be biased in a radially outward direction, and wherein the sheath recesses may be configured to allow the plurality of sensor carrier locking arms to expand in a radially outward direction. The retraction spring may be preloaded before the application of the second force, and wherein disengagement of the plurality of sensor carrier locking arms causes the retraction spring to expand in a proximal direction.

[0298] In these method implementations, the retraction spring may be in a preloaded state before the second force is applied, and the retraction spring may include a first end coupled to the sharp element carrier and a second end coupled to the sensor carrier.

[0299] In these method implementations, applying a second force further causes the drive spring to shift the sensor carrier to the bottom portion of the applicator.

[0300] In these method implementations, the analyte sensor can be an in vivo analyte sensor configured to measure the level of the analyte in the body fluid of the object.

[0301] In many embodiments, an applicator is provided for inserting an analyte sensor into a body of a subject, the applicator comprising: a drive spring; a retraction spring; a sensor carrier; a sharps carrier coupled to a sharps; and an analyte sensor; wherein the drive spring is configured to displace the sensor carrier and the sharps carrier from a first position spaced apart from the skin surface to a second position adjacent to the skin surface when a first force is applied to the applicator, and wherein a portion of the sharps and the analyte sensor is positioned below the skin surface and in contact with bodily fluids of the subject at the second position, and wherein the retraction spring is configured to displace the sharps carrier from the second position within the applicator to a third position and retract the sharps from the skin surface when a second force is applied to the applicator.

[0302] In these applicator implementations, the application of the first force may include applying a force in the distal direction, and the application of the second force may include applying a force in the proximal direction.

[0303] In embodiments of these applicators, the applicator may further include a firing pin and a sheath, wherein the firing pin is configured to disengage one or more sheath tabs of the sheath from one or more sensor carrier latches of the sensor carrier upon application of a first force, causing a drive spring to expand. The drive spring may be in a preloaded state before the first force is applied, and wherein the drive spring is configured to expand in a distal direction in response to the disengagement of the one or more sheath tabs from the one or more sensor carrier latches. The drive spring is configured to receive an increased load before the firing pin disengages from the one or more sheath tabs. The drive spring may be in a preloaded state before the first force is applied, and wherein the drive spring may include a first end coupled to the firing pin and a second end coupled to the sensor carrier.

[0304] In these applicator embodiments, the applicator may also include a sensor control unit coupled to a sensor carrier, wherein a distal portion of the sensor control unit may be configured to contact the skin surface at a second location.

[0305] In these applicator embodiments, the applicator may also include one or more sensor carrier tabs of the sensor carrier, configured to travel in a distal direction along one or more sheath tracks of the sheath between a first position and a second position.

[0306] In these applicator embodiments, the applicator may also include one or more sensor carrier buffers of the sensor carrier configured to bias against the inner surface of the sheath between a first position and a second position.

[0307] In these applicator embodiments, the applicator may further include a plurality of sensor carrier locking arms of the sensor carrier, wherein the sensor carrier locking arms are configured to disengage from the sharp element carrier and cause a retraction spring to expand in response to the application of a second force. The applicator may also include a plurality of sheath recesses of a sheath, wherein the plurality of sheath recesses are configured to receive the plurality of sensor carrier locking arms and cause the sensor carrier locking arms to disengage from the sharp element carrier. Each of the plurality of sensor carrier locking arms may be biased in a radially outward direction, and wherein the sheath recesses are configured to allow the plurality of sensor carrier locking arms to expand in the radially outward direction. The retraction spring may be preloaded before the application of the second force, and wherein the retraction spring is configured to expand in a proximal direction when the plurality of sensor carrier locking arms disengage from the sharp element carrier.

[0308] In these applicator embodiments, the retraction spring may be in a preloaded state before the second force is applied, and the retraction spring may include a first end coupled to the sharp element carrier and a second end coupled to the sensor carrier.

[0309] In these applicator embodiments, the drive spring may also be configured to shift the sensor carrier to the bottom portion of the applicator in response to the application of a second force.

[0310] In these applicator implementations, the analyte sensor may be an in vivo analyte sensor configured to measure the level of the analyte in the body fluid of the subject.

[0311] In many embodiments, an assembly for use in an applicator is provided, the assembly comprising: a sharp member module including a sharp member portion and a bushing portion, wherein the sharp member portion may include a sharp member shaft, a sharp member proximal end coupled to the bushing portion, and a sharp member distal tip configured to penetrate the skin surface of a subject, wherein the sharp member shaft includes a sensor channel configured to receive at least a portion of an analyte sensor, wherein the sensor channel may be spaced apart from the sharp member distal tip, and wherein the sharp member distal tip includes an offset tip portion configured to create an opening in the skin surface.

[0312] In these component implementations, the sharp element module may also include stainless steel material.

[0313] In these component implementations, the sharp part module may also include plastic material.

[0314] In these component implementations, the offset tip portion may also be configured to prevent damage to the sensor tip portion of the analyte sensor during the sensor insertion process.

[0315] In these component implementations, the cross-sectional area of ​​the offset tip portion may be smaller than the cross-sectional area of ​​the sharp member shaft.

[0316] In these component implementations, the offset tip portion may include a separate element coupled to the tip shaft.

[0317] In these component implementations, the sensor channel may include one or more sidewalls of a sharp member shaft. An offset tip portion may be formed from a portion of one or more sidewalls of the sharp member shaft. The sensor channel may include a first sidewall and a second sidewall, wherein the offset tip portion may be formed from the end of the first sidewall of the sharp member shaft, and wherein the end of the second sidewall may be located proximal to the end of the first sidewall.

[0318] In many embodiments, a method for manufacturing an analyte monitoring system is provided, comprising: sterilizing a sensor subassembly including a sensor and a sharp part; assembling the sterilized sensor subassembly into a sensor control device; assembling the sensor control device into an applicator; and packaging the applicator having the sensor control device therein for dispensing.

[0319] In these method implementations, the sensor control device can be as follows: Figures 20A to 21GAny one of them shown or substantially shown.

[0320] In these method implementations, the applicator may be as follows: Figures 22A to 29G Any one of them shown or substantially shown.

[0321] In many embodiments, a method for manufacturing an analyte monitoring system is provided, the method comprising: assembling a sensor control device including a sensor and a sharp element; assembling the sensor control device into an applicator; sterilizing the applicator having the sensor control device therein using a focused electron beam; and packaging the applicator having the sensor control device therein for dispensing.

[0322] In these method implementations, the sensor control device can be as follows: Figures 30A to 31G Any one of them shown or substantially shown.

[0323] In these method implementations, the applicator may be as follows: Figures 32A to 35G Any one of them shown or substantially shown.

[0324] Examples of implementation methods for environmentally conscious packaging and components

[0325] According to embodiments of this disclosure, analyte monitoring systems combining a two-piece or one-piece architecture can be shipped to users in sealed packaging. More specifically, in embodiments employing a two-piece architecture, the applicator 150 and the sensor container or tray 810 can be shipped in a single sealed package. Alternatively, the applicator 150 and the sensor container or tray 810 can be shipped in separate sealed packages. Conversely, in embodiments employing a one-piece architecture, the one-piece applicator 5150 can be shipped in a single sealed package. According to embodiments of this disclosure, the sealed packaging may include a sealed foil pouch or any other sealed packaging known to those skilled in the art. The sealed packaging described herein can be designed to maintain a low moisture conversion ratio (MVTR), thereby providing a stable shelf life for both one-piece and two-piece analyte monitoring systems. For example, as Figure 36 The chart depicts MVTR testing on many different materials and seals at 30°C and 65% relative humidity.

[0326] According to embodiments of this disclosure, the sealed packaging may be resealable. For example, the sealed packaging may include a resealing mechanism, such as a zipper-type interlocking closure, or any other method or system known to those skilled in the art.

[0327] Additionally, sealed packaging may include pre-paid, pre-printed return shipping labels that allow users to return used applicators, containers, and / or sensor controls for recycling or sharp parts for disposal. Furthermore, the sealed packaging described herein can prove advantageous in eliminating component parts and various manufacturing process steps. For example, by carefully planning humidity control during manufacturing, the sealed packaging described herein can eliminate the need for desiccants or allow the use of smaller, readily available desiccants within the sealed packaging. Moreover, pressure decay leakage testing may no longer be required during the manufacturing process. For example, pressure decay testing is performed during manufacturing once the applicator has been assembled and packaged. Thus, the housing and cap are designed using materials that allow for proper sealing between components to ensure the product meets its expected shelf life. However, if foil-sealed bags are used, rigorous pressure decay testing of different components is no longer necessary.

[0328] According to embodiments of this disclosure, any applicator embodiment described herein and any of its components, including but not limited to housings, sheaths, sharps carriers, electronic device carriers, firing pins, sharps bushings, sensor module embodiments, actuators, and sensor containers or trays, can be made of a variety of rigid materials. In some embodiments, for example, the component can be made of engineering thermoplastics, such as acetal or polyoxymethylene. Using a single material to construct the various components of the applicator embodiments described herein can be advantageous in terms of improved recyclability, lubricity, and tight tolerance control. Specifically, acetal can be used to provide lubricity (i.e., low friction) between parts that move relative to each other (e.g., sheaths and housings, sharps carriers and housings). This reduced friction helps provide sufficient force for successful sensor insertion. Using acetal can also reduce the need for pressure decay testing during manufacturing. In other embodiments, for example, other materials having the same or similar properties as acetal, such as polybutylene terephthalate (PBT), can be used for any or all of the above components. Furthermore, the use of sealable packaging reduces the need for tolerance control of tight components that typically require a proper seal between the applicator housing and the cap, thus allowing for manufacturing from a single material. Parts with smaller tolerances often require tightly controlled machining and processes, increasing manufacturing costs. Therefore, using a single material reduces manufacturing costs. For example, after any metal parts (such as the drive spring, battery, and retraction spring) are separated using a magnet, all remaining parts made of the same material can be easily recycled.

[0329] Exemplary implementations and features are set forth in the following numbered clauses.

[0330] 1. An assembly for delivering an analyte sensor, comprising:

[0331] A reusable applicator configured to deliver a first analyte sensor, the reusable applicator having a proximal portion and a distal portion and comprising:

[0332] case;

[0333] A sensor carrier configured to releasably receive a first analyte sensor;

[0334] A sharp object carrier, configured to releasably receive a sharp object module; and

[0335] An actuator, movable relative to the housing, has the following characteristics:

[0336] The first position, in which the sensor carrier and the sharp element carrier are located on the proximal portion of the reusable applicator.

[0337] The second position, wherein the sensor carrier and the sharp element carrier are located at the distal portion of the reusable applicator, for delivering the first analyte sensor from the reusable applicator, and

[0338] In the third position, after the first analyte sensor is delivered, the sensor carrier is located at the distal portion of the reusable applicator, and the sharp element carrier is located at the proximal portion of the reusable applicator.

[0339] The first, second, and third positions are different, and the actuator is configured to return from the third position to the first position to deliver another analyte sensor.

[0340] 2. The assembly for delivering the analyte sensor as described in Clause 1, wherein the reusable applicator further includes a drive spring for moving the sensor carrier and the sharp part carrier from the proximal portion to the distal portion and a retraction spring for moving the actuator to a third position.

[0341] 3. The assembly for conveying an analyte sensor as described in Clause 2, wherein the drive spring is actuated by movement of an actuator from a first position to a second position.

[0342] 4. The assembly for delivering an analyte sensor as described in Clause 2 or 3, wherein the retraction spring is actuated by movement of the sensor carrier from a proximal position to a distal position of the reusable applicator.

[0343] 5. The assembly for delivering an analyte sensor according to any one of Clauses 1 to 4, wherein the reusable applicator further includes a latch to hold the sensor carrier at the distal portion of the reusable applicator as the actuator moves from the second position toward the third position.

[0344] 6. The assembly for delivering an analyte sensor according to any one of Clauses 1 to 5, wherein, with the actuator in the third position, the sharps carrier can be accessed from the proximal portion of the reusable applicator to release the sharps module.

[0345] 7. The assembly for delivering an analyte sensor according to any one of Clauses 1 to 6, wherein the actuator further includes a visual indicator of the actuator's position.

[0346] 8. The assembly for delivering an analyte sensor as described in Clause 7, wherein the actuator includes a button configured to extend a first predetermined length relative to the housing in a first position, extend a second predetermined length relative to the housing in a second position, and extend a third predetermined length relative to the housing in a third position, wherein the third predetermined length is greater than the first predetermined length and the first predetermined length is greater than the second predetermined length.

[0347] 9. The assembly for delivering the analyte sensor as described in Clause 8, wherein the button is configured to be opened to remove the sharps module.

[0348] 10. An assembly for delivering an analyte sensor according to any one of clauses 1 to 9, wherein the reusable applicator assembly is made of recyclable material.

[0349] 11. The assembly for delivering an analyte sensor as described in Clause 10, wherein the reusable applicator comprises acetal.

[0350] 12. The assembly for delivering the analyte sensor according to any one of clauses 1 to 11 further includes a sealable container for packaging a reusable applicator assembly.

[0351] 13. The assembly for delivering an analyte sensor as described in Clause 12, wherein the sealable container has a low moisture conversion rate.

[0352] 14. The assembly for delivering an analyte sensor as described in Clause 13, wherein the sealable container is configured to eliminate the need for a desiccant.

[0353] 15. The assembly for delivering the analyte sensor according to any one of Clauses 1 to 14 further includes an applicator cap that is hermetically coupled to the housing using a gasket-less seal.

[0354] 16. A method of using an assembly for delivering an analyte sensor, comprising:

[0355] A reusable applicator having a proximal portion and a distal portion is provided. The reusable applicator includes a housing, a sensor carrier having a first analyte sensor releasably received therein, a sharps carrier having a sharps module releasably received therein, and an actuator movable relative to the housing.

[0356] The actuator of the reusable applicator assembly is moved from a first position to a second position to move the sensor carrier and the sharp part carrier from the proximal portion of the reusable applicator toward the distal portion of the reusable applicator to deliver the analyte sensor from the sensor carrier.

[0357] After delivering the first analyte sensor, the sharp-point carrier is moved from the distal portion of the reusable applicator toward the proximal portion of the reusable applicator, and the actuator of the reusable applicator assembly is moved to a third position; and

[0358] The actuator is returned from the third position to the first position to receive another analyte sensor for delivery;

[0359] The first, second, and third positions are different.

[0360] 17. The method of using an assembly for delivering an analyte sensor as described in Clause 16, wherein the reusable applicator further includes a drive spring to move the sensor carrier and the sharps carrier from the proximal portion to the distal portion.

[0361] 18. A method of using an assembly for delivering an analyte sensor as described in Clause 16 or 17, wherein the reusable applicator further includes a retraction spring to move the actuator to a third position.

[0362] 19. The method of using an assembly for delivering an analyte sensor as described in Clause 17 or 18, wherein, after returning the actuator from the third position to the first position, the method further comprises:

[0363] By moving the sharp-piece carrier from the proximal portion of the reusable applicator to the distal portion of the reusable applicator, the retraction spring is reloaded using the actuator of the reusable applicator assembly; and

[0364] The drive spring is reloaded by moving the sensor carrier and the sharp part carrier from the distal part of the reusable applicator to the proximal part of the reusable applicator.

[0365] 20. A method of using an assembly for delivering an analyte sensor according to any one of Clauses 16 to 19, wherein the reusable applicator further includes a latch to hold the sensor carrier at a distal portion of the reusable applicator as the actuator moves from a second position toward a third position.

[0366] 21. The method of using the component for delivering the analyte sensor according to any one of Clauses 16 to 20 further includes approaching the sharps carrier from the proximal portion of the reusable applicator to release the sharps module.

[0367] 22. A method of using an assembly for delivering an analyte sensor according to any one of Clauses 16 to 21, wherein the reusable applicator includes a visual indicator of the position of the actuator.

[0368] 23. A method of using an assembly for delivering an analyte sensor according to any one of Clauses 16 to 22, wherein the actuator includes a button, and the method further includes opening the button to approach and remove the first sharp element module when the actuator is in a third position.

[0369] 24. A component comprising:

[0370] A reusable applicator configured to insert at least a portion of an analyte sensor beneath the skin surface and into contact with bodily fluids, the reusable applicator comprising:

[0371] case;

[0372] An actuator configured to move in a distal direction relative to the housing;

[0373] A sharp component carrier, releasably connected to a sharp component module;

[0374] A reusable applicator base is releasably engaged with a disposable sensor carrier, the disposable sensor carrier being configured to releasably hold the sensor control device; and

[0375] The sensor control device includes an analyte sensor.

[0376] The sensor control device is configured to advance from a first position within the reusable applicator to a second position adjacent to the skin surface in a distal direction after applying a first force to the actuator.

[0377] The reusable applicator is also configured to eject a disposable sensor carrier and a sharp piece module from the actuator in response to the application of a second force thereon.

[0378] 25. The component according to Clause 24 further includes a drive spring having a first end in contact with the firing pin, wherein applying a first force to the actuator causes the drive spring to expand.

[0379] 26. The component described in Clause 25 further includes a retraction spring disposed within the sharp element carrier.

[0380] 27. The component according to Clause 26, wherein the reusable applicator base includes one or more carrier locking arms configured to engage a sharp element carrier.

[0381] 28. The assembly according to Clause 27, wherein the expansion of the drive spring causes the reusable applicator base, retraction spring, sharps carrier, sharps module, disposable sensor carrier, and sensor control device to be advanced toward the skin surface in a distal direction.

[0382] 29. The component according to Clause 28, wherein the one or more carrier locking arms are configured to disengage from the sharp element carrier when the sensor control device is advanced from the first position to the second position, and wherein the retraction spring is configured to expand after the one or more carrier locking arms disengage from the sharp element carrier.

[0383] 30. The component according to any one of Clauses 24 to 29, wherein the sharp element module includes a sharp element bushing configured to engage with a sharp element carrier.

[0384] 31. The component as described in Clause 30, wherein the sharp element module further includes a sharp element.

[0385] 32. The component according to any one of Clauses 24 to 31, wherein the disposable sensor carrier includes one or more latches configured to engage with one or more corresponding benches of the reusable applicator base.

[0386] 33. The component according to any one of clauses 24 to 32, wherein the actuator is at a first height relative to the housing before the first force is applied, wherein the actuator is configured to return to a second height relative to the housing after the first force is applied, and wherein the second height is greater than the first height.

[0387] 34. The component according to any one of clauses 24 to 33, wherein applying a second force to the actuator causes the distal portion of the actuator to contact the sharp element carrier.

[0388] 35. The component according to Clause 34, wherein the sharp object carrier includes one or more sharp object carrier retaining arms, and wherein contact between the distal portion of the actuator and the sharp object carrier causes the one or more sharp object carrier retaining arms to deploy and detach from the sharp object module.

[0389] 36. The component according to Clause 35, wherein the distal portion of the actuator is configured to eject the sharp element module from the sharp element carrier.

[0390] 37. The component according to any one of clauses 24 to 36, wherein applying a second force to the actuator causes the reusable applicator base to re-engage and retain the sharp element carrier.

[0391] 38. The component according to Clause 37, wherein the sharp element carrier causes the retraction spring to be recompressed and reloaded through re-engagement of the reusable applicator base.

[0392] 39. A method of using an assembly including a reusable applicator and a first sensor control device, the reusable applicator comprising a housing, an actuator configured to move in a distal direction relative to the housing, a sharps carrier releasably coupled to a first sharps module, and a reusable applicator base releasably engaged with a first disposable sensor carrier, the method comprising:

[0393] The reusable applicator is placed against the skin surface, and a first force is applied to the actuator to advance the first sensor control device from a first position within the reusable applicator to a second position adjacent to the skin surface.

[0394] Remove the reusable applicator from the skin surface and leave the first sensor control device on the skin surface; and

[0395] A second force is applied to the actuator to eject the first sharp component module and the first disposable sensor carrier from the reusable applicator.

[0396] 40. The method according to clause 39, wherein the reusable applicator further includes a drive spring having a first end in contact with the firing pin, the method further including causing the drive spring to expand in response to the application of a first force on the actuator.

[0397] 41. The method according to Clause 40, wherein the reusable applicator further includes a retraction spring disposed within the sharp element carrier.

[0398] 42. The method according to Clause 41, wherein the reusable applicator base includes one or more carrier locking arms configured to engage a sharp element carrier.

[0399] 43. The method described under clause 42 further includes:

[0400] In response to the expansion of the drive spring, the reusable applicator base, retraction spring, sharps carrier, sharps module, disposable sensor carrier, and first sensor control device are advanced toward the skin surface in a distal direction.

[0401] 44. The method described under clause 43 further includes:

[0402] When the first sensor control device moves from the first position to the second position, it causes the one or more carrier locking arms to disengage from the sharp element carrier; and

[0403] This causes the retraction spring to expand after one or more carrier locking arms disengage from the sharp element carrier.

[0404] 45. The method according to any one of clauses 39 to 44, wherein the sharp element module includes a sharp element bushing configured to engage with a sharp element carrier.

[0405] 46. ​​The method according to Clause 45, wherein the sharp element module further includes a sharp element.

[0406] 47. The method according to any one of clauses 39 to 46, wherein the first disposable sensor carrier includes one or more latches configured to engage with one or more corresponding benches of a reusable applicator base.

[0407] 48. The method according to any one of clauses 39 to 47, wherein the actuator is at a first height relative to the housing before the first force is applied, wherein the actuator is configured to return to a second height relative to the housing after the first force is applied, and wherein the second height is greater than the first height.

[0408] 49. The method according to any one of clauses 39 to 48 further comprises:

[0409] In response to the application of a second force to the actuator, the distal portion of the actuator comes into contact with the sharp object carrier.

[0410] 50. The method according to clause 49, wherein the sharps carrier includes one or more sharps carrier retaining arms, the method further comprising:

[0411] In response to contact between the distal portion of the actuator and the sharp element carrier, the one or more sharp element carrier retaining arms extend and detach from the sharp element module.

[0412] 51. The method according to any one of clauses 39 to 50 further comprises:

[0413] The second sharp component module and the second disposable sensor carrier are loaded into the reusable applicator through the distal end of the reusable applicator.

[0414] 52. The method described under Clause 51 further includes:

[0415] After loading the second sharp component module and the second disposable sensor carrier into the reusable applicator, the second sensor control device is loaded into the reusable applicator through the distal end of the reusable applicator.

[0416] 53. The method described under clause 51 further includes:

[0417] The second sensor control device is loaded into the reusable applicator via the distal end of the reusable applicator, while the second sharp component module and the second disposable sensor carrier are loaded into the reusable applicator.

[0418] In summary, an assembly and method for delivering an analyte sensor are disclosed, the analyte sensor including a reusable applicator having a proximal portion and a distal portion. The reusable applicator may include a housing, a sensor carrier configured to releasably receive a first analyte sensor, a sharps carrier configured to releasably receive a sharps module, and an actuator movable relative to the housing. The actuator may include three positions: a first position where the sensor carrier and the sharps carrier are at the proximal portion of the reusable applicator; a second position where the sensor carrier and the sharps carrier are at the distal portion of the reusable applicator for delivering the first analyte sensor; and a third position where, after delivering the first analyte sensor from the reusable applicator, the sensor carrier is at the distal portion of the reusable applicator and the sharps carrier is at the proximal portion of the reusable applicator, wherein the first, second, and third positions are different, and wherein the actuator is configured to return from the third position to the first position for delivering another analyte sensor.

[0419] This specification covers and explicitly envisions methods that are non-surgical, non-invasive, and performed outside the body. These methods are typically performed by users who are not required to be medical professionals.

[0420] 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 combined and substituted with those from any other embodiment. If a feature, element, component, function, or step is described only with respect to one embodiment, it should be understood that such feature, element, component, function, or step may be used with every other embodiment described herein, unless expressly stated otherwise. Therefore, this paragraph serves at any time as the premise and written support for the introduction of the claims, combining features, elements, components, functions, and steps from different embodiments, or substituting features, elements, components, functions, and steps from another embodiment for features, elements, components, functions, and steps of one embodiment, even if such combinations or substitutions are not expressly stated in particular cases in the following description. Thus, for purposes of illustration and description, the above description of specific embodiments of the disclosed subject matter has been presented. It is expressly acknowledged that it would be overly cumbersome to explicitly describe every possible combination and substitution, especially considering that the permissibility of each and every such combination and substitution will readily be recognized by those skilled in the art.

[0421] While these embodiments are readily available for various modifications and substitutions, specific examples have been shown in the accompanying drawings and described in detail herein. It will be apparent to those skilled in the art that various modifications and variations can be made to the methods and systems of the disclosed subject matter without departing from the spirit or scope of the disclosed subject matter. Therefore, the disclosed subject matter is intended to include modifications and variations within the scope of the appended claims and their equivalents. Furthermore, any features, functions, steps, or elements of these embodiments, as well as negative limitations defining the scope of the claims by features, functions, steps, or elements not within the scope of the claims, may be stated in or added to the claims.

Claims

1. An assembly for delivering an analyte sensor, comprising: A reusable applicator configured to deliver a first analyte sensor, the reusable applicator having a proximal portion and a distal portion and comprising: case; A sensor carrier configured to releasably receive the first analyte sensor; Sharp object carrier, configured to releasably receive sharp object module; and An actuator movable relative to the housing, the actuator having: In the first position, the sensor carrier and the sharp element carrier are located at the proximal portion of the reusable applicator. In the second position, the sensor carrier and the sharp element carrier are located at the distal portion of the reusable applicator for delivering the first analyte sensor from the reusable applicator. In the third position, after the first analyte sensor is delivered, the sensor carrier is located at the distal portion of the reusable applicator, and the sharp element carrier is located at the proximal portion of the reusable applicator. The first position, the second position, and the third position are different, and the actuator is configured to return from the third position to the first position for delivering another analyte sensor, and the sharp part module is configured to be removable from the proximal portion of the reusable applicator.

2. The assembly for delivering an analyte sensor according to claim 1, wherein, The reusable applicator further includes: a drive spring to move the sensor carrier and the sharp element carrier from the proximal portion to the distal portion; and a retraction spring to move the actuator to the third position.

3. The assembly for delivering an analyte sensor according to claim 2, wherein, The drive spring is actuated by the movement of the actuator from the first position to the second position.

4. The assembly for delivering an analyte sensor according to claim 2, wherein, The retraction spring is actuated by the movement of the sensor carrier from a proximal position to a distal position of the reusable applicator.

5. The assembly for delivering an analyte sensor according to claim 1, wherein, The reusable applicator also includes a latch to hold the sensor carrier at the distal portion of the reusable applicator as the actuator moves from the second position toward the third position.

6. The assembly for delivering an analyte sensor according to claim 1, wherein, With the actuator in the third position, the sharp part carrier can approach from the proximal portion of the reusable applicator to release the sharp part module.

7. The assembly for delivering an analyte sensor according to claim 1, wherein, The actuator also includes a visual indicator of the actuator's position.

8. The assembly for delivering an analyte sensor according to claim 7, wherein, The actuator includes a button configured to extend relative to the housing by a first predetermined length in a first position, a second predetermined length relative to the housing in a second position, and a third predetermined length relative to the housing in a third position, wherein the third predetermined length is greater than the first predetermined length and the first predetermined length is greater than the second predetermined length.

9. The assembly for delivering an analyte sensor according to claim 8, wherein, The button is configured to be turned on to remove the sharp component module.

10. The assembly for delivering an analyte sensor according to claim 1, wherein, The reusable applicator assembly is made of recyclable materials.

11. The assembly for delivering an analyte sensor according to claim 10, wherein, The reusable applicator includes acetal.

12. The assembly for delivering the analyte sensor according to claim 1, further comprising a sealable container for packaging the reusable applicator assembly.

13. The assembly for delivering an analyte sensor according to claim 12, wherein, The sealable container has a low moisture conversion rate.

14. The assembly for delivering an analyte sensor according to claim 13, wherein, The sealable container is configured to eliminate the need for a desiccant.

15. The assembly for delivering an analyte sensor according to claim 1, further comprising an applicator cap that is hermetically coupled to the housing using a gasket-less seal.

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