Applicator and assembly for insertion into in vivo analyte sensor

Abstract

Applicators and assemblies for insertion into an in vivo analyte sensor are provided. Wherein the assembly includes an insert, a first cradle assembly, a retraction spring, and a second cradle assembly, where the first cradle assembly, the retraction spring, and the second cradle assembly are configured to advance in a distal direction toward the skin of the subject from a proximal position located entirely within the interior of the insert to a distal position. The applicator includes an analyte sensor, a sensor electronics carrier, and a sharpening carrier, where the sensor electronics carrier and sharpening carrier are configured to advance from a first location within the applicator spaced from the skin surface to a second location adjacent the skin surface upon application of a first force to the applicator in a first direction. Also included is an applicator assembly for inserting an in vivo glucose sensor into a subject. The present disclosure provides a reliable sensor insertion device, for use in conjunction with a dermal sensor, easy to use by a patient, and less prone to error.

Description

[0001] This application is a divisional application of Chinese Patent Application No. 202211091194.1 entitled "Applicator and Assembly for Insertion of In Vivo Analyte Sensor", which in turn is a divisional application of Chinese Patent Application No. 201880020852.3 entitled "System, Apparatus and Method for Insertion of Analyte Sensor" (based on International Patent Application No. PCT / US2018 / 014745, filed on January 22, 2018). Technical Field

[0002] The subject matter described herein generally relates to systems, apparatuses, and methods for using an applicator and sensor control unit in an in vivo analyte monitoring system, particularly to an in vivo analyte sensor and assembly, and more specifically to an applicator assembly for inserting an in vivo glucose sensor into a subject's body. Background Technology

[0003] 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 them.

[0004] 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 judgment, pain associated with glucose testing, and cost.

[0005] To increase patient adherence to frequent glucose monitoring programs, in vivo analyte monitoring systems can be used, in which a sensor control device can be worn on the body of an individual requiring analyte monitoring. For improved personal 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 a sensor, such as a dermal sensor that senses the level of the user's analyte in bodily fluids located in the dermis, using an applicator or insertion mechanism, such that the sensor comes into contact with the bodily fluid. The sensor control device can also be configured to transmit analyte data to another device from which the individual or their healthcare provider (HCP) can review the data and make treatment decisions.

[0006] While current sensors are convenient for users, they are also prone to malfunction due to incorrect insertion. These malfunctions can result from user errors, lack of proper training, poor user coordination, overly complex procedures, and other issues. This is particularly true for analyte monitoring systems with dermal sensors, which are typically smaller in size than sensors used to measure analyte levels in interstitial fluid (ISF), and require insertion using shorter sharps (also known as “guides” or “needles”) than those used for ISF sensors. For example, some prior art systems may rely too heavily on the precise assembly and deployment of the sensor control device and applicator by the individual user. Other prior art systems may utilize sharps insertion and retrieval mechanisms that are prone to premature withdrawal before the sensor can be properly implanted. Additionally, for dermal sensors, some prior art systems may utilize sharps that are not optimally configured to create an insertion path in the dermis without damaging surrounding tissue. These and other challenges described herein can lead to incorrectly inserted or damaged sensors, resulting in inaccurate monitoring of a patient's analyte levels.

[0007] Therefore, there is a need for more reliable sensor insertion devices, systems, and methods, especially for use with dermal sensors that are easy for patients to use and less prone to errors. Summary of the Invention

[0008] This document provides example embodiments of systems, apparatus, and methods for assembling and using applicators and sensor control devices for in vivo analyte monitoring systems, and in particular, in which dermal sensors are used. The applicator can be provided to the user in a sterile package containing an electronic housing that includes the sensor control device. A separate structure from the applicator, such as a container, can also be provided to the user as a sterile package containing a sensor module and a sharps module. The user can couple the sensor module to the electronic housing, and the sharps can be coupled to the applicator via an assembly process that includes inserting the applicator into the container in a specific manner. After assembly, the applicator can be used to position the sensor control device on the human body, wherein the sensor comes into contact with the wearer's bodily fluids (e.g., skin fluid). The embodiments provided herein are improvements to prevent or reduce the possibility of incorrect sensor insertion or damage. Other improvements and advantages are also provided. Various configurations of these devices are described in detail through embodiments that are only examples.

[0009] After studying the following figures and detailed description, other systems, apparatuses, methods, features, and advantages of the subject matter described herein will be or will become apparent to those skilled in the art. All such additional systems, apparatuses, methods, features, and advantages are intended to be included in this specification, within the scope of the subject matter described herein, and protected by the appended claims. Features of the exemplary embodiments should in no way be construed as limiting the appended claims, particularly those features not explicitly described in the claims. Attached Figure Description

[0010] By studying the accompanying drawings, the details of the subject matter described herein, regarding its structure and operation, may be readily apparent, wherein the same reference numerals refer to the same parts. The parts in the drawings need not be to scale, but rather the emphasis is on illustrating the principles of the subject matter. Furthermore, all descriptions are intended to convey concepts, wherein relative dimensions, shapes, and other detailed properties are illustrated schematically rather than literally or precisely.

[0011] Figure 1 It is a system overview of sensor applicators, reading devices, monitoring systems, networks, and remote systems.

[0012] Figure 2A This is a block diagram depicting an example embodiment of a reading device.

[0013] Figure 2B and Figure 2C This is a block diagram depicting an example embodiment of a sensor control device.

[0014] Figure 3A This is a near-end perspective view depicting an example embodiment of a user preparing a tray for a component.

[0015] Figure 3B This is a side view depicting an example embodiment of a user preparing an applicator device for a component.

[0016] Figure 3C This is a near-end perspective view depicting an example embodiment of a user inserting an applicator device into a tray during assembly.

[0017] Figure 3D This is a near-end perspective view depicting an example embodiment of a user removing the applicator device from a tray during assembly.

[0018] Figure 3E This is a proximal perspective view depicting an example embodiment of a patient applying a sensor using an applicator device.

[0019] Figure 3F This is a proximal perspective view depicting an example embodiment of a patient with a sensor applied and an applicator device used.

[0020] Figure 4A This is a side view depicting an example embodiment of the applicator device coupled to the cap.

[0021] Figure 4B This is a side perspective view depicting an example embodiment of the applicator device and cap disengagement.

[0022] Figure 4C This is a perspective view depicting an example embodiment of the applicator device and the electronic device housing.

[0023] Figure 5 This is a near-end perspective view depicting an example embodiment of a tray coupled with a sterilization cap.

[0024] Figure 6A This is a near-end perspective sectional view depicting an example embodiment of a tray with a sensor delivery component.

[0025] Figure 6B It is a perspective view depicting the near end of the sensor delivery component.

[0026] Figure 7A This is a side view depicting an example embodiment of the housing.

[0027] Figure 7B This is a perspective view depicting an example embodiment of the housing.

[0028] Figure 7C This is a side sectional view depicting an example embodiment of the housing.

[0029] Figure 7D and Figure 7E This is a side sectional view depicting a locking rib portion of an example embodiment of a housing with a partial sheath.

[0030] Figure 7F and Figure 7G This is a side sectional view depicting the locking rib portion of another example embodiment of the housing and a portion of the sheath.

[0031] Figure 7H This is a side sectional view depicting the locking rib portion of another example embodiment of the housing and a portion of the sheath.

[0032] Figure 7I This is a side sectional view depicting the locking rib portion of another example embodiment of the housing and a portion of the sheath.

[0033] Figure 8A This is a side view depicting an example embodiment of the sheath.

[0034] Figure 8B This is a perspective view depicting an example embodiment of the sheath.

[0035] Figure 8C This is a close-up perspective view of an example embodiment depicting the distal side of the brake latch of the sheath.

[0036] Figure 8D This is a side view of an example embodiment depicting the features of the sheath.

[0037] Figure 8E This is an end view of an example embodiment of the sheath near the proximal end.

[0038] Figures 8F to 8H This is a perspective view depicting another example embodiment of the sheath during various stages of assembly with other applicator components.

[0039] Figure 9A This is a near-end perspective view depicting an example embodiment of a sensor electronics bracket.

[0040] Figure 9B This is a remote perspective view depicting an example embodiment of a sensor electronics bracket.

[0041] Figure 9C This is a remote perspective view depicting another example embodiment of a sensor electronics bracket.

[0042] Figure 9D This is a side sectional view depicting another example embodiment of a sensor electronics bracket, including its housing and sheath.

[0043] Figure 9E This is a close-up side sectional view depicting another example embodiment of a sensor electronics bracket together with its housing.

[0044] Figure 10A This is a near-end perspective view of an example embodiment of a sharp object holder.

[0045] Figure 10B This is a side sectional view depicting an example embodiment of a sharp object holder.

[0046] Figure 10C This is a side sectional view depicting another example embodiment of the sharp object holder assembly within the applicator.

[0047] Figure 10D This is a labeled side sectional view depicting another example embodiment of a sharp object holder assembly, together with a sensor electronics holder.

[0048] Figure 10E This is a side sectional view depicting another example embodiment of a sharp object holder assembly, which is part of a sensor electronics holder.

[0049] Figure 10F This is a side sectional view depicting another example embodiment of the sharp object holder assembly and sheath within the applicator.

[0050] Figure 11A This is a perspective view depicting an example embodiment of the sharp object module.

[0051] Figure 11B This is a perspective view of another example embodiment of the sharp object module.

[0052] Figure 11C and Figure 11D It describes Figure 11B A schematic diagram of the sharp object module.

[0053] Figure 11E and Figure 11F They are assembled with the sensor module. Figure 11B Side view and top view of the sharp object module.

[0054] Figure 11G This is a perspective view of another example embodiment of the sharp object module.

[0055] Figure 11H It describes Figure 11G A side view of the sharp object module.

[0056] Figure 11I and Figure 11J They are assembled with the sensor module. Figure 11G Side section view and side view of the sharp object module.

[0057] Figures 12A to 12D This is a side sectional view depicting an example embodiment of the applicator device during various deployment phases.

[0058] Figures 13A to 13D This is a side sectional view depicting another example embodiment of the applicator device during various deployment phases.

[0059] Figures 14A to 14C This is a side sectional view depicting another example embodiment of the applicator device during various deployment phases, wherein, Figure 14A-1 and Figure 14A-2 yes Figure 14A A partial enlarged view of the applicator device in the image; Figure 14B-1 and Figure 14B-2 yes Figure 14B A partial enlarged view of the applicator device in the image; Figure 14C-1 and Figure 14C-2 yes Figure 14C A partial enlarged view of the applicator device.

[0060] Figure 15A and Figure 15B This is a side sectional view depicting another example embodiment of the applicator device during various deployment phases.

[0061] Figures 16A to 16C This is a side sectional view depicting another example embodiment of the applicator device during various deployment phases.

[0062] Figure 17 This is a side sectional view depicting another example embodiment of the applicator device.

[0063] Figure 17-1 yes Figure 17 A partial enlarged view of the applicator device.

[0064] Figure 18 This is a partial cross-sectional view depicting another example embodiment of the applicator device. Detailed Implementation

[0065] Before describing this subject matter in detail, it will be understood that the invention is not limited to the specific embodiments described, as variations are of course possible. It will also be understood that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting, as the scope of the invention will be limited only by the appended claims.

[0066] As used herein and in the appended claims, the singular forms “a,” “an,” and “the” include plural references unless the context clearly indicates otherwise.

[0067] The publications discussed herein provide only their disclosure prior to the filing date of this application. Nothing herein is to be construed as an admission that the invention is not qualified prior to such publications due to prior disclosure. Furthermore, the dates of the publications provided may differ from the actual publication dates, which may require independent verification.

[0068] Typically, embodiments of the present invention include systems, apparatus, and methods for use with dermal sensor insertion applicators in conjunction with in vivo analyte monitoring systems. Therefore, many embodiments include in vivo analyte sensors structurally configured such that at least a portion of the sensor is located in or capable of being located in a 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.

[0069] Furthermore, for each embodiment of the methods disclosed herein, the systems and apparatuses capable of performing each embodiment of those embodiments are covered within the scope of the invention. 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, transmitter, receiver, processor, and / or controller (e.g., for executing instructions), which can perform any and all method steps or facilitate the execution of any and all method steps. These sensor control device embodiments can be used and may be able to be used to implement those steps performed by the sensor control device according to any and all methods described herein.

[0070] As described above, numerous embodiments of systems, apparatuses, and methods are described herein, providing improved assembly and use of dermal sensor insertion devices for use with in vivo analyte monitoring systems. In particular, several embodiments of the invention are designed to improve sensor insertion methods for in vivo analyte monitoring systems, specifically to prevent premature retraction of the inserted sharp object during the sensor insertion process. For example, some embodiments include a dermal sensor insertion mechanism with increased firing velocity and delayed sharp object retraction. In other embodiments, the sharp object retraction mechanism may be motion-actuated such that the sharp object is not retracted until the user pulls the applicator away from the skin. Thus, to name only a few advantages, these embodiments reduce the likelihood of premature retraction of the inserted sharp object during sensor insertion; reduce the likelihood of incorrect sensor insertion; and reduce the likelihood of damage to the sensor during insertion. Several embodiments of the invention also provide an improved sharp object insertion module to address the small size of dermal sensors and the relatively shallow insertion path present in the dermal layer of the object. Additionally, several embodiments of the invention are designed to prevent undesirable axial and / or rotational movement of the applicator components during sensor insertion. Therefore, to name just a few advantages, these embodiments reduce the instability of the positioned dermal sensor, irritation at the insertion site, damage to surrounding tissues, and the possibility of capillary rupture leading to blood contamination of the skin fluid. Additionally, to mitigate inaccurate sensor readings that may be caused by trauma at the insertion site, several embodiments of the invention reduce the depth of needle penetration relative to the sensor tip during insertion.

[0071] However, before describing these aspects of the embodiments in detail, it is necessary to first describe examples of devices that may exist in, for example, in an in vivo analyte monitoring system, and examples of their operation, all of which can be used in conjunction with the embodiments described herein.

[0072] Various types of in vivo analyte monitoring systems exist. For example, a "continuous analyte monitoring" system (or "continuous glucose monitoring" system) can continuously transmit data from a sensor control device to a reader without prompting, such as automatically according to a schedule. As another example, a "flash analyte monitoring" system (or "flash glucose monitoring" system, or simply "flash system") can transmit data from a sensor control device in response to a scan or request for data from a reader device, for example, using near field communication (NFC) or radio frequency identification (RFID) protocols. In vivo analyte monitoring systems may also operate without lever calibration.

[0073] In vivo analyte monitoring systems can be distinguished from "ex vivo" systems, which come into contact with biological samples outside the body (or "extracorporeal") and typically include an instrument with a port for receiving an analyte test strip carrying the user's bodily fluids, which can be analyzed to determine the user's blood glucose level.

[0074] An in vivo monitoring system may include sensors that, when located inside the body, come into contact with the user's bodily fluids and sense the levels of analytes contained therein. The sensors may be part of a sensor control unit located on the user's body and containing electronics and a power source that enable and control the sensing of the analytes. To name just a few examples, 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.

[0075] 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 and form. To name just a few examples, this device and its variations may be referred to as a “handheld reading device,” “reading device” (or simply “reader”), “handheld electronics” (or simply “handheld device”), “portable data processing” device or unit, “data receiver,” “receiver” device or unit (or simply “receiver”), or “remote” device or unit. Other devices, such as personal computers, have also been used with or included in in vivo and in vitro monitoring systems.

[0076] Example embodiments of in vivo analyte monitoring systems

[0077] Figure 1 This is a conceptual diagram depicting an example embodiment of an analyte monitoring system 100, which includes a sensor applicator 150, a sensor control device 102, and a reading 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 a 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 wired or wireless technologies can be used to communicate with the reading device 120 via communication path 140. 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 reading device 120, and can use power port 123 to recharge the device battery. See below for reference. Figure 2AFurther details regarding the reading device 120 are provided below. The reading device 120 can communicate with the local computer system 170 via communication path 141 using wired or wireless technology. The local computer system 170 may include one or more of a laptop computer, desktop computer, tablet computer, tablet phone, smartphone, set-top box, video game console, or other computing device, and wireless communication may include any of a number of applicable wireless network 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 using the wired or wireless technology described above, similar to how the reading device 120 may communicate with the network 190 via communication path 142. The network 190 may be any of many networks, such as private and public networks, local area networks (LANs), or wide area networks (WANs). The trusted computer system 180 may include a server that provides authentication services and secure data storage, and may communicate with the network 190 via communication path 144 using wired or wireless technology.

[0078] Example embodiments of reading devices

[0079] Figure 2A This is a block diagram depicting an example embodiment of a reader device 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. Further, it may include a multi-function transceiver 232 that can communicate with the antenna 234 via Wi-Fi, NFC, Bluetooth, BTLE, and GPS. As those skilled in the art will understand, these components are electrically and communicatively coupled in a manner that forms a functional device.

[0080] Example embodiments of sensor control devices

[0081] Figure 2B and Figure 2C This is a block diagram depicting an example 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 2BThe 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 transmitter, 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 across many different chips (and portions thereof).

[0082] Memory 163 is also included within ASIC 161 and can be shared by various functional units within ASIC 161, or distributed across 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 coupled to power supply 170, which can be a coin cell 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 reading device 120 (not shown), for example, where a resident software application requires minimal further processing to display the data.

[0083] Figure 2C Similar to Figure 2B The system comprises two discrete semiconductor chips, 162 and 174, which may be packaged together or separately. Here, AFE 162 resides on ASIC 161. Processor 166 is integrated on chip 174 with power management circuitry 164 and communication circuitry 168. AFE 162 includes memory 163, and chip 174 includes memory 165, which may be isolated or distributed internally. In one example embodiment, 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 embodiment, 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.

[0084] Example embodiments of the assembly process for sensor control devices

[0085] The components of the sensor control device 102 can be obtained by the user in multiple packages, and require final assembly by the user before being delivered to the appropriate user location. Figures 3A to 3D An example embodiment of the process by which a user assembles the sensor control device 102 is depicted, including preparing individual components before coupling the components to prepare the sensor for delivery. Figures 3E to 3F An example embodiment is described in which the sensor control device 102 is delivered to the appropriate delivery location by selecting an appropriate delivery location and applying the device 102 to the appropriate user location.

[0086] Figure 3A This is a near-end perspective view depicting an example embodiment of a container 810 prepared by a user for the assembly process, the container here configured as a tray (although other packaging may also be used). This preparation is accomplished by the user removing the cover 812 from the tray 810 to expose the platform 808, for example by peeling off the non-adhesive portion of the cover 812 from the tray 810, thus removing the adhesive portion of the cover 812. In various embodiments, removing the cover 812 is appropriate as long as the platform 808 is sufficiently exposed within the tray 810. The cover 812 can then be set aside.

[0087] Figure 3B This is a side view depicting an example embodiment of an applicator device 150 being prepared for assembly by a user. The applicator device 150 may be provided in a sterile package sealed by a cap 708. Preparation of the applicator device 150 may include separating the housing 702 from the cap 708 to expose the sheath 704. Figure 3C This can be achieved by unscrewing (or otherwise separating) the cap 708 from the housing 702. The cap 708 can then be set aside.

[0088] Figure 3C This is a near-end perspective view depicting an example embodiment where a user inserts the applicator device 150 into the tray 810 during assembly. Initially, after aligning the housing orientation feature 1302 (or, slot or recess) and the tray orientation feature 924 (support or brake), the user can insert the sleeve 704 into the platform 808 within the tray 810. Inserting the sleeve 704 into the platform 808 temporarily unlocks the sleeve 704 relative to the housing 702 and also temporarily unlocks the platform 808 relative to the tray 810. At this stage, removing the applicator device 150 from the tray 810 will result in the same state as before the applicator device 150 was initially inserted into the tray 810 (i.e., the process can be reversed or interrupted at this point and then repeated without result).

[0089] The sleeve 704 can be held in place within the platform 808 relative to the housing 702 while the housing 702 advances distally, coupling with the platform 808 to advance distally relative to the tray 810. This step unlocks and folds the platform 808 within the tray 810. The sleeve 704 can contact and disengage a locking feature (not shown) within the tray 810, which unlocks the sleeve 704 relative to the housing 702 and prevents the sleeve 704 from moving (relatively) while the housing 702 continues to advance distally. At the end of the advance of the housing 702 and the platform 808, the sleeve 704 is permanently unlocked relative to the housing 702. Sharp objects and sensors (not shown) within the tray 810 can be coupled to an electronic housing (not shown) within the housing 702 at the end of the advance distally of the housing 702. The operation and interaction of the applicator device 150 and the tray 810 are further described below.

[0090] Figure 3D This is a proximal perspective view depicting an example embodiment of a user removing the applicator device 150 from the tray 810 during assembly. The user can remove the applicator 150 from the tray 810 by advancing the housing 702 proximal to the tray 810 or by other movements having the same final effect as disengaging the applicator 150 from the tray 810. The applicator device 150 is removed, in which the sensor control device 102 (not shown) is fully assembled (sharp object, sensor, electronics) and positioned for transport.

[0091] Figure 3E This is a proximal perspective view depicting an example embodiment of a patient using the applicator device 150 to apply the sensor control device 102 to a target area of ​​the skin (e.g., the abdomen or other suitable location). Advancing the housing 702 distally allows the sheath 704 to fold within the housing 702 and applies the sensor to the target location, causing an adhesive layer on the underside of the sensor control device 102 to adhere to the skin. As the housing 702 is fully advanced, the sharp object automatically retracts, while the sensor (not shown) remains in place to measure analyte levels.

[0092] Figure 3F This is a proximal perspective view of an example embodiment of a patient with the sensor control device 102 in the application position. The user can then remove the applicator 150 from the application site.

[0093] Compared with existing technology systems, the reference Figures 3A-3FThe system 100, as described elsewhere herein, can reduce or eliminate the possibility of accidental breakage, permanent deformation, or improper assembly of the applicator components. Because the applicator housing 702 directly engages the platform 808 when the sleeve 704 is unlocked, rather than indirectly via the sleeve 704, the relative angle between the sleeve 704 and the housing 702 will not cause breakage or permanent deformation of the arm or other components. The likelihood of relatively large forces (e.g., in conventional devices) during assembly is reduced, which in turn reduces the possibility of unsuccessful user assembly.

[0094] Example embodiments of sensor applicator devices

[0095] Figure 4A This is a side view depicting an example embodiment of the applicator device 150 coupled to the nut 708. This is an example of how the applicator 150 is transported to and received by the user before the user assembles the sensor. 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 application device 150 for removing the electronic device housing 706 and the adhesive patch 105 from within the sensor electronics bracket 710 of the sheath 704 when the cap 708 is in place.

[0096] Example embodiments of tray and sensor module components

[0097] Figure 5 This is a near-end perspective view of an example embodiment of a tray 810 having a sterilization cap 812 removably coupled thereto, which may represent how the package is transported to and received by the user prior to assembly.

[0098] Figure 6A This is a near-end perspective sectional view depicting the sensor delivery components within tray 810. Platform 808 is slidably coupled within tray 810. Desiccant 502 is fixed relative to tray 810. Sensor module 504 is mounted within tray 810.

[0099] Figure 6B This is a more detailed near-end perspective view of sensor module 504. Here, the retaining arm extension 1834 of platform 808 releasably secures sensor module 504 in place. Module 2200 is coupled to connector 2300, sharps module 2500, and sensor (not shown), allowing it to be removed as a whole during assembly.

[0100] Example embodiment of the applicator housing

[0101] Figure 7AThis is a side view depicting an example embodiment of an applicator housing 702, which may include an internal cavity with support structures for applicator function. A user can push the housing 702 in a distal direction to initiate 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 example embodiment, various features are shown, including a housing orientation feature 1302 for orienting the device during assembly and use. A tamper ring groove 1304 may be a recess located around the outer periphery of the housing 702, at the distal end of the tamper ring protector 1314, and at the proximal end of the tamper ring retainer 1306. The tamper ring groove 1304 retains the tamper ring, allowing the user to identify whether the device has been tampered with or otherwise used. The housing thread 1310 secures the housing 702 to the complementary thread on the cap 708 by aligning with and rotating in a clockwise or counterclockwise direction. Figure 4A and Figure 4B The side gripping area 1316 of the housing 702 provides an outer surface location where a user can grip the housing 702 for use. The gripping protrusion 1318 is a ridge that slightly bulges relative to the side gripping area 1316, which helps to easily remove the housing 702 from the cap 708. The shark teeth 1320 may be protrusions with flat sides located on clockwise edges to cut the tamper-evident ring (not shown) and retain the tamper-evident ring in place after the user has unscrewed the cap 708 and the housing 702. In the example embodiment, four shark teeth 1320 are used, but more or fewer shark teeth may be used as needed.

[0102] Figure 7B This 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, with three 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 rib that can be extended along sheath 704 (e.g., reference 704). Figure 8A The surface of the described guide rail 1418 passes through the guide edge (also referred to as the "sheath guide") 1326. The insertion rigid stop 1322 may be a flat, distal-facing surface of the housing guide rib 1321 located near the proximal end of the housing guide rib 1321. The insertion rigid stop 1322 provides for abutting the sheath 704 during use. Figure 8BThe sensor electronics bracket travel limiter surface 1420 prevents any further movement of the sensor electronics bracket travel limiter surface 1420 in the proximal direction. During assembly, the bracket connecting post 1327 passes through the hole 1510 of the sensor electronics bracket 710. Figure 9A The sensor electronics bracket connection 1328 may be a circular, distal-facing surface of the housing guide rib 1321 that is connected to the sensor electronics bracket 710.

[0103] Figure 7C This depicts a side cross-section of an example embodiment of the housing. In the example embodiment, the side cross-sectional outlines of the housing guide rib 1321 and locking rib 1340 are shown. The locking rib 1340 includes a sheath hook-and-loop guide feature 1330 near its distal end, which flares outward from the central axis 1346 of the housing 702 at its distal end. Each sheath hook-and-loop guide feature 1330 results in... Figure 8C The brake latch round portion 1404 of the sheath 704 bends inward toward the central axis 1346 as the sheath 704 moves toward the proximal end of the housing 702. Once past the distal end of the sheath latch guide feature 1330, the brake latch 1402 of the sheath 704 is locked in place in the locking groove 1332. Thus, due to the surface having a plane nearly perpendicular to the central axis 1346, such as... Figure 8C As shown in the brake latch flat portion 1406, the brake latch 1402 cannot be easily moved in the distal direction.

[0104] As the housing 702 moves further toward the skin surface in the distal direction, and as the sheath 704 advances toward the distal end of the housing 702, the brake latch 1402 moves into the unlocking recess 1334, and the applicator 150 is in the "standby" position, ready for use. When the user applies further force to the proximal end of the housing 702 while pressing the sheath 704 against the skin, the brake latch 1402 passes over the firing brake 1344. This initiates the firing sequence (e.g., as referenced) by releasing stored energy in the deflected brake latch 1402. Figures 12A to 12D(Described) The brake latch travels proximally toward the sheath stop ramp 1338 relative to the skin surface, which is slightly flared outward relative to the central axis 1346 and slows the movement of the sheath 704 during firing sequences. After the unlocking recess 1334, the next recess encountered by the brake latch 1402 is the final locking recess 1336, which the brake latch 1402 enters at the end of a user-performed stroke or push sequence. The final locking recess 1336 may be a proximally facing surface perpendicular to the central axis 1346, which engages the brake latch flat portion 1406 after the brake latch 1402 has passed through, and prevents reuse of the device by firmly holding the sheath 704 in place relative to the housing 702. The insertion rigid stop 1322 of the housing guide rib 1321 prevents the sheath 704 from advancing proximally relative to the housing 702 by engaging the sensor electronics bracket travel limiter surface 1420.

[0105] Figure 7D and Figure 7E This is a close-up side view of an example embodiment of the locking rib 1340 of the applicator housing 702 as the brake latch 1402 of the sheath 704 moves toward the proximal end of the housing 702. Figure 7D The housing 704 is shown in a "locked" state, wherein the brake circular portion 1404 of the brake latch 1402 has passed over the housing latch insertion feature 1330 and is positioned in the locking groove 1332 of the locking rib 1340. When force is applied to the proximal end of the housing 702, the brake circular portion 1404 advances proximally into the unlocking groove 1334, placing the applicator 150 in a "standby" position. When further force is applied to the proximal end of the housing 702, the applicator 150 is "fired" as the brake circular portion 1404 advances proximally from the unlocking groove 1334 and passes the firing brake 1344. Then, the housing 704 is further advanced proximally, such that the brake circular portion 1404 slides forward on the firing surface 1337, as... Figure 7E As shown. In this embodiment, the firing surface 1337 is substantially parallel to the central axis 1346. As the sheath 704 continues to advance proximally, the brake circular portion 1404 reaches the sheath stop ramp 1338, which slows the movement of the sheath 704. When the brake circular portion 1404 reaches the final locking groove 1336, the brake latch flat portion 1406 (not shown) is engaged and securely holds the sheath 704 in place relative to the housing 702.

[0106] Figure 7F and Figure 7GThis is a close-up side view of an alternative embodiment of the locking rib 2340, designed to increase the firing velocity of a sharp object from a sensor applicator. Here, the locking rib 2340 includes an inwardly braking ramp 2335 to reduce friction between the sheath 704 and the housing 2702 during firing. The locking rib 2340 also includes a sheath stop ramp 2338 located proximal to the firing surface 2337. Figure 7F In the diagram, the sheath 704 is initially shown in a "locked" state, with the brake circular portion 1404 of the brake latch 1402 having passed over the sheath latch insertion feature 2330 and positioned in the locking groove 2332. When force is applied to the proximal end of the housing 2702, the brake circular portion 1404 advances into the unlocked groove 2334, placing the applicator 150 in a "ready" position. When further force is applied to the proximal end of the housing 2702, the applicator 150 is "activated" as the brake circular portion 1404 passes the activated brake 2344.

[0107] like Figure 7G As shown, the brake circular portion 1404 then advances towards the proximal end of the housing 2702 in the "free travel" state, passing the inward brake ramp 2335. When advancing proximal to the "free flight" state, the brake circular portion 1404 may be discontinuous or not in contact with the inward brake ramp 2335 and the firing surface 2337. At this point, since there is almost no friction between the brake circular portion 1404 and the inward brake ramp 2335 and firing surface 2337, the brake circular portion 1404 can advance easily and quickly, thus increasing the firing speed of the sharp object from the applicator. Relative to Figure 7D and Figure 7E The illustrated embodiment further positions a sheath stop ramp 2338 proximally along the locking rib 2340, providing an edge portion to frictionally engage the brake circle 1404 and slow the movement of the sheath 704. The sheath stop ramp 2338 may have an inclined shape and provide increased frictional contact as the brake circle 1404 advances in the proximal direction. Finally, when the brake circle 1404 reaches the final locking recess 2336, the brake latch flat portion 1406 (not shown) engages and securely holds the sheath 704 in place relative to the housing 2702. The locking recess 2336 prevents rearward or distal movement of the brake circle 1404 and the sheath 704. This embodiment reflects relative to Figure 7D and Figure 7E The embodiments depicted in the text have a higher firing rate, which also helps prevent the premature retraction of sharp objects.

[0108] Figure 7HThis is a close-up side view of an alternative embodiment of the locking rib 6340, which is designed to maintain a downward force on the sheath 6704 during firing, thereby preventing unwanted movement of the sheath 6704 during sensor insertion. Here, the sheath 6704 is shown in a “locked” state, with the brake circular portion 6404 of the brake latch 6402 located in the locking recess 6332. When force is applied to the proximal end of the housing 6702, the brake circular portion 6404 advances into the unlocking recess 6334, placing the applicator in a “ready” position. When further force is applied to the proximal end of the housing 6702, the applicator is “fired,” and the brake circular portion 6404 advances toward the proximal end of the housing 6702 on the inclined firing surface 6338. The angled firing surface 6338 may be angled toward the central axis 1346, thereby increasing the downward force on the sheath 6704 as the brake circular portion 6404 advances in the proximal direction. In the depicted embodiment, the brake circular portion 6404 is in continuous contact with the angled firing surface 6338. The locking groove 6336 prevents the brake circular portion 6404 and the sheath 6704 from moving rearward or distally. This embodiment reflects a slower firing speed compared to the aforementioned embodiments and can be used, for example, as a reference. Figures 14A-14C and Figures 15A-15B Describes the process of a sharp object retracting due to motion.

[0109] Figure 7I This is a close-up side view of another alternative embodiment of the locking rib 7340, also designed to maintain a downward force on the sheath 6704 during firing, which in turn prevents unwanted movement of the sheath 6704 during sensor insertion. Here, the sheath 6704 is shown in a "fired" state, with the brake circular portion 6404 of the brake latch 6402 positioned in a bidirectional locking groove 7336. As the brake circular portion 6404 advances into the bidirectional locking groove 7336, further movement of the sheath 6704 in the proximal or distal direction is prevented. This reduces unwanted movement of the sheath 6704 during sensor insertion. Furthermore, in some embodiments, as referenced... Figures 14A-14C and Figures 15A-15B The described bidirectional locking groove 7336 provides retention of the sheath 6704 during the retraction process of a motion-actuated sharp object. For example, it can be... Figure 7I As seen in the diagram, the angled firing surface 7338 is angled toward the central axis 1346, such that the downward force on the sheath 6704 increases as the brake circular portion 6404 advances in the proximal direction. In the depicted embodiment, the brake circular portion 6404 is in continuous contact with the angled firing surface 7338. This embodiment reflects a slower firing speed and can be used, for example, as a reference. Figures 14A-14C and Figures 15A-15B Describes the process of a sharp object retracting due to motion.

[0110] Example embodiment of the applicator sheath

[0111] Figure 8A and Figure 8B The images depict a side view and a perspective view of an exemplary embodiment of the sheath 704. In this exemplary embodiment, the sheath 704 can grade the sensor control device 102 above the user's skin surface before application. The sheath 704 may also include features to help hold a sharp object 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 brake latch 1402 is located near the proximal end of the sheath 704, which will be referenced below. Figure 8C Further description. The sheath 704 may have a generally cylindrical cross-section, with a first radius at the proximal portion (closer to the top of the figure) shorter than a second radius at the distal portion (closer to the bottom of the figure). A plurality of brake gaps 1410 are also shown, three in the example embodiment. The sheath 704 may include one or more brake gaps 1410, each brake gap being a cutout having space for the sheath latch guide feature 1330 to enter distally until the distal surface of the locking rib 1340 contacts the proximal surface of the brake gap 1410.

[0112] Guide rails 1418 are disposed between the sensor electronics bracket travel limiter face 1420 and the cutout around the locking arm 1412 at the proximal end of the sheath 704. Each guide rail 1418 may be a channel between two ridges, wherein the guide edge 1326 of the housing guide rib 1321 may slide relative to the sheath 704 at the distal end.

[0113] Locking arms 1412 are located near the distal end of the sheath 704 and may include an attachment distal end and a free proximal end, the free proximal end of which may include a locking arm connector 1416. When the locking arm connector 1416 of the locking arm 1412 engages the locking connector 1502 of the sensor electronics bracket 710, the locking arm 1412 can lock the sensor electronics bracket 710 to the sheath 704. Locking arm reinforcing ribs 1414 may be located near the center of each locking arm 1412 and may serve as reinforcement points for other weak points of each locking arm 1412 to prevent excessive bending or breakage of the locking arm 1412.

[0114] Brake latch reinforcement feature 1422 can be positioned along the distal portion of brake latch 1402 and can provide reinforcement to brake latch 1402. Alignment notch 1424 can be a cutout near the distal end of sheath 704, providing an opening for the user to align with the sheath orientation feature of platform 808. Reinforcing rib 1426 can include here a triangular arched wall, which provides support for brake base 1436. Housing guide clearance 1428 can be a cutout for the distal surface of housing guide rib 1321 to slide during use.

[0115] Figure 8C This is a close-up perspective view depicting an exemplary embodiment of the brake latch 1402 of the housing 704. The brake latch 1402 may include a brake latch bridge 1408 located near or at its proximal end. The brake latch 1402 may also include a brake latch flat 1406 located on the distal side of the brake latch bridge 1408. The outer surface of the brake latch bridge 1408 may include a brake latch circular portion 1404, which is a circular surface that allows the brake latch bridge 1408 to move more easily through the inner surface of the housing 702 (e.g., locking rib 1340).

[0116] Figure 8D This is a side view depicting an example embodiment of the sheath 704. Here, the alignment notch 1424 is relatively close to the brake clearance 1410. The brake clearance 1410 is located at a relatively proximal position on the distal portion of the sheath 704.

[0117] Figure 8E This is an end view depicting an example embodiment of the proximal end of the sheath 704. Here, the rear wall 1446 for the guide rail provides a channel for slidably coupling with the housing guide rib 1321 of the housing 702. The sheath rotation limiter 1448 may be a slot that reduces or prevents rotation of the sheath 704.

[0118] Figures 8F to 8H This is a perspective view of an alternative example embodiment of the sheath 6704 at different stages of assembly with other components of the applicator. Figure 8F As shown, sheath 6704 may have many features similar to those in the previous reference. Figures 8A-8C The sleeve 704 described has the same features. For example, the sleeve 6704 may include one or more brake latches 6404 having one or more brake circular portions 6402 attached thereto. However, the overall length of the sleeve 6704 may be shorter than that of the sleeve 702. In addition, the sleeve 6704 may include one or more inner sleeve ribs 6425 disposed on the inner surface of the sleeve 6704, and these ribs extend inward in a direction toward the central axis of the sleeve 6704.

[0119] Go to Figure 8GThe perspective view shows the assembly stage of the sleeve 6704 with the applicator housing 6702 and the sensor electronics bracket 6710. One or more inner sleeve ribs 6425 of the sleeve 6704 can connect with one or more corresponding rib slots 6519 in the sensor electronics bracket 6710. The mating connection between the corresponding ribs 6425 and slots 6519 helps maintain the axial alignment of the sleeve 6704 and the sensor electronics bracket 6710 during the sensor insertion process. Furthermore, the connection between the ribs 6425 and slots 6519 reduces lateral and rotational movement between the applicator components, which in turn reduces the possibility of incorrect sensor insertion.

[0120] Go to Figure 8H The perspective view shows the assembly stage of the sheath 6704 with the applicator housing 6702 and the sensor electronics housing 706, which has been inserted into the sensor electronics bracket 6710. The inner sheath rib 6425 is also shown.

[0121] It should be noted that although six inner sheath ribs 6425 and six corresponding rib slots 6519 are depicted, any number of ribs and slots fall entirely within the scope of the invention. Furthermore, while ribs 6425 are depicted as having rounded surface edges, in other embodiments, ribs 6425 may have rectangular or triangular shapes, and rib slots 6519 may have corresponding receiving shapes for connection with ribs 6425. Additionally, although ribs 6425 are depicted as being disposed on the inner circumferential surface of sheath 6704, ribs 6425 may also be disposed on any other surface of sheath 6704, or on the portion therein that contacts the sensor electronics bracket 6710.

[0122] Example embodiment of sensor electronics bracket

[0123] Figure 9AThis is a proximal perspective view depicting an example embodiment of a sensor electronics holder 710 that holds sensor electronics within an applicator 150. It also holds a sharps holder 1102 with a sharps module 2500. In this example embodiment, the sensor electronics holder 710 generally has a hollow, flat cylindrical shape and may include one or more deflectable sharps holder 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 brake or retaining feature 1526 located at or near its proximal end. A shock-absorbing lock 1534 may be an outwardly extending extension on the outer circumference of the sensor electronics holder 710 and may lock the sensor electronics holder 710 to increase safety before detonation. Rotation limiter 1506 may be a relatively short protrusion extending proximally on the proximal surface of sensor electronics bracket 710, which limits rotation of bracket 710. Sharp object bracket locking arm 1524 may be connected to sharp object bracket 1102, as shown below. Figures 10A-10E Described.

[0124] Figure 9B This is a distal perspective view of the sensor electronics holder 710. Here, one or more sensor electronics holding spring arms 1518 (e.g., three) are generally biased toward the position shown and include a brake 1519 that can pass over 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 on 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 brake 1519 from the sensor control device 102, thereby releasing the sensor control device 102 from the applicator 150.

[0125] Figure 9C This is a perspective view of an alternative example embodiment of the sensor electronics bracket 6710. (As shown) Figure 9C As shown, the sensor electronics bracket 6710 may have many features similar to those in the previous reference. Figures 9A to 9B The sensor electronics bracket 710 described has the same features. Additionally, the sensor electronics bracket 6710 also includes one or more slot ribs 6519 disposed along the outer circumferential surface. (As in...) Figures 8F-8H As best seen in the image, the notch rib 6519 is configured to connect with the inner sheath rib 6425 to maintain axial alignment between the sheath and the sensor electronics bracket, and to reduce lateral and rotational movement between the applicator components during the sensor insertion process.

[0126] Figure 9D and Figure 9E Alternative embodiments of a sensor electronics holder for insertion into the dermis are described. These embodiments include a retaining mechanism to couple the applicator housing to the sensor electronics holder while also allowing the sensor electronics holder to advance a limited distance from proximal to distal during sharp object insertion into the skin. The retaining mechanism is operable to further increase the velocity of sharp object insertion during firing while delaying sharp object retraction, as referenced below. Figures 13A-13D Further described. In other embodiments (e.g., as...) Figures 14A-14C and Figures 15A-15B As shown, the retaining mechanism can also provide a displacement area between the sensor electronics bracket and the sheath, through which the motion-actuated sharp object retaining mechanism can be activated.

[0127] Figure 9D This is a side sectional view of an alternative embodiment of the sensor electronics bracket 2710, shown here with an applicator housing 3702 and a sheath 704. Here, the applicator 150 is depicted in a "locked state," with the brake circular portion 1404 of the sheath 704 positioned in a locking groove 2332 of the locking rib 2340 of the housing 3702. A thermal post 1333 is provided at the distal end of the housing guide rib 3321 of the housing 3702. The thermal post 1333 can extend through the hole 1510 of the sensor electronics bracket 2710 in the distal direction. The distal portion 1339 of the thermal post 1333 can be opened such that the distal portion is larger than the hole 1510 of the sensor electronics bracket 2710, and to prevent the thermal post 1333 from slipping out of the hole 1510 due to the resistance of the hole flange 1513. The thermal post 1333 may have a length greater than the thickness of the bore flange 1513, allowing for spaced movement between the sensor electronics bracket 2710 and the housing 3702 along a longitudinal axis passing through the center of the thermal post 1333 (as in...). Figures 13A-13D (As further described in the text). Figure 9D As shown, when the applicator 150 is depicted as being in a “locked state,” the proximal end (or base) of the hot post 1333 approaches or aligns with the sensor electronics bracket 2710, the bore 1510, and the bore flange 1513. During the firing sequence, the sensor electronics bracket 2710 is displaced in the distal direction, creating a gap between the proximal end (or base) of the hot post 1333 and the sensor electronics bracket 2710, the bore 1510, and the bore flange 1513.

[0128] Figure 9EThis is a side sectional view of an alternative embodiment of the sensor electronics bracket 710 and housing 4702. One or more latch arms 1329 are provided at the distal end of the housing guide rib 4321 of the housing 4702. The latch arms 1329 extend distally through the hole 1510 of the sensor electronics bracket 2710. A latch brake 1331 is provided at the end of each latch arm 1329. The latch brake 1331 can open such that the distal end of the latch arm 1329 is larger than the hole 1510 of the sensor electronics bracket 2710, and prevents the latch arm 1329 from completely disengaging from the hole 1510 due to the hole flange 1513. The latch arm 1329 may also have a length greater than the thickness of the flange 1513, allowing spaced movement between the sensor electronics bracket 2710 and the housing 4702 along the longitudinal axis. Figure 9E The movement of the embodiment depicted during the "lock" and "fire" phases is similar to Figure 9D The movement of the illustrated embodiment, and Figures 12A-12D and Figures 13A-13D This is further illustrated in the text. Additionally, see reference [link / reference] Figure 9D and Figure 9E The described embodiments can also be implemented via a motion-actuated sharp object retraction mechanism, which will be referred to Figures 14A-14C and Figures 15A-15B Further description.

[0129] Example embodiment of a sharp object holder

[0130] Figure 10A and Figure 10B These are a proximal perspective view and a side sectional view, respectively, depicting an exemplary embodiment of the sharps holder 1102. The sharps holder 1102 can grasp and hold the sharps module 2500 within the applicator 150. It can also automatically retract due to one or more springs changing from a preloaded compressed state to an expanded state during insertion, as shown in the reference... Figures 12A-12D and Figures 13A-13D Described. An anti-rotation groove 1608 may be located near the distal end of the sharp object holder 1102, when it is situated within the central area of ​​the sharp object holder locking arm 1524 (e.g.). Figure 9A As shown), the anti-rotation groove prevents the sharp object holder 1102 from rotating. The anti-rotation groove 1608 may be located between portions of the sharp object holder base ramp 1610, which ensures that the sharp object holder 1102 is fully retracted through the sleeve 704 when the sharp object holder 1102 retracts at the end of the expansion process.

[0131] like Figure 10BAs shown, sharps retaining arms 1618 may be located inside the sharps holder 1102 about a central axis, and a sharps retaining clip 1620 may be included at the distal end of each arm 1618. The sharps retaining clip 1620 may have a proximal surface that may be nearly perpendicular to the central axis and may abut against the distal-facing surface of the sharps hub 2516. Figure 11A ).

[0132] Figures 10C to 10E Alternative embodiments of sharp object holder assemblies are depicted, each comprising an inner sharp object holder and an outer sharp object holder. These embodiments provide a delay resulting from a separate retraction process for each sharp object holder, occurring during the firing sequence, wherein a dermal sensor is implanted into the dermis of the object prior to sharp object retraction. The introduction of this delay significantly reduces the likelihood of the sharp object retracting prematurely during the insertion process.

[0133] Figure 10C This is a side view of an alternative embodiment of a two-piece sharps holder assembly, including an inner sharps holder 3102 and an outer sharps holder 3152, as well as a sensor electronics holder 710, a sheath 704, and a housing 2702. The inner sharps holder 3102 may include one or more sharps retaining arms 3104 for retaining a sharps module 2500. The sharps retaining arms 3104 may further include sharps retaining clips 3106 located at the distal end of each arm 3104. Figure 11A As shown, the sharps retainer 3106 may have a proximal surface that is nearly perpendicular to the central axis and may abut the distal surface of the sharps hub 2516. A bottom internal spring retaining channel 3108 is provided on the proximal surface of the internal sharps holder 3102, which retains the distal end of the internal spring 1106, shown as preloaded and compressed before the sharps holder assembly retracts. One or more internal holder latches 3110 are also provided at or near the proximal end of the internal sharps holder 3102. The internal holder latches 3110 may include a substantially flat surface facing the distal end of the applicator 150 and extending radially outward from the central longitudinal axis of the internal sharps holder 3102.

[0134] Still referencing Figure 10CAn external sharps bracket 3152 may be located outside and surrounding the internal sharps bracket 3102. At the proximal end of the external sharps bracket 3152, a top internal spring retaining channel 3158 is provided, which can retain the proximal end of the internal spring 1106. The top internal spring retaining channel 3158 of the external sharps bracket 3152 and the bottom internal spring retaining channel 3108 of the internal sharps bracket 3102 each provide a surface for retaining the end of the internal spring 1106. The external sharps bracket 3152 may also include an external spring retaining channel 3162 for retaining the proximal end of an external spring 1104, which is also shown in a preloaded and compressed state before the sharps bracket assembly retracts. Figure 10C As shown, the outer spring 1104 is depicted as having a larger length and radius than the inner spring 1106. However, springs 1104 and 1106 may have equal dimensions and / or radii, or, alternatively, the inner spring 1106 may have a larger radius and / or length than the outer spring 1104. In some embodiments, the outer spring 1104 has a stiffness equal to or greater than that of the inner spring 1106.

[0135] Refer again Figure 10C The external sharps holder 3152 may also include one or more external holder latches 3160. The external holder latches 3160 may include a substantially flat surface facing the proximal end of the applicator 150 and extending radially inward toward the central longitudinal axis of the external sharps holder 3152. The flat surfaces of the external holder latches 3160 and the planes of the internal holder latches 3110 may face each other and be aligned along a longitudinal axis extending from the proximal end to the distal end of the applicator 150. (As shown in...) Figures 12A-12D and Figures 13A-13DAs described, when the applicator 150 is in the "locked" state, the inner bracket latch 3110 is positioned at a distance from the proximal end of the outer bracket latch 3160. As the sheath 704 advances in the proximal direction, the applicator 150 is "fired," releasing the sharps bracket locking arm 1524 of the sensor electronics bracket 710 into its outwardly biased position. Subsequently, the force generated by the expansion of the inner spring 1106 and the outer spring 1104 causes the outer sharps bracket 3152 to advance in the proximal direction. Additionally, the counterforce generated by the expansion of the inner spring 1106 causes the inner sharps bracket 3102 to remain in a relatively identical position, thereby preventing premature retraction of the sharps. Similarly, the counterforce generated by the expansion of the outer spring 1104 causes the sensor electronics bracket 710 to remain in a relatively identical position (or to shift towards the skin surface in the distal direction). As the outer sharp object holder 3152 advances further in the proximal direction, the outer holder latch 3160 engages the inner holder latch 3110. The proximal force caused by the holder latches 3160 and 3110 causes the inner sharp object holder 3102 to move in the applicator 150 in the proximal direction, thereby retracting the sharp object (not shown).

[0136] Figure 10D This is a side view of another embodiment of a two-piece sharps bracket assembly, including an inner sharps bracket 4102 and an outer sharps bracket 4152. Similar to the previous embodiment, the inner sharps bracket 4102 may include one or more sharps retaining arms 4104 with sharps retaining clips 4106, and one or more inner bracket latches 4110 located at or near the proximal end of the inner sharps bracket 4102. The outer sharps bracket 4152 may also include a spring retaining channel 4162 for retaining a spring 1104, and an outer bracket latch 4160 for engagement with the inner bracket latch 4110. These configurations are consistent with reference to the... Figure 10C The described embodiments operate in a similar manner.

[0137] Still referencing Figure 10D The two-piece sharp object holder assembly includes a spring 1104 (with... Figure 10C The two springs depicted are opposite. Additionally, the internal sharp object bracket brake 4114 is located at the distal end of the internal sharp object bracket 4102 (e.g., Figure 10D(As indicated by the label), for engaging with the bracket holding brake 1517 located on the sensor electronics bracket 710. Engagement of the internal sharps bracket brake 4114 with the bracket holding brake 1517 causes the internal sharps bracket 4102 and the sensor electronics bracket 710 to remain locked in place while a sharps object penetrates the skin surface during insertion. During the “firing” of the applicator 150, the internal sharps bracket brake 4114 can disengage from the bracket holding brake 1517. When the sharps bracket locking arm 1524 of the sensor electronics bracket 710 is released (as shown by the label), the internal sharps bracket brake 4114 is disengaged from the bracket holding brake 1517. Figure 12B and Figure 13B As shown, spring 1104 expands from its preloaded compressed state. Subsequently, the outer sharp object holder 4152 advances in the proximal direction while the inner sharp object holder 4102 remains relatively in the same position, thus preventing premature retraction of the sharp object. As the outer sharp object holder 4152 continues to advance in the proximal direction, the outer holder latch 4160 engages the inner holder latch 4110, and the proximal force applied by the outer holder latch 4160 to the inner holder latch 4110 causes the inner sharp object holder latch 4114 to disengage from the holder holding latch 1517. The outer holder latch 4160 then pulls the inner sharp object holder 4102 into the applicator 150 in the proximal direction, thereby retracting the sharp object (not shown).

[0138] refer to Figure 10D Those skilled in the art will understand that other retaining devices can be used instead of the internal bracket brake arm 4112 and the bracket retaining brake 1517. For example, in alternative embodiments, a latch, hook, ball lock, latch, pin, or other similar retaining device can be used to hold the internal sharp object bracket 4102 in a “locked” position with the sensor electronics bracket 710 until sufficient force from the external sharp object bracket 4152 causes the retaining device to disengage, thereby allowing the internal sharp object bracket 4102 to advance in the proximal direction. In other alternative embodiments, a thread can be used between the internal sharp object bracket 4102 and the sensor electronics bracket 710 to hold the internal sharp object bracket 4102 in place during the “firing” sequence of the applicator 150 (e.g., Figures 12A-12D and Figures 13A-13D (As shown). Subsequently, as the outer sharp object holder 4152 continues to advance in the proximal direction, the proximal force of the outer sharp object holder 4152 can cause the inner sharp object holder 4102 to rotate and disengage itself from the sensor electronics holder 710. It will be understood that these exemplary retaining devices and their equivalents fall within the scope of the embodiments disclosed herein.

[0139] Figure 10EThis is a side view of another embodiment of a two-piece sharps holder, which includes an inner sharps holder 5102 and an outer sharps holder 5152. Similar to the previous embodiments, the inner sharps holder 5102 may include one or more sharps retaining arms 5104 with sharps retaining clips 5106. The outer sharps holder 5152 may include a spring retaining channel 5162 for retaining a spring 1104.

[0140] Still referencing Figure 10E The outer sharps holder 5152 may include one or more angled latch arms 5164 extending inwardly from the proximal top of the outer sharps holder 5152, such that each angled latch arm 5164 may be inclined in a downward direction toward the distal portion of the inner sharps holder 5102. Each angled latch arm 5164 may include a latch arm flange 5166 at its distal end, which may be formed by an end portion providing a substantially flat surface facing the proximal direction (i.e., similar to reference). Figure 10D The external bracket latch 4160 is described. Additionally, each distal end of one or more angled latch arms 5164 may engage with one or more angled keyways 5116 of the internal sharps bracket 5102. The angled keyways 5116 may be formed by cutouts having a generally “tilted rectangular” shape in the outer cylindrical surface of the internal sharps bracket 5102 and extend circumferentially from the proximal end to the distal end of the internal sharps bracket 5102.

[0141] Refer again Figure 10E The internal sharp object holder 5102 also includes one or more locking protrusions 5118 on the outer cylindrical surface of the proximal portion of the internal sharp object holder 5102. The locking protrusions 5118 may consist of a fixed spherical, hemispherical, or other circular structure extending outwards away from the central longitudinal axis of the internal sharp object holder 5102 and engaging with a holder protrusion groove 1521 located on the distal portion of the sensor electronics holder 710. The holder protrusion groove 1521 may be formed by a cutout in the spring-aligned ridge 1516 of the sensor electronics holder 710, wherein the cutout has an open end from which the locking protrusions 5118 can slidably disengage during rotation of the internal sharp object holder 5102.

[0142] refer to Figure 10E The embodiment shown will now be described in general terms as follows: the relative movement of the outer sharp object holder 5152, the inner sharp object holder 5102, and the spring 1104 during the “firing” of the applicator 150. When the sharp object holder locking arm 1524 of the sensor electronics holder 710 is released (as shown in the image), Figure 12B and Figure 13BAs shown, spring 1104 expands from its preloaded compressed state. Subsequently, the outer sharp object holder 5152 advances in the proximal direction. Because the locking lug 5118 engages in the holder lug groove 1521, the inner sharp object holder 5102 remains relatively in the same position, thus preventing premature retraction of the sharp object. As the outer sharp object holder 5152 continues to advance in the proximal direction, the force exerted on the angled keyway 5116 by the angled latch arm 5164 due to the angular orientation of the tilted keyway 5116 causes the inner sharp object holder 5102 to rotate. Due to the rotation of the inner sharp object holder 5102, the locking lug 5118 slidably advances toward the open end of the holder lug groove 1521 of the sensor electronics holder 710. When the locking lug 5118 reaches the open end of the holder lug groove 1521, the inner sharp object holder 5102 disengages from the sensor electronics holder 710. As the outer sharp object holder 5152 advances further in the proximal direction, the latch arm flange 5166 engages with the proximal portion of the angled keyway 5116 and begins to pull the inner sharp object holder 5102 into the applicator 150 in the proximal direction, thereby retracting the sharp object (not shown).

[0143] like Figure 10E As shown, two angled latch arms 5164 and two angled keyways 5116 are depicted. However, it will be understood that any number of angled latch arms 5164 and / or angled keyways 5116 can be used. Additionally, although the bracket protrusion groove 1521 is in Figure 10E The cutout is shown as having an "L-shaped" cutout, but any number of cutout shapes with an open end (such as a "curve" or "linear ramp") are suitable, from which the locking bump 5118 can be slidably disengaged.

[0144] Figure 10F This is a close-up side sectional view depicting another exemplary embodiment of the sharps holder assembly 8102 and the sheath 8704 within the applicator. According to one aspect of these embodiments, the sharps holder assembly 8102 may include a sharps holder groove 8104 disposed on the surface of the sharps holder assembly 8102 and along the path of the sharps holder retaining feature 1526 of the sensor electronics holder 710 traveling during the retraction of the needle (not shown). Similarly, according to another aspect of these embodiments, the sheath 8704 may include a sheath groove 8706 disposed on the surface of the sheath 8704 and along the path of the sharps holder locking arm 1524 of the sensor electronics holder 710 traveling during the retraction of the needle. As further described below, reference... Figures 16A-16CThe sharps holder slot 8104 and sheath slot 8706 can be configured to receive the sharps holder locking and retaining feature 1526 and the sharps holder locking arm 1524, respectively, to allow for a two-stage needle retraction process. Specifically, according to some embodiments, when the locking arm 1524 of the sensor electronics holder 710 is received in the sharps holder slot 8104 and sheath slot 8706, the locking arm 1524 can be partially deflected outwards, causing the sharps holder 8102 to move a limited distance in the proximal direction due to the expansion force of a preloaded compression spring 1104 disposed in the sharps holder 8102. In this way, the needle can be partially retracted or held in a fixed position relative to the skin surface, preventing further penetration of the needle into the dermis or subcutaneous tissue of the target.

[0145] Example embodiments of sharp object modules

[0146] Figure 11A It describes the sensor module 504 ( Figure 6B A perspective view of an example embodiment of the sharps module 2500 before internal assembly. The sharps 2502 may include a distal end 2506 that can penetrate the skin while carrying the sensor tail within the hollow portion or recess of the sharps shaft 2504, so that the effective surface of the sensor tail comes into contact with bodily fluids. A hub-driven cylinder 2508 provides a surface for pushing the sharps holder during insertion. A hub-small cylinder 2512 provides a hub contact surface 1622 for the sharps. Figure 10B The extended space of the hub latch 2516. The hub latch positioning cylinder 2514 provides a distal-facing surface of the hub latch 2516 for abutting the sharp object hub contact surface 1622. The hub latch 2516 may include a tapered surface that opens the sharp object retaining clip 1620 during installation of the sharp object module 2500.

[0147] Figures 11B to 11HExample embodiments of a sharps module at various stages of assembly for inserting a dermal analyte sensor are shown. According to one aspect of these embodiments, angulating the sensor and / or the inserting sharps relative to a reference point allows the tip of the insertion needle and the tip of the sensor to be co-located, and further, creates a single point of contact on the skin surface. Thus, when the sensor is inserted into an object, the sharps can create a leading edge on the skin surface to form an insertion path for inserting the sensor into the dermis. In some embodiments, for example, the sharps and / or the dermal sensor may be angled relative to a reference point (e.g., relative to each other, relative to the skin surface, or relative to the base of the applicator) for insertion, wherein the angle of the sharps differs from the angle of the sensor. For example, the reference point may be the skin surface to be pierced for dermal insertion, or it may be a reference or component of the sensor applicator kit. In some embodiments, the sharps may be angled relative to the sensor. For example, when designed such that the sharps are angled relative to the sensor, the needle creates a leading edge for the sensor during operation of the applicator kit. Furthermore, the needle design itself, and the positioning of the needle relative to the sensor, can be implemented in any desired configuration, including all those configurations disclosed in U.S. Patent Publication No. 2014 / 0171771, which are incorporated herein by reference in their entirety for all purposes.

[0148] In addition, although reference Figures 11B to 11J Many of the example embodiments described relate to dermal analyte sensors and dermal inserts, but those skilled in the art will understand that the size and structure of any embodiment can be configured for use with analyte sensors that can be positioned outside the dermal space, such as in the subcutaneous tissue (or even completely through the subcutaneous tissue) (e.g., 3 mm to 10 mm below the skin surface, depending on the location of the skin on the body).

[0149] Figure 11B This is a perspective view depicting an example embodiment of a sharp object module 2550 that can be used to insert a dermal sensor. The sensor module 504 is shown here. Figure 6B ) Sharp object module 2550 before assembly, and it may include reference Figure 11AThe components similar to those in the described embodiments include a sharp object 2552, a sharp object shaft 2554, a distal end of a sharp object 2556, a hub push cylinder 2558, a hub mini-cylinder 2562, a hub latch 2566, and a hub latch positioning cylinder 2564. The sharp object 2552 may be positioned eccentrically within the sharp object module 2550 relative to a longitudinal axis 2545 extending through the center of the hub latch 2566, the hub mini-cylinder 2562, and the hub push cylinder 2558. Additionally, the sharp object module 2550 may include a sharp object pad 2568 parallel to and adjacent to a portion of the sharp object 2552. A sharp object spacer 2568 can be positioned between sensor 104 (not shown) and sharp object 2552 along the proximal portion of sharp object 2552, and can ensure that sensor 104 and sharp object 2552 remain spaced apart at the proximal portion of sharp object 2552. During molding, sharp object 2552 can be positioned off-center, wherein each hub component 2558, 2562, 2566 can be made of rigid plastic material.

[0150] Figure 11C and Figure 11D These are two descriptions of the sensor module 504 ( Figure 6B The image shows a side view of the sharp object module 2550 before assembly. The sharp object module includes a sharp object 2552, a gasket 2568, a hub push cylinder 2558, a hub mini-cylinder 2562, and a hub latch 2566. In some embodiments, the relative distance between the sharp object 2552 and the hub component can be positioned as follows: For example, the distance S1 between the sharp object 2552 and the radial center of the hub can be in the range of 0.50 mm to 1 mm (e.g., 0.89 mm). The height S2 of the sharp object gasket 2568 can be in the range of 3 mm to 5 mm (e.g., 3.26 mm). The height S3 of the hub can be in the range of 5 mm to 10 mm (e.g., 6.77 mm). The length S4 of the sharp object 2552 can be in the range of 1.5 mm to 25 mm (e.g., 8.55 mm) and can depend on the position of the insertion point on the object.

[0151] Figure 11E A side sectional view is depicted of the sharp object module 2550, including a sharp object 2552, a sharp object washer 2568, and wheel hub components (wheel hub latch 2566, wheel hub small cylinder 2562, and wheel hub push cylinder 2558), when assembled with the sensor module 504. (See also...) Figure 11EAs seen in the image, the sharp object 2552 is positioned within a sharp object groove 2208 of the sensor module 504, which includes a curved inner surface 2250 at its distal end. The curved inner surface 2250 of the sensor module 504 can contact a portion of the sharp object 2552 and cause deflection, such that the distal end 2556 of the sharp object is oriented towards the central longitudinal axis 2545. (As shown in...) Figure 11H In the best view, the sharp object 2552 can be positioned such that the distal portion and the central longitudinal axis 2545 form an acute angle S. θ It can be in the range of 5° to 20°. In some embodiments, for example, S θ It can be within the range of 5° to 17°, or 7° to 15°, or 9° to 13°, for example 9°, 10°, 11°, 12° or 13°.

[0152] Still referencing Figure 11E Near the distal end of sensor module 504 is a protrusion 2251, which enhances the perfusion of bodily fluids (e.g., dermal fluid). Although in Figure 11E The surface is shown as curved, but protrusion 2251 can be shaped in any desired manner. Additionally, in some embodiments, multiple protrusions may be present. U.S. Patent Publication No. 2014 / 0275907 (which is incorporated herein by reference in its entirety for all purposes) describes sensor devices with different protrusion configurations, each of which can be implemented by the embodiments described herein. Many embodiments described herein show a needle exiting from the protrusion, and in other embodiments, the needle may exit from the base of the sensor device adjacent to the protrusion and extend from that location beyond the end of sensor 104.

[0153] Still referencing Figure 11E and Figure 11F The sensor 104 may be a dermal sensor and may include a sensor tail 2408 located at the distal end of the sensor 104, which may be positioned in a direction substantially parallel to the central longitudinal axis 2545. The distal end of the sensor tail 2408 may be close to, or spaced from, a portion of the shaft 2554 of the sharp object, resting therein, or resting on it. Figure 11E As further depicted, the sharp object pad 2568 provides a spaced relationship between the proximal portion of the sharp object 2552 and the sensor 104, such that the proximal portion of the sharp object 2552 and the sensor 104 do not contact each other. The sensor module 504 may further include a sensor connector 2300 for receiving the proximal portion of the sensor 104 that is perpendicular to the distal end of the sensor 104.

[0154] Figure 11FThis is a top-down cross-sectional view of sensor module 504. Sensor module 504 may include one or more sensor module latches 2202 for coupling to a housing (not shown) of sensor control device 102. Sensor module 504 may also include sensor connector 2300, which may have sensor contacts 2302 for coupling to a proximal portion of sensor 104. Sensor connector 2300 may be made of silicone rubber and encapsulates a compliant carbon-impregnated polymer module that serves as a conductive contact 2302 between sensor 104 and circuit contacts for electronics within sensor control device 102. 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. Although three contacts 2302 are depicted, it will be understood that connector 2300 may have fewer contacts (e.g., two) or more contacts (e.g., four, five, six, etc.) depending on the specific type or configuration of sensor 104. The sensor connector 2300 can be further coupled to the sensor module 504 via two connector posts 2206, which are positioned within the connector 2300 through the same number of holes. Although two connector posts 2206 are depicted, it will be understood that any number of connector posts 2206 can be used to couple the connector 2300 to the sensor module 504.

[0155] Figure 11G and Figure 11H These are perspective and side views, respectively, of another example embodiment of the sharp object module 2600 that can be used to insert a dermal sensor. Here, a view is shown in conjunction with sensor module 504 (…). Figure 6B ) Sharp object module 2600 before assembly, which may include reference Figure 11A and Figure 11B Components similar to those in the described embodiments include a sharp object 2602, a sharp object shaft 2604, a distal end of a sharp object 2606, a hub push cylinder 2608, a hub mini-cylinder 2612, a hub hook-and-loop catch 2616, and a hub hook-and-loop catch positioning cylinder 2614. In some embodiments, the sharp object 2602 may be a "pre-bent" needle, including a proximal portion 2603 that originates from a point outside the sharp object module 2600 and intersects at an angle with the center point of the hub (e.g., via the hub push cylinder 2608). The sharp object 2602 may also include a distal portion 2605 that extends in a distal direction from a point near the distal portion of the hub toward an insertion point on the user's skin at an angle. Figure 11HAs shown, the sharp object 2602 may include an angled portion 2607 located outside the hub push cylinder 2608, which may have an angle of substantially 90° between the proximal portion 2603 and the distal portion 2605 of the sharp object 2602. The sharp object module 2600 may also include a bending fin guide 2620 for holding the "pre-bent" sharp object 2602 in place during assembly and / or use, and for preventing lateral or rotational movement of the sharp object 2602 relative to the hub component. After the molding process is completed, and before assembling the sharp object module 2600 with the sensor module 504, the proximal portion 2603 of the sharp object 2602 may be "trimmed" from the hub.

[0156] Figure 11I and Figure 11J The diagram shows a side sectional view and a side view of the sharp object module 2600 (including the hub latch 2616, the hub cylinder 2612, and the hub push cylinder 2608) assembled with the sensor module 504. (See also...) Figure 11I As seen in the image, sensor module 504 includes a sharp object groove 2208 through which a sharp object 2602 extends in an angled distal direction. As previously described, the proximal portion of the sharp object 2602 passes through a curved fin guide 2620, which couples to the distal portion of sensor module 504. Sensor module 504 may also include a sensor 104, which may be a dermal sensor. Figure 11I As seen in the image, the sharp object 2602 and the sensor tail 2408 can form an acute angle S at the point where their respective longitudinal axes converge. θ . Angle S θ It can be within the range of 5° to 20°. In some embodiments, for example, S θ The angle can be within the range of 5° to 17°, or 7° to 15°, or 9° to 13°, for example, 9°, 10°, 11°, 12°, or 13°. In some embodiments, the distal sharp point 2606 is located at a distance S6, which is proximal to the end of the sensor tail 2408. The distance S6 can be within the range of 0.02 mm to 0.10 mm, for example, 0.05 mm, 0.06 mm, or 0.07 mm.

[0157] Still referencing Figure 11I and Figure 11J The sensor module 504 may further include a sensor connector 2300 for receiving a proximal portion of the sensor 104, which is relatively perpendicular to the distal end of the sensor 104. The sensor module 504 may further include one or more sensor module latches 2202 for coupling to a housing (not shown) of the sensor control device 102. The sensor connector 2300 may include a reference... Figure 11F The same structure is described.

[0158] In the above embodiments, the sharp object may be made of a flexible material such as stainless steel (e.g., a material used to manufacture acupuncture needles), and its dimensions are configured such that the applicator is used to insert at least a portion of the dermal sensor into the dermis, but without penetrating the dermis of the skin. According to some embodiments, the sharp object has a cross-sectional diameter (width) from 0.1 mm to 0.5 mm. For example, the sharp object may have a diameter from 0.1 mm to 0.3 mm, such as from 0.15 mm to 0.25 mm, or for example, from 0.16 mm to 0.22 mm. A given sharp object may have a constant (i.e., uniform) width along its entire length, or it may have a varying (i.e., variable) width along at least a portion of its length (e.g., the distal portion used to pierce the skin surface). For example, refer to… Figure 11I In the embodiment shown, the width of the sharp object 2602 may be narrowed along the distal portion between the curved fin guide 1620 and the distal end of the sharp object 2606.

[0159] The sharp object may also have a length that allows the dermal sensor to be inserted precisely into the dermal layer and then not inserted further. The insertion depth can be controlled by the length of the sharp object, the construction of the base and / or other applicator components that limit the insertion depth. The sharp object may have a length between 1.5 mm and 25 mm. For example, the length of the sharp object may be from 1 mm to 3 mm, from 3 mm to 5 mm, from 5 mm to 7 mm, from 7 mm to 9 mm, from 9 mm to 11 mm, from 11 mm to 13 mm, from 13 mm to 15 mm, from 15 mm to 17 mm, from 17 mm to 19 mm, from 19 mm to 21 mm, from 21 mm to 23 mm, from 23 mm to 25 mm, or a length greater than 25 mm. It will be appreciated that while the sharp object may have a length of up to 25 mm, in some embodiments, the entire length of the sharp object is not inserted into the object because it would extend beyond the dermal space. The uninserted length of the sharp object can be used to handle and manipulate the sharp object in the applicator kit. Therefore, while the sharp object can have a length of up to 25 mm, in some embodiments, the insertion depth of the sharp object into the skin of the subject will be limited to the dermis, for example, approximately 1.5 mm to 4 mm, depending on the skin location, as described in more detail below. However, in all embodiments disclosed herein, the sharp object can be configured to extend beyond the dermal space, for example, into (or even completely through) the subcutaneous tissue (e.g., 3 mm to 10 mm below the skin surface, depending on the location of the skin on the body). Additionally, in some example embodiments, the sharp object described herein may comprise a hollow or partially hollow insertion needle having an internal space or lumen. However, in other embodiments, the sharp object described herein may comprise a solid insertion needle without an internal space and / or lumen. Furthermore, the sharp object of the applicator kit of the present invention may also be bladed or bladeless.

[0160] Similarly, in the above embodiments, the dermal sensor is sized such that at least a portion of the sensor is located within the dermis and not deeper, and a portion extends beyond the skin in the transdermal positioning embodiments. That is, the dermal sensor is sized such that when the dermal sensor is fully or substantially fully inserted into the dermis, the distal portion of the sensor (insertion portion or insertion length) is located within the dermis of the object, and when the sensor is operatively positioned transdermally, no portion of the sensor extends beyond the dermis of the object.

[0161] The size (e.g., length) of the sensor can be selected based on the body part of the object into which the sensor will be inserted, as the depth and thickness of the epidermis and dermis exhibit a degree of variability depending on the skin location. For example, the epidermis is only about 0.05 mm thick on the eyelids, but about 1.5 mm thick on the palms and soles. The dermis is the thickest of the three layers of skin, and its thickness ranges from about 1.5 mm to 4 mm depending on the skin location. To implant the distal end of the sensor into the dermis of the object without penetrating it, the length of the insertion portion of the dermal sensor should be greater than the thickness of the epidermis, but should not exceed the combined thickness of the epidermis and dermis. These methods may include determining the insertion site on the user's body and the depth of the dermis at that site, as well as selecting an applicator kit of appropriate size for that site.

[0162] In some aspects, the sensor is an elongated sensor with a maximum dimension (or “length”) ranging from 0.25 mm to 4 mm. The length of the inserted sensor, in embodiments where only a portion of the sensor is inserted through the dermis, ranges from 0.5 mm to 3 mm, for example from 1 mm to 2 mm, such as 1.5 mm. The size of the sensor can also be expressed by its aspect ratio. In some embodiments, the dermal sensor has an aspect ratio of approximately 30:1 to approximately 6:1 in length to width (diameter). For example, the aspect ratio can be from approximately 25:1 to approximately 10:1, including 20:1 and 15:1. The inserted portion of the dermal sensor has sensing chemical properties.

[0163] However, all embodiments disclosed herein can be configured such that at least a portion of the sensor is positioned outside the dermis, for example, within (or through) subcutaneous tissue (or fat). For example, the sensor can be sized such that when the sensor is fully or substantially fully inserted into the body, the distal portion of the sensor (the insertion portion or insertion length) is positioned within the subcutaneous tissue (beyond the dermis of the subject), and when the sensor is operatively positioned, no portion of the sensor is inserted outside the subcutaneous tissue of the subject. As mentioned above, subcutaneous tissue typically exists in an area 3 mm to 10 mm below the surface of the external skin, depending on the location of the skin on the body.

[0164] Example of applicator deployment

[0165] Figures 12A-12D This is a side sectional view depicting an example embodiment of the applicator 150 during expansion of the sensor control device 102. The applicator 150 may include a dermal sensor for sensing the level of analytes in the dermis of a subject.

[0166] Figure 12A The applicator 150 is shown in a position ready to contact the skin surface of an object before firing. The brake circular portion 1404 of the sheath 704 is positioned in a "locking" recess 2332 in the locking rib of the applicator housing 2702. An outer sharps bracket 3152 is coupled to an inner spring 1106 and an outer spring 1104, both springs being in a preloaded compressed state. The outer sharps bracket 3152 is also held by one or more sharps bracket locking arms 1524 of the sensor electronics bracket 710. The sensor electronics bracket 710 is positioned within the proximal portion of the sheath 704, wherein the inner diameter of the sheath 704 is configured to deflect the sharps bracket locking arms 1524 in an inward direction. The distal portion of the outer sharps bracket 3152 contacts the proximal-facing surface of the sensor electronics bracket 710. Similarly, the distal portion of the inner sharps bracket 3102 is coupled to the proximal-facing surface of the sensor electronics bracket 710. The sharp object 2552 and the sensor 104 are positioned inside the sheath 704.

[0167] exist Figure 12BIn the diagram, the applicator 150 is shown in a "firing" state, where the force applied to the proximal end of the housing 2702 causes the housing 2702 to move in the distal direction relative to the sheath 704. At this time, the sharp object 2552 and the sensor 104 extend from the distal end of the sheath 704 and have penetrated or are penetrating the skin layer of the object. The forward movement of the housing 2702 causes the brake circle 1404 to move in the proximal direction relative to the housing 2702, which in turn causes the brake circle 1404 to enter a "free-flight" state, where the brake circle 1404 moves on the firing surface 2337 in a discontinuous or non-contact manner. The sharp object holder locking arm 1524 of the sensor electronics bracket 710 has also crossed the inner diameter of the sheath 704 and is freely deflected outward into its biased position (indicated by the outward-pointing arrow). Subsequently, the sharp object holder locking arm 1524 disengages from the outer sharp object holder 3152, and then begins to move in the proximal direction due to the expansion of the inner spring 1106 and the outer spring 1104 (indicated by the upward arrow). The expansion of the inner spring 1106 also applies a force in the distal direction, causing the inner sharp object holder 3102 to remain coupled to the sensor electronics holder 710. Similarly, the expansion of the outer spring 1104 also applies a force in the distal direction, securing the sensor electronics holder 710 in the distal position.

[0168] exist Figure 12C During this process, due to the continuous expansion of the internal spring 1106 and the external spring 1104, the external sharp object holder 3152 continues to move in the proximal direction (indicated by the upward arrow). After moving a predetermined distance in the proximal direction, the external holder latch 3160 of the external sharp object holder 3152 engages the internal holder latch 3110 of the internal sharp object holder 3102. Figure 12C As shown, the sharp object 2552 and the sensor 104 are held in their respective positions due to the expansion force generated by the springs 1104 and 1106 in the distal direction.

[0169] exist Figure 12D In the process, the force of the external bracket latch 3160 pulls the internal sharp object bracket 3102 in the proximal direction (indicated by a thin upward arrow). Then, the internal sharp object bracket 3102 retracts the sharp object 2552 via the sensor electronics bracket 710, allowing the sensor 104 to be implanted into the dermis of the object. The applicator 150 is shown in a "locked" state, with the brake circular portion 1404 of the sheath 704 having advanced past the sheath stop ramp (not shown) and positioned within the final locking groove 2336 of the housing 2702. (As in...) Figure 12D As further shown, both the inner sharp object holder 3102 and the outer sharp object holder 3152 are fully retracted into the applicator 150.

[0170] Figures 13A-13D This is a side sectional view depicting an alternative embodiment of the applicator 151 during deployment of a sensor control device 102, which may include a dermal sensor for sensing the level of analyte in the dermis of a subject. Typically, as referenced... Figures 12A-12D As described, applicator 151 operates in a similar manner to applicator 150, but additionally includes a retaining mechanism to couple housing 3702 and sensor electronics bracket 2710. The retaining mechanism operates to further increase the speed of sharp object insertion during firing while delaying the retraction sequence of the sharp object, as further described below.

[0171] like Figure 13A As shown, the applicator 151 is in a "locked" state before firing. The sharp object 2552 and sensor 104 are positioned within the sheath 704, and the applicator 151 is ready to be positioned against the skin of the object. The applicator housing 3702 includes a thermal post 1333 located on the distal portion of the housing guide rib 3321. The thermal post 1333 includes an open end 1339 and extends from the housing guide rib 3321 through a hole 1510 in the distal direction through the sensor electronics bracket 2710. During the "locked" state, the proximal-facing portion of the sensor electronics bracket 2710 abuts against the proximal base of the thermal post 1333.

[0172] Figure 13B The applicator 151 is shown in a "firing" state, where a force applied to the proximal end of housing 3702 causes housing 3702 to move relative to sheath 704 in the distal direction. Sharp object 2552 and sensor 104 extend from the distal end of sheath 704 and have penetrated or are penetrating the skin layer of the object. Sharp object holder locking arm 1524, which has crossed the inner diameter of sheath 704, deflects outward to its biased position (indicated by an outward-pointing arrow) and disengages from outer sharp object holder 3152. Due to the expansion of inner spring 1106 and outer spring 1104, outer sharp object holder 3152 then begins to move in the proximal direction. The expansion of inner spring 1106 and outer spring 1104, and the movement of outer sharp object holder 3152 in the proximal direction, generate corresponding counterforces in the distal direction against inner sharp object holder 3102 and sensor electronics holder 2710 (indicated by downward-pointing arrows). This force causes the internal sharp object holder 3102 and the sensor electronics holder 2710 to advance further along the thermal post 1333 in the distal direction, thereby increasing the velocity of the sharp object in the distal direction during insertion. At this point, the internal sharp object holder 3102 and the sensor electronics holder 2710 remain coupled.

[0173] exist Figure 13CDuring this process, due to the continuous expansion of the internal spring 1106 and the external spring 1104, the external sharp object holder 3152 continues to move in the proximal direction (indicated by the upward arrow). The sensor electronics holder 2710 has advanced along the thermal post 1333 in the distal direction until it reaches the open end 1339 of the thermal post. The open end 1339, larger than the hole 1510, abuts the flange 1513 in the sensor electronics holder 2710, thereby preventing the sensor electronics holder 2710 from completely disengaging from the housing guide rib 3321 of the housing 3702. After moving a predetermined distance in the proximal direction, the external holder latch 3160 (not shown) of the external sharp object holder 3152 engages the internal holder latch 3110 (not shown) of the internal sharp object holder 3102 (in the circled area "K"). The sharp object 2552 and the sensor 104 remain in the extended state outside the sheath 704.

[0174] Figure 13D The applicator 151 is shown in a "locked" state. The successive expansion of the inner spring 1106 and the outer spring 1104 causes the outer sharp object holder 3152 to advance further in the proximal direction. Subsequently, the outer holder latch 3160 (not shown) engages with the inner sharp object holder 3102 and pulls the inner sharp object holder 3102 in the proximal direction (indicated by a thin upward arrow). Next, the inner sharp object holder 3102 retracts the sharp object 2552 via the sensor electronics holder 2710, allowing the sensor 104 to be implanted into the dermis of the object. The brake circular portion 1404 of the sheath 704 is positioned in the final locking recess 2336, and both the inner sharp object holder 3102 and the outer sharp object holder 3152 are fully retracted into the applicator 151.

[0175] refer to Figures 13A-13D In the embodiments described herein, the thermal post 1333 is depicted as a retaining mechanism to couple the housing 3702 and the sensor electronics bracket 2710. However, it should be understood that different retaining mechanisms may be used, such as those described in reference [reference needed]. Figure 9E The described latch arm 1329, latch, hook, ball lock, latch, pin and / or other similar retaining devices and structures.

[0176] refer to Figures 12A-12D and Figures 13A-13D The embodiments described herein include a sharp object bracket assembly comprising an internal spring for maintaining the position of an internal sharp object bracket. Those skilled in the art will understand that other means and mechanisms for maintaining the position of an internal sharp object bracket fall entirely within the scope of the disclosed embodiments. For example, an internal sharp object bracket brake for engaging with a sensor electronics bracket (as described in reference...) Figure 10D (Described), an internal sharp object bracket (as described) having one or more locking protrusions for engaging with a sensor electronics bracket (as referenced) Figure 10E The described, as well as the latches, hooks, ball locks, latches, pins and threads, can be used alone or in combination to hold the internal sharp object holder in place during the "firing" sequence of the applicator.

[0177] Figures 14A-14C This is a side sectional view depicting another alternative embodiment of the applicator 152 during deployment of the sensor control device 102. As in the previous embodiment, the applicator 152 is initially positioned against the skin of the object and applies force to the proximal end of the housing 7702, causing the housing 7702 to move distally relative to the sheath 6704. The sharp object 2552 and the sensor 104 then extend from the distal end of the sheath 6704 and penetrate the skin layer of the object. However, unlike the previous embodiment ( Figures 12A-12D and Figures 13A-13D Unlike other devices, the applicator 152 uses a motion-actuated sharps retraction mechanism, as described in further detail below, which retracts the sharps when the user moves the applicator 152 away from the skin.

[0178] Figure 14A The applicator 152 is shown in an early "locked" state after the brake circular portion 1404 of the sheath 6704 has advanced on the inclined firing surface 7338, due to the user applying a first force to the applicator and reaching the bidirectional locking groove 7336. At this stage, the sharp object 2252 has penetrated the skin layer, and the sensor 104 has been inserted into the dermis. Furthermore, as best seen in reference numeral 14A-1, one or more sharp object holder locking arms 6524 of the sensor electronics bracket 6710 are biased outward and pushed against one or more corresponding bracket arm ramps 6415 of the sheath 6704. In this position, the bracket arm ramps 6415 apply a downward thrust to the locking arms 6524, thereby restraining the sharp object holder 1102 on the sensor electronics bracket 6710. Additionally, as seen in reference 14A-2, the latch arm 1329 of housing 7702 extends through the hole 1510 of sensor electronics bracket 6710. At this stage, the distal edge of the housing is flush with the hole 1510 and the hole flange 1513 of sensor electronics bracket 6710.

[0179] Figure 14BThe applicator 152 is shown after being in a “locked” state when the user begins to move it away from the skin by applying a second force to it. The second force (which may be in the proximal direction or in an “upward” direction) may, for example, be in the opposite direction to the first force, which may be in the distal direction or in a “downward” direction. An adhesive layer (not shown) on the bottom surface of the sensor control 102 holds the sensor control 102 to the skin of the object, and the movement of the applicator 152 in the proximal direction results in a pulling force on the sensor electronics bracket 6710 relative to the housing 7702. As best seen in reference numeral 14B-1, the bracket arm bevel 6415 includes a beveled end face that applies a force to the locking arm 6524 in the distal direction and causes the sensor electronics bracket 6710 to separate from the housing 7702. Therefore, as indicated by reference 14B-2, when the flange 1513 moves toward the latch brake 1331 of the latch arm 1329, the sensor electronics bracket 6710 moves relative to the housing 7702 in the distal direction (i.e., toward the skin).

[0180] Figure 14C The applicator 152 is shown when pulled away from the skin. As seen in reference numeral 14C-1, the locking arm 6524 has passed over the bracket arm ramp 6415. Subsequently, the sharps bracket 1102 is released, and the sharps bracket 1102 moves in the proximal direction under the force of the compression spring 1104, thereby retracting the sharps 2252. Moreover, as shown in reference numeral 14C-2, the sensor electronics bracket 6710 cannot move further away from the housing 7702 when the latch brake 1331 of the latch arm 1329 abuts the flange 1513. Subsequently, when the user pulls the applicator 152 away from the skin, the sensor control device 102 disengages from the sensor electronics bracket 6710 and is now attached to the skin with the sensor 104 inserted.

[0181] Figures 15A-15B These are a side sectional view and a perspective sectional view, both depicting an alternative embodiment of the applicator 153 during deployment of the sensor control device 102. The applicator 153 also employs a motion-actuated sharp-point retraction mechanism and generally operates in a similar manner to the applicator 152, as shown in reference [reference missing]. Figures 14A to 14C Described.

[0182] Go to Figure 15AThe image shows the applicator 153 in a pre-firing state, ready to be positioned against the skin surface of the object. The brake circular portion 1404 of the sheath 6704 is positioned in a "locking" recess 6332 of the locking rib 6340 in the housing 6702. Additionally, the locking rib 6340 includes an inclined firing surface 6338, which generates a downward force on the sheath 6704 during firing. The sheath 6704 also includes an inner sheath rib 6425 disposed on the inner surface of the sheath 6704. (See previous reference...) Figures 8F-8H As described, the connection between the inner sheath rib 6425 and the rib slot (not shown) of the sensor electronics bracket 6710 maintains the axial alignment of the sheath 6704 and the sensor electronics bracket 6710, and further prevents unwanted rotational and / or lateral movements during the sensor insertion process.

[0183] Still referencing Figure 15A The sharp object holder 1102 is coupled to a compression spring 1104 in a preloaded compressed state. The sharp object holder 1102 is held by one or more holder locking arms 6524 of the sensor electronics holder 6710. Before firing, the sharp object 2552 and the sensor 104 are positioned within the sheath 6704.

[0184] Go to Figure 15B The image shows the applicator 153 in an early "locked" state after sensor 104 has been inserted but before the sharp object 2552 has retracted. The brake circular portion 1404 has advanced over the inclined firing surface 6338 and reached the final locking groove 6336 in the locking rib 6340, which prevents further movement of the sheath 6704 relative to the housing 6702 in the distal direction. Additionally, the sheath 6704 includes a sheath travel limiter flange 6720 that abuts against the bottom edge 6331 of the housing 6702 in the "locked" state, thereby preventing further movement of the sheath 6704 relative to the housing 6702 in the proximal direction. Therefore, in the "locked" state, further movement of the sheath 6704 relative to the housing 6702 in either the proximal or distal direction is prevented. Additionally, at this stage, the bracket locking arm 6524 has not crossed the ramp 6415 of the sheath 6704, and the flange 1513 of the sensor electronics bracket 6710 is flush with the housing 6702. Therefore, the motion-actuated sharp object retraction mechanism has not yet been activated. Subsequently, when the user pulls the applicator 153 away from the skin, the bracket locking arm 6524 will cross the ramp 6415, thereby releasing the sharp object bracket 1102 and activating the sharp object retraction mechanism (as per reference). Figure 14C (Described).

[0185] refer to Figures 14A-14C and Figures 15A-15B The embodiments described herein should be understood to be related to... Figures 12A-12D and Figures 13A-13DCompared to the applicators shown, embodiments such as applicators 152 and 153 typically have a slower effective insertion speed. Additionally, Figures 14A-14C and Figures 15A-15B The sheath 6704 may have a higher quality than the reference. Figures 12A-12D and Figures 13A-13D The depicted sheath is of a short length. Furthermore, in some embodiments, the sheath 6704 may also include a base surface coated with an adhesive for adhesion to the user's skin.

[0186] Figures 16A-16C This is a side sectional view depicting another alternative example embodiment of the applicator 154 during deployment of the sensor control device 102. As in the previous embodiments, the applicator 154 is initially positioned against the skin of the object and a force is applied to the proximal end of the housing 702, causing the housing 702 to move in a distal direction relative to the sheath 8704. The sharp object 2552 and the sensor 104 then extend from the distal end of the sheath 8704 and penetrate the skin layer of the object. According to one aspect of the disclosed embodiments, the applicator 154 may include a two-stage needle retraction mechanism, wherein the sharp object 2252 is partially retracted in the first stage to minimize further penetration of the sharp object 2552 into the object, while the sensor 104 can further penetrate tissue, such as the dermis or subcutaneous tissue, to reach its final position. As further described below, in many embodiments, the two-stage needle retraction mechanism may be implemented by a plurality of slots, including a sheath slot 8706 and a sharp object holder slot 8104 (as in...). Figure 10F (As depicted in the image), each slot can be configured to receive at least a portion of the sharp object holder locking arm 1524 of the sensor electronics holder 710.

[0187] First refer to Figure 16A The image shows the applicator 154 in a "locked" state before firing, with the applicator 154 ready to be positioned against the skin surface of the object. The sharp object 2552 and the sensor 104 are positioned within the sheath 8704. The sensor electronics bracket 710 rests radially against the inner diameter of the sheath 8704.

[0188] Figure 16B The applicator 154 is shown after a force has been applied to the proximal end of housing 702, causing housing 702 to move in the distal direction relative to sheath 8704. Sharp object 2552 and sensor 104 extend from the distal end of sheath 8704 and have penetrated or are penetrating the skin layer of the object. As sheath 8704 moves in the proximal direction relative to housing 702 and sensor electronics bracket 710, at least a portion of each sharp object bracket locking arm 1524 of sensor electronics bracket 710 can be received in a sharp object bracket slot 8104 provided on sharp object bracket 8102 and a sheath slot 8706 provided on sheath 8704. (See also...) Figure 10FWhen a portion of each locking arm 1524 is received in slots 8104 and 8706, the locking arm 1524 may be partially deflected in the outward direction, allowing the sharps holder 8102 to move a limited distance in the proximal direction due to the expansion force of the preloaded compression spring 1104 in the sharps holder 8102. In this way, according to one aspect of these embodiments, during or after the first stage of the two-stage needle retraction process, the sharps 2552 may be partially retracted or held in a fixed position relative to the skin surface. Additionally, according to another aspect of these embodiments, during the first stage of the two-stage sharps retraction, the distal portion of the sensor 104 may continue to penetrate tissue, such as the dermis or subcutaneous tissue of the object, while the proximal portion of the sensor 104 may remain within the sharps 2552.

[0189] Figure 16C The second stage of the applicator 154 during the two-stage needle retraction process is shown. As the housing 702 continues to move distally relative to the sheath 8704, the sharps holder locking arm 1524 of the sensor electronics bracket 710 has passed the inner diameter of the sheath 8704 and is freely deflected outwards into its biased position. Subsequently, the sharps holder locking arm 1524 disengages from the sharps holder 8102, and due to the further expansion of the spring 1104, the sharps holder 8102 moves further proximally, causing the sharps 2552 to retract further into the applicator 154. (Also possible...) Figure 16C As seen in the image, the applicator 154 is shown in a "locked" state, with the brake circular portion 1404 of the sheath 8704 having advanced past the sheath stop ramp 1338 and located within the final locking groove 1336 of the housing 702.

[0190] refer to Figures 16A-16CAs will be understood by those skilled in the art in the embodiments described, embodiments with a two-stage needle retraction mechanism, such as applicator 154, can be configured to reduce the penetration depth of the sharp object 2252 relative to, for example, a sensor tip. In this way, these embodiments can reduce early sensor attenuation or inaccuracy during the first few hours after insertion, which may be caused by trauma to the insertion site. Furthermore, while the sharp object holder slot 8104 and the sheath slot 8706 are depicted respectively at certain locations along the sharp object holder 8102 and the sheath 8704, those skilled in the art will understand that other locations along the sharp object holder 8102 and / or the sheath 8704, constructions (e.g., three, four, or five slots) and / or geometries (e.g., angled surfaces, curved surfaces, recessed surfaces, etc.) adapted to cause partial release of the sharp object holder locking arm fall entirely within the scope of the invention. In some embodiments, for example, the height of the sheath slot 8706 in the sheath 8704 can be varied to alter the timing of retraction relative to how far the sheath 8704 has retracted. Similarly, in other embodiments, the height of the sharp object holder slot 8104 can be varied to change the distance by which the sharp object 2552 is partially retracted.

[0191] Go to Figure 17 A side sectional view of another example alternative embodiment is provided, in which the applicator 155 is shown ready for use in a "standby" position. According to one aspect of these embodiments, the applicator 155 may include a compliant two-stage needle retraction mechanism, which can be referenced... Figures 16A-16CThe described embodiments operate in a similar manner. In many embodiments, for example, the applicator 155 may include a sharps bracket slot 8104 of a sharps bracket 8102 and a sheath slot 8706 of a sheath 8704, each slot being configured to receive at least a portion of a locking arm 6524 of a sensor electronics bracket 6710. During operation, when a portion of each locking arm 6524 is received in slots 8104 and 8706, the locking arm 6524 may be partially deflected in an outward direction, allowing the sharps bracket 8102 to move a limited distance in a proximal direction due to the expansion force of a preloaded compression spring (not shown) disposed in the sharps bracket 8102. In this way, according to one aspect of these embodiments, during or after the first stage of the two-stage needle retraction process, the sharps 2552 may be partially retracted or held in a fixed position relative to the skin surface, while the distal portion of the sensor 104 may continue to penetrate tissue, such as the dermis or subcutaneous tissue. As the housing 7702 continues to move in the distal direction, the second stage of the two-stage needle retraction mechanism is activated. Specifically, the locking arm 6524 can pass over the inner diameter of the sheath 8704 and deflect outward into its biased position, thereby disengaging from the sharp object holder 8102, which in turn moves further in the proximal direction due to the further expansion of the spring, and retracts the sharp object 2552 into the applicator 155.

[0192] Still referencing Figure 17 According to another aspect of these embodiments, the applicator 155 may include a compliance mechanism between the sensor electronics bracket 6710 and the housing 7702. In some embodiments, such as in Figure 17 As best seen in reference numeral 17-1, the housing 7702 of the applicator 155 may include one or more latch arms 1329 that extend through holes 1510 in the sensor electronics bracket 6710. At the distal end of the latch arm 1329, one or more latch brakes 1331 prevent the latch arm 1329 from disengaging from the sensor electronics bracket 6710. Furthermore, as in... Figure 17 As seen in label 17-1, the bottom edge of the bore flange 1513 and one or more latch brakes 1331 are spaced apart by a predetermined gap amount α, which allows limited movement of the sheath 8704, the sharp object holder 8102, the sensor electronics holder 6710 and the sensor control unit 102 together relative to the housing 7702.

[0193] According to one aspect of these embodiments, the predetermined gap α allows the sensor electronics bracket 6710 to omnidirectionally move relative to the housing 7702, which in turn can cause angular displacement of the sharp object 2552 and the sensor 104 relative to the housing 7702 during insertion. For example, when the applicator 155 is in the "ready" position, as Figure 17As shown, the distal portion of the analyte sensor 104 and the longitudinal axis 8545 of the housing 7702 are substantially parallel to each other. According to one aspect of these embodiments, when a force is applied to the housing 7702 and the applicator 155 is fired, the sensor electronics bracket 6710 can be omnidirectionally moved relative to the housing 7702, resulting in the distal portion of the analyte sensor 104 and the longitudinal axis 8545 being non-parallel. At this point, the sharp object 2552 and the sensor 104 can penetrate the tissue along a path of least resistance, rather than being forced to move in the same axial direction as the housing 7702. This, in turn, reduces damage to the tissue during penetration and reduces early signal attenuation or sensor inaccuracy during the first few hours after insertion.

[0194] Figure 18 This is a partial cross-sectional view of another example embodiment of the applicator 156, which also has a compliance mechanism. According to one aspect of some embodiments, the housing 3702 of the applicator 156 may include a thermal post 1333 that extends through a hole 1510 in the sensor electronics bracket 2710. The thermal post 1333 may have an open distal end 1339 configured to prevent the thermal post 1333 from detaching from the sensor electronics bracket 2710. Furthermore, with reference to... Figure 17 Similar to the described embodiments, the bottom edge of the bore flange 1513 and the open distal end 1339 of the thermal post 1333 can be spaced apart by a predetermined gap amount α, which allows for limited freedom of movement of the sensor electronics bracket 2710.

[0195] According to another aspect of these embodiments, the predetermined gap α allows for omnidirectional movement of the sheath, sensor electronics bracket 2710, and sensor control unit 102 relative to housing 3702, and allows for angular displacement of the sharp object 2552 and sensor 104 during insertion. Still referring to Figure 18 The degree and range of the angular displacement θ of the sharp object 2552 and the sensor 104 can be a function of a predetermined gap amount α. In some embodiments, for example, a predetermined gap α of 0.5 mm can result in an angular displacement of approximately 2 degrees and 0.6 mm. Those skilled in the art will recognize that these measurements are provided for illustrative purposes only and are in no way intended to limit the predetermined gap or angular displacement to any particular value or range of values.

[0196] refer to Figure 17 and Figure 18 While some embodiments including a compliance mechanism are described as being combined with a two-stage needle retraction mechanism, those skilled in the art will understand that the compliance mechanism can be combined with an applicator having other types of retraction mechanisms, such as those described in reference to [reference missing]. Figures 12A-12D , Figures 13A-13D , Figures 14A-14C and Figures 15A-15BThe embodiments described herein, as well as the applicators described in U.S. Patent Publication No. 2013 / 0150691 and U.S. Patent Publication No. 2016 / 0331283, are incorporated herein by reference in their entirety for all purposes.

[0197] refer to Figures 12A-12D , Figures 13A-13D , Figures 14A-14C , Figures 15A-15B , Figures 16A-16C , Figure 17 and Figure 18 Although the embodiments described herein use a sharp object 2552, it should be understood that the sharp object 2552 can be used as described herein. Figures 11A-11J Any sharp objects, sharp object modules, and sensor modules described.

[0198] refer to Figures 12A-12D , Figures 13A-13D , Figures 14A-14C , Figures 15A-15B , Figures 16A-16C , Figure 17 and Figure 18 Any applicator embodiment thereof, and any of its components, including but not limited to Figures 11A-11J The embodiments of the sharps, sharps modules, and sensor modules disclosed herein will be understood by those skilled in the art to be sized and constructed for use with sensors configured to sense the level of analytes in bodily fluids in the epidermis, dermis, or subcutaneous tissue of a subject. In some embodiments, for example, the size and structure of the sharps and distal portions of the analyte sensor disclosed herein may be configured to be positioned at a specific distal depth (i.e., the furthest point of penetration in the tissue or layer of the subject's body, e.g., in the epidermis, dermis, or subcutaneous tissue). For some applicator embodiments, for example, in embodiments with a two-stage needle retraction mechanism, those skilled in the art will understand that the size and structure of certain embodiments of the sharps may be configured to be positioned at different distal depths within the subject relative to the final distal depth of the analyte sensor. In some embodiments, for example, the sharps may be positioned at a first distal depth in the subject's epidermis before retraction, while the distal portion of the analyte sensor may be positioned at a second distal depth in the subject's dermis. In other embodiments, the sharps may be positioned at a first distal depth in the subject's dermis before retraction, while the distal portion of the analyte sensor may be positioned at a second distal depth in the subject's subcutaneous tissue. In other embodiments, the sharp object 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's body.

[0199] This document describes a number of deflectable structures, including but not limited to a deflectable brake latch 1402, a deflectable locking arm 1412, a sharps bracket locking arm 1524, a sharps retaining arm 1618, and a module latch 2202. These deflectable structures are made of an elastic material, such as plastic or metal (or others), and operate in a manner well known to those skilled in the art. Each deflectable structure has a resting state or position in which the elastic material is biased. If a force is applied that causes the structure to deflect or move from this resting state or position, the bias of the elastic material will return the structure to the resting state or position once the force is removed (or reduced). In many cases, these structures are configured with an arm having a brake or latch, but other structures or constructions with the same characteristics of maintaining deflection capability and returning to a resting position may be used, including but not limited to legs, clamps, hooks, supports on the deflectable member, etc.

[0200] It should be noted that all features, elements, components, functions, and steps described with reference to any embodiments 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 with reference to only one embodiment, it should be understood that, unless expressly stated otherwise, that feature, element, component, function, or step may be used with every other embodiment described herein. Therefore, this paragraph serves as the premise and written support for introducing claims at any time that combine features, elements, components, functions, and steps from different embodiments, or substitute features, elements, components, functions, and steps from one embodiment for features, elements, components, functions, and steps from another embodiment, even if the following description does not expressly state in particular that such combinations or substitutions are possible. It is expressly acknowledged that expressing every possible combination and substitution would be overly cumbersome, especially assuming that those skilled in the art will readily recognize the permissibility of each and every such combination and substitution.

[0201] While these embodiments are readily adaptable to various modifications and alternatives, specific examples have been illustrated in the figures and described in detail herein. However, it should be understood that these embodiments are not limited to the specific forms disclosed, but rather, they will cover all modifications, equivalents, and substitutions falling within the spirit of the invention. Furthermore, any features, functions, steps, or elements of these embodiments may be recited in or added to the claims, and the scope of the claims may be negatively limited by features, functions, steps, or elements that do not fall within the inventive scope of the claims.

Claims

1. A component comprising: Inserts, including: A first bracket assembly is disposed inside the insert, the first bracket assembly including a sharp object configured to insert a portion of a glucose sensor into the body of the subject; A retraction spring is disposed inside the insert, the retraction spring including a proximal end disposed inside the first bracket assembly; The second bracket assembly includes one or more bracket arms extending proximally and offset in a radially outward direction; and One or more bracket arm ramps, The first bracket assembly, the retraction spring, and the second bracket assembly are configured to advance toward the skin of the object from a proximal position, which is entirely within the interior of the insert, to a distal position. The one or more proximal-extending bracket arms are configured to prevent expansion of the retraction spring when the first bracket assembly, the retraction spring, and the second bracket assembly are in the proximal position. Wherein, after the first bracket assembly, the retraction spring, and the second bracket assembly have advanced from the proximal position, each of the one or more proximal-extending bracket arms is configured to traverse a corresponding bracket arm ramp among the one or more bracket arm ramps, and The retraction spring is configured to expand after each of the one or more proximal-extending bracket arms crosses the corresponding bracket arm ramp of the one or more bracket arm ramps.

2. The component according to claim 1, wherein, Each of the one or more proximal-extending bracket arms is configured to deflect in a radially outward direction when it traverses the corresponding bracket arm ramp in the one or more bracket arm ramps.

3. The component of claim 1 further includes a sensor control device, the sensor control device including a glucose sensor coupled to sensor electronics.

4. The component according to claim 3, wherein, The sensor control device is configured to be positioned on the skin of the object when the first bracket assembly, the retraction spring, and the second bracket assembly are in the distal position.

5. The component according to claim 1, wherein, Each of the one or more proximal-extending bracket arms is biased against a corresponding bracket arm ramp in one or more bracket arm ramps.

6. The component according to claim 5, wherein, Each of the one or more proximal-extending bracket arms includes a corresponding lateral extension retaining feature.

7. The component according to claim 6, wherein, The corresponding lateral extension retaining feature is provided on the proximal end of each of the proximal extending bracket arms.

8. The component according to claim 7, wherein, The corresponding lateral extension retaining feature includes a brake.

9. The component according to claim 6, wherein, Each of the one or more proximal-extending bracket arms is configured to prevent the retraction spring from expanding via the corresponding lateral extension retaining feature.

10. The component of claim 1, wherein, Each of the one or more bracket arm ramps includes an inclined end face.

11. The component according to claim 2, wherein, Each of the one or more proximal-extending bracket arms is further configured to deflect in a radially outward direction after traversing the respective bracket arm ramp in the one or more bracket arm ramps.

12. The component according to claim 1, wherein, The retraction spring includes a compression spring.

13. The component of claim 12, wherein, The compression spring is in a preloaded compressed state, while the first bracket assembly, the retraction spring, and the second bracket assembly advance from the proximal position to the distal position.

14. The component of claim 12, wherein, The compression spring is biased to cause the first bracket assembly to retract proximally away from the skin of the object.

15. The component according to claim 1, wherein, The first bracket assembly, the retraction spring, and the second bracket assembly are further configured to advance along a linear path.

16. The component of claim 4, wherein, When the first bracket assembly, the retraction spring, and the second bracket assembly are in the proximal position, at least a portion of the glucose sensor is disposed in the sharp object.

17. The component according to claim 3, wherein, The sensor control device further includes an adhesive portion configured to secure the sensor control device to the skin of the object.

18. The component according to claim 3, wherein, The sensor electronics include a processor, memory, power supply, and communication circuitry, the communication circuitry being configured to wirelessly transmit data indicating glucose levels.

19. The component of claim 1, further comprising a cap removably attached to the insert via a plurality of threads, wherein, The cover includes an internal space containing a sterile environment.

20. The component of claim 1, wherein, When the first bracket assembly, the retraction spring, and the second bracket assembly are in the proximal position, the first bracket assembly and the second bracket assembly are releasably connected.

21. The component of claim 20, wherein, The first bracket assembly is configured to separate from the second bracket assembly after the first bracket assembly, the retraction spring, and the second bracket assembly reach the distal position.

22. The component of claim 1, wherein, The retraction spring is configured to apply a force that retracts the first bracket assembly after the first bracket assembly, the retraction spring, and the second bracket assembly have reached the distal position.

23. The component according to claim 3, wherein, The sensor control device also includes a sensor hub. The glucose sensor is a portion of a distal sensor unit, comprising both a distal sensor unit and a proximal sensor unit. The portion of the remote sensor unit is configured to sense the glucose level of the object. The proximal sensor portion is coupled to the sensor center, and The distal sensor section is substantially orthogonal to the proximal sensor section.

24. An applicator for inserting an in vivo analyte sensor, the applicator comprising: Analyte sensor; A sensor electronics bracket, including at least one deflectable locking structure; as well as Sharp object holder, coupled to a spring and a sharp object. The sensor electronics holder and the sharp object holder are configured to advance from a first position spaced apart from the skin surface within the applicator to a second position adjacent to the skin surface when a first force is applied to the applicator along a first direction. A portion of the sharp object and the analyte sensor are positioned below the skin surface at the second position. The sharp object holder is configured to retract within the applicator and retract the sharp object from the skin surface when a second force is applied to the applicator in a second direction, wherein the second force causes the at least one deflectable locking structure to disengage from the sharp object holder and causes the spring connected to the sharp object holder to expand.

25. The applicator according to claim 24, wherein, The second direction is opposite to the first direction.

26. The applicator according to claim 24, wherein, The second direction is away from the skin surface.

27. The applicator according to claim 24, wherein, The at least one deflectable locking structure is a plurality of deflectable locking arms.

28. The applicator according to claim 24, wherein, The analyte sensor is an in vivo analyte sensor configured to measure the level of an analyte in bodily fluids located in the skin layer of a subject.

29. The applicator according to claim 24, wherein, The at least one deflectable locking structure engages with the upper surface of the sharp object holder, while the sensor electronics holder and the sharp object holder are configured to advance from the first position to the second position.

30. The applicator according to claim 24, wherein, The at least one deflectable locking structure applies a downward force to the sharp object bracket as the sensor electronics bracket and the sharp object bracket are configured to move from the first position to the second position.

31. The applicator according to claim 24, wherein, The spring includes a compression spring.

32. The applicator according to claim 31, wherein, When the sensor electronics bracket and the sharp object bracket move between the first position and the second position, the compression spring is in a preloaded compressed state.

33. The applicator according to claim 31, wherein, The compression spring is biased to advance the sharp object holder in the proximal direction and apply a third force to the sensor electronics holder in the distal direction.

34. An applicator assembly for inserting an in vivo glucose sensor into a subject's body, the applicator assembly comprising: Sharps holder assembly, including: A sharp object, the sharp object comprising a sharp object hub and a sharp object distal end; A plurality of sharp object retaining arms extending proximally, the plurality of sharp object retaining arms being configured to retain the sharp object hub; and One or more locking protrusions, the one or more locking protrusions protruding outward along a direction away from the central longitudinal axis of the sharp object bracket assembly; A sensor electronics bracket, the sensor electronics bracket being configured to retain a sensor control device, the sensor electronics bracket including one or more bracket protrusion slots, wherein the one or more locking protrusions of the sharp object bracket subassembly are configured to engage with the one or more bracket protrusion slots of the sensor electronics bracket; The sensor control device includes sensor electronics and the in vivo glucose sensor, wherein the in vivo glucose sensor includes: The proximal portion is connected to the sensor electronics; and The distal portion is configured to lie beneath the user's skin surface and in contact with the object's bodily fluids; and The sharp object holder assembly, the sensor electronics holder, and the sensor control device are configured to move from a proximal position to a distal position. The sharps holder subassembly is configured to rotate in response to a force applied along the central longitudinal axis of the sharps holder assembly. Each of the one or more locking protrusions is configured to slidably advance toward the open end of each corresponding bracket protrusion slot in the one or more bracket protrusion slots during rotation of the sharp object bracket assembly. The advancement of each of the one or more locking protrusions toward the opening end causes the sharp object bracket assembly to disengage from the sensor electronics bracket and retracts the sharp object to the retracted position.

35. The applicator assembly of claim 34, wherein, Each of the one or more locking bumps is disposed on the outer cylindrical surface of the sharp object bracket assembly.

36. The applicator assembly of claim 35, wherein, Each of the one or more locking bumps is also disposed on the proximal portion of the sharp object bracket assembly.

37. The applicator assembly of claim 34, wherein, Each of the one or more bracket bump slots includes a cutout located in the sensor electronics bracket.

38. The applicator assembly of claim 37, wherein, The cut includes a first groove having the open end and a second groove substantially perpendicular to the first groove.

39. The applicator assembly of claim 34, wherein, The open end of each corresponding bracket bump groove in the one or more bracket bump grooves is arranged in the proximal portion of the sensor electronics bracket.

40. The applicator assembly of claim 37, wherein, The incision includes an L-shaped incision.

41. The applicator assembly of claim 34, further comprising a retraction spring, wherein, The retraction spring includes: The proximal end, the connection between the proximal end and the distal surface of the sharp object holder assembly; and The proximal end is connected to the proximal-facing surface of the sharp object holder assembly.

42. The applicator assembly of claim 41, wherein, Before the one or more locking protrusions advance toward the opening end, the retraction spring is in a preloaded and compressed state.

43. The applicator assembly of claim 41, wherein, The retraction spring is configured to apply force to the distal surface of the sharp object holder assembly to retract the sharp object to the retracted position.

44. The applicator assembly of claim 34, wherein, Each of the plurality of sharp object retaining arms extending proximally includes a distal end with a sharp object retaining clip.

45. The applicator assembly of claim 44, wherein, The sharps retainer includes a proximal surface that is nearly perpendicular to the central longitudinal axis of the sharps holder assembly.

46. ​​The applicator assembly of claim 45, wherein, The proximal surface is configured to be adjacent to the distal surface of the hub of the sharp object.

47. The applicator assembly of claim 34 further includes a sheath having a distal end for placement on the skin surface of the object.

48. The applicator assembly of claim 47, further comprising a housing of the applicator configured to receive a manual force applied in a distal direction along the central longitudinal axis of the sharp object carrier subassembly.

49. The applicator assembly of claim 48, wherein, The housing and the sheath are configured such that, while the sheath is held on the skin surface of the object, the manual force causes the housing to advance relative to the sheath in the distal direction.

50. The applicator assembly of claim 34, wherein, The sensor electronics include one or more processors, memory, wireless communication circuitry, and power supply.

51. The applicator assembly of claim 50, wherein, The wireless communication circuit is configured to transmit data indicating the glucose level of the object according to Bluetooth or Bluetooth Low Energy communication protocol.

52. The applicator assembly of claim 34, wherein, The sharp object holder assembly, the sensor electronics holder, and the sensor control device are further configured to advance along a linear path from the proximal position to the distal position.

53. The applicator assembly of claim 47, wherein, The sheath is configured such that the distal portion of the in vivo glucose sensor is located below the skin surface of the subject while still remaining on the skin surface of the subject.

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