Applicators and assemblies for inserting in vivo analyte sensors

Abstract

The present application provides an applicator and assembly for inserting an analyte sensor into the body. An applicator includes: an analyte sensor; a sensor electronics bracket; a sharps bracket coupled to a sharp; a distal end of the applicator configured to be positioned on a user's skin surface; and a proximal end of the applicator configured to receive a force applied by the user, wherein the sensor electronics bracket, the sharps bracket, and the sharps are configured to advance a predetermined distance in a distal direction in response to the application of the force, wherein the sharps bracket and the sharps are configured to partially retract a portion of the predetermined distance in a proximal direction when the sensor electronics bracket is advanced in the distal direction, and wherein the sharps bracket and the sharps are further configured to fully retract into the applicator after the sharps and a portion of the analyte sensor are positioned below the skin surface and contacted with bodily fluid.

Description

[0001] This application is a divisional application of the Chinese patent application with application number 201880020852.3 and name “Systems, devices and methods for analyte sensor insertion” (based on the international patent application with international application date of January 22, 2018 and international application number PCT / US2018 / 014745). Technical Field

[0002] The subject matter described herein generally relates to systems, devices, and methods for using an applicator and a sensor control unit in an in vivo analyte monitoring system. Background Art

[0003] Detection and / or monitoring of analyte levels (e.g., glucose, ketones, lactate, oxygen, hemoglobin A1C, etc.) can be extremely important to the health of individuals with diabetes. Patients with diabetes can experience complications including loss of consciousness, cardiovascular disease, retinopathy, neuropathy, and nephropathy. Diabetic patients often need to monitor their glucose levels to ensure they remain within a clinically safe range and can also use this information to determine if and / or when insulin is needed to lower their glucose levels or when additional glucose is needed to raise their glucose levels.

[0004] Growing clinical data demonstrates a strong correlation between glucose monitoring frequency 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, testing discretion, pain associated with glucose testing, and cost.

[0005] In order to increase patient compliance with a frequent glucose monitoring program, an in vivo analyte monitoring system can be used, wherein a sensor control device can be worn on the body of an individual requiring analyte monitoring. To improve the comfort and convenience of the individual, 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 includes inserting a sensor, such as a dermal sensor that senses a user's analyte level in a body fluid located in the dermis of a person, using an applicator or insertion mechanism so that the sensor comes into contact with the body fluid. The sensor control device can also be configured to transmit the analyte data to another device from which the individual or their healthcare provider (HCP) can review the data and make treatment decisions.

[0006] Although galvanic sensors are convenient for users, they are also prone to malfunction due to incorrect insertion. These malfunctions can be caused by user error, lack of proper training, poor user coordination, overly complex procedures, and other problems. This is especially true for analyte monitoring systems with dermal sensors, which typically have smaller dimensions than sensors used to measure analyte levels in interstitial fluid (ISF), and dermal sensors are inserted using sharp objects (also referred to as "introducers" or "needles") that are shorter than those used for ISF sensors. For example, some prior art systems may rely too much on the precise assembly and deployment of sensor controls and applicators performed by individual users. Other prior art systems may utilize sharp object insertion and retrieval mechanisms that are prone to premature retraction before the sensor can be correctly implanted. In addition, for dermal sensors, some prior art systems may utilize sharp objects that are not optimally configured to create an insertion path in the dermis without causing damage to surrounding tissue. These challenges and other challenges described herein can result in incorrectly inserted or damaged sensors, resulting in an inability to correctly monitor the patient's analyte levels.

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

[0008] Provided herein are example embodiments of systems, devices, and methods for assembling and using an applicator and a sensor control device for an in vivo analyte monitoring system, and in particular, wherein a dermal sensor is used. The applicator can be provided to a user in a sterile package containing an electronics housing of the sensor control device. A structure separated from the applicator, such as a container, can also be provided to the user as a sterile package containing a sensor module and a sharp object module. The user can couple the sensor module to the electronics housing, and can couple the sharp object to the applicator by an assembly process including inserting the applicator into the container in a particular manner. After assembly, the applicator can be used to position the sensor control device on the human body, wherein the sensor contacts the wearer's body fluids (e.g., skin fluid). The embodiments provided herein are improvements to prevent or reduce the possibility of sensor error insertion or damage. Other improvements and advantages are also provided. The various configurations of these devices are described in detail by examples only.

[0009] Other systems, devices, methods, features, and advantages of the subject matter described herein will be or will become apparent to one skilled in the art upon examination of the following drawings and detailed description. It is intended that all such additional systems, devices, methods, features, and advantages be included within this description, be within the scope of the subject matter described herein, and be protected by the following claims. Features of the example embodiments should in no way be construed to limit the appended claims without expressly reciting those features in the claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0010] The details of the subject matter described herein, both as to its structure and operation, may be apparent by studying the accompanying drawings, in which like reference numerals refer to like parts. The components in the drawings are not necessarily to scale, with emphasis placed on illustrating the principles of the subject matter. Furthermore, all illustrations are intended to convey concepts, in which relative sizes, shapes, and other detailed attributes may be illustrated schematically rather than literally or precisely.

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

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

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

[0014] Figure 3A is a proximal perspective view of an example embodiment depicting a user preparing a tray for assembly.

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

[0016] Figure 3C is a proximal perspective view of an example embodiment depicting a user inserting an applicator assembly into a tray during assembly.

[0017] Figure 3D is a proximal perspective view of an example embodiment depicting a user removing an applicator assembly from a tray during assembly.

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

[0019] Figure 3F is a proximal perspective view of an example embodiment depicting a patient with a sensor applied and an applicator assembly in use.

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

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

[0022] Figure 4C is a perspective view of an example embodiment depicting an applicator assembly and the distal end of the electronics housing.

[0023] Figure 5 is a proximal perspective view depicting an example embodiment of a tray coupled to a sterilization cap.

[0024] Figure 6A is a proximal perspective cutaway view depicting an example embodiment of a tray with a sensor delivery component.

[0025] Figure 6B is a proximal perspective view depicting the sensor delivery component.

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

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

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

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

[0030] Figure 7F and Figure 7G is a side cross-sectional view depicting a locking rib portion of another example embodiment of a housing and a portion of a boot.

[0031] Figure 7H is a side cross-sectional view depicting a locking rib portion of another example embodiment of a housing and a portion of a boot.

[0032] Figure 7I is a side cross-sectional view depicting a locking rib portion of another example embodiment of a housing and a portion of a boot.

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

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

[0035] Figure 8Cis a close-up perspective view of an example embodiment depicting the distal side of a brake buckle of a sheath.

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

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

[0038] Figures 8F to 8H are perspective views depicting another example embodiment of a sheath in various stages of assembly with other applicator components.

[0039] Figure 9A is a proximal perspective view depicting an example embodiment of a sensor electronics bracket.

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

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

[0042] Figure 9D is a side cross-sectional view depicting another example embodiment of a sensor electronics bracket along with a housing and sheath.

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

[0044] Figure 10A is a proximal perspective view of an example embodiment of a sharps holder.

[0045] Figure 10B is a side cross-sectional view depicting an example embodiment of a sharps holder.

[0046] Figure 10C is a side cross-sectional view depicting another example embodiment of a sharps holder assembly within an applicator.

[0047] Figure 10D is a labeled side cross-sectional view depicting another example embodiment of a sharps bracket assembly along with a portion of a sensor electronics bracket.

[0048] Figure 10E is a side cross-sectional view depicting another example embodiment of a sharps bracket assembly along with a portion of a sensor electronics bracket.

[0049] Figure 10F is a side cross-sectional view depicting another example embodiment of a sharps carrier assembly and sheath within an applicator.

[0050] Figure 11A is a perspective view depicting an example embodiment of a sharps module.

[0051] Figure 11B is a perspective view of another example embodiment of a sharps module.

[0052] Figure 11C and Figure 11D It depicts Figure 11B Schematic diagram of the sharp object module.

[0053] Figure 11E and Figure 11F Assembled with sensor modules Figure 11B Schematic side view and top view of the sharp object module.

[0054] Figure 11G is a perspective view of another example embodiment of a sharps module.

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

[0056] Figure 11I and Figure 11J Assembled with sensor modules Figure 11G Side cross-sectional view and side view of the sharp object module.

[0057] 12A to 12D are side cross-sectional views depicting an example embodiment of an applicator assembly during various stages of deployment.

[0058] 13A to 13D is a side cross-sectional view depicting another example embodiment of an applicator assembly during various stages of deployment.

[0059] 14A to 14C is a side cross-sectional view depicting another example embodiment of an applicator assembly during various stages of deployment.

[0060] Figure 15A and Figure 15B is a side cross-sectional view depicting another example embodiment of an applicator assembly during various stages of deployment.

[0061] 16A to 16C is a side cross-sectional view depicting another example embodiment of an applicator assembly during various stages of deployment.

[0062] Figure 17 is a side cross-sectional view depicting another example embodiment of an applicator assembly.

[0063] Figure 18 is a partial cross-sectional view depicting another example embodiment of an applicator assembly. DETAILED DESCRIPTION

[0064] Before describing the present subject matter in detail, it is to be understood that the present invention is not limited to the particular embodiments described, as such may, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting, as the scope of the present invention will be limited only by the appended claims.

[0065] As used herein and in the appended claims, the singular forms "a," "an," and "the" include plural references unless the context clearly dictates otherwise.

[0066] The publications discussed herein are provided solely as of their disclosure prior to the filing date of the present application. Nothing herein is to be construed as an admission that the present invention is not entitled to antedate such publications by virtue of prior disclosure. Furthermore, the dates of publications provided may differ from actual publication dates, which may need to be independently confirmed.

[0067] In general, embodiments of the present invention include systems, devices, and methods for dermal sensor insertion applicators for use with in vivo analyte monitoring systems. Thus, many embodiments include in vivo analyte sensors that are structurally configured such that at least a portion of the sensor is located or capable of being located within the body of a user to obtain information about at least one analyte of the body. However, it should be noted that the embodiments disclosed herein can be used with in vivo analyte monitoring systems that incorporate in vitro capabilities, as well as with purely in vitro or ex vivo analyte monitoring systems, including completely non-invasive systems.

[0068] In addition, for each embodiment of the method disclosed herein, systems and devices capable of performing each of those embodiments are encompassed within the scope of the present 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 supplies, communication circuitry, transmitters, receivers, processors, and / or controllers (e.g., for executing instructions) that can perform any and all method steps or facilitate the performance of any and all method steps. These sensor control device embodiments may be used and may be capable of being used to implement the steps performed by the sensor control device according to any and all methods described herein.

[0069] As described above, numerous embodiments of systems, devices, and methods are described herein that provide improved assembly and use of dermal sensor insertion devices for use with in vivo analyte monitoring systems. In particular, several embodiments of the present invention are designed to improve sensor insertion methods for in vivo analyte monitoring systems, and more specifically, to prevent premature withdrawal of an insertion sharp during the sensor insertion process. For example, some embodiments include a dermal sensor insertion mechanism with increased firing speed and delayed sharp withdrawal. In other embodiments, the sharp withdrawal mechanism can be motion-activated, such that the sharp is not withdrawn until the user pulls the applicator away from the skin. Thus, to name a few advantages, these embodiments can reduce the likelihood of premature withdrawal of the insertion sharp during sensor insertion; reduce the likelihood of incorrect sensor insertion; and reduce the likelihood of sensor damage during sensor insertion. Several embodiments of the present invention also provide an improved insertion sharp module to address the small size of dermal sensors and the relatively shallow insertion path present in the subject's dermis. Furthermore, several embodiments of the present invention are designed to prevent unwanted axial and / or rotational movement of applicator components during sensor insertion. Thus, these embodiments can reduce the instability of the positioned dermal sensor, irritation at the insertion site, damage to surrounding tissue, and the potential for capillary rupture leading to contamination of the skin fluid with blood, to name a few advantages. Additionally, to mitigate inaccurate sensor readings that can result from trauma at the insertion site, several embodiments of the present invention can reduce the depth of penetration of the needle tip relative to the sensor tip during insertion.

[0070] However, before describing these aspects of the embodiments in detail, it is first necessary to describe examples of devices that may be present in an in vivo analyte monitoring system, and examples of their operation, all of which may be used with the embodiments described herein.

[0071] There are various types of in vivo analyte monitoring systems. For example, a "continuous analyte monitoring" system (or "continuous glucose monitoring" system) can continuously transmit data from a sensor control device to a reader device without prompting, such as automatically according to a schedule. As another example, a "flash analyte monitoring" system (or "flash glucose monitoring" system, or simply a "flash" system) can transmit data from a sensor control device in response to a scan or request for data by a reader device, such as using a near field communication (NFC) or radio frequency identification (RFID) protocol. In vivo analyte monitoring systems can also operate without requiring finger calibration.

[0072] In vivo analyte monitoring systems can be distinguished from "in vitro" systems, which contact a biological sample outside the body (or "ex vivo") and generally include a meter device having a port for receiving an analyte test strip carrying a user's bodily fluid, which can be analyzed to determine the user's blood glucose level.

[0073] In-vivo monitoring systems may include sensors that, when located in the body, contact a user's bodily fluids and sense the level of an analyte contained therein. The sensors may be part of a sensor control device that is located on the user's body and contains electronics and a power supply that enable and control analyte sensing. Sensor control devices and variations thereof may also be referred to as "sensor control units," "on-body electronics" devices or units, "on-body" devices or units, or "sensor data communication" devices or units, to name a few examples.

[0074] The in vivo monitoring system may also include a device that receives the sensed analyte data from the sensor control device and processes and / or displays the sensed analyte data to the user in any number of formats. To name a few examples, this device and its variations may be referred to as a "handheld reading device," a "reading device" (or simply a "reader"), a "handheld electronic device" (or simply a "handheld device"), a "portable data processing" device or unit, a "data receiver," a "receiver" device or unit (or simply a "receiver"), or a "remote" device or unit. Other devices, such as personal computers, have also been used with or included in in vivo and in vitro monitoring systems.

[0075] Example Embodiments of In Vivo Analyte Monitoring Systems

[0076] Figure 1 is a conceptual diagram depicting an example embodiment of an analyte monitoring system 100 that includes a sensor applicator 150, a sensor control device 102, and a reader 120. Here, the sensor applicator 150 can be used to deliver the sensor control device 102 to a monitoring location on the user's skin, where the sensor 104 is held in place for a period of time by an adhesive patch 105. Figure 2B and Figure 2C 1 and can communicate with the reading device 120 via a communication path 140 using wired or wireless technology. Example wireless protocols include Bluetooth, Bluetooth Low Energy (BLE, BTLE, Bluetooth SMART, etc.), near field communication (NFC), etc. A user can use the screen 122 and input 121 to monitor the applications installed in the memory on the reading device 120, and can use the power port 123 to recharge the device battery. Figure 2ADetailed descriptions of the reader device 120 are provided below. The reader device 120 can communicate with a local computer system 170 via a communication path 141 using either wired or wireless technology. The local computer system 170 can include one or more of a laptop computer, desktop computer, tablet computer, phablet, smartphone, set-top box, video game console, or other computing device, and the wireless communication can include any of a number of applicable wireless network protocols, including Bluetooth, Bluetooth Low Energy (BTLE), Wi-Fi, and the like. The local computer system 170 can communicate with a network 190 via a communication path 143, similar to how the reader device 120 can communicate with the network 190 via a communication path 142, using either wired or wireless technology as previously described. The network 190 can be any of a variety of networks, such as private and public networks, local or wide area networks, and the like. The trusted computer system 180 can include a server that can provide authentication services and secure data storage, and can communicate with the network 190 via a communication path 144 using either wired or wireless technology.

[0077] Example embodiments of a reading device

[0078] Figure 2A 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 component 121, and a processing core 206 comprising a communication processor 222 coupled to a memory 223 and an application processor 224 coupled to a memory 225. Separate memory 230, an RF transceiver 228 with an antenna 229, and a power supply 226 with a power management module 238 may also be included. A multifunction transceiver 232 may further be included, which may communicate with the antenna 234 via Wi-Fi, NFC, Bluetooth, BTLE, and GPS. As will be understood by those skilled in the art, these components are electrically and communicatively coupled to form a functional device.

[0079] Example Embodiments of Sensor Control Devices

[0080] Figure 2B and Figure 2C 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) that may have most of the processing power for presenting final result data suitable for display to a user. Figure 2B, a single semiconductor chip 161, which may be a custom application-specific integrated circuit (ASIC), is depicted. Certain high-level functional units are shown within ASIC 161, 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 devices depending on the communication protocol). In this embodiment, both AFE 162 and processor 166 function as analyte monitoring circuitry, but in other embodiments, either circuit may perform analyte monitoring functions. 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 (or portions thereof).

[0081] Memory 163 is also included in ASIC 161 and can be shared by various functional units present in ASIC 161, or can be distributed among two or more thereof. 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 the in vivo analyte sensor 104, receives measurement data from it, and outputs the data in digital form to processor 166, which in turn processes the data to obtain final results such as glucose discrete values and trend values. This data can then be provided to communication circuit 168 to be sent to reading device 120 (not shown) via antenna 171, for example, where a resident software application requires minimal further processing to display the data.

[0082] Figure 2C Similar to Figure 2B , but includes two discrete semiconductor chips 162 and 174, which can 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 can be isolated or distributed within them. 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 one chip, and processor 166 and power management circuitry 164 are on another chip. It should be noted that other chip combinations are possible, including three or more chips, each responsible for a separate function as described, or sharing one or more functions for fail-safe redundancy.

[0083] Example embodiment of an assembly process for a sensor control device

[0084] The components of the sensor control device 102 are available to the user in a variety of packages, requiring final assembly by the user before being shipped to the appropriate user location. Figures 3A to 3D An example embodiment of the process of assembling the sensor control device 102 by a user is depicted, including preparing the individual components before coupling the components to prepare the sensor for delivery. Figures 3E to 3F An example embodiment is depicted in which the sensor control device 102 is delivered to the appropriate delivery location by selecting the appropriate delivery location and applying the device 102 to the appropriate user location.

[0085] Figure 3A 810 for the assembly process, the container is here configured as a tray (although other packaging may also be used). The user can complete this preparation by removing the cover 812 from the tray 810 to expose the platform 808, for example, by peeling the non-adherent portion of the cover 812 from the tray 810, thereby removing the adhered portion of the cover 812. In various embodiments, removing the cover 812 is appropriate as long as the platform 808 is fully exposed within the tray 810. The cover 812 can then be set aside.

[0086] Figure 3B 708 is a side view of an example embodiment depicting a user preparing the applicator device 150 for assembly. 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 accomplished by unscrewing (or otherwise separating) the cap 708 from the housing 702. The cap 708 can then be set aside.

[0087] Figure 3C 810 ). FIG1 is a proximal perspective view of an example embodiment depicting a user inserting the applicator assembly 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 (standoff or detent), the user can insert the sheath 704 into the platform 808 within the tray 810. Inserting the sheath 704 into the platform 808 temporarily unlocks the sheath 704 relative to the housing 702 and also temporarily unlocks the platform 808 relative to the tray 810. At this stage, removing the applicator assembly 150 from the tray 810 will result in the same state as before the applicator assembly 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).

[0088] The sheath 704 can remain in position relative to the housing 702 within the platform 808 while the housing 702 is advanced distally, coupling with the platform 808 to advance the platform 808 distally relative to the tray 810. This step causes the platform 808 to unlock and fold within the tray 810. The sheath 704 can contact and disengage a locking feature (not shown) within the tray 810, which unlocks the sheath 704 relative to the housing 702 and prevents (relative) movement of the sheath 704 while the housing 702 continues to advance the platform 808 distally. At the end of advancement of the housing 702 and platform 808, the sheath 704 is permanently unlocked relative to the housing 702. The sharps and sensors (not shown) within the carriage 810 can be coupled to the electronics housing (not shown) within the housing 702 at the end of distal advancement of the housing 702. The operation and interaction of the applicator device 150 and the tray 810 are further described below.

[0089] Figure 3D 810 is a proximal perspective view of an example embodiment depicting a user removing the applicator assembly 150 from the tray 810 during assembly. The user removes the applicator 150 from the tray 810 by proximally advancing the housing 702 relative to the tray 810, or other motion that has the same net effect of disengaging the applicator 150 from the tray 810. The applicator assembly 150 is removed with the sensor control assembly 102 (not shown) fully assembled therein (sharp, sensor, electronics) and positioned for delivery.

[0090] Figure 3E is a proximal perspective view of an example embodiment depicting a patient applying the sensor control device 102 to a target area of skin (e.g., on the abdomen or other appropriate location) using the applicator device 150. Distally advancing the housing 702 allows the sheath 704 to fold within the housing 702 and apply the sensor to the target location, causing the adhesive layer on the bottom side of the sensor control device 102 to adhere to the skin. When the housing 702 is fully advanced, the sharps automatically retract, while the sensor (not shown) remains in place to measure the analyte level.

[0091] Figure 3F is a proximal perspective view of an example embodiment of a patient depicting the sensor control device 102 in the application position.The user can then remove the applicator 150 from the application site.

[0092] Compared with the existing technology system, the reference Figures 3A-3FThe system 100 described elsewhere herein can provide a reduction or elimination of the likelihood of accidental breakage, permanent deformation, or improper assembly of applicator components. Because the applicator housing 702 directly engages the platform 808 when the sheath 704 is unlocked, rather than indirectly engaging via the sheath 704, the relative angle between the sheath 704 and the housing 702 will not cause breakage or permanent deformation of the arms or other components. During assembly, the likelihood of relatively large forces (such as in conventional devices) will be reduced, which in turn reduces the likelihood of a user failing to assemble the device successfully.

[0093] Example embodiments of a sensor applicator assembly

[0094] Figure 4A is a side view depicting an example embodiment of the applicator assembly 150 coupled with the screw cap 708. This is one example of how the applicator 150 may be shipped to and received by a user prior to the user assembling the sensor. Figure 4B is a side perspective view depicting the applicator 150 and cap 708 after detachment. Figure 4C is a perspective view of an example embodiment depicting the distal end of applicator device 150 removing electronics housing 706 and adhesive patch 105 from their position within sensor electronics bracket 710 of sheath 704 when cap 708 is in place.

[0095] Example embodiments of tray and sensor module assemblies

[0096] Figure 5 is a proximal perspective view depicting an example embodiment of a tray 810 having a sterilization cover 812 removably coupled thereto, which may represent how the package may be shipped to and received by a user prior to assembly.

[0097] Figure 6A 810 is a perspective, proximal end view of a sensor delivery assembly depicting the sensor delivery assembly within the tray 810. The platform 808 is slidably coupled within the tray 810. The desiccant 502 is fixed relative to the tray 810. The sensor module 504 is mounted within the tray 810.

[0098] Figure 6B is a proximal perspective view depicting sensor module 504 in greater detail. Here, retaining arm extension 1834 of platform 808 releasably secures sensor module 504 in place. Module 2200 is coupled with connector 2300, sharps module 2500, and sensor (not shown) so that it can be removed along with sensor module 504 during assembly.

[0099] Example Embodiments of Applicator Housings

[0100] Figure 7Ais a side view depicting an example embodiment of an applicator housing 702 that may include an internal cavity having a support structure for the applicator function. A user may push the housing 702 in a distal direction to initiate the applicator assembly process, which then also results in delivery of the sensor control device 102, after which the cavity of the housing 702 may be used as a receptacle for sharps. 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 recessed portion located around the periphery of the housing 702, distal to the tamper ring protector 1314 and proximal to the tamper ring retainer 1306. The tamper ring groove 1304 may retain the tamper ring so that a user can identify whether the device has been tampered with or otherwise used. The housing threads 1310 may secure the housing 702 to complementary threads on the cap 708 by aligning with the complementary cap threads and rotating in a clockwise or counterclockwise direction. Figure 4A and Figure 4B ). The side gripping areas 1316 of the housing 702 can provide an outer surface location where a user can grip the housing 702 to use it. The gripping protrusions 1318 are slightly raised ridges relative to the side gripping areas 1316 that can help easily remove the housing 702 from the cap 708. The shark teeth 1320 can be raised portions with flat sides located on the clockwise edge to shear off a tamper-evident ring (not shown) and hold the tamper-evident ring in place after the user has unscrewed the cap 708 and housing 702. In the exemplary embodiment, four shark teeth 1320 are used, but more or fewer shark teeth can be used as desired.

[0101] Figure 7B is a perspective view depicting the distal end of the housing 702. Here, three housing guide structures (or "guide ribs") 1321 are positioned at 120 degree angles relative to each other and at 60 degree angles relative to the locking structures (or "locking ribs") 1340, of which there are also three at 120 degree angles relative to each other. Other angular orientations, symmetrical or asymmetrical, and any number of one or more 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 guide rib that can be positioned along the sheath 704 (e.g., with reference to FIG. 1 ). Figure 8A The guide rail 1418 (described above) is passed through a guide edge (also referred to as a "sheath guide") 1326. The insertion hard stop 1322 can be a flat, distally facing surface of the housing guide rib 1321 located near the proximal end of the housing guide rib 1321. The insertion hard stop 1322 provides a means for abutting the sheath 704 ( Figure 8B) of the sensor electronics bracket travel limiter face 1420, preventing any further movement of the sensor electronics bracket travel limiter face 1420 in the proximal direction. During assembly, the bracket connection post 1327 passes through the hole 1510 ( Figure 9A ). The sensor electronics bracket connection portion 1328 can be a rounded, distal-facing surface of the housing guide rib 1321 that connects to the sensor electronics bracket 710.

[0102] Figure 7C 1 is a side cross-section of an exemplary embodiment of the housing. In the exemplary embodiment, a side cross-sectional profile of the housing guide rib 1321 and the locking rib 1340 is shown. The locking rib 1340 includes a sheath buckle guide feature 1330 near the distal end of the locking rib 1340, which flares outwardly from the central axis 1346 of the housing 702 at the distal end. Each sheath buckle guide feature 1330 causes the housing 702 to be locked. Figure 8C The detent buckle round portion 1404 of the detent buckle 1402 of the sheath 704 is shown to flex inwardly 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 buckle introduction feature 1330, the detent buckle 1402 of the sheath 704 is locked in place in the locking groove 1332. Thus, due to the planar surface having a plane that is nearly perpendicular to the central axis 1346, as shown in FIG. Figure 8C As shown by the brake buckle flat portion 1406 in FIG, the brake buckle 1402 cannot be easily moved in the distal direction.

[0103] As the housing 702 is moved further in the distal direction toward the skin surface, and as the sheath 704 advances toward the distal end of the housing 702, the brake catch 1402 moves into the unlocking recess 1334, and the applicator 150 is in the "standby" position, ready for use. As the user applies force further toward the proximal end of the housing 702 while pressing the sheath 704 against the skin, the brake catch 1402 overrides the firing brake 1344. This initiates the firing sequence (e.g., as described with reference to FIG. 1 ). 12A to 12D1346 and slows the movement of the sheath 704 during the firing sequence. After unlocking notch 1334, the next notch encountered by the detent buckle 1402 is the final lockout notch 1336, into which the detent buckle 1402 enters at the end of the stroke or push sequence performed by the user. The final lockout notch 1336 may be a proximally facing surface perpendicular to the central axis 1346 that engages the detent buckle flat 1406 after the detent buckle 1402 passes and prevents reuse of the device by securely holding the sheath 704 in place relative to the housing 702. An interposed hard stop 1322 of the housing guide rib 1321 prevents proximal advancement of the sheath 704 relative to the housing 702 by engaging the sensor electronics bracket travel limiter surface 1420.

[0104] Figure 7D and Figure 7E is a close-up side view of an example embodiment of locking rib 1340 of applicator housing 702 as detent buckle 1402 of sheath 704 moves toward the proximal end of housing 702. Figure 7D The sheath 704 is shown in a "locked" state, wherein the brake circle 1404 of the brake buckle 1402 has passed the sheath buckle introduction 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 circle 1404 advances proximally into the unlocking groove 1334, placing the applicator 150 in the "standby" position. When further force is applied to the proximal end of the housing 702, the applicator 150 is "fired" as the brake circle 1404 advances proximally from the unlocking groove 1334 and past the firing brake 1344. The sheath 704 is then further advanced proximally, causing the brake circle 1404 to slidably advance on the firing surface 1337, as shown in FIG. Figure 7E In this embodiment, the firing surface 1337 is substantially parallel to the central axis 1346. As the guard 704 continues to advance proximally, the detent circle 1404 reaches the guard stop ramp 1338, which slows the movement of the guard 704. When the detent circle 1404 reaches the final latch groove 1336, the detent snap flat 1406 (not shown) is engaged and securely holds the guard 704 in place relative to the housing 702.

[0105] Figure 7F and Figure 7G23 is a close-up side view of an alternative embodiment of a locking rib 2340 designed to increase the firing speed of a sharp object from a sensor applicator. Here, the locking rib 2340 includes an inward detent 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 , the sheath 704 is initially shown in a "locked" state, wherein the detent dome 1404 of the detent buckle 1402 has passed over the sheath buckle lead-in feature 2330 and is positioned in the locking recess 2332. When force is applied to the proximal end of the housing 2702, the detent dome 1404 is advanced into the unlocking recess 2334, placing the applicator 150 in the "standby" position. When further force is applied to the proximal end of the housing 2702, the applicator 150 is "fired" as the detent dome 1404 passes the firing detent 2344.

[0106] like Figure 7G As shown, the brake circle 1404 is then advanced toward the proximal end of the housing 2702 in a "free travel" state, wherein the brake circle 1404 passes over the inward brake ramp 2335. When advancing proximally in the "free flight" state, the brake circle 1404 can be discontinuous, or not in contact with the inward brake ramp 2335 and the firing surface 2337. In this regard, since there is little to no friction between the brake circle 1404 and the inward brake ramp 2335 and the firing surface 2337, the brake circle 1404 can be easily and quickly advanced, and in this way, the firing speed of the sharp object from the applicator is increased. Figure 7D and Figure 7E The illustrated embodiment further positions the sheath stop ramp 2338 proximally along the locking rib 2340, providing an edge portion to frictionally engage the detent circle 1404 and slow the movement of the sheath 704. The sheath stop ramp 2338 can have an inclined shape and provide increased frictional contact as the detent circle 1404 advances in the proximal direction. Finally, when the detent circle 1404 reaches the final latch groove 2336, the detent snap flat 1406 (not shown) engages and securely holds the sheath 704 in place relative to the housing 2702. The latch groove 2336 prevents the detent circle 1404 and sheath 704 from moving rearwardly or distally. This embodiment reflects the detent circle 1404 and sheath 704 relative to the housing 2702. Figure 7D and Figure 7E The embodiment depicted in the drawings has a higher firing speed, which also helps prevent premature retraction of the sharp object.

[0107] Figure 7HFIG6 is a close-up side view of an alternative embodiment of a locking rib 6340 designed to maintain a downward force on the sheath 6704 during the firing process, which in turn prevents unwanted movement of the sheath 6704 during the sensor insertion process. Here, the sheath 6704 is shown in a "locked" state, with the detent dome 6404 of the detent buckle 6402 positioned in the locking recess 6332. When force is applied to the proximal end of the housing 6702, the detent dome 6404 advances into the unlocking recess 6334, placing the applicator in the "standby" position. When further force is applied to the proximal end of the housing 6702, the applicator is "fired," and the detent dome 6404 advances on the inclined firing surface 6338 toward the proximal end of the housing 6702. The inclined firing surface 6338 can be angled toward the central axis 1346 so that as the detent circular portion 6404 advances in the proximal direction, the downward force on the sheath 6704 increases. In the depicted embodiment, the detent circular portion 6404 is in continuous contact with the inclined firing surface 6338. The locking groove 6336 prevents the detent circular portion 6404 and the sheath 6704 from moving rearward or distally. This embodiment reflects a slower firing speed relative to the previous embodiment and can be used, for example, with reference to Figures 14A-14C and Figures 15A-15B The motion-actuated sharp object retraction process is described.

[0108] Figure 7I 7336, which is a close-up side view of another alternative embodiment of the locking rib 7340, which is also designed to maintain a downward force on the sheath 6704 during firing, which in turn prevents unwanted movement of the sheath 6704 during the sensor insertion process. Here, the sheath 6704 is shown in a "fired" state, wherein the detent circle 6404 of the detent buckle 6402 is positioned in the bidirectional locking groove 7336. When the detent circle 6404 advances into the bidirectional locking groove 7336, the sheath 6704 is prevented from further movement in either the proximal or distal direction. This can reduce unwanted movement of the sheath 6704 during the sensor insertion process. Additionally, in some embodiments, as shown in reference Figures 14A-14C and Figures 15A-15B As described, the bi-directional locking groove 7336 can provide for securing the sheath 6704 during the motion-activated sharp object retraction process. Figure 7I As seen in FIG, the inclined firing surface 7338 is angled toward the central axis 1346 so that as the detent circular portion 6404 advances in the proximal direction, the downward force on the sheath 6704 increases. In the depicted embodiment, the detent circular portion 6404 is in continuous contact with the inclined firing surface 7338. This embodiment reflects a slower firing speed and can be used, for example, with reference to FIG. Figures 14A-14C and Figures 15A-15B The motion-actuated sharp object retraction process is described.

[0109] Example Embodiments of Applicator Sheaths

[0110] Figure 8A and Figure 8B 1 and 2 depict a side view and a perspective view, respectively, of an example embodiment of the sheath 704. In this example embodiment, the sheath 704 allows the sensor control device 102 to be graded above the user's skin surface prior to application. The sheath 704 may also include features that help hold the 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. The brake buckle 1402 is located near the proximal end of the sheath 704 and will be referenced below. Figure 8C Further described. The sheath 704 can have a generally cylindrical cross-section with a first radius at a proximal portion (closer to the top of the figure) being shorter than a second radius at a distal portion (closer to the bottom of the figure). A plurality of detent gaps 1410 are also shown, three in the illustrated embodiment. The sheath 704 can include one or more detent gaps 1410, each of which can be a cutout having space for distal entry of the sheath buckle lead-in feature 1330 until the distal surface of the locking rib 1340 contacts the proximal surface of the detent gap 1410.

[0111] Guide rails 1418 are provided between the sensor electronics bracket travel limiter surface 1420 at the proximal end of the sheath 704 and the cutout around the locking arm 1412. Each guide rail 1418 may be a channel between two ridges where the guide edge 1326 of the housing guide rib 1321 may slide distally relative to the sheath 704.

[0112] The locking arms 1412 are disposed near the distal end of the sheath 704 and may include an attached distal end and a free proximal end that may include a locking arm connection portion 1416. When the locking arm connection portion 1416 of the locking arms 1412 engages the locking connection portion 1502 of the sensor electronics bracket 710, the locking arms 1412 may lock the sensor electronics bracket 710 to the sheath 704. A locking arm reinforcement rib 1414 may be disposed near the center of each locking arm 1412 and may serve as a reinforcement point for an otherwise weak point of each locking arm 1412 to prevent the locking arms 1412 from excessive bending or breaking.

[0113] Brake buckle reinforcement feature 1422 may be located along the distal portion of brake buckle 1402 and may provide reinforcement to brake buckle 1402. Alignment notch 1424 may be a cutout near the distal end of sheath 704 that provides an opening for a user to align with the sheath orientation feature of platform 808. Reinforcement rib 1426 may include a buttress, here triangular, that provides support for brake base 1436. Housing rail gap 1428 may be a cutout for the distal surface of housing guide rib 1321 to slide during use.

[0114] Figure 8C is a close-up perspective view of an example embodiment of a detent buckle 1402 depicting the sheath 704. The detent buckle 1402 can include a detent buckle bridge 1408 located near or at its proximal end. The detent buckle 1402 can also include a detent buckle flat 1406 located on the distal side of the detent buckle bridge 1408. The outer surface of the detent buckle bridge 1408 can include a detent buckle rounded portion 1404, which is a rounded surface that allows the detent buckle bridge 1408 to more easily move past the inner surface of the housing 702 (e.g., the locking rib 1340).

[0115] Figure 8D 704. FIG. 704 is a side view depicting an example embodiment of a sheath 704. Here, the alignment notch 1424 can be relatively close to the detent gap 1410. The detent gap 1410 is located at a relatively proximal position on the distal portion of the sheath 704.

[0116] Figure 8E is an end view of an example embodiment depicting the proximal end of the sheath 704. Here, the rear wall 1446 for the guide rail may provide a channel to slidably couple with the housing guide ribs 1321 of the housing 702. The sheath rotation limiter 1448 may be a notch that reduces or prevents rotation of the sheath 704.

[0117] Figures 8F to 8H is a perspective view of an alternative exemplary embodiment of a sheath 6704 in various stages of assembly with the other components of the applicator. Figure 8F As shown, the sheath 6704 may have many of the same Figures 8A-8C 6704 may have the same features as those described above for the sheath 704. For example, the sheath 6704 may include one or more detent buckles 6404 having one or more detent circular portions 6402 attached thereto. However, the overall length of the sheath 6704 may be shorter than that of the sheath 702. Furthermore, the sheath 6704 may include one or more inner sheath ribs 6425 disposed on an inner surface of the sheath 6704 and extending inwardly toward the central axis of the sheath 6704.

[0118] Go to Figure 8G, depicting a stage of assembly of the sheath 6704 with the applicator housing 6702 and the sensor electronics bracket 6710 in perspective view. One or more inner sheath ribs 6425 of the sheath 6704 can connect with one or more corresponding rib notches 6519 in the sensor electronics bracket 6710. The mating connection between the corresponding ribs 6425 and notches 6519 can help maintain axial alignment of the sheath 6704 and the sensor electronics bracket 6710 during the sensor insertion process. Furthermore, the connection between the ribs 6425 and notches 6519 can reduce lateral and rotational movement between the applicator components, which in turn can reduce the likelihood of incorrect sensor insertion.

[0119] Go to Figure 8H , the sheath 6704 is shown in perspective view at a stage of assembly with the applicator housing 6702 and the sensor electronics housing 706, which has been inserted into the sensor electronics bracket 6710. The inner sheath ribs 6425 are also shown.

[0120] It should be noted that while six inner jacket ribs 6425 and six corresponding rib notches 6519 are depicted, any number of ribs and notches is fully within the scope of the present invention. Furthermore, while the ribs 6425 are depicted as having rounded surface edges, in other embodiments, the ribs 6425 may have a rectangular or triangular shape, and the rib notches 6519 may have a corresponding receiving shape for connecting with the ribs 6425. Furthermore, while the ribs 6425 are depicted as being disposed on the inner circumferential surface of the jacket 6704, the ribs 6425 may be disposed on any other surface of the jacket 6704, or on a portion thereof that contacts the sensor electronics bracket 6710.

[0121] Example Embodiments of a Sensor Electronics Bracket

[0122] Figure 9AFIG2 is a proximal perspective view of an example embodiment of a sensor electronics carrier 710 that can hold sensor electronics within the applicator 150. It can also hold the sharps carrier 1102 with the sharps module 2500. In this example embodiment, the sensor electronics carrier 710 has a generally hollow, rounded, flat cylindrical shape and can include one or more deflectable sharps carrier locking arms 1524 (e.g., three) extending proximally from a proximal surface surrounding a centrally located spring alignment ridge 1516 for maintaining alignment of the spring 1104. Each locking arm 1524 has a detent or retaining feature 1526 located at or near its proximal end. A shock lock 1534 can be an outwardly extending extension located on the outer circumference of the sensor electronics carrier 710 and can lock the sensor electronics carrier 710 for added safety prior to firing. The rotation limiter 1506 can be a relatively short protrusion extending proximally on the proximal surface of the sensor electronics bracket 710 that limits the rotation of the bracket 710. The sharps bracket locking arm 1524 can be connected to the sharps bracket 1102, as described below with reference to Figures 10A-10E Descriptive.

[0123] Figure 9B 15 is a perspective view of the distal end of the sensor electronics bracket 710. Here, one or more sensor electronics retention spring arms 1518 (e.g., three) are generally biased toward the position shown and include a detent 1519 that can pass through the distal surface of the electronics housing 706 of the device 102 when housed within a recess or cavity 1521. In some embodiments, after the sensor control device 102 has been adhered to the skin using the applicator 150, the user pulls the applicator 150 in a proximal direction (i.e., away from the skin). The adhesive force holds the sensor control device 102 to the skin and overcomes the lateral force applied by the spring arms 1518. As a result, the spring arms 1518 deflect radially outward and disengage the detent 1519 from the sensor control device 102, thereby releasing the sensor control device 102 from the applicator 150.

[0124] Figure 9C is a perspective view of an alternative example embodiment of the sensor electronics bracket 6710. Figure 9C As shown, the sensor electronics bracket 6710 may have many of the same Figures 9A to 9B In addition, the sensor electronics bracket 6710 also includes one or more notched ribs 6519 disposed along the outer circumferential surface. Figure 8F-8H As best seen in FIG, notch ribs 6519 are configured to connect with inner sheath ribs 6425 to maintain axial alignment of the sheath and sensor electronics bracket and reduce lateral and rotational movement between applicator components during the sensor insertion process.

[0125] Figure 9D and Figure 9E Alternative embodiments of sensor electronics carriers for insertion into the dermal sensor are depicted. These embodiments include a retention mechanism to couple the applicator housing to the sensor electronics carrier while also allowing the sensor electronics carrier to advance a limited distance in the proximal to distal direction while the sharp is inserted into the skin. The retention mechanism is operable to further increase the speed of sharp insertion during firing while delaying retraction of the sharp, as described below with reference to Figures 13A-13D In other embodiments (e.g., Figures 14A-14C and Figures 15A-15B As shown), the retention mechanism may also provide a displacement region between the sensor electronics bracket and the sheath through which a motion-activated sharps retention mechanism may be activated.

[0126] Figure 9D FIG2 is a side cross-sectional view of an alternative embodiment of a 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 detent circle 1404 of the sheath 704 positioned within the locking recess 2332 of the locking rib 2340 of the housing 3702. Distal to the housing guide rib 3321 of the housing 3702 is a thermal stud 1333. The thermal stud 1333 can extend distally through the aperture 1510 of the sensor electronics bracket 2710. A distal portion 1339 of the thermal stud 1333 can be flared such that the distal portion is larger than the aperture 1510 of the sensor electronics bracket 2710 and prevents the thermal stud 1333 from sliding out of the aperture 1510 due to the resistance of the aperture flange 1513. The thermal post 1333 may have a length greater than the thickness of the aperture 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 (e.g., Figures 13A-13D as further described in ). Figure 9D As shown, when the applicator 150 is depicted as being in a "locked state," the proximal end (or base) of the thermal stud 1333 is proximal to or flush against the sensor electronics bracket 2710, the aperture 1510, and the aperture flange 1513. During a firing sequence, the sensor electronics bracket 2710 is displaced in a distal direction, creating a spaced relationship between the proximal end (or base) of the thermal stud 1333 and the sensor electronics bracket 2710, the aperture 1510, and the aperture flange 1513.

[0127] Figure 9EFIG4 is a side cross-sectional view of an alternative embodiment of the sensor electronics bracket 710 and housing 4702. One or more snap arms 1329 are provided at the distal end of the housing guide rib 4321 of the housing 4702. The snap arms 1329 can extend distally through the aperture 1510 of the sensor electronics bracket 2710. A snap stop 1331 is provided at the end of each snap arm 1329. The snap stop 1331 can be expanded such that the distal end of the snap arm 1329 is larger than the aperture 1510 of the sensor electronics bracket 2710 and prevents the snap arm 1329 from completely disengaging from the aperture 1510 due to the aperture flange 1513. The snap arms 1329 can also have a length greater than the thickness of the flange 1513, allowing for spaced-apart movement between the sensor electronics bracket 2710 and the housing 4702 along the longitudinal axis. Figure 9E The embodiment depicted in FIG. 1 has movements during the "locked" and "fired" phases similar to those of FIG. Figure 9D The movement of the embodiment shown, and in Figures 12A-12D and Figures 13A-13D In addition, reference Figure 9D and Figure 9E The described embodiments may also be implemented with a motion-activated sharps retraction mechanism, which will be referred to as Figures 14A-14C and Figures 15A-15B Further description.

[0128] Example Embodiments of Sharps Holders

[0129] Figure 10A and Figure 10B 1 and 2 depict a proximal perspective view and a side cross-sectional view, respectively, of an exemplary embodiment of a sharps holder 1102. The sharps holder 1102 can grasp the sharps module 2500 and retain it within the applicator 150. It can also automatically retract during insertion due to one or more springs changing from a preloaded, compressed state to an expanded state, as shown in FIG. Figures 12A-12D and Figures 13A-13D Near the distal end of the sharps holder 1102 may be an anti-rotation slot 1608 which, when located within the center region of the sharps holder locking arm 1524 (e.g., Figure 9A ), the anti-rotation slot prevents rotation of the sharps holder 1102. The anti-rotation slot 1608 can be located between portions of the sharps holder base ramp 1610, which can ensure that the sharps holder 1102 is fully retracted through the sheath 704 when the sharps holder 1102 is retracted at the end of the expansion process.

[0130] like Figure 10BAs shown, the sharps retaining arms 1618 can be positioned within the sharps carrier 1102 about the central axis and can include a sharps retaining clip 1620 at the distal end of each arm 1618. The sharps retaining clips 1620 can have a proximal surface that can be nearly perpendicular to the central axis and can abut a distal-facing surface of the sharps hub 2516 ( Figure 11A ).

[0131] Figures 10C to 10E Alternative embodiments of sharps holder assemblies are described, each comprising an inner sharps holder and an outer sharps holder. These embodiments provide a delay resulting from a separate retraction process for each sharps holder, which occurs during the firing sequence, wherein a dermal sensor is implanted into the subject's dermis before the sharps are retracted. The introduction of the delay significantly reduces the likelihood of premature sharp withdrawal during the insertion process.

[0132] Figure 10C 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 the sensor electronics holder 710, the sheath 704, and the housing 2702. The inner sharps holder 3102 may include one or more sharps retaining arms 3104 for retaining the sharps module 2500. The sharps retaining arms 3104 may further include a sharps retaining clip 3106 located at the distal end of each arm 3104. Figure 11A As shown, the sharps retaining clip 3106 may have a proximal surface that may be approximately perpendicular to the central axis and may abut the distal-facing surface of the sharps hub 2516. On the proximal surface of the inner sharps carrier 3102, a bottom inner spring retaining channel 3108 is provided that may retain the distal end of the inner spring 1106, which is shown in a preloaded and compressed state before the sharps carrier assembly is retracted. One or more inner carrier latches 3110 are also provided at or near the proximal end of the inner sharps carrier 3102. The inner carrier latch 3110 may include a substantially flat surface that faces the distal end of the applicator 150 and extends radially outward from the central longitudinal axis of the inner sharps carrier 3102.

[0133] Still refer to Figure 10C, the external sharps holder 3152 can be located outside of and surround the internal sharps holder 3102. At the proximal end of the external sharps holder 3152, a top inner spring retaining channel 3158 is provided which can retain the proximal end of the inner spring 1106. The top inner spring retaining channel 3158 of the external sharps holder 3152 and the bottom inner spring retaining channel 3108 of the internal sharps holder 3102 each provide a surface for retaining the end of the inner spring 1106. The external sharps holder 3152 can also include an outer spring retaining channel 3162 for retaining the proximal end of the outer spring 1104, which is also shown as being in a preloaded and compressed state before the sharps holder assembly is retracted. Figure 10C As shown, outer spring 1104 is shown as having a greater length and radius than inner spring 1106. However, springs 1104, 1106 may have equal size and / or radius, or, in the alternative, inner spring 1106 may have a greater radius and / or length than outer spring 1104. In some embodiments, outer spring 1104 has a stiffness equal to or greater than inner spring 1106.

[0134] Reference again Figure 10C , the external sharps tray 3152 may further include one or more external tray latches 3160. The external tray latches 3160 may include a substantially flat surface that faces the proximal end of the applicator 150 and extends radially inwardly toward the central longitudinal axis of the external sharps tray 3152. The flat surface of the external tray latch 3160 and the flat surface of the internal tray latch 3110 may face each other and be aligned along a longitudinal axis extending from the proximal end of the applicator 150 to the distal end. As in Figures 12A-12D and Figures 13A-13DAs described in , when the applicator 150 is in the "locked" state, the internal bracket latch 3110 is positioned proximal to the external bracket latch 3160 in a spaced relationship. When the sheath 704 is advanced in the proximal direction, the applicator 150 is "fired" and the sharps bracket locking arm 1524 of the sensor electronics bracket 710 is released into its outwardly biased position. Subsequently, the force generated by the expansion of the internal spring 1106 and the external spring 1104 causes the external sharps bracket 3152 to advance in the proximal direction. In addition, the opposing force generated by the expansion of the internal spring 1106 causes the internal sharps bracket 3102 to remain in the same relatively position, thereby preventing premature retraction of the sharps. Similarly, the opposing force generated by the expansion of the external spring 1104 causes the sensor electronics bracket 710 to remain in the same relatively position (or to be displaced in the distal direction toward the skin surface). As the outer sharps carrier 3152 is further advanced in the proximal direction, the outer carrier latch 3160 engages the inner carrier latch 3110. The proximal force caused by the carrier latches 3160, 3110 causes the inner sharps carrier 3102 to move proximally into the applicator 150, thereby retracting the sharps (not shown).

[0135] Figure 10D 4 is a side view of another embodiment of a two-piece sharps tray assembly, including an inner sharps tray 4102 and an outer sharps tray 4152. Similar to the previous embodiment, the inner sharps tray 4102 may include one or more sharps retaining arms 4104 with sharps retaining clips 4106, and one or more inner tray latches 4110 located at or near the proximal end of the inner sharps tray 4102. The outer sharps tray 4152 may also include a spring retaining channel 4162 for retaining the spring 1104, and an outer tray latch 4160 for connecting with the inner tray latch 4110. These structures are similar to those of the reference Figure 10C The described embodiments operate in a similar manner.

[0136] Still refer to Figure 10D The two-piece sharps holder assembly includes a spring 1104 (with Figure 10C In addition, an internal sharps holder brake 4114 is provided at a distal portion of the internal sharps holder 4102 (e.g., Figure 10D), for engaging the carriage retaining brake 1517 located on the sensor electronics bracket 710. The engagement of the internal sharps bracket brake 4114 with the carriage retaining brake 1517 causes the internal sharps bracket 4102 and the sensor electronics bracket 710 to remain locked in place while the sharps penetrates the skin surface during the insertion process. During a "firing" of the applicator 150, the internal sharps bracket brake 4114 may be disengaged from the carriage retaining brake 1517. When the sharps bracket locking arm 1524 of the sensor electronics bracket 710 is released (as shown in FIG. Figure 12B and Figure 13B 150 ), the spring 1104 expands from its preloaded, compressed state. Subsequently, the outer sharps tray 4152 advances in the proximal direction while the inner sharps tray 4102 remains relatively in the same position, thereby preventing premature retraction of the sharps. As the outer sharps tray 4152 continues to advance in the proximal direction, the outer tray latch 4160 engages the inner tray latch 4110, and the proximal force applied by the outer tray latch 4160 to the inner tray latch 4110 causes the inner sharps tray latch 4114 to disengage from the tray retaining latch 1517. The outer tray latch 4160 then pulls the inner sharps tray 4102 in the proximal direction into the applicator 150, thereby retracting the sharps (not shown).

[0137] refer to Figure 10D , those skilled in the art will appreciate that other retaining devices may be used in place of the internal carriage brake arm 4112 and carriage retaining brake 1517. For example, in alternative embodiments, a snap, hook, ball lock, latch, pin, or other similar retaining device may be utilized to hold the internal sharps carriage 4102 in a "locked" position with the sensor electronics carriage 710 until sufficient force from the external sharps carriage 4152 causes the retaining device to disengage, thereby allowing the internal sharps carriage 4102 to advance in the proximal direction. In other alternative embodiments, threads may be used between the internal sharps carriage 4102 and the sensor electronics carriage 710 to hold the internal sharps carriage 4102 in place during the "fire" sequence of the applicator 150 (e.g., Figures 12A-12D and Figures 13A-13D ). Subsequently, as the outer sharps holder 4152 continues to advance in the proximal direction, the proximal force of the outer sharps holder 4152 can cause the inner sharps holder 4102 to rotate and disengage itself from the sensor electronics holder 710. It will be understood that these exemplary retention arrangements and their equivalents fall within the scope of the embodiments disclosed herein.

[0138] Figure 10Eis a side view of yet another embodiment of a two-piece sharps tray including an inner sharps tray 5102 and an outer sharps tray 5152. Similar to the previous embodiments, the inner sharps tray 5102 may include one or more sharps retaining arms 5104 with sharps retaining clips 5106. The outer sharps tray 5152 may include a spring retaining channel 5162 for retaining a spring 1104.

[0139] Still refer to Figure 10E , the outer sharps holder 5152 may include one or more angled snap arms 5164 extending in an inward direction from a proximal top portion of the outer sharps holder 5152 such that each angled snap arm 5164 may be angled in a downward direction toward a distal portion of the inner sharps holder 5102. Each angled snap arm 5164 may include a snap arm flange 5166 at a distal end that may be comprised of an end portion that provides a substantially flat surface facing in a proximal direction (i.e., similar to the reference Figure 10D 4. The outer carrier latch 4160 described above. Additionally, each distal end of the one or more angled snap arms 5164 can be matingly engaged with one or more angled keyways 5116 of the inner sharps carrier 5102. The angled keyways 5116 can be formed by cutouts having a generally "tilted rectangular" shape in the outer cylindrical surface of the inner sharps carrier 5102 and extend circumferentially from the proximal end to the distal end of the inner sharps carrier 5102.

[0140] Reference again Figure 10E , the internal sharps bracket 5102 further includes one or more locking tabs 5118 on an outer cylindrical surface of a proximal portion of the internal sharps bracket 5102. The locking tabs 5118 may be comprised of fixed spherical, hemispherical, or other rounded structures that extend outwardly away from the central longitudinal axis of the internal sharps bracket 5102 and that may be matingly engaged with bracket tab slots 1521 located on the distal portion of the sensor electronics bracket 710. The bracket tab slots 1521 may be comprised of cutouts in the spring alignment ridge 1516 of the sensor electronics bracket 710, wherein the cutouts have open ends from which the locking tabs 5118 may be slidably disengaged upon rotation of the internal sharps bracket 5102.

[0141] refer to Figure 10E With the illustrated embodiment, the relative movement of the outer sharps holder 5152, the inner sharps holder 5102, and the spring 1104 during a "firing" of the applicator 150 will now be generally described. Figure 12B and Figure 13B1521, the inner sharps tray 5102 remains relatively in the same position due to the locking tab 5118 engaging the bracket tab slot 1521, thereby preventing premature retraction of the sharps. As the outer sharps tray 5152 continues to advance in the proximal direction, the force exerted by the angled snap arms 5164 on the angled key slot 5116 causes the inner sharps tray 5102 to rotate due to the angular orientation of the angled key slot 5116. As the inner sharps tray 5102 rotates, the locking tab 5118 slidably advances toward the open end of the bracket tab slot 1521 of the sensor electronics tray 710. When the locking tab 5118 reaches the open end of the bracket tab slot 1521, the inner sharps tray 5102 disengages from the sensor electronics tray 710. As the outer sharps holder 5152 is advanced further in the proximal direction, the snap arm flange 5166 engages the proximal portion of the angled keyway 5116 and begins to pull the inner sharps holder 5102 in the proximal direction into the applicator 150, thereby retracting the sharps (not shown).

[0142] like Figure 10E As shown, two angled snap arms 5164 and two angled key slots 5116 are depicted. However, it will be understood that any number of angled snap arms 5164 and / or angled key slots 5116 may be used. Additionally, although the bracket tab slots 1521 are Figure 10E 10 is shown as having an "L-shaped" cut, but any number of cut shapes having an open end (e.g., a "curved" or "linear ramp") are suitable, from which the locking tab 5118 can be slidably disengaged.

[0143] Figure 10F is a close-up side cross-sectional view of another example embodiment depicting a sharps holder assembly 8102 and a sheath 8704 within an applicator. According to one aspect of these embodiments, the sharps holder assembly 8102 may include a sharps holder slot 8104 disposed on a surface of the sharps holder assembly 8102 and along a path that the sharps holder retention feature 1526 of the sensor electronics holder 710 travels during retraction of the needle (not shown). Similarly, according to another aspect of these embodiments, the sheath 8704 may include a sheath slot 8706 disposed on a surface of the sheath 8704 and along a path that the sharps holder locking arm 1524 of the sensor electronics holder 710 travels during retraction of the needle. As further described below, reference Figures 16A-16C, the sharps holder slot 8104 and the sheath slot 8706 can be configured to receive the sharps holder locking retention 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 the sheath slot 8706, the locking arm 1524 can partially deflect in an outward direction, which causes the sharps holder 8102 to move a limited distance in a proximal direction due to the expansion force of the preloaded compression spring 1104 disposed in the sharps holder 8102. In this manner, the needle can be partially retracted or maintained in a fixed position relative to the skin surface, such that the needle can be prevented from further penetrating the dermis or subcutaneous tissue of the subject.

[0144] Example Embodiments of Sharps Modules

[0145] Figure 11A is depicted in the sensor module 504 ( Figure 6B ) prior to assembly within a sharps module 2500. Sharps 2502 may include distal tips 2506 that may penetrate the skin while carrying the sensor tail within the hollow portion or recess of sharp shaft 2504 to expose the active surface of the sensor tail to bodily fluids. Hub push cylinder 2508 may provide a surface for the sharps carrier to push against during insertion. Hub small cylinder 2512 may provide a surface for the sharps hub contact surface 1622 ( Figure 10B ). The hub snap detent positioning cylinder 2514 may provide a distally facing surface of the hub snap detent 2516 for abutting the sharp hub contact surface 1622. The hub snap detent 2516 may include a tapered surface that opens the sharps retaining clip 1620 during installation of the sharps module 2500.

[0146] Figures 11B to 11HExample embodiments of a sharps module for inserting a dermal analyte sensor at various stages of assembly are shown. According to one aspect of these embodiments, angling the sensor and / or the insertion sharp relative to a reference point enables the end of the insertion needle and the end of the sensor to be co-located, and in addition, a single contact point can be created on the surface of the skin. In this way, when the sensor is inserted into the object, the sharps can create a leading edge on the surface of the skin to form an insertion path for inserting the sensor into the dermis. In some embodiments, for example, the sharps and / or the dermal sensor can 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 is different from the angle of the sensor. For example, the reference point can be the surface of the skin to be pierced for dermal insertion, or can be a reference or component of the sensor applicator kit. In some embodiments, the sharps can be set at a certain angle relative to the sensor. For example, when designed so 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, as well as the positioning of the needle relative to the sensor, may be implemented in any desired configuration, including all those disclosed in US Patent Publication No. 2014 / 0171771, which is incorporated herein by reference in its entirety for all purposes.

[0147] In addition, although the reference Figures 11B to 11J Many of the example embodiments described relate to dermal analyte sensors and dermal insertions, but one skilled in the art will understand that the size and structure of any embodiment may be configured for use with an analyte sensor that may be positioned outside of the dermal space, such as within (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).

[0148] Figure 11B is a perspective view depicting an example embodiment of a sharp object module 2550 that can be used to insert a dermal sensor. Figure 6B ) before assembling the sharps module 2550, and which may include the reference Figure 11AComponents similar to those of the described embodiments include a sharp 2552, a sharp shaft 2554, a sharp distal end 2556, a hub push cylinder 2558, a hub small cylinder 2562, a hub snap detent 2566, and a hub snap detent positioning cylinder 2564. The sharp 2552 can be positioned within the sharp module 2550 at an off-center position relative to the longitudinal axis 2545, which extends through the center of the hub snap detent 2566, the hub small cylinder 2562, and the hub push cylinder 2558. Additionally, the sharp module 2550 can include a sharp spacer 2568 that is parallel to and adjacent a portion of the sharp 2552. A sharp spacer 2568 can be positioned between the sensor 104 (not shown) and the sharp 2552 along the proximal portion of the sharp 2552 and can ensure that the sensor 104 and the sharp 2552 remain spaced apart at the proximal portion of the sharp 2552. During the molding process, the sharp 2552 can be positioned in an off-center position, wherein each hub member 2558, 2562, 2566 can be constructed of a rigid plastic material.

[0149] Figure 11C and Figure 11D are two depictions of the sensor module 504 ( Figure 6B ) is a side view of a sharp module 2550 prior to assembly, the sharp module including a sharp 2552, a spacer 2568, a hub push cylinder 2558, a hub small cylinder 2562, and a hub latch 2566. In some embodiments, the relative distances between the sharp 2552 and the hub components can be positioned as follows. For example, the distance S1 between the sharp 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 spacer 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 2552 can be in the range of 1.5 mm to 25 mm (e.g., 8.55 mm) and can depend on the location of the insertion site on the subject.

[0150] Figure 11E A side cross-sectional view of the sharps module 2550 including the sharps 2552, sharps spacer 2568, and hub components (hub snap catch 2566, hub small cylinder 2562, and hub push cylinder 2558) when assembled with the sensor module 504 is depicted. Figure 11EAs seen in FIG, the sharps 2552 are positioned within the sharps slot 2208 of the sensor module 504, which includes a curved inner surface 2250 at the distal end. The curved inner surface 2250 of the sensor module 504 can contact a portion of the sharps 2552 and cause deflection such that the distal end 2556 of the sharps is oriented toward the central longitudinal axis 2545. As shown in FIG. Figure 11H As best seen in FIG. 2 , the sharp tip 2552 can be positioned such that the distal portion and the central longitudinal axis 2545 form an acute angle S. θ , which may be in the range of 5° to 20°. In some embodiments, for example, S θ It may be in the range of 5° to 17°, or 7° to 15°, or 9° to 13°, such as 9°, 10°, 11°, 12° or 13°.

[0151] Still refer to Figure 11E Near the distal end of the sensor module 504 is a protrusion 2251 that enhances the perfusion of body fluids (e.g., dermal fluid). Figure 11E 2251 is shown as a curved surface, but the protrusion 2251 can be shaped in any desired manner. In addition, in some embodiments, there may be multiple protrusions. 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 of the embodiments described herein show a needle emerging from the protrusion, and in other embodiments, the needle can emerge from the base of the sensor device adjacent to the protrusion and extend from that location over the end of the sensor 104.

[0152] Still refer to Figure 11E and Figure 11F , the sensor 104 can be a dermal sensor and can include a sensor tail 2408 at the distal end of the sensor 104, which can be positioned in a direction substantially parallel to the central longitudinal axis 2545. The distal end of the sensor tail 2408 can be adjacent to the distal sharp tip 2556, or can be spaced apart from, stationary in, or stationary on a portion of the sharp shaft 2554. Figure 11E As further depicted in FIG, the sharp washer 2568 provides a spaced relationship between the proximal portion of the sharp 2552 and the sensor 104 so that the proximal portion of the sharp 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 perpendicularly relative to the distal end of the sensor 104.

[0153] Figure 11Fis a top-down cross-sectional view of the sensor module 504. The sensor module 504 may include one or more sensor module buckles 2202 for coupling with the housing (not shown) of the sensor control unit 102. The sensor module 504 may also include a sensor connector 2300, which may have sensor contacts 2302 for coupling with the proximal portion of the sensor 104. The sensor connector 2300 may be made of silicone rubber that encapsulates a compliant carbon-impregnated polymer module that serves as conductive contacts 2302 between the sensor 104 and circuit contacts for electronics within the sensor control unit 102. When assembled in a compressed state after transfer from the container to the applicator and after application to the user's skin, the connector may also serve as a moisture barrier for the sensor 104. While three contacts 2302 are depicted, it will be understood that the 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 the sensor 104. Sensor connector 2300 can further be coupled to sensor module 504 via two connector posts 2206 that are positioned through the same number of holes in connector 2300. While two connector posts 2206 are depicted, it will be understood that any number of connector posts 2206 can be used to couple connector 2300 to sensor module 504.

[0154] Figure 11G and Figure 11H , respectively, a perspective view and a side view of another exemplary embodiment of a sharp object module 2600 that can be used to insert a dermal sensor. Figure 6B ) before assembly of the sharps module 2600, which may include the reference Figure 11A and Figure 11B Components similar to those of the described embodiments include a sharp 2602, a sharp shaft 2604, a sharp distal end 2606, a hub push cylinder 2608, a hub small cylinder 2612, a hub snap catch 2616, and a hub snap catch positioning cylinder 2614. In some embodiments, the sharp 2602 can be a "pre-bent" needle that includes a proximal portion 2603 that begins at a point outside of the sharp module 2600 and intersects a center point of the hub (e.g., through the hub push cylinder 2608) at a certain angle. The sharp 2602 can also include a distal portion 2605 that extends in a distal direction from a point near the distal portion of the hub at a certain angle toward an insertion point on the user's skin. Figure 11HAs shown, the sharp 2602 may include an angled portion 2607 located outside the hub push cylinder 2608, which may have a substantially 90° angle between the proximal portion 2603 and the distal portion 2605 of the sharp 2602. The sharp module 2600 may also include a curved fin guide 2620 that is used to hold the "pre-bent" sharp 2602 in place during assembly and / or use and may prevent lateral or rotational movement of the sharp 2602 relative to the hub assembly. After the molding process is complete and before the sharp module 2600 is assembled with the sensor module 504, the proximal portion 2603 of the sharp 2602 may be "trimmed" from the hub.

[0155] Figure 11I and Figure 11J A side cross-sectional view and a side view are shown, respectively, of the sharp object module 2600 (including the hub buckle latch 2616, the hub small cylinder 2612 and the hub push cylinder 2608) when assembled with the sensor module 504. Figure 11I As seen in FIG, the sensor module 504 includes a sharps slot 2208 through which a sharp 2602 can extend in an angled distal direction. As previously described, the proximal portion of the sharp 2602 passes through a curved fin guide 2620, which couples to the distal portion of the sensor module 504. The sensor module 504 may also include a sensor 104, which may be a dermal sensor. As shown in FIG. Figure 11I As seen in FIG. 2 , the sharp object 2602 and the sensor tail 2408 may form an acute angle S at the point where their respective longitudinal axes converge. θ . Angle S θ It can be in the range of 5° to 20°. In some embodiments, for example, S θ The angle may be in 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 tip 2606 is located at a distance S6 that is proximal to the end of the sensor tail 2408. The distance S6 may be in the range of 0.02 mm to 0.10 mm, for example, 0.05 mm, 0.06 mm, or 0.07 mm.

[0156] Still refer to 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, the proximal portion being relatively perpendicular to the distal end of the sensor 104. The sensor module 504 may further include one or more sensor module buckles 2202 for coupling with a housing (not shown) of the sensor control device 102. The sensor connector 2300 may include reference Figure 11F Same structure as described.

[0157] In the above embodiments, the sharps may be made of a flexible material such as stainless steel (e.g., the material used to make acupuncture needles) and are sized so that the applicator is used to insert at least a portion of the dermal sensor into the dermis layer, but not through the dermis layer of the skin. According to certain embodiments, the sharps have a cross-sectional diameter (width) from 0.1 mm to 0.5 mm. For example, the sharps may have a diameter from 0.1 mm to 0.3 mm, such as from 0.15 mm to 0.25 mm, such as from 0.16 mm to 0.22 mm. A given sharp may have a constant (i.e., uniform) width along its entire length, or may have a varying (i.e., changing) width along at least a portion of its length (e.g., the end portion used to pierce the skin surface). For example, referring to Figure 11I In the illustrated embodiment, the width of the sharps 2602 may narrow along a distal portion between the curved fin guide 1620 and the distal sharp tip 2606 .

[0158] The sharp may also have a length that will just insert the dermal sensor into the dermis and not further. The insertion depth may be controlled by the length of the sharp, the base, and / or the construction of other applicator components that limit the insertion depth. The sharp may have a length between 1.5 mm and 25 mm. For example, the length of the sharp 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 although the sharp may have a length of up to 25 mm, in certain embodiments, the entire length of the sharp is not inserted into the subject because it would extend beyond the dermal space. The uninserted length of the sharp may be used to handle and manipulate the sharp in the applicator kit. Thus, while the sharps may have a length of up to 25 mm, in those certain embodiments, the insertion depth of the sharps into the skin on the subject will be limited to the dermis, e.g., 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 sharps may be configured to extend beyond the dermal space, e.g., 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 exemplary embodiments, the sharps described herein may include a hollow or partially hollow insertion needle having an interior space or lumen. However, in other embodiments, the sharps described herein may include a solid insertion needle having no interior space and / or lumen. Furthermore, the sharps of the applicator kits of the present invention may also be bladed or bladeless.

[0159] Likewise, in the above embodiments, the dermal sensor is sized such that at least a portion of the sensor is positioned within the dermis and no deeper, and a portion extends beyond the skin in 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-most portion (insertion portion or insertion length) of the sensor is positioned within the dermis of the subject, and when the sensor is operably positioned transdermally, no portion of the sensor is inserted beyond the dermis of the subject.

[0160] The size (e.g., length) of the sensor can be selected based on the body part of the subject into which the sensor will be inserted, as the depth and thickness of the epidermis and dermis exhibit a certain degree of variability depending on the skin location. For example, the epidermis is only about 0.05 mm thick on the eyelids, but is about 1.5 mm thick on the palms of the hands and soles of the feet. The dermis is the thickest of the three layers of skin and ranges in thickness from about 1.5 mm to 4 mm depending on the skin location. In order to implant the distal end of the sensor into the dermis layer of the subject, but not through the dermis layer, 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 an insertion site on the user's body and determining the depth of the dermis layer at that site, and selecting an applicator kit of an appropriate size for that site.

[0161] In some aspects, the sensor is an elongated sensor having a longest dimension (or "length") 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, e.g., from 1 mm to 2 mm, e.g., 1.5 mm. The size of a sensor can also be expressed in terms of its aspect ratio. In some embodiments, the dermal sensor has an aspect ratio of length to width (diameter) of about 30:1 to about 6:1. For example, the aspect ratio can be from about 25:1 to about 10:1, including 20:1 and 15:1. The inserted portion of the dermal sensor has a sensing chemical property.

[0162] 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) the 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 most distal portion (insertion portion or insertion length) of the sensor is positioned within the subcutaneous tissue (beyond the dermis of the subject), and when the sensor is operably positioned, no portion of the sensor is inserted beyond the subcutaneous tissue of the subject. As described above, the subcutaneous tissue typically exists in a region 3 mm to 10 mm below the outer skin surface, depending on the location of the skin on the body.

[0163] Example Embodiments of Applicator Deployment

[0164] Figures 12A-12D is a side cross-sectional view depicting an example embodiment of an applicator 150 during expansion of the sensor control device 102 , which may include a dermal sensor for sensing analyte levels in a dermal layer of a subject.

[0165] Figure 12A The applicator 150 is shown in a position ready to be positioned against a subject's skin surface prior to firing. The detent circular portion 1404 of the sheath 704 is positioned in a "lock" recess 2332 in the locking rib of the applicator housing 2702. The external sharps holder 3152 is coupled to the internal spring 1106 and the external spring 1104, both of which are in a preloaded, compressed state. The external sharps holder 3152 is also retained by one or more sharps holder locking arms 1524 of the sensor electronics holder 710. The sensor electronics holder 710 is positioned within the proximal portion of the sheath 704, with the inner diameter of the sheath 704 configured to deflect the sharps holder locking arms 1524 in an inward direction. The distal portion of the external sharps holder 3152 contacts the proximal-facing surface of the sensor electronics holder 710. Similarly, the distal portion of the internal sharps holder 3102 is coupled to the proximal-facing surface of the sensor electronics holder 710. The sharp object 2552 and the sensor 104 are positioned within the sheath 704.

[0166] exist Figure 12B, the applicator 150 is shown in a "fired" state, wherein a force applied to the proximal end of the housing 2702 causes the housing 2702 to move in a distal direction relative to the sheath 704. At this point, the sharps 2552 and sensor 104 extend from the distal end of the sheath 704 and have penetrated or are penetrating the skin layer of the subject. The advancement of the housing 2702 causes the detent circular portion 1404 to advance in a proximal direction relative to the housing 2702, which in turn causes the detent circular portion 1404 to enter a "free flight" state, wherein the detent circular portion 1404 moves over the firing surface 2337 with discontinuous or no contact. The sharps bracket locking arms 1524 of the sensor electronics bracket 710 have also cleared the inner diameter of the sheath 704 and are free to deflect outwardly into their biased position (indicated by the outward arrow). Subsequently, the sharps tray locking arm 1524 disengages from the outer sharps tray 3152, which in turn begins to move in the proximal direction due to the expansion (indicated by the upward arrow) of the inner spring 1106 and the outer spring 1104. The expansion of the inner spring 1106 also applies a force in the distal direction, causing the inner sharps tray 3102 to remain coupled to the sensor electronics tray 710. Similarly, the expansion of the outer spring 1104 also applies a force in the distal direction, securing the sensor electronics tray 710 in the distal position.

[0167] exist Figure 12C , the outer sharps tray 3152 continues to move in the proximal direction (indicated by the upward arrow) due to the continued expansion of the inner spring 1106 and the outer spring 1104. After moving a predetermined distance in the proximal direction, the outer tray latch 3160 of the outer sharps tray 3152 engages the inner tray latch 3110 of the inner sharps tray 3102. Figure 12C As shown, the sharp object 2552 and the sensor 104 are maintained in their respective positions due to the expansion force generated by the springs 1104, 1106 in the distal direction.

[0168] exist Figure 12D , the internal sharps bracket 3102 is pulled in the proximal direction (indicated by the elongated upward arrow) by the force of the external bracket latch 3160. The internal sharps bracket 3102 then retracts the sharps 2552 through the sensor electronics bracket 710, causing the sensor 104 to be implanted into the dermis of the subject. The applicator 150 is shown in a "locked" state, wherein the detent circle 1404 of the sheath 704 has advanced past the sheath stop ramp (not shown) and is located within the final lock groove 2336 of the housing 2702. As shown in Figure 12D As further shown in FIG, both the inner sharps holder 3102 and the outer sharps holder 3152 are fully retracted into the applicator 150.

[0169] Figures 13A-13D is a side cross-sectional view depicting an alternative embodiment of an applicator 151 during deployment of a sensor control device 102, which may include a dermal sensor for sensing an analyte level in a subject's dermis. Figures 12A-12D As depicted, applicator 151 operates in a similar manner to applicator 150, but additionally includes a retention mechanism to couple housing 3702 and sensor electronics bracket 2710. The retention mechanism operates to further increase the speed of sharp insertion during firing while delaying the sharp retraction sequence, as further described below.

[0170] like Figure 13A 704, and the applicator 151 is shown in a "locked" state prior to firing. The sharps 2552 and sensor 104 are positioned within the sheath 704, and the applicator 151 is ready to be positioned against the subject's skin. The applicator housing 3702 includes a heat stake 1333 located on a distal portion of the housing guide rib 3321. The heat stake 1333 includes a flared end 1339 and extends from the housing guide rib 3321 in a distal direction through the aperture 1510 of the sensor electronics bracket 2710. During the "locked" state, the proximal-facing portion of the sensor electronics bracket 2710 abuts the proximal base of the heat stake 1333.

[0171] Figure 13B The applicator 151 is shown in a "fired" state, wherein a force applied to the proximal end of the housing 3702 causes the housing 3702 to move in a distal direction relative to the sheath 704. The sharps 2552 and sensor 104 extend from the distal end of the sheath 704 and have penetrated or are penetrating the skin layer of the subject. The sharps carrier locking arms 1524, having passed the inner diameter of the sheath 704, deflect outwardly into their biased positions (indicated by the outward arrows) and disengage from the external sharps carrier 3152. Due to the expansion of the internal spring 1106 and the external spring 1104, the external sharps carrier 3152 then begins to move in a proximal direction. The expansion of the internal spring 1106 and the external spring 1104, as well as the proximal movement of the external sharps carrier 3152, creates a corresponding opposing force in the distal direction (indicated by the downward arrows) against the internal sharps carrier 3102 and the sensor electronics carrier 2710. This force causes the internal sharps bracket 3102 and the sensor electronics bracket 2710 to advance further in the distal direction along the thermal post 1333, thereby increasing the speed of the sharp in the distal direction during insertion. At this point, the internal sharps bracket 3102 and the sensor electronics bracket 2710 remain coupled.

[0172] exist Figure 13C, the outer sharps bracket 3152 continues to move in the proximal direction (indicated by the upward arrow) due to the continued expansion of the inner spring 1106 and the outer spring 1104. The sensor electronics bracket 2710 has advanced in the distal direction along the heat stake 1333 until it reaches the flared end 1339 of the heat stake. The flared end 1339, which is larger than the aperture 1510, abuts the flange 1513 in the sensor electronics bracket 2710, thereby preventing the sensor electronics bracket 2710 from fully disengaging from the housing guide rib 3321 of the housing 3702. After moving a predetermined distance in the proximal direction, the outer bracket latch 3160 (not shown) of the outer sharps bracket 3152 engages the inner bracket latch 3110 (not shown) of the inner sharps bracket 3102 (in the circled area "K"). The sharps 2552 and sensor 104 remain in the extended state outside the sheath 704.

[0173] Figure 13D 104 is shown in a "locked" position. The applicator 151 is shown in a "locked" position. Continued expansion of the inner spring 1106 and the outer spring 1104 causes the outer sharps carriage 3152 to advance further in the proximal direction. Subsequently, the outer carriage latch 3160 (not shown) engages the inner sharps carriage 3102 and pulls the inner sharps carriage 3102 in the proximal direction (indicated by the elongated upward arrow). The inner sharps carriage 3102 then retracts the sharps 2552 via the sensor electronics carriage 2710, allowing the sensor 104 to be implanted in the dermis of the subject. The detent circular portion 1404 of the sheath 704 is positioned in the final lockout groove 2336, and both the inner sharps carriage 3102 and the outer sharps carriage 3152 are fully retracted into the applicator 151.

[0174] refer to Figures 13A-13D In the embodiment of FIG. 3 , the thermal stud 1333 is described as a retaining mechanism to couple the housing 3702 and the sensor electronics bracket 2710. However, it should be understood that a different retaining mechanism may be used, such as the one described with reference to FIG. Figure 9E The described snap arms 1329, snaps, hooks, ball locks, latches, pins and / or other similar retaining devices and structures.

[0175] refer to Figures 12A-12D and Figures 13A-13D The embodiments in the present invention describe a sharps holder assembly including an internal spring for maintaining the position of the internal sharps holder. Those skilled in the art will appreciate that other devices and mechanisms for maintaining the position of the internal sharps holder are well within the scope of the disclosed embodiments. For example, an internal sharps holder brake for engaging the sensor electronics holder (e.g., a reference to FIG. 1 ) may be provided. Figure 10D ), an internal sharps bracket having one or more locking tabs for engaging with the sensor electronics bracket (as described in reference Figure 10E described), as well as snaps, hooks, ball locks, latches, pins and threads may be used alone or in combination to hold the internal sharps holder in place during the "firing" sequence of the applicator.

[0176] Figures 14A-14C is a side cross-sectional view of another alternative embodiment of the applicator 152 during deployment of the sensor control device 102. As with the previous embodiments, the applicator 152 is initially positioned against the skin of the subject and a force is applied to the proximal end of the housing 7702, causing the housing 7702 to move in a distal direction relative to the sheath 6704. The sharps 2552 and sensor 104 then extend from the distal end of the sheath 6704 and penetrate the skin layers of the subject. However, unlike the previous embodiments ( Figures 12A-12D and Figures 13A-13D ), the applicator 152 utilizes a motion-activated sharps retraction mechanism that retracts the sharps as the user moves the applicator 152 away from the skin, as described in further detail below.

[0177] Figure 14A 63. The applicator 152 is shown in an early "locked" state after the detent circular portion 1404 of the sheath 6704 has advanced over the inclined firing surface 7338, due to the user applying a first force on the applicator and reaching the bidirectional locking groove 7336. At this stage, the sharps 2252 have penetrated the skin layer and the sensor 104 has been inserted into the dermis. In addition, as best seen in the callout 14A-1, one or more sharps bracket locking arms 6524 of the sensor electronics bracket 6710 are biased in an outward direction and are urged against one or more corresponding bracket arm ramps 6415 of the sheath 6704. In this position, the bracket arm ramps 6415 exert a downward thrust on the locking arms 6524, thereby trapping the sharps bracket 1102 on the sensor electronics bracket 6710. Additionally, as seen in callout 14A-2, snap arms 1329 of housing 7702 extend through aperture 1510 of sensor electronics bracket 6710. At this stage, the distal edge of the housing is flush with aperture 1510 and aperture flange 1513 of sensor electronics bracket 6710.

[0178] Figure 14B14B-1 , the applicator 152 is shown after being in a "locked" state when the user begins to move the applicator 152 away from the skin by applying a second force to the applicator 152. The second force (which may be in a proximal or "upward" direction), for example, may be in an opposite direction to the first force, which may be in a distal or "downward" direction. An adhesive layer (not shown) on the bottom surface of the sensor control assembly 102 holds the sensor control assembly 102 to the subject's skin, and movement of the applicator 152 in the proximal direction causes a pulling force on the sensor electronics bracket 6710 relative to the housing 7702. As best seen in callout 14B-1 , the bracket arm ramp 6415 includes a beveled end surface that applies a force in a distal direction to the locking arm 6524 and causes the sensor electronics bracket 6710 to separate from the housing 7702. Thus, as shown in reference 14B-2, when the aperture flange 1513 moves proximate the snap stop 1331 of the snap arm 1329, the sensor electronics bracket 6710 moves in a distal direction relative to the housing 7702 (ie, toward the skin).

[0179] Figure 14C 14C-1, the locking arm 6524 has cleared the bracket arm ramp 6415. Subsequently, the sharps bracket 1102 is released and moves in the proximal direction under the force of the compression spring 1104, thereby retracting the sharps 2252. Furthermore, as shown in callout 14C-2, the sensor electronics bracket 6710 cannot move further away from the housing 7702 when the snap stop 1331 of the snap arm 1329 abuts the flange 1513. Subsequently, when the user pulls the applicator 152 away from the skin, the sensor control unit 102 is separated from the sensor electronics bracket 6710 and is now attached to the skin with the sensor 104 inserted.

[0180] Figures 15A-15B are a side cross-sectional view and a perspective cross-sectional view, respectively, both depicting another alternative embodiment of an applicator 153 during deployment of the sensor control device 102. The applicator 153 also utilizes a motion-activated sharp object retraction mechanism and generally operates in a similar manner to the applicator 152, as described with reference to FIG. 14A to 14C Descriptive.

[0181] Go to Figure 15A, shows the applicator 153 in a pre-fired state, ready to be positioned against the skin surface of a subject. The detent circular portion 1404 of the sheath 6704 is positioned in the "locking" groove 6332 of the locking rib 6340 in the housing 6702. In addition, the locking rib 6340 includes an inclined firing surface 6338 that 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. As previously described with reference to Figure 8F-8H As depicted, the connection between the inner sheath ribs 6425 and the rib notches (not shown) of the sensor electronics bracket 6710 maintains axial alignment of the sheath 6704 and the sensor electronics bracket 6710 and further prevents unwanted rotational and / or lateral movement during the sensor insertion process.

[0182] Still refer to Figure 15A , the sharps bracket 1102 is coupled to a compression spring 1104 in a preloaded, compressed state. The sharps bracket 1102 is retained by one or more bracket locking arms 6524 of the sensor electronics bracket 6710. Prior to firing, the sharps 2552 and sensor 104 are positioned within the sheath 6704.

[0183] Go to Figure 15B , shows the applicator 153 in an early "locked" position, after the sensor 104 has been inserted but before the sharps 2552 have been retracted. The detent circle 1404 has advanced over the inclined firing surface 6338 and reached the final lockout recess 6336 in the locking rib 6340, which prevents the sheath 6704 from further movement in the distal direction relative to the housing 6702. In addition, the sheath 6704 includes a sheath travel limiter flange 6720, which, in the "locked" position, abuts against the bottom edge 6331 of the housing 6702, thereby preventing further movement of the sheath 6704 in the proximal direction relative to the housing 6702. Thus, in the "locked" position, the sheath 6704 is prevented from further movement in either the proximal or distal direction relative to the housing 6702. Additionally, at this stage, the carriage locking arm 6524 has not cleared the ramp 6415 of the sheath 6704, and the flange 1513 of the sensor electronics bracket 6710 is flush with the housing 6702. Thus, the motion-activated sharps retraction mechanism has not yet been activated. Subsequently, when the user pulls the applicator 153 away from the skin, the carriage locking arm 6524 will clear the ramp 6415, thereby releasing the sharps bracket 1102 and activating the sharps retraction mechanism (as described in reference to FIG. Figure 14C description).

[0184] refer to Figures 14A-14C and Figures 15A-15B In the embodiment, it should be understood that Figures 12A-12D and Figures 13A-13DEmbodiments such as applicators 152 and 153 generally have slower effective insertion speeds than the applicators shown. Figures 14A-14C and Figures 15A-15B The sheath 6704 may have a Figures 12A-12D and Figures 13A-13D The sheath is depicted as being of a short length. Additionally, in some embodiments, the sheath 6704 can further include a base surface coated with an adhesive for adhering to a user's skin surface.

[0185] Figures 16A-16C is a side sectional view of another alternative example embodiment of the applicator 154 during deployment of the sensor control device 102. As with the previous embodiments, the applicator 154 is initially positioned against the skin of the subject 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 sharps 2552 and sensor 104 then extend from the distal end of the sheath 8704 and penetrate the skin layers of the subject. According to one aspect of the disclosed embodiments, the applicator 154 may include a two-stage needle retraction mechanism in which the sharps 2552 are partially retracted in a first stage to minimize further penetration of the sharps 2552 into the subject, while the sensor 104 may 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 can be implemented by a plurality of slots, including the sheath slot 8706 and the sharps holder slot 8104 (e.g., in FIG. Figure 10F ), each slot may be configured to receive at least a portion of a sharps bracket locking arm 1524 of the sensor electronics bracket 710.

[0186] First reference Figure 16A , shows the applicator 154 in a "locked" state prior to firing, wherein the applicator 154 is ready to be positioned against the skin surface of a subject. The sharps 2552 and sensor 104 are positioned within the sheath 8704. The sensor electronics bracket 710 rests radially against the inner diameter of the sheath 8704.

[0187] Figure 16B 8704. Figure 10F. ) When a portion of each locking arm 1524 is received in the slots 8104 and 8706, the locking arms 1524 can partially deflect in an 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 manner, according to one aspect of these embodiments, the sharp 2552 can be partially retracted, or maintained in a fixed position relative to the skin surface, during or after the first stage of the two-stage needle retraction process. Additionally, according to another aspect of these embodiments, during the first stage of the two-stage sharp retraction, the distal portion of the sensor 104 can continue to penetrate tissue, e.g., the dermis or subcutaneous tissue of the subject, while the proximal portion of the sensor 104 can remain within the sharps 2552.

[0188] Figure 16C The applicator 154 is shown in the second stage of the two-stage needle retraction process. As the housing 702 continues to move in the distal direction relative to the sheath 8704, the sharps holder locking arms 1524 of the sensor electronics bracket 710 have passed the inner diameter of the sheath 8704 and are free to deflect outwardly into their biased positions. Subsequently, the sharps holder locking arms 1524 disengage from the sharps holder 8102, which in turn moves further in the proximal direction due to further expansion of the spring 1104, thereby causing the sharps 2552 to be further retracted into the applicator 154. As can also be seen in FIG. Figure 16C As seen in , the applicator 154 is shown in a “locked” state, wherein the detent circle 1404 of the sheath 8704 has advanced past the sheath stop ramp 1338 and is located within the final lockout groove 1336 of the housing 702.

[0189] refer to Figures 16A-16C154, can be configured to reduce the penetration depth of the sharp 2252 relative to, for example, the sensor tip. In this way, these embodiments can reduce early sensor degradation or sensor inaccuracy during the first few hours after insertion, which can be caused by trauma to the insertion site. Furthermore, while the sharps holder slot 8104 and sheath slot 8706 are depicted as being located at certain locations along the sharps holder 8102 and sheath 8704, respectively, those skilled in the art will appreciate that other configurations (e.g., three, four, or five slots) and / or geometries (e.g., angled surfaces, curved surfaces, concave surfaces, etc.) along the sharps holder 8102 and / or sheath 8704, adapted to cause partial release of the sharps holder locking arm, are well within the scope of the present 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 been retracted. Similarly, in other embodiments, the height of the sharps holder slot 8104 can be varied to change the distance that the sharps 2552 are partially retracted.

[0190] Go to Figure 17 , provides a side cross-sectional view of another exemplary alternative embodiment, wherein 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 that may be used with reference to FIG. Figures 16A-16CThe applicator 155 can operate in a similar manner to the embodiments described above. In many embodiments, for example, the applicator 155 can include a sharps holder slot 8104 of the sharps holder 8102 and a sheath slot 8706 of the sheath 8704, each of which can be configured to receive at least a portion of a locking arm 6524 of the sensor electronics holder 6710. During operation, when a portion of each locking arm 6524 is received in the slots 8104 and 8706, the locking arm 6524 can partially deflect in an outward direction, allowing the sharps holder 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 holder 8102. In this manner, according to one aspect of these embodiments, during or after the first stage of a two-stage needle retraction process, the sharp 2552 can be partially retracted or maintained in a fixed position relative to the skin surface while the distal portion of the sensor 104 can 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 arms 6524 can clear the inner diameter of the sheath 8704 and deflect outwardly into their biased positions, thereby disengaging the sharps carrier 8102, which in turn moves further in the proximal direction due to further expansion of the spring and retracts the sharps 2552 into the applicator 155.

[0191] Still refer to Figure 17 According to another aspect of these embodiments, the applicator 155 may include a compliant mechanism between the sensor electronics bracket 6710 and the housing 7702. In some embodiments, such as in Figure 17 As best seen in callout 17-1 of FIG. 17 , the housing 7702 of the applicator 155 may include one or more snap arms 1329 that may extend through the aperture 1510 of the sensor electronics bracket 6710. At the distal end portion of the snap arms 1329, one or more snap detents 1331 may prevent the snap arms 1329 from disengaging from the sensor electronics bracket 6710. Additionally, as shown in FIG. Figure 17 As seen in the annotation 17-1 of , the bottom edge of the hole flange 1513 and one or more snap brakes 1331 are in a spaced relationship with a predetermined gap amount α, which allows limited movement of the sheath 8704, sharps holder 8102, sensor electronics holder 6710 and sensor control unit 102 relative to the housing 7702.

[0192] According to one aspect of these embodiments, the predetermined gap α can allow for universal movement of the sensor electronics bracket 6710 relative to the housing 7702, which in turn can result in angular displacement of the sharps 2552 and sensor 104 relative to the housing 7702 during insertion. For example, when the applicator 155 is in the "standby" position, as shown in FIG. 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 force is applied to the housing 7702 and the applicator 155 is fired, the sensor electronics bracket 6710 can undergo universal motion relative to the housing 7702 and cause the distal portion of the analyte sensor 104 and the longitudinal axis 8545 to be in a non-parallel relationship. In this regard, the sharps 2552 and sensor 104 can be guided through tissue along a path of least resistance rather than being forced to move in the same axial direction as the housing 7702, which in turn can reduce tissue damage during penetration and reduce early signal attenuation or sensor inaccuracies during the first few hours after insertion.

[0193] Figure 18 is a partial cross-sectional view of another example embodiment of an applicator 156 further having a compliant mechanism. According to one aspect of some embodiments, the housing 3702 of the applicator 156 may include a thermal stake 1333 that may extend through the hole 1510 of the sensor electronics bracket 2710. The thermal stake 1333 may have a flared distal end 1339 that may be configured to prevent the thermal stake 1333 from detaching from the sensor electronics bracket 2710. Figure 17 Similar to the described embodiment, the bottom edge of the aperture flange 1513 and the flared distal end 1339 of the heat stake 1333 may be in a spaced relationship by a predetermined gap amount a, which may allow for limited freedom of movement of the sensor electronics bracket 2710 .

[0194] According to another aspect of these embodiments, the predetermined gap α can allow for universal movement of the sheath, sensor electronics bracket 2710, and sensor control unit 102 relative to the housing 3702, as well as angular displacement of the sharp object 2552 and sensor 104 during insertion. Figure 18 The degree and range of the angular displacement θ between the sharp object 2552 and the sensor 104 can be a function of the 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.

[0195] refer to Figure 17 and Figure 18 Although some embodiments including a compliant mechanism are described as being combined with a two-stage needle retraction mechanism, those skilled in the art will appreciate that the compliant mechanism can be combined with applicators having other types of retraction mechanisms, such as those described with reference to FIG. Figures 12A-12D 、 Figures 13A-13D 、 Figures 14A-14C and Figures 15A-15BThose embodiments described, as well as applicators described in U.S. Patent Publication No. 2013 / 0150691 and U.S. Patent Publication No. 2016 / 0331283, which are incorporated herein by reference in their entirety for all purposes.

[0196] refer to Figures 12A-12D 、 Figures 13A-13D 、 Figures 14A-14C 、 Figures 15A-15B 、 Figures 16A-16C 、 Figure 17 and Figure 18 In the embodiment, although the sharp object 2552 is described, it should be understood that the sharp object 2552 can be used in this article. Figures 11A-11J Any sharp object, sharp object module, and sensor module described.

[0197] 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 of, and any component thereof, including but not limited to Figures 11A-11J Sharps, sharps modules, and sensor module embodiments, those skilled in the art will appreciate that the sizes and structures of the embodiments can be configured for use with sensors configured to sense analyte levels in bodily fluids in the epidermis, dermis, or subcutaneous tissue of a subject. In some embodiments, for example, the sizes and structures of the sharps and distal portions of the analyte sensors disclosed herein can be configured to be positioned at a specific end depth (i.e., the furthest penetration point in a tissue or layer of the subject's body, for example, 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 appreciate that the sizes and structures of certain embodiments of the sharps can be configured to be positioned at different end depths within the subject's body relative to the final end depth of the analyte sensor. In some embodiments, for example, the sharps can be positioned at a first end depth in the subject's epidermis prior to retraction, while the distal portion of the analyte sensor can be positioned at a second end depth in the subject's dermis. In other embodiments, the sharps can be positioned at a first end depth in the subject's dermis prior to retraction, while the distal portion of the analyte sensor can be positioned at a second end depth in the subject's subcutaneous tissue. In other embodiments, the sharp object may be positioned at a first tip depth prior to retraction and the analyte sensor may be positioned at a second tip depth, wherein the first tip depth and the second tip depth are both in the same layer or tissue of the subject's body.

[0198] A number of deflectable structures are described herein, including but not limited to a deflectable brake buckle 1402, a deflectable locking arm 1412, a sharps holder locking arm 1524, a sharps retaining arm 1618, and a module buckle 2202. These deflectable structures are constructed of a resilient material, such as plastic or metal (or other), and operate in a manner well known to those skilled in the art. Each deflectable structure has a resting state or position toward which the resilient material is biased. If a force is applied that causes the structure to deflect or move from the resting state or position, the bias of the resilient material will cause the structure to return to the resting state or position once the force is removed (or reduced). In many cases, these structures are configured as arms having brakes or buckles, but other structures or configurations that maintain the same characteristics of deflection capability and the ability to return to a resting position may be used, including but not limited to legs, clips, hooks, supports on the deflectable member, and the like.

[0199] It should be noted that all features, elements, components, functions, and steps described with reference to any embodiment provided herein are intended to be freely combined and substituted with those from any other embodiment. If a feature, element, component, function, or step is described with reference to only one embodiment, it should be understood that, unless expressly stated otherwise, that feature, element, component, function, or step can be used with every other embodiment described herein. Therefore, this paragraph serves as a prerequisite basis and written support for introducing a claim at any time that combines features, elements, components, functions, and steps from different embodiments, or substitutes 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 that such a combination or substitution is possible in a particular case. It is expressly acknowledged that expressing every possible combination and substitution would be unduly burdensome, particularly given that one of ordinary skill in the art would readily recognize the permissibility of each and every such combination and substitution.

[0200] While these embodiments are susceptible to various modifications and alternative forms, specific examples thereof are shown in the drawings and described in detail herein. However, it should be understood that these embodiments are not limited to the specific forms disclosed, but rather, these embodiments are intended to cover all modifications, equivalents, and alternatives falling within the spirit of the invention. In addition, any features, functions, steps, or elements of these embodiments may be recited in or added to the claims, and negative limitations on the scope of the claims may be imposed by not including any features, functions, steps, or elements that fall within the scope of the claims.

Claims

1. An applicator, comprising: analyte sensors; sensor electronics bracket; a sharp object bracket, coupled with the sharp object; a distal end of the applicator configured to be positioned on a skin surface of a user; as well as The proximal end of the applicator is configured to receive a force applied by the user, wherein the sensor electronics bracket, the sharps bracket, and the sharps are configured to advance in a distal direction a predetermined distance in response to application of the force, wherein the sharps carrier and the sharp are configured to partially retract a portion of the predetermined distance in the proximal direction as the sensor electronics carrier advances in the distal direction, and Wherein the sharps holder and sharps are further configured to be fully retracted into the applicator after the sharps and a portion of the analyte sensor are positioned beneath the skin surface and in contact with bodily fluid.

2. The applicator of claim 1, wherein: The analyte sensor is an in vivo analyte sensor configured to measure an analyte level in the bodily fluid.

3. The applicator of claim 1 , further comprising: a sheath having a surface with a plurality of grooves; as well as a plurality of locking arms of the sensor electronics bracket, wherein when the sharps holder and sharps are partially retracted, at least a portion of each of the plurality of locking arms engages the plurality of slots, and Wherein, the plurality of slots are configured to allow the plurality of locking arms to partially deflect outward.

4. The applicator of claim 3, further comprising one or more springs disposed in the sharps holder, in, The one or more springs are configured to partially expand in response to the plurality of locking arms being partially deflected outward.

5. The applicator of claim 4, wherein: The one or more springs are in a preloaded, compressed state prior to advancement of the sensor electronics bracket and the sharps bracket in the distal direction.

6. The applicator of claim 5, wherein: The one or more springs bias the sharps holder to advance in the proximal direction.

7. The applicator of claim 6, wherein: The one or more springs are further biased to fully expand when the plurality of locking arms are disengaged from the sharps holder.

8. The applicator of claim 3, wherein: The plurality of slots include sharps holder slots provided on the sharps holder and sheath slots provided on the sheath of the applicator.

9. The applicator of claim 1, wherein: The sensor electronics bracket is configured to move relative to the housing of the applicator to cause angular displacement between the housing of the applicator on the one hand and the sharps bracket coupled to the sharp and the analyte sensor on the other hand.

10. The applicator of claim 9, wherein: The sensor electronics bracket is further configured for universal movement relative to the housing of the applicator via a compliant mechanism.

11. The applicator of claim 10, wherein: The compliant mechanism includes a plurality of snap arms configured to extend through apertures in the sensor electronics bracket.

12. The applicator of claim 11, wherein: The compliant mechanism further includes a predetermined gap between a plurality of snap arm detents of the plurality of snap arms and an aperture flange of the sensor electronics bracket.

13. The applicator of claim 12, wherein: The degree of the angular displacement is a function of the amount of the predetermined gap.

14. The applicator of claim 10, wherein: The compliant mechanism includes a heat stake configured to extend through a hole in the sensor electronics bracket.

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