Systems, devices, and methods for inserting analyte sensors

Abstract

To provide an applicator and the like for inserting at least a portion of an in vivo analyte sensor for sensing an analyte level in a body fluid of a subject that reduces tissue damage at the sensor insertion site and increases the likelihood of successful sensor insertion.SOLUTION: Wherein the applicator includes a drive spring, a withdrawal spring, a sensor electronics carrier, a sharp carrier comprising a sharp portion, and an analyte sensor, wherein the drive spring, upon application of a first force to the applicator, displaces the sensor electronics carrier and the sharp carrier from a first position within the applicator in spaced relation to the skin surface to a second position adjacent the skin surface, wherein the sharp portion and a portion of the analyte sensor are positioned beneath the skin surface and in contact with a bodily fluid of the subject in the second position; The withdrawal spring displaces the sharps carrier from the second position to a third position within the applicator, wherein application of a second force to the applicator withdraws the sharp from the skin surface.SELECTED DRAWING: Figure 18A

Description

Cross-reference to Related Applications

[0001] This application is a divisional application of Japanese Patent Application No. 2025-26588, which is a divisional application of Japanese Patent Application No. 2024-31538, which is a divisional application of Japanese Patent Application No. 2021-531135, filed on June 6, 2019, claiming the priority of U.S. Provisional Patent Application No. 62 / 784,074, filed on December 21, 2018.

Technical Field

[0002] The subject matter described herein generally relates to systems, devices, and methods for using an applicator for inserting at least a portion of an analyte sensor into a subject's body.

Background Art

[0003] The detection and / or monitoring of levels of analytes such as glucose, ketones, lactate, oxygen, hemoglobin A1C, etc. can be extremely important for the health of individuals suffering from diabetes. Patients suffering from type 2 diabetes may experience complications including loss of consciousness, cardiovascular disease, retinopathy, neuropathy, and nephropathy. Diabetic patients generally need to monitor their glucose levels to confirm that they are maintained within a clinically safe range, and use this information to determine whether insulin is needed to reduce glucose levels in the body, and / or when insulin is needed, or when additional glucose is needed to increase glucose levels in the body.

[0004] Increasing clinical data has shown a strong correlation between the frequency of glucose monitoring and blood glucose control. However, despite such a correlation, many individuals diagnosed with diabetes do not monitor their glucose levels as frequently as needed due to a combination of factors including convenience, freedom of testing, pain associated with glucose testing, and cost.

[0005] To ensure patients adhere more closely to frequent glucose monitoring schedules, an in vivo analyte monitoring system can be used, which allows for the attachment of a sensor-controlled device to the body of the individual requiring analyte monitoring. To improve comfort and convenience for the individual, the sensor-controlled device may have a small form factor and can be assembled and applied by the individual using a sensor applicator. This application process includes the step of inserting at least a portion of a sensor that senses the user's analyte levels into a bodily fluid located in a layer of the human body using an applicator or insertion mechanism, thereby bringing the sensor into contact with the bodily fluid. The sensor-controlled device may also be configured to transmit analyte data to another device from which the individual or their healthcare provider (HCP) can review the data and make treatment decisions.

[0006] While current sensors may be convenient for users, they are susceptible to malfunctions. These malfunctions can be caused by user error, lack of proper training, insufficient user adjustment, overly complex procedures, physiological responses to the inserted sensor, and other issues. For example, some prior art systems may rely too heavily on the precise assembly and deployment of the sensor control device and applicator by individual users. Other prior art systems may utilize sharp insertion and withdrawal mechanisms, which can easily injure surrounding tissue at the sensor insertion site, potentially leading to inaccurate analyte level measurements. These challenges, and other challenges described herein, may lead to improper insertion and / or suboptimal analyte measurements by the sensor, potentially resulting in an inability to adequately monitor the patient's analyte levels. [Overview of the project] [Problems that the invention aims to solve]

[0007] Therefore, there is a demand for more reliable sensor insertion devices, systems, and methods that are easy for patients to use and less prone to errors. [Means for solving the problem]

[0008] Provided herein are exemplary embodiments of systems, devices, and methods for the assembly and use of applicators and sensor control devices for in vivo analyte monitoring systems. The applicator can be provided to the user in a sterile package containing the electronic component housing of the sensor control device. According to some embodiments, a separate structure from the applicator, such as a container, can also be provided to the user as a sterile package containing a sensor module and a sharp component module. The user can connect the sensor module to the electronic component housing and the sharp component to the applicator by an assembly process involving the insertion of the applicator into the container in a specified manner. In other embodiments, the applicator, the sensor control device, the sensor module, and the sharp component module can be provided in a single package. The applicator can be used to position the sensor control device on the human body so that the sensor comes into contact with the wearer's bodily fluids. The embodiments provided herein are improvements to prevent or reduce the possibility of the sensor being improperly inserted, damaged, or inducing a harmful physiological response. Other improvements and advantages are also provided. Various configurations of these devices are described in detail by several embodiments, which are merely examples.

[0009] Other systems, devices, methods, features, and advantages of the subject matter described herein will be apparent to those skilled in the art by examining the following drawings and "Modes for Carrying Out the Invention." Such additional systems, devices, methods, features, and advantages are included herein, within the scope of the subject matter described herein, and are intended to be protected by the appended claims. Features of exemplary embodiments should not be construed as limiting the appended claims unless those features are expressly enumerated in the claims.

[0010] Details relating to the structure and operation of the subject matter described herein may become apparent by examining the accompanying drawings, in which similar reference numbers refer to similar parts. The components in the drawings are not necessarily to scale and are exaggerated to illustrate the principles of the subject matter. Furthermore, all figures are intended to convey concepts, and here relative sizes, shapes, and other detailed attributes may be illustrated schematically, without exaggeration or accuracy. [Brief explanation of the drawing]

[0011] [Figure 1] System overview of sensor applicators, reader devices, monitoring systems, networks, and remote systems [Figure 2A] Block diagram showing an exemplary embodiment of a reader device. [Figure 2B] Block diagram of an exemplary embodiment of a sensor control device [Figure 2C] Block diagram of an exemplary embodiment of a sensor control device [Figure 3A] A step-by-step diagram illustrating an exemplary embodiment of the assembly and application of the system shown in Figure 1, incorporating a two-component architecture. [Figure 3B] Continuation of Figure 3A [Figure 3C] Continuation of Figure 3B [Figure 3D] Continuation of Figure 3C [Figure 3E] Continuation of Figure 3D [Figure 3F] Continuation of Figure 3E [Figure 3G] Continuation of Figure 3F [Figure 4A] Side view of an exemplary embodiment of an applicator device connected to a cap. [Figure 4B] Side perspective view of an exemplary embodiment of a disconnected applicator device and cap. [Figure 4C] Perspective view of an exemplary embodiment of the distal end of an applicator device and an electronic component housing. [Figure 5]Proximal perspective view of an exemplary embodiment of a tray with a sterilization lid [Figure 6A] Proximal perspective cutaway view of an exemplary embodiment of a tray with sensor delivery components [Figure 6B] Proximal perspective view of sensor delivery components [Figure 7A] Side view of an exemplary embodiment of a housing [Figure 7B] Perspective view of an exemplary embodiment of the distal end of a housing [Figure 7C] Side cross-sectional view of an exemplary embodiment of a housing [Figure 8A] Side view of an exemplary embodiment of a sheath [Figure 8B] Perspective view of an exemplary embodiment of the proximal end of a sheath [Figure 8C] Enlarged perspective view of an exemplary embodiment of the distal side of a detent snap of a sheath [Figure 8D] Side view of an exemplary embodiment of a characteristic portion of a sheath [Figure 8E] End view of an exemplary embodiment of the proximal end of a sheath [Figure 8F] Perspective view of an exemplary embodiment of the compressible distal end of an applicator [Figure 8G] Cross-sectional view of exemplary geometry relating to an embodiment of the compressible distal end of an applicator [Figure 8H] Cross-sectional view of exemplary geometry relating to an embodiment of the compressible distal end of an applicator [Figure 8I] Cross-sectional view of exemplary geometry relating to an embodiment of the compressible distal end of an applicator [Figure 8J] Cross-sectional view of exemplary geometry relating to an embodiment of the compressible distal end of an applicator [Figure 8K] Cross-sectional view of exemplary geometry relating to an embodiment of the compressible distal end of an applicator [Figure 8L] Perspective view of an exemplary embodiment of an applicator with a compressible distal end [Figure 8M] Cross-sectional view of an exemplary embodiment of an applicator with a compressible distal end [Figure 9A]Proximal perspective view of an exemplary embodiment of a sensor electronic component carrier [Figure 9B] Distal perspective view of an exemplary embodiment of a sensor electronic component carrier. [Figure 10] Proximal perspective view of an exemplary embodiment of a sharp parts carrier [Figure 11] Side cross-sectional view of an exemplary embodiment of a sharp parts carrier [Figure 12A] Top perspective view of an exemplary embodiment of a sensor module [Figure 12B] Bottom perspective view of an exemplary embodiment of a sensor module [Figure 13A] Perspective view of an exemplary embodiment of a sensor connector [Figure 13B] Compressed perspective view of an exemplary embodiment of a sensor connector [Figure 14] Perspective view of an exemplary embodiment of the sensor [Figure 15A] Bottom perspective view of an exemplary embodiment of a sensor module assembly. [Figure 15B] Top perspective view of an exemplary embodiment of a sensor module assembly [Figure 16A] Partial enlarged view of an exemplary embodiment of a sensor module assembly [Figure 16B] Partial enlarged view of an exemplary embodiment of a sensor module assembly [Figure 17A] Perspective view of an exemplary embodiment of a sharp parts module [Figure 17B] Perspective view of another exemplary embodiment of the sharp parts module [Figure 17C] Side view of another exemplary embodiment of the sharp parts module [Figure 17D] Perspective view of another exemplary embodiment of the sharp parts module [Figure 17E] Cross-sectional view of an exemplary embodiment of the applicator [Figure 17F] Flowchart of an exemplary embodiment of a method for sterilizing an applicator assembly [Figure 17G] Photograph of an exemplary embodiment of the tip of a sharp part. [Figure 17H]Photograph of an exemplary embodiment of the tip of a sharp part. [Figure 17I] Perspective view of an exemplary embodiment of a sharp parts module [Figure 17J] Perspective view of an exemplary embodiment of a sharp parts module [Figure 18A] Cross-sectional view of an exemplary embodiment of the applicator [Figure 18B] Exploded view showing various components of an exemplary embodiment of the applicator. [Figure 19A] Cross-sectional view of an exemplary embodiment of the applicator during a stage of deployment. [Figure 19B] Perspective view of an exemplary embodiment of the sheath [Figure 19C] Perspective view of an exemplary embodiment of a sensor electronic component carrier [Figure 19D] Cross-sectional view of an exemplary embodiment of the applicator during a stage of deployment. [Figure 19E] Perspective view of an exemplary embodiment of a sheath-sensor electronic component carrier assembly. [Figure 19F] Partial enlarged view of an exemplary embodiment of a sheath-sensor electronic component carrier assembly [Figure 19G] Cross-sectional view of an exemplary embodiment of the applicator during a stage of deployment. [Figure 19H] Partial enlarged view of an exemplary embodiment of a sheath-sensor electronic component carrier assembly [Figure 19I] Partial enlarged view of an exemplary embodiment of a sheath-sensor electronic component carrier assembly [Figure 19J] Cross-sectional view of an exemplary embodiment of the applicator during a stage of deployment. [Figure 19K] Partial enlarged view of an exemplary embodiment of a sheath-sensor electronic component carrier assembly [Figure 19L] Partial enlarged view of an exemplary embodiment of a sheath-sensor electronic component carrier assembly [Figure 20A] An exemplary embodiment of the applicator, and a perspective view of the embodiment. [Figure 20B] An exemplary embodiment of the applicator, and a front side view of the embodiment. [Figure 20C] An exemplary embodiment of the applicator, a rear side view of the embodiment. [Figure 20D] This is an exemplary embodiment of the applicator, and is a left side view of the embodiment. [Figure 20E] An exemplary embodiment of the applicator, a right side view of the embodiment. [Figure 20F] This is an exemplary embodiment of the applicator, and a top view of the embodiment. [Figure 20G] An exemplary embodiment of the applicator, and a bottom view of the embodiment. [Figure 21A] Another exemplary embodiment of the applicator, a perspective view of the embodiment. [Figure 21B] Another exemplary embodiment of the applicator, and a front side view of the embodiment. [Figure 21C] Another exemplary embodiment of the applicator, a rear side view of the embodiment. [Figure 21D] Another exemplary embodiment of the applicator, a left side view of the embodiment. [Figure 21E] Another exemplary embodiment of the applicator, a right side view of the embodiment. [Figure 21F] Another exemplary embodiment of the applicator, a top view of the embodiment. [Figure 21G] Another exemplary embodiment of the applicator, a bottom view of the embodiment. [Figure 22A] This is an exemplary embodiment of a sensor control device, and a perspective view of the embodiment. [Figure 22B] This is an exemplary embodiment of a sensor control device, and is a front side view of the embodiment. [Figure 22C] This is an exemplary embodiment of a sensor control device, and is a rear side view of the embodiment. [Figure 22D] This is an exemplary embodiment of a sensor control device, and is a left side view of the embodiment. [Figure 22E] This is an exemplary embodiment of a sensor control device, and is a right side view of the embodiment. [Figure 22F] This is an exemplary embodiment of a sensor control device, and is a top view of the embodiment. [Figure 22G] This is an exemplary embodiment of a sensor control device, and a bottom view of the embodiment. [Figure 23A] Another exemplary embodiment of a sensor control device, a perspective view of the embodiment. [Figure 23B] Another exemplary embodiment of a sensor control device, a front side view of the embodiment. [Figure 23C] Another exemplary embodiment of a sensor control device, a rear side view of the embodiment. [Figure 23D] Another exemplary embodiment of a sensor control device, a left side view of the embodiment. [Figure 23E] Another exemplary embodiment of a sensor control device, a right side view of the embodiment. [Figure 23F] Another exemplary embodiment of a sensor control device, a top view of the embodiment. [Figure 23G] Another exemplary embodiment of a sensor control device, a bottom view of the embodiment. [Figure 24A] Another exemplary embodiment of a sensor control device, a perspective view of the embodiment. [Figure 24B] Another exemplary embodiment of a sensor control device, a front side view of the embodiment. [Figure 24C] Another exemplary embodiment of a sensor control device, a rear side view of the embodiment. [Figure 24D] Another exemplary embodiment of a sensor control device, a left side view of the embodiment. [Figure 24E] Another exemplary embodiment of a sensor control device, a right side view of the embodiment. [Figure 24F] Another exemplary embodiment of a sensor control device, a top view of the embodiment. [Figure 24G] Another exemplary embodiment of a sensor control device, a bottom view of the embodiment. [Figure 25A] Another exemplary embodiment of a sensor control device, a perspective view of the embodiment. [Figure 25B] Another exemplary embodiment of a sensor control device, a front side view of the embodiment. [Figure 25C] Another exemplary embodiment of a sensor control device, a rear side view of the embodiment. [Figure 25D] Another exemplary embodiment of a sensor control device, a left side view of the embodiment. [Figure 25E] Another exemplary embodiment of a sensor control device, a right side view of the embodiment. [Figure 25F] Another exemplary embodiment of a sensor control device, a top view of the embodiment. [Figure 25G] Another exemplary embodiment of a sensor control device, a bottom view of the embodiment. [Figure 26A] Another exemplary embodiment of a sensor control device, a perspective view of the embodiment. [Figure 26B] Another exemplary embodiment of a sensor control device, a front side view of the embodiment. [Figure 26C] Another exemplary embodiment of a sensor control device, a rear side view of the embodiment. [Figure 26D] Another exemplary embodiment of a sensor control device, a left side view of the embodiment. [Figure 26E] Another exemplary embodiment of a sensor control device, a right side view of the embodiment. [Figure 26F] Another exemplary embodiment of a sensor control device, a top view of the embodiment. [Figure 26G] Another exemplary embodiment of a sensor control device, a bottom view of the embodiment. [Figure 27A] Another exemplary embodiment of a sensor control device, a perspective view of the embodiment. [Figure 27B] Another exemplary embodiment of a sensor control device, a front side view of the embodiment. [Figure 27C] Another exemplary embodiment of a sensor control device, a rear side view of the embodiment. [Figure 27D] Another exemplary embodiment of a sensor control device, a left side view of the embodiment. [Figure 27E]Another exemplary embodiment of a sensor control device, a right side view of the embodiment. [Figure 27F] Another exemplary embodiment of a sensor control device, a top view of the embodiment. [Figure 27G] Another exemplary embodiment of a sensor control device, a bottom view of the embodiment. [Figure 28A] Another exemplary embodiment of a sensor control device, a perspective view of the embodiment. [Figure 28B] Another exemplary embodiment of a sensor control device, a front side view of the embodiment. [Figure 28C] Another exemplary embodiment of a sensor control device, a rear side view of the embodiment. [Figure 28D] Another exemplary embodiment of a sensor control device, a left side view of the embodiment. [Figure 28E] Another exemplary embodiment of a sensor control device, a right side view of the embodiment. [Figure 28F] Another exemplary embodiment of a sensor control device, a top view of the embodiment. [Figure 28G] Another exemplary embodiment of a sensor control device, a bottom view of the embodiment. [Figure 29A] Another exemplary embodiment of a sensor control device, a perspective view of the embodiment. [Figure 29B] Another exemplary embodiment of a sensor control device, a front side view of the embodiment. [Figure 29C] Another exemplary embodiment of a sensor control device, a rear side view of the embodiment. [Figure 29D] Another exemplary embodiment of a sensor control device, a left side view of the embodiment. [Figure 29E] Another exemplary embodiment of a sensor control device, a right side view of the embodiment. [Figure 29F] Another exemplary embodiment of a sensor control device, a top view of the embodiment. [Figure 29G] Another exemplary embodiment of a sensor control device, a bottom view of the embodiment. [Figure 30A] An exemplary embodiment of the applicator, and a perspective view of the embodiment. [Figure 30B] An exemplary embodiment of the applicator, a front side view of the embodiment. [Figure 30C] An exemplary embodiment of the applicator, a rear side view of the embodiment. [Figure 30D] This is an exemplary embodiment of the applicator, and is a left side view of the embodiment. [Figure 30E] An exemplary embodiment of the applicator, a right side view of the embodiment. [Figure 30F] This is an exemplary embodiment of the applicator, and a top view of the embodiment. [Figure 30G] An exemplary embodiment of the applicator, and a bottom view of the embodiment. [Figure 31A] Another exemplary embodiment of the applicator, a perspective view of the embodiment. [Figure 31B] Another exemplary embodiment of the applicator, a front side view of the embodiment. [Figure 31C] Another exemplary embodiment of the applicator, a rear side view of the embodiment. [Figure 31D] Another exemplary embodiment of the applicator, a left side view of the embodiment. [Figure 31E] Another exemplary embodiment of the applicator, a right side view of the embodiment. [Figure 31F] Another exemplary embodiment of the applicator, a top view of the embodiment. [Figure 31G] Another exemplary embodiment of the applicator, a bottom view of the embodiment. [Figure 32A] This is an exemplary embodiment of a sensor control device, and a perspective view of the embodiment. [Figure 32B] This is an exemplary embodiment of a sensor control device, and is a front side view of the embodiment. [Figure 32C] This is an exemplary embodiment of a sensor control device, and is a rear side view of the embodiment. [Figure 32D] This is an exemplary embodiment of a sensor control device, and is a left side view of the embodiment. [Figure 32E] This is an exemplary embodiment of a sensor control device, and is a right side view of the embodiment. [Figure 32F] This is an exemplary embodiment of a sensor control device, and is a top view of the embodiment. [Figure 32G] This is an exemplary embodiment of a sensor control device, and a bottom view of the embodiment. [Figure 33A] Another exemplary embodiment of a sensor control device, a perspective view of the embodiment. [Figure 33B] Another exemplary embodiment of a sensor control device, a front side view of the embodiment. [Figure 33C] Another exemplary embodiment of a sensor control device, a rear side view of the embodiment. [Figure 33D] Another exemplary embodiment of a sensor control device, a left side view of the embodiment. [Figure 33E] Another exemplary embodiment of a sensor control device, a right side view of the embodiment. [Figure 33F] Another exemplary embodiment of a sensor control device, a top view of the embodiment. [Figure 33G] Another exemplary embodiment of a sensor control device, a bottom view of the embodiment. [Figure 34A] Another exemplary embodiment of a sensor control device, a perspective view of the embodiment. [Figure 34B] Another exemplary embodiment of a sensor control device, a front side view of the embodiment. [Figure 34C] Another exemplary embodiment of a sensor control device, a rear side view of the embodiment. [Figure 34D] Another exemplary embodiment of a sensor control device, a left side view of the embodiment. [Figure 34E] Another exemplary embodiment of a sensor control device, a right side view of the embodiment. [Figure 34F] Another exemplary embodiment of a sensor control device, a top view of the embodiment. [Figure 34G] Another exemplary embodiment of a sensor control device, a bottom view of the embodiment. [Figure 35A] Another exemplary embodiment of a sensor control device, a perspective view of the embodiment. [Figure 35B] Another exemplary embodiment of a sensor control device, a front side view of the embodiment. [Figure 35C] Another exemplary embodiment of a sensor control device, a rear side view of the embodiment. [Figure 35D] Another exemplary embodiment of a sensor control device, a left side view of the embodiment. [Figure 35E] Another exemplary embodiment of a sensor control device, a right side view of the embodiment. [Figure 35F] Another exemplary embodiment of a sensor control device, a top view of the embodiment. [Figure 35G] Another exemplary embodiment of a sensor control device, a bottom view of the embodiment. [Modes for carrying out the invention]

[0012] Before describing the subject matter in detail, it should be understood that this disclosure is not limited to the specific embodiments described herein and is therefore naturally subject to change. It should also be understood that the terms used herein are intended solely to describe specific embodiments and are not intended to limit them, for the scope of this disclosure is limited only by the appended claims.

[0013] As used in this specification and the appended claims, the singular forms "a, an" and "the" refer to multiple subjects unless the context explicitly indicates otherwise.

[0014] The publications discussed herein are provided only with respect to disclosures prior to the filing date of this application. No part of this specification should be construed as an acknowledgment that this disclosure has no prior rights over such publications, on the grounds that these publications have been previously disclosed. Furthermore, the publication dates provided herein may differ from the actual publication dates and may need to be verified individually.

[0015] Generally, embodiments of this disclosure include systems, devices, and methods for the use of analyte sensor insertion applicators for use in conjunction with in vivo analyte monitoring systems. Accordingly, many embodiments include in vivo analyte sensors which are structurally configured such that at least a portion of the sensor is positioned on or can be positioned on the user's body to acquire information about at least one analyte in the body. However, it should be noted that embodiments disclosed herein can also be used in conjunction with in vivo analyte monitoring systems that incorporate in vitro functionality, and with purely in vitro or extra vivo analyte monitoring systems (including completely non-invasive systems).

[0016] Furthermore, with respect to each embodiment of the methods disclosed herein, systems and devices capable of carrying out each of these embodiments are included within the scope of this disclosure. For example, embodiments of sensor control devices are disclosed, which may include one or more sensors, an analyte monitoring circuit (e.g., an analog circuit), a memory (e.g., for storing instructions), a power supply, a communication circuit, a transmitter, a receiver, a processor, and / or a controller (e.g., for executing instructions stored in memory) capable of carrying out or facilitating the execution of any of the method steps described herein. These embodiments of sensor control devices may be used, or may be made usable, to implement the steps carried out by the sensor control device from any of the methods described herein.

[0017] As described above, numerous embodiments of systems, devices, and methods are described herein that provide improved assembly and use of analyte sensor insertion devices for use with in vivo analyte monitoring systems. In particular, some embodiments of the present disclosure are designed to improve the method of sensor insertion into in vivo analyte monitoring systems, especially to minimize trauma to the insertion site during the sensor insertion process. Some embodiments include, for example, a powered sensor insertion mechanism configured to operate at a controlled speed faster than a manual insertion mechanism in order to reduce trauma to the insertion site. In other embodiments, an applicator with a compressible distal end can pull and flatten the skin surface of the insertion site, thereby reducing the likelihood of insertion failure due to skin tenting. In yet another embodiment, a sharp part with an offset tip, or a sharp part manufactured using plastic material or a coining manufacturing process, can also reduce trauma to the insertion site. In short, these embodiments can improve the likelihood of successful sensor insertion and reduce the amount of trauma to the insertion site, to name some of their advantages.

[0018] However, before describing these aspects of the embodiments in detail, it is desirable to first describe examples of devices that may be present internally, such as an in vivo analyte monitoring system, and examples of its operation, all of which can be used in conjunction with the embodiments described herein.

[0019] Various types of in vivo analyte monitoring systems exist. For example, a "Continuous Analyte Monitoring" system (or "Continuous Glucose Monitoring" system) can automatically and continuously transmit data from a sensor control device to a reader device without prompting, for example, according to a schedule. Another example is a "Flash Analyte Monitoring" system (or "Flash Glucose Monitoring" system or simply a "Flash" system) which can transmit data from a sensor control device in response to a scan or request for data by a reader device, for example, using Near Field Communication (NFC) or Radio Frequency Identification (RFID) protocols. In vivo analyte monitoring systems can also operate without the need for finger stick calibration.

[0020] In vivo analyte monitoring systems can be distinguished from "in vitro" systems, which include a measuring device that comes into contact with an external (or "ex vivo") biological sample and typically has a port for receiving an analyte test strip carrying the user's bodily fluids, thereby determining the user's blood glucose level by analyzing the bodily fluids.

[0021] The in vivo monitoring system may include a sensor that, while positioned within the body, comes into contact with the user's bodily fluids and senses the level of analytes contained in those fluids. The sensor may be part of a sensor control device that resides on the user's body and contains electronic components and a power supply that enable and control the sensing of the analytes. Sensor control devices and their variations may also be referred to, to name a few, as a "sensor control unit," an "on-body electronic component" device or unit, an "on-body" device or unit, or a "sensor data communication" device or unit.

[0022] The in vivo monitoring system may also include a device that receives sensed analyte data from the sensor control device, processes this sensed analyte data, and / or displays it to the user in any number of formats. This device and its variations may also be called, to name a few, a “handheld device,” a “reader device” (or simply “reader”), a “handheld electronic component” (or simply “handheld”), a “portable data processing” device or unit, a “data receiver,” a “receiver” device or unit (or simply “receiver”), or a “remote” device or unit. Other devices, such as personal computers, are also used with or incorporated into in vivo and in vitro monitoring systems.

[0023] Exemplary Embodiments of In Vivo Analytes Monitoring Systems Figure 1 is a conceptual diagram showing an exemplary embodiment of an analyte monitoring system 100, which includes a sensor applicator 150, a sensor control device 102, and a reader device 120. Here, the sensor applicator 150 can be used to deliver the sensor control device 102 to a monitoring location on the user's skin, where the sensor 104 is maintained in place for a period of time by an adhesive patch 105. The sensor control device 102 is further described in Figures 2B and 2C, and can communicate with the reader device 120 via a communication path 140 using wired or wireless techniques. Exemplary wireless protocols include Bluetooth®, Bluetooth Low Energy (BLE, BTLE, Bluetooth SMART, etc.), and near-field communication (NFC). The user can monitor applications installed in the memory on the reader device 120 using the screen 122 and input 121, and can recharge the device's battery using the power port 123. Although only one reader device 120 is illustrated, the sensor control device 102 can communicate with multiple reader devices 120. Each reader device 120 can communicate with each other and share data. Further details regarding the reader devices 120 are described below in relation to Figure 2A. The reader device 120 can communicate with the local computer system 170 via a communication path 141 using a wired or wireless communication protocol. The local computer system 170 may be a laptop, desktop, tablet, phablet, smartphone, set-top box, video game console, or other computing device, and the wireless communication may be one of many applicable wireless networking protocols, including Bluetooth®, Bluetooth Low Energy (BTLE), Wi-Fi, etc. The local computer system 170 can communicate with the 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 a wired or wireless communication protocol as described above.Network 190 can be any of many networks, such as private networks, public networks, local area networks, or wide area networks. Trusted computer system 180 may include a server, provide authentication services and secure data storage, and communicate with network 190 via a communication path 144 using wired or wireless techniques.

[0024] Exemplary Embodiments of a Reader Device Figure 2A is a block diagram showing an exemplary embodiment of a reader device 120 configured as a smartphone. Here, the reader device 120 may include a processing core 206 which includes a communication processor 222 coupled to a display 122; input components 121; and memory 223, and an application processor 224 coupled to memory 225. It may also include a power supply 226 which includes memory 230; an RF transceiver 228 with an antenna 229; and a power management module 238. Furthermore, the reader device 120 may also include a multifunction transceiver 232 which can communicate with the antenna 234 via Wi-Fi, NFC, Bluetooth®, BTLE, and GPS. As those skilled in the art will understand, these components are electrically and communicatively coupled to form a single functional device.

[0025] Exemplary Embodiments of Sensor-Controlled Devices Figures 2B and 2C are block diagrams illustrating exemplary embodiments of a sensor control device 102, which includes an analyte sensor 104 and sensor electronic components 160 (including an analyte monitoring circuit configuration), which can have most of the processing power for rendering final result data suitable for display to the user. In Figure 2B, a single semiconductor chip 161 is shown, which can be a dedicated application-specific integrated circuit (ASIC). Shown within the ASIC 161 are specific higher-order functional units, including an analog front-end (AFE) 162, a power management (or control) circuit configuration 164, a processor 166, and a communication circuit configuration 168 (which can be implemented as a transmitter, receiver, transceiver, passive circuit, or other, depending on the communication protocol). In this embodiment, both the AFE 162 and the processor 166 are used as the analyte monitoring circuit configuration, but in other embodiments, either circuit can perform the analyte monitoring function. The processor 166 may include one or more processors, microprocessors, controllers, and / or microcontrollers, each of which may be a discrete chip or distributed across a number of different chips (or be part of a number of different chips).

[0026] Memory 163 is also included in the ASIC 161 and can be shared by various functional units present within the ASIC 161, or distributed across two or more of them. Memory 163 can also be a separate chip. Memory 163 can be volatile and / or non-volatile memory. In this embodiment, the ASIC 161 is connected to a power supply 170, which may be a coin cell battery or the like. The AFE 162 is connected to the in vivo analyte sensor 104, receives measurement data from it, and outputs the data in digital format to the processor 166, which processes this data to obtain discrete and trend values ​​of glucose as the final result. This data can then be supplied to a communication circuit configuration 168 via the antenna 171 to send it to, for example, a reader device 120 (not shown), where minimal further processing by a resident software application is required to display the data.

[0027] Figure 2C is similar to Figure 2B, but includes two discrete semiconductor chips 162 and 174, which may be packaged together or separately. Here, the AFE 162 resides on the ASIC 161. The processor 166 is integrated on chip 174 together with a power management circuit configuration 164 and a communication circuit configuration 168. The AFE 162 includes memory 163, and chip 174 includes memory 165, which may be internally isolated or distributed. In one exemplary embodiment, the AFE 162 is combined with the power management circuit configuration 164 and the processor 166 on a single chip, while the communication circuit configuration 168 is on a separate chip. In another exemplary embodiment, both the AFE 162 and the communication circuit configuration 168 are on a single chip, and the processor 166 and the power management circuit configuration 164 are on a separate chip. Furthermore, other combinations of chips are also possible, including three or more chips, each performing a separate function as described above, or sharing one or more functions for fail-safe redundancy.

[0028] Exemplary Embodiment of Assembly Process for Sensor-Controlled Devices According to some embodiments, the user can obtain the components of the sensor control device 102 in multiple packages, and final assembly by the user is required before delivery to the appropriate user location. Figures 3A–3E illustrate an exemplary embodiment of the user assembly process for the sensor control device 102, which includes preparing the individual components before linking them together in preparation for sensor delivery. In other embodiments, such as those described with respect to Figures 17B–17F, the user can obtain the components of the sensor control device 102 and the applicator 150 in a single package. Figures 3F–3G illustrate an exemplary embodiment of delivery of the sensor control device 102 to the appropriate user location by selecting an appropriate delivery location and applying the device 102 to that location.

[0029] Figure 3A shows a sensor container or tray 810 having a removable lid 812. The user prepares the sensor tray 810 by removing the lid 812. The lid 812 acts as a sterile barrier to protect the contents of the sensor tray 810 and to maintain a sterile internal environment. By removing the lid 812, a platform 808 positioned within the sensor tray 810 is exposed, and a plug assembly 207 (partially shown) is placed within the platform 808 and strategically embedded within the platform 808. The plug assembly 207 includes a sensor module (not shown) and a sharp parts module (not shown). The sensor module supports a sensor 104 (Figure 1), and the sharp parts module supports an associated sharp part used to assist in the percutaneous delivery of the sensor 104 subcutaneously to the user during the application of the sensor control device 102 (Figure 1).

[0030] Figure 3B shows the sensor applicator 150 and how a user prepares the sensor applicator 150 for final assembly. The sensor applicator 150 includes a housing 702 sealed at one end with an applicator cap 708. In some embodiments, for example, an O-ring or another type of sealing gasket may seal the interface between the housing 702 and the applicator cap 708. In at least one embodiment, the O-ring or sealing gasket may be molded onto one of the housing 702 and the applicator cap 708. The applicator cap 708 provides a barrier to protect the contents of the sensor applicator 150. In particular, the sensor applicator 150 contains an electronic component housing (not shown) that holds the electronic components of the sensor control device 102 (Figure 1), and the applicator cap 708 may or may not maintain a sterile environment for these electronic components. Preparation of the sensor applicator 150 includes the step of disconnecting the housing 702 from the applicator cap 708, which can be achieved by loosening the screws and removing the applicator cap 708 from the housing 702. The applicator cap 708 may then be discarded or set aside.

[0031] Figure 3C shows the user inserting the sensor applicator 150 into the sensor tray 810. The sensor applicator 150 includes a sheath 704, which is configured to be accepted by the platform 808 to temporarily unlock the sheath 704 from the housing 702 and also to temporarily unlock the platform 808 from the sensor tray 810. When the housing 702 is advanced into the sensor tray 810, the plug assembly 207 (Figure 3A), which is located in the sensor tray 810 and contains the sensor and sharp component modules, is consequently connected to the electronic component housing located in the sensor applicator 150.

[0032] In Figure 3D, the user removes the sensor applicator 150 from the sensor tray 810 by pulling the housing 702 proximally toward the sensor tray 810.

[0033] Figure 3E shows the bottom and interior of the sensor applicator 150 after it has been removed from the sensor tray 810 (Figures 3A and 3C). The sensor applicator 150 is removed from the sensor tray 810 with the sensor control device 102 fully assembled therein and positioned for delivery to the target monitoring location. As shown, the sharp component 2502 extends from the bottom of the sensor control device 102 and supports a portion of the sensor 104 within its hollow or concave portion. The sharp component 2502 is configured to penetrate the user's skin, thereby positioning the sensor 104 in contact with bodily fluids.

[0034] Figures 3F and 3G show exemplary delivery of the sensor control device 102 to a target monitoring position 221, for example, on the back of the user's arm. Figure 3F shows the user advancing the sensor applicator 150 toward the target monitoring position 221. Upon engagement with the skin at the target monitoring position 221, the sheath 704 folds into the housing 702, thereby allowing the sensor control device 102 (Figures 3E and 3G) to advance and engage with the skin. With the assistance of the sharp component 2502 (Figure 3E), the sensor 104 (Figure 3E) advances percutaneously into the patient's skin at the target monitoring position 221.

[0035] Figure 3G shows the user withdrawing the sensor applicator 150 from the target monitoring position 221, with the sensor control device 102 securely attached to the user's skin. The adhesive patch 105 (Figure 1) applied to the bottom of the sensor control device 102 adheres to the skin, securing the sensor control device 102 in place. The sharp component 2502 (Figure 3E) is automatically withdrawn when the housing 702 fully advances to the target monitoring position 221, leaving the sensor 104 (Figure 3E) in place to measure the analyte level.

[0036] As described in some embodiments, with reference to Figures 3A–3G and elsewhere in this specification, system 100 can provide a reduction or elimination of the opportunity for accidental breakage, permanent deformation, or improper assembly of applicator components compared to systems of the prior art. The applicator housing 702 engages directly with the platform 808 rather than indirectly through the sheath 704 while the sheath 704 is unlocked, and the relative angle between the sheath 704 and the housing 702 does not result in breakage or permanent deformation of the arm or other components. The possibility of relatively large forces being generated during assembly (as in conventional devices) is reduced, thereby reducing the opportunity for user assembly failure. Further details relating to the applicator, its components, and modified embodiments thereof are described in U.S. Published Patent No. 2013 / 0150691, U.S. Published Patent No. 2016 / 0331283, and U.S. Published Patent No. 2018 / 0235520, all of which are incorporated herein by reference in their entirety for any purpose.

[0037] Exemplary Embodiments of Sensor Applicator Devices Figure 4A is a side view of an exemplary embodiment of the applicator device 150 coupled to the screw cap 708. This is one example of how the applicator 150 may be transported to and received by the user before being assembled with the sensor by the user. In other embodiments, the applicator 150 may also be transported to the user with the sensor and sharp parts contained within it. Figure 4B is a side perspective view of the applicator 150 and cap 708 after uncoupling. Figure 4C is a perspective view of an exemplary embodiment of the distal end of the applicator device 150, where the electronic component housing 706 and adhesive patch 105 have been removed from their positions where they would be held within the sensor electronic component carrier 710 of the sheath 704 when the cap 708 is in place.

[0038] Exemplary Embodiment of Tray and Sensor Module Assembly Figure 5 is a proximal perspective view of an exemplary embodiment of a tray 810 to which a sterile lid 812 is detachably attached, which in some embodiments may be a representative example of a method for transporting and receiving a package in an unassembled state to a user.

[0039] Figure 6A is a proximal perspective cutaway showing sensor delivery components within a tray 810 according to several embodiments. The platform 808 is slidably connected within the tray 810. The desiccant 502 is stationary relative to the tray 810. The sensor module 504 is installed within the tray 810.

[0040] Figure 6B is a proximal perspective view showing a more detailed exemplary embodiment of the sensor module 504. Here, the retaining arm extension 1834 of the platform 808 detachably secures the sensor module 504 in place. Module 2200 is connected to a connector 2300, a sharp parts module 2500, and a sensor (not shown), so that they can be removed together as the sensor module 504 during assembly.

[0041] Exemplary Embodiment of Applicator Housing Figure 7A is a side view of an exemplary embodiment of an applicator housing 702, which may include an internal cavity having a support structure for applicator functionality. A user can initiate the applicator assembly process by pushing the housing 702 distally, which can then trigger the delivery of the sensor control device 102, after which the cavity of the housing 702 can function as a container for sharp parts. This exemplary embodiment shows various feature portions, including a housing orientation feature portion 1302 for oriented the device during assembly and use. A tampering groove 1304 may be a recess positioned around the outer circumference of the housing 702, distal to the tampering protector 1314 and proximal to the tampering retainer 1306. The tampering groove 1304 can hold a tampering ring, allowing the user to identify whether the device has been tampered with or used. The housing threads 1310 align with the complementary cap threads, allowing the housing 702 to be secured to the complementary threads on the cap 708 (Figures 4A and 4B) by rotating clockwise or counterclockwise. The side grip zone 1316 of the housing 702 can provide an outer surface position from which the user can grip the housing 702 for use. The grip projection 1318 is a slightly raised portion relative to the side grip zone 1316, which can help to easily remove the housing 702 from the cap 708. The shark tooth projection 1320 can be a raised section with a flat side positioned on a clockwise edge for cutting and holding a tamper ring (not shown) in place after the user has unscrewed the cap 708 and housing 702. In this exemplary embodiment, four shark tooth projections 1320 are used, but the number used may be increased or decreased as needed.

[0042] Figure 7B is a perspective view of the distal end of the housing 702. Here, three housing guide structures (or "guide ribs") 1321 are arranged at an angle of 120° to each other and at an angle of 60° to the locking structures (or "locking ribs") 1340, and there are also three locking ribs 1340, also at an angle of 120° to each other. Other angular orientations, symmetric or asymmetric, and any number of structures 1321 and 1340 can be used. Here, structures 1321 and 1340 are each configured as planar ribs, but other shapes can also be used. Each guide rib 1321 includes a guide edge (also called a sheath guide rail) 1326 that can extend along the surface of the sheath 704 (e.g., the guide rail 1418 described in relation to Figure 8A). The insertable hard stop 1322 can be a flat, distal surface of the housing guide rib 1321, positioned near the proximal end of the housing guide rib 1321. The insertable hard stop 1322 provides a surface for the sensor electronic component carrier movement limiter surface 1420 (Figure 8B) of the sheath 704, which will abut during use and prevent the sensor electronic component carrier movement limiter surface 1420 from moving further proximal. The carrier interface post 1327 passes through the aperture 1510 (Figure 9A) of the sensor electronic component carrier 710 during assembly. The sensor electronic component carrier interface 1328 can be a rounded, distal surface of the housing guide rib 1321 that is joined to the sensor electronic component carrier 710.

[0043] Figure 7C is a side cross-sectional view of an exemplary embodiment of the housing. In this exemplary embodiment, the side cross-sectional profiles of the housing guide rib 1321 and the lock rib 1340 are shown. The lock rib 1340 includes a sheath snap introduction feature portion 1330 near its distal end, which extends outward distally from the central axis 1346 of the housing 702. Each sheath snap introduction feature portion 1330 bends the detent snap curved portion 1404 of the detent snap 1402 of the sheath 704 inward toward the central axis 1346, as shown in Figure 8C, as the sheath 704 moves toward the proximal end of the housing 702. Upon passing the distal point of the sheath snap introduction feature portion 1330, the detent snap 1402 of the sheath 704 locks into place in the lock groove 1332. Therefore, the detent snap 1402 cannot be easily moved distally by a surface having a plane substantially perpendicular to the central axis 1346, which is shown as the detent snap flat portion 1406 in Figure 8C.

[0044] As the housing 702 moves further proximal toward the skin surface, and as the sheath 704 advances toward the distal end of the housing 702, the detent snap 1402 is displaced into the unlock groove 1334, and the applicator 150 enters the armed position, ready for use. When the user applies further force to the proximal end of the housing 702 while pressing the sheath 704 against the skin, the detent snap 1402 passes through the firing detent 1344. This initiates the firing sequence by releasing the energy stored in the deflected detent snap 1402 as it moves proximal toward the skin surface toward the sheath stop ramp 1338, which is slightly outward relative to the central axis 1346 and slows the movement of the sheath 704 during the firing sequence. The next groove that the detent snap 1402 encounters after the unlock groove 1334 is the final lockout groove 1336, into which the detent snap 1402 enters at the end of the stroke or press sequence performed by the user. The final lockout recess 1336 can be a proximal-facing surface perpendicular to the central axis 1346, which, after the detent snap 1402 has passed, engages with the detent snap flat portion 1406 to securely hold the sheath 704 in place relative to the housing 702, thereby preventing reuse of the device. The insertion hard stop 1322 of the housing guide rib 1321 prevents the sheath 704 from advancing proximal to the housing 702 by engaging with the sensor electronic component carrier movement limiter surface 1420.

[0045] Exemplary Embodiment of an Applicator Sheath Figures 8A and 8B are a side view and a perspective view, respectively, showing exemplary embodiments of the sheath 704. In this exemplary embodiment, the sheath 704 can position the sensor control device 102 above the user's skin surface before application. The sheath 704 may also contain feature portions that assist in holding sharp parts in place for proper application of the sensor, determining the force required for sensor application, and guiding the sheath 704 relative to the housing 702 during application. The detent snap 1402 is located near the proximal end of the sheath 704 and is described further below with reference to Figure 8C. The sheath 704 as a whole may have a cylindrical cross-section, the cross-section having a first radius in the proximal section (closer to the top of the figure), which is shorter than a second radius in the distal section (closer to the bottom of the figure). Multiple detent clearances 1410 are also shown, which are three in this exemplary embodiment. The sheath 704 may include one or more detent clearances 1410, each of which may be a notch having space for the sheath snap introduction feature portion 1330 to pass distally until the distal surface of the lock rib 1340 contacts the proximal surface of the detent clearance 1410.

[0046] The guide rails 1418 are positioned between the sensor electronic component carrier movement limiter surface 1420 at the proximal end of the sheath 704 and the notches around the lock arm 1412. Each guide rail 1418 can form a channel between two ridges, where the guide edge 1326 of the housing guide rib 1321 can slide distally relative to the sheath 704.

[0047] The lock arm 1412 is positioned near the distal end of the sheath 704 and may include a distal end to which it is attached and a free proximal end, the proximal end of which may include a lock arm interface 1416. The lock arm 1412 can lock the sensor electronic component carrier 710 to the sheath 704 when the lock arm interface 1416 of the lock arm 1412 engages with the lock interface 1502 of the sensor electronic component carrier 710. Lock arm reinforcing ribs 1414 may be positioned near the center of each lock arm 1412 and can act as reinforcement points for weak points of the lock arm 1412 to prevent the lock arm 1412 from bending excessively or breaking.

[0048] The detent snap reinforcing feature portion 1422 can be positioned along the distal section of the detent snap 1402 and can provide reinforcement to the detent snap 1402. The alignment notch 1424 can be a notch near the distal end of the sheath 704, which provides an opening for user alignment with the sheath orientation feature portion of the platform 808. The reinforcing rib 1426 may include a buttress, which is here formed into a triangle and provides support to the detent base 1436. The housing guide rail clearance 1428 can be a notch for sliding the distal surface of the housing guide rib 1321 during use.

[0049] Figure 8C is an enlarged perspective view of an exemplary embodiment of a detent snap 1402 of the sheath 704. The detent snap 1402 may include a detent snap bridge 1408 located near or at its proximal end. The detent snap 1402 may also include a detent snap flat portion 1406 distal to the detent snap bridge 1408. The outer surface of the detent snap bridge 1408 may include a detent snap curved portion 1404, which is a rounded surface that allows for easier movement of the detent snap bridge 1408 across the inner surface of the housing 702, such as a lock rib 1340.

[0050] Figure 8D is a side view of an exemplary embodiment of the sheath 704. Here, the alignment notch 1424 can be relatively close to the detent clearance 1410. The detent clearance 1410 is located relatively proximal on the distal portion of the sheath 704.

[0051] Figure 8E is an end view of an exemplary embodiment of the proximal end of the sheath 704. Here, the rear wall 1446 of the guide rail can provide a channel for slidably connecting to the housing guide rib 1321 of the housing 702. The sheath rotation limiter 1448 can be a notch that reduces or prevents rotation of the sheath 704.

[0052] Figure 8F is a perspective view of an exemplary embodiment of a compressible distal end 1450 that is detachable from the sheath 704 of the applicator 150. In a general sense, the embodiments described herein operate by flattening and pulling the skin surface at a predetermined site for sensor insertion. Furthermore, the embodiments described herein can also be used for other clothing applications, such as transdermal drug delivery, needle injection, wound closure suturing, device implantation, application of adhesive surfaces to skin, and similar applications.

[0053] As background, those skilled in the art will understand that skin is a highly anisotropic tissue from a biomechanical standpoint, varying greatly from individual to individual. This can affect, for example, the rate of drug diffusion, the ability of sharp objects to penetrate the skin, or the extent to which communication can take place between the underlying tissue and the surrounding environment when inserting sensors into the body at insertion sites guided by sharp objects.

[0054] In particular, the embodiments described herein relate to reducing skin anisotropy in a given area by flattening and stretching the skin, and thereby improving the applications described above. After smoothing the skin (e.g., flattening and removing wrinkles), a more consistent surface area contact interface can be formed by combining it with a similarly molded (e.g., flat) round adhesive pad of a sensor control unit. The closer the skin surface profile is to the profile specification of the surface of the designed device (or a contact area designed for drug delivery, for example), the more consistent contact (or drug delivery) can be achieved. This can also be advantageous for wearable adhesives by creating a continuum of adhesive-skin contact in a given wrinkle-free area. Other advantages include: (1) increased wear time for devices whose functionality depends on adhesion to the skin; and (2) a more predictable skin contact area, which improves drug delivery in transdermal drug / medicine delivery.

[0055] Furthermore, the combination of skin flattening (for example, as a result of tissue compression) and tensile strength can reduce the viscoelasticity of the skin and increase its rigidity, thereby increasing the success rate of sensor placement and function that rely on sharp parts.

[0056] Regarding sensor insertion, puncture wounds can contribute to early signal aberration (ESA) of the sensor, which may be mitigated by flattening and firming the skin. Known methods to minimize puncture wounds include: (1) reducing the size of the insertion device; or (2) limiting the length of the needle inserted into the body. However, these known methods may reduce the success rate of insertion due to skin conformability. For example, when the tip of a sharp component touches the skin, the skin deforms inward toward the body before the tip penetrates the skin. This decrease is also called "skin tenting." If a sharp component does not have sufficient rigidity due to a relatively small cross-sectional area and / or insufficient length, the sharp component may not be able to form an insertion point of sufficient size for passing the sensor through the skin and positioning it properly, or it may not be able to form it in the desired position due to deflection. The degree of skin tenting can vary between subjects and even within a single subject; that is, the distance between the sharp object and the skin surface can vary from one insertion to another. Reducing such variability by stretching and flattening the skin can result in a more accurate and consistent sensor insertion mechanism.

[0057] Referring to Figure 8F, a perspective view of an exemplary embodiment of the compressible distal end 1450 of the applicator 150 is shown. According to some embodiments, the compressible distal end 1450 can be manufactured from an elastomer material. In other embodiments, the compressible distal end 1450 can be made from a metal, plastic, composite leg or spring, or a combination thereof.

[0058] In some embodiments, the compressible distal end 1450 can be detached from the applicator 150 and used with a variety of other similar or dissimilar applicators or medical devices. In other embodiments, the compressible distal end 1450 can be manufactured as part of the sheath 704. In yet another embodiment, the compressible distal end 1450 can be attached to other parts of the applicator 150 (e.g., a sensor electronic component carrier) or used as a separate standalone device. Furthermore, although the compressible distal end 1450 is illustrated in Figures 8F and 8G as having a continuous ring-shaped geometry, other configurations are also available. For example, Figures 8H–8K are cross-sectional views showing various exemplary compressible distal ends having an octagonal geometry 1451 (Figure 8H), a star-shaped geometry 1452 (Figure 8I), a discontinuous ring-shaped geometry 1453 (Figure 8J), and a discontinuous rectangular geometry 1454 (Figure 8K). With respect to Figures 8J-8K, a compressible distal end with a discontinuous geometry will have multiple points or areas of contact with a given area of ​​skin. Those skilled in the art will understand that other geometries are also possible and are entirely within the scope of this disclosure.

[0059] Figures 8L and 8M are perspective and cross-sectional views, respectively, of an applicator 150 having a compressible distal end 1450. As shown in Figures 8L and 8M, the applicator 150 may also include an applicator housing 702, a sheath 704 to which the compressible distal end 1450 is attached, a sharp part 2502, and a sensor 104.

[0060] According to some embodiments, during operation, the compressible distal end 1450 of the applicator is first positioned on the skin surface of the subject. The subject then applies a force to the applicator, for example, distally, which causes the compressible distal end 1450 to pull and flatten a portion of the skin surface beneath it. In some embodiments, the compressible distal end 1450 can be made of an elastomer material and can be biased radially inward. In other embodiments, the compressible distal end 1450 can be biased radially outward. The force applied to the applicator can displace the edge portion of the compressible distal end 1450 in contact with the skin surface in a radially outward direction, thereby generating a radially outward force on the portion of the skin surface below the applicator, which pulls and flattens the skin surface.

[0061] Furthermore, according to some embodiments, applying force to the applicator moves a medical device, such as a sensor control unit, from a first position within the applicator to a second position adjacent to the skin surface. According to one aspect of some embodiments, the compressible distal end 1450 can be unloaded in the first position (e.g., before force is applied to the applicator) and loaded in the second position (e.g., after force is applied to the applicator). The medical device is then applied to the stretched and flattened portion of the skin surface below the compressible distal end 1450. According to some embodiments, the application of the medical device may include placing an adhesive patch 105 of the sensor control unit 102 on the skin surface and / or positioning at least a portion of the analyte sensor below the skin surface. The analyte sensor may be an in vivo analyte sensor configured to measure the level of an analyte in the subject's bodily fluids. In yet another embodiment, the application of the medical device may include placing a drug-loaded patch on the skin surface. Those skilled in the art will understand that the compressible distal end can be used in conjunction with any of the aforementioned medical applications and is not intended to be limited to use in applicators for inserting analyte sensors.

[0062] Exemplary Embodiment of Sensor Electronic Component Carrier Figure 9A is a proximal perspective view of an exemplary embodiment of a sensor electronic component carrier 710 capable of holding sensor electronic components within an applicator 150. It can also hold a sharp component carrier 1102 with a sharp component module 2500. In this exemplary embodiment, the sensor electronic component carrier 710 as a whole has a hollow, round, flat cylindrical shape and may include one or more (e.g., three) deflectable sharp component carrier locking arms 1524, which extend proximal from the proximal surface surrounding a centrally located spring alignment ridge 1516 for maintaining the alignment of the spring 1104. Each locking arm 1524 has a detent or retaining feature portion 1526 located at or near its proximal end. A shock lock 1534 may be a tab located on the outer circumference of the sensor electronic component carrier 710 that extends outward and can lock the sensor electronic component carrier 710 for further safety before firing. The rotation limiter 1506 can be a relatively short projection extending proximally on the proximal surface of the sensor electronic component carrier 710, which limits the rotation of the carrier 710. The sharp component carrier lock arm 1524 can be coupled to the sharp component carrier 1102 as described below with reference to Figures 10 and 11.

[0063] Figure 9B is a distal perspective view of the sensor electronic component carrier 710. Here, one or more (e.g., three) sensor electronic component holding spring arms 1518 are biased perpendicularly toward the illustrated position and include detents 1519 that can pass through the distal surface of the electronic component housing 706 of the device 102 when housed in a recess or cavity 1521. In a particular embodiment, after attaching the sensor control device 102 to the skin using the applicator 150, the user pulls the applicator 150 proximal, i.e., away from the skin. The adhesive force holds the sensor control device 102 on the skin, and this adhesive force overcomes the lateral force applied by the spring arms 1518. As a result, the spring arms 1518 deflect radially outward, releasing the sensor control device 102 from the applicator 150 by disengaging the detents 1519 from the sensor control device 102.

[0064] Exemplary Embodiment of a Sharp Parts Carrier Figures 10 and 11 are a proximal perspective view and a side cross-sectional view, respectively, of an exemplary embodiment of the sharp parts carrier 1102. The sharp parts carrier 1102 can grip the sharp parts module 2500 and hold it within the applicator 150. Near the distal end of the sharp parts carrier 1102, an anti-rotation slot 1608 can be provided to prevent the sharp parts carrier 1102 from rotating when it is positioned within the central area of ​​the sharp parts carrier lock arm 1524 (as shown in Figure 9A). The anti-rotation slot 1608 can be positioned between multiple sections of the chamfered portion 1610 of the sharp parts carrier base, thereby ensuring that the sharp parts carrier 1102 is completely withdrawn through the sheath 704 when it is withdrawn at the end of the deployment procedure.

[0065] As shown in Figure 11, the sharp parts holding arms 1618 can be positioned inside the sharp parts carrier 1102, around a central axis, and each arm 1618 may include a sharp parts holding clip 1620 at its distal end. The sharp parts holding clip 1620 may have a proximal surface which can be substantially perpendicular to the central axis and can abut against the distal surface of the sharp parts hub 2516 (Figure 17A).

[0066] Exemplary Embodiment of a Sensor Module Figures 12A and 12B are a top and bottom perspective view, respectively, of an exemplary embodiment of the sensor module 504. The module 504 can hold the connector 2300 (Figures 13A and 13B) and the sensor 104 (Figure 14). The module 504 can be securely coupled to the electronic component housing 706. One or more deflectable arms or module snaps 2202 can snap into the corresponding feature portions 2010 of the housing 706. The sharp component slot 2208 can provide a place for the sharp component tip 2502 to pass through and for the sharp component shaft 2504 to temporarily reside. The sensor ledge 2212 defines the position of the sensor in a horizontal plane, preventing the sensor from lifting the connector 2300 away from the post and keeping the sensor 104 parallel to the plane of the connector seal. It can also define the bending geometry of the sensor and the minimum bending radius. This restricts the vertical movement of the sensor, preventing the tower from protruding above the surface of the electronic component housing and defining the length of the sensor's tail below the patch surface. The sensor wall 2216 constrains the sensor, defining the sensor's bending geometry and minimum bending radius.

[0067] Figures 13A and 13B are perspective views of exemplary embodiments of the connector 2300 in an open and closed state, respectively. The connector 2300 can be made of silicone rubber, encapsulating a corresponding carbon-impregnated polymer module that functions as a conductive contact 2302 between the sensor 104 and the electrical circuit contacts for the electronic components in the housing 706. The connector can also function as a moisture barrier for the sensor 104 when assembled in a compressed state after transfer from the container to the applicator and after application to the user's skin. Multiple sealing surfaces 2304 can provide a watertight seal for the electrical contacts and sensor contacts. One or more hinges 2308 can connect the two distal and proximal portions of the connector 2300.

[0068] Figure 14 is a perspective view of an exemplary embodiment of the sensor 104. The neck 2406 can be a zone that allows the sensor to be folded, for example, 90°. A membrane on the tail 2408 can cover the active analyte sensing element of the sensor 104. The tail 2408 can be the portion of the sensor 104 that lies beneath the user's skin after insertion. The flag 2404 can include a contact and a sealing surface. The biasing tower 2412 can be a tab that biases the tail 2408 into the sharp part slot 2208. The biasing pivot 2414 can be a derivative of the biasing tower 2412 that contacts the inner surface of the needle to bias the tail into the slot. The biasing adjuster 2416 can reduce local bending of the tail connection and prevent damage to the sensor trace. The contact 2418 can electrically connect the active portion of the sensor to the connector 2300. The service loop 2420 can be moved 90° from the vertical direction to engage with the sensorledge 2212 (Figure 12B).

[0069] Figures 15A and 15B are a bottom perspective view and a top perspective view, respectively, of an exemplary embodiment of a sensor module assembly comprising a sensor module 504, a connector 2300, and a sensor 104. According to one aspect of the above-described embodiment, during or after insertion, the sensor 104 may be subjected to an axial force that pushes it proximal inward into the sensor module 504, as shown by force F1 in Figure 15A. According to some embodiments, this allows a reverse force F2 to be applied to the neck 2406 of the sensor 104, and as a result, a reverse force F3 can be transmitted to the service loop 2420 of the sensor 104. In some embodiments, the axial force F1 may be generated as a result of a sensor insertion mechanism designed to push the sensor by tissue, a sharp part extraction mechanism during insertion, or a physiological response generated by the tissue surrounding the sensor 104 (e.g., after insertion).

[0070] Figures 16A and 16B are partially enlarged views of exemplary embodiments of sensor module assemblies having specific axial reinforcing feature portions. Generally, the embodiments described herein address the mitigation of the effects of axial forces on a sensor as a result of insertion and / or withdrawal mechanisms or due to physiological responses to sensors within the body. As can be seen in Figures 16A and 16B, according to one aspect of these embodiments, the sensor 3104 comprises a proximal portion having a hook-shaped feature portion 3106 configured to engage with a catch-shaped feature portion 3506 of the sensor module 3504. In some embodiments, the sensor module 3504 may also include a clearance area 3508 that allows the distal portion of the sensor 3104 to swing backward during assembly in order to enable the assembly of the hook-shaped feature portion 3106 of the sensor module 3504 into and into the catch-shaped feature portion 3506 of the sensor module 3504.

[0071] According to another aspect of the above embodiment, the hook-shaped feature portion 3106 and the catch-shaped feature portion 3506 operate as follows. The sensor 3104 includes a proximal sensor portion connected to the sensor module 3504 as described above, and a distal sensor portion positioned below the skin surface in contact with bodily fluids. As seen in Figures 16A and 16B, the proximal sensor portion includes a hook-shaped feature portion 3106 adjacent to the catch-shaped feature portion 3506 of the sensor module 3504. During or after sensor insertion, one or more forces are applied in the proximal direction along the longitudinal axis of the sensor 3104. In response to the one or more forces, the hook-shaped feature portion 3106 engages with the catch-shaped feature portion 3506, thereby preventing proximal displacement of the sensor 3104 along the longitudinal axis.

[0072] According to another aspect of the above embodiment, the sensor 3104 can be assembled with the sensor module 3504 as follows. The sensor 3104 is loaded into the sensor module 3504 by displacing the proximal sensor portion laterally so that the hook-shaped feature portion 3106 is positioned proximal to the catch-shaped feature portion 3506 of the sensor module 3504. More specifically, when the proximal sensor portion is displaced laterally, the proximal sensor portion moves into the clearance area 3508 of the sensor module 3504.

[0073] Figures 16A and 16B illustrate the hook-shaped feature portion 3106 as part of the sensor 3104 and the catch-shaped feature portion 3506 as part of the sensor module 3504. However, those skilled in the art will understand that the hook-shaped feature portion 3106 can instead be part of the sensor module 3504, and similarly, the catch-shaped feature portion 3506 can instead be part of the sensor 3106. Similarly, those skilled in the art will recognize that other mechanisms (e.g., detents, latches, fasteners, screws, etc.) implemented on the sensor 3104 and sensor module 3504 to prevent axial displacement of the sensor 3104 are also possible and within the scope of this disclosure.

[0074] Exemplary Embodiment of a Sharp Parts Module Figure 17A is a perspective view of an exemplary embodiment of the sharp component module 2500 before assembly into the sensor module 504 (Figure 6B). The sharp component 2502 may include a distal tip 2506 that penetrates the skin while supporting the sensor tail within the hollow or recessed portion of the sharp component shaft 2504, allowing the active surface of the sensor tail to come into contact with bodily fluids. A hub pressing cylinder 2508 can provide a surface for pressing the sharp component carrier during insertion. A hub miniaturization cylinder 2512 can provide space for an extended portion of the sharp component hub contact surface 1622 (Figure 11). A hub snap fitting claw positioning cylinder 2514 can provide a distally facing surface of the hub snap fitting claw 2516 for contacting the sharp component hub contact surface 1622. The hub snap fitting claw 2516 may include a conical surface that releases the clip 1620 during installation of the sharp component module 2500. Further details relating to sharp component modules, sharp components, their components, and embodiments of modified versions thereof are described in U.S. Patent Publication No. 2014 / 0171771, which is incorporated herein by reference in its entirety for all purposes.

[0075] Figures 17B, 17C, and 17D show exemplary embodiments of plastic sharp parts modules. As background, according to one aspect of these embodiments, plastic sharp parts can be advantageous in at least two respects.

[0076] Firstly, compared to metal sharp parts, plastic sharp parts can reduce tissue trauma during the insertion process into the skin. For example, due to manufacturing processes such as chemical etching and mechanical molding, metal sharp parts typically feature sharp edges and burrs, which can cause tissue trauma at the insertion site. In contrast, plastic sharp parts can be designed with rounded edges and a smooth finish to reduce trauma when passing through tissue and positioning the sharp part. Furthermore, those skilled in the art will understand that reducing trauma during the insertion process leads to a reduction in ESA, which can improve the accuracy of analyte level readings immediately after insertion.

[0077] Secondly, plastic sharp parts can simplify the manufacturing and assembly process of the applicator. As with the embodiments already described, a particular applicator is provided to the user as two parts: (1) an applicator containing the sharp parts and sensor electronic components within the sensor control unit; and (2) a sensor container. This requires the user to assemble the sensor into the sensor control unit. One reason for this two-part assembly is to allow electron beam sterilization of the sensor to be performed separately from the applicator containing the metal sharp parts and sensor electronic components. Metal sharp parts, such as stainless steel sharp parts, have a higher density than sharp parts made of polymer or plastic material. As a result, electron beam scattering from the electron beam striking the metal sharp part can damage the sensor electronic components of the sensor control unit. By utilizing sharp plastic components, such as those made of polymer material, and additional shielding features to keep the electron beam path separated from the sensor electronic components, the applicator and sensor can be sterilized and packaged in a single package, thereby reducing manufacturing costs and simplifying the user's assembly process.

[0078] Referring to Figure 17B, a perspective view of an exemplary embodiment of a plastic sharp part module 2550 is shown, which may include a hub 2562 connected to the proximal end of the sharp part, a sharp part shaft 2554, a distal tip 2556 of the sharp part configured to penetrate the skin surface, and a sensor channel 2558 configured to receive at least a portion of the analyte sensor 104. Some or all of the components of the sharp part module 2550 may be made of plastic material, such as thermoplastic material, liquid crystal polymer (LCP), or similar polymer material. According to some embodiments, for example, the sharp part module may include polyetheretherketone material. In other embodiments, trauma caused during the insertion process can be reduced by applying silicone or other lubricants to the outer surface of the sharp part module and / or incorporating them into the polymer material of the sharp part module. Furthermore, to reduce trauma during insertion, one or more of the sharp component shaft 2554, the distal tip of the sharp component 2556, and the alignment feature portion 2568 (described below) may include filleted and / or smoothed edges.

[0079] In some embodiments, when assembled, the distal end of the analyte sensor can be located proximal to the distal tip 2556 of the sharp part. In other embodiments, the distal end of the analyte sensor and the distal tip 2556 of the sharp part are located at the same position.

[0080] According to another aspect of several embodiments, the plastic sharp part module 2550 may also include an alignment feature portion 2568 configured to prevent rotational movement of the sharp part module 2550 along its vertical axis 2545 during the insertion process, wherein the alignment feature portion 2568 can be positioned along the proximal portion of the sharp part shaft 2554.

[0081] Figures 17C and 17D are a side view and a perspective view, respectively, of another exemplary embodiment of the plastic sharp part module 2570. Similar to the embodiment described with respect to Figure 17B, the plastic sharp part module 2570 may include a hub 2582 connected to the proximal end of the sharp part, a sharp part shaft 2574, a distal tip 2576 of the sharp part configured to penetrate the skin surface, and a sensor channel 2578 configured to receive at least a portion of the analyte sensor 104. Some or all of the components of the sharp part module 2570 may be made of plastic material, such as thermoplastic material, LCP, or similar polymer material. In some embodiments, trauma caused during the insertion process can be reduced by applying silicone or other lubricants to the outer surface of the sharp part module 2570 and / or incorporating them into the polymer material of the sharp part module 2570.

[0082] According to some embodiments, the sharp part shaft 2574 may include a distal portion 2577, which terminates at a distal tip 2576 where at least a portion of the sensor channel 2578 is located. The sharp part shaft 2574 may also have a proximal portion 2575 adjacent to the distal portion 2577, where the proximal portion 2575 is solid, partially solid, or hollow and is connected to the hub 2582. Figures 17C and 17D illustrate the sensor channel 2578 as being located only within the distal portion 2577, but those skilled in the art will understand that the sensor channel 2578 may also extend through most of the sharp part shaft 2574 or along its entire length (as shown, for example, in Figure 17B) (including through at least a portion of the proximal portion 2575). Furthermore, according to another aspect of some embodiments, at least a portion of the proximal portion 2575 may have a greater wall thickness than the distal portion 2577, thereby reducing the possibility of the sharp part bending due to stress during the insertion process. According to another aspect of some embodiments, the plastic sharp part module 2570 may have one or more ribs (not shown) adjacent to the sharp part hub portion 2582, thereby reducing the compressive load around the hub 2582 and reducing the bending of the sharp part due to stress during the insertion process.

[0083] Figure 17E is a cross-sectional view of an exemplary embodiment of an applicator 150 having a plastic sharp parts module during an electron beam sterilization process. As indicated by the rectangular area A, the electron beam is focused onto the sensor 104 and the plastic sharp parts module 2550 of the applicator 150 during the sterilization process. According to some embodiments, a cap 708 is fixed to the applicator housing 702, thereby sealing the sensor control device 102 within the applicator 150. During the sterilization process, the electron beam scatters in this direction, as indicated by the diagonal arrows emanating from the plastic sharp parts module 2550, and the path of the sensor electronic component 160 is reduced because the plastic sharp parts module 2550 is used instead of a metal sharp part. Although Figure 17E shows a sterilization process with a focused electron beam, those skilled in the art will recognize that embodiments of applicators having a plastic sharp parts module can also be used during sterilization processes with an unfocused electron beam.

[0084] Figure 17F is a flowchart of an exemplary embodiment of method 1100 for sterilizing the applicator assembly according to the embodiment described above. In step 1105, the sensor control device 102 is loaded into the applicator 150. The sensor control device 102 may include various components, including: an electronic component housing; a printed circuit board positioned within the electronic component housing and containing a processing circuit configuration; an analyte sensor extending from the bottom of the electronic component housing; and a plastic sharp component module having a plastic sharp component extending through the electronic component housing. According to some embodiments, the plastic sharp component may also receive a portion of the analyte sensor extending from the bottom of the electronic component housing. As described above, in step 1110, the sensor control device 102 is sealed within the applicator 150 by securing the cap 708 to the applicator housing 702 of the applicator 150. In step 1115, the analyte sensor 104 and the plastic sharp part 2550 are sterilized by radiation while the sensor control device 102 remains positioned within the applicator 150.

[0085] According to some embodiments, the sensor control device 102 may also include at least one shield positioned within the electronic component housing, the one or more shields configured to shield the processing circuit configuration from radiation during the sterilization process. In some embodiments, the shield may include a magnet that generates a static magnetic field to divert radiation from the processing circuit configuration. Thus, the combination of the plastic sharp component module and the magnetic shield / deflector can work together to protect the sensor electronic components from radiation during the sterilization process.

[0086] Next, another exemplary embodiment of a sharp part designed to reduce trauma during sensor insertion and withdrawal processes will be described. More specifically, the particular embodiments described herein concern a sharp part made of a metallic material (e.g., stainless steel) and manufactured by a coining process. According to one aspect of the above embodiments, a coined sharp part may be characterized by having one sharp part tip and all other edges being rounded. As described above, metallic sharp parts manufactured by chemical etching and mechanical forming processes may result in sharp edges and unintended hook-shaped features. For example, Figure 17G is a photograph of a metallic sharp part 2502 manufactured by a chemical etching and mechanical forming process. As can be seen in Figure 17G, the metallic sharp part 2502 includes a distal sharp part tip 2506 having a hook-shaped feature. These and other unintended transitional features may lead to increased trauma to tissue during sensor insertion and withdrawal processes. In contrast, Figure 17H ​​is a photograph of a coined sharp part 2602, i.e., a metal sharp part manufactured by the coining process. As can be seen in Figure 17H, the coined sharp part 2602 also includes a distal tip 2606. However, the coined sharp part 2602 has only a smooth, rounded edge, with no unintended sharp edges or transitions whatsoever.

[0087] Similar to the embodiments of the sharp parts described above, the embodiment of the coining sharp part 2602 described herein can also be assembled within a sharp part module having a sharp portion and a hub portion. Similarly, the sharp portion comprises: a sharp part shaft; a sharp part proximal end connected to the distal end of the hub portion; and a sharp part distal tip configured to penetrate the skin surface. According to one aspect of the above embodiment, one or all of the sharp portion, sharp part shaft, and sharp part distal tip of the coining sharp part 2602 may have one or more rounded edges.

[0088] Furthermore, those skilled in the art will understand that embodiments of the coined sharp part 2602 described herein can also be used in conjunction with any of the sensors described herein, including in vivo analyte sensors configured to measure analyte levels in a subject's bodily fluids. For example, in some embodiments, the coined sharp part 2602 may include a sensor channel (not shown) configured to receive at least a portion of the analyte sensor. Similarly, in some embodiments of sharp part module assemblies utilizing the coined sharp part 2602, the distal end of the analyte sensor may be located proximal to the distal tip 2606 of the sharp part. In other embodiments, the distal end of the analyte sensor and the distal tip 2606 of the sharp part are located at the same position.

[0089] Next, other exemplary embodiments of sharp parts designed to reduce trauma during the sensor insertion process will be described. Referring again to Figure 17A, an exemplary embodiment of a sharp part module 2500 (illustrated without the analyte sensor) is shown, which includes a sharp part 2502 comprising a sensor channel having a U-shaped geometry configured to receive at least a portion of the analyte sensor, and a distal tip 2506 configured to penetrate the skin surface during the sensor insertion process.

[0090] In certain embodiments, the sharp component module may include a sharp component having a distal tip with an offset geometry configured to form a smaller opening in the skin compared to other sharp components (e.g., sharp component 2502 shown in Figure 17A). Moving to Figure 17I, a perspective view of an exemplary embodiment of a sharp component module 2620 (with an analyte sensor 104) having an offset tip portion is shown. Similar to the sharp component modules described above, the sharp component module 2620 may include: a sharp component shaft 2624 connected to a hub 2632 at its proximal end; a sensor channel 2628 configured to receive at least a portion of the analyte sensor 104; and a distal tip 2626 configured to penetrate the skin surface during the sensor insertion process.

[0091] According to one aspect of the above embodiment, one or more side walls 2629 forming the sensor channel 2628 are positioned along the sharp part shaft 2624 at a predetermined distance Dsc from the distal tip 2626. In certain embodiments, the predetermined distance Dsc can be 1 mm to 8 mm. In other embodiments, the predetermined distance Dsc can be 2 mm to 5 mm. Those skilled in the art will recognize that other predetermined distances Dsc are also available and are entirely within the scope of this disclosure. In other words, according to some embodiments, the sensor channel 2628 is spaced apart from the distal tip 2626. In this regard, the distal tip 2626 has a reduced cross-sectional footprint compared to, for example, the distal tip 2506 of a sharp part module 2500 whose sensor channel is adjacent to the distal tip 2506. According to another aspect of the above embodiment, the distal tip 2626 has an offset tip portion 2627 at its end, configured to prevent damage to the sensor tip 2408 during insertion and to form a small opening in the skin. In some embodiments, the offset tip portion 2627 can be a separate element connected to the distal end of the sharp component shaft 2624. In other embodiments, the offset tip portion 2627 can be formed from the distal tip 2506 or a portion of the sharp component shaft 2624. During insertion, as the sharp component moves into the skin surface, the offset tip portion 2627 can laterally pull and widen the skin surrounding the skin opening without further cutting the skin tissue. In this regard, the trauma that occurs during the sensor insertion process is relatively small.

[0092] Referring next to Figure 17J, a perspective view of another exemplary embodiment of the sharp part module 2640 (with analyte sensor 104) having an offset tip portion is shown. Similar to the embodiments described above, the sharp part module 2640 may include: a sharp part shaft 2644 connected to a hub 2652 at its proximal end; a sensor channel 2648 configured to receive at least a portion of the analyte sensor 104; and a distal tip 2646 configured to penetrate the skin surface during the sensor insertion process. According to one aspect of the above embodiment, the sensor channel 2648 may comprise a first side wall 2649a and a second side wall 2649b, the first side wall 2649a extending to the distal tip 2646, the end of which forms an offset tip portion 2647, and the second side wall 2649b positioned along the sharp part shaft 2644 at a predetermined distance from the distal tip 2646, the end of which is proximal to the first side wall 2649a. Those skilled in the art will understand that in other embodiments, the second side wall 2649b may extend to the distal tip 2646 instead of the first side wall 2649a to form an offset tip portion 2647. Furthermore, the offset tip portion 2647 may also be formed from a third or fourth side wall (not shown), and such geometries are also entirely within the scope of the present disclosure.

[0093] Those skilled in the art will recognize that, with respect to the embodiments of the sharp parts and sharp part modules described herein, some or all of the components may include metallic materials such as stainless steel, or plastic materials such as liquid crystal polymers. Furthermore, those skilled in the art will understand that any of the embodiments of the sharp parts and / or sharp part modules described herein may be used with or combined with any of the sensors, sensor modules, sensor electronic component carriers, sheaths, applicator devices, or other analyte monitoring systems described herein.

[0094] Exemplary Embodiment of a Powered Applicator Figures 18A and 18B are cross-sectional and exploded views, respectively, of exemplary embodiments of a powered applicator 4150 for inserting an analyte sensor into a subject's body. According to one aspect of the above embodiment, the housing 4702 of the powered applicator 4150 acts as a trigger, releasing a drive spring 4606 under light pressure to activate and push the sensor electronic component carrier 4710 downward, inserting the sharp component and analyte sensor into the subject's body. When the subject pulls the applicator 4150 away from the skin, a withdrawal spring 4604 is activated to withdraw the sharp component from the subject. According to one aspect of the above embodiment, the powered applicator 4150 can provide a faster and more controlled insertion speed compared to an applicator that relies on manual force for insertion. The powered applicator 4150 is further advantageous in that it can improve the success rate of insertion and reduce trauma to the insertion site compared to an applicator that relies on manual force for insertion.

[0095] The various components of the powered applicator 4150 will now be described with reference to Figures 18A and 18B. As can be seen in Figure 18A as a cross-sectional view of the assembled powered applicator 4150 (initial state) and in Figure 18B as an exploded view, the powered applicator 4150 may include the following components: housing 4702, sharp component carrier 4602, extraction spring 4604, sheath 4704, firing pin 4705, drive spring 4606, and sensor electronic component carrier 4710. Furthermore, although not shown, the powered applicator 4150 may also include any of the sensor control units, analyzer sensors, and sharp component embodiments described herein or in other publications incorporated herein by reference.

[0096] Figures 19A to 19L show various diagrams of exemplary embodiments of the powered applicator 4150 during different stages of deployment.

[0097] Figure 19A is a cross-sectional view showing the powered applicator 4150 in its initial state, where the distal end of the applicator 4150 is ready for positioning on the subject's skin surface. In this initial state, the drive spring 4606 and the withdrawal spring 4604 are pre-loaded. The drive spring 4606 includes a first end connected to the launch pin 4705 and a second end connected to the sensor electronic component carrier 4710. The withdrawal spring 4604 includes a first end connected to the sharp component carrier 4602 and a second end connected to the sensor electronic component carrier 4710. As can be best seen in Figure 19A, in the initial state, the sensor electronic component carrier 4710 and the sharp component carrier 4602 are in a first position within the applicator 4150, spaced apart from the skin surface.

[0098] According to one aspect of the above embodiment, in the initial state, the sensor electronic component carrier 4710 is connected to the sheath 4704 by one or more latch-tab structures. Figure 19B shows a perspective view of the sheath 4704 having one or more sheath stubs 4706. Figure 19C shows a perspective view of the sensor electronic component carrier 4710 having one or more corresponding sensor electronic component carrier latches 4603. In the initial state, as best seen in Figure 19A, one or more sensor electronic component carrier latches 4603 each engage with a corresponding sheath stub 4706. Figures 19B and 19C illustrate three sheath stubs 4706 and three sensor electronic component carrier latches 4603, but those skilled in the art will understand that fewer or more latch-tab structures can be used. Furthermore, these embodiments are entirely within the scope of the present disclosure.

[0099] Figure 19D is a cross-sectional view showing the powered applicator 4150 in firing position, where a force F1 is applied distally to the applicator 4150 (as indicated by the dark arrow). According to one aspect of the above embodiment, the application of force F1 causes the firing pin 4705 to move distally along the sheath 4704, and then disengages the sheath stub 4706 from the sensor electronic component carrier latch 4603 (as indicated by the white arrow). Disengaging the sheath stub 4706 from the sensor electronic component carrier latch 4603 causes the drive spring 4606 to extend distally, thereby "firing" the applicator 4150. As the drive spring 4606 extends distally, the sensor electronic component carrier 4710 and the sharp component carrier 4602 are also displaced distally to a second position adjacent to the skin surface.

[0100] According to some embodiments, applying a force F1 before disengaging the sheath stub 4706 can further compress the drive spring 4606, thereby increasing the load on the drive spring 4606.

[0101] According to one embodiment of the above, the "cylinder-on-cylinder" design of the sheath 4704 and the launch pin 4705 can provide stable simultaneous release of all three sensor electronic component carrier latches 4603. Furthermore, in some embodiments, certain feature parts can provide enhanced stability while displacing the sensor electronic component carrier 4710 and the sharp component carrier 4602 from a first position to a second position. For example, as can be seen in Figure 19E, the sensor electronic component carrier 4710 may include one or more sensor electronic component carrier tabs 4605 configured to move distally along one or more sheath rails 4707 of the sheath 4704. Furthermore, as can be seen in Figure 19F, according to some embodiments, the sensor electronic component carrier 4710 may include one or more sensor electronic component carrier bumpers 4607, each of which can bias against the inner surface of the sheath 4704 while displacing the sensor electronic component carrier 4710 and the sharp component carrier 4602 from a first position to a second position.

[0102] Figure 19G is a cross-sectional view showing the powered applicator 4150 in the inserted state, where the force F1 is still applied distally to the applicator 4150 (as indicated by the dark arrow). The force F1 allows the subject to press and hold the applicator 4150 against the skin during insertion. During insertion, the sharp component and a portion of the analyte sensor (not shown) are positioned below the skin surface, in contact with the subject's bodily fluids. Furthermore, the sharp component withdrawal process is not initiated at this stage. As can be best seen in Figure 19I, the sensor electronic component carrier lock arm 4524 remains constrained by the sheath 4704, thereby preventing the sharp component carrier 4602 (and the sharp component) from being withdrawn.

[0103] According to another embodiment of the above embodiment, when the sensor electronic component carrier 4710 reaches the second position during insertion, the sensor electronic component carrier 4710 and the distal portion of the sensor control unit (not shown) connected to the sensor electronic component carrier 4710 are left in contact with the skin surface. In some embodiments, the distal portion of the sensor control unit can be an adhesive surface.

[0104] Furthermore, according to some embodiments, as can be best seen in Figure 19H, during insertion, the sensor electronic component carrier tab 4605 positioned within the sheath rail 4707 moves in the displacement direction to a second position, but remains positioned above the bottom of the applicator 4150, as indicated by distance R.

[0105] Figure 19J is a cross-sectional view showing the powered applicator 4150 in the sharp part extraction state. According to one embodiment of the above, after the insertion state is completed, the subject applies a force F2 to the applicator 4150, this time in the proximal direction. The force F2 allows the subject to pull or remove the applicator 4150 away from the skin surface. By applying the force F2, the extraction spring 4604 displaces the sharp part carrier 4602 from a second position (e.g., adjacent to the skin surface) to a third position within the applicator 4150, thereby extracting the sharp part from the skin surface.

[0106] More specifically, when force F2 is applied, the drive spring 4606 displaces the sensor electronic component carrier 4710 toward the bottom portion of the applicator 4150. As can be seen in Figure 19J, a portion of the sensor electronic component carrier 4710 protrudes below the bottom of the sheath 4704. Similarly, as shown in Figure 19K, during the sharp component withdrawal state, the sensor electronic component carrier tab 4605 lies coplanar with the bottom of the sheath slot 4707.

[0107] According to another aspect of the above embodiment, as the force F2 is continuously applied, each sensor electronic component carrier lock arm 4524 is positioned within the sheath notch 4708, as is best seen in Figure 19L. As a result, the sensor electronic component carrier lock arm 4524, biased in the radially outward direction, can extend radially outward through the sheath notch 4708. The sensor electronic component carrier lock arm 4524 then disengages from the sharp component carrier 4602 and releases it, allowing the extraction spring 4604 to extend freely in the proximal direction. As the extraction spring 4604 extends proximal, the sharp component carrier 4602 is displaced to a third position within the applicator 4150 (e.g., the upper part of the sheath 4704), thereby extracting the sharp component from the skin surface.

[0108] Regarding the drive spring 4606 and the sharp part extraction spring 4604, although compression springs are shown in Figures 18A-18B and 19A-19L, those skilled in the art will understand that other types of springs, including but not limited to torsion springs, disc springs, leaf springs, etc., can be used in any of the embodiments described herein. Furthermore, those skilled in the art will understand that the insertion and extraction speeds of the applicator embodiments described herein can be changed by changing the stiffness or length of the drive spring and the extraction spring, respectively. Similarly, those skilled in the art will understand that the timing of sharp part extraction can be modified by modifying the depth of the sheath channel (for example, increasing the depth of the sheath channel allows for earlier extraction of the sharp part).

[0109] Those skilled in the art will understand that any embodiment of the applicator described herein, and any component thereof (including, but not limited to, embodiments of sharpening parts, sharpening part modules, and sensor modules), can be sized and configured for use with a sensor configured to sense the level of an analyte in the bodily fluids of a subject's epidermis, dermis, or subcutaneous tissue. For example, in some embodiments, both the sharpening parts and the distal portion of the analyte sensor disclosed herein can be sized and configured to position themselves at a specific edge depth (i.e., the deepest point of penetration within the tissue or layer of the subject's body, e.g., the epidermis, dermis, or subcutaneous tissue). With respect to some embodiments of the applicator, those skilled in the art will understand that certain embodiments of the sharpening parts can be sized and configured to position themselves at an edge depth within the subject's body that is different from the final edge depth of the analyte sensor. For example, in some embodiments, the sharpening part can be positioned at a first edge depth within the subject's epidermis before withdrawal, while the distal portion of the analyte sensor can be positioned at a second edge depth within the subject's dermis. In another embodiment, the sharp component can be positioned at a first end depth in the dermis of the subject before withdrawal, while the distal portion of the analyte sensor can be positioned at a second end depth in the subcutaneous tissue of the subject. In yet another embodiment, the sharp component can be positioned at a first end depth before withdrawal, and the analyte sensor can be positioned at a second end depth, both of which are located within the same layer or tissue of the subject's body.

[0110] Furthermore, with respect to any embodiment of the applicator described herein, including but not limited to the powered applicators of Figures 18A, 18B, and 19A-19L, those skilled in the art will know that the analyte sensor and one or more structural components connected to the analyte sensor, including but not limited to one or more spring mechanisms, can be positioned within the applicator at an off-center position with respect to one or more axes of the applicator. For example, in some embodiments of the applicator, the analyte sensor and spring mechanism can be positioned on a first side of the applicator at a first off-center position with respect to the axis of the applicator, and the sensor electronic components can be positioned on a second side of the applicator at a second off-center position with respect to the axis of the applicator. In other embodiments of the applicator, the analyte sensor, spring mechanism, and sensor electronic components can be positioned on the same side at an off-center position with respect to the axis of the applicator. Those skilled in the art will understand that other permutations and configurations are possible and are entirely within the scope of this disclosure, in which any or all of the applicator's analyte sensor, spring mechanism, sensor electronic components, and other components are positioned centrally or off-center with respect to one or more axes of the applicator.

[0111] Numerous deflectable structures are described herein, including but not limited to deflectable detent snaps 1402, deflectable locking arms 1412, sharp parts carrier locking arms 1524, sharp parts holding arms 1618, and module snaps 2202. These deflectable structures are made of elastic materials such as plastic or metal (or other) and operate in a manner known to those skilled in the art. Each of these deflectable structures has a stationary state or position, and the elastic material is biased toward this stationary state or position. When a force is applied to deflect or move the structure from this stationary state or position, the biasing of the elastic material causes the structure to return to the stationary state or position when the force is removed (or weakened). Often these structures are configured as arms with detents or snaps, but other structures or configurations can also be used that have the same characteristics in terms of deflection and the ability to return to the stationary position, including but not limited to legs, clips, catches, contact parts, etc., on the deflectable member.

[0112] Exemplary Embodiments of Applicators and Sensor Control Devices for Single-Component Architectures As described above, specific embodiments of the sensor control device 102 and applicator 150 can be provided to the user as multiple packages. For example, some embodiments, such as those described with respect to Figures 3A-3G, can have a "two-piece" architecture, which requires final assembly by the user and then allows for proper delivery of the sensor to the target monitoring location. More specifically, the sensor and related electronic components contained within the sensor control device are provided to the user in multiple (e.g., two) packages, each of which may or may not be sealed with a sterile barrier, but are at least contained within packaging. The user must open the packaging, manually assemble the components according to the instructions, and then deliver the sensor to the target monitoring location using the applicator. Referring again to Figures 3A-3G, for example, the sensor tray and applicator are provided to the user as separate packages, thus requiring the user to open each package and perform the final assembly of the system. In some applications, these separate sealed packages allow the tray and applicator to be sterilized in separate sterilization processes specific to the contents of each package, and not compatible with the contents of the other package.

[0113] More specifically, a tray containing a sensor and a plug assembly with sharp parts can be sterilized using radiation sterilization, such as electron beam (i.e., "e-beam") irradiation. However, radiation sterilization can damage electronic components located within the housing of the sensor control device. Consequently, if the applicator enclosing the housing of the sensor control device needs to be sterilized, it can be sterilized by another method, such as gas chemical sterilization using ethylene oxide. However, gas chemical sterilization can damage enzymes or other chemicals and biological preparations contained on the sensor. Due to these sterilization incompatibility issues, the tray and applicator may be sterilized in separate sterilization processes and then packaged separately, requiring the user to perform the final assembly of the components after receipt.

[0114] According to other embodiments of the present disclosure, the sensor control device (e.g., an analyte sensor device) may have a single-component architecture that incorporates a sterilization technique specifically designed for a single-component architecture. This single-component architecture allows the sensor control device assembly to be shipped to the user in a single sealed package that requires no final user assembly step whatsoever. Rather, the user only needs to open one package and then deliver the sensor control device to the target monitoring location. The single-component system architecture described herein can prove advantageous in terms of eliminating components, various manufacturing process steps, and user assembly steps. As a result, packaging and waste are reduced, and the possibility of user error or contamination of the system is mitigated.

[0115] According to several embodiments, a sensor subassembly (SSA) can be constructed and sterilized. This sterilization may be by radiation, such as an electron beam (e-beam radiation), but other sterilization methods may be used, including but not limited to gamma-ray radiation, X-ray radiation, or combinations thereof. Embodiments of a method for manufacturing an analyte monitoring system using this SSA are described here, as are embodiments of a sensor control device having this SSA and an applicator for use with it. The SSA can be manufactured and then sterilized. During sterilization, the SSA may include both the analyte sensor and the sharp part for insertion. The sterilized SSA can then be assembled to form a sensor control device (e.g., assembled into a sensor control device), for example, by positioning the sterilized SSA so that the sensor is in electrical contact with any electronic component in the sensor electronic component carrier. The sensor control device can then be assembled to form an applicator (e.g., as a single-part assembly), where the applicator (also called an analyte sensor inserter) is configured to apply the sensor control device to the user's body. This single-part assembly can be packaged and / or distributed (e.g., shipped) to users or healthcare professionals.

[0116] Figures 20A to 20G show a first embodiment of the applicator for use with a sensor control device having an SSA. Figures 21A to 21G show a second embodiment of the applicator for use with a sensor control device having an SSA.

[0117] Figures 22A to 22G show a first embodiment of a sensor control device having an SSA but without an adhesive patch. Figures 23A to 23G show a second embodiment of a sensor control device having an SSA and an adhesive patch.

[0118] Figures 24A to 24G show a third embodiment of the sensor control device, which has an SSA and a bottom groove but does not have an adhesive patch. Figures 25A to 25G show a fourth embodiment of the sensor control device, which has an SSA, a bottom groove, and an adhesive patch.

[0119] Figures 26A to 26G show a fifth embodiment of the sensor control device, which has an SSA but does not have an adhesive patch. Figures 27A to 27G show a sixth embodiment of the sensor control device, which has an SSA and an adhesive patch.

[0120] Figures 28A to 28G show a seventh embodiment of the sensor control device, which has an SSA and a bottom groove but does not have an adhesive patch. Figures 29A to 29G show an eighth embodiment of the sensor control device, which has an SSA, a bottom groove, and an adhesive patch.

[0121] According to other embodiments, a sensor control device including a battery and sensors can be incorporated into an applicator as a single-part assembly and sterilized using a focused electron beam (FEB). Alternatively, other sterilization methods, including but not limited to gamma-ray radiation, X-ray radiation, or a combination thereof, may be used. Embodiments of a method for manufacturing an analyte monitoring system and sterilizing it, for example, with an FEB, are described here, as are embodiments of a sensor control device and applicator for use therewith. A sensor control device including sensors and sharp parts can be manufactured or assembled, for example, the sensors can be positioned in electrical contact with any electronic component in the sensor electronic component carrier of the sensor control device. The sensor control device can then be assembled to form an applicator (for example, as a single-part assembly), where the applicator is configured to apply the sensor control device to the user's body. Subsequently, this assembled applicator, which has the sensor control device inside, can be sterilized, for example, with an FEB. The sterilized applicator can then be packaged and / or distributed (e.g., shipped) to users or healthcare professionals. In some embodiments, sealing with a desiccant and foil can be added to the sterilized single-part assembly before packaging.

[0122] Figures 30A to 30G show a first embodiment of the applicator for sterilization, for example, using an FEB. Figures 31A to 31G show a second embodiment of the applicator for sterilization, for example, using an FEB.

[0123] Figures 32A to 32G show a first embodiment of a sensor control device without an adhesive patch, for example, for sterilization by FEB. Figures 33A to 33G show a second embodiment of a sensor control device with an adhesive patch, for example, for sterilization by FEB.

[0124] Figures 34A to 34G show a third embodiment of a sensor control device having a bottom groove but without an adhesive patch, for example, for sterilization in an FEB. Figures 35A to 35G show a fourth embodiment of a sensor control device having a bottom groove and an adhesive patch, for example, for sterilization in an FEB.

[0125] In all embodiments illustrated and described in Figures 20A to 35G, solid lines may be alternatively represented as dashed lines that do not form part of the design. In all embodiments of sensor control devices described in Figures 22A to 29G and 32A to 35G, adhesive patches may be alternatively represented as dashed lines when shown as solid lines, and adhesive patches may be represented as dashed or solid lines when not shown.

[0126] Various aspects of the subject matter of the present invention are described below with reference to and / or supplement to the embodiments described herein, with the interrelationships and interchangeability of the following embodiments to be emphasized. In other words, unless otherwise specified or unless logically inconceivable, each feature of these embodiments can be combined with any other feature.

[0127] In numerous exemplary embodiments, a method is provided for applying a medical device to a subject using an applicator, the method comprising: positioning the distal end of the applicator on the skin surface of the subject, wherein at least a portion of the distal end comprises a compressible material; applying force to the applicator to advance the medical device from a first position within the applicator to a second position adjacent to the skin surface, causing the distal end of the applicator to pull and flatten the portion of the skin surface adjacent to the applicator; and applying the medical device to the pulled and flattened portion of the skin surface.

[0128] In embodiments of these methods, the step of applying a force to the applicator may further include a step of displacing at least a compressible portion of the distal end of the applicator in a radially outward direction. The step of displacing at least a compressible portion of the distal end of the applicator may further include a step of generating a radially outward force on the portion of the skin surface adjacent to the applicator.

[0129] In embodiments of these methods, the step of applying the medical device to the stretched and flattened portion of the skin surface may further include the step of placing the adhesive surface on the skin surface.

[0130] In embodiments of these methods, the step of applying the medical device to the stretched and flattened portion of the skin surface may further include the step of positioning at least a portion of the analyte sensor beneath the skin surface. The analyte sensor may be an in vivo analyte sensor configured to measure the level of analyte in the body fluids of the subject.

[0131] In embodiments of these methods, at least a portion of the compressible distal end of the applicator can be biased in a radially inward direction, or at least a portion of the compressible distal end of the applicator can be biased in a radially outward direction.

[0132] In embodiments of these methods, the compressible portion of the distal end can be unloaded at the first position, and the compressible portion of the distal end can be loaded at the second position.

[0133] In embodiments of these methods, the compressible portion of the distal end of the applicator may include one or more legs or springs, or combinations thereof, of an elastomer, metal, plastic, or composite material.

[0134] In embodiments of these methods, the compressible cross-section of at least a portion of the distal end of the applicator may include a continuous ring or a discontinuous shape.

[0135] In embodiments of these methods, the distal end of the applicator can be configured to be detachable from the applicator.

[0136] In numerous exemplary embodiments, a device is provided comprising a medical device and an applicator including a distal end configured to be positioned on the skin surface of a subject, wherein at least a portion of the distal end comprises a compressible material, and in response to the application of force to the applicator: the medical device may be configured to advance from a first position within the applicator to a second position adjacent to the skin, the distal end of the applicator may be configured to pull and flatten a portion of the skin surface adjacent to the applicator, and the medical device may be further configured to be applied to the pulled and flattened portion of the skin surface.

[0137] In these embodiments of the device, at least one compressible portion of the distal end of the applicator can be configured to displace radially outward in response to the application of force to the applicator. The at least one compressible portion of the distal end of the applicator can further be configured to generate a radially outward force on the portion of the skin surface adjacent to the applicator.

[0138] In embodiments of these devices, the medical device may include an adhesive surface that can be configured to bond to the skin surface.

[0139] In embodiments of these devices, the medical device may include an analyte sensor, and at least a portion of the analyte sensor may be configured to be positioned below the skin surface. The analyte sensor may be an in vivo analyte sensor configured to measure the level of analyte in the body fluids of the subject.

[0140] In these embodiments of the device, at least a portion of the compressible part of the distal end of the applicator can be biased in a radially inward direction, or at least a portion of the compressible part of the distal end of the applicator can be biased in a radially outward direction.

[0141] In these embodiments of the device, at least a portion of the compressible distal end can be unloaded at the first position, and at least a portion of the compressible distal end can be loaded at the second position.

[0142] In embodiments of these devices, the compressible portion of the distal end of the applicator may include one or more legs or springs made of elastomer material, metal, plastic, or composite material, or a combination thereof.

[0143] In embodiments of these devices, the compressible cross-section of at least a portion of the distal end of the applicator may include a continuous ring or a discontinuous shape.

[0144] In these embodiments of the device, the distal end of the applicator can be configured to be detachable from the applicator.

[0145] In many embodiments, an assembly is provided for use within an applicator, the assembly comprising a sharp part module including a sharp portion and a hub portion, the sharp portion may include a sharp part shaft, a sharp part proximal end connected to the distal end of the hub portion, and a sharp part distal tip configured to penetrate the skin surface of a subject, the sharp part module may further include a plastic material.

[0146] In these assemblies, the sharp part shaft may include one or more filleted edges.

[0147] In these assemblies, the sharp component module may further include a thermoplastic material.

[0148] In these assemblies, the sharp component module may further include a polyetheretherketone material.

[0149] In these assemblies, the sharp part shaft may include an alignment ledge configured to prevent rotational movement of the sharp part module along its vertical axis during the insertion process. The alignment ledge can be positioned along the proximal portion of the sharp part shaft.

[0150] In embodiments of these assemblies, the assembly may further include an analyte sensor, which may be an in vivo analyte sensor configured to measure the level of an analyte in the body fluids of the subject. The distal end of the analyte sensor may be positioned proximal to the distal tip of the sharp component. The distal end of the analyte sensor and the distal tip of the sharp component may be located at the same position. At least a portion of the analyte sensor may be positioned within the sensor channel of the sharp component shaft.

[0151] In these assemblies, the sharp component module may further include a liquid crystal polymer material.

[0152] In these assemblies, the assembly may further include a lubricant placed on the outer surface of the sharp component module.

[0153] In these assemblies, the plastic material may include a lubricant.

[0154] In embodiments of these assemblies, the assembly may further include a sensor channel, at least a portion of which may be located at the distal portion of the sharp part shaft. The sensor channel may extend from the proximal portion of the sharp part shaft to the distal portion of the sharp part shaft. The sensor channel may be configured not to extend beyond the distal portion of the sharp part shaft. The proximal portion of the sharp part shaft may be hollow. The proximal portion of the sharp part shaft may be solid. The wall thickness of at least a portion of the proximal portion of the sharp part shaft may be greater than the wall thickness of the distal portion of the sharp part shaft.

[0155] In embodiments of these assemblies, the assembly may further include one or more rib structures adjacent to the hub portion, and these one or more rib structures may be configured to reduce the compressive load around the hub portion.

[0156] In numerous embodiments, a method is provided for preparing an analyte monitoring system, the method comprising: loading a sensor control device into a sensor applicator, the sensor control device comprising an electronic component housing, a printed circuit board positioned within the electronic component housing and including a processing circuit configuration, an analyte sensor extending from the bottom of the electronic component housing, and a sharp component module comprising a plastic material and detachably connected to the electronic component housing, the sharp component module comprising a sharp component, the sharp component extending through the electronic component housing and receiving a portion of the analyte sensor extending from the bottom of the electronic component housing; providing a barrier to seal the sensor control device within the sensor applicator by fixing a cap to the sensor applicator; and sterilizing the analyte sensor and the sharp component with radiation while the sensor control device is positioned within the sensor applicator.

[0157] In embodiments of these methods, the sensor control device may further include at least one shield positioned within the electronic component housing, and the method may further include the step of shielding the processing circuit configuration from radiation by the at least one shield during sterilization. The at least one shield may include a magnet, and the step of shielding the processing circuit configuration with the at least one shield may include: generating a static magnetic field using the magnet; and diverting the radiation away from the processing circuit configuration using the static magnetic field. The step of sterilizing the analyte sensor and the sharp parts with radiation may further include the step of sterilizing the analyte sensor and the sharp parts using an unfocused electron beam.

[0158] In embodiments of these methods, the analyte sensor may be an in vivo analyte sensor configured to measure the level of analyte in bodily fluids located within the subject's body.

[0159] In embodiments of these methods, the sharp component module may further include a thermoplastic material.

[0160] In embodiments of these methods, the sharp component module may further include a polyetheretherketone material.

[0161] In embodiments of these methods, the step of sterilizing the analyte sensor and the sharp parts may further include the step of focusing an electron beam onto the analyte sensor and the sharp parts.

[0162] In many embodiments, an assembly is provided for use within an applicator, the assembly comprising a sharp component module including a sharp portion and a hub portion, the sharp portion may include a sharp component shaft, a sharp component proximal end connected to the distal end of the hub portion, and a sharp component distal tip configured to penetrate the skin surface of a subject, the sharp portion may further include a metallic material and may be formed by a coining process.

[0163] In these assemblies, the sharp portions may further include stainless steel material.

[0164] In these assemblies, the sharp portion does not include a sharp edge.

[0165] In these assemblies, the sharp portion may include one or more rounded edges.

[0166] In these assemblies, the sharp part shaft may include one or more rounded edges.

[0167] In these assemblies, the sharp part shaft and the distal tip of the sharp part may include one or more rounded edges.

[0168] In embodiments of these assemblies, the assembly can further include an analyte sensor, and the analyte sensor can be an in-vivo analyte sensor configured to measure the level of an analyte in the subject's body fluid. The distal end of the analyte sensor can be in a proximal position relative to the distal tip of the sharp component. The distal end of the analyte sensor and the distal tip of the sharp component can be in the same position. At least a portion of the analyte sensor can be positioned within the sensor channel of the sharp component shaft.

[0169] In many embodiments, a method is provided for maintaining the structural integrity of a sensor control unit that includes an analyte sensor and a sensor module, the method comprising: positioning a distal sensor portion of the analyte sensor beneath the skin surface in contact with body fluid, the analyte sensor capable of including a proximal sensor portion coupled to the sensor module, the proximal sensor portion including a hook-shaped feature adjacent to a catch-shaped feature of the sensor module; receiving one or more forces in a proximal direction along the longitudinal axis of the analyte sensor; and engaging the hook-shaped feature with the catch-shaped feature to prevent displacement of the analyte sensor in the proximal direction along the longitudinal axis.

[0170] In embodiments of these methods, the method can further include loading the analyte sensor into the sensor module by laterally displacing the proximal sensor portion to bring the hook-shaped feature proximal to the catch-shaped feature of the sensor module. The step of laterally displacing the proximal sensor portion can include moving the proximal sensor portion into a clearance area of the sensor module.

[0171] In embodiments of these methods, the one or more forces can be generated by a sharp component extraction process.

[0172] In embodiments of these methods, the one or more forces can be generated by a physiological response to the analyte sensor.

[0173] In embodiments of these methods, the analyte sensor may be an in vivo analyte sensor configured to measure the level of analyte in the bodily fluids of the subject.

[0174] In numerous embodiments, a sensor control unit is provided, which includes: a sensor module including a catch-shaped feature portion; and an analyte sensor including a distal sensor portion and a proximal sensor portion, wherein the distal sensor portion can be positioned below the skin surface in contact with bodily fluids; the proximal sensor portion can be connected to the sensor module and may include a hook-shaped feature portion adjacent to the catch-shaped feature portion, the hook-shaped feature portion can engage with the catch-shaped feature portion to prevent displacement of the analyte sensor in the proximal direction along the longitudinal axis of the analyte sensor caused by one or more forces acting on the analyte sensor.

[0175] In these embodiments of the sensor control unit, the sensor module can be configured to receive the analyte sensor by displacing the proximal sensor portion laterally and bringing the hook-shaped feature portion proximal to the catch-shaped feature portion of the sensor module. The sensor module may further include a clearance area configured to receive the proximal sensor portion when the proximal sensor portion can be displaced laterally.

[0176] In these embodiments of the sensor control unit, the one or more of the above forces can be generated by a sharp part extraction process.

[0177] In these embodiments of the sensor control unit, the one or more forces can be generated by a physiological response to the analyte sensor.

[0178] In these embodiments of the sensor control unit, the analyte sensor may be an in vivo analyte sensor configured to measure the level of analyte in the bodily fluids of the subject.

[0179] In numerous embodiments, a method is provided for inserting an analyte sensor into the body of a subject using an applicator, the method comprising: positioning the distal end of the applicator on the skin surface, wherein the applicator includes a drive spring, a pull-out spring, a sensor electronic component carrier, a sharp component carrier, and the analyte sensor; applying a first force to the applicator to displace the drive spring the sensor electronic component carrier and the sharp component carrier from a first position within the applicator that is spaced apart from the skin surface to a second position adjacent to the skin surface, and positioning the sharp component of the sharp component carrier and a portion of the analyte sensor below the skin surface in contact with the subject's bodily fluids; and applying a second force to the applicator to displace the pull-out spring the sharp component carrier from the second position to a third position within the applicator, and pulling the sharp component away from the skin surface.

[0180] In embodiments of these methods, the step of applying the first force may include a step of applying the force distally, and the step of applying the second force may include a step of applying the force proximally.

[0181] In embodiments of these methods, the applicator may further include a launch pin and a sheath, and the step of applying the first force to the applicator may further cause the launch pin to disengage one or more sheath stubs of the sheath from one or more sensor electronic component carrier latches of the sensor electronic component carrier, and extend the drive spring. The drive spring may be preloaded before the step of applying the first force, and the drive spring extends distally by disengaging the one or more sheath stubs. The step of applying the first force to the applicator increases the load on the drive spring before causing the launch pin to disengage the one or more sheath stubs. The drive spring may be preloaded before the step of applying the first force, and the drive spring may include a first end connected to the launch pin and a second end connected to the sensor electronic component carrier.

[0182] In embodiments of these methods, the applicator may further include a sensor control unit connected to the sensor electronic component carrier, the distal portion of which can contact the skin surface at the second position. The step of displacing the sensor electronic component carrier and the sharp component carrier from the first position to the second position may include the step of moving one or more sensor electronic component carrier tabs of the sensor electronic component carrier distally along one or more sheath rails of the sheath. One or more sensor electronic component carrier bumpers of the sensor electronic component carrier can be biased against the inner surface of the sheath while the sensor electronic component carrier and the sharp component carrier are being displaced from the first position to the second position.

[0183] In embodiments of these methods, the step of applying the second force further disengages the plurality of sensor electronic component carrier lock arms of the sensor electronic component carrier from the sharp component carrier and extends the extraction spring. The step of disengaging the plurality of sensor electronic component carrier lock arms from the sharp component carrier may include the step of positioning the plurality of sensor electronic component carrier lock arms within a plurality of sheath notches of the sheath. Each of the plurality of sensor electronic component carrier lock arms can be biased in a radially outward direction, and the sheath notches can be configured to extend the plurality of sensor electronic component carrier lock arms in a radially outward direction. The extraction spring can be preloaded before the step of applying the second force, and the step of disengaging the plurality of sensor electronic component carrier lock arms extends the extraction spring proximally.

[0184] In embodiments of these methods, the extraction spring may be preloaded before the step of applying the second force, and the extraction spring may include a first end connected to the sharp component carrier and a second end connected to the sensor electronic component carrier.

[0185] In embodiments of these methods, the step of applying the second force further involves the drive spring displacing the sensor electronic component carrier toward the bottom portion of the applicator.

[0186] In embodiments of these methods, the analyte sensor may be an in vivo analyte sensor configured to measure the level of analyte in the bodily fluids of the subject.

[0187] In numerous embodiments, an applicator is provided for inserting an analyte sensor into the body of a subject, the applicator comprising: a drive spring; a withdrawal spring; a sensor electronic component carrier; a sharp component carrier connected to a sharp component; and the analyte sensor, wherein the drive spring can be configured to displace the sensor electronic component carrier and the sharp component carrier from a first position within the applicator, spaced apart from the skin surface, to a second position adjacent to the skin surface, the sharp component and a portion of the analyte sensor can be positioned at the second position below the skin surface, in contact with the subject's bodily fluids, and the withdrawal spring can be configured to displace the sharp component carrier from the second position to a third position within the applicator, and to withdraw the sharp component from the skin surface, when a second force is applied to the applicator.

[0188] In these applicator embodiments, the application of the first force may include the application of a force in the distal direction, and the application of the second force may include the application of a force in the proximal direction.

[0189] In these embodiments of the applicator, the applicator may further include a launch pin and a sheath, the launch pin being configured to disengage one or more sheath stubs of the sheath from one or more sensor electronic component carrier latches of the sensor electronic component carrier and to extend a drive spring when the first force is applied. The drive spring may be preloaded before the first force is applied, and may be configured to extend distally in response to the disengagement of the one or more sheath stubs from the one or more sensor electronic component carrier latches. The drive spring may be configured to receive an increased load before the launch pin disengages the one or more sheath stubs. The drive spring may be preloaded before the first force is applied, and may include a first end connected to the launch pin and a second end connected to the sensor electronic component carrier.

[0190] In embodiments of these applicators, the applicator can further include a sensor control unit coupled to the sensor electronics carrier, and a distal portion of the sensor control unit can be configured to contact the skin surface at the second position.

[0191] In embodiments of these applicators, the applicator can further include one or more sensor electronics carrier tabs of the sensor electronics carrier, which are configured to move distally along one or more sheath rails of the sheath between the first position and the second position.

[0192] In embodiments of these applicators, the applicator can further include one or more sensor electronics carrier bumpers of the sensor electronics carrier, which can be configured to be biased against the inner surface of the sheath between the first position and the second position.

[0193] In these embodiments of the applicator, the applicator may further include a plurality of sensor electronic component carrier lock arms of the sensor electronic component carrier, which may be configured to disengage from the sharp component carrier and extend the extraction spring in response to the application of the second force. The applicator may further include a plurality of sheath notches of the sheath, which may be configured to receive the plurality of sensor electronic component carrier lock arms and disengage the sensor electronic component carrier lock arms from the sharp component carrier. Each of the plurality of sensor electronic component carrier lock arms may be biased in a radially outward direction, and the sheath notches may be configured to extend the plurality of sensor electronic component carrier lock arms in a radially outward direction. The extraction spring may be preloaded before the application of the second force, and the extraction spring may be configured to extend proximally when the plurality of sensor electronic component carrier lock arms are disengaged from the sharp component carrier.

[0194] In these applicator embodiments, the extraction spring can be preloaded before the application of the second force, and the extraction spring may include a first end connected to the sharp component carrier and a second end connected to the sensor electronic component carrier.

[0195] In these applicator embodiments, the drive spring can be further configured to displace the sensor electronic component carrier toward the bottom portion of the applicator in response to the application of the second force.

[0196] In these applicator embodiments, the analyte sensor may be an in vivo analyte sensor configured to measure the level of analyte in the bodily fluids of the subject.

[0197] In numerous embodiments, an assembly is provided for use within an applicator, the assembly comprising a sharp component module including a sharp portion and a hub portion, the sharp portion may include a sharp component shaft, a sharp component proximal end connected to the hub portion, and a sharp component distal tip configured to penetrate the skin surface of a subject, the sharp component shaft comprising a sensor channel configured to receive at least a portion of an analyte sensor, the sensor channel may be spaced apart from the sharp component distal tip, and the sharp component distal tip comprising an offset tip portion configured to form an opening in the skin surface.

[0198] In these assemblies, the sharp component module may further include stainless steel material.

[0199] In these assemblies, the sharp component module may further include plastic material.

[0200] In these assemblies, the offset tip portion can be further configured to prevent damage to the sensor tip portion of the analyte sensor during the sensor insertion process.

[0201] In these assemblies, the cross-sectional area of ​​the offset tip portion can be made smaller than the cross-sectional area of ​​the sharp part shaft.

[0202] In these assemblies, the offset tip portion may include a separate element connected to the sharp part shaft.

[0203] In embodiments of these assemblies, the sensor channel may include one or more sidewalls of the sharp component shaft. The offset tip portion may be formed from a portion of the one or more sidewalls of the sharp component shaft. The sensor channel may include a first sidewall and a second sidewall, the offset tip portion may be formed from the end of the first sidewall of the sharp component shaft, and the end of the second sidewall may be proximal to the end of the first sidewall.

[0204] In numerous embodiments, a method is provided for manufacturing an analyte monitoring system, the method comprising: sterilizing a sensor subassembly including a sensor and sharp parts; assembling the sterilized sensor subassembly into a sensor control device; assembling the sensor control device into an applicator; and packaging the applicator containing the sensor control device for distribution.

[0205] In embodiments of these methods, the sensor control device may be as shown or substantially shown in any of Figures 20A to 21G.

[0206] In embodiments of these methods, the applicator may be as shown or substantially as shown in any of Figures 22A to 29G.

[0207] In numerous embodiments, a method for manufacturing an analyte monitoring system is provided, the method comprising: the steps of: assembling a sensor control device including sensors and sharp parts; installing the sensor control device in an applicator; sterilizing the applicator containing the sensor control device with a focused electron beam; and packaging the applicator containing the sensor control device for distribution.

[0208] In embodiments of these methods, the sensor control device may be as shown or substantially shown in any of Figures 30A to 31G.

[0209] In embodiments of these methods, the applicator may be as shown or substantially as shown in any of Figures 32A to 35G.

[0210] It should be noted that all features, elements, components, functions, and steps described in relation to any embodiment provided herein are intended to be freely combined and substituted with features, elements, components, functions, and steps from any other embodiment. If a particular feature, element, component, function, or step is described in relation to only one embodiment, it should be understood that, unless otherwise specified, that feature, element, component, function, or step can be used with all other embodiments described herein. Therefore, this paragraph serves as prior foundation and codified support for introducing claims that combine features, elements, components, functions, and steps from multiple different embodiments, or replace features, elements, components, functions, and steps from one embodiment with those from another, even if such combinations or substitutions are not explicitly stated in the following description in a particular example. It is clearly acknowledged that an explicit enumeration of all possible combinations and substitutions would be an undue burden, especially when a person skilled in the art would readily recognize that all such combinations and substitutions are permissible.

[0211] These embodiments allow for various modifications and alternative forms, specific examples of which are illustrated in the drawings and described in detail herein. However, it should be understood that these embodiments are not limited to any particular form disclosed, but rather encompass all modifications, equivalents, and alternatives that fall within the spirit of this disclosure. Furthermore, any features, functions, steps, or elements of these embodiments may be enumerated or added to the claims, and negative limitations that define the scope of the claimed invention by features, functions, steps, or elements that fall outside that scope may also be enumerated or added to the claims.

[0212] Preferred embodiments of the present invention are described below in separate sections.

[0213] Embodiment 1 An assembly for use within an applicator, The aforementioned assembly is: A sharp component module comprising a sharp portion and a hub portion, wherein the sharp portion comprises a sharp component shaft, a sharp component proximal end connected to the distal end of the hub portion, and a sharp component distal tip configured to penetrate the skin surface of a subject. Equipped with, The aforementioned sharp portion further includes a metal material and is formed by a coining process, in the assembly.

[0214] Embodiment 2 The assembly according to Embodiment 1, wherein the sharp portion further comprises stainless steel material.

[0215] Embodiment 3 The assembly according to Embodiment 1, wherein the sharp portion does not have a sharp edge.

[0216] Embodiment 4 The assembly according to Embodiment 1, wherein the sharp portion comprises one or more rounded edges.

[0217] Embodiment 5 The assembly according to Embodiment 1, wherein the sharp part shaft has one or more rounded edges.

[0218] Embodiment 6 The assembly according to Embodiment 1, wherein the sharp part shaft and the distal tip of the sharp part are provided with one or more rounded edges.

[0219] Embodiment 7 The assembly further includes an analyzer sensor, The assembly according to Embodiment 1, wherein the analyte sensor is an in vivo analyte sensor configured to measure the level of an analyte in the body fluids of the subject.

[0220] Embodiment 8 The assembly according to Embodiment 7, wherein the distal end of the analyte sensor is located proximal to the distal tip of the sharp component.

[0221] Embodiment 9 The assembly according to Embodiment 7, wherein the distal end of the analyte sensor and the distal tip of the sharp part are located at the same position.

[0222] Embodiment 10 The assembly according to Embodiment 7, wherein at least a portion of the analyzer sensor is positioned within the sensor channel of the sharp component shaft.

[0223] Embodiment 11 A method for maintaining the structural integrity of a sensor control unit comprising an analyte sensor and a sensor module, The aforementioned method is: A step of positioning the distal sensor portion of the analyte sensor below the skin surface in contact with bodily fluids, wherein the analyte sensor comprises a proximal sensor portion connected to the sensor module, and the proximal sensor portion includes a hook-shaped feature portion adjacent to the catch-shaped feature portion of the sensor module; The step of receiving one or more forces in the proximal direction along the longitudinal axis of the analyte sensor; and The step of engaging the hook-shaped feature portion with the catch-shaped feature portion to prevent the analyte sensor from being displaced in the proximal direction along the longitudinal axis. Methods that include...

[0224] Embodiment 12 The method according to Embodiment 11, further comprising the step of loading the analyte sensor into the sensor module by displacing the proximal sensor portion laterally so that the hook-shaped feature portion is proximal to the catch-shaped feature portion of the sensor module.

[0225] Embodiment 13 The method according to Embodiment 12, wherein the step of displacing the proximal sensor portion laterally includes the step of moving the proximal sensor portion into the clearance area of ​​the sensor module.

[0226] Embodiment 14 The method according to Embodiment 11, wherein the one or more forces are generated by a sharp part extraction process.

[0227] Embodiment 15 The method according to Embodiment 11, wherein the one or more forces are generated by a physiological response to the analyte sensor.

[0228] Embodiment 16 The method according to Embodiment 11, wherein the analyte sensor is an in vivo analyte sensor configured to measure the level of analyte in the body fluids of the subject.

[0229] Embodiment 17 A sensor control unit, The aforementioned sensor control unit is: Sensor module including catch-shaped feature portion; and An analyte sensor comprising a distal sensor portion and a proximal sensor portion, wherein the distal sensor portion is configured to be positioned below the skin surface in contact with bodily fluids, and the proximal sensor portion is connected to the sensor module and has a hook-shaped feature portion adjacent to a catch-shaped feature portion, Equipped with, A sensor control unit wherein the hook-shaped feature portion engages with the catch-shaped feature portion to prevent displacement of the analyte sensor in the proximal direction along the longitudinal axis of the analyte sensor, caused by one or more forces acting on the analyte sensor.

[0230] Embodiment 18 The sensor control unit according to Embodiment 17 is configured to receive the analyte sensor by displacing the proximal sensor portion laterally and bringing the hook-shaped feature portion proximal to the catch-shaped feature portion of the sensor module.

[0231] Embodiment 19 The sensor control unit according to embodiment 18, further comprising a clearance area configured to receive the proximal sensor portion when the proximal sensor portion is displaced laterally.

[0232] Embodiment 20 The sensor control unit according to Embodiment 17, wherein the one or more forces are generated by a sharp part extraction process.

[0233] Embodiment 21 The sensor control unit according to Embodiment 17, wherein the one or more forces are generated by a physiological response to the analyte sensor.

[0234] Embodiment 22 The sensor control unit according to Embodiment 17, wherein the analyte sensor is an in vivo analyte sensor configured to measure the level of analyte in the body fluids of the subject.

[0235] Embodiment 23 An applicator for inserting an analyte sensor into a subject, Drive spring, Pulling spring, Sensor electronic component carrier, A sharp parts carrier equipped with sharp parts, and Includes an analyte sensor, The drive spring is configured to displace the sensor electronic component carrier and the sharp component carrier from a first position within the applicator, which is spaced apart from the skin surface, to a second position adjacent to the skin surface, where the sharp portion and a portion of the analyte sensor are positioned below the skin surface at the second position, in contact with the subject's bodily fluids, and An applicator configured such that the extraction spring displaces the sharp part carrier from the second position to a third position within the applicator, thereby drawing the sharp part away from the skin surface by applying a second force to the applicator.

[0236] Embodiment 24 The applicator according to Embodiment 23, wherein the application of the first force includes the application of a force in the distal direction, and the application of the second force includes the application of a force in the proximal direction.

[0237] Embodiment 25 The applicator according to Embodiment 23, further comprising a launch pin and a sheath, wherein the launch pin is configured to, upon application of the first force, disengage one or more sheath stubs of the sheath from one or more sensor electronic component carrier latches of the sensor electronic component carrier, thereby extending the drive spring.

[0238] Embodiment 26 The applicator according to Embodiment 25, wherein the drive spring is in a preloaded state before the application of the first force, and is configured to extend distally by disengaging one or more sheath stubs from one or more sensor electronic component carrier latches.

[0239] Embodiment 27 The applicator according to embodiment 25, wherein the drive spring is subjected to an increased load before the launch pin disengages from the one or more sheath stubs.

[0240] Embodiment 28 The applicator according to Embodiment 25, wherein the drive spring is in a preloaded state before the application of the first force and includes a first end connected to the launch pin and a second end connected to the sensor electronic component carrier.

[0241] Embodiment 29 The applicator according to embodiment 25, further comprising one or more sensor electronic component carrier tabs of the sensor electronic component carrier configured to move distally along one or more sheath rails of the sheath between the first position and the second position.

[0242] Embodiment 30 The applicator according to embodiment 25, further comprising one or more sensor electronic component carrier bumpers of the sensor electronic component carrier configured to bias the inner surface of the sheath between the first position and the second position.

[0243] Embodiment 31 The applicator according to embodiment 23, further comprising a sensor control unit connected to the sensor electronic component carrier, wherein the distal portion of the sensor control unit is configured to contact the skin surface at the second position.

[0244] Embodiment 32 The applicator according to Embodiment 23, further comprising a plurality of sensor electronic component carrier locking arms of the sensor electronic component carrier, the sensor electronic component carrier locking arms being configured to disengage from the sharp component carrier and to extend the pull-out spring upon application of the second force.

[0245] Embodiment 33 The applicator according to embodiment 32, further comprising a plurality of sheath notches in the sheath, the plurality of sheath notches configured to receive the plurality of sensor electronic component carrier lock arms and to disengage the sensor electronic component carrier lock arms from the sharp component carrier.

[0246] Embodiment 34 The applicator according to embodiment 33, wherein each of the plurality of sensor electronic component carrier lock arms is biased in a radially outward direction, and the sheath notch is configured to allow the plurality of sensor electronic component carrier lock arms to extend in a radially outward direction.

[0247] Embodiment 35 The applicator according to embodiment 32, wherein the extraction spring is in a preloaded state before the application of the second force, and the extraction spring is configured to extend proximally when the plurality of sensor electronic component carrier lock arms disengage from the sharp component carrier.

[0248] Embodiment 36 The applicator according to Embodiment 23, wherein the extraction spring is in a preloaded state before the application of the second force, and the extraction spring includes a first end connected to the sharp component carrier and a second end connected to the sensor electronic component carrier.

[0249] Embodiment 37 The applicator according to embodiment 23, wherein the drive spring is configured to displace the sensor electronic component carrier toward the bottom portion of the applicator upon application of the second force.

[0250] Embodiment 38 The applicator according to Embodiment 23, wherein the analyte sensor is an in vivo analyte sensor configured to measure the level of an analyte in the body fluids of the subject.

[0251] Embodiment 39 A method for inserting an analyte sensor into a subject using an applicator, A step of positioning the distal end of an applicator on the skin surface, wherein the applicator comprises a drive spring, a pull spring, a sensor electronic component carrier, a sharp component carrier, and an analyzer sensor. The steps include: applying a first force to the applicator, displacing the sensor electronic component carrier and the sharp component carrier by the drive spring from a first position within the applicator that is spaced apart from the skin surface to a second position adjacent to the skin surface, thereby positioning the sharp portion of the sharp component carrier and a portion of the analyte sensor below the skin surface in contact with the subject's bodily fluids; and The step of applying a second force to the applicator, thereby displacing the sharp part carrier from the second position to a third position within the applicator by the extraction spring, and pulling the sharp part carrier away from the skin surface. Methods that include...

[0252] Embodiment 40 The method according to Embodiment 39, wherein the application of the first force includes the application of a force in the distal direction, and the application of the second force includes the application of a force in the proximal direction.

[0253] Embodiment 41 The method according to Embodiment 39, wherein the applicator further comprises a firing pin and a sheath, and by applying a first force to the applicator, the firing pin disengages one or more sheath stubs of the sheath from one or more sensor electronic component carrier latches of the sensor electronic component carrier, thereby extending a drive spring.

[0254] Embodiment 42 The method according to Embodiment 41, wherein the drive spring is in a pre-loaded state before the application of the first force, and the drive spring is extended distally by disengaging one or more sheath stubs.

[0255] Embodiment 43 The method according to embodiment 41, wherein the load on the drive spring is increased by the application of the first force before the launch pin disengages from the one or more sheath stubs.

[0256] Embodiment 44 The method according to Embodiment 41, wherein the drive spring is in a pre-loaded state before the application of the first force and includes a first end connected to the launch pin and a second end connected to the sensor electronic component carrier.

[0257] Embodiment 45 The method according to Embodiment 39, wherein the applicator further includes a sensor control unit connected to the sensor electronic component carrier, the distal portion of the sensor control unit in contact with the skin surface at the second position.

[0258] Embodiment 46 The method according to Embodiment 41, wherein one or more sensor electronic component carrier tabs of the sensor electronic component carrier move distally along one or more sheath rails of the sheath, thereby displacing the sensor electronic component carrier and the sharp component carrier from a first position to a second position.

[0259] Embodiment 47 The method according to Embodiment 41, wherein, while the sensor electronic component carrier and the sharp component carrier are displaced from the first position to the second position, one or more sensor electronic component carrier bumpers of the sensor electronic component carrier bias against the inner surface of the sheath.

[0260] Embodiment 48 The method according to Embodiment 39, wherein the application of the second force disengages the plurality of sensor electronic component carrier lock arms of the sensor electronic component carrier from the sharp component carrier, thereby extending the pull-out spring.

[0261] Embodiment 49 The method according to Embodiment 48, wherein the plurality of sensor electronic component carrier lock arms are positioned in a plurality of sheath notches of the sheath, and the plurality of sensor electronic component carrier lock arms are disengaged from the sharp component carrier.

[0262] Embodiment 50 The method according to embodiment 49, wherein each of the plurality of sensor electronic component carrier lock arms is biased in a radially outward direction, and the sheath notch is configured to allow the plurality of sensor electronic component carrier lock arms to extend in a radially outward direction.

[0263] Embodiment 51 The method according to Embodiment 48, wherein the extraction spring is in a pre-loaded state before the application of the second force, and the extraction spring is extended in the proximal direction by disengaging the plurality of sensor electronic component carrier lock arms.

[0264] Embodiment 52 The method according to Embodiment 39, wherein the extraction spring is in a pre-loaded state before the application of the second force, and the extraction spring includes a first end connected to the sharp component carrier and a second end connected to the sensor electronic component carrier.

[0265] Embodiment 53 The drive spring displaces the sensor electronic component carrier toward the bottom portion of the applicator by the application of the second force, as described in Embodiment 39.

[0266] Embodiment 54 The method according to embodiment 39, wherein the analyte sensor is an in vivo analyte sensor configured to measure the level of analyte in the body fluids of the subject. [Explanation of symbols]

[0267] 100 Analytical Substance Monitoring System 102 Sensor control devices 104 Sensors, Analytical Sensors, In Vivo Analytical Sensors 105 Adhesive Patches 120 Reader Devices 121 Input, Input Components 122 screens, displays 123 Power Ports 140-144 Communication paths 150 Sensor Applicators 160 Sensor Electronic Components 161 Semiconductor chips, ASICs 162 Analog Front-End (AFE), Semiconductor Chips 163, 165, 223, 225, 230 memory 164 Power Management (or Control) Circuit Configuration 166 processors 168 Communication Circuit Configuration 170 Local Computer System 170 Power supply 171, 229, 234 antennas 174 Semiconductor Chips 180 Reliable Computer Systems 190 Networks 206 processing cores 207 Plug Assembly 221 Target monitoring position 222 Communication Processors 224 Application Processors 226 Power supply 228 RF Transceiver 232 Multifunctional Transceiver 238 Power Management Modules 502 Desiccant 504 Sensor Module 702 Applicator Housing 704 Sheath 706 Electronic component housing 708 Applicator cap, screw cap, cap 710 Sensor Electronic Component Carrier 808 Platform 810 Sensor Container, Sensor Tray 812 Lid, sterile lid 1302 Feature section for housing orientation 1304 Tampering groove 1306 Tampering Retainer 1310 Housing thread 1314 Tampering Protector 1316 Side grip zone 1318 Grip protrusion 1320 Shark tooth-like projections 1321 Housing guide structure, guide rib, housing guide rib, structure 1322 Insertion hard stop 1326 Guide edge, sheath guide rail 1327 Carrier Interface Post 1328 Sensor Electronic Component Carrier Interface 1330 Features for introducing sheath snap 1332 Lock groove 1334 Unlock groove 1336 Final lockout groove, final lockout recess 1338 Sheath stop lamp 1340 Structure, Rock Rib 1344 Launching Detent 1346 Central axis 1402 Detent Snap 1404 Detent snap curved surface portion 1406 Detent Snap Flat Section 1408 Detent Snap Bridge 1410 Detent clearance 1412 Lock Arm 1414 Reinforcement ribs for lock arms 1416 Lock Arm Interface 1418 Guide Rail 1420 Sensor Electronic Component Carrier Movement Limiter Surface 1422 Detent snap reinforcement feature 1424 Alignment notches 1426 Reinforcement ribs 1428 Housing guide rail clearance 1436 Detent Base 1446 Rear wall of guide rail 1448 Sheath Rotation Limiter 1450 Compressible distal end 1451 Octagonal Geometry 1452 Star-shaped geometry 1453 Discrete ring-shaped geometry 1454 Discontinuous rectangular geometry 1502 Lock Interface 1506 RPM limiter 1510 Aperture 1516 Spring alignment ridge 1518 Spring arm for holding sensor electronic components 1519 Detent 1524 Sharp parts carrier lock arm 1526 Detent or retaining feature portion 1534 Shock Lock 1608 Anti-rotation slot 1610 Sharp parts carrier base chamfered section 1618 Sharp parts holding arm 1620 Clip for holding sharp parts 1622 Sharp parts hub contact surface 1834 Holding arm extension 2200 modules 2202 Module Snap 2208 Sharp parts slot 2212 Senseledge 2216 Sensor Wall 2300 connector 2302 Conductive Contact 2304 Sealing surface 2308 Hinge 2404 Flag 2406 Neck 2408 Tail 2412 Tsukesei Tower 2414 Biased support point 2416 Force Adjuster 2418 Contact 2420 Service Loop 2500 Sharp Parts Module 2502 Sharp parts, metal sharp parts 2504 Sharp Shaft Parts 2506 Distal tip, sharp parts Distal tip 2508 Hub pressing cylinder 2512 Hub Small Cylinder 2514 Cylinder for positioning claws for hub snap fitting 2516 Hub snap fitting claw part 2545 Vertical axis 2550 Plastic Sharp Parts Module 2554 Sharp Shaft Parts 2556 Sharp part distal tip 2558 sensor channels 2562 Hub 2568 Alignment feature section 2570 Plastic Sharp Parts Module 2574 Sharp Shaft Parts 2575 Proximal portion 2576 Sharp part distal tip 2577 Distal portion 2578 Sensor Channels 2582 Hub, sharp parts hub section 2602 Cast Sharp Parts 2606 Sharp part distal tip 2620 Sharp Parts Module 2624 Sharp Shaft Parts 2626 Distal tip 2627 Offset tip 2628 sensor channels 2629 Side wall 2632 Hub 2644 Sharp Shaft Parts 2646 Distal tip 2647 Offset tip 2648 sensor channels 2649a First side wall 2649b Second side wall 2652 Hub 3104 Sensor 3106 Hook-shaped feature 3504 Sensor Module 3506 Catch-shaped feature 3508 Clearance Area 4150 Powered Applicator 4524 Sensor Electronic Component Carrier Lock Arm 4602 Sharp parts carrier 4603 Sensor Electronic Component Carrier Latch 4604 Extraction spring 4605 Sensor Electronic Component Carrier Tab 4606 Drive spring 4607 Sensor Electronic Component Carrier Bumper 4702 Housing 4704 Sheath 4705 Launch pin 4706 Sea Stub 4707 Sheath Rail 4708 Sea Snotch 4710 Sensor Electronic Component Carrier

Claims

1. An applicator for inserting an analyte sensor into a subject, Drive spring, Pulling spring, Sensor electronic component carrier, A sharp parts carrier equipped with sharp edges. Launch pin, Sheath, and Includes an analyte sensor, The launch pin is configured such that, upon application of a first force, one or more sheath stubs of the sheath are disengaged from one or more sensor electronic component carrier latches of the sensor electronic component carrier, thereby extending the drive spring. The drive spring is configured to displace the sensor electronic component carrier and the sharp component carrier from a first position within the applicator, which is spaced apart from the skin surface, to a second position adjacent to the skin surface, where the sharp portion and a portion of the analyte sensor are positioned below the skin surface at the second position, in contact with the subject's bodily fluids, and An applicator configured such that the extraction spring displaces the sharp part carrier from the second position to the third position within the applicator, thereby extracting the sharp portion from the skin surface.

2. The applicator according to claim 1, wherein the application of the first force includes the application of a force in the distal direction, and the application of the second force includes the application of a force in the proximal direction.

3. The applicator according to claim 1, wherein the drive spring is in a preloaded state before the application of the first force, and is configured to extend distally by disengaging one or more sheath stubs from one or more sensor electronic component carrier latches.

4. The applicator according to claim 1, wherein the drive spring is subjected to an increased load before the launch pin disengages from the one or more sheath stubs.

5. The applicator according to claim 1, wherein the drive spring is in a preloaded state before the application of the first force and includes a first end connected to the launch pin and a second end connected to the sensor electronic component carrier.

6. The applicator according to claim 1, further comprising one or more sensor electronic component carrier tabs of the sensor electronic component carrier, configured to move distally along one or more sheath rails of the sheath between the first position and the second position.

7. The applicator according to claim 1, further comprising one or more sensor electronic component carrier bumpers of the sensor electronic component carrier, configured to bias the inner surface of the sheath between the first position and the second position.

8. The applicator according to claim 1, further comprising a sensor control unit connected to the sensor electronic component carrier, wherein the distal portion of the sensor control unit is configured to contact the skin surface at the second position.

9. The applicator according to claim 2, further comprising a plurality of sensor electronic component carrier locking arms of the sensor electronic component carrier, wherein the sensor electronic component carrier locking arms are configured to disengage from the sharp component carrier and extend the pull-out spring upon application of the second force.

10. The applicator according to claim 9, further comprising a plurality of sheath notches in the sheath, the plurality of sheath notches configured to receive the plurality of sensor electronic component carrier lock arms and to disengage the sensor electronic component carrier lock arms from the sharp component carrier.

11. The applicator according to claim 10, wherein each of the plurality of sensor electronic component carrier lock arms is biased in a radially outward direction, and the sheath notch is configured to allow the plurality of sensor electronic component carrier lock arms to extend in a radially outward direction.

12. The applicator according to claim 9, wherein the withdrawal spring is in a preloaded state before the application of the second force, and the withdrawal spring is configured to extend proximally when the plurality of sensor electronic component carrier lock arms disengage from the sharp component carrier.

13. The applicator according to claim 2, wherein the extraction spring is in a pre-loaded state before the application of the second force, and the extraction spring includes a first end connected to the sharp component carrier and a second end connected to the sensor electronic component carrier.

14. The applicator according to claim 2, wherein the drive spring is configured to displace the sensor electronic component carrier toward the bottom portion of the applicator upon application of the second force.

15. The applicator according to claim 1, wherein the analyte sensor is an in vivo analyte sensor configured to measure the level of an analyte in the body fluid of the subject.

16. The applicator according to claim 1, further comprising a sensor control device including a sensor electronic component and the analyte sensor, wherein the analyte sensor includes a proximal portion configured to electrically contact the sensor electronic component and the sensor electronic component, and a distal portion configured to be located beneath the skin of a subject and to be in contact with the subject's bodily fluids, the distal portion configured to detect an analyte in the bodily fluids at the second position.

Images