Analyte monitoring systems, devices and methods

Abstract

Systems, devices and methods are provided for inserting at least a portion of an in vivo analyte sensor for sensing an analyte level in a bodily fluid of a subject. In particular, various embodiments of applicators and components thereof designed to reduce trauma to tissue at the sensor insertion site and increase the likelihood of successful sensor insertion are disclosed.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of priority to U.S. Provisional Patent Application No. 63 / 296,262, filed January 4, 2022, which is expressly incorporated by reference in its entirety into this application for all purposes. [Technical field]

[0002] The subject matter described herein relates generally to in vivo analyte monitoring systems, devices and methods. [Background technology]

[0003] Detecting and / or monitoring the levels of analytes such as glucose, ketones, lactate, oxygen, hemoglobin A1C, etc., can be very important to the overall health of a person, especially a diabetic patient. Patients suffering from diabetes can experience complications including loss of consciousness, cardiovascular disease, retinopathy, neuropathy, and nephropathy. Generally, diabetic patients need to monitor their glucose levels to ensure they are maintained within a clinically safe range, and can use this information to determine if and / or when insulin is needed to lower glucose levels in the body, or when additional glucose is needed to raise glucose levels in the body.

[0004] A growing body of clinical data indicates that there is a strong correlation between glucose monitoring frequency and glycemic control. However, despite such correlation, many individuals diagnosed with a diabetic condition do not monitor their glucose levels as frequently as they should due to a combination of factors including the convenience, discretion of testing, pain associated with glucose testing, and cost.

[0005] Devices have been developed for automated monitoring of analytes, such as glucose, in bodily fluids, such as bloodstream, interstitial fluid ("ISF"), or other biological fluids. Some of these analyte measurement devices are configured such that at least a portion of the device is placed beneath the surface of a user's skin, e.g., in a blood vessel or subcutaneous tissue of the user, to provide in vivo monitoring. Summary of the Invention [Problem to be solved by the invention]

[0006] As analyte monitoring devices and systems continue to be developed, there is a need for analyte monitoring devices, systems and methods, and manufacturing processes for analyte monitoring devices and systems, that provide cost-effective, convenient, and discreet monitoring to encourage frequent analyte monitoring to improve glycemic control. Additionally, there is a need for analyte monitoring devices, systems and methods that reduce the pain and trauma associated with analyte monitoring and testing.

[0007] Current sensors, while convenient for users, are also prone to malfunction. Such malfunctions can occur due to user error, lack of proper training, lack of user coordination, overly complicated procedures, and physiological reactions to the inserted sensor. This is especially true for analyte monitoring systems that have sensors that are inserted with a sharp tip (also known as an "introducer" or "needle") and used to measure analyte levels in the ISF. Furthermore, some conventional systems use sharp tips that can cause trauma to the surrounding tissue at the sensor insertion site, which can lead to inaccurate analyte level measurements. These and other problems described herein can lead to failure to properly monitor a patient's analyte levels.

[0008] Thus, there is a need for sensor insertion devices, systems and methods that are reliable, easy for the patient to use, less prone to error, and that reduce insertion site trauma. [Means for solving the problem]

[0009] Provided herein are exemplary embodiments of systems, devices, and methods for assembling and using an applicator and a sensor control unit of an in vivo analyte monitoring system. The applicator may be provided to a user in a sterile package that contains the electronics housing of the sensor control unit. According to some embodiments, a structure other than the applicator, such as a knife, may also be provided to a user in a sterile package that contains a sensor module and a sharpened tip module. The user may couple the sensor module to the electronics housing and further couple the sharpened tip to the applicator in an assembly process that includes inserting the applicator into a container in a particular manner. In other embodiments, the applicator, the sensor control unit, the sensor module, and the sharpened tip module may be provided in a single package. In some embodiments, the applicator includes a sensor having a sharpened or V-shaped tip and / or a sharpened tip having a V-shaped cross-sectional area. The V-shaped sensor and V-shaped sharpened tip described herein are configured to minimize skin penetration and puncture size upon sensor insertion. In some embodiments, the applicator is tipless and therefore does not include a tip or a tip module. In tipless applicator embodiments described herein, the sensor can be configured to provide the necessary physical characteristics to enhance insertion effectiveness.

[0010] An applicator may be used to place the sensor control device on the human body with the sensor in contact with the wearer's bodily fluids. The embodiments provided herein provide improvements to prevent or reduce the likelihood that the sensor will cause an adverse physiological response. Other improvements and advantages are also provided. Various configurations of these devices are described in detail in the embodiments, but are by way of example only.

[0011] Other systems, devices, methods, features, and advantages of the subject matter described herein will be or become apparent to one of ordinary skill in the art upon examination of the following drawings and detailed description. All such additional systems, devices, methods, features, and advantages are intended to be included herein, be within the scope of the subject matter described herein, and be protected by the accompanying claims. No features of the example embodiments are intended to be construed as limiting the appended claims, unless expressly recited in the claims.

[0012] Details of the subject matter presented herein, both in structure and operation, will be apparent from a consideration of the accompanying drawings, in which like reference numerals refer to like parts. The components shown in the drawings are not necessarily to scale, emphasis instead being placed upon illustrating the principles of the subject matter. Moreover, all drawings are intended to convey concepts, and have generally depicted relative sizes, shapes, and other detailed attributes, neither literally nor precisely. [Brief description of the drawings]

[0013] [Figure 1] 1 is a system schematic diagram of a sensor applicator, a reader, a monitoring system, a network, and a remote system. [Figure 2A] FIG. 2 is a block diagram illustrating an exemplary embodiment of a reading device. [Figure 2B] FIG. 2 is a block diagram illustrating an exemplary embodiment of a sensor control device. [Figure 2C] FIG. 2 is a block diagram illustrating an exemplary embodiment of a sensor control device. [Figure 3A] 2A-2C illustrate stages in the assembly and application of an exemplary embodiment of the system of FIG. 1 incorporating a two-part structure. [Figure 3B] 2A-2C illustrate stages in the assembly and application of an exemplary embodiment of the system of FIG. 1 incorporating a two-part structure. [Figure 3C] 2A-2C illustrate stages in the assembly and application of an exemplary embodiment of the system of FIG. 1 incorporating a two-part structure. [Figure 3D] 2A-2C illustrate stages in the assembly and application of an exemplary embodiment of the system of FIG. 1 incorporating a two-part structure. [Figure 3E] 2A-2C illustrate stages in the assembly and application of an exemplary embodiment of the system of FIG. 1 incorporating a two-part structure. [Figure 3F] 2A-2C illustrate stages in the assembly and application of an exemplary embodiment of the system of FIG. 1 incorporating a two-part structure. [Figure 3G] 2A-2C illustrate stages in the assembly and application of an exemplary embodiment of the system of FIG. 1 incorporating a two-part structure. [Figure 4A] 1 is a side view of an exemplary embodiment of an applicator device coupled with a cap. [Figure 4B] 1 is a perspective view of an exemplary embodiment of the cap separated from the applicator device. [Figure 4C] 1 is a perspective view illustrating an exemplary embodiment of an applicator device and a distal end of an electronics housing. [Diagram 5] FIG. 13 is a proximal perspective view of an exemplary embodiment of a tray with an associated sterile lid. [Figure 6A] FIG. 1C is a proximal perspective cutaway view illustrating an exemplary embodiment of a tray having a sensor delivery element. [Figure 6B] FIG. 13 is a proximal perspective view showing a sensor delivery element. [Figure 7A] FIG. 2 is a side view of an exemplary embodiment of a housing. [Figure 7B] 1 is a perspective view of an exemplary embodiment of a distal end of a housing. FIG. [Figure 7C] FIG. 2 is a side cross-sectional view of an exemplary embodiment of a housing. [Figure 8A] FIG. 2 is a side view of an exemplary embodiment of a sheath. [Figure 8B] 1 is a perspective view of an exemplary embodiment of a proximal end of a sheath. [Figure 8C] FIG. 13 is an enlarged perspective view of an exemplary embodiment of a distal side of a detent snap portion of a sheath. [Figure 8D] FIG. 13 is a side view illustrating an exemplary embodiment of a sheath feature. [Figure 8E] 1A-1C show an end view of an exemplary embodiment of the proximal end of the sheath. [Figure 9A] FIG. 1 is a proximal perspective view of an exemplary embodiment of a device carrier. [Figure 9B] FIG. 1 is a distal perspective view of an exemplary embodiment of a device carrier. [Figure 10] FIG. 13 is a proximal perspective view of an exemplary embodiment of a sharpened carrier. [Figure 11] 1 is a side cross-sectional view of an exemplary embodiment of a sharpened carrier; [Figure 12A] FIG. 2 illustrates a top perspective view of an exemplary embodiment of a sensor module. [Figure 12B] FIG. 2 illustrates a bottom perspective view of an exemplary embodiment of a sensor module. [Figure 13A] FIG. 13 is a perspective view of an exemplary embodiment of a sensor connection. [Figure 13B] FIG. 13 is a perspective view of an exemplary embodiment of a sensor connection. [Figure 14A] FIG. 1 is a perspective view of an exemplary embodiment of a sensor. [Figure 14B] FIG. 1 is a side view of an exemplary sensor according to an embodiment of the disclosed subject matter. [Figure 14C] 1A-1C are a side view and a blow-out view of an exemplary sensor tip according to one embodiment of the disclosed subject matter; [Figure 15A] FIG. 1 is a perspective view of an exemplary embodiment of a sharpened module. [Figure 15B] FIG. 1 is a perspective view of an exemplary embodiment of a sharpened module and a blow-out view of its distal tip. [Figure 15C] FIG. 15C is a lateral perspective view showing an enlarged distal tip of the sharpened module shown in FIG. 15B. [Figure 15D] FIG. 15C is a cross-sectional view of an embodiment of a sharpened tip for the sharpened module shown in FIG. 15B. [Figure 15E]FIG. 13 is an enlarged perspective view of a tip according to one embodiment of the disclosed subject matter. [Figure 15F] FIG. 13 is an enlarged side view of a tip according to one embodiment of the disclosed subject matter. [Figure 15G] FIG. 1 is a cross-sectional view of a tip according to one embodiment of the disclosed subject matter. [Figure 15H] 15H is a cross-sectional view of the tip shown in FIG. 15G, further including a sensor according to an embodiment of the disclosed subject matter. [Figure 15I] FIG. 1 is a cross-sectional view of a tip according to one embodiment of the disclosed subject matter. [Figure 15J] 15I, further including a sensor according to an embodiment of the disclosed subject matter. [Figure 15K] FIG. 2 is a partial perspective view of a sharpened module and a blow-out view of its distal tip according to one embodiment of the disclosed subject matter. [Figure 15L] FIG. 13 is an enlarged perspective view of a distal tip of a sharpened module including a sensor according to one embodiment of the disclosed subject matter. [Figure 16A] 1 is a cross-sectional view of a tipless applicator according to one embodiment of the disclosed subject matter; [Figure 16B] 16B-16C are cross-sectional views of the blunt tip applicator shown in FIG. 16A during various stages of operation. [Figure 16C] 16B-16C are cross-sectional views of the blunt tip applicator shown in FIG. 16A during various stages of operation. [Figure 16D] 16B-16C are cross-sectional views of the blunt tip applicator shown in FIG. 16A during various stages of operation. [Figure 16E] 16B-16C are cross-sectional views of the blunt tip applicator shown in FIG. 16A during various stages of operation. [Figure 16F] 16B-16C are cross-sectional views of the blunt tip applicator shown in FIG. 16A during various stages of operation. [Figure 16G] 16B-16C are cross-sectional views of the blunt tip applicator shown in FIG. 16A during various stages of operation. [Figure 16H] 16B-16C are cross-sectional views of the blunt tip applicator shown in FIG. 16A during various stages of operation. [Figure 16I] 16B is a cross-sectional view of an exemplary embodiment of the tipless applicator shown in FIG. 16A. [Figure 16J] 1 is a cross-sectional view of an exemplary embodiment of a guide sensor control device assembly. [Figure 16J-1] FIG. 13 is a blown-up view of an exemplary embodiment of a guide sensor control device assembly. [Figure 16K] 1A-1C are cross-sectional views of an exemplary embodiment of an applicator without a sharp tip. [Figure 17A] 1 is a cross-sectional view of an exemplary embodiment of a tipless applicator in accordance with an embodiment of the disclosed subject matter. [Figure 17A-1] 1 is a blow-out view of an exemplary embodiment of a tipless applicator in accordance with an embodiment of the disclosed subject matter; [Figure 17A-2] 1 is a blow-out view of an exemplary embodiment of a tipless applicator in accordance with an embodiment of the disclosed subject matter; [Figure 17B] 17B-17C are cross-sectional views of the blunt tip applicator shown in FIG. 17A at various stages in operation. [Figure 17C] 17B-17C are cross-sectional views of the blunt tip applicator shown in FIG. 17A at various stages in operation. [Figure 17D] 17B-17C are cross-sectional views of the blunt tip applicator shown in FIG. 17A at various stages in operation. [Figure 18A] 1A-1D are cross-sectional views of a powered tipless applicator during various stages of operation. [Figure 18B] 1A-1D are cross-sectional views of a powered tipless applicator during various stages of operation. [Figure 18C] 1A-1D are cross-sectional views of a powered tipless applicator during various stages of operation. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0014] Before describing the subject matter of this application in detail, it should be understood that the disclosure is not limited to particular embodiments described, which, of course, vary. Moreover, the scope of the disclosure will be limited only by the appended claims, and it should also be understood that the terminology used herein is used only for the purpose of describing particular embodiments, and is not intended to be limiting.

[0015] As used in this specification and the appended claims, the original English indefinite articles and the singular definite articles include plurals unless the context makes clear otherwise.

[0016] The publication information set forth herein is provided solely for its disclosure prior to the filing date of the present application. Nothing herein should be construed as an admission that the present disclosure is not entitled to antedate such information by virtue of prior disclosure of such publication. Further, the publication dates provided may be different from the actual publication dates, which may need to be independently confirmed.

[0017] In general, embodiments of the present disclosure include systems, devices, and methods for using an analyte sensor insertion applicator with an in vivo analyte monitoring system. The applicator may be provided to a user in a sterile package containing an electronics housing of a sensor control device. According to some embodiments, a structure other than the applicator, such as a container, may also be provided to a user in a sterile package containing a sensor module and a sharpening module. The user may couple the sensor module to the electronics housing and further couple the sharpening to the applicator using an assembly process that includes inserting the applicator into the container in a particular manner. In other embodiments, the applicator, sensor control device, sensor module, and sharpening module may be provided in a single package. The applicator may be used to place the sensor control device on the human body with the sensor in contact with the wearer's bodily fluids. The embodiments described herein provide improvements that reduce the likelihood that the sensor will be improperly inserted, damaged, or produce an adverse physiological response. Other improvements and advantages are also provided. Various configurations of these devices are described in detail in exemplary embodiments only.

[0018] Additionally, many embodiments include in vivo analyte sensors in which at least a portion of the sensor is located or structurally configured to be located within a user's body to obtain information about at least one analyte within the body. However, it should be noted that the embodiments disclosed herein may be used with in vivo analyte monitoring systems that incorporate in vitro capabilities, as well as true in vitro or ex vivo analyte monitoring systems, including completely non-invasive systems. Additionally, the scope of the present disclosure encompasses systems and devices capable of implementing any and all method embodiments disclosed herein. For example, sensor controller embodiments are disclosed, which may include one or more sensors, analyte monitoring circuitry (e.g., analog circuitry), memory (e.g., for storing instructions), power sources, communication circuitry, transmitters, receivers, processors, and / or controllers (e.g., for executing instructions) that may perform or facilitate the execution of any and all method steps. These sensor controller embodiments may be used or be capable of being used to perform the steps performed by the sensor controller from any and all methods described herein.

[0019] As mentioned above, herein are described numerous embodiments of systems, devices, and methods for an improved sensor insertion device for use with an in vivo analyte monitoring system. Some embodiments of the present disclosure also provide an improved insertion tip module and sensor. Many embodiments of the present disclosure are designed to improve sensor insertion methods for in vivo analyte monitoring systems, minimizing trauma to the insertion site during the sensor insertion process and reducing overall interference with sensor performance. Some embodiments include an applicator with a tip having, for example, a V-shaped cross-sectional area including an apex. This allows for smaller skin penetration, resulting in less traumatic, smaller wounds at the insertion site, which may reduce the risk of early signal attenuation ("ESA"). In other embodiments, the applicator includes a sensor with a V-shaped tip, which may minimize trauma to the insertion site during the sensor insertion process and improve the likelihood of successful sensor insertion. In yet other embodiments, an applicator without a tip is configured to penetrate the skin with a sensor having a sharp or pointed V-shaped tip to reduce trauma to the insertion site. In some blunt applicator embodiments, the design utilizes the deformation or "tenting" of the skin during insertion as a potential energy source to provide more efficient insertion, thus improving the likelihood of successful sensor insertion and reducing the amount of trauma at the insertion site, to name a few advantages.

[0020] Before describing these aspects of the embodiments in detail, it is first desirable to describe example devices that may be present, for example, in an in vivo analyte monitoring system, and example operations thereof, all of which may be used with the embodiments described herein.

[0021] There are various types of in vivo analyte monitoring systems. For example, a "continuous analyte monitoring" system (or "continuous glucose monitoring" system) may transmit data continuously, unprompted, e.g., automatically, on a schedule, from the sensor controller to the reader. As another example, a "flash analyte monitoring" system (or "flash glucose monitoring" system, or simply "flash" system) may transfer data from the sensor controller in response to a scan or data request by the reader, e.g., using near field communication (NFC) or radio frequency identification (RFID) protocols. In vivo analyte monitoring systems may operate without the need for finger-prick calibration.

[0022] In vivo analyte monitoring systems can be distinguished from "in vitro" (or "ex vivo") systems, which contact a biological sample outside the body; "in vitro" systems typically include a meter having a port that accepts an analyte test strip carrying a user's bodily fluid that can be analyzed to determine the user's blood glucose level.

[0023] The in-vivo monitoring system includes a sensor that, when located in vivo, contacts a user's bodily fluid and senses the level of an analyte in the bodily fluid. The sensor may be part of a sensor control device located on the user's body, the sensor control device including electronics and a power source that enable and control the analyte sensing. The sensor control device and variations thereof may also be referred to as a "sensor control unit," an "on-body electronics" device or unit, an "on-body" device or unit, or a "sensor data communication" device or unit, by way of example only.

[0024] An in-vivo monitoring system may also include a device that receives and processes the sensed analyte data from the sensor control device and / or displays the sensed analyte data for a user in any number of forms. This device and variations may also be referred to as a "hand-held reader," "reader" (or simply "reader"), a "hand-held electronic device" (or simply "handheld"), a "portable data processing" device or unit, a "data receiver," "receiver" device or unit (or simply "receiver"), or a "remote" device or unit, by way of example only. Other devices, such as personal computers, have also been used with or incorporated into in-vivo and in-vitro monitoring systems.

[0025] Exemplary In Vivo Analyte Monitoring System FIG. 1 is a conceptual diagram illustrating an exemplary embodiment of an analyte monitoring system 100 including a sensor applicator 150, a sensor control device 102, and a reader 120. The sensor applicator 150 is used to deliver the sensor control device 102 to a monitoring location on a 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 FIGS. 2B and 2C, and may communicate with the reader 120 via a communication path using wired or wireless technology. Examples of wireless protocols include Bluetooth, Bluetooth low energy (BLE, BTLE, Bluetooth SMART, etc.), Near Field Communication (NFC), etc. A user may monitor applications installed in the memory of the reader 120 using the screen 122 and input 121, and recharge the device's battery using the power port 123. The reader 120 is described in more detail with respect to FIG. 2A. The reading device 120 may communicate with a local computer system 170 over a communication path 141 using wired or wireless technology. The local computer system 170 may include one or more of a laptop, desktop, tablet, phablet, smartphone, set-top box, video game console, or other computing device, and the wireless communication may include any of a number of available wireless network protocols, including Bluetooth, Bluetooth low energy, Wi-Fi, etc. The local computer system 170 may communicate with the network 190 over a communication path 143 in a similar manner to how the reading device 120 communicates with the network 190 over a communication path 142, using wired or wireless technology as previously described. The network 190 may be any of a number of networks, including private and public networks, local area or wide area networks, etc. The trusted computer system 180 may include a server, provide authentication services and secure data storage, and may communicate with the network 190 over a communication path 144 using wired or wireless technology.

[0026] Exemplary Reading Device 2A is a block diagram illustrating an exemplary embodiment of a reading device configured as a smartphone, where the reading device 120 may include a display 122, an input 121, and a processing core 206 including a communication processor 222 coupled to a memory 223 and an application processor 224 coupled to a memory 225. The reading device 120 may further include another memory 230, an RF transceiver 228 having an antenna 229, and a power source 226 having a power management module 238. The reading device 120 may further include a multi-function transceiver 232 that may communicate via Wi-Fi, NFC, Bluetooth, BTLE, and GPS using an antenna 234. As will be appreciated by those skilled in the art, these components are electrically and communicatively coupled to form a functional device.

[0027] Exemplary Sensor Control Device 2B and 2C are block diagrams illustrating an exemplary embodiment of a sensor controller 102 having an analyte sensor 104 and a sensor electronics 160 (including analyte monitoring circuitry) that may contain most of the processing power to render final result data suitable for display to a user. In FIG. 2B, a single semiconductor chip 161 is shown that may be a custom application specific integrated circuit (ASIC). Within the ASIC 161 are shown certain high level functional units including an analog front end (AFE) 162, a power management (or control) circuit 164, a processing unit 166, and a communication circuit 168 (which may be implemented as a transmitter, a receiver, a transceiver, passive circuitry, or otherwise according to a communication protocol). In this embodiment, both the AFE 162 and the processing unit 166 are used as analyte monitoring circuitry, although in other embodiments, either circuitry may perform the analyte monitoring function. The processing unit 166 may include one or more processing units, microprocessors, controllers, and / or microcontrollers, each of which may be a discrete chip or may be distributed among (part of) multiple different chips.

[0028] Memory 163 is also included in the ASIC 161 and may be shared by the various functional units in the ASIC 161 or distributed among two or more of them. Additionally, memory 163 may be a separate chip. Memory 163 may be volatile and / or non-volatile memory. In this embodiment, the ASIC 161 is coupled to a power source 172, which may be a coin cell or the like. The AFE 162 interconnects with the in vivo analyte sensor 104 to receive measurement data therefrom and outputs the data in digital form to a processor 166, which then processes the data into final result glucose discrete and trend values, etc. This data is then provided to a communication circuit 168 for transmission by antenna 171 to a reader 120 (not shown), with minimal further processing required by a resident software application, for example to display the data.

[0029] FIG. 2C is similar to FIG. 2B, but instead includes two discrete semiconductor chips 162, 174, which may be packaged together or separately. Here, the AFE 162 resides in the ASIC 161. The processing unit 166 is integrated with the power management circuitry 164 and the communication circuitry 168 on the chip 174. The AFE 162 includes memory 163, and the chip 174 includes memory 165, which may be separate or distributed among them. In one exemplary embodiment, the AFE 162 is combined with the power management circuitry 164 and the processing unit 166 on one chip, and the communication circuitry 168 is on another chip. In another exemplary embodiment, both the AFE 162 and the communication circuitry 168 are on one chip, and the processing unit 166 and the power management circuitry 164 are on another chip. It should be noted that other combinations including three or more chips, each responsible for a different function or sharing one or more functions for fail-safe redundancy, are also possible.

[0030] Exemplary Assembly Process for Sensor Control Device According to some embodiments, the components of the sensor control device 102 may be obtained by the user in multiple packages that require final assembly by the user before delivery to the appropriate user location. Figures 3A-3E illustrate an exemplary embodiment of an assembly process for the sensor control device 102 by the user, including steps of preparing the separate components before connecting the components to prepare for sensor delivery. In other embodiments, the sensor control device 102 and applicator 150 components may be obtained by the user as a single package. Figures 3F-3G illustrate an exemplary embodiment of delivering the sensor control device 102 to the appropriate user location by selecting the appropriate delivery location and then applying the device 102 to that location.

[0031] 3A shows a sensor container or tray 810 with a removable lid 812. A user prepares the sensor tray 810 by removing the lid 812, which acts as a sterile barrier to protect the contents of the sensor tray 810 and otherwise maintain a sterile internal environment. Removal of the lid 812 exposes a platform 808 located within the sensor tray 810, with a (partially visible) plug assembly 207 arranged within and otherwise strategically embedded within the platform 808. The plug assembly 207 includes a sensor module (not shown) and a sharpened module (not shown). The sensor module carries a sensor 104 (FIG. 1), and the sharpened module carries an associated sharpened portion that is used to aid in transdermal delivery of the sensor 104 beneath the user's skin upon application of the sensor control device 102 (FIG. 1).

[0032] 3B illustrates the sensor applicator 150 and a user preparing 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 other 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 includes an electronics housing (not shown) that holds the electrical components for the sensor control device 102 (FIG. 1), and the applicator cap 708 may or may not maintain a sterile environment for the electrical components. Preparing the sensor applicator 150 includes removing the housing 702 from the applicator cap 708, which may be accomplished by unscrewing the applicator cap 708 from the housing 702. The applicator cap 708 may then be discarded or otherwise set aside.

[0033] 3C illustrates a user inserting a sensor applicator 150 into a sensor tray 810. The sensor applicator 150 includes a sheath 704 configured to be received by a platform 808, temporarily unlocking the sheath 704 from the housing 702, which in turn temporarily unlocks the platform 808 from the sensor tray 810. Advancement of the housing 702 into the sensor tray 810 results in a plug assembly 207 (FIG. 3A) arranged in the sensor tray 810, including the sensor and sharpened module, being coupled to an electronics housing arranged in the sensor applicator 150.

[0034] In FIG. 3D, the user removes the sensor applicator 150 from the sensor tray 810 by retracting the housing 702 proximally from the sensor tray 810.

[0035] 3E shows the bottom or interior of the sensor applicator 150 after removal from the sensor tray 810 (FIGS. 3A, 3C). The sensor applicator 150 is removed from the sensor tray 810 with the sensor control unit 102 fully assembled therein and positioned for delivery to a target monitoring location. As shown, a tip 2502 extends from the bottom of the sensor control unit 102 and carries a portion of the sensor 104 in a cavity or recessed portion therein. The tip 2502 is configured to penetrate the skin of a user, thereby positioning the sensor 104 in contact with bodily fluids.

[0036] 3F, 3G show an example of delivering the sensor control unit 102 to a target monitoring location 221, such as the back of a user's upper extremity. FIG. 3F shows a user advancing the sensor applicator 150 towards the target monitoring location 221. Upon engaging the skin at the target monitoring location 221, the sheath 704 collapses into the housing 702, allowing the sensor control unit 102 (FIGS. 3E, 3G) to advance and engage the skin. With the aid of the tip 2502 (FIG. 3E), the sensor 104 (FIG. 3E) is advanced percutaneously beneath the patient's skin at the target monitoring location 221.

[0037] 3G shows the user retracting the sensor applicator 150 from the target monitoring location 221 with the sensor control unit 102 successfully attached to the user's skin. The adhesive patch 105 (FIG. 1) applied to the bottom of the sensor control unit 102 adheres to the skin and ensures that the sensor control unit 102 is in the proper position. The tip 2502 (FIG. 3E) automatically retracts once the housing 702 is fully advanced to the target monitoring location 221, while the sensor 104 (FIG. 3E) is left in the proper position to measure the analyte level.

[0038] 3A-3G and elsewhere herein, system 100 may reduce or eliminate the risk of accidental damage, permanent deformation, or incorrect assembly of applicator components as compared to conventional systems. Because applicator housing 702 directly engages platform 808 during sheath 704 unlocking, rather than indirectly engaging through sheath 704, the relative angle between sheath 704 and housing 702 is unlikely to cause damage or permanent deformation of arms or other components. The likelihood of relatively large forces (as in conventional devices) during assembly is reduced, which in turn reduces the likelihood of user assembly failure. Further details regarding the applicator, its components, and alternative embodiments are described in U.S. Patent Application Publication Nos. 2013 / 0150691, 2016 / 0331283, and 2018 / 0235520, all of which are incorporated by reference in their entireties and for all purposes.

[0039] Exemplary embodiments of a sensor applicator device FIG. 4A is a side view of an exemplary embodiment of the applicator device 150 coupled with a threaded cap 708. This is one example of how the applicator 150 may be shipped and received by a user prior to being assembled with a sensor by the user. In other embodiments, the applicator 150 may be shipped to a user with the sensor and tip housed therein. FIG. 4B is a side perspective view showing the applicator 150 and cap 708 after separation. FIG. 4C is a perspective view of an exemplary embodiment of the distal end of the applicator device 150 with the electronics housing 706 and adhesive patch 105 removed from the position where they would have been held within the device carrier 710 of the sheath 704 when the cap 708 was closed.

[0040] Exemplary Tray and Sensor Module Assembly FIG. 5 is a proximal perspective view showing an exemplary embodiment of a tray 810 to which a sterile lid 812 is removably coupled and which may be representative of how the package may be shipped and received by a user prior to assembly.

[0041] 6A is a proximal perspective cutaway view showing the sensor delivery elements in a tray 810. A platform 808 is slidably coupled within the tray 810. A desiccant 502 is stationary relative to the tray 810. A sensor module 504 is placed within the tray 810.

[0042] 6B is a proximal perspective view showing the sensor module 504 in greater detail, where the retention arm extension 1834 of the platform 808 releasably secures the sensor module 504 in place. The module 2200 is coupled with the connection portion 2300, the sharpened module 2500, and the sensor (not shown) so that they may be removed together as the sensor module 504 during assembly.

[0043] Exemplary embodiments of the applicator housing 7A is a side view of an exemplary embodiment of an applicator housing 702 that may include an internal cavity with support structure for the applicator's functions. A user pushes the housing 702 distally to activate the applicator assembly process, which in turn also ejects the sensor control device 102, after which the cavity in the housing 702 may act as a receiver for a sharp point. In the exemplary embodiment, various features are shown, including a housing orientation feature 1302 for orienting the device during assembly and use. The tamper ring groove 1304 may be a recess located on the outer periphery of the housing 702 distal to the tamper ring protection portion 1314 and proximal to the tamper ring retention portion 1306. The tamper ring groove 1304 retains a tamper ring to allow a user to identify if the device has been tampered with or used in any way. The housing screws 1310 may be aligned with the complementary threads on the cap 708 (FIGS. 4A, 4B) and rotated in a clockwise or counterclockwise direction to secure the housing 702 to the complementary threads on the cap 708. A side gripping zone 1316 on the housing 702 may provide an exterior location for a user to grip the housing 702 for use. The gripping protrusions 1318 are slightly raised ridges relative to the side gripping zones 1316 and may help facilitate removal of the housing 702 from the cap 708. The shark teeth 1320 are raised portions with flat sides located on the clockwise edge that may shear a tamper ring (not shown) and hold the tamper ring in place after the user unscrews the cap 708 and housing 702. In the exemplary embodiment, four shark teeth 1320 are used, although more or less may be used as desired.

[0044] 7B is a perspective view of the distal end of the housing 702, where three housing guide structures (or "guide ribs") 1321 are disposed at 120 degrees to each other and at 60 degrees to three locking structures (or "locking ribs") 1340, which are also at 120 degrees to each other. Other angular orientations, symmetrical or asymmetrical, may also be used, as may any number of one or more structures 1321, 1340. Here, each structure 1321, 1340 is configured as a flat rib, although other shapes may also be used. Each guide rib 1321 includes a guide edge (also referred to as a "sheath guide rail") 1326 that may pass along the surface of the sheath 704 (e.g., guide rail 1418 described with respect to FIG. 8A). The insertion hard stop 1322 may be a flat, distally facing surface of the housing guide rib 1321 located near the proximal end of the housing guide rib 1321. The insertion hard stop 1322 provides an abutting surface during use for the sensor electronics carrier travel limiter surface 1420 (FIG. 8B) of the sheath 704 to prevent the sensor electronics carrier travel limiter surface 1420 from moving further in the proximal direction. The carrier interface post 1327 passes through an opening 1510 (FIG. 9A) in the device carrier 710 during assembly. The device carrier interface 1328 may be a rounded, distally facing surface of the housing guide rib 1321 that interfaces with the device carrier 710.

[0045] 7C is a side cross-sectional view of an exemplary embodiment of the housing. In the exemplary embodiment, the side cross-sectional profile of the housing guide rib 1321 and the locking rib 1340 are shown. The locking rib 1340 includes a sheath snap introduction feature 1330 near the distal end of the locking rib 1340 that extends distally outward from the central axis 1346 of the housing 702. Each sheath snap introduction feature 1330 bends the detent snap round portion 1404 of the detent snap portion 1402 of the sheath 704 inward toward the central axis 1346 as the sheath 704 moves toward the proximal end of the housing 702, as shown in FIG. 8C. Once past the distal point of the sheath snap introduction feature 1330, the detent snap portion 1402 of the sheath 704 is locked into place in the locked groove 1332. Thus, the detent snap portion 1402 may be prevented from easily moving in the distal direction by a surface having a plane generally perpendicular to the central axis 1346, shown in FIG. 8C as the detent snap flat 1406.

[0046] As the housing 702 moves further proximally toward the skin surface and the sheath 704 advances toward the distal end of the housing 702, the detent snap 1402 shifts into the unlocking groove 1334 and the applicator 150 is in a "ready" position, ready for use. As the user applies more force to the proximal end of the housing 702, the detent snap 1402 passes over the firing detent 1344 while the sheath 704 presses against the skin. This initiates a firing sequence due to the release of energy stored in the deflected detent snap 1402 traveling proximally toward the skin surface toward the sheath stop ramp 1338, which flares outward slightly about the central axis 1346, slowing the movement of the sheath 704 during the firing sequence. After the unlock groove 1334, the next groove that the detent snap portion 1402 encounters is the final lockout groove 1336 that the detent snap portion 1402 enters at the end of the stroke or push sequence made by the user. The final lockout recess 1336 is a proximally facing surface perpendicular to the central axis 1346 that engages with the detent snap flats 1406 after the detent snap portion 1402 has passed, preventing reuse of the device by positively holding the sheath 704 in the proper position relative to the housing 702. The insertion hard stop 1322 on the housing guide rib 1321 prevents the sheath 704 from advancing proximally relative to the housing 702 by engaging the sensor electronics carrier travel limiter face 1420.

[0047] Exemplary embodiments of the applicator sheath 8A and 8B are side and perspective views, respectively, illustrating an exemplary embodiment of a sheath 704. In this exemplary embodiment, the sheath 704 may position the sensor control device 102 above the user's skin surface prior to application. The sheath 704 may also include features to hold the tip in position for proper sensor application, identify the force required to apply the sensor, and help guide the sheath 704 relative to the housing 702 during application. A detent snap 1402 is near the proximal end of the sheath 704, as will be further described next with respect to FIG. 8C. The sheath 704 has a generally cylindrical cross section, with a first radius of the proximal portion (near the top of the figure) being shorter than a second radius of the distal portion (near the bottom of the figure). Also shown are a plurality of detent clearances 1410, 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-in feature 1330 to pass distally until the distal surface of the locking rib 1340 contacts the proximal surface of the detent clearance 1410.

[0048] The guide rails 1418 are disposed between the sensor electronics carrier travel limiter face 1420 at the proximal end of the sheath 704 and a notch around the locking arm portion 1412. Each guide rail 1418 is a channel between two ridges where the guide edge 1326 of the housing guide rib 1321 can slide distally relative to the sheath 704.

[0049] The locking arm portions 1412 may include an attached distal end and a free proximal end disposed near the distal end of the sheath 704, which may include a locking arm portion interface 1416. When the locking arm portion interface 1416 of the locking arm portion 1412 engages the lock interface 1502 of the device carrier 710, the locking arm portion 1412 may lock the device carrier 710 to the sheath 704. A locking arm strengthening rib 1414 is disposed near a central position of each locking arm portion 1412 and acts as a strengthening point for an otherwise weak point of each locking arm portion 1412 to prevent the locking arm portions 1412 from bending excessively and breaking.

[0050] The detent snap reinforcement feature 1422 may be located along a distal portion of the detent snap portion 1402 to reinforce the detent snap portion 1402. The alignment notch 1424 may be a cutout near the distal end of the sheath 704 to provide an opening for user alignment with the sheath orientation feature of the platform 808. The reinforcement rib 1426 may include a buttress, here triangular, and support the detent base 1436. The housing guide rail clearance 1428 may be a cutout to allow the distal surface of the housing guide rib 1321 to slide during use.

[0051] 8C is a close-up perspective view illustrating an exemplary embodiment of a detent snap portion 1402 of the sheath 704. The detent snap portion 1402 can include a detent snap bridge portion 1408 located near or at its proximal end. The detent snap portion 1402 can also include a detent snap flat portion 1406 distal to the detent snap bridge portion 1408. The exterior surface of the detent snap bridge portion 1408 can include a detent snap round portion 1404, which is a rounded surface that facilitates movement of the detent snap bridge portion 1408 across an interior surface of the housing 702, such as, for example, a locking rib 1340.

[0052] 8D is a side view illustrating 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 at a relatively proximal location of the distal portion of the sheath 704.

[0053] 8E is an end view of an exemplary embodiment of the proximal end of the sheath 704, where the rear wall of the guide rail 1446 can provide a channel for slidably coupling with 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. In a general sense, the embodiments described herein operate by flattening and stretching the skin surface at a predetermined site for inserting a sensor. Additionally, the embodiments described herein can be used in other medical applications, such as, for example, transdermal drug delivery, needle injections, suturing to close wounds, implanting devices, and applying adhesive surfaces to the skin.

[0054] By way of background, those skilled in the art will appreciate that skin is a highly anisotropic tissue from a biomechanical standpoint and varies greatly between individuals, which may affect, for example, the rate of drug diffusion, the ability to penetrate the skin with a tip, or the degree of communication between the tissue underlying the skin and the surrounding environment with respect to the insertion of a sensor into the body at a tip-guided insertion site.

[0055] Exemplary embodiments of device carriers 9A is a proximal perspective view of an exemplary embodiment of a device carrier 710 that may hold a sensor electronics device in the applicator 150. It may also hold a sharpened carrier 1102 having a sharpened module 2500. In this exemplary embodiment, the carrier 710 has a generally hollow round flattened cylindrical shape and may further include one or more deflectable sharpened carrier locking arms 1524 (e.g., three) that extend proximally from a proximal surface surrounding a centrally located spring alignment ridge 1516 for maintaining alignment of the springs 1104. Each locking arm 1524 has a detent or retention feature 1526 located at or near its proximal end. A shock lock 1534 may be an outwardly extending tab located on the periphery of the device carrier 710 that may lock the device carrier 710 for added safety prior to firing. The rotation limiter 1506 is a relatively short protrusion that extends proximally on the proximal surface of the device carrier 710 and can limit rotation of the carrier 710. The sharpened carrier lock arm portion 1524 can then interconnect with the sharpened carrier 1102 as described with respect to FIGS.

[0056] 9B is a distal perspective view of the device carrier 710, where one or more sensor electronics retaining spring arms 1518 (e.g., three) are normally biased toward the position shown and further include detents 1519 that may pass through a distal surface of the electronics housing 706 of the device 102 when received in the recess or cavity 1521. In one embodiment, after the sensor control unit 102 is adhered to the skin with the applicator 150, the user pulls the applicator 150 in a proximal direction, i.e., away from the skin. The adhesive forces hold the sensor control unit 102 on the skin and overcome the lateral force applied by the spring arms 1518. As a result, the spring arms 1518 flex radially outward, disengaging the detents 1519 from the sensor control unit 102, thereby releasing the sensor control unit 102 from the applicator 150.

[0057] Exemplary embodiments of the advanced carrier 10 and 11 are proximal perspective and side cross-sectional views, respectively, of an exemplary embodiment of the sharpened carrier 1102. The sharpened carrier 1102 may grip the sharpened module 2500 and hold it within the applicator 150. Near the distal end of the sharpened carrier 1102 may be an anti-rotation slot 1608 that prevents rotation of the sharpened carrier 1102 when located within the central region of the sharpened carrier locking arm portion 1524 (as shown in FIG. 9A ). The anti-rotation slot 1608 may be located between sections of the sharpened carrier base chamfer 1610 to ensure that the sharpened carrier 1102 is fully retracted through the sheath 704 when the sharpened carrier 1102 is retracted at the end of the deployment procedure.

[0058] 11, the tip-retaining arms 1618 are positioned within the tip carrier 1102 about a central axis and may further include a tip-retaining clip 1620 at a distal end of each arm 1618. The tip-retaining clip 1620 may have a proximal surface generally perpendicular to the central axis and may abut a distally facing surface of the tip hub 2516 (FIG. 15A).

[0059] Exemplary Sensor Module 12A and 12B are top and bottom perspective views, respectively, of an exemplary embodiment of a sensor module 504. The module 504 can hold a connection 2300 (FIGS. 13A and 13B) and a sensor 104 (FIG. 14A). The module 504 can be securely coupled to an electronics housing 706. One or more flexible arms or module snaps 2202 can snap into corresponding features 2010 of the housing 706. The prong slot 2208 can provide a location for the prong tip 2502 to pass through and for the prong shaft 2504 to temporarily rest. The sensor ledge 2212 defines the sensor position in a horizontal plane, prevents the sensor from lifting the connection 2300 off the post, and keeps the sensor 104 parallel to the plane of the connection seal. It can also define the bending geometry and minimum bend radius of the sensor. It may limit the vertical travel of the sensor, prevent the tower from protruding above the electronics housing surface, and define the length of the sensor tail below the patch surface. The sensor walls 2216 may constrain the sensor and define the sensor bending geometry and minimum bend radius.

[0060] 13A and 13B are perspective views illustrating an exemplary embodiment of the connection 2300 in an open and closed state, respectively. The connection 2300 may be fabricated from silicone rubber encapsulating a compliant carbon impregnated polymer module that serves as a conductive contact 2302 between the sensor 104 and the electrical circuit contacts for the electronic elements in the housing 706. The connection may also serve as a moisture barrier for the sensor 40 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 may provide a water-tight seal for the electrical contacts and the sensor contacts. One or more hinges 2308 may connect the two distal and proximal portions of the connection 2300.

[0061] FIG. 14A is a perspective view of an exemplary embodiment of the sensor 104. The neck 2406 can be a zone where the sensor can be folded, for example, 90 degrees. The membrane on the tail 2408 can cover the active analyte sensing element of the sensor 104. The tail 2408 can be the part of the sensor 104 that is located under the user's skin after insertion. The flag 2404 can include a contact portion and a sealing surface. The bias tower 2412 can be a tab that biases the tail 2408 into the tip slot 2208. The bias fulcrum 2414 can be a branch of the bias tower 2412 that contacts the inner surface of the needle to bias the tail into the slot. The bias adjustment portion 2416 can reduce local bending of the connection of the tail and prevent damage to the sensor trace. The contact 2418 can electrically connect the active portion of the sensor to the connection portion 2300. The service loop 2420 may move the electrical path 90 degrees from the vertical to engage the sensor ledge 2212 (FIG. 12B).

[0062] 14B is a side view of an exemplary sensor 11900 in accordance with one or more embodiments of the present disclosure. The sensor 11900 may be similar in some respects to any of the sensors described herein and may be used in an analyte monitoring system to detect a particular analyte concentration. As shown, the sensor 11900 includes a tail 11902, a flag 11904, and a neck 11906 interconnecting the tail 11902 and the flag 11904. The tail 11902 includes an enzyme or other chemical or biological substance, and in some embodiments, a membrane may cover the chemical. In use, the tail 11902 is transdermally received under the skin of a user, and the chemical contained therein helps facilitate monitoring the presence of an analyte in a bodily fluid.

[0063] The tail 11902 is received within a cavity or concave portion (not shown) of the tip, which may at least partially circumscribe the tail 11902 of the sensor 11900. As shown, the tail 11902 may extend at an angle θ from the horizontal. In some embodiments, the angle θ may be about 85°. Thus, unlike other sensor tails, the tail 11902 does not extend perpendicularly from the flag 11904, but instead may extend at an angle off-vertical. This may be advantageous to help maintain the tail 11902 in the concave portion of the tip.

[0064] The tail 11902 includes a first or lower end 11908a and a second or upper end 11908b opposite the lower end 11908a. A tower 11910 may be provided at or near the upper end 11908b and extend vertically upward from the location where the neck 11906 interconnects the tail 11902 to the flag 11904. In operation, as the nose moves laterally, the tower 11910 helps pivot the tail 11902 towards the nose and otherwise remains within the concave portion of the nose. Additionally, in some embodiments, the tower 11910 may provide or otherwise define a protrusion 11912 extending laterally therefrom. When the sensor 11900 is mated with the tip and the tail 11902 extends into the concave portion of the tip, the protrusion 11912 can engage an inner surface of the concave portion. During operation, the protrusion 11912 can help keep the tail 11902 within the concave portion.

[0065] The flag 11904 can include a generally flat surface on which one or more sensor contacts 11914 are disposed. The sensor contacts 11914 can be configured to align with a corresponding number of compatible carbon-impregnated polymer modules contained within the interface.

[0066] In some embodiments, as shown, the neck 11906 can provide or otherwise define a recess or bend 11916 that extends between the flag 11904 and the tail 11902. The bend 11916 can be advantageous to provide flexibility to the sensor 11900 and help prevent the neck 11906 from bending.

[0067] In some embodiments, a notch 11918 (shown in dashed lines) may optionally be defined in the flag near the neck 11906. The notch 11918 may provide flexibility and tolerance to the sensor 11900 when mounting the sensor 11900 in a mounting portion. More specifically, the notch 11918 may help absorb interference forces that may occur when mounting the sensor 11900 in a mounting portion.

[0068] FIG. 14C illustrates an embodiment of a sensor 11950 that includes a modified tail 11919. In some embodiments, the first or bottom end 11909a is chiseled or tapered to form the bottom end 11909a with one or more chamfered edges. In some embodiments, the bottom end 11909a includes a single chamfered edge 11911. More specifically, the sensor tail 11919 includes a bottom end 11909a that forms a tip 11909b with a sharp V-shaped apex. This sensor design may be advantageous in reducing the overall footprint of the sensor 11950 and further minimizing the size of skin penetration and puncture trauma when tissue is expanded during sensor insertion. As a result, the risk of trauma causing ESA may be reduced by the bottom end 11909a of the sensor 11950 having a V-shaped tip 11909b with a sharp apex.

[0069] In general, the sensor may be understood as including a tail, a flag, and a neck aligned along a plane having a longitudinal axis and a transverse axis. A spring-like structure may be created by turning the neck of the sensor in various orientations. Between the tail and the flag, the neck may include at least two turns about the longitudinal axis to provide a spring-like structure. The at least two turns provide overlapping layers of the neck structure about the axis of the plane shared by the tail, the flag, and the neck, and the neck itself may remain unbroken. These overlapping turns constitute the spring-like structure. In some embodiments, the overlapping layers of the neck are oriented vertically. In some embodiments, the overlapping layers of the neck are oriented horizontally.

[0070] The neck turns may be produced by folding the neck of the sensor from a larger neck structure, laser cutting the sensor from a sheet of material that contains the sensor, printing the sensor including a structure with turns, stamping the sensor from a sheet of material from which the sensor is constructed, or other suitable manufacturing process to precisely bend the neck.

[0071] Exemplary embodiments of the sharpened module FIG. 15A is a perspective view of an exemplary embodiment of the tip module 2500 prior to assembly into the sensor module 504 (FIGS. 12A, 12B). The tip 2502 includes a distal tip 2506 that may penetrate the skin while carrying the sensor tail in a cavity or recess in the tip shaft 2504, and may bring the active surface of the sensor tail into contact with bodily fluids. The hub push barrel 2508 may provide a surface to push against the tip carrier during insertion. The hub small barrel 2512 may provide space for the tip hub contact surface 1622 (FIG. 11) to extend. The hub snap claw positioning barrel 2514 may provide a distally facing surface for the hub snap claw 2516 against which the tip hub contact surface 1622 abuts. The hub snap claw 2516 may include a conical surface that releases the clip 1620 during installation of the tip module 2500. Further details regarding the sharpening module, the sharpening portion, their components, and alternative embodiments are described in U.S. Patent Application Publication No. 2014 / 0171771, which is incorporated by reference in its entirety and for all purposes.

[0072] Figure 15B shows another exemplary embodiment of a sharpened module 2530 and a blown-out view of its distal portion, showing the cavity or recess of the sharpened shaft 2534 and the distal tip 2536. Figure 15C further shows an enlarged side perspective view of the distal tip 2536 which may penetrate the skin while carrying a sensor tail (not shown) in the cavity or recess of the sharpened shaft 2534, and may bring the active surface of the sensor tail into contact with bodily fluids. The sharpened tip 2532 using a U-shape is also shown in cross section in Figure 15D.

[0073] We now describe an exemplary embodiment of a tip designed to reduce trauma during the sensor insertion and retraction process. FIG. 15E is an enlarged perspective view of tip 2592. In FIG. 15E, the sharp distal tip 2596a includes a double chamfered edge or transition 2599 adjacent at a proximal portion of the distal tip 2596a to form the distal tip 2596a having an apex 2596b. Specifically, the double chamfered edge 2599 is concavely angled to form the sharp distal tip 2596a. Referring again to FIG. 15E, the distal portion is provided with a concavely angled distal tip 2596a. As shown in FIG. 15F, the angled distal tip 2596a can be provided with a first concavely angled tip 2593 and a second steeply angled tip 2595. More specifically, a first concave angled tip 2593 tapers to a second steeply angled tip 2595. An exemplary configuration including multiple edges and faces provides a sharp point to reduce penetration force and reduce trauma and bleeding to the subject. In this embodiment, the sharp tip 2592 has a generally V-shaped profile.

[0074] 15G and 15I are cross-sectional views of two embodiments of tips described herein. FIG. 15G is a cross-sectional view of an embodiment previously described, showing a generally U-shaped cross-sectional area of ​​tip 2502. FIG. 15I is a cross-sectional view of an embodiment showing a V-shaped cross-sectional area of ​​tip 2592, with apex 2596a. In some embodiments, apex 2596a includes a bottom portion of the cross-sectional area that does not have a sharp edge. Furthermore, unlike embodiments such as the U-shaped tip shown in FIG. 15G, the bottom portion of the cross-sectional area is not flat. FIGs. 15H and 15J are cross-sectional views of the embodiments shown in FIGs. 15G and 15I, respectively, showing examples of tips supporting sensor 11900 or sensor 11950, respectively.

[0075] 15K is a perspective view showing an example embodiment of a sharpened module 2590 having one or more chamfered edges and a V-shaped geometry configured to create a smaller opening in the skin than other sharpened portions (e.g., sharpened portion 2502 shown in FIG. 15A). Here, sharpened module 2590 is shown prior to assembly with sensor module 504 (FIGS. 12A, 12B), which may include similar components to the embodiment described for FIG. 15A, including sharpened portion 2592, sharpened shaft 2594, sharpened distal tip 2596a, hub push barrel (not shown), hub small barrel 2652, hub snap tab 2656, and hub snap tab positioning barrel (not shown). Similar to the sharpened module 2500 described above, and further shown in the blow-up diagram of FIG. 15K, the sharpened module 2590 includes a sharpened shaft 2594 connected at a proximal end to a distal end of the hub portion 2692, a sensor channel 2598 configured to receive at least a portion of an analyte sensor, such as, for example, analyte sensor 11950, and a distal tip 2596a configured to penetrate the skin surface during the sensor insertion process.

[0076] 15L shows a front perspective view of the sharpened shaft 2594, including a sharpened module 2590 including one or more sidewalls 2699 and a longitudinally extending sensor channel 2598, which together form a V-shaped cross-sectional area of ​​the sharpened portion including an apex 2596b. Further, the sensor channel 2598 is configured to receive at least a portion of any analyte sensor described herein, such as, for example, analyte sensor 11900 or 11950. In some embodiments, such as the embodiment shown in FIG. 15L, the sensor channel 2598 is configured to receive at least a portion of the analyte sensor 11900. According to one aspect of the embodiment, one or all of the sharpened portion 2592, the sharpened shaft 2594, and / or the sharpened distal tip 2596a of the sharpened portion 2592 may include one or more concave chamfered edges.

[0077] 15K, 15L, according to one aspect of the embodiment, one or more sidewalls 2699 forming the sensor channel 2598 are disposed along the sharpened shaft 2594 and adjacent the distal tip 2596a. Specifically, the one or more sidewalls 2699 are disposed along the sharpened shaft 2594 such that the one or more sidewalls 2699 terminate distally relative to the sensor channel 2598. In some embodiments, for example, the one or more sidewalls 2699 terminate from an apex 2596b (as shown in FIG. 15E) of the sharpened distal tip 2596a. The one or more sidewalls 2699 terminate adjacent a proximal end of the distal tip 2596a to form one or more chamfered edges. The one or more chamfered edges are configured to be concavely sloped and define the apex 2596b of the distal tip 2596a. In some embodiments, the apex 2596b is located at the center of the sharpened distal tip 2596a. According to one aspect of the embodiment, the sharpened portion 2592 can be characterized as having a sharpened V-shaped distal tip 2596a and all other edges having double chamfered edges.

[0078] The V-shaped tip 2596a of the tip 2592 is designed to provide a smaller surface area and occupy less cross-sectional area compared to, for example, the distal tip 2506 of the tip module 2500. The cross-sectional area of ​​the distal tip 2596a is the smallest cross-sectional area of ​​the tip module 2590. During insertion, when the tip 2592 moves below the skin surface, the sharp point geometry and V-shaped cross-sectional area of ​​the tip 2592 as shown in FIGS. 15E-15L penetrates the skin by forming a smaller trauma due to the smaller tip size. For sensor insertion, the puncture trauma may contribute to the ESA of the sensor. In this regard, the embodiments described herein form a smaller trauma and, as a result, reduce the risk of ESA during the sensor insertion process.

[0079] Further, one skilled in the art will appreciate that the embodiments of the tip 2592 described herein may be used with any of the sensors described herein, including in vivo analyte sensors configured to measure analyte levels in a subject's bodily fluid. Further, the embodiments of the tip described herein may be used with in vivo analyte sensors that include a V-shaped tip. For example, in some embodiments, as shown in FIG. 15K, the tip 2592 may include a sensor channel 2598 configured to receive at least a portion of an analyte sensor 11950 having a V-shaped tip 11909b. Furthermore, the V-shaped tip 11909b of the sensor 11950 may be adjacent the tip 2592 to enable the tip 2592 to create an insertion path for the sensor 11950. In this embodiment, the design of the tip itself, and the placement of the needle relative to the sensor, may be made to reduce the trauma caused by the assembly during insertion. The distal portion of the sensor body has a width sized to fit within the sensor channel 2598. For example, the V-shaped tip 11909b of the sensor 11950 is designed to have a complementary shape to the V-shaped cross-sectional area of ​​the tip 2592. In this embodiment, the V-shaped tip 11909b of the sensor 11950 is configured such that the tip 11909b is coaxial with the apex 2596b of the tip 2592 and to better track the distal tip 2596a when penetrated into the skin of a subject.

[0080] Exemplary embodiments of the applicator without a sharp tip Various exemplary embodiments of the tipless applicator will now be described. Referring first to FIG. 16A, a cross-sectional view of an exemplary embodiment of a tipless applicator 7150 (in an initial state) is shown. According to one aspect of some embodiments, the tipless applicator assembly 7150 may include one or more of the following components: a housing 7702 that may be movable relative to the subject's skin between a proximal position and a distal position, a guide 7102, an analyte sensor 12900, a device carrier feature 7710 configured to releasably hold the sensor control device 102, and a spring-loaded system including a plurality of spring elements (e.g., spring elements 746a, 746b) configured to engage a proximal portion of the guide 7102. Additionally, in many embodiments, the guide 7102 may be hollow and have a generally cylindrical shape. In many embodiments, the guide 7102 may also include multiple ramp surfaces 703a, 703c (eg, two) and a groove or detent section 703b disposed between the ramp surfaces.

[0081] In accordance with other aspects of some embodiments, the device carrier features 7710 may have a concave or partially concave geometric shape that is complementary to the shape of the sensor control unit 102. For example, in some embodiments, the device carrier features 7710 may include a hollow, round, flattened cylindrical shape configured to releasably receive the sensor control unit 102.

[0082] 16A , in some embodiments, the guide 7102 includes a sensor support channel 2798, at least a portion of which may be disposed at a distal end of the guide 7102. In some embodiments, the distal end of the guide 7102 may be configured to be disposed on the skin of a subject. According to some embodiments, a first end of the sensor support channel 2798 may terminate at the distal end of the guide 7102. In some embodiments, the proximal end of the guide 7102 may be hollow. In other embodiments, the proximal end of the guide 7102 may be solid.

[0083] According to other aspects of some embodiments, at least a portion of the proximal end of the guide 7102 may be wider than a distal end of the guide 7102. Additionally, in some embodiments, the first ramp 703a may be located at the proximal end of the guide 7102, while the second ramp 703c may be located distally relative to the first ramp 703a and the groove section 703b. According to some embodiments, the width of the groove or detent section 703b of the guide 7102 may be narrower than the width of the first ramp 703a and the second ramp 703c (at least where the sections connect).

[0084] Further referring to FIG. 16A, according to another aspect of some embodiments, the analyte sensor 12900 may be at least partially disposed in the sensor support channel 2798 and supported by the guide 7102. The analyte sensor 12900 may include components similar to those of the embodiment described with respect to FIG. 14C. In many embodiments, the analyte sensor 12900 includes a tip 12909b (as shown in FIG. 16D) that has sufficient sharpness to initiate and complete insertion without the need for a separate sharpened tip. Thus, the analyte sensor 12900 may include a predetermined free length to provide the necessary stiffness to facilitate effective insertion into the subject's skin. According to one aspect of the embodiment, the stiffness of the sensor may be determined by the free length of the sensor (e.g., an analyte sensor with a shorter free length will be stiffer). This may reduce effects from the "skin tenting" phenomenon that occurs when the tip of the sharpened tip contacts the skin and the skin deforms toward the body prior to penetration. A result of "skin tenting" is that if the tip or sensor is not stiff enough, the tip or sharp sensor may not create a large enough insertion point or flexure may place the sensor in an improper location.

[0085] 16A , according to some embodiments, the blunt applicator 7150 includes an alignment shaft 2768 for maintaining longitudinal alignment of the guide 7102, which may move axially within the alignment shaft 2768 while in mutual contact with the spring-loaded system. In some embodiments, the alignment shaft 2768 has a cylindrical geometry. According to one aspect of some embodiments, when the blunt applicator 7150 is in an initial stage, the guide 7102 is partially disposed within the alignment shaft 2768 of the device support 7710. According to another aspect of some embodiments, when the blunt applicator 7150 has completed the insertion and retraction steps, the guide 7102 may be fully disposed within the alignment shaft 2768.

[0086] According to another aspect of some embodiments, multiple spring elements may be disposed within or along the alignment shaft 2768 to facilitate movement or positioning of the guide 7102. In particular, multiple spring elements may be configured to control the position of the guide 7102, accelerate or decelerate the speed of the guide 7102 during insertion and / or retraction, and further limit the free length of the sensor during various stages of operation. In this regard, the stiffness of the sensor may be maintained to maintain effective insertion. In some embodiments, multiple low friction rollers, ball and plunger sets, or their equivalents may be used to provide the spring elements for a spring loaded system. As shown in FIG. 16A, two pairs of ball plunger sets 746a, 746b may be used, an upper ball plunger set 746a and a lower ball plunger set 746b, each set including a first ball plunger that interacts with the left side of the guide 7102 and a second ball plunger that interacts with the right side of the guide 7102. Specifically, each ball plunger set 746a, 746b may include a spring having one end fixed along the alignment shaft 2768 (or alternatively, other stationary structure of the blunt applicator 7150, such as the housing 7702), and a second end of the spring may include a ball structure configured to engage a portion or side of the guide 7102 as it travels along the alignment shaft 2768. According to other aspects of the embodiment, each spring may be partially or fully compressed and / or extended during various stages of operation of the blunt applicator 7150. According to yet other aspects of the embodiment, each spring element may be configured to be compressed and / or extended at different times. For example, in some embodiments, during one retraction stage, the upper ball plunger set 746a may be positioned further inward toward the center of the alignment shaft 2768 than the lower ball plunger set 746b.In this regard, the retraction mechanism of the blunt applicator assembly may rely, at least in part, on the upward force of the subject's skin during insertion, in combination with the ball plunger's interaction with the ramp surfaces 703a, 703c of the guide 7102, to allow the guide 7102 to be retracted into the receptacle 711 within the housing 7702. One skilled in the art will also appreciate that embodiments of the present disclosure may allow for reuse of the blunt applicator 7150.

[0087] 16B-16H are various cross-sectional views illustrating an exemplary embodiment of a tipless applicator assembly 7150 during various stages of operation.

[0088] FIG. 16B is a cross-sectional view of an exemplary embodiment of a blunt applicator assembly 7150 for inserting an analyte sensor 12900 into a subject. In an initial state, the distal end of the guide 7102 contacts the skin surface of the subject. In this initial state, the lower ball plunger set 746b engages with a groove or detent section 703b of the guide 7102, as shown in FIG. 16B. According to one aspect of the embodiment, the ball portion of each ball plunger set of the lower spring element 746b contacts the detent section 703b, and the corresponding spring of each ball plunger set is in a partially compressed state. As shown in FIG. 16B, a force is applied to the blunt applicator 7150 to move it in a distal direction toward the skin of the subject.

[0089] FIG. 16C illustrates a cross-sectional view of the applicator assembly 7150 as the blunt applicator 7150 continues to move distally (e.g., downward) and generates a distal force against the skin. Meanwhile, according to one aspect of the embodiment, the lower ball plunger set 746b exerts a force on the groove section 703b of the guide 7102 to prevent the guide 7102 from moving until it receives a sufficient force in the proximal direction. As the applicator 7150 continues to move distally, the distal end of the guide 7102 continues to press downward against the subject's skin. As a result, the force of the guide 7102 deforms the skin surface, which in turn exerts a counteracting force on the guide 7102 in the proximal direction, as shown in FIG. 16C. As a result, the lower ball plunger set 746b begins to disengage from the groove section 703b.

[0090] 16D, as the applicator assembly 7150 continues to move distally, the downward force from the applicator 7150 further deforms the skin, which in turn increases the reaction force of the skin imparted proximally to the guide 7102. The upward force imparted by the skin becomes greater than the force imparted by the spring-loaded system to hold the guide 7102 in place. As a result, as the guide 7102 begins to advance proximally inside the alignment shaft, the lower ball plunger set 746b disengages from the groove section 703b of the guide 7102. According to another aspect of some embodiments, the ramp surface of the guide 7102 and the reaction force imparted by the deformed or stretched skin ultimately accelerates the guide 7102 proximally (e.g., upward), which in turn exposes the sharpened tip 12909b of the analyte sensor 12900 disposed within the sensor support channel 2798. The acceleration of the guide 7102 increases the velocity of the skin relative to the sensor 12900 as the skin follows the guide 7102. In this regard, the blunt tip applicator assembly 7150 utilizes the skin deformation or tenting of the skin during insertion as a potential energy source to further prime the guide 7102 and increase the relative velocity between the skin and the sensor. This increased velocity may facilitate the effectiveness of insertion. The sharp tip sensor 12900 begins to be inserted into the skin as it protrudes from the sensor support channel 2798.

[0091] FIG. 16E shows the applicator assembly 7150 as it continues to move distally toward the skin. At the stage shown in FIG. 16E, the guide 7102 continues to accelerate in the proximal direction until the first ramp 703a engages the upper ball plunger set 746a, which impedes the movement of the guide 7102. This ensures that the length of the sensor during insertion is short enough to maintain the desired stiffness for effective insertion and prevent bending of the sensor. At this stage, contact between the guide 7102 and the upper ball plunger set 746a increases the force applied to the skin, thereby causing further skin deformation. As this occurs, the reaction force generated by the skin overcomes the force from the ball plunger sets 746a, 746b, accelerating the guide 7102 in the proximal direction (e.g., away from the skin).

[0092] 16F shows the applicator assembly 7150 as it continues to move downward after sensor insertion. The guide 7102 continues to advance proximally into the housing 7702 due to the reaction force generated by the skin. According to some embodiments, at this stage, sensor insertion may continue as more length of the sensor enters the subject's skin. Additionally, at this stage, the upper ball plunger set 746a is located in the guide groove 703b. At this stage, the guide 7102 remains partially protruding from the distal end and has not been fully retracted into the applicator 7150.

[0093] FIG. 16G illustrates the tipless applicator assembly 7150 at a stage where the sensor is fully inserted. In some embodiments, the movement of the housing is slowed or stopped by the sensor control unit 102 contacting the skin. According to one aspect of the embodiment, at the stage illustrated in FIG. 16G, the analyte sensor 12900 has reached a desired insertion depth in the subject's skin. In some embodiments, the distal end of the guide 7102 can be flush with the lower surface of the sensor control unit 102. As illustrated in FIG. 16G, the guide groove section 703b has now advanced proximally of the upper ball plunger pair 746a. Thus, both ball plunger pairs 746a, 746b contact the second ramp 703c of the guide 7102. This exerts a proximal force on the guide 7102, thereby pushing the guide 7102 further into the housing 7702 and away from the device carrier 7710. With respect to guide ramp shapes and ball plunger forces, one of ordinary skill in the art will recognize that certain embodiments of guide ramps and ball plungers may be optimally sized and configured to enhance axial forces in either the distal or proximal direction to ensure reliable insertion and / or retraction. For example, a greater slope of a certain guide ramp surface may enhance insertion and / or retraction speed. Alternatively, certain guide ramp shapes may enhance initial acceleration.

[0094] Figure 16H is a cross-sectional view showing the tipless applicator assembly 7150 in a retracted state. As shown in Figure 16H, the sensor 12900 is inserted into the subject's skin to a desired insertion depth and the guide 7102 is fully retracted into the applicator 7150 and is not accessible to the user. The tipless applicator assembly 7150 is further advantageous because it does not have a sharp tip and is not considered a biohazard.

[0095] Further, as shown in FIG. 16I, according to some embodiments, the blunt applicator assembly 7150 includes a container 711 coupled to or within the applicator 7150. According to some embodiments, the container 711 can be configured to collect used guides. In some embodiments in which the blunt applicator assembly 7150 is reusable, a user can reload a new guide and sensor control device into the distal end of the applicator. By doing so, a proximal force is applied to the used guide 7102a, pushing it upward into the applicator 7150 until it is collected in the container 711. In some embodiments, the container 711 is designed and configured to collect multiple used guides. Instead, the used guide 7102a can be ejected from an opening in the proximal surface of the applicator 7150 each time the user loads a new guide 7102b.

[0096] FIG. 16J illustrates a guide sensor control unit assembly that may be configured to be loaded into a reusable tipless applicator such as those illustrated in FIGS. 16A-16I. As illustrated in the blow-out view of FIG. 16J-1, a seal 7105 may be disposed at the interface between the guide 7102 and the sensor control unit 102 to prevent contaminants from entering the interior of the sensor control unit 102. According to one aspect of the embodiment, the seal 7105 may include an overmolded elastomeric material. In some embodiments, the seal 7105 may include a single annular ring configured to contact the guide 7102. In other embodiments, the seal 7105 may include a plurality of discrete elastomeric elements configured to contact corresponding locations along the guide 7102. According to other aspects of some embodiments, the seal 7105 may include at least one concave surface 7107 configured to contact the guide 7102. In some embodiments, the sensor control unit 102 may include a housing fabricated from a hard plastic material that is different from the elastomeric material of the seal 7105. In other embodiments, the housing of the sensor control device 102 may be fabricated from the same material as the seal 7105, such that the housing and seal are of one piece construction. Those skilled in the art will appreciate that the guide 7102, or at least some portions thereof, may comprise an elastomeric material or have one or more concave surfaces to provide a barrier against contamination entering the interior of the sensor control device 102.

[0097] 16K illustrates a blunt applicator assembly 8150 similar to the blunt applicator assembly 7150 illustrated in FIGS. 16A-16I, but further includes a guide 8102 having a short sharpened distal end 8999. Specifically, the guide 8102 includes a sharpened distal end 8999 having sufficient sharpness to initiate skin penetration and facilitate insertion of the sensor 12900 to a fully inserted stage or a desired insertion depth. In some embodiments, a first end of the sensor support channel 2898 extends and terminates in the sharpened distal end 8999 of the guide 8102.

[0098] Another exemplary embodiment of a blunt applicator 9150 is shown in the cross-sectional view of FIG. 17A. Referring now to FIG. 17A, various components of the blunt applicator 9150 will be described. In particular, FIG. 17A shows a cross-sectional view of the blunt applicator 9150 in an initial state along with two blow-up views (FIG. 17A-1, FIG. 17A-2), which may include the following components: a housing 9702, a sheath 9704, a guide 902, a retraction spring 946, and a device carrier 9710. FIG. 17A also shows the sensor control device 102 and a sensor 13900 disposed entirely within the blunt applicator 9150. Those skilled in the art will appreciate that the blunt applicator 9150 may include any embodiment of a housing, a sheath, a device carrier, and / or an analyte sensor described herein or in other documents incorporated herein.

[0099] FIG. 17A illustrates the tipless applicator 9150 in an initial state prior to insertion, with the housing 9702 in a proximal position relative to the sheath 9704. According to aspects of the embodiment, the sheath 9704 is slidably coupled to the housing 9702 and partially disposed within the housing 9702. Although FIG. 17A illustrates the sheath 9704 and housing 9702 as having a generally cylindrical geometry, one skilled in the art will appreciate that other geometries may be used. According to other aspects of the embodiment, as best seen in the blow-out view of FIG. 17A-2, the spring 946 may include a distal end of the spring 946 in contact with a proximal end of the guide 902 and a proximal end of the spring 946 in contact with the spring retaining element 9712. In some embodiments, the spring retaining element 9732 may be an arm extending proximally from the device carrier 9710, as described in more detail below. In other embodiments (not shown), the spring retaining element 9732 can include features of the sheath 9704.

[0100] 17A , according to aspects of some embodiments, in an initial configuration, the retraction spring 946 is semi-compressed, i.e., not fully compressed or extended, and is pre-loaded against the guide 902 while the housing 9702 is positioned proximally from the sheath 9704. In other embodiments, the retraction spring 946 can be fully compressed.

[0101] According to another aspect of some embodiments, the sheath 9704 generally encloses or defines a cavity within which the guide 902 and device carrier 9710 are movable from a proximal position to a distal position completely into the applicator. In many embodiments, the device carrier 9710 is configured to releasably hold the sensor control unit 102 having a distal surface for placement on the subject's skin. In some embodiments, a guide positioning ring (not shown) may be provided that receives one end of the guide 902. Additionally, in some embodiments, the device carrier 9710 may include a proximally extending latch 9733 (as shown in the blow-out view of FIG. 17A-2) configured to hold the guide 902 in a retracted position after insertion is complete. At least a portion of the guide 902 extends through and engages the device carrier 9710 and the sensor control unit 102 and is movable therein during insertion (e.g., prior to completing retraction). As described above, in some embodiments, the device carrier 9710 can also include one or more deflectable arms 9732 for holding the retraction spring 946 in a compressed or partially compressed state. In some embodiments, the one or more deflectable arms 9732 can also engage an outer surface or wall of the guide 9732. The one or more movable arms 9732 can be maintained engaged with the guide 9732 when the device carrier 9710 is in the proximal position.

[0102] According to another aspect of the embodiment, the guide 902 may have a hollow and / or generally cylindrical shape and include a sensor support channel or slot 2998, at least a portion of which may be located at a distal portion of the guide 902. In some embodiments, the sensor support channel or slot 2998 may include a distal end that does not extend beyond the distal portion of the guide 902. The proximal portion of the guide 902 may be hollow and include a conical or partial conical surface.

[0103] According to another aspect of some embodiments, the analyte sensor 13900 is at least partially disposed within a sensor support channel or slot 2998 and supported by one or more support walls of the guide 902, as best seen in the blow-out view of FIG. 17A-1. The sensor tail of the analyte sensor 13900 may be disposed in the sensor support channel 2998. The analyte sensor 13900 may include a tip 13909b having sufficient sharpness to initiate and complete insertion without the need for a separate sharpened tip. In some embodiments, the sensor 13900 includes a sensor tail 13909b having a lower end with a V-shaped tip. Additionally, the analyte sensor 13900 includes a sufficient free length to provide the necessary sensor stiffness to facilitate effective insertion into the subject's skin. The stiffness of the sensor is determined by the free length of the sensor. For example, an analyte sensor with a shorter free length will be stiffer. The analyte sensor 13900 may include similar components to the embodiment described with respect to FIG. 14C.

[0104] 17B shows a cross section of the applicator 9150 as a user applies force in a distal direction (as indicated by the downward arrow) to the housing 9702. In some embodiments, a predetermined minimum force must be used to advance the attachment snaps 9726 past the detents 9724. After overriding the detents 9724, for example, the snaps 9726 are displaced radially such that further recession of the housing 9702 relative to the sheath 9704 further advances the guide 902, device carrier 9710, and sensor control unit 102 continuously toward the skin from a proximal position toward a distal position. At this stage, the distal end of the guide 902 protrudes distally beyond the distal surface of the sensor control unit 102.

[0105] 17C, which shows the applicator 9150 as the guide 902 and distal portion of the sensor 13900 contact the subject's skin surface. The sharp tip 13909b of the sensor then pierces the skin and inserts the sensor insertion portion of the sensor 13900 into the subject's skin while the sensor 13900 is supported by the guide 902. In some embodiments, during this phase, the inner surface of the proximal portion 9704a of the sheath 9704 remains engaged with the carrier arm portion 9732, preventing radial displacement of the arm portion 9732 and thus maintaining the retraction spring 946 in a compressed or partially compressed state.

[0106] 17D, which shows the applicator 9150 when the sensor 13900 has reached its insertion depth and the device carrier 9710 and sensor control unit 102 have reached a distal position. In some embodiments, the sensor control unit 102 includes an adhesive pad that engages the subject's skin surface at this stage.

[0107] According to other aspects of the embodiment, the spring retaining element 9732 causes the retraction spring 946 to expand and retract, causing the guide 902 to assume a retracted position. In some embodiments, for example, the spring 946 is a passive element that expands during retraction to return the guide 902 to its initial position, or is instead captured by the latch 9733 (FIG. 17A) at some point in between, allowing the guide 902 to assume a position different from its initial position. According to many embodiments, the sensor 13900 is maintained in the inserted position and the sensor control unit 102 remains attached to the skin.

[0108] 17D, in some embodiments, retraction may be actuated by advancing the carrier arms 9732 distally past the shelf 9704b of the sheath and clearing the support wall. This causes the carrier arms 9732 to flex radially outwardly into the larger diameter distal portion 9704c of the sheath 9704. As the carrier arms 9732 flex outwardly, the shoulders of the carrier arms 9732 are no longer in interference with the guide 902 in a proximally retracted position within the applicator 9150. According to other aspects of some embodiments, the retraction step may also be facilitated by a reaction force generated by the skin (and skin deformation), as previously described with respect to FIGS. 16A-16J.

[0109] According to another aspect of some embodiments, the housing 9702 is maintained in the distal position by a lockout feature. In some embodiments, for example, the sheath snap of the sheath 9704 can be moved up to the lockover feature 9722 of the housing 9702. The housing 9702 and sheath 9704 then no longer slidably move relative to one another, indicating to the user that the insertion portion has been used.

[0110] It should be noted that while a compression spring is shown in FIGS. 17A-17D for the retraction spring 946, one skilled in the art would recognize that other types of springs, including but not limited to torsion springs, disc springs, leaf springs, and the like, may be used in any of the embodiments described herein. Additionally, one skilled in the art would recognize that the insertion efficiency of the applicator embodiments described herein may be varied by varying the insertion speed, the length, material and shape of the sensor, or the reaction force of the guide and its engagement with the sensor during insertion. Additionally, the insertion efficiency may also be varied by pre-penetrating the skin. Similarly, one skilled in the art would recognize that the insertion and retraction speed of the applicator embodiments described herein may also be varied by varying the stiffness or length of the retraction spring, and the insertion force and travel length of the sensor.

[0111] In some embodiments, the applicator is a powered applicator and may include an insertion spring that drives the sensor (and other elements) under the subject's skin. In powered applicator embodiments, the insertion spring is compressed and pre-loaded prior to firing.

[0112] 18A-18C show cross-sectional views of a powered, tipless applicator 18150 at various stages of operation. In many respects, the applicator 18150 operates similarly to the applicator 9150 described with respect to FIGS. 17A-17D. For example, the applicator 18150 may include many of the same components as the applicator 9150, including a housing 18702, a sheath 18704, a retraction spring 18946, a device carrier 18710, and a guide 18902, each of which operates substantially similarly to the corresponding components of the applicator 9150 (FIGS. 17A-17D). According to one aspect of the embodiment, however, the applicator 18150 further includes an insertion spring 18948 configured to facilitate powered (or partially powered) insertion of the sensor.

[0113] 18A , the applicator 18150 is shown in an initial stage where a user begins to apply a force in a distal direction (as indicated by the downward arrow on the applicator 18150) to the housing 18702. According to one aspect of the embodiment, prior to application of the force, the carrier 18710, guide 18902, and sensor control device 102 are in a proximal position completely within the applicator 18150. According to another aspect of the embodiment, both the insertion spring 18948 and the retraction spring 18946 are in a compressed or partially compressed state.

[0114] 18B, an actuated insertion spring 18948 is shown, which advances the device carrier 18710, the sensor control device 102, and the guide 18902 from a proximal position to a distal position (as indicated by the downward arrow on the right side of the applicator 18150). At this stage, the guide 18902 is configured to contact the subject's skin and support the sensor 13900 during insertion. In some embodiments, the insertion spring 18948 is triggered when the housing 18702 advances distally a predetermined distance in response to a force applied in the distal direction. For example, the housing 18702 can be configured to disengage a retaining element (not shown) from the insertion spring 18948, stretching the insertion spring 18948. In some embodiments, the insertion spring 18948 can be actuated, for example, by a separate button that can be depressed only when the housing has advanced distally a predetermined distance. Those skilled in the art will appreciate that other mechanisms for actuating the insertion spring 18948 may be used and are within the scope of the present invention.

[0115] 18C, the sensor 13900 is shown after reaching the insertion depth (FIG. 18C shows the sensor insertion portion of the sensor 13900). At this stage, the sensor control unit 102 has also reached a distal position. In some embodiments, the sensor control unit 102 may include an adhesive patch or a distally facing adhesive surface configured to adhere the sensor control unit 102 to the subject's skin. According to another aspect of the embodiment, the retraction spring 18946 is actuated to retract the guide 18902 proximally to a retracted position. In some embodiments, the retracted position of the guide 18902 is the same as the initial proximal position of the guide 18902 shown in FIG. 18A. In other embodiments, the retracted position of the guide 18902 may differ from the initial proximal position of the guide 18902 shown in FIG. 18A. The applicator 18150 may then be removed from the user's skin, leaving behind the sensor control unit 102 and the sensor 13900.

[0116] In some embodiments, either or both of the sheath 18704 and / or the guide 18902 can be locked into a retracted position. As described with respect to FIGS. 17A-17D, the applicator 18150 can include a lockout mechanism that indicates to a user that the applicator has been used.

[0117] It should be noted that all features, elements, components, functions, and steps described with respect to any embodiment herein are intended to be freely combinable and interchangeable with any other embodiment. If a feature, element, component, function, or step is described with respect to only one embodiment, it should be understood that the feature, element, component, function, or step can be used with all other embodiments described herein, unless expressly stated otherwise. Thus, this paragraph serves to satisfy the preceding supporting statement requirement for introducing a claim, in any case where a combination of features, elements, components, functions, and steps from different embodiments, or a substitution of features, elements, components, functions, and steps from one embodiment with those from another embodiment, even if the following description does not expressly state that such combination or substitution is possible in a particular case. Thus, the foregoing description of specific embodiments of the disclosed subject matter has been provided for the purposes of illustration and description. In particular, it is clearly recognized that it would be an undue burden to describe all possible combinations and substitutions, since all such combinations and substitutions would be readily apparent to one of ordinary skill in the art.

[0118] Although the present embodiment may be in various modifications and alternative forms, specific examples have been shown in the drawings and described in detail herein. It will be apparent to those skilled in the art that various modifications and variations are possible without departing from the spirit and scope of the disclosed subject matter. Accordingly, the disclosed subject matter is intended to cover such modifications and variations within the scope of the appended claims and equivalents. Furthermore, any feature, function, step, or element of the present embodiment may be recited in the claims or in addition, and may also be recited with a negative limitation that defines the scope of the claims by features, functions, steps, or elements that are not within the scope of the invention. [Explanation of symbols]

[0119] 102 Sensor control device 104 Sensors 150 Applicator 504 Sensor Module 7102 Guide 703a First Lamp 703c Second Lamp 946 Spring 2500, 2530, 2590 Advanced Module

Claims

1. In an assembly for use with a sensor applicator, the assembly comprising: The sharpened module including the sharpened tip and hub Including, the sharpened portion includes a sharpened shaft, a sharpened proximal end coupled to the distal end of the hub portion, one or more sidewalls forming a sensor channel, and a sharpened distal tip configured to penetrate below the surface of the subject's skin; The assembly wherein the one or more sidewalls and the sensor channel include a V-shaped cross-sectional area having an apex.

2. The assembly of claim 1 , wherein the one or more sidewalls are disposed along the sharpened shaft and include one or more chamfered edges.

3. The assembly of claim 2 , wherein the one or more chamfered edges are concavely tapered toward the sharp distal tip.

4. The assembly of claim 2 , wherein the one or more chamfered edges comprises two chamfered edges.

5. 10. The assembly of claim 1, wherein the first concave angled tip tapers to a second steeply angled tip.

6. The assembly of claim 1 , wherein the one or more sidewalls are adjacent the sharp distal tip.

7. The assembly of claim 1 , wherein the one or more sidewalls terminate distally from the sensor channel.

8. The assembly of claim 1 , wherein the one or more sidewalls terminate at the apex.

9. The assembly of claim 1 , wherein the one or more sidewalls terminate adjacent a proximal portion of the sharp distal tip.

10. an analyte sensor, the analyte sensor being an in vivo analyte sensor configured to measure an analyte level in a bodily fluid of the subject; The assembly of claim 1 further comprising:

11. The assembly of claim 10 , wherein the analyte sensor includes a sensor tail positioned proximal to the sharp distal tip.

12. the analyte sensor includes a sensor tail; The assembly of claim 10 , wherein the sensor tail and the sharp distal tip are co-localized.

13. The assembly of claim 10 , wherein at least a portion of the analyte sensor is located within the sensor channel of the sharpened shaft.

14. 11. The assembly of claim 10, wherein the analyte sensor includes a sensor tail having a width sized to fit within the sensor channel.

15. The assembly of claim 11 , wherein the sensor tail further comprises an active surface configured to contact a bodily fluid of the subject.

16. The assembly of claim 11 , wherein the sensor tail includes a V-shaped tip.

17. The assembly of claim 12 , wherein the sensor tail includes one or more chamfered edges.

18. The assembly of claim 1 , wherein the vertex is located at a center of the sensor channel.

19. The assembly of claim 1 , wherein the cross-sectional area of ​​the distal tip is less than the V-shaped cross-sectional area of ​​the one or more sidewalls and the sensor channel.

20. The assembly of claim 1 , wherein the cross-sectional area of ​​the distal tip is the smallest cross-sectional area of ​​the sharpened module.

21. The assembly of claim 1 , wherein the apex includes a bottom portion that does not have a sharp edge.

Images